Aciclovir Aristo 800 mg dispersible tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
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 questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
Contents of the leaflet:
- What Aciclovir Aristo is and what it is used for
- What you need to know before taking Aciclovir Aristo
- How to take Aciclovir Aristo
- Possible side effects
- How to store Aciclovir Aristo
- Contents of the pack and other information
1. What Aciclovir Aristo is and what it is 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 taking Aciclovir Aristo
Do not take Aciclovir Aristo:
- 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 taking Aciclovir Aristo:
- If you have any kidney disease or are elderly. Your doctor may need to reduce your dose. You should also drink sufficient amounts of fluid during treatment to maintain adequate hydration.
- If you have genital herpes infection, it is recommended to take precautions during sexual intercourse even while undergoing antiviral treatment.
Other medicines and Aciclovir Aristo
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Inform 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 might be pregnant, or are planning 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 adverse 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 impaired.
3. How to take Aciclovir Aristo
Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Your doctor will determine the correct dose, frequency, and duration of treatment.
Remember to take your medicine.
Your doctor will inform you of the duration of your treatment with Aciclovir Aristo. Do not stop treatment prematurely.
The usual doses for adults are:
- for treatment of herpes zoster infections: one 800 mg tablet five times a day, every four hours, omitting the nighttime dose.
- for treatment of chickenpox: one 800 mg tablet five times a day, every four hours, omitting the nighttime dose.
The usual doses for children over 6 years of age are:
- for treatment of chickenpox: one 800 mg tablet four times a day.
For children under 6 years of age, other formulations are recommended.
Dissolve the tablet in a minimum of 50 ml of water and shake before taking.
It is recommended that you drink plenty of fluids during this treatment.
If you think that the effect 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Aciclovir Aristo
Do not take a double dose to make up for missed doses; simply wait for your next dose.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Frequent adverse effects (may affect up to 1 in 10 people)
- Headache, dizziness, feeling tired, fever.
- Nausea, vomiting, diarrhoea, stomach pain.
- Itching, skin rashes (sometimes caused by sensitivity to sunlight).
Uncommon adverse effects (may affect up to 1 in 100 people)
- Hair loss.
- Urticaria (hives).
Rare adverse 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 adverse effects (may affect up to 1 in 10,000 people)
- Anaemia (decrease in red blood cells) or leucopenia (decrease in white blood cells), bruising (due to decreased platelet count).
- Agitation, confusion, tremors, difficulty with movement, difficulty speaking, confusion or seeing or hearing things that are not there (hallucinations), changes in personality and behaviour, seizures, drowsiness, encephalopathy (brain dysfunction), coma. These effects are usually reversible and have typically 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 immediately if you experience any of the following symptoms of allergy: sudden 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 take any more tablets unless your doctor tells you to.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This 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 800 mg of aciclovir.
- The other components (excipients) are: core: microcrystalline cellulose (E460), magnesium aluminium silicate, sodium carboxymethyl starch (potato type A), povidone K30, magnesium stearate (E572). Coating: hypromellose, titanium dioxide (E171), macrogol 400, macrogol 8000.
Appearance of the product and contents of the pack
White, biconvex, elongated dispersible tablets, scored on both sides.
PVC/Aluminum blister.
Pack containing 35 tablets.
Pack containing 500 tablets (hospital pack).
Only certain 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 the most recent review of this leaflet: 1 0/2022
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es