Prospect: information for the user

Valganciclovir Aurovitas 450 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Valganciclovir Aurovitas and how it is used

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

3.How to take Valganciclovir Aurovitas

4.Possible adverse effects

5.Storage of Valganciclovir Aurovitas

6.Contents of the package and additional information

Valganciclovir Aurovitas belongs to a group of medicines that directly act 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 pose a life-threatening risk.

Valganciclovir is used:

-for the treatment of retinitis (retina infection) caused by cytomegalovirus in adult patients with AIDS (Acquired Immune Deficiency Syndrome). CMV infection in the retina of the eye can cause vision problems and even blindness.

-for the prevention of cytomegalovirus (CMV) disease inadults and childrenwho have not been infected by CMV and who have received an organ transplant from a donor who was infected by CMV.

Do not take Valganciclovir Aurovitas

-if you are allergic to valganciclovir, gancicloviror any of the other ingredients of this medication (listed in section 6).

-if you are breastfeeding.

Warnings and precautions

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

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

Be especially careful with valganciclovir:

-if you have a low number of white blood cells in your blood, red blood cells or platelets (small cells involved in blood clotting). Your doctor will perform a blood test before starting to take valganciclovir and will perform more blood tests while you are on treatment.

-if you are receiving radiation therapy or hemodialysis.

-if you have kidney problems. Your doctor may prescribe a lower dose and you may need to have blood tests frequently during treatment.

-if you are taking ganciclovir capsules and your doctor tells you to change your treatment to valganciclovir tablets. It is essential 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 medications

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

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

-imipenem-cilastatina (antibiotic). Taking this medication with valganciclovir may cause seizures (convulsions).

-zidovudine, didanosine, lamivudine, stavudine, tenofovir, abacavir, emtricitabine or similar medications for the treatment of HIV/AIDS.

-adefovir or any other medication used for the treatment of hepatitis B.

-probenecid (medication for the treatment of gout). Taking probenecid and valganciclovir at the same time may increase the amount of ganciclovir in the blood.

-micophenolate mofetil, cyclosporin or tacrolimus (used after transplants).

-vincristine, vinblastine, doxorubicin, hydroxyurea or similar medications for the treatment of cancer.

-trimethoprim, combinations of trimethoprim/sulfamethoxazole and dapsone (antibiotics).

-pentamidine (medication for the treatment of parasites or lung infections).

-flucytosine or amphotericin B (antifungal agents).

Taking Valganciclovir Aurovitas with food and drinks

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

Pregnancy, breastfeeding and fertility

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

You should not take valganciclovir during breastfeeding. Before starting treatment, you should stop breastfeeding your baby.

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

Men whose partners may become pregnant or may become pregnant should use a condom while taking valganciclovir and should continue to use a condom for 90 days after completing treatment.

Driving and operating machinery

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, consult your doctor or pharmacist again.

Valganciclovir tablets should be handled with care. Do not break or crush them. Swallow them whole with food whenever possible. If you accidentally touch a broken tablet, wash your hands thoroughly with water and soap, and if the powder from the tablets has come 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 adhere 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 medication 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 HIV patients (also known as 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 HIV patients with 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 taking valganciclovir. If your retinitis worsens while you are taking this dose, your doctor will tell you if you should repeat the induction treatment (as above) or if they decide to give you a different medication to treat the CMV infection.

Older patients

Valganciclovir has not been studied in older patients.

Patients with kidney problems

If your kidneys do not function properly, your doctor may advise 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 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 until 100 days. If your child has received a kidney transplant, your doctor may recommend that you take the prescribed dose until 200 days.

For children who cannot swallow the coated valganciclovir tablets, the oral powder solution of valganciclovir may 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, phone 91 562 04 20, indicating the medication 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 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 the missed doses.

If you interrupt treatment with Valganciclovir Aurovitas

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 medicinecan cause side effects, although not everyone will experience them.

Allergic reactions

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

-raised, itchy skin rash (hives or urticaria).

-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 valganciclovir and you may need urgent medical treatment:

Very common:may affect more than 1 in 10 people

•decreased white blood cell count, with signs of infection such as sore throat, mouth ulcers, or fever.

•decreased red blood cell count, with signs that include shortness of breath or fatigue, palpitations, or paleness.

Common:may affect up to 1 in 10 people

•blood infection (sepsis), with symptoms that include fever, chills, palpitations, confusion, and difficulty speaking.

•decreased platelet count, with signs that include frequent bruising or bleeding, blood in urine or stools, or bleeding gums, which may be severe.

•severe decrease in blood cell count.

•pancreatitis, with signs such as severe stomach pain that radiates to the back.

•seizures.

Uncommon:may affect up to 1 in 100 people

•bone marrow failure to produce blood cells.

•hallucinations (hearing or seeing things that are not real).

•abnormal thoughts or feelings, loss of contact with reality.

•kidney function failure.

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

Other side effects

Inform 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, pharyngitis).

•loss of appetite.

•headache.

•cough.

•shortness of breath.

•diarrhea.

•nausea.

•abdominal pain.

•eczema.

•fatigue.

•fever.

Common:may affect up to 1 in 10 people

•influenza.

•urinary tract infection, with signs that include fever, frequent urination, or pain while urinating.

•skin and subcutaneous tissue infection.

•mild allergic reaction, with signs that include itching and skin redness.

•weight loss.

•feeling of depression, anxiety, or confusion.

•sleep disorders.

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

•changes in sensation, tingling, pins and needles, or burning sensation.

•changes in taste.

•chills.

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

•ear pain.

•low blood pressure, which may cause dizziness or fainting.

•swallowing difficulties.

•constipation, gas, indigestion, abdominal pain, or bloating.

•mouth ulcers.

•abnormal liver and kidney function test results.

•nocturnal sweating.

•itching, skin rash.

•hair loss.

•back pain, muscle or joint pain, muscle spasms.

•feeling of dizziness, weakness, or general discomfort.

Uncommon:(may affect up to 1 in 100 people

•feeling of unease.

•tremor, agitation.

•hearing loss.

•irregular heartbeat.

•hives, dry skin.

•blood in urine.

•infertility in men (see "Fertility" section).

•chest pain.

Only in patients with AIDS treated with valganciclovir for CMV infection, retinal detachment has occurred.

Additional side effects in children and adolescents

The side effects reported in children and adolescents are similar to those reported for 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 the Vigilance of Medicinal Products for Human Use:www.notificaram.es. By 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 blister pack and the box after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Valganciclovir Aurovitas

-The active ingredient is valganciclovir. Each film-coated tablet contains 450 mg of valganciclovir (as hydrochloride).

-The other components are:

Core of the tablet:microcrystalline cellulose (grades 101 and 102), crospovidone (type B), povidone (K-30), magnesium stearate.

Coating of the tablet:hypromellose (3 cP, 6 cP), titanium dioxide (E171), macrogol 400, polysorbate 80, iron oxide red (E172).

Appearance of the product and contents of the package

Film-coated tablets of pink color, 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 blisters of Polyamide/Aluminum/PVC-Aluminum and in high-density polyethylene (PEAD) bottles with a polypropylene closure and cotton wadding.

Packaging sizes:

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

PEAD bottles:60 and 1000 film-coated tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the Marketing Authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D,

28036 Madrid

Spain

Responsible for Manufacturing:

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 with 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 comprimidos recubiertos con película 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

Last review date of this leaflet: July 2018

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es).