Package Insert: Information for the User

Aciclovir Aristo 800 mg Dispersible Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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 old.

Do not takeAciclovir Aristo:

• 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 Aristo:

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

Other medications and Aciclovir Aristo

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Aciclovir passestobreast milk. Contact your doctor or pharmacist if you are breastfeeding.

Driving and operating 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 your ability is affected.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. 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 Aciclovir Aristo treatment. Do not discontinue treatment before then.

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

Usual doses for children over 6 years old are:

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

For children under 6 years old, it is recommended to use other presentations.

Dissolve the tablet in a minimum of 50 ml of water and shake before taking.

It is recommended that you drink plenty of liquid while on this treatment.

If you estimate that the action of Aciclovir Aristo is too strong or too weak, inform 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Aciclovir Aristo

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 (liver inflammation), jaundice (yellowing 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 takemore 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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: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 store at a temperature above 25°C. Store in the original packaging to protect it from humidity.

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.

Medications 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 unused packaging and medications. By doing so, you will help protect the environment.

Composition of Aciclovir Aristo:

• The active ingredient is aciclovir. One tablet contains 800 mg of aciclovir.
• The other components (excipients) are: core: microcrystalline cellulose (E460), aluminium 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 contents of the packaging

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

PVC/Aluminium blister.

Packaging containing 35 tablets.

Packaging containing 500 tablets (clinical packaging).

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Holderof the marketing authorization

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 Torrejón de Ardoz

Madrid- Spain

Responsible Manufacturer

Laboratorios Medicamentos Internacionales, S.A

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Last review date of this leaflet: 10/2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es