ACICLOVIR MABO 800 mg TABLETS

Introduction

Package Leaflet: Information for the User

Aciclovir Mabo 800 mg Tablets EFG

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Aciclovir Mabo 800 mg and what is it used for
2. What you need to know before you take Aciclovir Mabo 800 mg
3. How to take Aciclovir Mabo 800 mg
4. Possible side effects
5. Storage of Aciclovir Mabo 800 mg
6. Contents of the pack and further information

1. What is Aciclovir Mabo 800 mg and what is it used for

Aciclovir Mabo 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 Mabo 800 mg

Do not take Aciclovir Mabo

• 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 or pharmacist before taking Aciclovir:

• If you have kidney disease or are elderly. Your doctor may need to reduce your dose. Also, you should drink enough liquid 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 Mabo

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

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist 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 like 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..

Aciclovir Mabo 800 mg contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per tablet; this is, essentially “sodium-free”.

3. How to take Aciclovir Mabo 800 mg

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 infections caused by herpes zoster: 1 tablet of 800 mg 5 times a day, every 4 hours, omitting the night dose
• For the treatment of varicella: 1 tablet of 800 mg 5 times a day, every 4 hours, omitting the night dose.

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

• For the treatment of varicella: 1 tablet of 800 mg 4 times a day for 5 days.

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

Aciclovir Mabo 800 mg tablets should be swallowed whole with a little water.

It is recommended to drink plenty of liquid while on this treatment.

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

If you take more Aciclovir Mabo 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 ingested.

If you forget to take Aciclovir Mabo

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 increase 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 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, hallucinations, changes in personality and behavior, seizures, drowsiness, encephalopathy (brain disorder), coma. These effects are generally reversible and usually occur 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 immediatelyif you experience any of the 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 Mabo. Do not takeany more tablets unless your doctor tells you to.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency https//www.notificaram.es.By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aciclovir Mabo 800 mg

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

Store below 30°C. Store in the original packaging to protect from moisture.

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.

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 Mabo

• The active ingredient is aciclovir. Each tablet contains 800 mg of aciclovir.
• The other ingredients (excipients) are: microcrystalline cellulose (E-460i), sodium carboxymethyl starch (from potato), povidone, magnesium stearate (E-572), and anhydrous colloidal silica.

Appearance of the Product and Contents of the Pack

The tablets are oblong and white.

PVC-Aluminum blisters.

Packs of 35 tablets and 500 tablets (clinical pack).

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer

TEDEC-MEIJI FARMA, S.A.

Ctra. M-300, Km. 30,500.

28802, Alcalá de Henares, Madrid.

or

ONE PHARMA S.A

60th Km N.N.R Athinon-Lamias - Sximatari

32009 - Greece

Date of Last Revision of this Package Leaflet: June 2021

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