ACICLOVIR PENSA 800 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Aciclovir Pensa 800 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 Package Leaflet

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

1. What is Aciclovir Pensa and what is it used for

Aciclovir Pensa contains the active substance aciclovir. It belongs to a group of medicines called antivirals. It is used to treat infections caused by viruses.

Aciclovir Pensa is indicated for:

• Treatment of chickenpox and herpes zoster.

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

Do not take Aciclovir Pensa

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

Do not take Aciclovir Pensa if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Aciclovir Pensa.

Warnings and Precautions

Consult your doctor or pharmacist before taking Aciclovir Pensa if:

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

Consult your doctor or pharmacist if you have any doubts about taking Aciclovir Pensa.

It is important to drink enough liquid while taking Aciclovir Pensa.

Other Medicines and Aciclovir Pensa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription or herbal medicines.

In particular, tell 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, Breast-feeding, and Fertility

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

Driving and Using Machines

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 that your ability is affected.

Aciclovir Pensacontains sodium

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

3. How to Take Aciclovir Pensa

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Taking this medicine

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

The score line is only to facilitate breaking the tablet if you have difficulty swallowing it whole and not to divide it into equal doses.

Your doctor will tell you how long and what dose of your treatment with this medicine. There is also another dose of 200 mg available in tablets on the market.

Treatment of chickenpox and herpes zoster

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

Your doctor may adjust the dose of Aciclovir Pensa if:

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

If you have any further questions about the use of this medicine, ask your doctor.

If you take more Aciclovir Pensa than you should

Aciclovir Pensa is not normally harmful unless you take too much over several days. Talk to your doctor or pharmacist if you take too much Aciclovir Pensa. Take the pack with you.

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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Aciclovir Pensa

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

Do not take a double dose to make up for forgotten doses.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 Pensa and consult your doctor immediately.Symptoms may include:

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

Other side effects include:

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

• headache,
• dizziness,
• feeling or being sick,
• diarrhea,
• stomach pain,
• rash,
• skin rashes caused by sunlight (photosensitivity),
• itching,
• feeling tired,
• unexplained fever (high temperature) and feeling of fainting, especially when standing up.

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

• itchy skin rash,
• hair loss.

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

• abnormal 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 (thrombocytopenia),
• feeling weak,
• feeling agitated or confused,
• agitation or tremors,
• hallucinations (seeing or hearing things that are not there),
• seizures,
• unusual sleepiness or drowsiness,
• unsteadiness when walking and lack of coordination,
• difficulty speaking,
• inability to think or judge clearly,
• unconsciousness (coma),
• paralysis of part or all of the body,
• behavioral, speech, and eye movement disorders,
• stiffness of the neck and sensitivity to light,
• inflammation of the liver (hepatitis),
• yellow color of the skin and eyes (jaundice),
• kidney problems where little or no urine is passed,
• pain in the lower back, kidney area of the back, or just above the hip (kidney pain).

Reporting of Side Effects

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

5. Storage of Aciclovir Pensa

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

Do not store above 30°C.

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

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 Further Information

Composition of Aciclovir Pensa

• The active substance is aciclovir. Each tablet contains 800 mg of aciclovir.
• The other ingredients (excipients) are: microcrystalline cellulose, povidone K30, sodium carboxymethyl starch (type A) (derived from potato starch), and magnesium stearate.

Appearance of the Product and Contents of the Pack

Aciclovir Pensa 800 mg tablets are presented as white, elongated, biconvex tablets, and scored on one face.

The score line is only to facilitate breaking the tablet if you have difficulty swallowing it whole and not to divide it into equal doses.

They are presented in packs of 35 tablets in aluminum/PVC blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

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 under the following names:

Spain: Aciclovir Pensa 800 mg tablets EFG

Portugal: Aciclovir toLife

Italy: Aciclovir Pensa Pharma

Date of the last revision of this leaflet:September 2022

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