Leaflet: information for the user

Aciclovir Mabo 800 mg tablets EFG

Read this 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 should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking 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 additional information

Aciclovir Mabo belongs to a group of medicines called antivirals.

It is used to treat infections caused by the herpes virus, shingles, and chickenpox viruses in adults and children over 6 years old.

Do not take Aciclovir Mabo

• If you are allergic to aciclovir, valaciclovir, or any of the other components of this medication (listed in section 6).

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 lower your dose. Also, you must 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 though antiviral treatment has been initiated.

Other medications and Aciclovir Mabo

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Inform your doctor if you have taken recently probenecid, cimetidina, or micofenolato de mofetilo (medication used in transplant patients) (medication used in transplant patients).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machinery

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 your ability is affected. .

Aciclovir Mabo 800 mg contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide on the correct dose, frequency, and duration of treatment.

Remember to take your medication.

Your doctor will inform you of the duration of your Aciclovir treatment. Do not discontinue treatment before then.

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 nighttime dose
• For the treatment of chickenpox::1 tablet of 800 mg 5 times a day, every 4 hours, omitting the nighttime dose.

Usual doses for children over 6 years old are:

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

For children under 6 years old, 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 estimate that the action of Aciclovir Mabo is too strong or too weak, inform 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Aciclovir Mabo

Do not take a double dose to compensate for the missed doses, simply wait for the next dose.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

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

Less frequent side effects (may affect up to 1 in 100 people)

• Hair loss.
• Urticaria.

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

• Abnormal blood test results (reversible increase in bilirubin and liver enzymes, increases in blood urea and creatinine).
• Difficulty breathing.
• Angioedema (swelling of the lips, eyes, and tongue).
• Severe and sudden allergic reaction (anaphylactic reaction).

Very rare side effects (may affect up to 1 in 10,000 people)

• Anemia (decrease in red blood cell count) or leucopenia (decrease in white blood cell count), thrombocytopenia (decrease in platelet count).
• Agitation, confusion, tremors, difficulty moving, difficulty speaking, hallucinations, changes in personality and behavior, convulsions, somnolence, encephalopathy (brain alteration), coma. These effects are generally reversible and usually occur in patients with kidney disorders or predisposing factors.
• Hepatitis (liver inflammation), jaundice (yellowing of the skin and eyes), acute renal failure, renal pain (may be associated with renal failure).

Inform your doctorimmediatelyif you experience any of the allergy symptoms: sudden shortness of breath, palpitations or chest tightness, collapse, swelling of eyelids, face, lips, or other parts of the body, skin rash or petechiae. 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 type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Usehttps://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication 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 medication after the expiration date indicated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Aciclovir Mabo

• The active ingredient is aciclovir. Each tablet contains 800 mg of aciclovir.
• The other components (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 packaging

The tablets are oblong and white in color.

PVC-Aluminum blisters.

Packages with 35 tablets and 500 tablets (clinical package).

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Responsible for manufacturing

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

Last review date of this leaflet: June 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.