Valcyclox

Package leaflet: Information for the user

Valcyclox 450 mg film-coated tablets
Valganciclovir
Please read this leaflet carefully before 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Valcyclox is and what it is used for
2. What you should know before taking Valcyclox
3. How to take Valcyclox
4. Possible side effects
5. How to store Valcyclox
6. Contents of the pack and other information

1. What Valcyclox is and what it is used for

Valcyclox belongs to a group of medicines that work by directly preventing the replication of viruses. Valganciclovir, the active substance in the tablets, is converted in the body to ganciclovir. Ganciclovir prevents the cytomegalovirus (CMV) from multiplying and infecting healthy cells in the body. In patients with weakened immune systems, CMV can cause infections in various organs, which may be life-threatening.

Valcyclox is used:

• for the treatment of CMV retinitis in adult patients with acquired immunodeficiency syndrome (AIDS). CMV infection of the retina can lead to vision problems and may even result in blindness.
• for the prevention of CMV infection in CMV-negative adults and children who have received an organ transplant from CMV-positive donors.

2. Important information before taking Valcyclox

When not to take Valcyclox:

• if the patient is allergic to valganciclovir or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to ganciclovir, acyclovir, or valacyclovir, which are medicines used to treat other viral infections;
• if the patient is breastfeeding.

Warnings and precautions
Before starting treatment with Valcyclox, discuss this with your doctor or pharmacist.
When to exercise special caution when taking Valcyclox

• if the patient has a low number of white blood cells, red blood cells, or platelets (small cells involved in blood clotting); the treating physician will arrange blood tests before starting Valcyclox and may require additional blood tests during treatment;
• if the patient is undergoing radiotherapy or hemodialysis;
• if the patient has kidney problems. The treating physician may prescribe a reduced dose and may require regular blood tests during treatment;
• if the patient is currently taking ganciclovir capsules and the doctor has decided to switch to Valcyclox tablets. It is extremely important not to take more tablets than prescribed by the doctor to avoid the risk of overdose.

Valcyclox with other medicines
Tell your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
Taking Valcyclox together with other medicines may affect the blood concentration of the drug and may cause harmful effects. Inform your doctor if the patient is currently taking any medicine containing:

• imipenem with cilastatin (an antibacterial medicine); taking these together with Valcyclox may cause seizures;
• zidovudine, didanosine, lamivudine, tenofovir, abacavir, emtricitabine, or other similar medicines used in the treatment of AIDS;
• ribavirin, pegylated interferons, adefovir, or entecavir, used in the treatment of hepatitis B or C;
• probenecid (a medicine used to treat gout); concomitant use of probenecid and Valcyclox may increase the blood concentration of ganciclovir;
• mycophenolate mofetil (used after organ transplantation);
• vincristine, vinblastine, adriamycin, hydroxyurea, or similar medicines used in the treatment of cancer;
• cidofovir, foscarnet used in the treatment of viral infections;
• trimethoprim, trimethoprim-sulfonamide combinations, or dapsone (antibacterial medicines);
• pentamidine (a medicine used to treat parasitic diseases or lung infections);
• flucytosine or amphotericin B (antifungal medicines).

Valcyclox with food and drink
Valcyclox should be taken with food. If food cannot be taken for any reason, the patient should continue taking the usual dose of Valcyclox.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant, she should not take Valcyclox unless otherwise advised by a doctor.
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor. Taking Valcyclox during pregnancy may harm the unborn child.
Do not take Valcyclox if the patient is breastfeeding. If the doctor intends to start treatment with Valcyclox, the patient should stop breastfeeding before starting this medicine.
Women of childbearing potential must use effective contraception during treatment with Valcyclox.
Men should use a condom during sexual intercourse with a partner who could become pregnant during treatment with Valcyclox and for 90 days after stopping the medicine.

Driving and operating machinery
Do not drive or operate any vehicles or machinery if dizziness, fatigue, tremors, or confusion occur during treatment.
Before taking any medicine, consult a doctor or pharmacist.

3. How to take Valcyclox

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
Handle the tablets with care. Do not break or crush them. Swallow the tablets whole, preferably with food. If you accidentally touch a damaged tablet,
wash your hands thoroughly with soap and water. If the powder from the tablet gets into your eyes, rinse the eyes thoroughly with sterile water, or if unavailable, with plain water.
Follow the number of tablets prescribed by your doctor to avoid overdose.
If possible, Valcyclox tablets should be taken with food – see section 2.

Adults
Prevention of CMV disease in transplant recipients
Treatment should be started within 10 days after transplantation. The usual recommended dose is
2 tablets ONCE daily. Continue this dose for up to 100 days after transplantation.
For kidney transplant recipients, your doctor may recommend continuing treatment for 200 days.

Treatment of active CMV retinitis in patients with AIDS
(called induction therapy)
The usual recommended dose of Valcyclox is 2 tablets TWICE daily, taken for 21 days (three weeks). Unless otherwise directed by your doctor, do not take this dose for longer than 21 days,
as this may increase the risk of adverse effects.

Long-term maintenance treatment to prevent recurrence of active CMV retinitis in patients with AIDS
The usual recommended dose is 2 tablets ONCE daily. Try to take the tablets at the same time each day. Your doctor will decide how long you should continue taking Valcyclox. If retinitis worsens during treatment with this dose, your doctor may recommend repeating the induction therapy (as above) or may decide to start another medicine to treat CMV infection.

Elderly patients
Valcyclox has not been studied in elderly patients.

Patients with impaired kidney function
For patients with impaired kidney function, your doctor may prescribe a lower number of tablets per day or may recommend taking Valcyclox only on certain days of the week. It is very important to take exactly the number of tablets prescribed by your doctor.

Patients with impaired liver function
Valcyclox has not been studied in patients with impaired liver function.

Children and adolescents
Prevention of CMV disease in transplant recipients
In children and adolescents, treatment should be started within 10 days after transplantation.
The dose will depend on the child's size and should be taken once daily.
The treating doctor will determine the most appropriate dose based on the child's height, body weight, and kidney function. Continue this dose for up to 100 days after transplantation.
For kidney transplant recipients, your doctor may recommend continuing treatment for 200 days.
For children who cannot swallow Valcyclox tablets, valganciclovir should be administered as a powder for oral solution.

Accidental overdose of Valcyclox
If a patient has taken or suspects having taken more tablets than prescribed, contact your doctor immediately or go to hospital. Taking more than the prescribed dose may cause severe adverse effects, particularly affecting the blood or kidneys. Hospital treatment may be necessary.

Missed dose of Valcyclox
If a patient forgets to take a tablet, take the missed dose as soon as possible, and then take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Valcyclox treatment
Do not stop taking this medicine unless your doctor tells you to stop.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Allergic reactions
Sudden and severe allergic reactions to valganciclovir (anaphylactic shock) occur no more frequently
than in 1 out of 100 patients. If any of the symptoms listed below occur, STOP taking Valcyclox and seek immediate medical attention at a hospital:

• raised, itchy skin rash (urticaria);
• sudden swelling of the throat, face, lips or mouth, which may cause difficulty swallowing or breathing;
• sudden swelling of hands, feet or ankles.

The adverse reactions listed below occurred during treatment with valganciclovir or
ganciclovir.
Very common adverse reactions (may occur in more than 1 out of 10 patients):

• Blood disorders: decreased number of white blood cells in the blood (neutropenia), which may lead to increased susceptibility to infections; decreased amount of oxygen-carrying pigment in the blood (anaemia), which may cause fatigue and shortness of breath during physical exertion.
• Respiratory disorders: shortness of breath or difficulty breathing (dyspnoea).
• Gastrointestinal disorders: diarrhoea.

Common adverse reactions (may occur in 1 to 10 out of 100 patients):

• Blood disorders: decreased number of leukocytes (white blood cells that fight infections) in the blood (leukopenia); decreased number of platelets (thrombocytopenia), which may lead to increased bruising or bleeding; simultaneous decrease in several types of blood cells (pancytopenia).
• Nervous system disorders: headache, difficulty sleeping (insomnia), disturbances in taste perception, reduced sensation, tingling or pricking sensation on the skin (paraesthesiae), loss of sensation in hands or feet (peripheral neuropathy), dizziness, seizures.
• Eye disorders: eye pain, swelling inside the eye, retinal detachment, seeing floating spots.
• Ear disorders: ear pain.
• Respiratory disorders: cough.
• Gastrointestinal disorders: nausea and vomiting, abdominal pain, constipation, bloating, excessive flatulence, indigestion, difficulty swallowing.
• Skin disorders: skin inflammation, itching, night sweats.
• Musculoskeletal disorders: back pain, muscle or joint pain, muscle stiffness, muscle cramps.
• Infections: oral fungal infection (candidiasis), bacterial or viral infections in the blood, connective tissue inflammation, inflammation or infection of kidneys or urinary bladder.
• Liver disorders: increased activity of certain liver enzymes, detectable only through blood tests.
• Kidney disorders: changes in normal kidney function.
• Nutritional disorders: loss of appetite (anorexia), weight loss.
• General symptoms: fatigue, fever, pain, chest pain, feeling of weakness, malaise.
• Mood or behavioural disorders: depression, anxiety, confusion or impaired logical thinking.

Uncommon adverse reactions (may occur in 1 to 10 out of 1,000 patients):

• Heart disorders: changes in heart rhythm (arrhythmia).
• Circulatory disorders: low blood pressure, which may lead to dizziness or fainting.
• Blood disorders: reduced production of blood cells in the bone marrow.
• Nervous system disorders: tremor.
• Eye disorders: redness, eye swelling (conjunctivitis), visual disturbances.
• Ear disorders: deafness.
• Gastrointestinal disorders: abdominal distension, mouth ulcers, pancreatitis, which may present as severe abdominal and back pain.
• Skin disorders: hair loss (alopecia), itchy rash or swelling (urticaria), and dry skin.
• Kidney disorders: presence of blood in urine (haematuria), kidney failure.
• Liver disorders: increased activity of an enzyme called alanine aminotransferase (detectable only through blood tests).
• Fertility disorders: male infertility.
• Mood or behavioural disorders: unusual changes in mood or behaviour, loss of contact with reality such as hearing voices or seeing things that are not there, feeling agitated.

Rare adverse reactions (may occur in 1 to 10 out of 10,000 patients):

• Blood disorders: impaired production of all types of blood cells (red blood cells, white blood cells and platelets) in the bone marrow.

Retinal detachment (separation of the inner layer of the eye) has occurred only in AIDS patients
receiving valganciclovir for CMV infection.
Additional adverse reactions in children and adolescents
Adverse reactions reported in children and adolescents are similar to those reported in adult
patients.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Valcyclox

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and packaging after "Expiry date" or "EXP". The expiry date refers to the last day of the stated month.
There are no special requirements for storage conditions of this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Valcyclox contains

• The active substance is 450 mg of valganciclovir in the form of 496.3 mg valganciclovir hydrochloride.
• Other ingredients are:

Tablet core: microcrystalline cellulose PH101, crospovidone type A, povidone K30 and stearic acid 50.
Coating: hypromellose 3 cP, hypromellose 6 cP, titanium dioxide (E171), macrogol 400, iron oxide red (E172) and polysorbate 80.

What Valcyclox looks like and contents of the pack
Valcyclox is a 450 mg film-coated tablet with the following appearance:
Pink, oval, biconvex film-coated tablets measuring 16.7 mm by 7.8 mm, embossed with the letter "J" on one side and the number 156 on the other.
Valcyclox is available in OPA-Aluminum-PVC/Aluminum blisters in a cardboard box containing 10 or 60 tablets, and in HDPE bottles with a PP screw cap with sealing and child-resistant closure, in a cardboard box containing 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturers/Importers:
STADA Arzneimittel AG
Stadastrasse 2 – 18, 61118 Bad Vilbel, Germany
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola, PLA 3000; Malta
STADA Arzneimittel GmbH
Muthgasse 36/2, 1190 Wien, Austria

This medicinal product is authorised for marketing in the Member States of the European Economic Area under the following names:
Netherlands: Valcycloxciclovir CF 450 mg, filmomhulde tabletten
Austria: Valcycloxciclovir STADA 450 mg Filmtabletten
Croatia: Valcycloxciclovir STADA 450 mg filmom obložene tablete
France: Valcycloxciclovir EG 450 mg, comprimé pelliculé
Germany: Valcycloxciclovir STADA 450mg Filmtabletten
Poland: Valcyclox
Slovenia: Valcycloxciklovir STADA 450 mg filmsko obložene tablete