ACICLOVIR CINFA 800 mg DISPERSIBLE TABLETS

Introduction

Package Leaflet: Information for the User

Aciclovir Cinfa 800 mg Dispersible Tablets EFG

Aciclovir

Read this entire leaflet carefully before starting to take this medication, as 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 medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this 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 taking Aciclovir Cinfa
3. How to take Aciclovir Cinfa
4. Possible side effects
5. Storage of Aciclovir Cinfa

Contents of the packaging and additional information

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

Aciclovir belongs to the group of medications 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 taking Aciclovir Cinfa

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 Cinfa:

• If you have kidney disease or are elderly. Your doctor may need to reduce the dose. Also, you should drink enough fluid 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.

Other Medications and Aciclovir Cinfa

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

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become 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 Using 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 that your ability is impaired.

Aciclovir Cinfa contains Sodium

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

3. How to take Aciclovir Cinfa

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

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

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Aciclovir. Do not stop treatment before.

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 varicella: 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 of age are:

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

Dissolve the tablet in at least 50 ml of water and stir before taking.

The score line is only for breaking the tablet if you find it difficult to swallow whole.

It is recommended to drink plenty of fluid while taking this treatment.

If you think the effect of aciclovir is too strong or too weak, tell 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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 medications, this medication can cause side effects, although not everyone will experience them.

Common Side Effects(may affect up to 1 in 10 patients)

• 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 patients)

• Hair loss.
• Hives.

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

• 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 patients)

• Anemia (decrease in red blood cells) or leukopenia (decrease in white blood cells), bruising (due to a decrease in 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 (yellowing 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 allergy symptoms: sudden 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 takemore tablets unless your doctor tells you to.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's pharmacovigilance system: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Aciclovir Cinfa

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

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C. Store in the original packaging to protect from moisture.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the Packaging and Additional Information

Composition ofAciclovir Cinfa

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

The other components (excipients) are:

• Core of the tablet: microcrystalline cellulose, sodium carboxymethyl starch (type A) (from potato), colloidal anhydrous 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 Contents of the Packaging

White, oblong, coated tablets with a score line on one side and marked with the code "A800C" on the other. They are packaged in PVC-PVDC/aluminum blisters. Each package contains 35 dispersible tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Leaflet:October 2020

Other Sources of Information

Detailed and updated information about this medication 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 medication 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/62478/P_62478.html

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