ACICLOVIR 200 mg Tablets

2. What you need to know before you 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 taking Aciclovir:

• If you have any kidney disease or are elderly. Your doctor may need to reduce your dose. Also, you should drink plenty of fluid during treatment to maintain adequate hydration.
• If you have genital herpes, it is recommended to take precautions during sexual intercourse even if you have started antiviral treatment.

Taking Aciclovir Normon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor if you have taken probenecid, cimetidine, or mycophenolate mofetil (a medicine used in transplant patients) recently.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Driving and using machines

Some side effects like drowsiness or sleepiness may affect your ability to concentrate and react. Do not drive or operate machinery if you feel that your ability is affected.

Aciclovir Normon 200 mg contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Aciclovir Normon 200 mg contains sodium

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

3. How to take Aciclovir Normon

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, 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 to take Aciclovir. Do not stop treatment before then.

The usual doses for adults are:

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

The usual doses for children are:

• for the treatment of infections caused by herpes simplex and prevention of infections caused by herpes simplex 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): will be treated with half the adult dose.

There are other presentations available more suitable for children under 6 years.

• for the treatment of varicella:
• children (over 6 years) and adolescents: four 200 mg tablets four times a day
• children between 2 and 6 years: two 200 mg tablets four times a day.

There are other presentations available more suitable for children under 6 years.

It is recommended to drink plenty of fluid while taking this treatment.

If you think the effect of this medicine is too strong or too weak, tell 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Aciclovir Normon

Do not take a double dose to make up for forgotten doses, simply wait for the next dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

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

• Hair loss.
• Hives.

Rare side 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).
• Breathing difficulties.
• Angioedema (swelling of the lips, eyes, and tongue).
• Sudden and severe allergic reaction (anaphylactic reaction).

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

• Anemia (decrease in the number of red blood cells) or leukopenia (decrease in the number of white blood cells), bruising (due to a decrease in the number of platelets).
• Agitation, confusion, tremors, difficulty moving, difficulty speaking, confusion or imagining things (hallucinations), changes in personality and behavior, seizures, drowsiness, encephalopathy (brain disorder), coma. These effects are generally reversible and usually occurred in patients with kidney disorders or predisposing factors.
• Hepatitis (inflammation of the liver), jaundice (yellow color of the skin and eyes), acute kidney failure, kidney pain (may be associated with kidney failure).

Tell your doctor immediatelyif you experience any of the following symptoms of allergy: wheezing, palpitations or chest tightness, 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 takeany more tablets unless your doctor tells you to.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaRAM.es. By reporting side 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.

Do not store above 30°C. Store in the original package.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 ingredients are lactose monohydrate, microcrystalline cellulose (E-460i), sodium carboxymethylcellulose (type A) (derived from potato starch), povidone (E-1201), and magnesium stearate (E-572).

Appearance and packaging

PVC/Aluminum blister.

White, round, and biconvex tablets.

Package with 25 and 500 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Date of last revision of this leaflet:April 2022.

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

You can access detailed and up-to-date information about this medicine 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/62298/P_62298.html