Package Leaflet: Information for the User

Valganciclovir Normon 450mg Film-Coated Tablets

Read this 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 others even if they have similar symptoms to yours, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Valganciclovir Normon belongs to a group of medicines that act directly 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 threat.

Valganciclovir Normon is used:

Do not take Valganciclovir Normon:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Valganciclovir.

• If you have a low blood count of white blood cells, red blood cells, or platelets (small cells involved in blood clotting). Your doctor will perform a blood test before starting to take Valganciclovir tablets 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 frequent blood tests during treatment.
• If you are taking ganciclovir capsules and your doctor tells you to switch to Valganciclovir tablets. It is essential 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

Inform your doctor or pharmacist if you are taking or have recently taken or may need to 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. Inform your doctor if you are already taking any of the following medicines:

• imipenem-cilastatin (antibiotic). Taking this medicine with Valganciclovir may cause seizures (convulsions)
• zidovudine, didanosine, lamivudine, tenofovir, abacavir, emtricitabine, or similar medicines for the treatment of HIV/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 together 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, combinations of trimethoprim/sulfamethoxazole, 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 you cannot eat for any reason, you should continue taking your usual dose of Valganciclovir.

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, inform your doctor. Taking Valganciclovir while pregnant may cause harm to the fetus.

You should 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.

Males whose partners may become pregnant or may become pregnant should use a condom while taking Valganciclovir and should continue using 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 medicine.

Consult your doctor or pharmacist before using any medicine.

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 must 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 thoroughly with water and soap. If the powder from the tablets has come 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 adhere to the number of tablets prescribed by your doctor.

Valganciclovir tablets should be taken with food whenever possible — See section2.

Adults:

Prevention of CMV disease in transplant patients

You should start taking this medication 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 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 patients with AIDS and 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 tell you 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 you can 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 will tell you to take fewer tablets each day

or only take the tablets on certain days of the week. Itis 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 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 which dose is most suitable 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 they take the prescribed dose 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot 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 the missed doses.

If you interrupt treatment with Valganciclovir Normon

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 medicine can cause side effects, although not everyone will experience them.

Allergic reactions

In 1 in every 100 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).
• Sudden swelling of the throat, face, lips, and mouth that may cause difficulty swallowing or breathing.
• Sudden inflammation of the 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 you more likely to catch infections, a decrease in the pigment of the blood that carries oxygen (anemia), which may cause fatigue and difficulty breathing when exercising.
• Respiratory effects: feeling short of breath and difficulty breathing (dyspnea).
• Gastrointestinal effects: diarrhea.

Common side effects(may affect 1 to 10 patients in every 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 may cause petechiae and bleeding, and a decrease in the number of various types of blood cells at the same time (pancytopenia).
• Central nervous system effects: headache, difficulty sleeping (insomnia), taste disorder (dysgeusia), decreased sensitivity to touch (hypoesthesia), tingling or itching in the skin (paresthesia), loss of sensation in the hands or feet (peripheral neuropathy), dizziness, and seizures (convulsions).
• Eye effects: eye pain, inflammation within the eye (edema), separation of the inner layer of the eye (retinal detachment), and floating spots.
• Ear effects: ear pain.
• Respiratory effects: cough.
• Gastrointestinal effects: nausea and vomiting, stomach pain, constipation, gas, indigestion (dyspepsia), and difficulty swallowing (dysphagia).
• Skin effects: skin inflammation (dermatitis), itching (pruritus), and nocturnal sweating.
• Musculoskeletal, articular, and bone effects: 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 skin cells (cellulitis), inflammation or infection of the kidneys or bladder.
• Liver effects: increase in some liver enzymes, which can only be seen in blood tests.
• Kidney effects: changes in normal kidney function.
• Appetite and weight effects: loss of appetite (anorexia) and weight loss.
• General effects: fatigue, fever, pain, chest pain, loss of energy (asthenia), and general discomfort (discomfort).
• Mood and behavior effects: depression, anxiety, confusion, and disturbed thoughts.

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

• Heart effects: changes in normal heart rhythm (arrhythmias).
• Circulatory effects: low blood pressure (hypotension), which may cause dizziness or weakness.
• Blood effects: a decrease in the production of blood cells in the bone marrow
• Nervous system effects: agitation or tremors (tremor).
• Eye effects: redness and inflammation of the eyes (conjunctivitis) and abnormal vision
• Ear effects: hearing loss.
• Gastrointestinal effects: inflammation of the stomach, mouth ulcers, and inflammation of the pancreas (pancreatitis) with severe stomach and back pain.
• Skin effects: hair loss (alopecia), itching or swelling (urticaria), and dry skin.
• Kidney effects: blood in the urine (hematuria) and kidney failure.
• Liver effects: an increase in the liver enzyme called alanine aminotransferase (which can only be detected in blood tests).
• Fertility effects: infertility in men.
• Mood and behavior effects: unexpected changes in mood and behavior, loss of contact with reality such as hearing voices or seeing things that are not there, agitation.

Very rare side effects(may affect 1 to 10 patients in every 10,000):

• Blood effects: failure in the production of 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, 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 side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse. Even if it is side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use https://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 packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of valganciclovir Normon

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

Appearance of valganciclovir Normon and contents of the packaging

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

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

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760, Tres Cantos – Madrid

(SPAIN)

Last revision date of this leaflet: March 2016

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