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Package leaflet: Information for the patient

Valganciclovir 450 mg Film-coated Tablets

(valganciclovir)

What is in this leaflet

1.    What Valganciclovir 450 mg Film-coated Tablets are and what they are used for

2.    What you need to know before you take Valganciclovir 450 mg Film-coated Tablets

3.    How to take Valganciclovir 450 mg Film-coated Tablets

4.    Possible side effects

5.    How to store Valganciclovir 450 mg Film-coated Tablets

6.    Contents of the pack and other information

1.    What Valganciclovir 450 mg Film-coated Tablets are and what they are used for

Valganciclovir 450 mg Film-coated Tablets contains the active substance valganciclovir (as valganciclovir hydrochloride). Valganciclovir 450 mg Film-coated 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.

Valganciclovir 450 mg Film-coated Tablets are used:

•    for treatment of CMV infections of the retina of the eye in 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 patients 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 take Valganciclovir 450 mg Film-coated Tablets

Do not take Valganciclovir 450 mg Film-coated Tablets:

•    if you are allergic to valganciclovir or any of the other ingredients of this medicine (listed in section 6)

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

•    if you are breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Valganciclovir 450 mg Film-coated Tablets:

•    if you have low numbers of white blood cells, red blood cells or platelets (small cells involved in blood clotting) in your blood or a history of low numbers of blood cells when taking other medicines. Your doctor will carry out blood tests before you start taking Valganciclovir 450 mg Film-coated Tablets and more tests will be done while you are taking the tablets

•    if you are having radiotherapy or blood dialysis

•    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 450 mg Film-coated Tablets, or if your doctor changes your dose during the treatment. 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 Valganciclovir 450 mg Film-coated Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you take other medicines at the same time as taking Valganciclovir 450 mg Film-coated Tablets the combination could affect the amount of medicine in 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 with Valganciclovir 450 mg Film-coated Tablets can cause convulsions (fits)

•    zidovudine, didanosine, lamivudine, tenofovir, abacavir, emtricitabine, rilpivirine, etravirine, efavirenz, raltegravir, duranavir, enfuvirtide, maraviroc or similar kinds of medicines used to treat AIDS

•    ribavirin, pegylated interferons, adefovir, entecavir, boceprevir and telaprevir used to treat Hepatitis B/C

•    probenecid (a medicine used to treat gout). Taking probenecid and Valganciclovir 450 mg Film-coated Tablets at the same time could increase the amount of ganciclovir in your blood

•    mycophenolate mofetil (used after transplantations). Taking mycophenolate mofetil with Valganciclovir 450 mg Film-coated Tablets may cause decreases in white blood cells which can lead to frequent infections.

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

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

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

•    pentamidine (medicine to treat parasite or lung infections)

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

Pregnancy, breast-feeding and fertility

You should not take Valganciclovir 450 mg Film-coated Tablets if you are pregnant unless your doctor recommends it. If you are pregnant, think you may be pregnant or planning to have a baby, ask your doctor for advice before taking this medicine. Taking Valganciclovir 450 mg Film-coated Tablets when you are pregnant could harm your unborn baby.

Do not take Valganciclovir 450 mg Film-coated Tablets if you are breast-feeding. If your doctor wants you to begin treatment with Valganciclovir 450 mg Film-coated Tablets you must stop breastfeeding before you start to take this medicine.

Women of child-bearing age must use effective contraception when taking Valganciclovir 450 mg Film-coated Tablets. Men whose partners could become pregnant should use condoms while taking Valganciclovir 450 mg Film-coated 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 suffer from fits, feel drowsy or sleepy, dizzy, clumsy or unsteady, tired, shaky or confused while taking this medicine.

3. How to take Valganciclovir 450 mg Film-coated Tablets

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.

If you accidentally touch damaged tablets, wash _

your hands thoroughly with soap and water. If any —I—>)— powder from the tablets gets in your eyes, rinse your eyes with sterile water or clean water if you do not have sterile water.

Do not take more tablets than prescribed by your doctor to avoid overdose.

Adults:

Prevention of CMV disease in transplant patients

You should start to take this medicine within 10 days of your transplant. The recommended 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 recommended 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 recommended 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 450 mg Film-coated 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.

Older people

Valganciclovir 450 mg Film-coated Tablets has not been studied in older people.

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 is very important that you only take the number of tablets prescribed by your doctor.

Patients with liver problems

Valganciclovir 450 mg Film-coated Tablets has 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 kidney function. Your child should continue with this dose for up to 100 days following their transplant. If your child has received a kidney transplant, your doctor may advise to take the dose for 200 days.

Method of administration

•    Valganciclovir 450 mg Film-coated Tablets should, whenever possible, be taken with food.

If you are unable to eat for any reason, you should still take your dose of Valganciclovir 450 mg Film-coated Tablets as usual.

•    Swallow the tablet whole. Do not crush or break the tablets.

•    For children who can't swallow valganciclovir film-coated tablets, other formulations may be available. Ask your pharmacist.

If you take more Valganciclovir 450 mg Film-coated 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, liver or kidneys. Other side effects may include stomach pain, being sick, diarrhoea, fits and shaking. You may need hospital treatment.

If you forget to take Valganciclovir 450 mg Film-coated 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 a forgotten dose.

If you stop taking Valganciclovir 450 mg Film-coated Tablets

Do 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.

Stop taking Valganciclovir 450 mg Film-coated Tablets and contact your doctor or go to your nearest hospital emergency department immediately if you think you may have any of the following side effects:

Very common (may affect more than 1 in 10 people):

•    low white blood cell counts (severe neutropenia) where you may notice frequent infections, such as fever, chills, sore throat or mouth ulcers.

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

•    a reduction in the number of leucocytes (blood cells that fight infection) in the blood, a reduction in the number of platelets in the blood - which can cause bruising and bleeding, a reduction in the number of several types

of blood cells at the same time and severe anaemia, a reduction in the number of red blood cells, you may feel weak, fatigued or short of breath. These may also be seen in blood tests and may be caused due to decrease in production of blood cells by the bone marrow (bone marrow failure)

•    abnormal functioning of the liver or a rise in some liver enzymes, which will only be seen during blood tests

•    reduced functioning of the kidneys (which may include signs like swollen ankles, feet or hands due to water retention, decreased need to urinate, muscle cramps, high blood pressure)

•    fits (convulsions)

•    swelling within the eye (oedema), separation of the back of the eye (detached retina which has only been reported in AIDS patients taking valganciclovir for CMV retinitis),

•    infections caused by bacteria or viruses in the blood (sepsis) - which may cause high fever, chills, headache, confusion and rapid breathing

•    inflammation of cellular tissue (cellulitis), inflammation or infection of the kidneys or bladder (which may include signs such as pain or discomfort when urinating, blood in urine, pain in your abdomen, back pain, needing to urinate more often during the day or night).

Uncommon (may affect up to 1 in 100 people):

•    kidney failure; kidney disease with little or no urine, drowsiness, nausea, vomiting, breathlessness

•    severe allergic reaction (anaphylactic shock) with 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

•    deafness

•    inflammation of the pancreas (pancreatitis): where you may notice severe upper stomach pain and back, often with nausea and vomiting.

These are serious side effects. You may need medical attention.

Other side effects that have occurred during treatment with valganciclovir or ganciclovir are given below:

Very common (may affect more than 1 in 10 people):

•    a reduction in the pigment in the blood that carries oxygen (anaemia) - which can cause tiredness and breathlessness when you exercise

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

•    diarrhoea.

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

•    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

•    eye pain, seeing floaters

•    earache

•    coughing

•    feeling and being sick, stomach ache, constipation, wind, indigestion (dyspepsia), difficulty swallowing (dysphagia)

•    inflamed skin (dermatitis), itching (pruritus), sweating at night

•    back pain, pain in the muscles (myalgia) or joints (arthralgia), stiff muscles (rigor), muscle cramps

•    fungal infection in the mouth (oral candidiasis)

•    your kidneys may not work as well and your blood creatinine (a waste product) levels may be higher as a result

•    decreased or loss of appetite, weight loss

•    tiredness, fever, chills, pain, chest pain, unusual weakness (asthenia), generally feeling unwell (malaise)

•    depression, feeling anxious, confused, having unusual thoughts.

Uncommon (may affect up to 1 in 100 people):

•    changes to the normal heart beat (arrhythmia)

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

•    shaking or trembling (tremor)

•    red, swollen eyes (conjunctivitis), abnormal vision

•    swollen stomach, mouth ulcers

•    hair loss (alopecia), itchy rash or swellings (urticaria), dry skin

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

•    infertility in men

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

Side effects in children and adolescents

The side effects reported in children and adolescents are similar to the side effects reported for adults but with, in some cases, increased frequencies.

Reporting of side effects

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 side effects directly via the national reporting system:

UK

The Yellow Card Scheme, at

www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie E-mail: medsafety@hpra.ie.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Valganciclovir 450 mg Film-coated Tablets

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.

After opening, use within 3 months.

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.

6. Contents of the pack and other information

What Valganciclovir 450 mg Film-coated Tablets contains

The active substance is valganciclovir. Each tablet contains 450 mg valganciclovir (as valganciclovir hydrochloride).

The other ingredients (excipients) are: Tablet core - cellulose, microcrystalline (E460); crospovidone and stearic acid (E570). Film-coat - hypromellose (E464); titanium dioxide (E171); macrogol; iron oxide red (E172) and polysorbate (E433).

What Valganciclovir 450 mg Film-coated Tablets looks like and contents of the pack

Valganciclovir 450 mg Film-coated Tablets are pink film-coated, oval, biconvex, bevelled edge tablets marked with "M" on one side of the tablet and "V45" on the other side, with dimensions 18.4 mm x 8.4 mm.

Valganciclovir 450 mg Film-coated Tablets are packed in HDPE bottles with a child resistant cap containing 60 film-coated tablets.

Marketing Authorisation Holder

Generics [UK] Ltd., Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Manufacturer

Mylan Hungary Kft.

H-2900 Komarom Mylan utca 1.

Hungary

Generics [UK] Limited Potters Bar Hertfordshire EN6 1TL

United Kingdom

This medicinal product is authorised in the Member States of the EEA under the following names:

Cyprus    Valganciclovir Mylan 450 mg

Film-coated Tablets

Czech Republic Valganciclovir Mylan 450 mg, potahovane tablety

450 mg, comprime pellicule Valganciclovir Mylan 450 mg Filmtabletten

Valganciclovir Mylan 450 mg Film-coated Tablets Valganciclovir 450 mg Film-coated Tablets Valganciclovir Mylan Valganciclovir Mylan Valganciclovir Mylan 450 mg Valganciclovir MYLAN 450 mg comprimidos recubiertos con pelicula EFG

Valganciclovir Mylan 450 mg, filmomhulde tabletten Valganciclovir 450 mg Film-coated Tablets

This leaflet was last revised in December 2014