Aciclovir Kern Pharma 200 mg dispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Aciclovir Kern Pharma 200 mg dispersible tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Leaflet contents:

1. What Aciclovir Kern Pharma is and what it is used for
2. What you need to know before taking Aciclovir Kern Pharma
3. How to take Aciclovir Kern Pharma
4. Possible side effects
5. How to store Aciclovir Kern Pharma
6. Contents of the pack and other information

1. What Aciclovir Kern Pharma is and what it is used for

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

This medicine is indicated for the treatment of: skin and mucosal infections caused by the herpes simplex virus in immunocompromised patients (with weakened immune system), and for its prevention; genital herpes (effective during the first episode of genital herpes); herpes zoster in immunocompetent patients (with adequately functioning immune system); and varicella.

It is also indicated in patients at risk (e.g. diabetics, malnourished, etc.) and/or with severe herpes zoster, as the benefit is smaller in other patients.

2. What you need to know before taking Aciclovir Kern Pharma

Do not take Aciclovir Kern Pharma

If you are allergic (hypersensitive) to aciclovir or to any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine.

• If you have kidney disease or are elderly, your doctor may use a lower dose. You should also drink sufficient fluids during treatment to maintain adequate hydration.
• In elderly patients, adequate fluid intake is recommended while receiving high oral doses of aciclovir.
• Care should be taken to avoid potential transmission of the virus, especially when active lesions are present. To avoid transmission of infection to a partner, sexual contact should be avoided in patients with genital herpes who have visible lesions.

Children and adolescents

This medicine is indicated for the treatment and prevention of herpes simplex virus infections in immunocompromised children. See section 3. How to take Aciclovir Kern Pharma.

There is no established dosage regimen for suppression of herpes simplex virus recurrences in immunocompromised children.

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

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

Taking Aciclovir Kern Pharma with other medicines

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

Concomitant administration with probenecid (a medicine used to treat gout), cimetidine (a medicine used to treat stomach acidity), or mycophenolate (used to prevent rejection of transplanted organs) increases the half-life of aciclovir and the area under the plasma concentration-time curve. This should be taken into account by your doctor, although dosage adjustment is usually not required.

No other drug interactions have been reported. However, drugs that alter renal physiology could influence the pharmacokinetics of aciclovir.

Taking Aciclovir Kern Pharma with food and drinks

Aciclovir tablets may be dispersed in at least 50 ml of water or swallowed whole with a small amount of water.

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before taking any medicine.

Experience in humans is limited; therefore, aciclovir should only be used when a previous assessment of benefit versus risk justifies its use.

Breastfeeding

Consult your doctor or pharmacist before taking any medicine.

Studies conducted in humans have shown that aciclovir may appear in breast milk after administration of this medicine; therefore, natural breastfeeding is not recommended.

Driving and using machines

Due to the characteristics of this medicine, such effects are unlikely. However, fatigue, headache, and mild neurological reactions have been observed in some cases. These reactions should be taken into account when driving or operating machinery.

3. How to take Aciclovir Kern Pharma

The first dose should be taken 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 advice. Remember to take your medicine.

Aciclovir tablets may be dispersed in a minimum of 50 ml of water, or swallowed whole with a little water. The score line is intended solely for dividing the tablet if you have difficulty swallowing it whole.

Your doctor will determine how long you should take this medicine. Do not stop the treatment early.

Adults:

Patients with normal renal function:

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

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

• For suppression of recurrences caused by herpes simplex virus in immunocompetent patients (adequate immune system function): 1 tablet 4 times a day at intervals of approximately 6 hours, or 2 tablets twice a day every 12 hours. Treatment should be periodically interrupted at intervals of 6 to 12 months to monitor for possible changes in the disease course.
• For prevention of herpes simplex virus infections in immunocompromised patients: 1 tablet 4 times a day at intervals of 6 hours. In severely immunocompromised patients and in those with intestinal absorption difficulties, 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 impaired renal function:

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

Elderly patients

• In elderly patients, adequate fluid intake is recommended while receiving high oral doses of aciclovir.
• In elderly patients with impaired renal function, a reduced dose should be administered.

Pediatric population

• For the treatment of herpes simplex virus infections and prevention in immunocompromised children:

• Children over 2 years of age: should be treated with adult doses.

• Children under 2 years of age: should receive half the adult dose.

• For the treatment of varicella (chickenpox) infections:

• 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.

Dosage may be more accurately calculated as 20 mg per kg of body weight (not exceeding 800 mg 4 times daily).

If you take more Aciclovir Kern Pharma than you should

Since aciclovir is only partially absorbed through the gastrointestinal tract, the occurrence of severe toxic effects after ingestion of 5 g of aciclovir in a single dose is unlikely.

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 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 therefore be considered as a treatment option in cases of symptomatic overdose.

If you forget to take Aciclovir Kern Pharma

Do not take a double dose to make up for missed doses. Simply continue with your regular treatment schedule as soon as possible.

If you stop taking Aciclovir Kern Pharma

Do not interrupt treatment earlier than advised by your doctor, as your recovery may not be complete and your illness may recur.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them.

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

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

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

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

This medicine may cause other very rare adverse effects such as agitation, confusion, tremors, difficulty in movement, difficulty speaking, confusion or imagining things (hallucinations), seizures, drowsiness, encephalopathy (brain dysfunction), coma. These effects are generally reversible and usually occur in patients with renal impairment or other predisposing factors (see section Warnings and precautions).

Reporting of adverse effects

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

5. Storage of Aciclovir Kern Pharma

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aciclovir Kern Pharma

• The active substance is aciclovir. Each tablet contains 200 mg of aciclovir.

• The other components are: microcrystalline cellulose, povidone K-30, magnesium aluminium silicate, magnesium stearate, sodium carboxymethyl starch (type A) (derived from potato starch), indigotine (indigo carmine) (E-132), polyethylene glycol 400 and 8000, hydroxypropylmethylcellulose.

Appearance of the product and pack contents

Dispersible, round, film-coated blue tablets, scored on both sides. The score line is intended to facilitate breaking the tablet for ease of swallowing and is not intended to divide the tablet into equal doses.

Each pack contains 25 or 100 tablets, packed in PVC/PVDC/Al blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent revision of this leaflet: April 2015

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