Aciclovir Pensa 200 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Aciclovir pensa 200 mg tablets EFG

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Package leaflet contents

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. How to store Aciclovir pensa
6. Contents of the pack and other information

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

Aciclovir pensa contains an active substance called aciclovir. It belongs to a group of medicines known as antivirals. It is used to treat infections caused by viruses.

Aciclovir pensa is indicated for:

• Treatment of chickenpox and herpes zoster.
• Treatment of cold sores, genital herpes, and other infections caused by herpes simplex.
• Prevention of recurrent infections.
• Prevention of these infections in immunocompromised patients, patients with impaired immune system function.

2. What you need to know before starting to take Aciclovir pensa

Do not take Aciclovirpensa

• 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 Aciclovirpensa if the above applies to you. If you are unsure, speak with your doctor or pharmacist before taking Aciclovirpensa.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Aciclovir pensa if:

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

Consult your doctor or pharmacist if you have any doubts regarding the use of Aciclovir pensa.

It is important to drink an adequate amount of fluid while taking Aciclovir pensa.

Other medicines and Aciclovir pensa

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

In particular, 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, lactation and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and Use of Machines

Some adverse 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 impaired.

Aciclovir pensa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to take Aciclovir pensa

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor again.

How to take this medicine

• Take this medicine orally.
• Swallow the tablet whole with some water.
• You may take this medicine with or without food.
• Start taking Aciclovir pensa as soon as possible.

Your doctor will tell you how long to take this medicine and what dose to use. Another dosage of 800 mg tablets is also available on the market.

Treatment of chickenpox and shingles

• The usual dose is 800 mg, taken 5 times a day.
• There should be an interval of 4 hours 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, taken 5 times a day.
• There should be an interval of 4 hours between doses. For example: 7, 11, 15, 19, and 23 hours.
• You should take Aciclovir pensa for 5 days or longer if your doctor instructs you to do so.

For prevention of recurrent infections

• The usual dose is 200 mg, taken 4 times a day.
• There should be an interval of 6 hours between doses.
• You should take Aciclovir pensa for as long as your doctor advises.

For prevention of these conditions in immunocompromised patients, patients with impaired immune system function.

• The usual dose is 200 mg, taken 4 times a day.
• You should leave an interval of 6 hours between doses.
• You should take Aciclovir pensa for as long as your doctor advises.

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 usually not harmful unless you take too much for several days. Speak to your doctor or pharmacist if you have taken an excessive amount of Aciclovir pensa. Take the pack with you.

Symptoms of an overdose include gastrointestinal effects 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 at telephone number: 91 562 04 20, indicating the medication 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 forgotten doses.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse 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:

• skin rash, itching or hives,
• 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,
• nausea or feeling unwell,
• diarrhoea,
• stomach pain,
• rash,
• skin rash caused by sunlight (photosensitivity),
• pruritus,
• feeling tired,
• unexplained fever (high temperature) and feeling faint, especially when standing.

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

• itchy skin rash,
• hair loss.

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

• changes in blood and urine test results,
• increased levels of liver enzymes.

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

• reduction in the number of red blood cells in the blood (anaemia),
• 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),
• seizures,
• unusual drowsiness or somnolence,
• 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,
• disturbances in behaviour, speech and eye movements,
• neck stiffness and sensitivity to light,
• inflammation of the liver (hepatitis),
• yellowing of the skin and eyes (jaundice),
• kidney problems resulting in little or no urine output,
• pain in the lower back, the kidney area of the back or just above the hip (renal pain).

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Aciclovir pensa Storage

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 stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Aciclovir pensa

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

Appearance of the medicinal product and contents of the container

Aciclovir pensa 200 mg tablets are presented as white, round, biconvex tablets, marked on one side with "200".

They are packaged in containers of 25 tablets, arranged in aluminum/PVC blisters.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer Responsible

Pharmaceutical Works Polpharma S.A.

19 Pelplinska Str.

83-200 Starogard Gdanski

Poland

This medicinal product is authorized in the European Economic Area member states under the following names:

Spain: Aciclovir pensa 200 mg tablets EFG

Portugal: Aciclovir toLife

Italy: Aciclovir Pensa Pharma

Date of latest review of this leaflet: September 2022

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