Patient Information Leaflet

Aciclovir pensa 200 mg Tablets EFG

Read this 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 others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Table of Contents

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

Aciclovircontainsa active ingredient called aciclovir. It belongs to a group of medicines known as antivirals. It is used in the treatment of infections caused by viruses.

Acicloviris indicated for:

• Treatment of chickenpox and shingles.
• Treatment of cold sores, genital herpes and other herpes simplex infections.
• In the detection of recurrent infections.
• In the detection of these problems in immunocompromised patients, patients with inadequate immune system function.

You should not take Aciclovir pensapensa

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

You should not take Aciclovir pensaif the above applies to you. If you are unsure, talk to your doctor or pharmacist before taking Aciclovir pensa.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeAciclovirpensa if:

• your kidney function is impaired,
• you are over 65 years old.

Consult your doctor or pharmacistif you have any questions about taking Aciclovirpensa.

It is important to drink enough fluids while taking Aciclovirpensa.

Other medicines and Aciclovir pensa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including those bought without a prescription or herbal medicines.

Particularly, inform your doctor if you are taking any of the following medicines:

• probenecid, used to treat gout,
• cimetidine, used to treat peptic ulcers,
• mycophenolate mofetil, a medicine used in transplant patients.

Pregnancy, breastfeeding and fertility

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.

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 pensacontains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor again.

Administration of this medication

• Take this medication orally.
• Take the tablet whole with a little water.
• You can take this medication with or without food.
• Start taking Aciclovir as soon as possible.

Your doctor will indicate the duration and dosage of your treatment with this medication. There is also another dosage of 800 mg in tablets available in the market.

Treatment of chickenpox and shingles

• The usual dose is 800 mg, 5 times a day.
• You should leave a 4-hour space between doses. For example: 7, 11, 15, 19, and 23 hours.
• You should take Aciclovir for 7 days.

Treatment of cold sores and genital herpes

• The usual dose is 200 mg, 5 times a day.
• You should leave a 4-hour space between doses. For example: 7, 11, 15, 19, and 23 hours.
• You should take Aciclovir for 5 days or more if your doctor indicates.

In the detection of recurrent infections

• The usual dose is 200 mg, 4 times a day.
• You should leave a 6-hour space between doses.
• You should take Aciclovir until your doctor indicates.

In the detection of these problems in immunocompromised patients, patients with inadequate immune system function.

• The usual dose is 200 mg, 4 times a day.
• You should leave a 6-hour space between doses.
• You should take Aciclovir until your doctor indicates.

Your doctor may adjust the Aciclovir dosage if:

• You are a child,
• You are over 65 years old,
• You have kidney problems, if you have kidney problems, it is essential to drink plenty of water while being treated with Aciclovir.

If you have any other doubts about the use of this medication, ask your doctor.

If you take more Aciclovir than you should

Aciclovir is not harmful, unless you take too much for several days. Talk to your doctor or pharmacist if you take too much Aciclovir. Bring the packaging with you.

The symptoms of an overdose include effects on the stomach and intestines, such as nausea or vomiting, and effects on the central nervous system, such as confusion.

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

If you forget to take Aciclovir, take it as soon as you remember. However, if it is almost time for your next dose, omit the missed dose.

Do not take a double dose to compensate for the missed doses.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects may occur:

Allergic reactions(may affect up to 1 in 1,000 people):

If you experience an allergic reaction,stop taking Aciclovir and consult your doctor immediately.The symptoms may include:

• hives, itching, or urticaria on the skin,
• swelling of the face, lips, tongue, or other parts of the body,
• difficulty breathing, wheezing, or shortness of breath,
• collapse.

Other side effects include:

Frequent: (may affect up to 1 in 10 people):

• headache,
• dizziness,
• feeling or being sick,
• diarrhea,
• stomach pain,
• eruption,
• skin eruptions caused by sunlight (photosensitivity),
• pruritus,
• sensation of fatigue,
• unexplained fever (high temperature) and feeling of faintness, especially when standing.

Infrequent (may affect up to 1 in 100 people):

• pruritic skin eruption.
• hair loss.

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

• alteration of blood and urine tests,
• increase in liver enzymes.

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

• reduction in the number of red blood cells in the blood (anemia),
• reduction in the number of white blood cells in the blood (leucopenia),
• reduction in the number of platelets in the blood (cells that help blood to clot) (thrombocytopenia),
• feeling weak,
• feeling agitated or confused,
• agitation or tremors,
• hallucinations (seeing or hearing things that are not there),
• convulsions,
• unusual sleepiness or somnolence,
• instability when walking and lack of coordination,
• difficulty speaking,
• inability to think or judge clearly,
• unconsciousness (coma),
• paralysis of part or all of the body,
• behavior, speech, and eye movement disorders,
• neck stiffness and light sensitivity,
• inflammation of the liver (hepatitis),
• yellowing of the skin and eyes (jaundice),
• renal problems where little or no urine is passed,
• lower back pain, renal area back pain, or pain just above the hip (renal pain).

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 prospectus. 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.

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date shown on the packaging and blister 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 medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Aciclovir pensa

• The active ingredient is aciclovir. Each tablet contains 200 mg of aciclovir.
• The other components (excipients) are: microcrystalline cellulose, povidone K30, sodium carboxymethyl starch (type A) (derived from potato starch) and magnesium stearate.

Appearance of the product and content of the packaging

Aciclovir pensa 200 mg tablets are presented in white, round, biconvex tablets, marked on one face with “200”.

They are presented in packs of 25 tablets, conditioned in Aluminio/PVC blisters.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Pharmaceutical Works Polpharma S.A.

19 Pelplinska Str.

83-200 Starogard Gdanski

Poland

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain: Aciclovir pensa 200 mg tablets EFG

Portugal: Aciclovir toLife

Italy: Aciclovir Pensa Pharma

Last review date of this leaflet: September 2022

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.