ACICLOVIR PENSA 800 mg DISPERSIBLE TABLETS

Introduction

Patient Information Leaflet

Aciclovir Pensa 800 mg Dispersible Tablets EFG

Read the entire 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 questions, 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 you, 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 viral infections.

This medication is indicated for the treatment of herpes zoster in immunocompetent patients (patients with a properly functioning immune system) and for chickenpox.

It is also indicated for patients at risk (diabetics, malnourished, etc.) and/or with severe herpes zoster, with the benefit being lower in other 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 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. Additionally, you should drink enough fluids during treatment to maintain adequate hydration.
• In elderly patients, adequate fluid intake is recommended while taking high doses of aciclovir orally.
• Caution should be exercised to avoid potential transmission of the virus, especially when active lesions are present. To avoid transmission of the infection to your partner, you should avoid sexual contact if you have genital herpes with visible lesions.

Children and adolescents

This medication is recommended for children over 6 years old for the treatment of chickenpox. See section 3. How to take Aciclovir Pensa.

For the treatment of chickenpox in children over 6 years old, other presentations may be more suitable.

Taking Aciclovir Pensa with other medications

Inform your doctor or pharmacist if you are using or have recently used any other medications, including those purchased without a prescription.

Concomitant administration with probenecid (a medication used to treat gout), cimetidine (a medication for treating 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 dose adjustment may not be necessary.

No other drug interactions have been described, although medications that alter renal physiology may affect 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 any 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 any medication.

Studies in humans show that after administration of this medication, aciclovir may appear in breast milk, so breastfeeding should be avoided.

Driving and using machines

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

3. How to take Aciclovir Pensa

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

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 completing it.

Adults:

Patients with normal renal function:

• Herpes zoster: 1 tablet of 800 mg 5 times a day at 4-hour intervals, omitting the nighttime dose, for 7 days.
• Chickenpox: 1 tablet of 800 mg 5 times a day at 4-hour intervals, omitting the nighttime dose, for 7 days.

Patients with impaired renal function:

• Herpes zoster: 1 tablet of 800 mg 2 times a day for patients with a creatinine clearance of less than 10 ml/minute and 1 tablet of 800 mg 3 or 4 times a day at 6-8 hour intervals for patients with a creatinine clearance of 10-25 ml/minute.
• Chickenpox: 1 tablet of 800 mg 2 times a day for patients with a creatinine clearance of less than 10 ml/minute and 1 tablet of 800 mg 3 or 4 times a day at 6-8 hour intervals 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 impaired renal function, a reduced dose should be administered.

Pediatric population:

• Chickenpox: children over 6 years old: 1 tablet of 800 mg 4 times a day for 5 days.

If you think the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Aciclovir Pensa than you should

Since aciclovir is only partially absorbed orally, it is unlikely to cause severe toxic effects 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 healthcare professionals in case of overdose

Aciclovir is dialyzable. Hemodialysis significantly increases the elimination of aciclovir from the blood and may 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 your usual treatment as soon as possible.

If you stop taking Aciclovir Pensa

Do not stop treatment before your doctor advises, as your recovery 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.

Common (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 blood cell counts, 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), seizures, drowsiness, encephalopathy (brain disorder), coma. These effects are generally reversible and usually affect patients with renal impairment or other predisposing factors (see Warnings and precautionssection).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for human use: 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 any unused medication in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Aciclovir Pensa

• The active ingredient is aciclovir. Each tablet contains 800 mg of aciclovir.
• The other ingredients are: microcrystalline cellulose, povidone K-30, aluminum and magnesium silicate, magnesium stearate, sodium carboxymethylcellulose (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, blue in color.

Each package contains 35 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 Health Products (AEMPS) http://www.aemps.gob.es/.