ACICLOVIR CINFA 800 mg TABLETS

Introduction

Package Leaflet: Information for the User

Aciclovir Cinfa 800 mg Tablets EFG

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Aciclovir Cinfa and what is it used for
2. What you need to know before you take Aciclovir Cinfa
3. How to take Aciclovir Cinfa
4. Possible side effects
5. Storage of Aciclovir Cinfa
6. Contents of the pack and further information

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

Aciclovir belongs to a group of medicines called antivirals.

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

2. What you need to know before you take Aciclovir Cinfa

Do not take Aciclovir Cinfa

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

Warnings and precautions

Talk to your doctor or pharmacist before you start taking aciclovir.

• If you have kidney disease or are elderly. Your doctor may need to reduce your dose. Also, you should 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 if you have started antiviral treatment.

Taking Aciclovir Cinfa with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

TELL YOUR DOCTOR IF YOU HAVE RECENTLY TAKEN PROBENECID, CIMETIDINE, OR MYCOPHENOLATE MOFETIL (A MEDICINE USED IN TRANSPLANT PATIENTS).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 using machines

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

Aciclovir Cinfa contains sodium

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

3. How to take Aciclovir Cinfa

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

Remember to take your medicine.

Your doctor will tell you the duration of your treatment with aciclovir. Do not stop treatment before.

The 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 night dose
• for the treatment of varicella: one 800 mg tablet five times a day, every four hours, omitting the night dose.

The usual doses for children over 6 years of age are:

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

For children under 6 years: 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 to drink plenty of liquid while on this treatment.

If you think the action of aciclovir is too strong or too weak, tell your doctor or pharmacist.

The score line is only to facilitate breaking the tablet if you find it 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 Toxicology Information Service, phone: 915 62 04 20, indicating the medicine and the amount taken.

If you forget to take Aciclovir Cinfa

Do not take a double dose to make up for forgotten doses, simply wait for the next dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Headache, dizziness, feeling tired, fever.
• Nausea, vomiting, diarrhea, stomach pain.
• Itching, skin rash (sometimes caused by sensitivity to sunlight

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

• Hair loss.
• Hives.

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

• Changes in 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).
• Sudden and severe allergic reaction (anaphylactic reaction).

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

• Anemia (decrease in the number of red blood cells) or leukopenia (decrease in the number of white blood cells), bruising (due to a decrease in the number of platelets).
• Agitation, confusion, tremors, difficulty moving, difficulty speaking, confusion or imagining things (hallucinations), changes in personality and behavior, seizures, drowsiness, encephalopathy (brain disorder), coma. These effects are generally reversible and usually occurred in patients with kidney disorders or predisposing factors.
• Hepatitis (inflammation of the liver), jaundice (yellow color of the skin and eyes), acute kidney failure, kidney pain (may be associated with kidney failure).

Tell your doctor immediatelyif you experience any of the following symptoms of allergy: wheezing, palpitations, or chest tightness, collapse, swelling of the eyelids, face, lips, or other parts of the body, skin rash or bruising. These symptoms may mean that you are allergic to aciclovir. Do not take any more tablets unless your doctor tells you to.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aciclovir Cinfa

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Aciclovir Cinfa

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

Appearance and packaging of the product

Aciclovir Cinfa is presented in the form of tablets. They are white, elongated, biconvex tablets with a score line on one side.

The tablets are packaged in Al/PVC blisters.

Carton box containing 35 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

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

Date of last revision of this package leaflet: May 2020

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

You can access detailed and updated information about this medicine by scanning the QR code included in the package leaflet and packaging with your mobile phone (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