VALGANCICLOVIR AUROVITAS 450 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Valganciclovir Aurovitas 450 mg film-coated tablets EFG

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

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

Valganciclovir Aurovitas 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 infection in the body's organs. This can be life-threatening.

Valganciclovir is used:

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

2. What you need to know before you take Valganciclovir Aurovitas

Do not take Valganciclovir Aurovitas

• 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 taking Valganciclovir Aurovitas.

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

Be careful with valganciclovir:

• if you have a low number of white blood cells, red blood cells or platelets (small cells involved in blood clotting) in your blood. Your doctor will perform a blood test before you start taking valganciclovir and will perform more tests while you are being treated.
• if you are receiving radiotherapy or haemodialysis.
• 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 switch to valganciclovir tablets. It is important that you do not take more tablets than prescribed by your doctor or you may be at risk of an overdose.

Taking Valganciclovir Aurovitas with other medicines

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

If you take other medicines at the same time as taking valganciclovir, 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 any of the following medicines:

• imipenem-cilastatin (an antibiotic). Taking this medicine with valganciclovir may cause seizures (fits).
• zidovudine, didanosine, lamivudine, stavudine, tenofovir, abacavir, emtricitabine or similar medicines for the treatment of AIDS.
• adefovir or any other medicine used for the treatment of hepatitis B.
• probenecid (a medicine for the treatment of gout). Taking probenecid and valganciclovir at the same time may 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).

Taking Valganciclovir Aurovitas with food and drink

Valganciclovir should be taken with food. If for any reason you cannot eat, you should continue to take your dose of valganciclovir as usual.

Pregnancy, breast-feeding and fertility

Do 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. If you take valganciclovir when you are pregnant, it may harm the unborn baby.

Do not take valganciclovir during breast-feeding. Before starting treatment, you must stop breast-feeding.

Women of childbearing age must use effective contraceptive methods while taking valganciclovir and for at least 30 days after the end of treatment.

Men whose partners may become pregnant or may be pregnant must use a condom while taking valganciclovir and must continue to use it for 90 days after the end of treatment.

Driving and using machines

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

Consult your doctor or pharmacist before using any medicine.

3. How to take Valganciclovir Aurovitas

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

Valganciclovir tablets 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, and if the powder from the tablets comes into contact with your eyes, rinse them with sterile water or tap water if sterile water is not available.

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

Valganciclovir tablets 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 receiving 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 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 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 to take valganciclovir. If your retinitis worsens while you are taking this dose, your doctor will tell you whether you should repeat the induction treatment (as above) or may decide to give you a different medicine to treat the CMV infection.

Elderly patients

Valganciclovir has not been studied in elderly patients.

Patients with kidney problems

If your kidneys do not work properly, your doctor may tell you to take fewer tablets each 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

Valganciclovir 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 which dose is most suitable based on the child's height, weight and kidney function. You should continue with this dose until 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 film-coated tablets, the oral solution powder of valganciclovir can be used.

If you take more Valganciclovir Aurovitas than you should

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

Contact your doctor or hospital immediately if you have taken or think you have taken more valganciclovir tablets than you should. Taking more tablets can cause serious side effects, particularly affecting the blood or kidneys. You may need hospital treatment.

If you forget to take Valganciclovir Aurovitas

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 missed doses.

If you stop taking Valganciclovir Aurovitas

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

• raised itchy rash (hives or nettlerash).
• 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 valganciclovir and you may need urgent medical treatment:

Very common: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 that include shortness of breath or tiredness, palpitations or pale skin.

Common:may affect up to 1 in 10 people

• blood infection (sepsis), with symptoms that include fever, chills, palpitations, confusion and difficulty speaking.
• decrease in the number of platelets, with signs that include bleeding or bruising more easily than usual, blood in urine or stools or bleeding from the gums, which can be severe.
• severe decrease in the number of blood cells.
• pancreatitis, with signs such as severe stomach pain that spreads to the back.
• seizures.

Uncommon:may affect up to 1 in 100 people

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

The following side effects have been reported with valganciclovir or ganciclovir.

Other side effects

Tell your doctor or pharmacist if you notice any of the following side 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.
• diarrhoea.
• nausea.
• abdominal pain.
• eczema.
• feeling tired.
• fever.

Common:may affect up to 1 in 10 people

• flu.
• urinary tract infection, with signs that include fever, need to urinate more frequently, pain when urinating.
• skin and subcutaneous tissue infection.
• mild allergic reaction, with signs that include itching and redness of the skin.
• weight loss.
• feeling depressed, anxious or confused.
• sleep disorders.
• feeling weak or numb in hands and feet, which can affect your balance.
• changes in touch, tingling, prickling, pinching or burning sensation.
• 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 bloating.
• mouth ulcers.
• abnormal results of liver and kidney laboratory tests.
• night sweats.
• itching, skin rash.
• hair loss.
• back pain, muscle and joint pain, muscle spasms.
• feeling dizzy, weak or unwell.

Uncommon:(may affect up to 1 in 100 people

• feeling restless.
• tremors, agitation.
• deafness.
• irregular heartbeat.
• hives, dry skin.
• blood in the urine.
• infertility in men (see section "Fertility").
• chest pain.

In patients with AIDS treated with valganciclovir for CMV infection, separation of the inner layer of the eye (retinal detachment) has 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 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 through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Valganciclovir Aurovitas

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 blister and carton after EXP. The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Valganciclovir Aurovitas

• The active ingredient is valganciclovir. Each film-coated tablet contains 450 mg of valganciclovir (in the form of hydrochloride).
• The other components are:

Tablet core:microcrystalline cellulose (grade-101 and grade-102), crospovidone (type B), povidone (K-30), magnesium stearate.

Tablet coating:hypromellose (3 cP, 6 cP), titanium dioxide (E171), macrogol 400, polysorbate 80, red iron oxide (E172).

Appearance of the Product and Container Contents

Film-coated tablets are pink, oval, biconvex, with the mark “H” on one face and “96” on the other. The size is 16.8 mm x 7.9 mm.

Valganciclovir Aurovitas film-coated tablets are available in Polyamide/Aluminum/PVC-Aluminum blisters and in high-density polyethylene (HDPE) bottles with a polypropylene cap and cotton fillers.

Container sizes:

Blister:10, 30, 60, and 100 film-coated tablets.

HDPE bottles:60 and 1000 film-coated tablets.

Only some container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D,

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

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

Germany: Valganciclovir PUREN 450mg Filmtabletten

Cyprus: Valganciclovir Aurovitas 450 mg επικαλυμμ?νο με λεπτ? υμ?νιο δισκ?α

Denmark: Valganciclovir “Orion”

Spain: Valganciclovir Aurovitas 450 mg film-coated tablets EFG

Finland: Valganciclovir Orion 450 mg kalvopäällysteiset tabletit

France: VALGANCICLOVIR ARROW 450 mg, comprimé pelliculé

Italy: Valganciclovir Aurobindo

Netherlands: Valganciclovir Aurobindo 450 mg, filmomhulde tabletten

Portugal: Valganciclovir Aurobindo

Sweden: Valganciclovir Orion 450 mg filmdragerade tabletter

Date of the last revision of this leaflet: July 2018

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