ACICLOVIR CUVE 800 mg TABLETS

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.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Aciclovir Cuve and what is it used for
2. What you need to know before you take Aciclovir Cuve
3. How to take Aciclovir Cuve
4. Possible side effects

5 Conservation of Aciclovir Cuve

1. Contents of the pack and further information

1. What is Aciclovir Cuve and what is it used for

Aciclovir 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 you take 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

Consult 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. Also, you should drink enough fluid during treatment to maintain adequate hydration.
• If you have genital herpes infection, it is recommended to take precautions during sexual intercourse even if you have started antiviral treatment.

Other Medicines and Aciclovir Cuve

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Aciclovir passes into breast milk. Contact your doctor or pharmacist if you are breastfeeding.

Driving and Using 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 that your ability is affected.

This medicine contains less than 23 mg of sodium (1mmol) per tablet; it is essentially "sodium-free".

3. How to Take Aciclovir Cuve

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, 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 indicate the duration of your treatment with Aciclovir. Do not stop treatment before.

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

Use in Children and Adolescents

The usual doses for children over 6 years of age are:

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

For children under 6 years of age: it is recommended to use the available suspension (Aciclovir 400 mg/5 ml oral suspension).

The score line is only for breaking and facilitating swallowing but not for dividing into equal doses.

Dissolve the tablet in sufficient water and shake before taking. If you prefer, you can swallow the tablet whole with the help of a little water.

It is recommended to drink plenty of fluid while taking this treatment.

If you think the effect of Aciclovir Cuve is too strong or too weak, tell your doctor or pharmacist.

If You Take More Aciclovir Cuve Than You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If You Forget to Take Aciclovir Cuve

Do not take a double dose to make up for forgotten doses, simply wait for the next dose.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common Side Effects (may affect up to 1 in 10 people)

• Headache, dizziness, feeling tired, fever.
• Nausea, vomiting, diarrhea, stomach pain.
• Itching, skin rash (sometimes caused by sensitivity to sunlight).

Uncommon Side Effects (may affect up to 1 in 100 people)

• Hair loss.
• Hives.

Rare Side 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).
• Severe allergic reaction (anaphylactic reaction).

Very Rare Side Effects (may affect up to 1 in 10,000 people)

• Anemia (decrease in the number of red blood cells) or leukopenia (decrease in the number of white blood cells), bruising (due to a decrease in the number of platelets).
• Agitation, confusion, tremors, difficulty moving, difficulty speaking, confusion or imagining things (hallucinations), changes in personality and behavior, seizures, drowsiness, encephalopathy (brain disorder), coma. These effects are generally reversible and usually occurred in patients with kidney disorders or predisposing factors.
• Hepatitis (inflammation of the liver), jaundice (yellow color of the skin and eyes), acute kidney failure, kidney pain (may be associated with kidney failure).

Tell your doctor immediatelyif you experience any of the following symptoms of allergy: 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 takemore tablets unless your doctor tells you to.

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation 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 which is stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Aciclovir Cuve

• The active substance is aciclovir. Each tablet contains 800 mg of aciclovir.
• The other ingredients (excipients) are microcrystalline cellulose, sodium carboxymethylcellulose type A, povidone, magnesium stearate, and anhydrous colloidal silica.

Appearance of the Product and Contents of the Pack

White, oblong, and scored tablets. They are packaged in PVC-PVDC/Aluminum and Aluminum/Aluminum blisters. Each pack 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 Last Revision of this Leaflet: April 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)