PATIENT INFORMATION LEAFLET

Valaciclovir Combix 500 mg 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 the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

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

Valaciclovir Combix can be used for:

• Treating shingles (in adults).
• Treating skin and genital herpes infections (in adults and adolescents over 12 years old). It is also used to prevent these infections from recurring.
• Treating fevers (in adults and adolescents over 12 years old).
• Preventing CMV infection after organ transplants (in adults and adolescents over 12 years old).
• Treating and preventing eye infections caused by HSV.

Do not take Valaciclovir Combix

• If you are allergic to valaciclovir or aciclovir or any of the other components of this medication (listed in section 6).
• Do not take Valaciclovir Combix if the above point affects you. If you are unsure, speak with your doctor or pharmacist before taking Valaciclovir Combix.
• If you have any kidney disease or are elderly, your doctor may use a lower dose. You must also drink enough liquid during treatment to maintain adequate hydration.
• If you have ever developed a skin 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

Consult 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 initially presents with symptoms similar to the flu and a rash on the face, followed by a more widespread rash with elevated body temperature, elevated liver enzymes observed in blood tests, 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 lymph node inflammation, stop taking valaciclovir and consult your doctor immediately.

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

Prevention of genital herpes transmission to others

If you are taking Valaciclovir Combix to treat or prevent genital herpes, or have had genital herpes in the past, you must practice safe sex, including the use of condoms. This is important to prevent transmitting the infection to others. Do not have sex if you have genital ulcers or blisters.

Use of other medications

Inform your doctor or pharmacist if you are using, or have recently used, other medications, including those purchased without a prescription or herbal medications.

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

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

Pregnancy and breastfeeding

Valaciclovir is usually not 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 for you against the risk to the baby if you take valaciclovir while pregnant or breastfeeding.

Driving and operating machinery

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.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The dose you should take will depend on why your doctor prescribed Valaciclovir Combix. Your doctor will indicate the appropriate dosage.

Herpes zoster treatment

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

Febrile treatment

• 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 only take Valaciclovir Combix for one day (two doses).

Epidermal and genital herpes virus infections treatment

• 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 indicates. For recurrent infections, the treatment duration is usually 3-5 days.

Prevention of recurrent infections by VHS once you have had them

• The usual dose is one 500 mg tablet per 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 avoid infection with CMV (citomegalovirus)

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

Your doctor may adjust the dose of Valaciclovir Combix if:

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

→Speak with your doctor before taking Valaciclovir Combix if any of the above points affect you.

Medication intake

• Take this medication orally.
• Swallow the tablets whole with a glass of water.
• Take Valaciclovir Combix at the same time every day.
• Take Valaciclovir Combix according to the instructions of 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 regularly throughout the day. This will help you reduce the adverse effects that may affect the kidneys or the nervous system. Your doctor will monitor you to detect these signs. Nervous system adverse effects may include feeling confused or agitated, or feeling abnormally sleepy or drowsy.

If you take more Valaciclovir Combix than you should

Valaciclovir is usually not harmful, unless you take too much over several days. If you take too many tablets, you may experience nausea, vomiting, or feel confused, agitated, or abnormally drowsy. Speak with your doctor or pharmacist if you take too much valaciclovir. Bring the packaging with you. You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication 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 there is little time left for the next dose, omit the missed dose.
• Do not take a double dose to compensate for the missed dose.

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

Symptoms to be aware of

• 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, which causes difficulty breathing (angioedema)
• drop in blood pressure leading to collapse.

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

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

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

• nausea
• dizziness
• vomiting
• diarrhea
• sensitivity to sunlight (photosensitivity)
• rash

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

• feeling confused
• seeing or hearing things that do not exist (hallucinations)
• feeling very drowsy
• shaking
• feeling agitated

These side effects of the nervous system 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)
• lower back pain (renal pain)
• blood in urine

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

These side effects of the nervous system 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 to be produced

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

Of unknown frequency(the frequency cannot be estimated from the available data):

• Drug Reaction with Eosinophilia and Systemic Symptoms, known as DRESS, is characterized by widespread rash, fever, elevated liver enzymes, blood disorders (eosinophilia), lymph node inflammation, and other organs of the body involved. See also section 2.
• Tubulointerstitial nephritis (inflammation of the kidneys).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed 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.

Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or in the 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 Valaciclovir Combix

-The active ingredient 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 content of the packaging

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

Valaciclovir Combix 500 mg tablets are available in packaging sizes of 10 and 42 tablets coated with a film.

The tablets of Valaciclovir Combix are film-coated white, capsule-shaped, biconvex tablets with the mark “500” on one face and scored on the other.

The score is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Holder of the marketing authorization

Laboratorios Combix, S.L.U.

C/Badajoz, 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

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

Last review date of this leaflet December 2022

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