TEVA UK Ref: 231-30-82232-A LEA VALGANCICLOVIR 450mg FC TABS TUK <ZAG Version: 8    30 JUNE 2014

VALGANCICLOVIR 450 mg FILM-COATED TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talkto your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET:

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

OWHAT VALGANCICLOVIR IS AND WHAT IT IS USED FOR

Valganciclovir with food and drink

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.

Pregnancy, breast-feeding and fertility Pregnancy

You should not take Valganciclovir ifyou 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.

Breast-feeding

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 taking this medicine.

Fertility

Women of childbearing age

Women of childbearing age must use effective contraception when taking Valganciclovir.

Men

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.

Valganciclovir belongs to a group of medicines, which work directly to prevent the growth of viruses. In the body, the active ingredient in the tablet called 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.

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.

Valganciclovir contains lactose Sugar intolerance

This medicine contains lactose. Ifyou have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Valganciclovir is used:

•    for treatment of CMV-infections of the retina ofthe eye in patients with acquired immunodeficiency syndrome (AIDS). CMV-infection ofthe retina ofthe eye can causevision problems and even blindness

•    to prevent CMV-infections in patients who are not infected with CMV and who have received an organ transplant from somebody who was infected by CMV.

Ask your doctor or pharmacist for advice before taking any medicine.

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WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALGANCICLOVIR

Do not take Valganciclovir:

•    if you are allergic to valganciclovir or any ofthe other ingredients of Valganciclovir (listed in section 6)

•    if you are allergic to ganciclovir, acyclovir or valaciclovir, which are medicines used to treat other virus infections

•    ifyouarebreast-feeding.

Always take this medicine exactly as your doctor or pharmacist has told you to. Check with your doctor or pharmacist ifyou are not sure.

You have to be careful when handling your tablets. Do not break or crush them.You should swallowthem whole and with food whenever possible. Ifyou 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 ifyou do not have sterile water.

You must stick to the number of tablets as instructed by your doctor to avoid overdose.

Valganciclovir tablets should, whenever possible, be taken with food - see section 2.

Warnings and precautions

Talk to your doctor or pharmacist before

taking Valganciclovir.

Take special care with Valganciclovir

•    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

•    ifyouarehavingradiotherapyor haemodialysis

•    ifyou have a problem with your kidneys. Your doctor may need to prescribe a reduced dose for you and may need to checkyour blood frequently during treatment

•    ifyou are currentlytaking ganciclovir capsules and your doctor wants you to switch to Valganciclovirtablets. It is important that you do not take more than the number of tablets prescribed by your doctor or you could risk an overdose.

Children

Present studies do not sufficiently show how the medicine is working in children.

Other medicines and Valganciclovir

Tell your doctor or pharmacist ifyou are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Adults:

Prevention of CMV disease in transplant patients

You should startto take this medicine within 10 days ofyourtransplant.The usual dose is two tablets taken once daily. You should continue with this dose for up to 100 days following yourtransplant. Ifyou 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 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. Ifyour 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.

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:

•    imipenem-cilastatin (an antibiotic).Taking this with Valganciclovir can cause convulsions (fits)

•    zidovudine, didanosine or similar kinds of drugs used to treat AIDS

•    probenecid (a medicine against gout). Taking probenecid and Valganciclovir at the same time could increase the amount of ganciclovir in your blood

•    mycophenolate mofetil (used after transplantations)

•    vincristine, vinblastine, adriamycin, hydroxyurea or similar kinds of drugs to treat cancer

•    cidofovir, foscarnet, or nucleoside analogues used against viral infections

•    trimethoprim, trimethoprim/sulpha combinations and dapsone (antibiotics)

•    pentamidine (drug to treat parasite or lung infections)

•    flucytosine or amphotericin B (anti-fungal agents).

Older people

Valganciclovir has not been studied in older people.

Renal impairment

Ifyour kidneys are not working properly, your doctor may instruct you to take fewer tablets each day or only to take yourtablets on certain days each week. It is very important that you only take the number of tablets prescribed byyour doctor.

Hepatic impairment

Valganciclovir has not been studied in patients with liver problems.

If you take more Valganciclovir than you should

Contact your doctor or hospital immediately ifyou have taken, orthinkthatyou have taken, more tablets than you should.Taking too manytablets can cause serious side effects, particularly affecting your blood or kidneys. You may need hospital treatment.

If you forget to take Valganciclovir

Ifyou forget to take yourtablets, 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.

Teva Pharmaceuticals Europe B.V

R EG0107773

Version 1.2 Approved

If you stop taking Valganciclovir

You must not stop taking your medicine unless your doctor tells you to.

Ifyou have any further questions on the use of this medicine, askyour doctor or pharmacist.

^ POSSIBLE SIDE EFFECTS

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

Allergic reactions

Up to 1 in every 100 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 immediately ifyou experience any of the following:

•    a raised, itchy skin rash (hives)

•    sudden swelling ofthe throat, face, lips and mouth which may cause difficulty swallowing or breathing

•    sudden swelling ofthe hands, feet or ankles.

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

•    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.

•    Rare: may affect upto 1 in 1,000 people.

Very common side effects:

•    effects on the blood: a reduction in the number of white blood cells in the blood (neutropenia) - which will make you more likely to get infections, a reduction in the pigment in the blood that carries oxygen (anaemia) - which can cause tiredness and breathlessness when you exercise

•    effects on breathing: feeling short of breath or having trouble breathing (dyspnoea)

•    effects on the stomach and digestive system: diarrhoea.

Common side effects:

•    effects on the blood: a reduction in the number of leucocytes (blood cells that fight infection) in the blood (leucopenia), a reduction in the number of platelets in the blood (thrombocytopenia) - which can cause bruising and bleeding, a reduction in the number of several types of blood cells at the same time (pancytopenia)

•    effects on the nervous system: headache, difficulty sleeping (insomnia), strange tastes (dysgeusia), becoming less sensitive to touch (hypoaesthesia), prickly or tingling skin (paraesthesia), loss of feeling in the hands or feet (peripheral neuropathy), dizziness, fits (convulsions)

•    effects in the eye: eye pain, swelling within the eye (oedema), separation of the back ofthe eye (detached retina), seeing floaters

•    effects in the ear: earache

•    effects on breathing: coughing

•    effects on the stomach and digestion: feeling and being sick, stomach ache, constipation, wind, indigestion (dyspepsia), difficulty swallowing (dysphagia)

•    effects on the skin: inflamed skin (dermatitis), itching (pruritus), sweating at night

•    effects on the muscles, joints or bones: back pain, pain in the muscles (myalgia) orjoints (arthralgia), stiff muscles (rigor), muscle cramps

•    infections: fungal infection in the mouth (oral candidiasis), infections caused by bacteria or viruses in the blood, inflammation of cellular tissue (cellulitis), inflammation or infection ofthe kidneys or bladder

•    effects in the liver: a rise in some liver enzymes, which will only be seen during blood tests

•    effects in the kidney: changes to the normal working ofthe kidneys

•    effects on eating: loss of appetite (anorexia), weight loss

•    general effects: tiredness, fever, pain, chest pain, loss of energy (asthenia), generally feeling unwell (malaise)

•    effects on mood or behaviour: depression, feeling anxious, confused, having unusual thoughts.

Uncommon side effects:

•    effects in the heart: changes to the normal heart beat (arrhythmia)

•    effects on circulation: low blood pressure (hypotension), which can cause you to feel light headed or faint

•    effects on the blood: a decrease in the production of blood cells in the bone marrow

•    effects in the nerves: shaking or trembling (tremor)

•    effects in the eyes: red, swollen eyes (conjunctivitis), abnormal vision

•    effects in the ears: deafness

•    effects on the stomach or digestion: swollen stomach, mouth ulcers, inflammation ofthe pancreas (pancreatitis) where you may notice severe pain in the stomach and back

•    effects on the skin: hair loss (alopecia), itchy rash or swellings (urticaria), dry skin

•    effects in the kidneys: blood in the urine (haematuria), kidney failure

•    effects in the liver: a rise in the liver enzyme called alanine aminotransferase (which will only be seen during blood tests)

•    effects on fertility: infertility in men

•    effects on mood or behaviour: having unusual changes in mood and behaviour, losing contact with reality such as hearing voices or seeing things that are not there, feeling agitated.

Rare side effects:

•    effects on the blood: failure of the production of all types of blood cells (red blood cells, white blood cells and platelets) in the bone marrow.

Reporting of side effects

If you get any side effects, talkto your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

HOW TO STORE VALGANCICLOVIR

Keep this medicine out of the sight and reach of children.

Do not use Valganciclovir afterthe expiry date, which is stated on the label and carton after EXP.The expiry date refers to the last day ofthat month.

This medicine does not require any special storage condition.

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 to protect the environment.

©CONTENTS OF THE PACK AND OTHER INFORMATION

What Valganciclovir contains:

The active substance is 450 mg of valganciclovir, present as 496.3 mg of valganciclovir hydrochloride.

The other ingredients in the tablet are microcrystalline cellulose (E460(i)), mannitol (E421), magnesium stearate (E572), colloidal anhydrous silica (E551), crospovidone,typeA (E1202).The ingredients in the film-coat are hypromellose (E464), lactose monohydrate, titanium dioxide (El71), triacetin (E1518) and iron oxide red (E172).

What Valganciclovir looks like and contents of the pack

Valganciclovirtablets are oval, pink film-coated tablets with bevelled edges and debossing "93" on one side, "5465" on the other side.

Valganciclovir450 mg Film-coatedTablets are available in the following pack sizes: PVC/ACLAR/PVC/Aluminium blister available in packs of 30 and 60 tablets.

High density polyethylene (HDPE) bottles with one canister of desiccant (3 g) and a polypropylene (PP) child resistant (CR) closures available in packs of 30 and 60 tablets.

For bottles:

The medicine should be used within 9 months after the first opening of the bottle.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

TEVA UK Limited, Eastbourne,

BN22 9AG, UK

Manufacturer

PLIVA Croatia Ltd

Prilaz baruna Filipovica 25,10000 Zagreb Croatia

This leaflet was last revised in: 06/2014 PL 00289/1798

TEUZD

82232-A 500 x155

Teva Pharmaceuticals Europe B.V

R EG0107773

Version 1.2 Approved