Valganciclovir Aurovitas 450 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Valganciclovir Aurovitas 450 mg film-coated tablets EFG

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do 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 Aurovitas is and what it is used for
2. What you need to know before taking Valganciclovir Aurovitas
3. How to take Valganciclovir Aurovitas
4. Possible side effects
5. How to store Valganciclovir Aurovitas
6. Contents of the pack and other information

1. What Valganciclovir Aurovitas is and what it is 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 in the tablets, valganciclovir, is metabolized into ganciclovir. Ganciclovir prevents the virus known as cytomegalovirus (CMV) from multiplying and invading healthy cells. In patients with a weakened immune system, CMV can cause organ infections in the body, which may be life-threatening.

Valganciclovir is used:

• for the treatment of retinitis (an infection of the retina) caused by cytomegalovirus in adult patients with AIDS (Acquired Immunodeficiency Syndrome). CMV infection in the retina of the eye can lead to vision problems and even blindness.
• for the prevention of cytomegalovirus (CMV) disease in adults and children who have not been infected with CMV and who have received an organ transplant from a donor who was infected with CMV.

2. What you need to know before taking 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 breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Valganciclovir Aurovitas.

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

Take special care with valganciclovir:

• if you have low levels of white blood cells, red blood cells, or platelets (small cells involved in blood clotting). Your doctor will perform a blood test before you start taking valganciclovir and will carry out further blood tests during treatment.
• if you are receiving radiotherapy or haemodialysis.
• if you have kidney problems. Your doctor may prescribe a lower dose and may require frequent blood tests during treatment.
• if you are taking ganciclovir capsules and your doctor advises switching your treatment to valganciclovir tablets. It is important not to take more tablets than prescribed by your doctor, as this could increase the risk of overdose.

Taking Valganciclovir Aurovitas with other medicines

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

Taking other medicines together with valganciclovir may affect the amount of medicine reaching the bloodstream or could cause harmful effects. Inform your doctor if you are already taking any of the following medicines:

• imipenem-cilastatin (an antibiotic). Taking this medicine together with valganciclovir may cause seizures (fits).
• zidovudine, didanosine, lamivudina, 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 used to treat gout). Taking probenecid and valganciclovir 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/sulfa combinations, or dapsone (antibiotics).
• pentamidine (a medicine used to treat 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 are unable to eat, you should continue taking your dose of valganciclovir as usual.

Pregnancy, breastfeeding, and fertility

You must not take valganciclovir if you are pregnant unless your doctor specifically recommends it. If you are pregnant or planning to become pregnant, inform your doctor. Taking valganciclovir during pregnancy may cause harm to the unborn baby.

You must not take valganciclovir while breastfeeding. You must stop breastfeeding before starting treatment.

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

Men whose partners are or may become pregnant must use a condom during treatment with valganciclovir and continue using it for 90 days after stopping treatment.

Driving and using machines

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 medicine.

3. How to take Valganciclovir Aurovitas

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

Valganciclovir tablets must be handled with care. They must not be broken or crushed. You must swallow them whole, and always with food whenever possible. If you accidentally touch a broken tablet, wash your hands thoroughly with soap and water. If the tablet powder has come into contact with your eyes, rinse them with sterile water, or with tap water if sterile water is not available.

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

Valganciclovir tablets should always 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 your transplant. 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 continue taking the tablets for up to 200 days.

Treatment of CMV retinitis in AIDS patients (also known as induction treatment)

The usual dose of valganciclovir is two tablets taken TWICE daily for 21 days (three weeks). Do not continue this dose for longer than 21 days unless instructed by your doctor, as this dose may increase the risk of possible 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. Try to take the tablets at the same time each day. Your doctor will advise you how long you should continue taking valganciclovir. If your retinitis worsens while taking this dose, your doctor will decide whether you should repeat the induction treatment (as above) or whether to switch you to 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 are not functioning properly, your doctor may instruct you to take fewer tablets each 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

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 their transplant. The dose will depend on the child's size and should be taken ONCE daily. Your doctor will determine the most appropriate dose based on the child's height, weight, and renal function. This dose should be continued until 100 days post-transplant. If your child has received a kidney transplant, your doctor may recommend continuing the prescribed dose up to 200 days.

For children unable to swallow valganciclovir coated tablets, valganciclovir oral solution powder may be used.

If you take more Valganciclovir Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

Contact your doctor or hospital immediately if you have taken or think you have taken more valganciclovir tablets than you should. Taking more tablets than prescribed may cause serious adverse effects, particularly affecting the blood or kidneys. You may require 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 then take the next dose at your usual scheduled time. Do not take a double dose to make up for a missed dose.

If you stop taking Valganciclovir Aurovitas

Do 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 everybody gets them.

Allergic reactions

In 1 out of 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 department if you experience any of the following effects:

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

Serious adverse effects

Tell your doctor immediately if you notice any of the following serious adverse effects. Your doctor may ask you to stop taking valganciclovir, and you may require 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 including shortness of breath or fatigue, palpitations, or paleness.

Common: may affect up to 1 in 10 people

• Blood infection (sepsis), with symptoms including fever, chills, palpitations, confusion, and difficulty speaking.
• Decrease in the number of platelets, with signs including more frequent bleeding or bruising than normal, blood in urine or stools, or bleeding from gums, which may become severe.
• Severe decrease in blood cells.
• Pancreatitis, with signs such as severe stomach pain spreading to the back.
• Seizures.

Uncommon: may affect up to 1 in 100 people

• Inability 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 function failure.

The following are adverse effects reported with valganciclovir or ganciclovir.

Other adverse effects

Tell your doctor or pharmacist if you notice 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.
• Nausea.
• Abdominal pain.
• Eczema.
• Feeling of tiredness.
• Fever.

Common: may affect up to 1 in 10 people

• Influenza (flu).
• Urinary tract infection, with signs including fever, increased need to urinate, pain when urinating.
• Skin and underlying tissue infection.
• Mild allergic reaction, with signs including skin itching and redness.
• Weight loss.
• Feeling of depression, anxiety, or confusion.
• Sleep disorders.
• Sensation of weakness or numbness in hands and feet, which may affect your balance.
• Changes in sense of touch, tingling, pins and needles, prickling, or burning sensation.
• 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 swelling.
• Mouth ulcers.
• Abnormal results in liver and kidney laboratory tests.
• Night sweats.
• Itching, skin rash.
• Hair loss.
• Back pain, muscle and joint pain, muscle spasms.
• Dizziness, weakness, or general malaise.

Uncommon: (may affect up to 1 in 100 people)

• Restlessness.
• Tremor, agitation.
• Deafness.
• Irregular heartbeat.
• Hives, dry skin.
• Blood in the urine.
• Infertility in men (see section “Fertility”).
• Chest pain.

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

Additional adverse effects in children and adolescents

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 the carton after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valganciclovir Aurovitas

• The active substance is valganciclovir. Each film-coated tablet contains 450 mg of valganciclovir (as 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, iron oxide red (E172).

Appearance of the product and contents of the pack

Film-coated, pink, oval, biconvex tablets with the imprint “H” on one side and “96” on the other. The size is 16.8 mm × 7.9 mm.

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

Pack sizes:

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

HDPE bottles: 60 and 1000 film-coated tablets.

Only some pack sizes may be commercially available.

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 European Economic Area member states 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 most recent review of this leaflet: July 2018

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