ACICLOVIR ARISTO 200 mg DISPERSIBLE TABLETS

Introduction

Package Leaflet: Information for the User

Aciclovir Aristo 200 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, pharmacist, or nurse. 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 other 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 in children, adolescents, and adults to treat and prevent infections caused by the herpes simplex virus, genital herpes, herpes zoster, and varicella virus.

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

Do not takeAciclovir Aristo

• if 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:

• If you have kidney disease or are elderly. Your doctor may need to reduce your dose. Also, you should drink plenty of fluids during treatment to maintain adequate hydration.
• If you have genital herpes, it is recommended to take precautions during sexual intercourse even if you have started antiviral treatment.

Other medicines and Aciclovir Aristo

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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

Remember to take your medicine.

Your doctor will tell you how long to take Aciclovir Aristo. Do not stop treatment before then.

The 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 night 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 varicella and herpes zoster infections: four 200 mg tablets, five times a day, every four hours, omitting the night dose

The 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 (from 2 to 18 years): the dose is the same as for adults.
  • infants (from 28 days to 23 months): will be treated with half the adult dose.

There are other presentations available that are more suitable for children under 6 years.

• for the treatment of varicella:

• 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.

There are other presentations available that are more suitable for children under 6 years.

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

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

If you think that 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 (telephone: 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 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 takeany more tablets unless your doctor tells you to.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: 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 30°C. Store in the original packaging to protect from light and moisture.

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

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 other information

Composition of Aciclovir Aristo:

• The active substance is aciclovir. One tablet contains 200 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), indigo carmine (E132). Coating: hypromellose, macrogol 400, macrogol 8000.

Appearance and packaging

PVDC/Al blister.

Package containing 25 tablets.

Package containing 500 tablets (clinical package).

Not all 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 Health Products (AEMPS) www.aemps.gob.es