Leaflet: information for the user

Aciclovir cinfa 800 mg tablets EFG

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, 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.

1. What Aciclovir cinfa is and for what it is used

2. What you need to know before starting to take Aciclovir cinfa

3. How to take Aciclovir cinfa

4. Possible side effects

5. Storage of Aciclovir cinfa

6. 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 any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take aciclovir.

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

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

Taking Aciclovir cinfa with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

INFORM YOUR DOCTOR IF YOU HAVE TAKEN RECENTLY PROBENECID, CIMETIDINE OR MICOFENOLATE MOFETIL (MEDICATION USED IN TRANSPLANTED PATIENTS).

Pregnancy, breastfeeding and fertility

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

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

Driving and operating machinery

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 medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

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

Your doctor will decide on 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 stop treatment before then.

Usual 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.

Usual doses for children over 6 years old are:

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

For children under 6 years old: it is recommended to use the available suspension (Aciclovir 400 mg/5 ml oral suspension).

Swallow the tablets whole with a little water.

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.

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

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: 915 62 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 can cause side effects, although not everyone will experience them.

Frequent side effects (may affect up to 1 in 10 people)

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

Less frequent side effects (may affect up to 1 in 100 people)

• Hair loss.
• Urticaria.

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

• Alteration of blood tests (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).

Very rare side effects (may affect up to 1 in 10,000 people)

• 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), alterations in personality and behavior, convulsions, somnolence, encephalopathy (brain alteration), coma. These effects are generally reversible and usually appeared in patients with kidney disorders or predisposing factors.
• Hepatitis (inflammation of the liver), jaundice (yellow discoloration of the skin and eyes), acute renal failure, renal pain (may be associated with renal failure).

Inform your doctorimmediatelyif 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 prospectus. You can also

report them directly through the Spanish System for 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 Aciclovir cinfa

• The active ingredient is aciclovir. Each tablet contains 800 mg of aciclovir.
• The other components are: Microcrystalline cellulose, povidone K-30, sodium carboxymethyl starch (type A) (derived from potato starch) and magnesium stearate.

Appearance of the product and content of the packaging

Aciclovir cinfa is presented in the form of tablets. They are white, elongated, biconvex tablets with a notch on one face.

The tablets are packaged in Al/PVC blisters.

Carton box containing 35 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Responsible for manufacturing

Pharmaceutical Works Polpharma SA Pelplinska 19

83-200 Starogard Gdanski

Poland

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet : May 2020

Detailed and updated information on this medicine 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 medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85061/P_85061.html

QR code to: https://cima.aemps.es/cima/dochtml/p/85061/P_85061.html