Leaflet: information for the user

Valganciclovir Tarbis 450 mg film-coated tablets EFG

Valganciclovir hydrochloride

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

• Keep this 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 similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before taking Valganciclovir Tarbis

3. How to take Valganciclovir Tarbis

4. Possible side effects

5. Storage of Valganciclovir Tarbis

6. Contents of the pack and additional information

This medication belongs to a group of medications that act directly to prevent the 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 put a person's life at risk.

This medication is used:

Do not take Valganciclovir Tarbis

• If you are allergic to valganciclovir, ganciclovir, or any of the other components of this medication (listed in section 6).
• If you are breastfeeding.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this medication

• If you are allergic to acyclovir, penciclovir, valacyclovir, or famciclovir. These are other medications used for viral infections.

Be especially careful with Valganciclovir Tarbis:

• 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 complete blood tests before you start taking this medication and you will need to have more blood tests while you are on treatment.
• If you are receiving radiation therapy or hemodialysis.
• If you have kidney problems. Your doctor will need to prescribe a lower dose and you may need to have frequent blood tests during treatment.
• If you are currently taking ganciclovir capsules and your doctor tells you to switch to this medication. It is essential that you do not take more than the number of tablets prescribed by your doctor, as you may be at risk of an overdose.

Other Medications and Valganciclovir Tarbis

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication, including those purchased without a prescription.

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

• Imipenem-cilastatin (antibiotic). Taking this medication with this medication may cause seizures (convulsions).
• Zidovudine, didanosine, lamivudine, stavudine, tenofovir, abacavir, emtricitabine, or similar medications for HIV treatment.
• Adefovir or any other medication for hepatitis B treatment.
• Probenecid (medication for gout treatment). Taking probenecid and this medication at the same time may increase the amount of ganciclovir in the blood.
• Mycophenolate mofetil, cyclosporine, or tacrolimus (used after transplants).
• Vincristine, vinblastine, doxorubicin, hydroxyurea, or similar medications for cancer treatment.
• Trimethoprim, trimethoprim/sulfamethoxazole combinations, and dapsone (antibiotics).
• Pentamidine (medication for parasite or lung infection treatment).
• Flucytosine or amphotericin B (antifungal agents)

Use of Valganciclovir Tarbis with Food and Drinks

This medication should be taken with food. If you cannot eat for any reason, you should still take your usual dose of this medication.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

You should not take this medication if you are pregnant, unless your doctor recommends it. If you are pregnant or intend to become pregnant, inform your doctor. Taking this medication while pregnant may cause harm to the fetus.

You should not take this medication during breastfeeding. If your doctor tells you to start treatment with this medication, you should stop breastfeeding before taking the tablets.

Women of childbearing age should use effective contraceptive methods while taking this medication and for at least 30 days after treatment has ended.

Males whose partners may become pregnant should use condoms while taking this medication and continue to use them for 90 days after treatment has ended.

Driving and Operating Machines

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

Consult your doctor or pharmacist before using any medication.

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

The tablets of this medication must be handled with care. They cannot be broken or crushed. 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 comes into contact with your eyes, rinse them with sterile water, or abundant running water if sterile water is not available.

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

The tablets of this medication should be taken with food whenever possible. See section 2.

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 patients with AIDS (also known as induction treatment)

The usual dose 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 your risk of possible side effects.

Long-term treatment to prevent the recurrence of active inflammation in patients with AIDS and 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 treatment with this medication. If your retinitis worsens while you are taking this dose, your doctor will tell you if you should repeat the induction treatment (as explained above) or if they may decide to give you a different medication to treat the CMV infection.

Older patients

This medication has not been studied in older patients.

Patients with kidney problems

If your kidneys do not function properly, your doctor will advise you to take fewer tablets per 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

This medication 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 on the most appropriate dose based on the child's height, weight, and renal function. You should continue with that dose for a maximum of 100 days. If your child has received a kidney transplant, your doctor may recommend that they take the prescribed dose for 200 days.

For children who cannot swallow the Valganciclovir Tarbis-coated tablets, valganciclovir powder for oral solution may be used.

If you take more Valganciclovir Tarbis than you should

Notify your doctor or hospital immediately if you have taken or think you have taken more tablets of this medication than you should. Taking too many 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 medication and the amount ingested

If you forget to take Valganciclovir Tarbis

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 doses.

If you interrupt treatment with Valganciclovir Tarbis

You should not interrupt treatment unless your doctor tells you to.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Allergic Reactions

In up to 1 in 1,000 people, a sudden and severe allergic reaction to valganciclovir (anaphylactic shock) may occur.STOPtaking this medicine and go to the nearest hospital emergency department if you experience any of the following symptoms:

• raised, itchy skin rash (hives)
• 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 this medicine, and you may need urgent medical treatment:

Very Common Side Effects(may affect more than 1 in 10 patients)

Common Side Effects(may affect up to 1 in 10 people)

Uncommon Side Effects(may affect up to 1 in 100 people)

The side effects that may occur during treatment 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(may affect more than 1 in 10 people)

Common(may affect up to 1 in 10 people)

Uncommon(may affect up to 1 in 100 people)

Only retinal detachment (separation of the inner layer of the eye) has been reported in patients with AIDS treated with this medicine 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 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 Pharmacovigilance of Medicines for Human Use:www.notificaRAM.esBy 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 of the bottle or on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need if you are unsure. By doing so, you will help protect the environment.

Composition of Valganciclovir Tarbis

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

The other components (excipients) are:

Tablet core: microcrystalline cellulose (E 460); crospovidone type A (E 1202), povidone (K-30) (E 1201), and stearic acid (E 570).

Tablet coating: hypromellose (E 464), titanium dioxide (E 171), macrogol 400, iron oxide red (E172), and polysorbate 80 (E 433).

Appearance of Valganciclovir Tarbis and contents of the package

The tablets of this medication are oval-shaped, pink, and biconvex, coated with a film, engraved with a “J” on one face and with “156” on the other face.

This medication is available in aluminum/aluminum blisters packaged in cardboard boxes containing 10, 30, or 60 tablets, and in HDPE bottles filled with purified cotton and a child-resistant polypropylene cap with an inner lining of pulp (comprising coating, wax, aluminum foil, PET, and thermal sealing, containing 60 tablets.Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Estate

PLA 3000 Paola

Malta

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medication is authorized in the member states of the European Economic Area with the following names:

Germany:Valganciclovir Amarox 450 mg Filmtabletten

Spain:Valganciclovir Tarbis 450 mg film-coated tablets

Netherlands:Valganciclovir Amarox 450 mg filmomhulde tabletten

United Kingdom:Valganciclovir Amarox 450 mg film-coated tablets

Last review date of this leaflet: April 2022

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)