Aciclovir CINFA 800 mg dispersible tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Aciclovir Cinfa 800 mg dispersible tablets EFG
Aciclovir
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Aciclovir Cinfa is and what it is used for
- What you need to know before taking Aciclovir Cinfa
- How to take Aciclovir Cinfa
- Possible side effects
- How to store Aciclovir Cinfa
Pack contents and other information
1. What Aciclovir Cinfa is and what it is used for
Aciclovir belongs to a group of medicines called antivirals.
It is used to treat infections caused by the varicella-zoster virus and the herpes zoster 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 medicine (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 your dose. Also, you should 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 Cinfa
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 may 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 somnolence may affect your ability to concentrate and react. Do not drive or operate machinery if you feel your ability is impaired.
Aciclovir Cinfa contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially "sodium-free".
3. How to take Aciclovir Cinfa
Follow exactly the instructions for use of this medicine as given 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 medicine.
Your doctor will inform you of the duration of your treatment with Aciclovir. Do not stop treatment early.
The recommended doses for adults are:
- for the treatment of herpes zoster infections: one 800 mg tablet five times daily, every four hours, omitting the nighttime dose
- for the treatment of chickenpox: one 800 mg tablet five times daily, 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 chickenpox: one 800 mg tablet four times daily.
Dissolve the tablet in at least 50 ml of water and shake before taking.
The score line is intended only for dividing the tablet if you find it difficult to swallow it whole.
It is recommended that you drink plenty of fluids during this treatment.
If you think the effect of aciclovir is too strong or too weak, inform your doctor or pharmacist.
If you take more Aciclovir Cinfa 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 Cinfa
Do not take a double dose to make up for forgotten doses; simply wait until the next scheduled dose.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Frequent adverse effects (may affect up to 1 in 10 patients)
- 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 patients)
- Hair loss.
- Hives.
Rare adverse 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 adverse effects (may affect up to 1 in 10,000 patients)
- Anaemia (decrease in red blood cells) or leucopenia (decrease in white blood cells), bruising (due to decrease in platelets).
- Restlessness, confusion, tremors, difficulty moving, difficulty speaking, confusion or imagining things (hallucinations), changes in personality and behaviour, seizures, drowsiness, encephalopathy (brain dysfunction), coma. These effects are generally reversible and usually occurred in patients with kidney disorders or predisposing factors.
- Hepatitis (liver inflammation), 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 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 take any more tablets unless your doctor tells you to.
Reporting of adverse effects
If you experience any type of adverse effect, consult 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Aciclovir Cinfa
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Do not store above 30°C. Keep in the original packaging to protect from moisture.
Medicines must 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 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 Cinfa
The active substance is aciclovir. Each dispersible tablet contains 800 mg of aciclovir.
The other components (excipients) are:
- Tablet core: microcrystalline cellulose, sodium carboxymethyl starch (type A) (from potato), colloidal anhydrous silica, povidone, magnesium stearate and talc.
- Coating: Opadry white Y-1-7000 (contains hypromellose, titanium dioxide and polyethylene glycol 400).
Appearance of the product and contents of the pack
White, oblong, coated tablets, with a score line on one side and marked with the code “A800C” on the other. They are packed 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 most recent review of this leaflet: October 2020
Other sources of information
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) http://www.aemps.gob.es/
You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/62478/P_62478.html
QR code link: https://cima.aemps.es/cima/dochtml/p/62478/P_62478.html