Aciclovir Cuve 800 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Aciclovir Cuve 800 mg tablets EFG
Aciclovir
Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any further questions, ask your doctor, pharmacist, or nurse.
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This medicine has been prescribed for you only, and must not be given to other people, even if they have the same symptoms as you. It could harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.
Contents of the leaflet
- What Aciclovir Cuve is and what it is used for
- What you need to know before taking Aciclovir Cuve
- How to take Aciclovir Cuve
- Possible side effects
- How to store Aciclovir Cuve
- Contents of the pack and other information
1. What Aciclovir Cuve 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 Cuve
Do not take Aciclovir Cuve:
- 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, pharmacist, or nurse before taking Aciclovir Cuve:
- If you have kidney disease or are elderly. Your doctor may need to reduce your dose. You should also drink an adequate amount of fluid 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 medicines and Aciclovir Cuve
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 breast-feeding
If you are pregnant or breast-feeding, 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 breast-feeding.
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.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".
3. How to take Aciclovir Cuve
Follow exactly the instructions for administering 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 the treatment prematurely.
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.
Use in children and adolescents
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).
The tablet score line is intended only for ease of splitting and swallowing, not for dividing into equal doses.
Dissolve the tablet in sufficient water and shake before taking. If preferred, you may swallow the tablet 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 Cuve is too strong or too weak, inform your doctor or pharmacist.
If you take more Aciclovir Cuve than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Aciclovir Cuve
Do not take a double dose to make up for forgotten doses; simply wait and take the next dose at the scheduled time.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Common 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 test results (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 hallucinations, changes in personality and behaviour, seizures, drowsiness, encephalopathy (brain dysfunction), coma. These effects are usually reversible and have generally 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).
Inform 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 Cuve. Do not take any more tablets unless your doctor tells you to.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor, pharmacist or nurse, 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Aciclovir Cuve
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 moisture.
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.
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 you are unsure, 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 Cuve
- The active substance is aciclovir. Each tablet contains 800 mg of aciclovir.
- The other components (excipients) are microcrystalline cellulose, sodium carboxymethylstarch type A, povidone, magnesium stearate and anhydrous colloidal silica.
Appearance of the product and contents of the pack
White, oblong, scored tablets. They are packaged in PVC-PVDC/Aluminum and Aluminum/Aluminum blisters. Each package contains 35 tablets.
Marketing Authorization Holder and Manufacturer
Pharmex Advanced Laboratories, S.L.
Ctra. A-431 Km. 19
14720 Almodóvar del Río (Córdoba) - Spain
Date of the most recent revision of this leaflet: April 2021
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/)