ACICLOVIR MABO 200 mg TABLETS

Introduction

Leaflet: Information for the user

Aciclovir Mabo 200 mg tablets EFG

• Read this leaflet carefully before starting to take this medicine, as it contains important information for you. Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Aciclovir Mabo 200 mg and what is it used for
2. What you need to know before taking Aciclovir Mabo 200 mg
3. How to take Aciclovir Mabo 200 mg
4. Possible side effects
5. Storage of Aciclovir Mabo
6. Package contents and additional information

1. What is Aciclovir Mabo 200 mg and what is it used for

Aciclovir belongs to a group of medicines called antivirals.

It is used to treat and prevent infections caused by the herpes simplex virus, genital herpes, herpes zoster, and varicella virus.

2. What you need to know before taking Aciclovir Mabo 200 mg

Do not take Aciclovir Mabo

• 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 to take 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, 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 using, have recently used, or may need to use any other medicine.

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 plan 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 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 impaired..

Aciclovir Mabo 200 mg contains sodium

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

3. How to take Aciclovir Mabo 200 mg

Follow the administration instructions for this medicine exactly as indicated 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 Mabo. Do not stop treatment before.

The usual doses for adults are:

• For the treatment of infections caused by herpes simplex: 1 tablet of 200 mg 5 times a day every 4 hours, omitting the night dose
• For the suppression of recurrences caused by herpes simplex virus: 1 tablet of 200 mg 4 times a day every 6 hours, or 2 tablets of 200 mg 2 times a day every 12 hours.
• For the prevention of infections caused by herpes simplex in immunocompromised patients: 1 tablet of 200 mg 4 times a day every 6 hours.
• For the treatment of varicella and herpes zoster infections: 4 tablets of 200 mg 5 times a day every 4 hours, omitting the night dose.

The usual doses for children are:

• For the treatment of infections caused by herpes simplex and prevention of infections caused by herpes simplex in immunocompromised children:

• Children and adolescents (2 to 18 years): the dose is the same as for adults.
• Infants (28 days to 23 months): will be treated with half the adult dose.

There are other presentations available that are more suitable for children under 6 years.

• For the treatment of varicella:

• Children (over 6 years) and adolescents: 4 tablets of 200 mg 4 times a day for 5 days.
• Children between 2 and 6 years: 2 tablets of 200 mg 4 times a day for 5 days.

There are other presentations available that are more suitable for children under 6 years.

Aciclovir Mabo 200 mg tablets should be swallowed whole with a little water.

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

If you think the effect 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 taken.

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 everyone 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, increase 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 red blood cells) or leukopenia (decrease in white blood cells), bruising (due to a decrease in platelets).
• Agitation, confusion, tremors, difficulty moving, difficulty speaking, hallucinations, changes in personality and behavior, seizures, drowsiness, encephalopathy (brain disorder), coma. These effects are usually reversible and typically 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 an allergic reaction: 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 indicate that you are allergic to Aciclovir Mabo. Do not takemore tablets unless your doctor tells you to.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) 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 200 mg

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

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

Do not use this medicine after the expiration date indicated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medicine in the SIGRE collection point at the 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. Package contents and additional information

Composition of Aciclovir Mabo

• The active ingredient is aciclovir. Each tablet contains 200 mg of aciclovir.
• The other ingredients (excipients) are: microcrystalline cellulose (E-460i), sodium carboxymethyl starch (type A) (from potato), povidone, magnesium stearate (E-572), and anhydrous colloidal silica.

Appearance of the product and package contents

The tablets are round and white.

PVC-Aluminum blisters

Packaging with 25 tablets and 500 tablets (clinical packaging)

Only some package 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 the last revision of this 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.