1. What this product is and what it is used for

Vercanza 450 mg tablets belong 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.

Vercanza 450 mg tablets are 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.

2. What you need to know before you use this product

Do not take Vercanza 450 mg tablets:

· If you are allergic to valganciclovir, ganciclovir or any of the other ingredients of this medicine (listed in section 6).

· If you are breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Vercanza 450 mg tablets.

· If you are allergic to aciclovir, penciclovir, valaciclovir or famciclovir. These are other medicines used for viral infections.

Take special care with Vercanza 450 mg tablets:

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 Vercanza 450 mg 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 Vercanza 450 mg 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.

Other medicines and Vercanza 450 mg tablets

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 Vercanza 450 mg tablets 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:

Imipenem-cilastatin (an antibiotic). Taking this with Vercanza 450 mg tablets can cause convulsions (fits).

Zidovudine, didanosine, lamivudine, stavudine, tenofovir, abacavir, emtricitabine or similar kinds of drugs used to treat AIDS.

Adefovir or any other medicines used to treat Hepatitis B.

Probenecid (a medicine against gout). Taking probenecid and Vercanza 450 mg tablets at the same time could increase the amount of ganciclovir in your blood.

Mycophenolate mofetil, ciclosporin or tacrolimus (used after transplantations).

Vincristine, vinblastine, doxorubicin, hydroxyurea or similar kinds of drugs to treat cancer.

Trimethoprim, trimethoprim/sulpha combinations and dapsone (antibiotics).

Pentamidine (drug to treat parasite or lung infections).

Flucytosine or amphotericin B (anti-fungal agents).

Vercanza 450 mg tablets with food and drink

Vercanza 450 mg tablets should be taken with food. If you are unable to eat for any reason, you should still take your dose of Vercanza 450 mg tablets as usual.

Pregnancy, breast-feeding and fertility

You should not take Vercanza 450 mg tablets if you are pregnant unless your doctor recommends it. If you are pregnant or planning to become pregnant you must tell your doctor. Taking Vercanza 450 mg tablets when you are pregnant could harm your unborn baby.

You must not take Vercanza 450 mg tablets if you are breast-feeding. If your doctor wants you to begin treatment with Vercanza 450 mg tablets you must stop breast-feeding before you start to take your tablets.

Women of childbearing age must use effective contraception when taking Vercanza 450 mg tablets and for at least 30 days after treatment has finished.

Men whose partners could become pregnant should use condoms while taking Vercanza 450 mg tablets and should continue to use condoms for 90 days after treatment has finished.

Driving and using machines

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.

3. How to use this product.

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.

Vercanza 450 mg tablets should, whenever possible, be taken with food – see section 2.

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 of Vercanza 450 mg tablets 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 Vercanza 450 mg tablets. 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.

Elderly patients

Vercanza 450 mg tablets have not been studied in elderly patients.

Patients with kidney problems

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 isvery importantthat you only take the number of tablets prescribed by your doctor.

Patients with liver problems

Vercanza 450 mg tablets have not been studied in patients with liver problems.

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 Vercanza film-coated tablets, Valganciclovir powder for oral solution can be used.

If you take more Vercanza 450 mg tablets than you should

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 Vercanza 450 mg tablets

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.

If you stop taking Vercanza 450 mg 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions

Up to 1 in every 1,000 people may have a sudden and severe allergic reaction to valganciclovir (anaphylactic shock).STOPtaking Vercanza 450 mg tablets and go to the accident and emergency department at your nearest hospital if you experience any of the following:

A raised, itchy skin rash (hives).

Sudden swelling of the throat, face, lips and mouth which may cause difficulty swallowing or breathing.

Sudden swelling of the hands, feet or ankles.

Serious side effects

Tell your doctor straight away if you notice any of the following serious side effects – your doctor may tell you to stop taking Vercanza and you may need urgent medical treatment:

Verycommonside effects(may affect more than 1 in 10 users):

Low white blood cell counts – with signs of infection such as sore throat, mouth ulcers or a fever.

Low red blood cell counts – signs include feeling short of breath or tired, palpitations or pale skin.

Common side effects(may affect up to 1 in 10 users):

Blood infection (sepsis) – signs include fever, chills, palpitations, confusion and slurred speech.

Low level of platelets – signs include bleeding or bruising more easily than usual, blood in urine or stools or bleeding from gums, the bleeding could be severe.

Severely low blood cell count.

Pancreatitis – signs are severe stomach pain which spreads into your back

Fits.

Uncommonside effects(may affect up to 1 in 100 users):

Failure of the bone marrow to produce blood cells.

Hallucinations – hearing or seeing things that are not real.

Abnormal thoughts or feelings, losing contact with reality.

Failure of kidney function.

The side effects that have occurred during treatment with valganciclovir or ganciclovir are given below.

Other side effects

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)

· Thrush and oral thrush.

· Upper respiratory tract infection (e.g., sinusitis, tonsillitis).

· Loss of appetite.

· Headache.

· Cough.

· Feeling short of breath.

· Diarrhea.

· Feeling or being sick.

· Abdominal pain.

· Eczema.

· Feeling tired.

· Fever.

Common: (may affect up to 1 in 10 people)

· Influenza.

· Urine infection – signs include fever, passing urine more often, pain when passing urine.

· Infection of the skin and the tissues under the skin.

· Mild allergic reaction – the signs may include red, itchy skin.

· Weight loss.

· Feeling depressed, anxious or confused.

· Trouble sleeping.

· Hands or feet feeling weak or numb, which may affect your balance.

· Changes to your sense of touch, tingling, tickling, pricking or burning feeling.

· Changes to the way things taste.

· Chills.

· Eye inflammation (conjunctivitis), eye pain or sight problems.

· Ear pain.

· Low blood pressure, which may make you feel dizzy or faint.

· Problems swallowing.

· Constipation, wind, indigestion, stomach pain, swelling of the abdomen.

· Mouth ulcers.

· Abnormal results of liver and kidney laboratory tests.

· Night sweats.

· Itching, rash.

· Hair loss.

· Back pain, muscle or joint pain, muscle spasms.

· Feeling dizzy, weak or generally unwell.

Uncommon:may affect up to 1 in 100 people

· Feeling agitated.

· Tremor, shaking.

· Deafness.

· Uneven heartbeat.

· Hives, dry skin.

· Blood in urine.

· Infertility in men – see ‘Fertility’ section.

· Chest pain.

Separation of the inner lining of the eye (detached retina) has only happened in AIDS patients treated with Vercanza for CMV infection.

Additional side effects in children and adolescents

The side effects reported in children and adolescents are similar to the side effects reported for adults.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via The National Pharmacovigilance and Drug Safety Centre (NPC). By reporting side affects you can help provide more information on the safety of this medicine.

5. How to store this product

· Do not store above 30 °C.

· Keep out of the reach and sight 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.

· 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.