Valganciclovir Cipla 450 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Valganciclovir Cipla 450 mg film-coated tablets EFG

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

2. What you need to know before taking Valganciclovir Cipla

3. How to take Valganciclovir Cipla

4. Possible side effects

5. How to store Valganciclovir Cipla

6. Contents of the container and other information

1. What Valganciclovir Cipla is and what it is 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 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 infection in the body's organs. This can be life-threatening.

Valganciclovir Cipla is used:

• for the treatment of retinitis (infection of the retina) caused by cytomegalovirus in adult patients with AIDS (Acquired Immunodeficiency Syndrome). CMV infection of the eye's retina can lead to vision problems and even blindness.

• for the prevention of CMV disease in adults and children who have not previously been infected with this virus, but who have received a solid organ transplant from a donor who was infected with CMV.

2. What you need to know before taking Valganciclovir Cipla

Do not take Valganciclovir Cipla:

• if you are allergic to valganciclovir, ganciclovir, or any of the other ingredients of this medicine (listed in section 6),
• if you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting valganciclovir.

• If you are allergic to aciclovir, penciclovir, valaciclovir, or famciclovir. These are other medicines used to treat viral infections.

Be cautious with valganciclovir:

• if you have low levels in your blood of white blood cells, red blood cells, or platelets (small cells involved in blood clotting). Your doctor will perform a blood test before you start taking valganciclovir and will carry out further blood tests during treatment.
• if you are receiving radiotherapy or haemodialysis.
• if you have kidney problems. Your doctor may prescribe a lower dose and may require frequent blood tests during treatment.
• if you are taking ganciclovir capsules and your doctor instructs you to switch your treatment to valganciclovir tablets. It is important not to take more tablets than prescribed by your doctor, as this may increase the risk of overdose.

Other medicines and Valganciclovir Cipla

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Taking other medicines together with valganciclovir may affect the amount of medicine reaching the bloodstream or may cause harmful effects.

Tell your doctor if you are already taking any of the following medicines:

• imipenem-cilastatin (an antibiotic). Taking this medicine with valganciclovir may cause seizures (fits),
• zidovudine, didanosine, lamivudine, stavudine, tenofovir, abacavir, emtricitabine, or similar medicines for the treatment of AIDS,
• adefovir or other medicines used to treat hepatitis B,
• probenecid (a medicine used to treat gout). Taking probenecid with valganciclovir may increase the amount of ganciclovir in your blood,
• mycophenolate mofetil, cyclosporine, or tacrolimus (used after organ transplants),
• vincristine, vinblastine, doxorubicin, hydroxyurea, or similar medicines used to treat cancer,
• trimethoprim, trimethoprim/sulfa combinations, or dapsone (antibiotics),
• pentamidine (a medicine used to treat parasites or lung infections),
• flucytosine or amphotericin B (antifungal agents).

Taking Valganciclovir Cipla with food and drink

Valganciclovir should be taken with food. If, for any reason, you are unable to eat, you should continue taking your usual dose of valganciclovir.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not take valganciclovir during pregnancy unless your doctor specifically recommends it. If you are pregnant or planning to become pregnant, you must inform your doctor. Taking valganciclovir during pregnancy may cause harm to your unborn baby.

You must not take Valganciclovir Cipla while breastfeeding. You must stop breastfeeding before starting treatment.

Women of childbearing potential must use effective contraceptive methods while taking Valganciclovir Cipla and for at least 30 days after stopping treatment.

Men whose partners may be pregnant or could become pregnant must use a condom while taking Valganciclovir Cipla and continue using it for 90 days after completing treatment.

Driving and using machines

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.

3. How to take Valganciclovir Cipla

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The tablets should be handled with care. Do not split or crush the tablets. They must be swallowed whole and with food whenever possible. If you accidentally touch a broken tablet, wash your hands thoroughly with soap and water. If the tablet powder has come into contact with your eyes, rinse them with sterile water, or with abundant water if sterile water is not available.

To avoid overdose, you must strictly adhere to the number of tablets prescribed by your doctor.

Valganciclovir tablets should be taken with food whenever possible. See section 2.

Recommended dose:

Adults:

Prevention of CMV infection in transplant patients

You should start taking this medicine within 10 days after transplantation. The usual dose is two tablets ONCE daily. You should continue this dose until 100 days after transplantation. If you have received a kidney transplant, your doctor may advise you to continue taking the tablets for up to 200 days.

Treatment of cytomegalovirus (CMV) retinitis in patients with AIDS (also known as induction therapy)

The usual dose of valganciclovir is two tablets taken TWICE daily for 21 days (three weeks). Do not continue this dose for longer than 21 days unless instructed by your doctor, as this dose may increase the risk of possible adverse effects.

Long-term treatment to prevent recurrence of active inflammation in AIDS patients with CMV retinitis (also known as maintenance therapy)

The usual dose is two tablets taken ONCE daily. Try to take the tablets at the same time each day. Your doctor will inform you how long you should continue taking valganciclovir. If your retinitis worsens while taking this dose, your doctor will decide whether to repeat the induction treatment (as above) or prescribe 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 are not functioning properly, your doctor will instruct you to take fewer tablets per day or to take the tablets only on certain days of the week. It is very important that you take only 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 after receiving the transplant. The dose taken will depend on the child's size and should be taken ONCE daily. Your doctor will determine the most appropriate dose based on your child's height, weight, and renal function. This dose should be continued until 100 days. If your child has received a kidney transplant, your doctor may recommend continuing the prescribed dose up to 200 days.

If you take more Valganciclovir Cipla 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 may cause serious adverse effects, particularly affecting the blood or kidneys. You may require hospital treatment.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Valganciclovir Cipla

If you forget to take your tablets, take the missed dose as soon as you remember, and then 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 Cipla

Do not stop treatment unless instructed by your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Allergic reactions

A sudden and severe allergic reaction to valganciclovir (anaphylactic shock) may occur in 1 out of every 1000 people. STOP taking valganciclovir and go immediately to the nearest hospital emergency department if you experience any of the following:

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

Serious adverse effects

Tell your doctor immediately if you notice any of the following serious adverse effects. Your doctor may tell you to stop taking the medicine, and you may require urgent treatment.

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

• Decrease in the number of white blood cells in the blood, with signs of infection such as sore throat, mouth ulcers, or fever.
• Decrease in the number of red blood cells, with signs including fatigue, shortness of breath, palpitations, or pale skin.

Common (may affect up to 1 in 10 people)

• Blood infection (sepsis), with signs including fever, chills, palpitations, confusion, and altered speech.
• Low platelet levels, with signs including bleeding or bruising more easily than normal, blood in urine or stools, or bleeding gums; bleeding may be severe.
• Severe reduction in blood cells.
• Pancreatitis, signs include severe stomach pain radiating to the back.
• Seizures

Uncommon (may affect up to 1 in 100 people)

• Failure of the bone marrow to produce blood cells
• Hallucinations (seeing or hearing things that are not real)
• Abnormal thoughts or feelings, loss of contact with reality
• Kidney function failure

The side effects observed during treatment with valganciclovir or ganciclovir are detailed below.

Other adverse effects

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

• Candidiasis and oral candidiasis
• Upper respiratory tract infection (e.g., sinusitis and tonsillitis)
• Loss of appetite
• Headache
• Cough
• Shortness of breath
• Diarrhea
• Malaise
• Abdominal pain
• Eczema
• Fatigue
• Fever

Common adverse effects (may affect up to 1 in 10 people)

• Influenza (flu)
• Urinary tract infection, signs include fever, more frequent urination, pain during urination
• Skin infection and infection of tissues beneath the skin
• Mild allergic reaction (signs may include red, itchy skin)
• Weight loss
• Depression, anxiety, or confusion
• Difficulty sleeping
• Weakness or numbness in hands or feet, which may affect balance
• Changes in sense of touch, tingling, prickling, pins and needles, or burning sensation
• Changes in taste
• Chills
• Eye inflammation (conjunctivitis), eye pain, or vision problems
• Ear pain
• Low blood pressure that may make you feel dizzy or weak
• Difficulty swallowing
• Constipation, gas, indigestion, stomach pain, abdominal swelling
• Mouth ulcers
• Abnormal kidney or liver function test results
• Night sweats
• Itching, rash
• Hair loss
• Back, muscle, or joint pain, muscle spasms
• Dizziness, weakness, or general malaise

Uncommon adverse effects (may affect up to 1 in 100 people)

• Restlessness
• Tremor, agitation
• Deafness
• Irregular heartbeat
• Hives, dry skin
• Blood in urine
• Infertility in men (see fertility section)
• Chest pain

Retinal detachment (separation of the inner layer of the eye) has been reported only in patients with AIDS who were treated with valganciclovir for CMV infection.

Additional adverse effects in children and adolescents

The adverse effects reported in children and adolescents are similar to those reported in adults.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Valganciclovir Cipla

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

Do not use this medicine after the expiry date stated on the tablet packaging and carton after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and other information

Composition of Valganciclovir Cipla

The active substance is valganciclovir. Each tablet contains valganciclovir hydrochloride equivalent to 450 mg of valganciclovir.

The other components (excipients) are:

• Tablet core: microcrystalline cellulose, crospovidone (Type B), povidone (K-30) and stearic acid 50.
• Coating: hypromellose, titanium dioxide (E171), macrogol and red iron oxide (E172).

Appearance of the tablet and contents of the Valganciclovir Cipla pack

Valganciclovir Cipla tablets are pink, film-coated, capsule-shaped, biconvex tablets with flat faces.

Length: 17.10 ± 0.20 mm (16.90 – 17.30)
Thickness: 8.10 ± 0.20 mm (7.90 – 8.30)

HDPE tablet container with a polypropylene child-resistant closure. Pack size: 60 tablets.

Aluminum/PVC/PE/PVDC blister packs. Pack size: 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Cipla Europe NV
De Keyserlei 60C, Bus-1301,
2018 Antwerp, Belgium

Manufacturer

S&D Pharma CZ, spol. s.r.o.,
Theodor 28, Pcchery (Pharmos a.s. facility),
1st Republic of the Czech Republic

Cipla Europe NV
De Keyserlei 60C, Bus-1301,
2018 Antwerp, Belgium

Local representative

Cipla Europe NV, Spanish branch
C/Guzmán el Bueno, 133, Edificio Britannia
28003 Madrid, Spain
Tel: 91 534 16 73

This medicinal product is authorized in the European Economic Area member states under the following names:

Sweden: Valganciclovir Cipla 450 mg filmdragerade tabletter
France: Valganciclovir Cipla 450 mg, comprimé pelliculé
Spain: Valganciclovir Cipla 450 mg comprimidos recubiertos con película EFG
Italy: Valganciclovir Cipla 450 mg compresse rivestite con film
Croatia: Valganciclovir Cipla 450 mg filmom obložene tablete

Date of the most recent review of this leaflet: November 2018

Other sources of information

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