Package Insert: Patient Information

Aciclovir Kern Pharma 200 mg Dispersible Tablets EFG

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, 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 not listed in this package insert. See section 4.

Aciclovir is an antiviral medication used in the treatment of infections caused by viruses.

This medication is indicated for the treatment of: skin and mucous membrane infections caused by the herpes simplex virus in immunocompromised patients (weakened immune system) and its prevention, genital herpes (effective in the first period of genital herpes), herpes zoster in immunocompetent patients (normal functioning immune system) and varicella.

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

Do not takeAciclovir Kern Pharma

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

Warnings and precautions

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

• If you have any kidney disease or are elderly, your doctor may use a lower dose. In addition, you should drink enough liquid during treatment to maintain adequate hydration.
• In elderly people, adequate fluid intake is recommended while on high doses of aciclovir by mouth.
• Care should be taken to avoid potential virus transmission, especially when active lesions are present.To avoid transmission of the infection to your partner, patients with genital herpes 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 the section3. How to take Aciclovir Kern Pharma.

No studied dosage is available for the treatment of suppression of recurrences by the herpes simplex virus in immunocompromised children.

For the treatment of chickenpox in children under 2 years, see the section3. How to take Aciclovir Kern Pharma.

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

Taking Aciclovir Kern Pharma with other medications

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

The simultaneous administration with probenecid (medication used for the treatment of gout), cimetidine (medication for the treatment of stomach acid) or mofetil (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 may influence the pharmacokinetics of aciclovir.

Taking Aciclovir Kern Pharma 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 should only be used in cases where the benefit-risk assessment previously 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 it is recommended to substitute breastfeeding.

Driving and operating machines

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

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

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

Follow these instructions unless your doctor has given you different indications. 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. The groove is only for breaking the tablet if it is difficult to swallow it whole.

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

Adults:

Patients with normal renal function:

• For thetreatment of infections caused by herpes simplex virus: 1 tablet 5 times a day at approximately 4-hour intervals, omitting the nocturnal dose, for 5 days.

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

• For thesuppression of recurrences caused by herpes simplex virusin immunocompetent patients (adequate functioning of the immune system): 1 tablet 4 times a day at approximately 6-hour intervals or 2 tablets 2 times a day, every 12 hours. Treatment will be interrupted periodically at intervals of6 to12 months to observe possible changes in the disease process.
• For theprevention of infections caused by herpes simplex virus in immunocompromised patients: 1 tablet 4 times a day at 6-hour intervals. In severely immunocompromised patients and those with intestinal absorption difficulties, the dose may be doubled to 400 mg (2 tablets) 4 times a day.
• For thetreatment of zoster infections: 4 tablets of 200 mg 5 times a day at 4-hour intervals, omitting the nocturnal dose, for 7 days.

Patients with altered renal function:

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

Geriatric patients

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

Pediatric population

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

• Children over 2 years old: will be treated with adult doses.
• Children under 2 years old: will be treated with half the adult dose.

• For the treatment of varicella infections:

• Children between 2 and 6 years old: 2 tablets of 200 mg 4 times a day for 5 days.
• Children under 2 years old: 1 tablet of 200 mg 4 times a day for 5 days.

The dosage can be calculated with greater accuracy as 20 mg per kg of body weight (without exceeding 800 mg 4 times a day).

If you take moreAciclovir Kern Pharma than you should

Since aciclovir is only partially absorbed by the digestive tract, it is unlikely that severe toxic effects will occur after ingestion of5 gof aciclovir in a single dose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 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 an option for treatment in cases of symptomatic overdose.

If you forgot to take Aciclovir Kern Pharma

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

If you interrupt the treatment with Aciclovir Kern Pharma

You should not interrupt the treatment before your doctor advises, as your cure may not be complete and your disease may recur.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

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

Rare (may affect up to 1 in 1,000 people): breathing difficulty, 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 (yellow discoloration of the skin), acute renal failure, renal pain.

This medication may produce other very rare adverse effects such as agitation, confusion, tremors, difficulty moving, difficulty speaking, confusion or imagination of things (hallucinations), seizures, somnolence, encephalopathy (brain alteration), coma. These effects are generally reversible and usually affect patients with renal alterations or other predisposing factors (see sectionWarnings and Precautions).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for human use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

Do not store at a temperature above25ºC.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Aciclovir Kern Pharma

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

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

Appearanceof the product and contents of the packaging

Dispersible tablets, round, coated, blue in color, scored on both faces. The score serves to break and facilitate swallowing but not to divide into equal doses.

Each package contains 25 or 100 tablets, packaged in a PVC/PVDC/Al blister.

Some package sizes may only be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet:April 2015

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