Valganciclovir Teva 450 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Valganciclovir Teva 450 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Valganciclovir Teva is and what it is used for
2. What you need to know before taking Valganciclovir Teva
3. How to take Valganciclovir Teva
4. Possible side effects
5. How to store Valganciclovir Teva
6. Contents of the pack and other information

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

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

Valganciclovir is used

• for the treatment of retinitis (infection of the retina in the eye) caused by cytomegalovirus in adult patients with acquired immunodeficiency syndrome (AIDS). CMV infection in the retina of the eye can cause vision problems and even blindness.
• for the prevention of cytomegalovirus (CMV) infections in adults and children who have not been infected with CMV, but who have received a solid organ transplant from a donor who was infected with CMV.

2. What you need to know before taking 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 breastfeeding your baby.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Valganciclovir Teva

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

Take special care with Valganciclovir Teva

• if you have low blood levels of white blood cells, red blood cells, or platelets (small cells involved in blood clotting). Your doctor will perform a blood test before you start taking Valganciclovir and will carry out further tests while you are taking the tablets
• if you are receiving radiotherapy or hemodialysis
• if you have kidney problems. Your doctor may prescribe a lower dose and you may need frequent blood tests during treatment
• if you are taking ganciclovir capsules and your doctor instructs you to switch your treatment to Valganciclovir tablets. It is important that you do not take more than the number of tablets prescribed by your doctor, as you may be at risk of overdose.

Taking Valganciclovir with other medicines

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

Taking other medicines together with Valganciclovir may affect the amount of medicine reaching the bloodstream or could cause harmful effects. Inform your doctor if you are already taking any of the following medicines:

• imipenem-cilastatin (an antibiotic). Taking this medicine together with Valganciclovir Teva may 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 (a medicine for the treatment of gout). Taking probenecid and Valganciclovir together may increase the amount of ganciclovir in the blood
• mycophenolate mofetil, cyclosporine, or tacrolimus (used after organ transplants)
• vincristine, vinblastine, doxorubicin, hydroxyurea, or similar medicines for the treatment of cancer
• trimethoprim, trimethoprim/sulfamethoxazole combinations, or dapsone (antibiotics)
• pentamidine (a medicine for the treatment of parasites or lung infections)
• flucytosine or amphotericin B (antifungal agents)

Taking Valganciclovir Teva with food and drink

Valganciclovir should be taken with food. If for any reason you are unable to eat, you should continue taking your usual dose of Valganciclovir.

Pregnancy, breastfeeding, and fertility

Pregnancy

You should not take Valganciclovir if you are pregnant unless your doctor advises you to do so. If you are pregnant or planning to become pregnant, you must inform your doctor. Taking Valganciclovir during pregnancy may cause harm to the unborn baby.

Breastfeeding

You must NOT take Valganciclovir while breastfeeding. If your doctor wants you to start treatment with Valganciclovir, you MUST STOP breastfeeding before starting this medicine.

Fertility

Women of childbearing potential

Women of childbearing age MUST use effective contraception while taking Valganciclovir Teva and for at least 30 days after treatment has ended.

Men

Men whose partners could become pregnant should use a condom while taking Valganciclovir and continue using it for 90 days after stopping treatment.

Driving and using machines

DO NOT drive or operate tools or machinery if you feel dizzy, tired, agitated, or confused while taking this medicine.

Valganciclovir Teva contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Valganciclovir Teva

Follow exactly the dosing instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You should 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 thoroughly with soap and water. If tablet powder has come into contact with your eyes, rinse them with sterile water, or clean water if sterile water is not available.

To avoid overdose, you must strictly follow the number of tablets prescribed by your doctor.

Valganciclovir tablets should always be taken with food whenever possible – see section 2 "Taking Valganciclovir Teva with food and drink".

Adults

Prevention of CMV infection in transplant patients

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

Treatment of CMV retinitis in AIDS patients (also known as induction treatment)

The usual dose of Valganciclovir is two tablets taken TWICE daily for 21 days (three weeks). Do not continue this dose for longer than 21 days unless instructed by your doctor, as this dose may increase the risk of possible adverse effects.

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

The usual dose is two tablets taken ONCE daily. Try to take the tablets at the same time each day. Your doctor will tell you how long you should continue taking Valganciclovir. If your retinitis worsens while you are on this dose, your doctor will decide whether you should repeat the induction treatment (as above) or whether to switch you to a different medicine for treating CMV infection.

Elderly patients

Valganciclovir Teva has not been studied in elderly patients.

Patients with renal impairment

If your kidneys are not functioning properly, your doctor will instruct you to take fewer tablets each day or to take tablets only on certain days of the week. It is VERY IMPORTANT that you take only 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 after receiving the transplant.

The dose will depend on the child's size and should be taken ONCE daily. Your doctor will determine the most appropriate dose based on your child's height, weight, and renal function.

Continue this dose until 100 days. If your child has received a kidney transplant, your doctor may recommend continuing the prescribed dose up to 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 may cause serious adverse effects, particularly affecting the blood or kidneys. Hospital treatment is required.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Valganciclovir Teva

If you forget to take your tablets, take the missed dose as soon as you remember, and then take the next dose at the usual time. DO NOT take a double dose to make up for the missed tablets.

If you stop taking Valganciclovir Teva

DO NOT stop treatment unless instructed by your doctor.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Valganciclovir may 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. STOP taking Valganciclovir and go to the nearest hospital emergency department if you experience any of the following:

• Raised, itchy skin rash (urticaria)
• Sudden swelling of the throat, face, lips, and mouth, which may cause difficulty swallowing or breathing
• Sudden swelling of hands, feet, or ankles

Serious side effects

Tell your doctor immediately if you notice any of the following serious side effects. Your doctor may ask you to stop taking Valcyte, and you may require 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 including breathlessness or tiredness, palpitations, or paleness

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

• Blood infection (sepsis), with signs including fever, chills, palpitations, confusion, and difficulty speaking
• Decrease in the number of platelets, with signs including more frequent bleeding or bruising than normal, blood in urine or stools, or bleeding from gums, which may become severe
• Severe decrease in blood cells
• Pancreatitis, with signs such as severe stomach pain spreading to the back
• Seizures

Uncommon side effects (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)
• Disturbed thoughts or feelings, loss of contact with reality
• Impaired kidney function

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
• Feeling of breathlessness
• Diarrhea
• Feeling unwell or illness
• Abdominal pain
• Eczema
• Tiredness
• Fever

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

• Influenza (flu)
• Urinary tract infection, with signs including fever, more frequent urination, pain when urinating
• Skin and subcutaneous tissue infection
• Mild allergic reactions, with signs including redness and swelling of the skin
• Weight loss
• Feeling depressed, anxious, or confused
• Sleep disorders
• Numbness or weakness in hands and feet, which may affect your balance
• Changes in sensation, tingling, prickling, pins and needles, or burning sensation
• Changes in taste
• Chills
  • Eye inflammation (conjunctivitis), inflammation inside the eye (edema), separation of the back layer of the eye (retinal detachment)#, eye pain, or vision problems
• Ear pain
• Low blood pressure, which may make you feel dizzy or cause blurred vision
• Difficulty swallowing
• Constipation, gas, indigestion, stomach pain, abdominal distension
• Mouth ulcers
• Abnormal results in liver and kidney laboratory tests
• Night sweats
• Itching, rash
• Hair loss
• Back, muscle, or joint pain, muscle spasms
• Dizziness, weakness, or general malaise

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

• Restlessness
• Tremors
• Deafness
• Irregular heartbeat
• Urticaria and dry skin
• Blood in urine
• Infertility in men (see section 2 “Pregnancy, breastfeeding 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.

#Retinal detachment has only occurred in patients with AIDS treated with Valcyte for CMV infection.

Additional side effects in children and adolescents

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

Reporting of side effects:

If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet.

You can also report them directly via the Spanish Pharmacovigilance System for Human 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 stated on the label and the carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Valganciclovir Teva

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

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

Appearance of the product and content of the pack

Valganciclovir Teva tablets are pink, film-coated, oval-shaped tablets with bevelled edges, engraved with “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 blisters available in packs of 10, 30 and 60 tablets.

High-density polyethylene (HDPE) bottles with a desiccant cartridge (3 g) and child-resistant polypropylene (PP) closure, 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, Spain

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 medicine is authorized in the European Economic Area member states and 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: Valganciclovir-ratiopharm 450 mg Filmtabletten
Italy: Valganciclovir Teva
Norway: Valganciclovir Teva
Poland: Valganciclovir Teva
Spain: Valganciclovir Teva 450 mg comprimidos recubiertos con película EFG
Sweden: Valganciclovir Teva
Slovenia: GANAXA 450 mg filmsko obložene tablete
Netherlands: Valganciclovir Teva 450 mg, filmomhulde tabletten
United Kingdom (Northern Ireland): Valganciclovir 450 mg Film-coated Tablets

Date of latest revision of this leaflet: December 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/.