VALACICLOVIR COMBIX 500 mg FILM-COATED TABLETS

2. What you need to know before you take Valaciclovir Combix

Do not take Valaciclovir Combix

• If you are allergic to valaciclovir or aciclovir or 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 not sure, talk to your doctor or pharmacist before taking Valaciclovir Combix.
• If you have kidney disease or are elderly, your doctor may use a lower dose. You should also drink plenty of fluid during treatment to stay hydrated.
• If you have ever developed a skin rash with fever, swollen lymph nodes, increased 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 old
• Your immune system is weakened
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with the use of valaciclovir. DRESS is characterized by symptoms similar to the flu and a rash on the face, followed by a more widespread rash with elevated body temperature, elevated liver enzymes, and an increase in a type of white blood cell (eosinophilia) and swollen 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 not sure if any of the above applies to you, talk to 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 the use of condoms. This is important to prevent spreading the infection to others. You should not have sexual intercourse if you have genital ulcers or blisters.

Using other medicines

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

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

Always tell your doctor or pharmacist about other medicines you are taking if you are taking valaciclovir for the treatment of shingles or after an organ transplant.

Pregnancy and breastfeeding

Valaciclovir is not normally recommended for use during pregnancy. If you are pregnant, think you may 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 while pregnant or breastfeeding.

Driving and using machines

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

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

3. How to take Valaciclovir Combix

Follow the instructions for taking this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist again.

The dose you should take will depend on why your doctor has prescribed Valaciclovir Combix for you. Your doctor will tell you the right dose.

Treatment of shingles

• 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 before 6 hours).
• You should take Valaciclovir Combix only for one day (two doses).

Treatment of HSV skin infections and genital herpes

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

Prevention of recurrent HSV infections once you have 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 take Valaciclovir Combix until your doctor tells you to stop.

To prevent CMV infection

• The usual dose is 2,000 mg (four 500 mg tablets) four times a day.
• You should space the doses 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.

Your doctor may adjust the dose of Valaciclovir Combix if:

• You are over 65 years old
• Your immune system is weakened
• You have kidney problems.

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

Taking 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 as instructed by your doctor or pharmacist.

People over 65 years old or with kidney problems

It is very important that while taking Valaciclovir Combix, you drink water regularlythroughout the day. This will help reduce the side effects that can affect the kidneys or nervous system. Your doctor will monitor you for signs of this. Nervous system side effects can include feeling confused or agitated, or feeling abnormally sleepy or drowsy.

If you take more Valaciclovir Combix than you should

Valaciclovir is not normally harmful, unless you take too much for several days. If you take too many tablets, you may feel sick, vomit, or feel confused, agitated, or abnormally drowsy. Talk to your doctor or pharmacist if you take too much valaciclovir. Take the pack with you. You can also call the Toxicology Information Service on 91 562 04 20, quoting 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 missed dose.

4. Possible side effects

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

Symptoms to look out for

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

• skin rash with redness, itching
• swelling of the lips, face, neck, and throat, causing difficulty breathing (angioedema)
• drop in blood pressure leading to collapse.

→ If you have an allergic reaction, stop taking Valaciclovir Combix and go to the 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
• diarrhea
• skin reaction after sun exposure (photosensitivity)
• rash

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

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

These nervous system side 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 stopped or the dose is reduced.

Other uncommon side effects:

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

Uncommon side effects may appear in your blood tests:

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

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

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

These nervous system side effects usually occur in people 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 stopped or the dose is reduced.

Other rare side effects:

• kidney problems that cause little or no urine production

If you experience side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

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

• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), characterized by widespread rash, fever, elevated liver enzymes, blood disorders (eosinophilia), and swollen lymph nodes. See also section 2.
• Kidney inflammation (tubulointerstitial nephritis).

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via the website: https://www.notificaram.es. By reporting side 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 pack after EXP. The expiry date is the last day of the month stated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Valaciclovir Combix

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

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

Appearance and packaging of the product

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 film-coated tablets.

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

The score line is only for breaking and making swallowing easier, but not to divide 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 last revision of this leaflet December 2022

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