Leaflet: information for the user

Aciclovir cinfa 200 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 what it is used for

2. What you need to know before you start taking 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 known as antivirals.

It is used to treat and prevent infections caused by the herpes simplex virus, genital herpes, shingles and the varicella virus.

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.

• If you have any kidney disease or are elderly. Your doctor may need to lower your dose. Also, you must drink enough liquid during treatment to maintain adequate hydration.

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

Use of Aciclovir cinfa with other medicines

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

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become 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 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 medicine contains less than 23 mg of sodium (1mmol) per tablet; this 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 treatment with aciclovir. Do not discontinue treatment before then.

Usual doses for adults are:

• For the treatment of infections caused by herpes simplex: one 200 mg tablet five times a day every four hours, omitting the nighttime dose
• For the suppression of recurrences caused by herpes simplex virus: one 200 mg tablet four times a day every six hours, or two 200 mg tablets twice a day every twelve hours
• For the prevention of infections caused by herpes simplex in immunocompromised patients: one 200 mg tablet four times a day every six hours
• For the treatment of chickenpox and herpes zoster infections: four 200 mg tablets five times a day every four hours, omitting the nighttime dose.

Usual doses for children are:

• For the treatment of infections caused by herpes simplex and prevention of infections caused by herpes simplex in immunocompromised children:
• Children and adolescents (2 to 18 years): the dose is the same as for adults
• Infants (28 days to 23 months): will be treated with half the adult dose.

Other presentations are available that are more suitable for children under 6 years old.

• For the treatment of chickenpox:
• Children (over 6 years) and adolescents: four 200 mg tablets four times a day
• Children between 2 and 6 years: two 200 mg tablets four times a day.

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: 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 (sometimes 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.

Medicines 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 200 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 contents of the packaging

Aciclovir cinfa is presented in the form of tablets. They are white, round, and biconvex tablets.

The tablets are packaged in Al/PVC blisters.

Carton box containing 25 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: September 2019

The 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/84468/P_84468.html

QR code to:https://cima.aemps.es/cima/dochtml/p/84468/P_84468.html