PYLIXA 125MG

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.

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).

PI / PIL