Rolixird 450 mg Film-Coated Tablets

ROLIXIRD 450 MG is indicated for the treatment of cytomegalovirus (CMV) retinitis in acquired immunodeficiency syndrome (AIDS) patients. In the prevention of CMV disease in solid organ transplant patients at risk. Valganciclovir is quickly changed in your body to release Ganciclovir, Ganciclovir prevents the growth and the increase in numbers of a virus called Cytomegalovirus (CMV).

Do not take ROLIXIRD 450 MG:

• If you have ever had an allergic reaction to valganciclovir, or to ganciclovir, or to any of the other ingredients of ROLIXIRD 450 MG.
• If you have ever had an allergic reaction to aciclovir or valaciclovir.

Take special care with ROLIXIRD 450 MG:

• If you have (or have recently had) low numbers of white blood cells, red blood cells or platelets (small cells involved in blood clotting) in your blood. Your doctor will perform blood tests before you start taking ROLIXIRD 450 MG and more tests will be done while you are taking ROLIXIRD 450 MG.
• If you have problems with your kidneys. Your doctor may need to prescribe a reduced dose for you and may need to check your blood frequently during treatment.
• If you are on haemodialysis or receiving radiotherapy. ROLIXIRD 450 MG film-coated tablets are not suitable for people on haemodialysis.
• If you are currently taking ganciclovir capsules and your doctor wants you to switch to ROLIXIRD 450 MG. It is important that you do not take more than the dose prescribed by your doctor or you could risk an overdose.

Safety and efficacy - studies of ROLIXIRD 450 MG use in children are limited.

Taking other medicines with ROLIXIRD 450 MG:

Always tell your healthcare professional if you are taking any other medicine (this includes complementary or traditional medicines). See Do not take ROLIXIRD 450 MG.

Do not share medicines prescribed for you with any other person. Always take ROLIXIRD 450 MG exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Your doctor will tell you how long your treatment with ROLIXIRD 450 MG will last. ROLIXIRD 450 MG should be taken with food. If you are unable to eat for any reason, you should still take the dose when it is due. ROLIXIRD 450 MG tablets should be handled with care and should not be broken or crushed. You should swallow them whole and with food whenever possible. If you do accidentally get the Valganciclovir hydrochloride on your skin, eyes or touch damaged tablets, wash the area thoroughly with soap and water. Your doctor will prescribe an appropriate dose according to your condition. It is VERY IMPORTANT that you follow these special dose instructions from your doctor. Your doctor will tell you how long your treatment with ROLIXIRD 450 MG will last. Do not stop treatment early. If you have the impression that the effect of ROLIXIRD 450 MG is too strong or weak, tell your doctor or pharmacist.

Effects when treatment with ROLIXIRD 450 MG 450mg is stopped: You must not stop taking ROLIXIRD 450 MG unless your doctor tells you to. If you have any further questions on the use of ROLIXIRD 450 MG, ask your doctor or pharmacist.

ROLIXIRD 450 MG can have side effects. Not all side effects reported for ROLIXIRD 450 MG are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ROLIXIRD 450 MG, please consult your doctor, pharmacist or other healthcare professional for advice. If any of the following happens, stop taking ROLIXIRD 450 MG and tell your doctor immediately or go to the casualty department at your nearest hospital: In adults are neutropenia, anaemia and diarrhoea. These are all very serious side effects. If you have them, you may have had a serious reaction to ROLIXIRD 450 MG. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Allergic reactions Infrequently, people may have a sudden and severe allergic reaction (anaphylactic shock) to ROLIXIRD 450 MG stop taking and go to the nearest hospital emergency room if you experience any of the following:
• Hives (a raised itchy skin),
• Sudden swelling of the throat, face, lips and mouth which may cause difficulty swallowing or breathing,
• Sudden swelling of the hands, feet or ankles.

These are all very frequent serious side effects. You may need urgent medical attention.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Store at or below 25 °C.

• Keep in original packaging until required for use.
• Do not store in a bathroom.
• Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewage systems (e.g. toilets).