VALGANCICLOVIR NORMON 450 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

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

Valganciclovir Normon 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 Normon is used:

• to treat CMV retinitis (infection of the retina of the eye) 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 infection 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 Normon

Do not take Valganciclovir Normon:

• 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 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 starting to take Valganciclovir tablets 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 frequent blood tests during treatment.
• If you are taking ganciclovir capsules and your doctor tells you to switch your treatment to Valganciclovir tablets. It is important that you do not take more than the number of tablets prescribed by your doctor or you may be at risk of an overdose.

Taking Valganciclovir Normon with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken or may take other medicines, including those obtained without a prescription.

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/sulfa combinations and dapsone (antibiotics)
• pentamidine (medicine for the treatment of parasites or lung infections)
• flucytosine or amphotericin B (antifungal agents)

Taking Valganciclovir Normon with food and drinks

Valganciclovir 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 recommends it. If you are pregnant or plan to become pregnant, you should tell your doctor. If you take Valganciclovir when you are pregnant, it may harm the fetus.

Do not take Valganciclovir during breastfeeding. If your doctor wants you to start treatment with Valganciclovir, you should stop breastfeeding before starting treatment.

Women of childbearing age should use effective contraceptive methods while taking Valganciclovir.

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

Driving and using machines

Do not drive or use machinery 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 Normon

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. In case of doubt, 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. If the powder from the tablets comes into contact with your eyes, rinse them with sterile water, or plenty of 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 2.

Adults

Prevention of CMV disease 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 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 patients with AIDS and 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 will tell you to take fewer tablets each day or to take the tablets only 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 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 your 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 dose prescribed until 200 days.

If you take more Valganciclovir Normon than you should

Contact your doctor or hospital immediately if you have taken or think you have taken more tablets than you should. Taking more 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, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Valganciclovir Normon

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 Normon

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 100 people, a sudden and severe allergic reaction to valganciclovir (anaphylactic shock) may occur. STOP taking Valganciclovir 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 may cause difficulty in swallowing or breathing.
• Sudden swelling of hands, feet or ankles.

The side effects reported during treatment with valganciclovir or ganciclovir are as follows.

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

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

Common side effects(may affect 1 to 10 patients in 100):

• Blood effects: decrease in the number of leukocytes (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 to touch (hypoesthesia), tingling or prickling sensation in the skin (paresthesia), loss of sensation in hands or feet (peripheral neuropathy), dizziness and fits (convulsions).
• 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 respiratory system: cough.
• Effects on the stomach and digestive system: 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 (rigor) and muscle cramps.
• Infections: fungal infection in the mouth (oral candidiasis), infections caused by bacteria or viruses 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, pain, chest pain, loss of energy (asthenia), general malaise (malaise).
• Effects on mood and behaviour: depression, anxiety, confusion and disturbed thoughts.

Uncommon side effects(may affect 1 to 10 patients in 1,000):

• Effects on the heart: changes in the normal 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 (tremor).
• Effects on the eyes: redness and inflammation of the eyes (conjunctivitis) and abnormal vision
• Effects on the ears: deafness.
• Effects on the stomach and digestive system: 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 side effects(may affect 1 to 10 patients in 10,000):

• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) https://www.notificaRAM.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Valganciclovir Normon

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 carton after EXP. The expiry date refers to the last day of that month.

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 to protect the environment.

6. Contents of the pack and further information

Composition of Valganciclovir Normon

• The active substance is 450 mg of valganciclovir, in the form of 496.3 mg of valganciclovir hydrochloride.
• The other ingredients in the tablet core are: povidone, crospovidone, microcrystalline cellulose and stearic acid. The ingredients of the coating are polyvinyl alcohol, titanium dioxide, polyethylene glycol/macrogol, talc and red iron oxide (E-172).

Appearance of Valganciclovir Normon and contents of the pack

Valganciclovir Normon film-coated tablets are pink, elliptical and biconvex.

Valganciclovir Normon is available in packs of 60 film-coated tablets.

Marketing authorisation holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760, Tres Cantos – Madrid

(SPAIN)

Date of the last revision of this leaflet: March 2016

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