Patient Information Leaflet

Aciclovir pensa 800 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.

Contents of the Leaflet

1. What Aciclovir pensa is and what it is used for
2. What you need to know before 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

Aciclovirpensacontains an 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.

Aciclovirpensais indicated for:

• Treatment of chickenpox and shingles.

Do not take Aciclovir Pensia

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

Do not take Aciclovir Pensiaif the above applies to you. If you are unsure, speak to your doctor or pharmacist before taking Aciclovir Pensia.

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 doubts related to the taking of Aciclovirpensa.

It is important to drink a sufficient amount of liquid while taking Aciclovirpensa.

Other medicines and Aciclovir Pensia

Inform your doctor or pharmacist if you are taking, have taken recently, or may have to take any other medicine, including those obtained 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 intend 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 affected.

Aciclovir Pensiacontains sodium

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

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

Aciclovir pensa intake

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

The groove is only for breaking the tablet if it is difficult to swallow whole.

Your doctor will indicate the duration and dosage of your treatment with this medication. There is also another dosage of 200 mg available in the market.

Herpes zoster and varicella treatment

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

Your doctor may adjust the Aciclovir pensa 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 pensa.

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

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,
• feeling tired,
• unexplained fever (high temperature) and feeling of fainting, especially when standing.

Less frequent (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),
• kidney problems where little or no urine is passed,
• lower back pain, kidney area pain, or pain just above the hip (renal pain).

Reporting 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 to the Spanish System for 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 86°F (30°C).

Do not use this medication after the expiration date that appears on the packaging and on the blister pack 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 the containers and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need.This will help protect the environment.

Composition of Aciclovir pensa

• The active ingredient is aciclovir. Each tablet contains 800 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 800 mg tablets are presented in white, elongated, biconvex, and scored tablets on one face.

The score is only for breaking the tablet if it is difficult to swallow whole and not for dividing it into equal doses.

They are presented in packs of 35 tablets conditioned in Aluminio/PVC blister.

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 800 mg tablets EFG

Portugal: Aciclovir toLife

Italy: Aciclo vir 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 for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.