Aciclovir Mabo 200 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aciclovir Mabo 200 mg tablets EFG

• 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may 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 Mabo 200 mg is and what it is 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. How to store Aciclovir Mabo 200 mg
6. Contents of the pack and other information

1. What Aciclovir Mabo 200 mg is and what it is 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, shingles (herpes zoster), and the varicella virus.

2. What you need to know before starting Aciclovir Mabo 200 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

Talk to your doctor or pharmacist before starting Aciclovir:

• If you have kidney disease or are elderly. Your doctor may need to reduce your dose. You should also drink sufficient amounts of fluid during treatment to maintain adequate 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 Mabo

Tell 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 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.

Aciclovir Mabo 200 mg contains sodium

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

3. How to take Aciclovir Mabo 200 mg

Follow exactly the instructions for use of 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 tell you how long you should take Aciclovir Mabo. Do not stop treatment prematurely.

The usual doses for adults are:

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

The usual doses for children are:

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

• Children and adolescents (from 2 to 18 years): the dose is the same as for adults.

• Infants (from 28 days to 23 months): should receive half the adult dose.

Other formulations are available that are more suitable for children under 6 years of age.

• For treatment of chickenpox:

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

• Children between 2 and 6 years: 2 tablets of 200 mg four times daily for 5 days.

Other formulations are available that are more suitable for children under 6 years of age.

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

It is recommended that you drink plenty of fluids while taking this medicine.

If you think that 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 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 until the next scheduled dose.

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 of tiredness, 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.

Rare adverse 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 adverse effects (may affect up to 1 in 10,000 people)

• Anaemia (decrease in red blood cell count) or leucopenia (decrease in white blood cell count), bruising (due to decreased platelet count).
• Agitation, confusion, tremors, difficulty with movement, difficulty speaking, hallucinations (seeing or imagining things), personality and behavioural changes, seizures, drowsiness, encephalopathy (brain dysfunction), 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).

Inform your doctor immediately if you experience any symptoms of allergy: sudden wheezing, palpitations or tightness in the chest, 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 take any more tablets unless instructed by your doctor.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 sight and reach of children.

Store below 30°C. Keep 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 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 collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aciclovir Mabo

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

Appearance of the product and contents of the pack

The tablets are round and white.

PVC-Aluminum blisters

Packs containing 25 tablets and 500 tablets (clinical pack)

Only some pack sizes may be commercially available.

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, Spain

or

ONE PHARMA S.A

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

32009 – Greece

Date of the most recent review of this leaflet: June 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.