Package Insert: Information for the User

Aciclovir Normon 800 mg Tablets EFG

aciclovir

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

Aciclovir belongs to a group of medicines called antivirals.

It is used to treat infections caused by the zoster virus and the varicella virus in adults and children over 6 years old.

Do not take Aciclovir Normon:

-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. You should also 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.

Taking Aciclovir Normon with other medications

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 (a 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 Normon 800 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 for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will determine 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 prematurely.

Usual doses for adults are:

• for the treatment of herpes zoster infections: one 800 mg tablet five times a day, every four hours, omitting the nighttime dose
• for the treatment of chickenpox: one 800 mg tablet five times a day, every four hours, omitting the nighttime dose.

Usual doses for children over 6 years old are:

• for the treatment of chickenpox: one 800 mg tablet four times a day.

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

It is recommended that you drink plenty of liquid while on this treatment. Scored tablet. The score is only for breaking the tablet if it is difficult to swallow whole.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Aciclovir Normon 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 Normon

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.

Side effectsfrequent (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).

Side effectsinfrequent (may affect up to 1 in 100 people)

• Hair loss.
• Urticaria.

Side effectsrare (may affect up to 1 in 1,000 people)

• Abnormal blood test results (reversible increases 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).

Side effectsvery rare (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, confusion or imagination of things (hallucinations), alterations in personality and behavior, convulsions, somnolence, encephalopathy (brain alteration), coma.These effects are generally reversible and normally appeared in patients with kidney disorders or predisposing factors.
• Hepatitis (liver inflammation), jaundice (yellow skin and eyes), acute renal failure, renal pain (may be associated with renal failure).

Inform your doctor immediately if you experience any of the following allergy symptoms: sudden shortness of breath, palpitations or chest tightness, collapse, swelling of eyelids, face, lips, or other body parts, skin rash or petechiae. These symptoms may indicate that you are allergic to Aciclovir.Do not take more 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 a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://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.

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

Medicines 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 packaging and unused medications. By doing so, you will help protect the environment.

Composition ofAciclovir Normon 800 mg tablets

• The active ingredient is aciclovir.
• The other components are microcrystalline cellulose (E-460i), sodium carboxymethyl starch (type A) (derived from potato starch), povidone (E-1201), magnesium stearate (E-572) and anhydrous colloidal silica (E-551).

Appearance of the product and contents of the packaging

Aluminum/PVC blister

White, elongated, biconvex, and scored tablets.

Packaging with 25 and 500 tablets.

Not all packaging sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Last review date of this leaflet:April 2022.

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

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/62297/P_62297.html