Valaciclovir Combix 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Valaciclovir Combix 500 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 must not be given to other people, even if they have the same symptoms, as it may harm them.

• If you experience any adverse reactions, consult your doctor or pharmacist, even if the adverse reactions are not listed in this leaflet.

Leaflet contents:

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

1. What Valaciclovir Combix is and what it is used for

Valaciclovir Combix belongs to a group of medicines called antivirals. It works by eliminating or stopping the growth of viruses known as herpes simplex (HSV), varicella zoster (VZV), and cytomegalovirus (CMV).

Valaciclovir Combix can be used for:

• Treating shingles (in adults).
• Treating HSV skin infections and genital herpes (in adults and adolescents over 12 years of age). It is also used to prevent the recurrence of these infections.
• Treating cold sores (in adults and adolescents over 12 years of age).
• Preventing CMV infection after organ transplantation (in adults and adolescents over 12 years of age).
• Treating and preventing HSV eye infections.

2. What you need to know before taking Valaciclovir Combix

Do not take Valaciclovir Combix

• If you are allergic to valaciclovir, aciclovir, or to any of the other ingredients of this medicine (listed in section 6).
• Do not take Valaciclovir Combix if the above applies to you. If you are unsure, speak with your doctor or pharmacist before taking Valaciclovir Combix.
• If you have kidney problems or are elderly, your doctor may prescribe a lower dose. Also, you should drink sufficient amounts of fluid during treatment to maintain adequate hydration.
• If you have ever developed a rash with fever, swollen lymph nodes, elevated liver enzymes, and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after taking valaciclovir.

Warnings and precautions

Talk to your doctor or pharmacist before taking Valaciclovir Combix if:

• You have kidney problems
• You have liver problems
• You are over 65 years of age
• Your immune system is weakened
• Drug Reaction with Eosinophilia and Systemic Symptoms, known as DRESS, has been reported with the use of valaciclovir. DRESS initially presents with flu-like symptoms and a rash on the face, followed by a more widespread rash, fever, elevated liver enzymes in blood tests, increased levels of a type of white blood cell (eosinophilia), and enlarged lymph nodes.

If you develop a severe rash associated with fever and swollen lymph nodes, stop taking valaciclovir and consult your doctor immediately.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking Valaciclovir Combix.

Preventing the spread of genital herpes to others

If you are taking Valaciclovir Combix to treat or prevent genital herpes, or have had genital herpes in the past, you should practice safe sex, including using condoms. This is important to avoid spreading the infection to others. You should not have sexual intercourse if you have genital ulcers or blisters.

Use of other medicines

Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines, including those obtained without a prescription or herbal medicines.

Tell your doctor or pharmacist if you are taking any medicine that affects the kidneys. These include: aminoglycosides, platinum-containing compounds, iodinated contrast agents, methotrexate, pentamidine, foscarnet, cyclosporine, tacrolimus, cimetidine, and probenecid.

Always inform your doctor or pharmacist about any other medicines you are taking if you are using valaciclovir for the treatment of herpes zoster or after an organ transplant.

Pregnancy and breastfeeding

Valaciclovir is generally not recommended for use during pregnancy. If you are pregnant, think you might be pregnant, or are planning to become pregnant, do not take Valaciclovir Combix without consulting your doctor.

Your doctor will weigh the benefits to you against the risks to the baby if you take valaciclovir during pregnancy or while breastfeeding.

Driving and using machines

Valaciclovir may cause side effects that could affect your ability to drive.

→ Do not drive or operate machinery unless you are certain that it does not affect you.

3. How to take Valaciclovir Combix

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

The dose you should take depends on why your doctor has prescribed Valaciclovir Combix for you. Your doctor will tell you the appropriate dosage.

Treatment of herpes zoster

• The usual dose is 1,000 mg (two 500 mg tablets) three times a day.
• You should take Valaciclovir Combix for seven days.

Treatment of cold sores

• The usual dose is 2,000 mg (four 500 mg tablets) twice a day.
• The second dose should be taken 12 hours after the first dose (not earlier than 6 hours).
• You should take Valaciclovir Combix for only one day (two doses).

Treatment of skin VHS infections and genital herpes

• The usual dose is 500 mg (one 500 mg tablet) twice a day.
• For the first infection, take Valaciclovir Combix for five days or up to ten days if your doctor instructs you to do so. For recurrent infections, treatment duration is usually 3–5 days.

Prevention of recurrent VHS infections after having had them

• The usual dose is one 500 mg tablet once a day.
• Some people with frequent recurrences may benefit from taking 250 mg twice a day.
• You should continue taking Valaciclovir Combix until your doctor tells you to stop treatment.

To prevent CMV (cytomegalovirus) infection

• The usual dose is 2,000 mg (four 500 mg tablets) four times a day.
• Doses should be spaced 6 hours apart.
• You will usually start taking Valaciclovir Combix as soon as possible after surgery.
• You should take Valaciclovir Combix for about 90 days after surgery, or until your doctor tells you to stop treatment.

Your doctor may adjust the dose of Valaciclovir Combix if:

• You are over 65 years of age
• You have a weakened immune system
• You have kidney problems.

→ Talk to your doctor before taking Valaciclovir Combix if any of the above apply to you.

How to take this medicine

• Take this medicine by mouth.
• Swallow the tablets whole with a glass of water.
• Take Valaciclovir Combix at the same time each day.
• Take Valaciclovir Combix exactly as instructed by your doctor or pharmacist.

Patients over 65 years of age or with kidney problems

It is very important that you drink water regularly throughout the day while taking Valaciclovir Combix. This will help reduce adverse effects that may affect the kidneys or nervous system. Your doctor will monitor you for signs of such effects. Nervous system side effects may include confusion, agitation, or feeling unusually sleepy or drowsy.

If you take more Valaciclovir Combix than you should

Valaciclovir is generally not harmful unless taken in excess over several days. If you take too many tablets, you may experience nausea, vomiting, or feel confused, agitated, or unusually drowsy. Contact your doctor or pharmacist if you take too much valaciclovir. Bring the packaging with you. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Valaciclovir Combix

• If you forget to take Valaciclovir Combix, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

4. Possible adverse effects

Like all medicines, Valaciclovir Combix may cause adverse effects in some people. The following adverse effects may occur with this medicine:

Symptoms to watch for

• Severe allergic reactions (anaphylaxis). These are rare in people taking valaciclovir. Rapid onset of symptoms including:

• skin rash with redness and itching

• swelling of the lips, face, neck, and throat, causing difficulty breathing (angioedema)

• drop in blood pressure leading to collapse.

→ If you experience an allergic reaction, stop taking Valaciclovir Combix and see a doctor immediately.

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

• headache

Common (may affect up to 1 in 10 people):

• nausea
• dizziness
• vomiting
• diarrhoea
• skin reaction after exposure to sunlight (photosensitivity)
• rash

Uncommon (may affect up to 1 in 100 people):

• feeling confused
• seeing or hearing things that are not there (hallucinations)
• feeling very drowsy
• tremors
• feeling agitated

These nervous system effects usually occur in patients with kidney problems, elderly patients, or transplant patients taking high doses of 8 grams or more of valaciclovir per day. They usually improve when valaciclovir is discontinued or the dose is reduced.

Other uncommon adverse effects:

• difficulty breathing (dyspnoea)
• stomach pain
• rash, sometimes with itching, hives (urticaria)
• pain in the lower back (renal pain)
• blood in urine

Uncommon changes may appear in blood tests:

• reduction in the number of white blood cells (leucopenia)
• reduction in the number of platelets, which are cells that help blood to clot (thrombocytopenia)
• increase in substances produced by the liver.

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

• unsteadiness when walking and lack of coordination (ataxia)
• slow and slurred speech (dysarthria)
• seizures (convulsions)
• altered brain function (encephalopathy)
• loss of consciousness (coma)
• confused or disturbed thoughts

These nervous system effects usually occur in patients with kidney problems, elderly patients, or transplant patients taking high doses of 8 grams or more of valaciclovir per day. They usually improve when valaciclovir is discontinued or the dose is reduced.

Other rare adverse effects:

• kidney problems causing little or no urine production

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Frequency not known (frequency cannot be estimated from the available data):

• Drug Reaction with Eosinophilia and Systemic Symptoms, known as DRESS, characterized by widespread rash, fever, elevated liver enzyme levels, blood disorders (eosinophilia), lymph node swelling, and involvement of other organs in the body. See also section 2.
• Inflammation of the kidneys (tubulointerstitial nephritis).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Valaciclovir Combix

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valaciclovir Combix

• The active substance is valaciclovir. Each tablet contains 500 mg of valaciclovir (as valaciclovir hydrochloride).

The other components are: microcrystalline cellulose (E460i), crospovidone, povidone, magnesium stearate, coating agent (titanium dioxide -E171-, macrogol, talc –E553b– and polyvinyl alcohol).

Appearance of the product and contents of the pack

Valaciclovir tablets are presented in PVDC/PVC-Aluminum blisters.

Valaciclovir Combix 500 mg film-coated tablets are available in pack sizes of 10 and 42 tablets.

Valaciclovir Combix tablets are white, capsule-shaped, biconvex, film-coated tablets marked "500" on one side and scored on the other.

The score line is intended only to facilitate breaking the tablet for ease of swallowing and is not intended to divide the tablet into equal doses.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/Badajoz, 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d’activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Misom Labs Ltd.

Malta Life Sciences Park

LS2.01.06

Industrial Estate

San Gwann, SGN 3000

Malta

Date of the most recent revision of this leaflet: December 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) www.aemps.gob.es.