Aciclovir CINFA 800 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Aciclovir cinfa 800 mg tablets EFG
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 must 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 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 adverse effects
- How to store Aciclovir cinfa
- Contents of the pack 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 varicella 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 aciclovir.
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If you have kidney disease or are elderly. Your doctor may need to reduce your dose. You should also drink sufficient fluids during treatment to maintain adequate hydration.
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If you have genital herpes infection, it is recommended to take precautions during sexual intercourse even after starting antiviral treatment.
Taking Aciclovir cinfa with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
TELL YOUR DOCTOR IF YOU HAVE RECENTLY TAKEN PROBENECID, CIMETIDINE, OR MYCOPHENOLATE MOFETIL (A MEDICINE USED IN TRANSPLANT PATIENTS).
Pregnancy, breastfeeding and fertility
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 sleepiness 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; therefore, it is essentially "sodium-free".
3. How to take Aciclovir cinfa
Follow exactly the instructions given by your doctor for taking this medicine. 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 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.
The usual doses for children over 6 years of age are:
- for the treatment of chickenpox: one 800 mg tablet four times a day.
For children under 6 years of age: it is recommended to use the available oral suspension (Aciclovir 400 mg/5 ml oral suspension).
Swallow the tablets whole with a little water.
It is recommended that you drink plenty of fluids during this treatment.
If you think that the effect of aciclovir is too strong or too weak, inform your doctor or pharmacist.
The score line is intended solely for splitting the tablet if you have difficulty swallowing it whole.
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: 915 62 04 20, stating the medicine and the amount ingested.
If you forget to take Aciclovir cinfa
Do not take a double dose to make up for missed doses; simply wait for your 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 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.
- 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 (reduced number of red blood cells) or leucopenia (reduced number of white blood cells), bruising (due to reduced number of platelets).
- Agitation, confusion, tremors, difficulty with movement, difficulty speaking, confusion or hallucinations (seeing or imagining things), changes in personality and behaviour, seizures, drowsiness, encephalopathy (brain dysfunction), coma. These effects are usually reversible and 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 tightness in the chest, 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 they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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 container after EXP. The expiry date is the last day of the month indicated.
Do not store above 30 °C.
Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines 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 tablet contains 800 mg of aciclovir.
- The other components are: microcrystalline cellulose, povidone K-30, sodium carboxymethyl starch (type A) (derived from potato starch) and magnesium stearate.
Appearance of the product and pack contents
Aciclovir cinfa is presented as tablets. The tablets are white, elongated, biconvex, and have a score line on one side.
The tablets are packaged in Al/PVC blisters.
Cardboard box containing 35 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain
Manufacturer
Pharmaceutical Works Polpharma SA Pelplinska 19
83-200 Starogard Gdanski
Poland
or
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain
Date of the most recent revision of this leaflet: May 2020
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/
You can access detailed and up-to-date 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/85061/P_85061.html
QR code to: https://cima.aemps.es/cima/dochtml/p/85061/P_85061.html