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Valganciclovir 450 mg film-coated tablets
Valganciclovir 450 mg film-coated tablets
valganciclovir
1. What valganciclovir is and what it is used for
2. What you need to know before you take valganciclovir
3. How to take valganciclovir
4. Possible side effects
5. How to store valganciclovir
6. Contents of the pack and other information
The name of your medicine is Valganciclovir 450 mg film-coated tablets (referred to as valganciclovir throughout this leaflet).
Valganciclovir belongs to a group of medicines, which work directly to prevent the growth of viruses. In the body the active ingredient in the tablets, 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.
Talk to your doctor or pharmacist before taking 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:
Valganciclovir should be taken with food. If you are unable to eat for any reason, you should still take your dose of valganciclovir as usual.
You should not take valganciclovir if you are pregnant unless your doctor recommends it. If you are pregnant or planning to become pregnant you must tell your doctor. Taking valganciclovir when you are pregnant could harm your unborn baby.
You must not take valganciclovir if you are breast-feeding. If your doctor wants you to begin treatment with valganciclovir you must stop breast-feeding before you start to take your tablets.
Women of childbearing age must use effective contraception when taking valganciclovir and for at least 30 days after treatment has finished.
Men whose partners could become pregnant should use condoms while taking valganciclovir and should continue to use condoms for 90 days after treatment has finished.
Do not drive or use any tools or machines if you feel dizzy, tired, shaky or confused while taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
You have to be careful when handling your tablets. Do not break or crush them.
You should swallow them whole and with food whenever possible. If you accidentally touch damaged tablets, wash your hands thoroughly with soap and water. If any powder from the tablets gets in your eyes, rinse your eyes with sterile water or clean water if you do not have sterile water.
You must stick to the number of tablets as instructed by your doctor to avoid overdose.
Valganciclovir should, whenever possible, be taken with food - see section 2.
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 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.
Valganciclovir has not been studied in elderly patients.
If your kidneys are not working properly, your doctor may instruct you to take fewer tablets each day or only to take your tablets on certain days each week.
It is very important that you only take the number of tablets prescribed by your doctor.
Valganciclovir has not been studied in patients with liver problems.
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 tablets, a valganciclovir powder for oral solution can be used.
Contact your doctor or hospital immediately if you have taken, or think that you have taken, more tablets than you should. Taking too many tablets can cause serious side effects, particularly affecting your blood or kidneys. You may need hospital treatment.
If you forget to take your tablets take the missed dose as soon as you remember and take the next dose at the usual time. Do not take a double dose to make up for the forgotten tablets.
You must not stop taking your medicine unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Up to 1 in every 1,000 people may have a sudden and severe allergic reaction to valganciclovir (anaphylactic shock). STOP taking valganciclovir and go to the accident and emergency department at your nearest hospital if you experience any of the following:
Tell your doctor straight away if you notice any of the following serious side effects – your doctor may tell you to stop taking this medicine and you may need urgent medical treatment:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
The side effects that have occurred during treatment with valganciclovir or ganciclovir are given below.
Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Separation of the inner lining of the eye (detached retina) has only happened in AIDS patients treated with valganciclovir for CMV infection.
The side effects reported in children and adolescents are similar to the side effects reported for adults.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report any side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information on the safety of this medicine.
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 bottle and carton after EXP. The expiry date refers to the last day of that month.
This medicinal product 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.
The active substance is 450 mg of valganciclovir, present as 496.3 mg of valganciclovir hydrochloride.
The other ingredients in the tablet are Povidone (K-30), crospovidone (Type A), cellulose microcrystalline (Vivapur Type 101) and stearic acid 50.
The ingredients in the film-coat are hypromellose (3 cP, 6 cP), titanium dioxide (E171), macrogol 400, iron oxide red (E172) and polysorbate 80.
Valganciclovir 450 mg film-coated tablets are oval, biconvex, pink coloured film-coated tablets.
They are packed in HDPE bottles containing 60 film-coated tablets
This leaflet was last revised in November 2020.
‘Zentiva’ is a registered trademark © 2020 Zentiva.
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