Valcyte 450 mg Tablet 60pcs

Valganciclovir 450 mg film-coated tablets

What Valganciclovir is used for

• Valganciclovir belongs to a group of medicines, which work directly to prevent the growth of viruses.
• In the body valganciclovir is changed into ganciclovir.
• Ganciclovir prevents a virus called cytomegalovirus (CMV) from multiplying and invading healthy cells.
• In patients with a weakened immune system, CMV can cause an infection in the body’s organs.
• This can be life threatening.

Valganciclovir is used:

• for the treatment of CMV-infections of the retina of the eye in adult patients with acquired immunodeficiency syndrome (AIDS). CMV-infection of the retina of the eye can cause vision problems and even blindness.
• to prevent CMV-infections in adults and children who are not infected with CMV and who have received an organ transplant from somebody who was infected by CMV.

Do not take Valganciclovir:

• if you are allergic to valganciclovir, ganciclovir or any of the other ingredients of this medicine.
• if you are breast-feeding.

Warnings and precautions

Tell your doctor about all of your health conditions, including:

• if you have low numbers of white blood cells, red blood cells or platelets (small cells involved in blood clotting) in your blood. Your doctor will carry out blood tests before you start taking Valganciclovir tablets and more tests will be done while you are taking the tablets.
• if you are having radiotherapy or haemodialysis
• if you have a problem 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 currently taking ganciclovir capsules and your doctor wants you to switch to Valganciclovir tablets. It is important that you do not take more than the number of tablets prescribed by your doctor or you could risk an overdose.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor straight away if you notice any of the following serious side effects:

• low blood cell counts
• blood infection
• pancreatitis
• convulsions
• hallucinations
• kidney or liver problems

Other side effects include:

• thrush
• infections
• loss of appetite
• headache
• diarrhea
• nausea and vomiting
• abdominal pain
• fever
• mild allergic reaction
• feeling depressed, anxious or confused
• trouble sleeping
• hands or feet feeling weak or numb
• eye inflammation
• low blood pressure
• night sweats
• hair loss
• back pain, muscle or joint pain, muscle spasms
• deafness
• uneven heartbeat
• blood in urine
• infertility in men

Other medicines and Valganciclovir:

• Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
• If you take other medicines at the same time as taking Valganciclovir the combination could affect the amount of drug that gets into your blood stream or could cause harmful effects.

Tell your doctor if you are already taking medicines that contain any of the following:

• some kinds of drugs used to treat AIDS
• medicines used to treat Hepatitis B
• probenecid (a medicine against gout). Taking probenecid and Valganciclovir at the same time could increase the amount of ganciclovir in your blood
• drugs used after transplantations
• drugs to treat cancer
• antibiotics
• pentamidine (drug to treat parasite or lung infections)
• anti-fungal agents

How to take Valganciclovir

• Adults:

Prevention of CMV disease in transplant patients

You should start to take this medicine within 10 days of your transplant. The usual dose is two tablets taken ONCE daily. You should continue with this dose for up to 100 days following your transplant. If you have received a kidney transplant; your doctor may advise you to take the tablets for 200 days.

Treatment of active CMV retinitis in AIDS patients (called induction treatment)

• The usual dose Valganciclovir is two tablets taken TWICE a day for 21 days (three weeks).
• Do not take this dose for more than 21 days unless your doctor tells you to, as this may increase your risk of possible side effects.

Longer term treatment to prevent recurrence of active inflammation in AIDS patients with CMV retinitis (called maintenance treatment)

• The usual dose is two tablets taken ONCE daily.
• You should try to take the tablets at the same time each day.
• Your doctor will advise you how long you should continue to take Valganciclovir.
• If your retinitis worsens while you are on this dose, your doctor may tell you to repeat the induction treatment (as above) or may decide to give you a different medicine to treat the CMV infection.

Use in children and adolescents:

Prevention of CMV disease in transplant patients

• Children should start to take this medicine within 10 days of their transplant.
• The dose given will vary depending on the size of the child and should be taken ONCE daily.
• Your doctor will decide the most appropriate dose based on your child’s height, weight and renal function.
• You should continue with this dose for up to 100 days.
• If your child has received a kidney transplant, your doctor may advise you to take the dose for 200 days.
• For children who are unable to swallow Valganciclovir film-coated tables, Valganciclovir powder for oral solution can be used.

How to store Valganciclovir

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date, which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.