VORISPORE 50MG FILM COATED TABLETS

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.

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).

PI / PIL