Package Leaflet: Information for the User

Valganciclovir Teva 450 mg Film-Coated Tablets

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Contents of the pack and additional information

Valganciclovir belongs to a group of medicines that act directly topreventthe growth of viruses. In the body, the active ingredient of the tablets, valganciclovir, is metabolized 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 pose a life-threatening risk.

Valganciclovir is used

• for the treatment of retinal infections of 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 inadults and childrenwho have not been infected with CMV, but who have received a solid organ transplant from a donor who was infected with CMV.

Do not take Valganciclovir Teva

• if you are allergic to valganciclovir, ganciclovir, or any of the other components of this medication (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 acyclovir, penciclovir, valaciclovir, or famciclovir. These are other medications used for viral infections.

Be especially careful with Valganciclovir TevaTeva

• if you have a low blood count of white blood cells, red blood cells, or platelets (small cells involved in blood clotting). Your doctor will perform a blood test before starting to take Valganciclovir and will perform more tests while you are taking the tablets
• if you are receiving radiation therapy or hemodialysis
• 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 change your treatment to Valganciclovir tablets.It is essential not to take more than the number of tablets prescribed by your doctor or you may be at risk of an overdose.

Valganciclovir taken with other medications

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

If you are taking other medications at the same time as Valganciclovir, the combination may affect the amount of medication that reaches the bloodstream or may cause harmful effects. Inform your doctor if you are already taking any of the following medications:

• imipenem-cilastatina (antibiotic). Taking this medication with Valganciclovir Teva may cause seizures (convulsions)
• zidovudine, didanosine, lamivudine, stavudine, tenofovir, abacavir, emtricitabine, or similar medications for the treatment of HIV/AIDS.
• adefovir or any other medication for the treatment of hepatitis B.
• probenecid (medication for the treatment of gout). Taking probenecid and Valganciclovir at the same time may increase the amount of ganciclovir in the blood
• micophenolate mofetil, cyclosporine, or tacrolimus (used after transplants)
• vincristine, vinblastine, doxorubicin, hydroxyurea, or similar medications for the treatment of cancer
• trimethoprim, combinations of trimethoprim/sulfamethoxazole, and dapsone (antibiotics)
• pentamidine (medication for the treatment of parasites or lung infections)
• flucytosine or amphotericin B (antifungal agents)

Valganciclovir Teva taken with food and drinks

Valganciclovir should be taken with food. If for any reason you cannot 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 recommends it. If you are pregnant or plan to become pregnant, you must inform your doctor. Taking Valganciclovir during pregnancy may cause harm to the fetus.

Breastfeeding

You should not take Valganciclovir during breastfeeding. If your doctor wants you to start treatment with Valganciclovir, you must stop breastfeeding before starting to take this medication.

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 ended.

Men

Men whose partners may become pregnant must use a condom while taking Valganciclovir and must continue to use a condom for 90 days after treatment has ended.

Driving and operating machinery

Do not drive or use tools or machinery if you feel dizzy, tired, agitated, or confused while taking this medication.

Valganciclovir Teva contains lactose

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

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

You must be careful when handling your tablets. DO NOT break or crush them.

You should swallow them whole and with food whenever possible. If you accidentally touch a broken tablet, wash your hands thoroughly with water and soap. If the powder from the tablets has come 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 adhere 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 medication 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 HIV patients (also known as 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 HIV patients with CMV retinitis (also known as 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 let you know how long you should continue taking Valganciclovir. If your retinitis worsens while you are taking this dose, your doctor will tell you if you should repeat the induction treatment (as above) or may decide to give you a different medication to treat the CMV infection.

Older patients

Valganciclovir Teva has not been studied in older patients.

Patients withrenalinsufficiency

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

Patients withhepaticinsufficiency

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 medication within 10 days of receiving the transplant.

The dose to be taken will depend on the child's size and should be taken ONCE a day. Your doctor will decide which dose is most suitable based on the child's height, weight, and renal function.

You should continue with that dose until 100 days. If your child has received a kidney transplant, your doctor may recommend that you take the prescribed dose until 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 need hospital treatment.

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

If you forgot 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 the missed tablets.

If you interrupt treatment with Valganciclovir Teva

DO NOT stop treatment unless your doctor tells you to.

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

Like all medicines, Valganciclovir may cause side effects, although not everyone will experience them.

Allergic reactions

In 1 in every 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 departmentwhen you experience any of the following symptoms:

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

Severe side effects

Inform your doctor immediately if you notice any of the following severe side effects. Your doctor may ask you to stop taking Valcyte and you may need urgent medical treatment:

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

• Decreased white blood cell count, with signs of infection such as sore throat, mouth ulcers, or fever
• Decreased red blood cell count, with signs that include shortness of breath or fatigue, 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 speakingand
• Decreased platelet count, with signs that include frequent bruising or bleeding, blood in urine or stool, or bleeding gums, which may be severe
• Severe decrease in blood cell count
• 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)

• Bone marrow failure to produce blood cells
• Hallucinations (seeing or hearing things that are not real)
• Disturbed thoughts or feelings, loss of contact with reality
• Renal failure

The side effects reported with valganciclovir or ganciclovir are as follows:

Other side effects

Inform 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
• Diarhea
• Feeling of illness or illness
• Abdominal pain
• Eczema
• Fatigue
• Fever.

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

• Influenza
• Urinary tract infection, with signs that include fever, frequent urination, and pain while urinating
• Skin and subcutaneous tissue infection
• Mild allergic reactions, with signs that include skin redness and swelling
• Weight loss
• Feeling of depression, anxiety, or confusion
• Sleep disturbances
• Numbness or weakness in hands and feet, which may affect your balance
• Changes in sensation, tingling, pins and needles, or burning sensation
• Changes in taste
• Chills
• • Eye inflammation (conjunctivitis), eye inflammation (edema), retinal detachment#, eye pain, or vision problems
• Ear pain
• Low blood pressure, which may cause dizziness or blurred vision
• Difficulty swallowing
• Constipation, gas, indigestion, abdominal pain, bloating
• Mouth ulcers
• Abnormal results in liver and kidney laboratory tests
• Nocturnal sweating
• Itching, rash
• Hair loss
• Back, 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, 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.

#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 for adults.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.

You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label and on the carton after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Valganciclovir Teva

• The active ingredient 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), 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 iron oxide red (E172).

Appearance of the product and contents of the package

Valganciclovir Teva tablets are film-coated, pink-colored, oval-shaped, with beveled edges, with the imprint "93" on one face and "5465" on the other.

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

PVC/ALC/PVC/Aluminum blisters available in packages of 10, 30, and 60 tablets.

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

For bottles:

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

Not all package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma S.L.U.

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

28108 Alcobendas

Madrid

Responsible for manufacturing

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

Prilaz baruna Filipovica 25, 10000 Zagreb

Croatia

Ó

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Ó

TEVA UK Ltd

Brampton Road, Hampden Park, Eastbourne,

East Sussex, BN22 9AG

United Kingdom

Ó

Teva Czech Industries s.r.o.

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

Republic of Czech

Ó

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80. 31-546, Krakow

Poland

Ó

TEVA PHARMA S.L.U.

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

Spain

Ó

Merckle GmbH

Ludwig-Merckle-Straße 3, 89143 Blaubeuren

Germany

Ó

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 Area and in the United Kingdom (Northern Ireland) with the following names:

Austria: Valganciclovir ratiopharm 450 mg Filmtabletten

Republic of Czech: 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 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 the last review of this leaflet: December 2021

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.es/.