ACICLOVIR PENSA 200 mg DISPERSIBLE TABLETS

Introduction

Leaflet: Information for the Patient

Aciclovir Pensa 200 mg Dispersible Tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience 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 is Aciclovir Pensa and what is it 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. Package contents and additional information

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

Aciclovir is an antiviral medication used to treat infections caused by viruses.

This medication is indicated for the treatment of: skin and mucous membrane infections caused by the herpes simplex virus in immunodepressed patients (weakened immune system) and its prevention, genital herpes (being effective in the first episode of genital herpes), herpes zoster in immunocompetent patients (with normal immune system function) and chickenpox.

It is also indicated for patients at risk (diabetics, malnourished, etc.) and/or with severe herpes zoster, with the benefit being lower in the rest of patients.

2. What you need to know before taking Aciclovir Pensa

Do not take Aciclovir Pensa

If you are allergic (hypersensitive) to aciclovir or any of the other components of this medication, including those listed in section 6.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

• If you have kidney disease or are elderly, your doctor may use a lower dose. Also, you should drink enough fluid during treatment to maintain adequate hydration.
• In elderly patients, adequate fluid intake is recommended while taking high doses of aciclovir orally.
• Caution should be taken to avoid potential transmission of the virus, especially when active lesions are present. To avoid transmission of the infection to the partner, patients with genital herpes with visible lesions should avoid sexual intercourse.

Children and adolescents

This medication is recommended for the treatment and prevention of infections caused by the herpes simplex virus in immunodeficient children. See section 3. How to take Aciclovir Pensa.

There is no established dosage for the treatment of recurrent herpes simplex virus infections in immunodepressed children.

For the treatment of chickenpox in children under 2 years of age, see section 3. How to take Aciclovir Pensa.

For the treatment of chickenpox in children over 6 years of age, other presentations are more suitable.

Taking Aciclovir Pensa with other medications

Inform your doctor or pharmacist if you are using or have recently used or may need to use any other medication, including those purchased without a prescription.

Concomitant administration with probenecid (a medication used to treat gout), cimetidine (a medication for the treatment of stomach acid), or mycophenolate (to prevent organ transplant rejection) increases the half-life of aciclovir and the area under the curve of its plasma concentrations, which should be taken into account by your doctor, although no dose adjustment is necessary.

No other drug interactions have been described, although medications that alter renal physiology could influence the pharmacokinetics of aciclovir.

Taking Aciclovir Pensa with food and drinks

Aciclovir tablets can be dispersed in a minimum of 50 ml of water or swallowed whole with a little water.

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before taking a medication.

Human experience is limited, so aciclovir will only be used in cases where the benefit-risk assessment of its application advises its use.

Breastfeeding

Consult your doctor or pharmacist before taking a medication.

Studies in humans show that after administration of this medication, aciclovir may appear in breast milk, so breastfeeding is not recommended.

Driving and using machines

Due to the characteristics of this medication, it is unlikely. However, it has been observed that in some cases, signs of fatigue, headache, and mild neurological reactions occur. These reactions should be taken into account when driving and operating machines.

3. How to take Aciclovir Pensa

The first dose should be administered as soon as possible after the infection has developed.

In the case of recurrent infections, it is advisable to start treatment at the first symptom or sign, or when lesions appear.

Follow these instructions unless your doctor has given you different instructions. Remember to take your medication.

Aciclovir tablets can be dispersed in a minimum of 50 ml of water or swallowed whole with a little water.

Your doctor will indicate the duration of your treatment with this medication. Do not stop treatment before.

Adults:

Patients with normal renal function:

• For the treatment of infections caused by the herpes simplex virus: 1 tablet 5 times a day at intervals of approximately 4 hours, omitting the nighttime dose, for 5 days.

In severely immunodepressed patients and those with difficulties in intestinal absorption, the dose may be doubled to 400 mg (2 tablets) 5 times a day.

• For the suppression of recurrences caused by the herpes simplex virus in immunocompetent patients (with normal immune system function): 1 tablet 4 times a day at intervals of approximately 6 hours or 2 tablets 2 times a day, every 12 hours. Treatment will be interrupted periodically at intervals of 6 to 12 months to observe possible changes in the disease process.
• For the prevention of infections caused by the herpes simplex virus in immunocompromised patients (with weakened immune system function): 1 tablet 4 times a day at intervals of 6 hours. In severely immunocompromised patients and those with difficulties in intestinal absorption, the dose may be doubled to 400 mg (2 tablets) 4 times a day.
• For the treatment of herpes zoster infections: 4 tablets of 200 mg 5 times a day at intervals of 4 hours, omitting the nighttime dose, for 7 days.

Patients with altered renal function:

• In the treatment of infections caused by the herpes simplex virus, in patients with a creatinine clearance equal to or less than 10 ml/minute, 1 tablet every 12 hours.
• In the treatment of herpes zoster infections, 4 tablets of 200 mg 2 times a day are recommended for patients with a creatinine clearance less than 10 ml/minute and 4 tablets of 200 mg 3 or 4 times a day at intervals of 6-8 hours for patients with a creatinine clearance of 10-25 ml/minute.

Elderly patients:

• In elderly patients, adequate fluid intake is recommended while taking high doses of aciclovir orally.
• In elderly patients with altered renal function, a reduced dose will be administered.

Pediatric population:

• For the treatment of infections caused by the herpes simplex virus and prevention in immunodepressed children:
• Children over 2 years of age: will be treated with adult doses.
• Children under 2 years of age: will be treated with half the adult dose.

• For the treatment of chickenpox:
• Children between 2 and 6 years of age: 2 tablets of 200 mg 4 times a day for 5 days.
• Children under 2 years of age: 1 tablet of 200 mg 4 times a day for 5 days.

The dosage can be calculated more accurately as 20 mg per kg of body weight (not exceeding 800 mg 4 times a day).

If you take more Aciclovir Pensa than you should

Since aciclovir is only partially absorbed orally, it is unlikely that serious toxic effects will occur after ingesting 5 g of aciclovir in a single dose.

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 medication and the amount ingested.

Information for the healthcare professional in case of overdose

Aciclovir is dialyzable. Hemodialysis significantly increases the elimination of aciclovir from the blood and may, therefore, be considered a treatment option in case of symptomatic overdose.

If you forget to take Aciclovir Pensa

Do not take a double dose to make up for forgotten doses, simply continue with the usual treatment as soon as possible.

If you stop taking Aciclovir Pensa

Do not stop treatment before your doctor advises, as your cure may not be complete and your disease may recur.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Frequent (may affect up to 1 in 10 people): headache, dizziness, nausea, vomiting, diarrhea, abdominal pain, itching, skin rashes (including photosensitivity), fatigue, fever.

Uncommon (may affect up to 1 in 100 people): urticaria, accelerated and diffuse hair loss.

Rare (may affect up to 1 in 1,000 people): difficulty breathing, reversible increase in bilirubin and related liver enzymes, skin inflammation, increased urea and creatinine in blood, severe allergic reaction throughout the body.

Very rare (may affect up to 1 in 10,000 people): decrease in hematological indices, hepatitis, jaundice (yellowing of the skin), acute kidney failure, kidney pain.

This medication may cause other very rare side effects such as agitation, confusion, tremors, difficulty moving, difficulty speaking, confusion or imagining things (hallucinations), convulsions, somnolence, encephalopathy (brain alteration), coma. These effects are generally reversible and usually affect patients with renal impairment or other predisposing factors (see section Warnings and precautions).

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 is not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Aciclovir Pensa

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

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Store at a temperature below 25°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Aciclovir Pensa

-The active ingredient is aciclovir. Each tablet contains 200 mg of aciclovir

-The other components are: microcrystalline cellulose, povidone K-30, aluminum and magnesium silicate, magnesium stearate, sodium carboxymethyl starch (type A) (derived from potato starch), indigo carmine (indigo dye) E-132, macrogol 400, macrogol 8000, hypromellose.

Appearance of the product and package contents

Dispersible tablets, coated blue.

Each package contains 25 dispersible tablets packaged in blisters.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Towa Pharmaceutical Europe, S.L.

C/ de Sant Martí 75-97

08107 Martorelles (Barcelona)

Spain

Date of the last revision of this leaflet: June 2015

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