Valganciclovir Tarbis 450 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Valganciclovir Tarbis 450 mg film-coated tablets EFG

Valganciclovir hydrochloride

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

Leaflet Contents

1. What Valganciclovir Tarbis is 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. How to store Valganciclovir Tarbis
6. Contents of the pack and other information

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

This medicine 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 to ganciclovir. Ganciclovir prevents the 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 may be life-threatening.

This medicine is used:

• for the treatment of CMV retinitis 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 CMV disease in adults and children who are not infected with this virus but who have received an organ transplant from a donor who was infected with CMV.

2. What you need to know before starting to take Valganciclovir Tarbis

Do not take Valganciclovir Tarbis

• if you are allergic to valganciclovir, ganciclovir, or any of the other ingredients of this medicine (listed in section 6).
• if you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine

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

Take special care with Valganciclovir Tarbis:

• if you have low blood counts of white blood cells, red blood cells, or platelets (small cells involved in blood clotting). Your doctor will perform blood tests before you start taking this medicine and you will need further blood tests during 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 require frequent blood tests during treatment.
• if you are currently taking ganciclovir capsules and your doctor instructs you to switch your treatment to tablets of this medicine. It is important not to take more tablets than prescribed by your doctor, as you may be at risk of overdose.

Other medicines and Valganciclovir Tarbis

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

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

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

Use of Valganciclovir Tarbis with food and drinks

This medicine should be taken with food. If for any reason you are unable to eat, you should still take your usual dose of this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

You must not take this medicine during breastfeeding. If your doctor prescribes treatment with this medicine, you must stop breastfeeding before starting to take the tablets.

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

Men whose partners may become pregnant must use condoms during treatment with this medicine and continue using them for 90 days after treatment has ended.

Driving and operating machinery

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

Consult your doctor or pharmacist before using any medication.

3. How to take Valganciclovir Tarbis

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

The tablets of this medicine must be handled with care. They must not be broken or crushed. You must swallow them whole and, whenever possible, with food. If you accidentally touch a broken tablet, wash your hands thoroughly with soap and water. If tablet powder comes into contact with your eyes, rinse them with sterile water, or with plenty of running water if sterile water is not available.

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

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

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 take the tablets for 200 days.

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

The usual dose is two tablets taken TWICE daily for 21 days (three weeks). Do not continue this dose for longer than 21 days unless directed by your doctor, as this dose may increase your risk of potential 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. You should try to take the tablets at the same time each day. Your doctor will inform you how long you should continue treatment with this medicine. If your retinitis worsens while you are taking this dose, your doctor will advise whether you should repeat the induction treatment (as described above) or may decide to give you a different medicine to treat the CMV infection.

Elderly patients

This medicine has not been studied in elderly patients.

Patients with kidney problems

If your kidneys are not working properly, your doctor will instruct you to take fewer tablets per day or to take the 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 liver problems

This medicine 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 must be taken ONCE daily. Your doctor will determine the most appropriate dose based on your child's height, weight, and renal function. This dose should be continued for up to a maximum of 100 days. If your child has received a kidney transplant, your doctor may recommend taking the prescribed dose for 200 days.

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

If you take more Valganciclovir Tarbis than you should

Contact your doctor or hospital immediately if you have taken or think you have taken more tablets of this medicine than you should. Taking too many tablets may cause serious adverse effects, particularly affecting the blood or kidneys. You may require hospital treatment.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 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 then take the next dose at your usual time. Do not take a double dose to make up for forgotten doses.

If you stop treatment with Valganciclovir Tarbis

You must not stop treatment unless instructed by your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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. STOP taking this medicine and go to the nearest hospital emergency department immediately if you experience any of the following:

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

Serious adverse effects

Contact your doctor immediately if you notice any of the following serious adverse effects. Your doctor may instruct you to stop taking this medicine, and you may require urgent medical treatment:

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

• decrease in white blood cell count, with signs of infection such as sore throat, mouth ulcers, or fever
• decrease in red blood cell count (anemia), with signs including shortness of breath, fatigue, palpitations, or pallor

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

• blood infection (sepsis), with signs including fever, chills, palpitations, confusion, and difficulty speaking
• decrease in platelet count, with signs including more frequent bleeding or bruising than normal, blood in urine or stools, or bleeding from gums, potentially leading to severe bleeding
• severe decrease in blood cell counts
• pancreatitis, with symptoms such as severe stomach pain radiating to the back
• seizures (epileptic fits)

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

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

The following adverse effects may occur during treatment with valganciclovir or ganciclovir:

Other adverse effects

Tell your doctor, pharmacist, or nurse if you experience any of the following adverse effects:

Very common (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
• diarrhea
• feeling or being sick
• abdominal pain
• eczema
• fatigue
• fever

Common (may affect up to 1 in 10 people)

• influenza (flu)

• urinary tract infection, with signs including fever, more frequent urination, pain during urination

• skin and subcutaneous tissue infection

• mild allergic reactions, with signs including skin redness and swelling

• weight loss

• feeling depressed, anxious, or confused

• sleep disorders

• numbness or weakness in hands and feet, which may affect your balance

• changes in touch sensation, tingling, prickling, pins and needles, or burning sensations

• changes in taste

• chills

• eye inflammation (conjunctivitis), eye pain, or vision problems

• ear pain

• low blood pressure, which may make you feel dizzy or faint

• difficulty swallowing

• constipation, gas, indigestion, stomach pain, abdominal distension

• mouth ulcers

• abnormal laboratory test results for liver and kidney function

• night sweats

• itching, rash

• hair loss

• back, muscle, or joint pain, muscle spasms

• dizziness, weakness, or general malaise

Uncommon (may affect up to 1 in 100 people)

• restlessness
• tremors
• deafness
• irregular heartbeat
• hives and dry skin
• blood in the urine
• infertility in men (see section on "Fertility")
• chest pain

Retinal detachment (separation of the inner layer of the eye) has only been reported in AIDS patients treated with this medicine for CMV infection.

Additional adverse effects in children and adolescents

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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if they are possible adverse reactions not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Valganciclovir Tarbis

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

Do not use this medicine after the expiry date stated on the label of the bottle or on the box after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valganciclovir Tarbis

The active substance is 450 mg of valganciclovir, present as 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 pack

The tablets of this medicine are oval, pink, biconvex, film-coated tablets, marked with a "J" on one side and "156" on the other.

This medicine is available in aluminum/aluminum blisters packed in cardboard boxes containing 10, 30 or 60 tablets, and in HDPE bottles filled with purified cotton and equipped with a child-resistant screw cap made of polypropylene, with an inner seal composed of pulp (comprising lining, wax, aluminum foil, PET, and thermal sealing), containing 60 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

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

The Netherlands

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

Germany: Valganciclovir Amarox 450 mg Filmtabletten

Spain: Valganciclovir Tarbis 450 mg film-coated tablets EFG

The Netherlands: Valganciclovir Amarox 450 mg filmomhulde tabletten

United Kingdom: Valganciclovir Amarox 450 mg film-coated tablets

Date of the most recent review of this leaflet: April 2022

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.gob.es/)