VALGANCICLOVIR TEVA 450 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

Contents of the pack and further information

1. What is Valganciclovir Teva 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 an infection in the body's organs. This can be life-threatening.

Valganciclovir is used

• to treat eye infections caused by cytomegalovirus in adult patients with acquired immune deficiency syndrome (AIDS). CMV infection in the eye can cause vision problems and even blindness

to prevent cytomegalovirus (CMV) infections in adults and children who have not been infected with CMV 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 Teva

Do not take Valganciclovir Teva

• 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 taking Valganciclovir Teva

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

Be careful with Valganciclovir Teva

• 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 starting Valganciclovir and will perform more tests while you are taking the tablets
• if you are receiving radiotherapy or haemodialysis
• if you have kidney problems. Your doctor may prescribe a lower dose and may need 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 tablets than prescribed by your doctor or you may be at risk of an overdose.

Taking Valganciclovir with other medicines

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, 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 Teva can cause seizures (fits)
• zidovudine, didanosine, lamivudine, stavudine, tenofovir, abacavir, emtricitabine or similar medicines for the treatment of AIDS.
• Adefovir or any other medicine for the treatment of Hepatitis B.
• probenecid (medicine for the treatment of gout). Taking probenecid and Valganciclovir at the same time can 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 Teva 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

Pregnancy

Do not take Valganciclovir if you are pregnant, unless your doctor recommends it. If you are pregnant or plan to become pregnant, you must inform your doctor. If you take Valganciclovir when you are pregnant, it may harm the unborn baby.

Breast-feeding

Do not take Valganciclovir during breast-feeding. If your doctor wants you to start treatment with Valganciclovir, you must stop breast-feeding before starting to take this medicine.

Fertility

Women of childbearing age

Women of childbearing age must use effective contraceptive methods while taking Valganciclovir Teva and for at least 30 days after treatment has finished.

Men

Men, whose partners may become pregnant, must use a condom while taking Valganciclovir and for 90 days after finishing treatment.

Driving and using machines

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

Valganciclovir Teva contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Valganciclovir Teva

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

You must be careful when handling your tablets. They must not be broken or crushed.

You must swallow them whole and with food whenever possible. If you accidentally touch a broken tablet, wash your hands carefully with soap and water. If the powder from the tablets comes into contact with your eyes, rinse them with sterile water, or clean water if sterile water is not available.

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

Valganciclovir tablets should be taken with food whenever possible - see section 2 “Taking Valganciclovir Teva with food and drinks”.

Adults

Prevention of CMV infection in transplant patients

You should start taking this medicine within 10 days of 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 Teva has not been studied in elderly patients.

Patients with renal impairment

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

Patients with hepatic impairment

Valganciclovir Teva 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 of 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 what dose is most suitable for your child based on their 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 Teva than you should

Contact your doctor or hospital immediately if you have taken or think you have taken more Valganciclovir Teva 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 Toxicology Information Service on 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Valganciclovir Teva

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 forgotten tablets.

If you stop taking Valganciclovir Teva

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, Valganciclovir can cause side effects, although not everybody gets them.

Allergic reactions

In 1 in 1,000 people, a sudden and severe allergic reaction to valganciclovir (anaphylactic shock) may occur. STOPtaking Valganciclovir and go to the emergency department of the nearest hospitalwhen you experience any of the following effects:

• Raised itchy rash (urticaria)
• Sudden swelling of the throat, face, lips and mouth that can 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 Valcyte and you may need urgent medical treatment:

Very common side effects(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 in the blood, with signs that include shortness of breath or tiredness, palpitations or paleness

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

• blood infection (sepsis), with signs that include fever, chills, palpitations, confusion and difficulty speaking
• decrease in the number of platelets, with signs that include bleeding or bruising more often than usual, blood in urine or faeces or bleeding from the gums, which can be severe
• severe decrease in the number of blood cells
• pancreatitis with signs such as severe stomach pain that radiates to the back
• seizures

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

• inability of the bone marrow to produce blood cells
• hallucinations (seeing or hearing things that are not real)
• disturbed thinking or feelings, loss of contact with reality
• kidney failure

The following side effects have been reported with valganciclovir or ganciclovir:

Other side effects

Tell your doctor, pharmacist or nurse if you notice any of the following 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, tonsillitis)
• loss of appetite
• headache
• cough
• shortness of breath
• diarrhoea
• feeling of being sick or sick
• abdominal pain
• eczema
• fatigue
• fever

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

• flu
• urinary tract infection, with signs that include fever, more frequent urination, pain when urinating
• skin and subcutaneous tissue infections
• mild allergic reactions, with signs that include redness and swelling of the skin
• weight loss
• feeling of depression, anxiety or confusion
• sleep disorders
• numbness or weakness in hands and feet, which can affect your balance
• changes in touch, tingling, prickling, pinching or burning sensation
• changes in taste
• chills
• eye inflammation (conjunctivitis), inflammation inside the eye (edema), separation of the back of the eye (retinal detachment), eye pain or vision problems
• ear pain
• low blood pressure, which can make you feel dizzy or have blurred vision
• difficulty swallowing
• constipation, gas, indigestion, stomach pain, abdominal distension
• mouth ulcers
• abnormal liver and kidney test results
• night sweats
• itching, rash
• hair loss
• back pain, muscle or joint pain, muscle spasms
• feeling of dizziness, weakness or general malaise

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

• agitation
• tremors
• deafness
• irregular heartbeat
• urticaria and dry skin
• blood in urine
• infertility in men (see section 2 “Pregnancy, breast-feeding and fertility”)
• chest pain

Rare: may affect up to 1 in 1,000 people

• Blood and bone marrow disorders: failure to produce all types of blood cells (red blood cells, white blood cells and platelets) in the bone marrow.

#Only in patients with AIDS treated with Valcyte for CMV infection has 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 in 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 to the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Valganciclovir Teva

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 is the last day of the month shown.

This medicine does not require any special storage conditions.

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. Contents of the pack and further information

Composition of Valganciclovir Teva

• The active ingredient is: 450 mg of valganciclovir, in the form of 496.3 mg of valganciclovir hydrochloride.

• The other ingredients are: microcrystalline cellulose (E460(i)), mannitol (E421), magnesium stearate (E470b), anhydrous colloidal silica (E551), crospovidone, type A (E1202). The excipients of the film coating are hypromellose (E464), lactose monohydrate, titanium dioxide (E171), triacetin (E1518) and red iron oxide (E172)

Appearance and packaging of the product

Valganciclovir Teva tablets are film-coated, oval, pink tablets with beveled edges, with the engraving “93” on one side and “5465” on the other.

Valganciclovir Teva 450 mg film-coated tablets are available in the following pack sizes:

PVC/ACLAR/PVC/Aluminum blister packs available in packs of 10, 30, and 60 tablets

High-density polyethylene (HDPE) bottles with a desiccant carton (3 g) and a child-resistant polypropylene (PP) cap, available in packs of 30 and 60 tablets.

For bottles:

This medicine should be used within 9 months of opening the bottle.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma S.L.U.

C/ Anabel Segura 11, Ed. Albatros B, 1st floor

28108 Alcobendas

Madrid

Manufacturer

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25, 10000 Zagreb

Croatia

Or

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Or

TEVA UK Ltd

Brampton Road, Hampden Park, Eastbourne,

East Sussex, BN22 9AG

United Kingdom

Or

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305, 74770 Opava-Komarov

Czech Republic

Or

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80, 31-546, Krakow

Poland

Or

TEVA PHARMA S.L.U.

C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza

Spain

Or

Merckle GmbH

Ludwig-Merckle-Straße 3, 89143 Blaubeuren

Germany

Or

HBM Pharma s.r.o

Sklabinska 30, SK-03680 Martin

Slovak Republic

This medicinal product is authorized in the Member States of the European Economic Areaand in the United Kingdom (Northern Ireland)under the following names:

Austria: Valganciclovir ratiopharm 450 mg Filmtabletten

Czech Republic: Valganciclovir Teva 450 mg

Denmark: Valganciclovir Teva

France: VALGANCICLOVIR TEVA 450 mg, comprimé pelliculé

Germany: TeValgan 450 mg Filmtabletten

Italy: Valganciclovir Teva

Norway: Valganciclovir Teva

Poland: Valganciclovir Teva

Spain: Valganciclovir Teva 450 mg film-coated tablets EFG

Sweden: Valganciclovir Teva

Slovenia: GANAXA 450 mg film-coated tablets

Netherlands: Valganciclovir Teva 450 mg, filmomhulde tabletten

United Kingdom (Northern Ireland): Valganciclovir 450 mg Film-coated Tablets

Date of last revision of this leaflet:December 2021

Detailed and updated information on this medicinal product is available on the website of the

Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.