ACICLOVIR PENSA 200 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Aciclovir Pensa 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 symptoms are the same as yours.
• If you experience 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 ingredient 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 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.

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 to any of the other ingredients of this medicine (listed in section 6).

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

Warnings and Precautions

Talk to your doctor or pharmacist before starting to take Aciclovir Pensa if:

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

Talk to 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, 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 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 of 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. In case of doubt, consult your doctor 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.

Your doctor will tell you the duration and dosage of your treatment with this medicine. There is also another dosage of 800 mg available in tablets on the market.

Treatment of chickenpox and shingles

• 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.

Treatment of cold sores and genital herpes

• The usual dose is 200 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 5 days or more if your doctor tells you to.

In the detection of recurrent infections

• The usual dose is 200 mg, 4 times a day
• You should leave a 6-hour gap between doses
• You should take Aciclovir Pensa until your doctor tells you to.

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 gap between doses.
• You should take Aciclovir Pensa until your doctor tells you to.

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 other doubts about the use of this medicine, ask your doctor.

If you take more Aciclovir Pensa than you should

Aciclovir Pensa is normally not harmful, unless you take too much for several days. Talk to your doctor or pharmacist if you take too much Aciclovir Pensa. Bring the pack 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

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 missed 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 suffer an allergic reaction, stop taking Aciclovir Pensaand consult your doctor immediately.The 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 faint, especially when standing.

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

• skin rash with itching.
• hair loss.

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

• changes in 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 (leukopenia),
• 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,
• feeling unusually sleepy or drowsy,
• 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 disorders, speech, and eye movement disorders,
• stiffness of the neck and sensitivity to light,
• inflammation of the liver (hepatitis),
• yellowing 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 they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: 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 packaging and on the blister after EXP. The expiry date is 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 ingredient is aciclovir. Each tablet contains 200 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 200 mg tablets are presented as white, round, and biconvex tablets, marked on one side with "200".

They are presented in packs of 25 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 200 mg tablets EFG

Portugal: Aciclovir toLife

Italy: Aciclovir Pensa Pharma

Date of Last Revision of this Leaflet

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.