VALGANCICLOVIR KERN PHARMA 450 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Valganciclovir Kern Pharma 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 and other information

1. What is Valganciclovir Kern Pharma and what is it used for
2. What you need to know before you take Valganciclovir Kern Pharma
3. How to take Valganciclovir Kern Pharma
4. Possible side effects

5 Storage of Valganciclovir Kern Pharma

1. Contents of the pack and further information

1. What is Valganciclovir Kern Pharma and what is it used for

Valganciclovir 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.

This medicine is used:

• For the treatment of retinitis (infection of the retina) caused by cytomegalovirus in adult patients with AIDS (Acquired Immune Deficiency Syndrome). CMV infection in the eye's retina can cause vision problems and even blindness.
• For the prevention of cytomegalovirus (CMV) disease in adults and children who have not had this virus, but have received a solid organ transplant from a donor who was infected with CMV.

2. What you need to know before you take Valganciclovir Kern Pharma

Do not take Valganciclovir Kern Pharma

• If you are allergic to valganciclovir or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to ganciclovir, aciclovir or valaciclovir, which are medicines used to treat other viral infections.
• If you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

Other medicines and Valganciclovir Kern Pharma

Tell your doctor or pharmacist that 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 (antibiotic). Taking this medicine with valganciclovir may cause seizures (fits).
• Zidovudine, didanosine, lamivudine, tenofovir, abacavir, emtricitabine or similar medicines for the treatment of AIDS.
• Ribavirin, pegylated interferons, adefovir and entecavir, for the treatment of Hepatitis B/C.
• Probenecid (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 (used after transplants).
• Vincristine, vinblastine, adriamycin, hydroxyurea or similar medicines for the treatment of cancer.
• Cidofovir or foscarnet used for the treatment of viral infections.
• Trimethoprim, trimethoprim/sulphamethoxazole combinations and dapsone (antibiotics).
• Pentamidine (medicine for the treatment of parasites or lung infections).
• Flucytosine or amphotericin B (antifungal agents).

Taking Valganciclovir Kern Pharma with food and drinks

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

Pregnancy, breastfeeding and fertility

Do not take valganciclovir if you are pregnant, unless your doctor advises you to. 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 fetus.

Do not take valganciclovir during breastfeeding. Before starting treatment, you must stop breastfeeding.

Women of childbearing age must use effective contraceptive methods while taking valganciclovir.

Men, whose partners may be pregnant or may become pregnant, must use a condom while taking this medicine and must continue to use it for 90 days after finishing treatment.

Driving and using machines

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

Consult your doctor or pharmacist before using any medicine.

3. How to take Valganciclovir Kern Pharma

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Valganciclovir tablets should be handled with care. They cannot 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 water and soap, and if the powder from the tablets comes into contact with your eyes, rinse them with sterile water or abundant 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, whenever possible, should be taken with food (see section Taking Valganciclovir Kern Pharma with food, drink and alcohol).

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 cytomegalovirus (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 taking 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 will tell you to take fewer tablets each day or only take the tablets on certain days of the week. It is very importantthat 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 child's size and should be taken ONCE a day. Your doctor will decide what dose is most suitable for your child based on their 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 until 200 days.

For children who cannot swallow the valganciclovir film-coated tablets, valganciclovir powder for oral solution can be used.

If you take more Valganciclovir Kern Pharma than you should

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 need hospital treatment.

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.

If you forget to take Valganciclovir Kern Pharma

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 Kern Pharma

Do not stop treatment unless your doctor tells you to.

If you have any further questions on the use of this product, 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 100 people, a sudden and severe allergic reaction to valganciclovir (anaphylactic shock) may occur. STOPtaking this medicine and go to the emergency department of the nearest hospital when you experience any of the following effects:

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

The side effects reported with valganciclovir or ganciclovir are as follows:

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

• Blood effects: decrease in the number of white blood cells in the blood (neutropenia), which will make you more likely to catch infections, a decrease in the pigment of the blood that carries oxygen (anaemia), which can cause tiredness and difficulty breathing when exercising.
• Respiratory effects: feeling short of breath and difficulty breathing (dyspnoea).
• Effects on the stomach and digestive system: diarrhoea.

Common(may affect up to 1 in 10 people)

• Blood effects: decrease in the number of leucocytes (blood cells that fight infection) in the blood (leucopenia), decrease in the number of platelets in the blood (thrombocytopenia), which can cause bruising and bleeding, and a decrease in the number of several types of blood cells at the same time (pancytopenia).
• Effects on the central nervous system: headache, difficulty sleeping (insomnia), disorder of taste (dysgeusia), decreased sensitivity in hands or feet (peripheral neuropathy), dizziness and seizures (fits).
• Effects on the eyes: eye pain, inflammation inside the eye (edema), separation of the inner layer of the eye (retinal detachment) and floaters.
• Effects on the ears: ear pain.
• Effects on the stomach and digestion: nausea and vomiting, stomach pain, constipation, gas, indigestion (dyspepsia) and difficulty swallowing (dysphagia).
• Effects on the skin: skin inflammation (dermatitis), itching (pruritus) and night sweats.
• Effects on muscles, joints and bones: back pain, muscle pain (myalgia), joint pain (arthralgia), muscle stiffness and muscle cramps.
• Infections: fungal infection in the mouth (oral candidiasis), bacterial or viral infections in the blood, inflammation of the skin cells (cellulitis), inflammation or infection of the kidneys or bladder.
• Effects on the liver: increase in some liver enzymes, which can only be seen in blood tests.
• Effects on the kidneys: changes in the normal functioning of the kidneys.
• Effects on food: loss of appetite (anorexia) and weight loss.
• General effects: tiredness, fever, chest pain, loss of energy (asthenia), general malaise.
• Effects on mood and behaviour: depression, anxiety, confusion and disturbed thoughts.

Uncommon(may affect up to 1 in 100 people)

• Effects on the heart: changes in heart rhythm (arrhythmias).
• Effects on circulation: low blood pressure (hypotension), which can cause you to feel faint or weak.
• Blood effects: a decrease in the production of blood cells in the bone marrow.
• Effects on the nerves: agitation or tremors.
• Effects on the eyes: redness and inflammation of the eyes (conjunctivitis) and abnormal vision.
• Effects on the ears: deafness.
• Effects on the stomach and digestion: stomach inflammation, mouth ulcers and pancreas inflammation (pancreatitis) with which you should notice severe stomach and back pain.
• Effects on the skin: hair loss (alopecia), itching or swelling (urticaria) and dry skin.
• Effects on the kidneys: blood in the urine (haematuria) and kidney failure.
• Effects on the liver: an increase in the liver enzyme called alanine aminotransferase (which can only be detected in blood tests).
• Effects on fertility: infertility in men.
• Effects on mood and behaviour: unexpected changes in mood and behaviour, loss of contact with reality such as hearing voices or seeing things that are not there, agitation.

Rare(may affect up to 1 in 1,000 people)

• Blood effects: failure to produce all types of blood cells (red blood cells, white blood cells and platelets) in the bone marrow.

Only in patients with AIDS treated with valganciclovir for CMV infection has retinal detachment (separation of the inner layer of the eye) 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 via the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Valganciclovir Kern Pharma

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

No special storage conditions are required.

Once the pack is opened, use within 9 months.

Do not use this medicine after the expiry date which is stated on the pack after “EXP”. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Place the pack and any unused medicine in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the pack and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Valganciclovir Kern Pharma

• The active substance is valganciclovir. Each tablet contains 450 mg of valganciclovir, in the form of 496.3 mg of valganciclovir hydrochloride.
• The other ingredients are:
• In the core: microcrystalline cellulose (E-460(i)), crospovidone, povidone K30 and stearic acid.
• In the coating: opadry pink, containing: hypromellose, macrogol 400, titanium dioxide (E-171) and red iron oxide (E-172).

Appearance of the product and pack contents

Film-coated tablets are pink and have a capsule shape.

High-density polyethylene (HDPE) bottle with a child-resistant polypropylene cap, containing a silica gel capsule to protect against moisture.

Pack size: 60 film-coated tablets.

Marketing authorisation holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Portugal: Valganciclovir Pharmakern 450 mg film-coated tablets

Date of last revision of this leaflet: June 2017

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