VALGANCICLOVIR 450 mg Film-Coated Tablets

Contents of the leaflet

1. Introduction
2. What is Valganciclovir Cipla and what is it used for
3. What you need to know before you take Valganciclovir Cipla
4. How to take Valganciclovir Cipla
5. Possible side effects
6. Storage of Valganciclovir Cipla
7. Container Contents and Additional Information

Introduction

Package Leaflet: Information for the User

Valganciclovir Cipla 450 mg film-coated tablets EFG

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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Valganciclovir Cipla and what is it used for
2. What you need to know before you take Valganciclovir Cipla
3. How to take Valganciclovir Cipla
4. Possible side effects
5. Storage of Valganciclovir Cipla

1. Contents of the pack and further information

1. What is Valganciclovir Cipla and what is it used for

Valganciclovir belongs to a group of medicines that act directly to prevent the growth of viruses. In the body, the active substance of the tablets, valganciclovir, is converted to ganciclovir. Ganciclovir prevents the virus called cytomegalovirus (CMV) from multiplying and invading healthy cells. In patients with a weakened immune system, CMV can cause infection in the body's organs. This can be life-threatening.

Valganciclovir Cipla is used:

• for the treatment of retinitis (infection of the retina) caused by cytomegalovirus in adult patients with AIDS (Acquired Immune Deficiency Syndrome). CMV infection in the eye can cause vision problems and even blindness.

for the prevention of CMV disease in adults and children who have not had this virus, but have received a solid organ transplant from a donor who was infected with CMV.

2. What you need to know before you take Valganciclovir Cipla

Do not take Valganciclovir Cipla:

• 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

Consult your doctor or pharmacist before starting to take valganciclovir.

• if you are allergic to aciclovir, penciclovir, valaciclovir, or famciclovir. These are other medicines used to treat viral infections.

Be cautious with valganciclovir:

• if you have a low number of white blood cells, red blood cells or platelets (small cells involved in blood clotting) in your blood. Your doctor will perform a blood test before you start taking valganciclovir and will perform more tests while you are being treated.
• if you are receiving radiotherapy or haemodialysis.
• if you have kidney problems. Your doctor may prescribe a lower dose and may need to perform frequent blood tests during treatment.
• if you are taking ganciclovir capsules and your doctor tells 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 may be at risk of an overdose.

Other medicines and Valganciclovir Cipla

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. If you take other medicines at the same time as taking valganciclovir, the combination may affect the amount of medicine that reaches the bloodstream or may cause harmful effects.

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

• imipenem-cilastatin (antibiotic). Taking this medicine with valganciclovir may cause seizures (attacks),
• zidovudine, didanosine, lamivudine, stavudine, tenofovir, abacavir, emtricitabine or similar medicines for the treatment of AIDS,
• adefovir or other medicines used to treat hepatitis B
• probenecid (medicine for the treatment of gout). Taking probenecid and valganciclovir at the same time may increase the amount of ganciclovir in the blood,
• mycophenolate mofetil, cyclosporin or tacrolimus (used after transplants),
• vincristine, vinblastine, doxorubicin, hydroxyurea or similar medicines for the treatment of cancer,
• trimethoprim, trimethoprim/sulfa combinations and dapsone (antibiotics),
• pentamidine (medicine for the treatment of parasites or lung infections),
• flucytosine or amphotericin B (antifungal agents).

Taking Valganciclovir Cipla with food and drinks

Valganciclovir should be taken with food. If for any reason you cannot eat, you should continue to take your usual dose of valganciclovir.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not take valganciclovir if you are pregnant, unless your doctor advises you to. If you are pregnant or want to become pregnant, you must tell your doctor. If you take valganciclovir when you are pregnant, it may harm your unborn child.

You should not take Valganciclovir Cipla during breast-feeding. Before starting treatment, you must stop breast-feeding.

Women of childbearing potential must use effective contraception while taking Valganciclovir Cipla and for at least 30 days after stopping treatment.

Men whose partners may become pregnant or are already pregnant, must use a condom while taking Valganciclovir Cipla and for 90 days after stopping treatment.

Driving and using machines

Do not drive or use machines if you feel dizzy, tired, agitated or confused while taking this medicine.

Consult your doctor or pharmacist before taking any medicine.

3. How to take Valganciclovir Cipla

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The tablets should be handled with care. Do not break or crush the tablets. They should be swallowed whole and with food whenever possible. If you accidentally touch a broken tablet, wash your hands carefully with soap and water, and if the powder from the tablets comes into contact with your eyes, rinse them with sterile water or plenty of water if sterile water is not available.

To avoid an overdose, you must adjust to the number of tablets prescribed by your doctor.

Valganciclovir tablets should be taken with food whenever possible. See section 2.

The recommended dose is:

Adults:

Prevention of CMV infection in transplant patients

You should start taking this medicine within 10 days after the transplant. The usual dose is two tablets ONCE a day. You should continue with this dose until 100 days after the transplant. If you have received a kidney transplant, your doctor may advise you to take the tablets for 200 days.

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

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

Long-term treatment to prevent the recurrence of active inflammation in AIDS patients with CMV retinitis (also called maintenance treatment)

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

Elderly patients

Valganciclovir has not been studied in elderly patients.

Patients with kidney problems

If your kidneys do not work properly, your doctor will tell you to take fewer tablets each day or only take the tablets on certain days of the week. It is very importantthat you only take the number of tablets prescribed by your doctor.

Patients with liver problems

Valganciclovir has not been studied in patients with liver problems.

Use in children and adolescents

Prevention of CMV disease in transplant patients

Children should start taking this medicine within 10 days after receiving the transplant. The dose to be taken will depend on the size of the child and should be taken ONCE a day. Your doctor will decide which dose is most suitable based on your child's height, weight and kidney function. You should continue with this dose until 100 days. If your child has received a kidney transplant, your doctor may recommend that they take the prescribed dose for 200 days.

If you take more Valganciclovir Cipla than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Valganciclovir Cipla

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 missed doses.

If you stop taking Valganciclovir Cipla

Do not stop treatment unless your doctor tells you to.

If you have any further questions on the use of this product, 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

In 1 in 1000 people, a sudden and severe allergic reaction to valganciclovir (anaphylactic shock) may occur. STOPtaking valganciclovir and go to the emergency department of the nearest hospital when you experience any of the following effects:

• raised itchy rash (hives),
• sudden swelling of the throat, face, lips and mouththat may cause difficulty in swallowing or breathing,
• sudden swelling of hands, feet or ankles,

Severe side effects

Tell your doctor immediately if you notice any of the following severe side effects. Your doctor may tell you to stop taking it and you may need urgent treatment.

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

• Decrease in the number of white blood cells in the blood with signs of infection such as sore throat, mouth ulcers or fever.
• Decrease in the number of red blood cells, with signs that include tiredness and difficulty breathing, palpitations or pale skin.

Common(may affect up to 1 in 10 people)

• Blood infection (sepsis), with signs that include fever, chills, palpitations, confusion and altered speech.
• Low levels of platelets, with signs that include bleeding or bruising more easily than normal, blood in urine or stools or bleeding gums, the bleeding can be severe.
• Severe decrease in the number of blood cells.
• Pancreatitis, the signs are severe stomach pain that radiates to the back.
• Seizures

Uncommon(may affect up to 1 in 100 people)

• Failure of the bone marrow to produce blood cells
• Hallucinations (seeing or hearing things that are not real)
• Abnormal thoughts or feelings, loss of contact with reality
• Kidney failure

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

Other side effects

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

• Candidiasis and oral candidiasis
• Upper respiratory tract infection (e.g. sinusitis and tonsillitis)
• Loss of appetite
• Headache
• Cough
• Shortness of breath
• Diarrhoea
• Nausea
• Abdominal pain
• Eczema
• Fatigue
• Fever

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

• Flu
• Urinary tract infection, the signs include fever, frequent urination, pain when urinating
• Skin and subcutaneous tissue infections
• Mild allergic reaction (the signs may include red skin and itching)
• Weight loss
• Depression, anxiety or confusion
• Difficulty sleeping
• Weak or numb hands or feet, which can affect balance
• Changes in your sense of touch, tingling, numbness, prickling or burning sensation
• Changes in the taste of food
• Chills
• Eye inflammation (conjunctivitis), eye pain or vision problems
• Ear pain
• Low blood pressure that can make you feel dizzy or weak
• Difficulty swallowing
• Constipation, gas, indigestion, stomach pain, abdominal bloating
• Mouth ulcers
• Abnormal kidney or liver test results
• Night sweats
• Itching, rash
• Hair loss
• Back, muscle or joint pain, muscle spasms
• Feeling dizzy, weak or unwell.

Uncommon side effects (may affect up to 1 in 100 people)

• Feeling agitated
• Tremors, agitation
• Deafness
• Irregular heartbeats
• Hives, dry skin
• Blood in urine
• Infertility in men (see fertility section)
• Chest pain

Only in patients with AIDS, treated with valganciclovir for CMV infection, has separation of the inner layer of the eye (retinal detachment) occurred.

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 experience 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 Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es.

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

5. Storage of Valganciclovir Cipla

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 carton and blister after EXP. The expiry date refers to the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Contents and Additional Information

Composition of Valganciclovir Cipla

The active ingredient is valganciclovir. Each tablet contains valganciclovir hydrochloride equivalent to 450 mg of valganciclovir.

The other components (excipients) are:

• Core of the tablet: microcrystalline cellulose, crospovidone (Type B), Povidone (K-30), and stearic acid 50.
• Coating: hypromellose, titanium dioxide (E171), macrogol, and red iron oxide (E172).

Appearance of the Tablet and Container Contents of Valganciclovir Cipla

Valganciclovir Cipla tablets are film-coated pink tablets, capsule-shaped, biconvex, and flat on both sides.

Length: 17.10 ± 0.20 mm (16.90 – 17.30)

Thickness: 8.10 ± 0.20 mm (7.90 – 8.30)

HDPE tablet container, with child-resistant polypropylene closure: Container size: 60 tablets.

Aluminum/PVC/PE/PVDC blister packs. Container size: 60 tablets

Marketing Authorization Holder

Cipla Europe NV,

De Keyserlei 58-60, Box-19, 2018 Antwerp

Belgium

Manufacturer

S&D Pharma CZ, spol. S.r.o, Theodor 28, Pcchery (Pharmos a.s. facility),

1. Czech Republic

or

Cipla Europe NV,

De Keyserlei 58-60, Box-19,

2018 Antwerp

Belgium

Local Representative

Cipla Europe NV, Spanish branch,

C/ Guzmán el Bueno, 133, Britannia building

1. Madrid

Tel: 91 534 16 73

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Sweden: Valganciclovir Cipla 450 mg film-coated tablets

Norway: Valganciclovir Cipla

Finland: Valganciclovir Cipla 450 mg film-coated tablets

Denmark: Valganciclovir Cipla

United Kingdom: Valganciclovir 450 mg film-coated tablets

Germany: Valganciclovir Cipla 450 mg film-coated tablets

France: Valganciclovir Cipla 450 mg, film-coated tablets

Spain: Valganciclovir Cipla 450 mg film-coated tablets EFG

Italy: Valganciclovir Cipla

Poland: Valganciclovir Cipla, 450 mg, film-coated tablets

Czech Republic: Valganciclovir Cipla 450 mg film-coated tablets

Slovakia: Valganciclovir Cipla 450 mg film-coated tablets

Hungary: Valganciclovir Cipla 450 mg film-coated tablets

Romania: Valganciclovir Cipla 450 mg film-coated tablets

Croatia: Valganciclovir Cipla 450 mg film-coated tablets

Netherlands: Valganciclovir Cipla 450 mg film-coated tablets

Date of the last revision of this leaflet: November 2018

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es