Leaflet: information for the user

Aciclovir Cinfa 800 mg dispersible tablets EFG

Aciclovir

Read this leaflet carefully before you start to take 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

Aciclovir belongs to a group of medicines called antivirals.

It is used to treat infections caused by the zoster virus and the varicella virus in adults and children over 6 years old.

Do not take Aciclovir Cinfa

-if you are allergic to aciclovir, valaciclovir or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Aciclovir Cinfa:

-if you have any kidney disease or are elderly. Your doctor may need to reduce your dose. You should also drink enough liquid during treatment to maintain proper hydration.

-if you have genital herpes infection, it is recommended to take precautions during sexual intercourse even after starting antiviral treatment.

Other medicines and Aciclovir Cinfa

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

Inform your doctor if you have taken recently probenecid, cimetidine or mycophenolate mofetil (medicine used in transplant patients).

Pregnancy and breastfeeding

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

Aciclovir passes into breast milk. Contact your doctor or pharmacist if you are breastfeeding.

Driving and operating machines

Some side effects such as drowsiness or sleepiness may affect your ability to concentrate and react. Do not drive or operate machinery if you feel your ability is affected.

Aciclovir Cinfa contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the correct dose, frequency, and duration of treatment.

Remember to take your medication.

Your doctor will inform you of the duration of your Aciclovir treatment. Do not discontinue treatment prematurely.

The recommended doses for adults are:

• for the treatment of herpes zoster infections: one 800 mg tablet five times a day, every four hours, omitting the nighttime dose
• for the treatment of chickenpox: one 800 mg tablet five times a day, every four hours, omitting the nighttime dose.

Use in children

The recommended doses for children over 6 years old are:

• for the treatment of chickenpox: one 800 mg tablet four times a day.

Dissolve the tablet in a minimum of 50 ml of water and shake before taking.

The groove is only for breaking the tablet if it is difficult to swallow whole.

It is recommended that you drink plenty of liquid while on this treatment.

If you estimate that the action of aciclovir is too strong or too weak, inform your doctor or pharmacist.

If you take more Aciclovir Cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Aciclovir Cinfa

Do not take a double dose to compensate for the missed doses, simply wait for the next dose.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Side effectsfrequent (may affect up to 1 in 10 patients)

• Headache, dizziness, feeling of fatigue, fever.
• Nausea, vomiting, diarrhea, stomach pain.
• Itching, skin rashes (sometimes caused by sensitivity to sunlight).

Side effectsless frequent (may affect up to 1 in 100 patients)

• Hair loss.
• Urticaria.

Side effectsrare (may affect up to 1 in 1,000 patients)

• Abnormal blood test results (reversible increases in bilirubin and liver enzymes, increases in blood urea and creatinine).
• Difficulty breathing.
• Angioedema (swelling of the lips, eyes, and tongue).
• Severe and sudden allergic reaction (anaphylactic reaction).

Side effectsvery rare (may affect up to 1 in 10,000 patients)

• Anemia (decrease in red blood cell count) or leucopenia (decrease in white blood cell count), thrombocytopenia (decrease in platelet count).
• Agitation, confusion, tremors, difficulty moving, difficulty speaking, confusion or imagination of things (hallucinations), changes in personality and behavior, convulsions, somnolence, encephalopathy (brain alteration), coma.These effects are generally reversible and normally appeared in patients with kidney disorders or predisposing factors.
• Hepatitis (liver inflammation), jaundice (yellow skin and eyes), acute renal failure, renal pain (may be associated with renal failure).

Inform your doctor immediately if you experience any of the following allergy symptoms: sudden shortness of breath, palpitations or chest tightness, collapse, swelling of eyelids, face, lips, or other parts of the body, skin rash or petechiae. These symptoms may indicate that you are allergic to aciclovir.Do not take more tablets unless your doctor tells you to.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear 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. Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Dispose of the 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 the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofAciclovir Cinfa

The active ingredient is aciclovir. Each dispersible tablet contains 800 mg of aciclovir.

The other components (excipients) are:

• Tablet core::microcrystalline cellulose, sodium carboxymethyl starch (type A) (from potato), anhydrous colloidal silica, povidone, magnesium stearate, and talc.
• Coating:Opadry white Y-1-7000 (contains hydroxypropyl methylcellulose, titanium dioxide, and polyethylene glycol 400).

Appearance of the product and content of the packaging

White, oval-shaped, coated tablets with a notch on one face and marked with the code “A800C” on the other. They are packaged in PVC-PVDC/aluminum blisters. Each package contains 35 dispersible tablets.

Holder of the marketing authorization and responsible for manufacturing

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet:October 2020

Other sources of information

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information on this medication by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/62478/P_62478.html

QR code to:https://cima.aemps.es/cima/dochtml/p/62478/P_62478.html