Label: information for the user

Aciclovir Mabo 200 mg tablets EFG

• Read this label carefully before starting to take this medicine, as it contains important information for youKeep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, 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 not listed in this label. See section 4.

1. What is Aciclovir Mabo 200 mg and how it is used

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

3. How to take Aciclovir Mabo 200 mg

4. Possible adverse effects

5. Storage of Aciclovir Mabo

6. Contents of the package and additional information

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, and the varicella virus.

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 should drink enough liquid during treatment to maintain proper hydration.
• If you have genital herpes, it is recommended to take precautions during sexual intercourse even after starting antiviral treatment.

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 recently taken probenecid, cimetidine, or mycophenolate mofetil(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 impaired..

Aciclovir Mabo 200 mg contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of 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 treatment with Aciclovir Mabo. Do not discontinue treatment before.

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 nocturnal 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 chickenpox and herpes zoster infections::4 tablets of 200 mg 5 times a day every 4 hours, omitting the nocturnal dose.

Usual doses for children are:

• For the treatment of herpes simplex infections and prevention of herpes simplex infections 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.

Other presentations are available that are more suitable for children under 6 years old.

• For the treatment of chickenpox:

• 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.

Other presentations are available that are more suitable for children under 6 years old.

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

It is recommended that you drink plenty of liquid while taking 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 may 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 (inflammation of the liver), 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 of 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 unused medications 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 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 anhydrous colloidal silica.

Appearance of the product and contents of the packaging

The tablets are round and white.

PVC-Aluminum blisters

Packages with 25 tablets and 500 tablets (clinical package)

Only some package sizes may be 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 medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.