Aciclovir Normon 200 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aciclovir Normon 200 mg tablets EFG

aciclovir

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Aciclovir Normon is and what it is used for
2. What you need to know before taking Aciclovir Normon
3. How to take Aciclovir Normon
4. Possible adverse effects
5. Storage of Aciclovir Normon
6. Contents of the pack and other information

1. What AciclovirNormon 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, herpes zoster, and the varicella virus.

2. What you need to know before starting to take Aciclovir Normon

Do not take Aciclovir Normon:

• if you are allergic to aciclovir, valaciclovir, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Aciclovir:

• If you have a kidney disease or are elderly. Your doctor may need to reduce your dose. You should also drink an adequate amount of fluid during treatment to maintain proper hydration.
• If you have genital herpes infection, it is recommended to take precautions during sexual intercourse even after starting antiviral treatment.

Taking Aciclovir Normon with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 is excreted in breast milk. Contact your doctor or pharmacist if you are breastfeeding.

Driving and operating machinery

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 Normon 200 mg contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Aciclovir Normon 200 mg contains sodium

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

3. How to take Aciclovir Normon

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

Remember to take your medicine.

Your doctor will inform you of the duration of your treatment with Aciclovir. Do not stop treatment prematurely.

The usual doses for adults are:

• for the treatment of herpes simplex infections: one 200 mg tablet five times daily every four hours, omitting the nighttime dose
• for suppression of recurrences caused by herpes simplex virus: one 200 mg tablet four times daily every six hours, or two 200 mg tablets twice daily every twelve hours
• for prevention of herpes simplex infections in immunocompromised patients: one 200 mg tablet four times daily every six hours
• for treatment of chickenpox and herpes zoster infections: four 200 mg tablets five times daily every four hours, omitting the nighttime dose.

The 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 of age): the dose is the same as for adults
• infants (28 days to 23 months): half the adult dose should be administered.

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

• for the treatment of chickenpox:
• children (over 6 years of age) and adolescents: four 200 mg tablets four times daily
• children between 2 and 6 years of age: two 200 mg tablets four times daily.

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

It is recommended that you drink plenty of fluids during this treatment.

If you think that the effect of this medicine 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Aciclovir Normon

Do not take a double dose to make up for missed doses; simply wait and take the next dose at the scheduled time.

4. Possible adverse effects

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

Common adverse effects (may affect up to 1 in 10 people)

• Headache, dizziness, feeling tired, 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.
• Hives.

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

• Changes in blood tests (reversible increases 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 cells) or leucopenia (decrease in white blood cells), bruising (due to decreased platelet count).
• Agitation, confusion, tremors, difficulty moving, difficulty speaking, hallucinations (seeing or imagining things), changes in personality and behaviour, seizures, drowsiness, encephalopathy (brain dysfunction), coma. These effects are usually reversible and have generally occurred 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 immediately if you experience any of the following 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. Do not take any more tablets unless your doctor tells you to.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aciclovir Normon

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

Store below 30 ºC. Keep in the original packaging.

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 should 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 have any doubts, 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 Normon 200 mg tablets

• The active substance is aciclovir.
• The other components are lactose monohydrate, microcrystalline cellulose (E-460i), sodium carboxymethylstarch (type A) (derived from potato starch), povidone (E-1201) and magnesium stearate (E-572).

Appearance of the product and contents of the pack

PVC/Aluminum blister.

White, round, biconvex tablets.

Pack containing 25 and 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Responsible for Manufacturing

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: April 2022.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/62298/P_62298.html