ACICLOVIR CINFA 200 mg TABLETS

Introduction

Package Leaflet: Information for the User

Aciclovir Cinfa 200 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4

Contents of the pack

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

1. What Aciclovir Cinfa 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 varicella virus

2. What you need to know before you take Aciclovir Cinfa

Do not take Aciclovir Cinfa

• 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 kidney disease or are elderly. Your doctor may need to reduce your dose. Also, you should drink enough liquid 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

Using Aciclovir Cinfa with other medicines

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines

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

Pregnancy, breastfeeding, and fertility

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 Cinfa contains sodium

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

3. How to take Aciclovir Cinfa

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, 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 indicate the duration of your treatment with aciclovir. Do not stop treatment before

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

It is recommended to drink plenty of liquid while under this treatment

If you think the action of aciclovir is too strong or too weak, tell your doctor or pharmacist

If you take more Aciclovir Cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 915 62 04 20, indicating the medicine and the amount taken

If you forget to take Aciclovir Cinfa

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)
• Difficulty breathing
• 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 take any 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 Cinfa

Keep this medicine out of the sight and reach of children

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

Do not store above 30°C

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 Cinfa

• The active substance is aciclovir. Each tablet contains 200 mg of aciclovir
• The other ingredients are: Microcrystalline cellulose, povidone K-30, sodium carboxymethyl starch (type A) (derived from potato starch), and magnesium stearate

Appearance of the product and pack contents

Aciclovir Cinfa is presented in the form of tablets. They are white, round, and biconvex tablets

The tablets are packaged in Al/PVC blisters

Carton box containing 25 tablets

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Pharmaceutical Works Polpharma SA Pelplinska 19

83-200 Starogard Gdanski

Poland

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of last revision of this leaflet: September 2019

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/84468/P_84468.html

QR code to: https://cima.aemps.es/cima/dochtml/p/84468/P_84468.html