ACICLOVIR ARISTO 800 mg DISPERSIBLE TABLETS

Introduction

Package Leaflet: Information for the User

Aciclovir Aristo 800 mg Dispersible Tablets EFG

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

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

Contents of the pack:

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

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

Aciclovir Aristo 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 Aristo

Do not takeAciclovir Aristoif:

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

Warnings and precautions

Consult your doctor or pharmacist before taking Aciclovir Aristo:

Other medicines and Aciclovir Aristo

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

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

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 medicine.

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 affected.

3. How to take Aciclovir Aristo

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. 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 Aristo. 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 of age, other formulations are recommended.

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

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

If you think the effect of Aciclovir Aristo is too strong or too weak, tell your doctor or pharmacist.

If you take more Aciclovir Aristo 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 medicine and the amount taken.

If you forget to take Aciclovir Aristo

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 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 (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 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 takeany more tablets unless your doctor tells you to.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aciclovir Aristo

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

Do not store above 25°C. Store in the original packaging to protect from moisture.

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.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Aciclovir Aristo:

• The active ingredient is aciclovir. One tablet contains 800 mg of aciclovir.
• The other ingredients (excipients) are: core: microcrystalline cellulose (E460), aluminum and magnesium silicate, sodium carboxymethyl starch (type A) (from potato), povidone K30, magnesium stearate (E572). Coating: hypromellose, titanium dioxide (E171), macrogol 400, macrogol 8000.

Appearance of the product and pack contents

White, biconvex, and elongated dispersible tablets, scored on both sides.

PVC/Aluminum blister pack.

Container with 35 tablets.

Container with 500 tablets (clinical container).

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 Torrejón de Ardoz

Madrid, Spain

Manufacturer

Laboratorios Medicamentos Internacionales, S.A.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Date of last revision of this leaflet: 10/2022

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