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APIMEX IV 500MG

DESCRIPTION

APIMEX is indicated for the treatment of patients with malignant pleural mesothelioma in combination with cisplatin. APIMEX is indicated as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after prior chemotherapy.

PACK SIZE

50ml

DOSAGE

You will not be expected to give APIMEX to yourself. It will be given to you by a person who is qualified to do so. APIMEX will be administered to you in a specialised unit in hospital. Your doctor will work out what dose you should receive. He/she will consider your diagnosis, your weight and height and kidney function. Your doctor will decide how long your treatment with APIMEX solution for infusion will last. After appropriate preparation and further dilution with a sterile saline or dextrose solution, APIMEX will be infused (dripped) into a large vein. The infusion will last approximately 10 minutes. You should usually receive your infusion every 21 days (3 weeks).

SPECIAL WARNINGS AND CONTRAINDICATIONS

Warnings and precautions Tell your doctor or healthcare provider before being given the injection: • if you currently have, or have previously had, problems with your kidneys, as you may not be able to receive APIMEX; • if you have heart disease or a history of heart disease; • if you have recently been vaccinated, as this can cause adverse effects with APIMEX (see “Other medicines and APIMEX ”); • if you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid before giving you APIMEX; • if you have had or are going to have radiation therapy, please tell your doctor, as there may be an early or late radiation reaction with APIMEX; • if you are taking NSAIDs (nonsteroidal anti-inflammatory drugs) (see “Other medicines and APIMEX ”); • While you are treated with APIMEX your doctor will perform regular blood tests to monitor changes in your blood count (see section 4). Your doctor may decide to change the dose or delay treating you depending on your general condition and if your blood cell counts are too low. If you are also receiving cisplatin, your doctor may make sure that you are properly hydrated and receive appropriate treatment before and after receiving cisplatin to prevent vomiting (feeling sick). Children and adolescents APIMEX is not indicated for treatment of children under 18 years.

COMPOSITION

• The active substance is Pemetrexed. APIMEX 500: Each vial contains 500 milligrams of pemetrexed (as pemetrexed dipotassium). APIMEX contains approximately 91,5 mg potassium per 500 mg vial. • The other ingredients are mannitol, hydrochloric acid and sodium hydroxide. Further dilution by a healthcare provider is required prior to administration.

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ARENTA 125MG

DESCRIPTION

The active substance aprepitant belongs to a group of medicines called anti-emetics and antinauseants (effective against nausea and vomiting). The brain has a specific area that controls nausea and vomiting. Aprepitant works by blocking signals to that area, thereby reducing nausea and vomiting. ARENTA is used in combination with other anti-emetic medicines to help prevent nausea and vomiting caused by cancer treatments (chemotherapy). ARENTA should not be used continuously for a long time (chronic use).

DOSAGE

Do not share medicines prescribed for you with any other person. Always take ARENTA exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Always take ARENTA together with other medicines prescribed for you to prevent nausea and vomiting. Check with the doctor, pharmacist or nurse if you are not sure. The usual dose is: Day 1: one 125 mg capsule 1 hour before you start your chemotherapy session; Days 2 and 3: one 80 mg capsule each day If no chemotherapy is given, take ARENTA in the morning. If chemotherapy is given, take ARENTA 1 (one) hour before you start your chemotherapy session. Your doctor will tell you if your treatment for nausea and vomiting will last for 3 or 4 days. If you have the impression that the effect of ARENTA is too strong or too weak, tell your doctor or pharmacist. ARENTA is for oral use. Swallow the capsule whole with some liquid. ARENTA can be taken with or without food.

SPECIAL WARNINGS AND CONTRAINDICATIONS

Warnings and precautions Take special care with ARENTA Before you take ARENTA, tell your doctor if you: • are taking, or plan to take any medicine, even those you may get without a prescription, or herbal products (see “Other medicines and ARENTA”); • take warfarin, as you will be monitored more closely; • take hormonal contraceptives, as efficacy may be reduced during treatment with ARENTA; • have liver problems. ARENTA has not been adequately studied in children; it should therefore not be given to children. Do not take ARENTA: • if you are hypersensitive (allergic) to aprepitant, or any of the other ingredients of ARENTA (listed in section 6); • with medicines containing: - pimozide (a medicine for motor tics), - terfenadine, astemizole (antihistamines) - cisapride (medicine for heartburn). See “Other medicines and ARENTA”. Safety and effectiveness of ARENTA in paediatric patients have not been established.

COMPOSITION

The active substance, aprepitant, is classified under anti-emetic and antivertigo preparations. Aprepitant works by inhibiting emesis induced by cytotoxic chemotherapeutic substances via central nervous system activity. Each capsule contains 125 mg aprepitant and 125 mg sucrose.

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ARENTA 80MG

DESCRIPTION

The active substance aprepitant belongs to a group of medicines called anti-emetics and antinauseants (effective against nausea and vomiting). The brain has a specific area that controls nausea and vomiting. Aprepitant works by blocking signals to that area, thereby reducing nausea and vomiting. ARENTA is used in combination with other anti-emetic medicines to help prevent nausea and vomiting caused by cancer treatments (chemotherapy). ARENTA should not be used continuously for a long time (chronic use).

DOSAGE

Do not share medicines prescribed for you with any other person. Always take ARENTA exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Always take ARENTA together with other medicines prescribed for you to prevent nausea and vomiting. Check with the doctor, pharmacist or nurse if you are not sure. The usual dose is: Day 1: one 125 mg capsule 1 hour before you start your chemotherapy session; Days 2 and 3: one 80 mg capsule each day If no chemotherapy is given, take ARENTA in the morning. If chemotherapy is given, take ARENTA 1 (one) hour before you start your chemotherapy session. Your doctor will tell you if your treatment for nausea and vomiting will last for 3 or 4 days. If you have the impression that the effect of ARENTA is too strong or too weak, tell your doctor or pharmacist. ARENTA is for oral use. Swallow the capsule whole with some liquid. ARENTA can be taken with or without food.

SPECIAL WARNINGS AND CONTRAINDICATIONS

Warnings and precautions Take special care with ARENTA Before you take ARENTA, tell your doctor if you: • are taking, or plan to take any medicine, even those you may get without a prescription, or herbal products (see “Other medicines and ARENTA”); • take warfarin, as you will be monitored more closely; • take hormonal contraceptives, as efficacy may be reduced during treatment with ARENTA; • have liver problems. ARENTA has not been adequately studied in children; it should therefore not be given to children. Do not take ARENTA: • if you are hypersensitive (allergic) to aprepitant, or any of the other ingredients of ARENTA (listed in section 6); • with medicines containing: - pimozide (a medicine for motor tics), - terfenadine, astemizole (antihistamines) - cisapride (medicine for heartburn). See “Other medicines and ARENTA”. Safety and effectiveness of ARENTA in paediatric patients have not been established.

COMPOSITION

The active substance, Aprepitant, is classified under anti-emetic and antivertigo preparations. Each capsule contains 80 mg aprepitant and 80 mg sucrose.

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ARENTA COMBI PACK 80MG & 125MG

DESCRIPTION

The active substance aprepitant belongs to a group of medicines called anti-emetics and antinauseants (effective against nausea and vomiting). The brain has a specific area that controls nausea and vomiting. Aprepitant works by blocking signals to that area, thereby reducing nausea and vomiting. ARENTA is used in combination with other anti-emetic medicines to help prevent nausea and vomiting caused by cancer treatments (chemotherapy). ARENTA should not be used continuously for a long time (chronic use).

PACK SIZE

2 & 1

DOSAGE

Do not share medicines prescribed for you with any other person. Always take ARENTA exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Always take ARENTA together with other medicines prescribed for you to prevent nausea and vomiting. Check with the doctor, pharmacist or nurse if you are not sure. The usual dose is: Day 1: one 125 mg capsule 1 hour before you start your chemotherapy session; Days 2 and 3: one 80 mg capsule each day If no chemotherapy is given, take ARENTA in the morning. If chemotherapy is given, take ARENTA 1 (one) hour before you start your chemotherapy session. Your doctor will tell you if your treatment for nausea and vomiting will last for 3 or 4 days. If you have the impression that the effect of ARENTA is too strong or too weak, tell your doctor or pharmacist. ARENTA is for oral use. Swallow the capsule whole with some liquid. ARENTA can be taken with or without food.

SPECIAL WARNINGS AND CONTRAINDICATIONS

Warnings and precautions Take special care with ARENTA Before you take ARENTA, tell your doctor if you: • are taking, or plan to take any medicine, even those you may get without a prescription, or herbal products (see “Other medicines and ARENTA”); • take warfarin, as you will be monitored more closely; • take hormonal contraceptives, as efficacy may be reduced during treatment with ARENTA; • have liver problems. ARENTA has not been adequately studied in children; it should therefore not be given to children. Do not take ARENTA: • if you are hypersensitive (allergic) to aprepitant, or any of the other ingredients of ARENTA (listed in section 6); • with medicines containing: - pimozide (a medicine for motor tics), - terfenadine, astemizole (antihistamines) - cisapride (medicine for heartburn). See “Other medicines and ARENTA”. Safety and effectiveness of ARENTA in paediatric patients have not been established.

COMPOSITION

The active substance, aprepitant, is classified under anti-emetic and antivertigo preparations. 1 x capsule containing 125 mg aprepitant and 125 mg sucrose. 2 x capsules containing 80 mg aprepitant and 80 mg sucrose.

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ARROW TERBINAFINE 250MG

DESCRIPTION

Terbinafine is an allylamine, which has a broad spectrum of antifungal activity. At low concentrations terbinafine is fungicidal against dermatophytes, moulds and certain fungi. The activity is fungicidal or fungistatic depending on the species. Terbinafine interferes specifically with fungal sterol biosynthesis at an early step. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine acts by the inhibition of squalene epoxidase in the fungal cell membrane. The enzyme squalene epoxidase is not linked to the cytochrome P450 system. When given orally, the medicine concentrates in skin at levels associated with fungicidal activity.

PACK SIZE

14s

DOSAGE

The duration of treatment varies according to the indication and the severity of the infection. Your doctor will decide what dose of ARROW TERBINAFINE HCI 250 Tablets you should take and will inform you for how long to take the medicine. Adults and children over 12 years: • The usual dose is one tablet a day. • The treatment usually lasts for between 6 weeks and 3 months your doctor will tell you for how long to take the medicine. Take your tablet with half a glass of water. If you have skipped a dose take another as soon as you remember or wait until it is time for your next dose.

SPECIAL WARNINGS AND CONTRAINDICATIONS

Rarely, cases of cholestasis and hepatitis have been reported, these usually occur within two months of starting treatment. If a patient presents with signs or symptoms suggestive of liver dysfunction such as pruritis, unexplained persistent nausea, anorexia or tiredness, or jaundice, vomiting, fatigue, abdominal pain or dark urine, or pale stools, hepatic origin should be verified and ARROW TERBINAFINE HCI 250 should be discontinued. Single dose pharmacokinetic studies in patients with pre existing liver disease have shown that the clearance of ARROW TERBINAFINE HCI 250 may be reduced by about 50 %. The therapeutic use of ARROW TERBINAFINE NCI 250 in patients with chronic or active live disease has not been studied in prospective clinical trials, and therefore cannot be recommended. ARROW TERBINAFINE HCI 250 should be used with caution in patients with psoriasis, as very rare cases of exacerbation of psoriasis have been reported.

COMPOSITION

ARROW TERBINAFINE HCI 250 Tablets contain 281,25 mg Terbinafine HCI equivalent to 250 mg Terbinafine per tablet. ARROW TERBINAFINE HCI 250 Tablets also contain the following inactive ingredients: Microcrystalline cellulose, Collodal Silica Anhydrous, Hydroxypropyl methyl cellulose. Sodium starch glycollate, and Magnesium stearate.

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ASTRAPAIN FORTE TABLETS

DESCRIPTION

Pain and pain associated with tension. Short term use in mild to moderate pain associated with anxiety or tension.

PACK SIZE

100

DOSAGE

Always take ASTRAPAIN FORTE TABLETS exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual dose is: Not recommended for children under the age of 12 years. Adults: Two tablets every 6 to 8 hours as needed. Not to be used for longer than 10 days. If you have the impression that the effect of ASTRAPAIN FORTE TABLETS is too strong or too weak, talk to your doctor or pharmacist.

SPECIAL WARNINGS AND CONTRAINDICATIONS

Do not take ASTRAPAIN FORTE TABLETS: • if you are hypersensitive (allergic) to paracetamol, codeine phosphate, caffeine, meprobamate or any of the other ingredients of ASTRAPAIN FORTE TABLETS as listed above. i) Contra-indications ASTRAPAIN FORTE TABLETS should not be used by patients with: • acute intermittent porphyria (inherited disorder of blood pigment metabolism). • by patients with kidney or liver insufficiency. • Safety of ASTRAPAIN FORTE TABLETS during pregnancy has not been established. • Asthma, respiratory depression especially in the presence of cyanosis and excessive bronchial (relating to air passages in lungs) secretion. • head injuries and conditions in which intracranial pressure (pressure inside the skull) is raised. • heart failure secondary to chronic lung disease, a history of heart disease, recurrent ts and all convulsive states. • Patients taking monoamine oxidase inhibitors or within 14 days of stopping such treatment. • Porphyria (inherited disorder of blood pigment metabolism). ii) Warnings Take special care with ASTRAPAIN FORTE TABLETS: Paracetamol administration in excess of the recommended dosage may cause severe liver damage. CONTRA-INDICATIONS: Hypersensitivity to any of the ingredients. It should not be administered to patients with acute intermittent porphyria. Patients with renal or hepatic insufficiency. Use of ASTRAPAIN FORTE TABLETS during pregnancy should be avoided. Asthma, respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion, head injuries and conditions in which intracranial pressure is raised, heart failure secondary to chronic lung disease, a history of cardiac disease, epilepsy, and all convulsive states, patients taking monoamine oxidise inhibitors or within 14 days of stopping such treatment. Porphyria.

COMPOSITION

WHAT ASTRAPAIN FORTE TABLETS CONTAINS • The active substances are (per tablet): Paracetamol ……………………………………320 mg Codeine Phosphate……………………………….8 mg Caffeine anhydrous………………………………32 mg Meprobamate……………………………………150 mg • The other ingredients are: Apple Green (CI 19140, CI 44090) Colloidal Silicone Dioxide (Aerosil 200), Magnesium Stearate, Nipastat (as preservative) - 0,025 % (m/m), Povidone K90, Powdered Acacia, Puri ed Talc, Starch Maize. Contains Tartrazine Contains no sugar.

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ASTRAPAIN SYRUP

DESCRIPTION

ASTRAPAIN SYRUP is used for the relief of mild to moderate pain, associated with fever.

PACK SIZE

100ml

DOSAGE

Always take ASTRAPAIN SYRUP exactly as instructed. You should check with your doctor or pharmacist if you are unsure. The usual dose is: DO NOT EXCEED THE RECOMMENDED DOSAGE. Not recommended for children under 2 years of age. Children 2 to 5 years: 5 ml three times a day. Children 6 years and older: 5 to 10 ml three times a day. Shake the bottle before use. If you have the impression that the effect of ASTRAPAIN SYRUP is too strong or too weak, talk to your doctor or pharmacist.

SPECIAL WARNINGS AND CONTRAINDICATIONS

Do not take ASTRAPAIN SYRUP: • If you are hypersensitive (allergic) to paracetamol, opiates or phenothiazines • If you suffer from kidney or liver problems • If you have an attack of bronchial asthma, respiratory depression, especially in the presence of cyanosis (bluish discolouration of skin due to lack of oxygen) and excessive bronchial (relating to air passages in the lungs) secretion. • If you have heart failure secondary to chronic lung disease, head injuries where the intracranial pressure (pressure inside the skull) is raised. • Do not give to children under the age of 2 years or to comatose-patients. Take special care with ASTRAPAIN SYRUP: In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must be contacted immediately. • If you take more than the recommended dose as it can cause severe liver damage. • If no symptomatic improvement results, a doctor should be consulted. • Do not use continuously for more than 10 days without consulting your doctor. • Do not drive or operate any tools or machines because this medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents. • Should be used with extreme caution in patients receiving monoaminoxidase inhibitors. • Pigments should be examined periodically for abnormal skin pigmentation or eye changes. • Patients suffering from renal or liver diseases should take paracetamol under medical supervision. • Do not exceed the prescribed dose because exceeding the prescribed dose, together with prolonged and continuous use of this medication, may lead to dependency and addiction.

COMPOSITION

COMPOSITION: Each 5 ml of syrup contains: Paracetamol ……………………………………120 mg Codeine Phosphate……………………………….5 mg Promethazine hydrochloride………………...…6.5 mg Preservatives: Methylparaben……………0,10 % m/v Propylparaben ...................… ..........…0,01 % m/v Alcohol content……....................... ......………12,5 % Sugar content……..........................………40 % (m/v)

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AZRASITE 200mg/5ml 15ml

DESCRIPTION

Azrasite 200 mg / 5 ml powder for oral suspension is a dry blend of azithromycin dihydrate and other excipients which yields on reconstitution with water, a suspension containing the equivalent of 200 mg azithromycin per 5 ml.

PACK SIZE

15ml

DOSAGE

Use in children: 1 year and older The total dose in children is 30 mg/kg which should be given as a single daily dose of 10 mg/kg for 3 days according to the following guidance: < 15 kg: 10 mg/kg once daily on days 1 - 3. 15 – 25 kg: 200 mg (5 ml) once daily on days 1 - 3. 26 – 35 kg: 300 mg (7,5 ml) once daily on days 1 - 3. 36 – 45 kg: 400 mg (10 ml) once daily on days 1 - 3. > 45 kg: Dose as per adults (Refer to Azithromycin 500 mg Tablets Professional information). Method of administration: Oral administration only

SPECIAL WARNINGS AND CONTRAINDICATIONS

Azrasite 200 mg/5 ml is contraindicated in patients with a known hypersensitivity to azithromycin, erythromycin, any of the macrolide antibiotics. Because of the theoretical possibility of ergotism, Azrasite 200 mg/5 ml and ergot derivatives should not be co- administered. Use in hepatic impairment: As the liver is the principal route of excretion of Azrasite 200 mg/5 ml, it should not be prescribed in patients with hepatic disease. Use in children under 1 year of age: The safety and efficacy of Azrasite 200 mg/5 ml have not been established.

COMPOSITION

Azrasite 200 mg/5 ml powder for oral suspension containing the equivalent of 200 mg azithromycin per 5 ml. Excipients: Sugar (sucrose): 3,9 g/5 ml

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AZRASITE 200mg/5ml 30ml

DESCRIPTION

Azrasite 200 mg / 5 ml powder for oral suspension is a dry blend of azithromycin dihydrate and other excipients which yields on reconstitution with water, a suspension containing the equivalent of 200 mg azithromycin per 5 ml.

PACK SIZE

30ml

DOSAGE

Use in children: 1 year and older The total dose in children is 30 mg/kg which should be given as a single daily dose of 10 mg/kg for 3 days according to the following guidance: < 15 kg: 10 mg/kg once daily on days 1 - 3. 15 – 25 kg: 200 mg (5 ml) once daily on days 1 - 3. 26 – 35 kg: 300 mg (7,5 ml) once daily on days 1 - 3. 36 – 45 kg: 400 mg (10 ml) once daily on days 1 - 3. > 45 kg: Dose as per adults (Refer to Azithromycin 500 mg Tablets Professional information). Method of administration: Oral administration only

SPECIAL WARNINGS AND CONTRAINDICATIONS

Azrasite 200 mg/5 ml is contraindicated in patients with a known hypersensitivity to azithromycin, erythromycin, any of the macrolide antibiotics. Because of the theoretical possibility of ergotism, Azrasite 200 mg/5 ml and ergot derivatives should not be co- administered. Use in hepatic impairment: As the liver is the principal route of excretion of Azrasite 200 mg/5 ml, it should not be prescribed in patients with hepatic disease. Use in children under 1 year of age: The safety and efficacy of Azrasite 200 mg/5 ml have not been established.

COMPOSITION

Azrasite 200 mg/5 ml powder for oral suspension containing the equivalent of 200 mg azithromycin per 5 ml. Excipients: Sugar (sucrose): 3,9 g/5 ml

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CILNEM 500MG VIAL

DESCRIPTION

CILNEM is an antibiotic medicine of the carbapenem group of antibiotics. It kills a wide range of bacteria (germs) that cause infections in various parts of the body.

PACK SIZE

20ml

DOSAGE

You will not be expected to give yourself CILNEM. It will be given to you by a person who is qualified to do so. Your doctor will decide how much CILNEM you need. This will depend upon your condition and the severity of your infection. Adults and adolescents The usual daily dose is 1 - 2 g administered in 3 - 4 divided doses. If you have kidney problems or if you weigh less than 70 kg, your doctor may lower your dose. Children The usual dose for children and infants (3 months or older) is 15 mg/kg every 6 hours. CILNEM is not recommended in children under 3 months of age and children with kidney problems.

SPECIAL WARNINGS AND CONTRAINDICATIONS

Tell your doctor or healthcare provider before CILNEM is given to you, if you have: • allergies to any medicines including antibiotics (sudden life-threatening allergic reactions require immediate medical treatment) • colitis (inflammation of the bowels) or any other gastrointestinal disease • any central nervous system disorders such as localised tremors or epileptic seizures • kidney or urinary problems, including reduced kidney function (CILNEM blood levels increase in patients with reduced kidney function. Central nervous system adverse reactions may occur if the dose is not adjusted to the kidney function) • liver problems. You may develop a positive test (Coombs test) which indicates the presence of antibodies that may destroy red blood cells. Your doctor will explain this to you. Tell your doctor if you are taking medicines called valproic acid or divalproex sodium (see “Other medicines and CILNEM”). Use in children CILNEM is not recommended in children less than 3 months of age or children with kidney problems.

COMPOSITION

Each vial contains 500 mg imipenem (as imipenem monohydrate) and 500 mg cilastatin (as cilastatin sodium salt). The other ingredient is sodium bicarbonate. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 20 ml vial contains 500 mg imipenem (as imipenem monohydrate) and 500 mg cilastatin (as cilastatin sodium salt). Excipient with known effect: Each vial contains sodium bicarbonate equivalent to approximately 1,6 millimole sodium (approximately 37,6 mg) per vial. Sugar free. Final concentration of the reconstituted solution is 5 mg/ml. Sterile powder for solution for infusion. White to almost white or light (pale) yellow powder.

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INFLAMAX PEADIATRIC SUSPENSION 100ml

DESCRIPTION

Inflamax Paediatric Suspension is indicated for the management of mild to moderate pain and inflammation. Inflamax Paediatric Suspension is also used to reduce fever. Inflamax Paediatric Suspension is used in the management of mild to moderate pain and inflammation in dysmenorrhoea, migraine. post-operative pain, dental pain, musculoskeletal and joint disorders such as ankylosing spondylitis, osteoarthritis and rheumatoid arthritis including juvenile rheumatoid arthritis, peri-articular disorders such as bursitis, tensosynovitis, and soft tissue disorders such as pains and sprains.

PACK SIZE

100ml

DOSAGE

Juvenile Rheumatoid Arthritis – 20 mg/kg of body mass daily in divided doses with up to 40 mg/kg being given daily if necessary. Inflamax Paediatric Suspension is not recommended for children under 1 year of age or in those weighing less than 7 kg. Pain: 5 mg/kg of body mass. A second dose of 5 mg/kg may be given after 2 hours if pain is not controlled. Thereafter 5 mg/kg every 4-6 hours. If pain persists for more than 7 days. Consult your doctor. Fever: 5 mg/kg of body mass every 4—6 hours. If fever persists more than three days consult your doctor. Age Daily Dosage Body Mass 1-2 years 2.5ml3-4timesdaily 7-12kg 3 – 7 years 2.5-5 ml 3 – 4 times daily 14 – 23 kg 8-12 years 10ml 3-4 times daily 25-40kg

SPECIAL WARNINGS AND CONTRAINDICATIONS

lnfiamax Paediatric Suspension should not be given to patients with peptic ulceration and should be used with caution in patients with a history of such disorders. lnflamax Paediatric Suspension should not be administered during the third trimester of pregnancy. Hypersensitivity to lbuprofen. There is considerable cross reactivity between aspirin and other non-steroidal anti-inflammatory medicines and it is generally recommended that patients who have had a hypersensitivity reaction to one particular non-steroidal anti-inflammatory medicine should avoid all non-steroidal anti-inflammatory medicines,

COMPOSITION

Each 5 ml of suspension contains 100 mg of ibuprofen.

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NEXIFLUX 20mg TABLETS 30s

DESCRIPTION

NEXIFLUX tablets are indicated for: Gestro-oesophageal reflux disease (GORD): – treatment of erosive oesophagitis - long -term management of patients with heated oesophagitis to prevent relapse; and – symptomatic treatment of gastro-oesophageal reflux disease Patients requiring continued NSAID therapy: – prevention of game and duodenal ulcers associated with NSAID (nonsteroidal anti-inflammatory drugs) therapy, in patients at risk. In combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori: – healing of Helicobacter pylori associated duodenal ulcer and – prevention of relapse of peptic ulcers’ In patients with Helicobacter pylori associated ulcer disease. NEXIFLUX may be used for pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion.

PACK SIZE

30s

DOSAGE

Children below 12 years: Not recommended for children younger than 12 years of age Adults: Your doctor will tell you which dose is suitable for you and for how long you should continue.

SPECIAL WARNINGS AND CONTRAINDICATIONS

Do not take NEXIFLUX if you: are hypersensitive (allergic) to esomeprazole or other medicines called benzimidalozes, or any of the other ingredients of Nexuflux, are taking medicinsed calles atazanavir or nelfinavir, medicines used to treat human immunodeficiency virus. In the presence of other medical problems may effect the use of Nexiflux - please refer to patient leaflet for more information.

COMPOSITION

Each NEXIFLUX 20 gastro-resistant tablet contains 20mg esomeprazole (as esomeprazole magnesium dihydrate). Contains sugar.

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NEXIFLUX 40mg TABLETS 30s

DESCRIPTION

NEXIFLUX tablets are indicated for: Gestro-oesophageal reflux disease (GORD): – treatment of erosive oesophagitis -long -term management of patients with heated oesophagitis to prevent relapse; and – symptomatic treatment of gastro-oesophageal reflux disease Patients requiring continued NSAID therapy: – prevention of game and duodenal ulcers associated with NSAID (nonsteroidal anti-inflammatory drugs) therapy, in patients at risk. In combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori: – healing of Helicobacter pylori associated duodenal ulcer and – prevention of relapse of peptic ulcers’ In patients with Helicobacter pylori associated ulcer disease. NEXIFLUX may be used for pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion.

PACK SIZE

30s

DOSAGE

Children below 12 years: Not recommended for children younger than 12 years of age Adults: Your doctor will tell you which dose is suitable for you and for how long you should continue.

SPECIAL WARNINGS AND CONTRAINDICATIONS

Do not take NEXIFLUX if you: are hypersensitive (allergic) to esomeprazole or other medicines called benzimidalozes, or any of the other ingredients of Nexuflux, are taking medicinsed calles atazanavir or nelfinavir, medicines used to treat human immunodeficiency virus. In the presence of other medical problems may effect the use of Nexiflux - please refer to patient leaflet for more information.

COMPOSITION

Each NEXIFLUX 40 gastro-resistant tablet contains 40mg esomeprazole (as esomeprazole magnesium dihydrate). Contains sugar.

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PYLIXA 125MG

DESCRIPTION

PYLIXA is used to treat peripheral neuropathic pain (long-lasting pain caused by damage to the nerves), due to diabetes or shingles in adults.

PACK SIZE

60s

DOSAGE

Always take PYLIXA exactly as your doctor has told you. Check with your doctor if you are not sure. Your doctor will determine what dose is appropriate for you. The usual dose is: 75 mg twice daily, (150 mg/day), with or without food. Based on individual patient response and tolerability, the dose may be increased to 150 mg twice daily after an interval of 3 to 7 days. • PYLIXA is a long-term treatment and you may need to take it for some time. Your doctor will tell you how long your treatment with PYLIXA will last. • PYLIXA is for oral use only. PYLIXA is taken orally with or without food. Swallow the capsule whole with water. • If you have the impression that the effect of PYLIXA is too strong or too weak, tell your doctor or pharmacist. Children and adolescents: The safety and efficacy in children and adolescents (under 18 years of age) has not been established and therefore PYLIXA should not be given to patients in this age group.

SPECIAL WARNINGS AND CONTRAINDICATIONS

Take special care with PYLIXA: • If you have diabetes and gain weight while you are taking PYLIXA, your doctor may need to make a change in your diabetic medicines. • If you experience an allergic reaction while you are taking PYLIXA, you must contact your doctor immediately. The symptoms of an allergic reaction include swelling of the face, lips, tongue, and throat, as well as a skin rash. • If you take PYLIXA you may experience dizziness, sleepiness, loss of consciousness, confusion, and mental impairment. This could increase the possibility of an accidental injury (fall) if you are an elderly patient. Therefore, you should be careful until you are used to any effect caused by PYLIXA. • If you take PYLIXA you may experience blurring or loss of vision, or other changes in eyesight, many of which are temporary. You should immediately tell your doctor if you experience any changes in your vision. • If you notice a decrease in passing urine while taking PYLIXA, you should tell your doctor. It may improve if you stop taking PYLIXA. • If you are taking PYLIXA, or shortly after stopping it, you may experience convulsions (including epilepsy). If this happens, contact your doctor immediately. You may also experience withdrawal symptoms after short-term or long-term treatment with PYLIXA, which include difficulty in sleeping, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, hyperhidrosis and dizziness. • If you have a history of a heart disease you should tell your doctor. Heart failure has been reported in some patients when they were taking PYLIXA. • If you are taking medicines for spinal cord injury, you may experience an increase in certain side effects such as sleepiness, when you are also taking PYLIXA. • Some people have had thoughts to harm or kill themselves while taking medicines belonging to the same group as PYLIXA for the treatment of different conditions. If you have thoughts of harming or killing yourself, at any time when you are taking PYLIXA, immediately contact your doctor. • When PYLIXA is taken with other medicines that may cause constipation (such as some types of pain medicines) it is possible that gastrointestinal problems may occur (e.g. constipation, blocked or paralysed bowel). Tell your doctor if you experience constipation, especially if you are prone to this problem. • If you have a history of alcoholism or substance abuse or dependence, you should tell your doctor. If you think you need more PYLIXA than prescribed, tell your doctor. • If you have a history of any serious medical conditions you should tell your doctor. There have been reports of reduction in brain function (encephalopathy) in some patients when they were taking PYLIXA.

COMPOSITION

• The active substance is pregabalin. Each hard capsule contains 125 mg of pregabalin. • The other ingredients are: pregelatinised starch, mannitol and talc. The hard capsule shell contains gelatin, titanium dioxide (E171) and black printing ink. The black printing ink contains shellac, black iron oxide (E172), propylene glycol (E1520) and ammonium hydroxide (E527).

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PYLIXA 25MG

DESCRIPTION

PYLIXA is used to treat peripheral neuropathic pain (long-lasting pain caused by damage to the nerves), due to diabetes or shingles in adults.

PACK SIZE

60s

DOSAGE

Always take PYLIXA exactly as your doctor has told you. Check with your doctor if you are not sure. Your doctor will determine what dose is appropriate for you. The usual dose is: 75 mg twice daily, (150 mg/day), with or without food. Based on individual patient response and tolerability, the dose may be increased to 150 mg twice daily after an interval of 3 to 7 days. • PYLIXA is a long-term treatment and you may need to take it for some time. Your doctor will tell you how long your treatment with PYLIXA will last. • PYLIXA is for oral use only. PYLIXA is taken orally with or without food. Swallow the capsule whole with water. • If you have the impression that the effect of PYLIXA is too strong or too weak, tell your doctor or pharmacist. Children and adolescents: The safety and efficacy in children and adolescents (under 18 years of age) has not been established and therefore PYLIXA should not be given to patients in this age group.

SPECIAL WARNINGS AND CONTRAINDICATIONS

Take special care with PYLIXA: • If you have diabetes and gain weight while you are taking PYLIXA, your doctor may need to make a change in your diabetic medicines. • If you experience an allergic reaction while you are taking PYLIXA, you must contact your doctor immediately. The symptoms of an allergic reaction include swelling of the face, lips, tongue, and throat, as well as a skin rash. • If you take PYLIXA you may experience dizziness, sleepiness, loss of consciousness, confusion, and mental impairment. This could increase the possibility of an accidental injury (fall) if you are an elderly patient. Therefore, you should be careful until you are used to any effect caused by PYLIXA. • If you take PYLIXA you may experience blurring or loss of vision, or other changes in eyesight, many of which are temporary. You should immediately tell your doctor if you experience any changes in your vision. • If you notice a decrease in passing urine while taking PYLIXA, you should tell your doctor. It may improve if you stop taking PYLIXA. • If you are taking PYLIXA, or shortly after stopping it, you may experience convulsions (including epilepsy). If this happens, contact your doctor immediately. You may also experience withdrawal symptoms after short-term or long-term treatment with PYLIXA, which include difficulty in sleeping, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, hyperhidrosis and dizziness. • If you have a history of a heart disease you should tell your doctor. Heart failure has been reported in some patients when they were taking PYLIXA. • If you are taking medicines for spinal cord injury, you may experience an increase in certain side effects such as sleepiness, when you are also taking PYLIXA. • Some people have had thoughts to harm or kill themselves while taking medicines belonging to the same group as PYLIXA for the treatment of different conditions. If you have thoughts of harming or killing yourself, at any time when you are taking PYLIXA, immediately contact your doctor. • When PYLIXA is taken with other medicines that may cause constipation (such as some types of pain medicines) it is possible that gastrointestinal problems may occur (e.g. constipation, blocked or paralysed bowel). Tell your doctor if you experience constipation, especially if you are prone to this problem. • If you have a history of alcoholism or substance abuse or dependence, you should tell your doctor. If you think you need more PYLIXA than prescribed, tell your doctor. • If you have a history of any serious medical conditions you should tell your doctor. There have been reports of reduction in brain function (encephalopathy) in some patients when they were taking PYLIXA.

COMPOSITION

• The active substance is pregabalin. Each hard capsule contains either 25 mg of pregabalin. • The other ingredients are: pregelatinised starch, mannitol and talc. The hard capsule shell contains gelatin, titanium dioxide (E171) and black printing ink. The black printing ink contains shellac, black iron oxide (E172), propylene glycol (E1520) and ammonium hydroxide (E527).

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PYLIXA 75MG

DESCRIPTION

PYLIXA is used to treat peripheral neuropathic pain (long-lasting pain caused by damage to the nerves), due to diabetes or shingles in adults.

PACK SIZE

60s

DOSAGE

Always take PYLIXA exactly as your doctor has told you. Check with your doctor if you are not sure. Your doctor will determine what dose is appropriate for you. The usual dose is: 75 mg twice daily, (150 mg/day), with or without food. Based on individual patient response and tolerability, the dose may be increased to 150 mg twice daily after an interval of 3 to 7 days. • PYLIXA is a long-term treatment and you may need to take it for some time. Your doctor will tell you how long your treatment with PYLIXA will last. • PYLIXA is for oral use only. PYLIXA is taken orally with or without food. Swallow the capsule whole with water. • If you have the impression that the effect of PYLIXA is too strong or too weak, tell your doctor or pharmacist. Children and adolescents: The safety and efficacy in children and adolescents (under 18 years of age) has not been established and therefore PYLIXA should not be given to patients in this age group.

SPECIAL WARNINGS AND CONTRAINDICATIONS

Take special care with PYLIXA: • If you have diabetes and gain weight while you are taking PYLIXA, your doctor may need to make a change in your diabetic medicines. • If you experience an allergic reaction while you are taking PYLIXA, you must contact your doctor immediately. The symptoms of an allergic reaction include swelling of the face, lips, tongue, and throat, as well as a skin rash. • If you take PYLIXA you may experience dizziness, sleepiness, loss of consciousness, confusion, and mental impairment. This could increase the possibility of an accidental injury (fall) if you are an elderly patient. Therefore, you should be careful until you are used to any effect caused by PYLIXA. • If you take PYLIXA you may experience blurring or loss of vision, or other changes in eyesight, many of which are temporary. You should immediately tell your doctor if you experience any changes in your vision. • If you notice a decrease in passing urine while taking PYLIXA, you should tell your doctor. It may improve if you stop taking PYLIXA. • If you are taking PYLIXA, or shortly after stopping it, you may experience convulsions (including epilepsy). If this happens, contact your doctor immediately. You may also experience withdrawal symptoms after short-term or long-term treatment with PYLIXA, which include difficulty in sleeping, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, hyperhidrosis and dizziness. • If you have a history of a heart disease you should tell your doctor. Heart failure has been reported in some patients when they were taking PYLIXA. • If you are taking medicines for spinal cord injury, you may experience an increase in certain side effects such as sleepiness, when you are also taking PYLIXA. • Some people have had thoughts to harm or kill themselves while taking medicines belonging to the same group as PYLIXA for the treatment of different conditions. If you have thoughts of harming or killing yourself, at any time when you are taking PYLIXA, immediately contact your doctor. • When PYLIXA is taken with other medicines that may cause constipation (such as some types of pain medicines) it is possible that gastrointestinal problems may occur (e.g. constipation, blocked or paralysed bowel). Tell your doctor if you experience constipation, especially if you are prone to this problem. • If you have a history of alcoholism or substance abuse or dependence, you should tell your doctor. If you think you need more PYLIXA than prescribed, tell your doctor. • If you have a history of any serious medical conditions you should tell your doctor. There have been reports of reduction in brain function (encephalopathy) in some patients when they were taking PYLIXA.

COMPOSITION

• The active substance is pregabalin. Each hard capsule contains 75 mg of pregabalin. • The other ingredients are: pregelatinised starch, mannitol and talc. The hard capsule shell contains gelatin, titanium dioxide (E171) and black printing ink. The black printing ink contains shellac, black iron oxide (E172), propylene glycol (E1520) and ammonium hydroxide (E527). In addition, the 75 mg capsules’ shells also contain red iron oxide (E172).

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VORISPORE 200MG FILM COATED TABLETS

DESCRIPTION

VORISPORE is an antifungal medicine. It works by killing or stopping the growth of the fungi that causes infections.

PACK SIZE

28s

DOSAGE

Always take VORISPORE exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide what dose you should receive for your condition and also for how long you need to receive it. The dose and duration of treatment will depend on how your body and the infection reacts on the treatment. Depending on your response to treatment, your doctor may increase or decrease your dose. Take your tablet at least one hour before, or one hour after a meal. Swallow the tablet whole with some water.

SPECIAL WARNINGS AND CONTRAINDICATIONS

Tell your doctor, pharmacist or healthcare provider before you take VORISPORE, if you: • are allergic to other azole type medicines (these are antifungal medicines, for example, fluconazole or ketoconazole. Ask your doctor or pharmacist if you are unsure); • are suffering from liver disease or have ever suffered from it. If you have liver disease, your doctor may prescribe a lower dose of VORISPORE. Your doctor should also monitor your liver function while you are being treated with VORISPORE by doing blood tests; • you are known to have cardiomyopathy (diseased heart muscle), irregular heartbeat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘long QTc syndrome’ (see section 2 “Do not take VORISPORE ”); • have electrolyte disturbances such as low potassium, calcium or magnesium; • have a kidney disease. Your doctor should monitor your renal function while you are being treated with VORISPORE by doing blood tests. You should also know that: You should avoid any sunlight and sun exposure while being treated. It is important to cover sun exposed areas of skin and use sunscreen with high sun protection factor (SPF), as an increased sensitivity of skin to the sun’s UV rays can occur. These precautions are also applicable to children. While being treated with VORISPORE, tell your doctor immediately if you develop: • sunburn • severe skin rash or blisters • bone pain. If you develop skin disorders as described above, your doctor may refer you to a dermatologist, who after consultation may decide that it is important for you to be seen on a regular basis. There is a small chance that skin cancer could develop with long-term use of VORISPORE. VORISPORE contains lactose monohydrate (a sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

COMPOSITION

• The active substance is voriconazole. Each VORISPORE 200 FC tablet contains 200 mg voriconazole. • The other ingredients are pregelatinised maize starch, lactose monohydrate, povidone K30, croscarmellose sodium, colloidal anhydrous silica and magnesium stearate. The tablet coating, Opadry II White OY-LS-28908, contains titanium dioxide (E171), lactose monohydrate, hypromellose (E464) and macrogol/PEG (E1521).

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VORISPORE 200MG IV

DESCRIPTION

VORISPORE is an antifungal medicine. It works by killing or stopping the growth of the fungi that causes infections.

PACK SIZE

10ml

DOSAGE

How to use VORISPORE VORISPORE should only be used under the supervision of a doctor. You will not be expected to give yourself VORISPORE. It will be given to you by a person who is qualified to do so. Your doctor will decide what dose (depending on your weight) you should receive for your condition and also for how long you need to receive it. The dose and duration of treatment will depend on how your body and the infection reacts on the treatment. Usually you will be given 6 mg VORISPORE per kg body mass, every 12 hours for the first 24 hours and thereafter 4 mg/kg every 12 hours as maintenance dose. If you use efavirenz (for HIV) or phenytoin (anti-seizure medicine), your doctor may adapt your dosage. See “Other medicines and VORISPORE”. Your doctor or other healthcare provider will give you VORISPORE through a slow infusion (a drip for 1 to 2 hours) into one of your large veins. Before it is used, VORISPORE powder for solution for infusion will be reconstituted and diluted to the correct concentration by your hospital pharmacist or nurse. You may be switched from the intravenous infusion to tablets once your condition improves. If you have the impression that the effect of VORISPORE is too strong or too weak, tell your doctor or pharmacist.

SPECIAL WARNINGS AND CONTRAINDICATIONS

Women of childbearing potential If you are a woman of childbearing potential you must always use effective contraception during treatment. See “Pregnancy and breastfeeding”. Tell your doctor or healthcare professional before being given VORISPORE, if you: · are allergic to other azole type medicines (for example, fluconazole or ketoconazole which are antifungal medicines. Ask your doctor or pharmacist if you are unsure); · if there is a possibility that you can get pregnant (if you are of childbearing age). VORISPORE cannot be used to treat patients who are pregnant or breastfeeding. Your doctor will advise you on effective contraception; · are suffering from liver disease or have ever suffered from it. If you have liver disease, your doctor may prescribe a lower dose of VORISPORE. Your doctor should also monitor your liver function while you are being treated with VORISPORE by doing blood tests; · you are known to have cardiomyopathy (diseased heart muscle), irregular heartbeat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘long QTc syndrome’; · have a metabolic disorder such as low potassium, calcium or magnesium; · have a kidney disease. Depending on the degree of kidney disease the doctor may decide to rather give you voriconazole tablets. Your doctor should monitor your renal function while you are being treated with VORISPORE by doing blood tests.

COMPOSITION

· The active substance is voriconazole. Each vial contains 200 mg voriconazole, equivalent to a 10 mg/ml solution when reconstituted by your hospital pharmacist or nurse. · The other ingredients are hydroxypropyl-beta-cyclodextrin (HP-beta-CD), sodium chloride and hydrochloric acid (for pH adjustment). VORISPORE contains sodium Each vial of VORISPORE contains 225,6 mg sodium chloride, which provides 88,74 mg sodium (main component of cooking/table salt). Talk to your doctor or pharmacist if you need 6 or more vials daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.

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VORISPORE 50MG FILM COATED TABLETS

DESCRIPTION

VORISPORE is an antifungal medicine. It works by killing or stopping the growth of the fungi that causes infections.

PACK SIZE

14s

DOSAGE

Always take VORISPORE exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide what dose you should receive for your condition and also for how long you need to receive it. The dose and duration of treatment will depend on how your body and the infection reacts on the treatment. Depending on your response to treatment, your doctor may increase or decrease your dose. Take your tablet at least one hour before, or one hour after a meal. Swallow the tablet whole with some water.

SPECIAL WARNINGS AND CONTRAINDICATIONS

Tell your doctor, pharmacist or healthcare provider before you take VORISPORE, if you: • are allergic to other azole type medicines (these are antifungal medicines, for example, fluconazole or ketoconazole. Ask your doctor or pharmacist if you are unsure); • are suffering from liver disease or have ever suffered from it. If you have liver disease, your doctor may prescribe a lower dose of VORISPORE. Your doctor should also monitor your liver function while you are being treated with VORISPORE by doing blood tests; • you are known to have cardiomyopathy (diseased heart muscle), irregular heartbeat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘long QTc syndrome’ (see section 2 “Do not take VORISPORE ”); • have electrolyte disturbances such as low potassium, calcium or magnesium; • have a kidney disease. Your doctor should monitor your renal function while you are being treated with VORISPORE by doing blood tests. You should also know that: You should avoid any sunlight and sun exposure while being treated. It is important to cover sun exposed areas of skin and use sunscreen with high sun protection factor (SPF), as an increased sensitivity of skin to the sun’s UV rays can occur. These precautions are also applicable to children. While being treated with VORISPORE, tell your doctor immediately if you develop: • sunburn • severe skin rash or blisters • bone pain. If you develop skin disorders as described above, your doctor may refer you to a dermatologist, who after consultation may decide that it is important for you to be seen on a regular basis. There is a small chance that skin cancer could develop with long-term use of VORISPORE.

COMPOSITION

• The active substance is voriconazole. Each VORISPORE 50 FC tablet contains 50 mg voriconazole. • The other ingredients are pregelatinised maize starch, lactose monohydrate, povidone K30, croscarmellose sodium, colloidal anhydrous silica and magnesium stearate. The tablet coating, Opadry II White OY-LS-28908, contains titanium dioxide (E171), lactose monohydrate, hypromellose (E464) and macrogol/PEG (E1521).

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XEVOLCIN 5MG

DESCRIPTION

XEVOLCIN FC is an antihistamine used for the treatment of allergic rhinitis.

PACK SIZE

10s

DOSAGE

Always take use XEVOLCIN FC exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Adults or children aged 6 years and older: The daily recommended dose is one tablet. The tablets should be swallowed whole with water and may be taken with or without food. Method of administration XEVOLCIN FC tablets should be swallowed whole with water and may be taken with or without food. You can take XEVOLCIN FC with meals, or independently of meals. If you have a sensitive stomach, you should best take XEVOLCIN FC after meals.

SPECIAL WARNINGS AND CONTRAINDICATIONS

XEVOLCIN FC is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless, you still need to use XEVOLCIN FC carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Do not share XEVOLCIN FC with any other person. • Ask your healthcare provider or pharmacist if you need more information or advice. • You must see a doctor if your symptoms worsen or do not improve after 5 days. Talk to your doctor or pharmacist before taking XEVOLCIN FC. Take special care with XEVOLCIN FC: If you are likely to be unable to empty your bladder (with conditions such as spinal cord injury or enlarged prostate), please ask your doctor for advice. If you suffer from epilepsy or are at risk of convulsions, please ask your doctor for advice as use of XEVOLCIN FC may cause seizure aggravation. If you are scheduled for allergy testing, ask your doctor if you should stop taking XEVOLCIN FC for several days before testing. This medicine may affect your allergy test results. Caution is advised if XEVOLCIN FC is taken at the same time as alcohol or other medicines acting on the brain. In sensitive patients, the concurrent administration of XEVOLCIN FC and alcohol or other medicines acting on the brain may cause additional reductions in alertness and impairment of performance. XEVOLCIN FC can be taken with or without food.

COMPOSITION

The active substance is levocetirizine dihydrochloride. Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride. The other ingredients are: microcrystalline cellulose (type 102), lactose monohydrate and magnesium stearate; the film-coating consists of hypromellose E464 (type 2910), titanium dioxide (E171) and macrogol (type 400).

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XEVOLCIN 5MG

DESCRIPTION

XEVOLCIN FC is an antihistamine used for the treatment of allergic rhinitis.

PACK SIZE

30s

DOSAGE

Always take use XEVOLCIN FC exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Adults or children aged 6 years and older: The daily recommended dose is one tablet. The tablets should be swallowed whole with water and may be taken with or without food. Method of administration XEVOLCIN FC tablets should be swallowed whole with water and may be taken with or without food. You can take XEVOLCIN FC with meals, or independently of meals. If you have a sensitive stomach, you should best take XEVOLCIN FC after meals.

SPECIAL WARNINGS AND CONTRAINDICATIONS

XEVOLCIN FC is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless, you still need to use XEVOLCIN FC carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Do not share XEVOLCIN FC with any other person. • Ask your healthcare provider or pharmacist if you need more information or advice. • You must see a doctor if your symptoms worsen or do not improve after 5 days. Talk to your doctor or pharmacist before taking XEVOLCIN FC. Take special care with XEVOLCIN FC: If you are likely to be unable to empty your bladder (with conditions such as spinal cord injury or enlarged prostate), please ask your doctor for advice. If you suffer from epilepsy or are at risk of convulsions, please ask your doctor for advice as use of XEVOLCIN FC may cause seizure aggravation. If you are scheduled for allergy testing, ask your doctor if you should stop taking XEVOLCIN FC for several days before testing. This medicine may affect your allergy test results. Caution is advised if XEVOLCIN FC is taken at the same time as alcohol or other medicines acting on the brain. In sensitive patients, the concurrent administration of XEVOLCIN FC and alcohol or other medicines acting on the brain may cause additional reductions in alertness and impairment of performance. XEVOLCIN FC can be taken with or without food.

COMPOSITION

The active substance is levocetirizine dihydrochloride. Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride. The other ingredients are: microcrystalline cellulose (type 102), lactose monohydrate and magnesium stearate; the film-coating consists of hypromellose E464 (type 2910), titanium dioxide (E171) and macrogol (type 400).

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