VALGANCICLOVIR TARBIS 450 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Valganciclovir Tarbis 450 mg film-coated tablets EFG

Valganciclovir hydrochloride

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

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

1. What is Valganciclovir Tarbis and what is it 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 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.

This medicine is used:

• to treat CMV retinitis in adult patients with Acquired Immune Deficiency Syndrome (AIDS). CMV infection in the retina of the eye can cause vision problems and even blindness.
• to prevent CMV disease in adults and children who are not infected with this virus but have received an organ transplant from a donor who is infected with CMV.

2. What you need to know before you 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 breast-feeding.

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.

Be particularly 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 perform blood tests before you start taking this medicine and will need to perform more tests while you are being treated.
• if you are receiving radiotherapy or haemodialysis.
• if you have kidney problems. Your doctor may need to prescribe a lower dose and you may need frequent blood tests during treatment.
• if you are currently taking ganciclovir capsules and your doctor tells you to switch to this medicine. It is important that you do not take more than the number of tablets prescribed by your doctor, as this could put you at risk of an overdose.

Other medicines and Valganciclovir Tarbis

Tell your doctor or pharmacist if you are taking or have recently taken or might 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 may cause harmful effects. Tell your doctor if you are already taking medicines that contain any of the following active substances:

• imipenem-cilastatin (an antibiotic). Taking this medicine with this medicine 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 (a medicine for treating gout). Taking probenecid and this medicine 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 (a medicine for the treatment of parasites or lung infections).
• flucytosine or amphotericin B (antifungal agents)

Using Valganciclovir Tarbis with food and drinks

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

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take this medicine if you are pregnant unless your doctor advises you to. If you are pregnant or planning to become pregnant, you must tell your doctor. Taking this medicine when you are pregnant may harm your unborn baby.

Do not take this medicine while you are breast-feeding. If your doctor advises you to start treatment with this medicine, you must stop breast-feeding before you start taking the tablets.

Women of childbearing potential must use effective contraception while taking this medicine and for at least 30 days after treatment has finished.

Men whose partners may become pregnant should use condoms while taking this medicine and continue to use them for 90 days after finishing treatment.

Driving and using machines

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

Ask your doctor or pharmacist for advice before taking any medicine.

3. How to take Valganciclovir Tarbis

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

The tablets of this medicine should be handled with care. They should not be broken or crushed. You should 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 plenty of running water if sterile water is not available.

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

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 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 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 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 treatment with this medicine. If your retinitis worsens while you are taking this dose, your doctor may tell you to 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 tell you to take fewer tablets per day or only take the tablets on certain days of the week. It is very important that you only take 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 of receiving 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 the most suitable dose based on your child's height, weight and kidney function. You should continue with this dose for up to 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 film-coated tablets, valganciclovir powder for oral solution can 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 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 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 forgotten doses.

If you stop taking Valganciclovir Tarbis

Do not stop treatment unless your doctor tells you to.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 casualty department of your nearest hospital if you experience any of the following effects:

• raised itchy rash (hives)
• sudden swelling of the throat, face, lips and mouth that may cause difficulty in swallowing or breathing.
• sudden swelling of the 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 this medicine and you may need urgent medical treatment:

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

• low white blood cell count, with signs of infection such as sore throat, mouth ulcers or fever
• low red blood cell count, with signs that include shortness of breath or tiredness, palpitations or pale skin

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
• low platelet count, with signs that include bleeding or bruising more easily than normal, blood in the urine or stools or bleeding from the gums, which can be severe
• severe decrease in blood cell count
• pancreatitis, with signs such as severe stomach pain that spreads 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)
• abnormal thoughts or feelings, loss of contact with reality
• kidney failure

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

Other side effects

Tell your doctor, pharmacist or nurse if you notice any of the following side effects:

Very common(may affect more than 1 in 10 people)

• candidiasis and oral candidiasis
• infection of the upper respiratory tract (e.g. sinusitis, tonsillitis)
• loss of appetite
• headache
• cough
• shortness of breath
• diarrhoea
• feeling or being sick
• abdominal pain
• eczema
• fatigue
• fever

Common(may affect up to 1 in 10 people)

• flu
• urinary tract infection, with signs that include fever, frequent urination, pain when urinating
• infection of the skin and subcutaneous tissue
• mild allergic reactions, with signs that include redness and swelling of the skin

• weight loss
• feeling depressed, anxious or confused
• sleep disorders
• numbness or weakness in hands and feet, which can affect your balance
• changes in touch, feeling of tingling, prickling, pinching or burning
• changes in taste
• chills
• eye inflammation (conjunctivitis), eye pain or vision problems
• ear pain
• low blood pressure, which can 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 pain, muscle or joint pain, muscle spasms
• feeling dizzy, weak or unwell

Uncommon(may affect up to 1 in 100 people)

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

Detachment of the inner layer of the eye (retinal detachment) has only 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 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 via the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es By reporting side effects, 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 which is stated on the label of the bottle or on the 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. Container Contents and Additional Information

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:

Core of the tablet: microcrystalline cellulose (E 460); crospovidone type A (E 1202), povidone (K-30) (E 1201), and stearic acid (E 570).

Coating of the tablet: hypromellose (E 464), titanium dioxide (E 171), macrogol 400, red iron oxide (E 172), and polysorbate 80 (E 433).

Appearance of Valganciclovir Tarbis and Container Contents

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

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 with a child-resistant polypropylene screw cap with an inner lining of pulp (composed of lining, wax, aluminum paper, PET, and thermal sealing), which contain 60 tablets.

Only some package 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

Netherlands

This medication 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

Netherlands: Valganciclovir Amarox 450 mg filmomhulde tabletten

United Kingdom: Valganciclovir Amarox 450 mg film-coated tablets

Date of the Last Revision of this Prospectus: April 2022

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