Aciclovir Normon 800 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aciclovir Normon 800 mg 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 effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Aciclovir Normon is and what it is used for
2. What you need to know before taking Aciclovir Normon
3. How to take Aciclovir Normon
4. Possible adverse effects
5. How to store Aciclovir Normon

Pack contents and additional information

1. What Aciclovir Normon 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 starting to take Aciclovir Normon

Do not take Aciclovir Normon:

• if you are allergic to aciclovir, valaciclovir, or any of the other ingredients of this medicine (listed in section 6).

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Warnings and precautions

Consult your doctor or pharmacist before starting to take Aciclovir:

• If you have any kidney disease or are elderly. Your doctor may need to reduce your dose. You should also drink enough fluids during treatment to maintain adequate hydration.
• If you have genital herpes infection, it is recommended to take precautions during sexual intercourse even if antiviral treatment has been started.

Taking Aciclovir Normon 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 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 operating machinery

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 Normon 800 mg contains sodium

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

3. How to take Aciclovir Normon

Follow exactly the instructions for administration of this medicine 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 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.

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).

It is recommended that you drink plenty of fluids during this treatment. Scored tablet. The score line is only intended to facilitate breaking the tablet if you have difficulty swallowing it whole.

If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you take more Aciclovir Normon than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Aciclovir Normon

Do not take a double dose to make up for missed 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 experiences them.

Frequent adverse effects (may affect up to 1 in 10 people)

• Headache, dizziness, feeling tired, fever.
• Nausea, vomiting, diarrhea, 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.

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, movement difficulties, speech difficulties, confusion or hallucinations, changes in personality and behaviour, seizures, drowsiness, encephalopathy (brain dysfunction), coma. These effects are usually reversible and 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 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: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aciclovir Normon

Keep this medicine out of the sight and reach of children.

Store below 30 ºC. Keep in the original packaging.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aciclovir Normon 800 mg tablets

• The active substance is aciclovir.
• The other components are microcrystalline cellulose (E-460i), sodium carboxymethylstarch (type A) (derived from potato starch), povidone (E-1201), magnesium stearate (E-572) and anhydrous colloidal silica (E-551).

Appearance of the product and contents of the pack

Al/PVC blister

White, elongated, biconvex, scored tablets.

Packs containing 25 and 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: April 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) 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 outer packaging. You may also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/62297/P_62297.html