Heviran

Package Leaflet: Information for the Patient

Heviran, 200 mg, Film-Coated Tablets

Heviran, 400 mg, Film-Coated Tablets

Heviran, 800 mg, Film-Coated Tablets

Aciclovir

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Heviran and what is it used for
• 2. Important information before taking Heviran
• 3. How to take Heviran
• 4. Possible side effects
• 5. How to store Heviran
• 6. Contents of the pack and other information

1. What is Heviran and what is it used for

Heviran is an antiviral medication.
It is used for:

• treatment of skin and mucous membrane infections caused by the herpes simplex virus, including primary and recurrent genital herpes;
• prevention of herpes simplex virus recurrences in patients with normal immunity;
• prevention of herpes simplex virus infections in patients with reduced immunity;
• treatment of infections caused by the varicella-zoster virus (chickenpox and shingles) .

2. Important information before taking Heviran

When Not to Take Heviran

• if the patient is allergicto acyclovir, valacyclovir, or any of the other ingredients of this medication (listed in section 6).

Warnings and Precautions

Before starting treatment with Heviran, the patient should discuss with their doctor if:

• the patient has kidney disease;
• the patient is taking other medications that may harm the kidneys;
• the patient is dehydrated;
• the patient is elderly.

In case of doubts whether the above circumstances apply to the patient, they should consult their doctor before starting treatment with Heviran.
During treatment, the patient should drink plenty of fluids to avoid the risk of kidney damage and reduce the risk of side effects.

Heviran and Other Medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take, especially:

• probenecid - a medication used for gout
• cimetidine - a medication mainly used for stomach and duodenal ulcers
• mycophenolate mofetil - a medication used after organ transplants
• theophylline - a medication used for asthma and other respiratory diseases.

Heviran with Food and Drink

The medication can be taken independently of meals.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.
The medication may be used during pregnancy only if the doctor believes the expected benefit to the mother outweighs the risk to the fetus.
Acyclovir passes into breast milk. Due to the risk of side effects in the breastfed child, the patient should decide with their doctor whether to stop taking the medication or stop breastfeeding while taking the medication.

Driving and Operating Machines

The medication may cause side effects that impair the ability to drive vehicles. The patient should not drive or operate machines unless they are sure they feel well.

Heviran Contains Sodium

The medication contains less than 1 mmol of sodium (23 mg) per tablet, which means it is considered "sodium-free".

3. How to Take Heviran

This medication should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The dosage may vary for different patients.
Treatment should be started as soon as possible after diagnosis.
During treatment, the patient should drink plenty of fluids to avoid the risk of kidney damage and reduce the likelihood of side effects.
The tablets should be swallowed with water.

Adult Dosage

Treatment of Herpes Simplex Virus Infections

The medication should be taken in a dose of 200 mg five times a day (approximately every 4 hours) with a nighttime interval. The medication is usually taken for 5 days, but in cases of severe primary infections, the doctor may extend the treatment.
For patients with significantly reduced immunity (e.g., after bone marrow transplantation), the doctor may double the dose to 400 mg.

Prevention of Herpes Simplex Virus Infections in Patients with Reduced Immunity

To prevent herpes simplex virus infection in patients with reduced immunity, 200 mg is given four times a day, approximately every 6 hours.
For patients with significantly reduced immunity (e.g., after bone marrow transplantation), the doctor may decide to increase the dose to 400 mg.

Treatment of Varicella-Zoster Virus Infections (Chickenpox and Shingles)

The medication should be taken in a dose of 800 mg five times a day (approximately every 4 hours), with a nighttime interval. The medication is usually taken for 7 days.
Treatment should be started as soon as possible after diagnosis. The best treatment results for both chickenpox and shingles are achieved when the medication is given within 24 hours of the first skin changes - rash.

Pediatric Dosage

Treatment of Herpes Simplex Virus Infections and Prevention of Herpes Simplex Virus Infections in Patients with Reduced Immunity:

Children aged 2 years and above

• dose as for adults. Children under 2 years
• half the adult dose.

Treatment of Varicella-Zoster Virus Infections:

Children aged 6 years and above

• 800 mg four times a day. Children aged 2 to 5 years
• 400 mg four times a day. Children under 2 years
• 200 mg four times a day.

The medication is taken for 5 days.
The dose can also be determined more precisely by administering 20 mg/kg of body weight (up to a maximum dose of 800 mg) four times a day.

Dosage in Elderly Patients

In elderly patients, the doctor will consider the possibility of impaired kidney function and adjust the dose accordingly (see: Dosage in patients with impaired kidney function).
During treatment, the patient should drink plenty of fluids.

Dosage in Patients with Impaired Kidney Function

Caution should be exercised when administering Heviran to patients with impaired kidney function.
During treatment, the patient should drink plenty of fluids.
During treatment of herpes simplex virus infections or prevention of these infections in patients with severe impaired kidney function (creatinine clearance less than 10 ml/min), the doctor may recommend reducing the dose to 200 mg given twice a day, approximately every 12 hours.
During treatment of varicella-zoster virus infections in patients with moderate impaired kidney function (creatinine clearance 10-25 ml/min), the doctor may recommend reducing the dose to 800 mg given three times a day, approximately every 8 hours, and in patients with severe impaired kidney function (creatinine clearance less than 10 ml/min) - reducing the dose to

800 mg twice a day, approximately every 12 hours.

Overdose of Heviran

In case of taking too much medication, the patient should inform their doctor or pharmacist or contact the nearest hospital emergency department for further advice.

Missed Dose of Heviran

In case of missing a dose, the patient should take it as soon as possible. If it is already time for the next dose, the patient should not take the missed dose. The patient should not take a double dose to make up for the missed dose.

Stopping Heviran Treatment

The patient should not stop taking the medication even if they feel well, unless advised to do so by their doctor.
In case of any further doubts about taking this medication, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Heviran can cause side effects, although not everybody gets them.
In case of the following rare (occurring in less than 1 in 1,000 patients)symptoms, the patient should immediately contact their doctor:

• shortness of breath, angioedema (e.g., swelling of the face, tongue, and throat, causing breathing difficulties)
• allergic reaction (often manifested as skin rash, blisters, and ulcers of the mouth and (or) eyes, sometimes with high fever).

During treatment, the following side effects may also occur:

Common (occurring in less than 1 in 10 patients):

• headache, dizziness
• nausea, vomiting, diarrhea, abdominal pain
• itching, rash (including sensitivity to light)
• fatigue, fever.

Uncommon (occurring in less than 1 in 100 patients):

• hives
• increased hair loss.

Very Rare (occurring in less than 1 in 10,000 patients):

• agitation, tremors
• coordination disorders (ataxia)
• speech disorders
• disorientation, hallucinations
• psychotic symptoms
• brain damage (encephalopathy)
• seizures, drowsiness, coma
• hepatitis and jaundice
• acute kidney failure, kidney pain. Kidney pain may be related to kidney failure. The patient should be given adequate fluids. Kidney function disorders usually resolve quickly after fluid supplementation in the patient and (or) after dose reduction or withdrawal of the medication.

There have been reports of acute kidney failure.
Heviran may cause changes in blood test results, and therefore the doctor may recommend regular blood tests. During treatment, the following may occur:

Rare (occurring in less than 1 in 1,000 patients):

• increased creatinine and urea levels in the blood (substances that indicate kidney function)
• increased liver enzyme activity and bilirubin in serum (substances that indicate liver function).

Very Rare (occurring in less than 1 in 10,000 patients):

• decreased platelet count, which may affect blood clotting. If unexplained bruising, red or purple spots on the skin occur, the patient should inform their doctor.
• decreased white blood cell count or anemia.

Reporting Side Effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medication.

5. How to Store Heviran

The medication should be stored out of sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect from light and moisture.
Do not use this medication after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medications should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medications they no longer use. This will help protect the environment.

6. Contents of the Pack and Other Information

What Heviran Contains

• The active substance of the medication is acyclovir. Each tablet contains 200 mg, 400 mg, or 800 mg of acyclovir.
• Other ingredients are: tablet core:microcrystalline cellulose, povidone, sodium carboxymethylcellulose, magnesium

stearate;
tablet coating: hypromellose, macrogol 6000, titanium dioxide, triethyl citrate, talc.

What Heviran Looks Like and Contents of the Pack

The 200 mg and 400 mg film-coated tablets are white, round, and biconvex.
The 800 mg film-coated tablets are white, oval, and biconvex, with a score line.
The tablet can be divided into equal doses.
The pack contains 30 tablets.

Marketing Authorization Holder and Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of Last Revision of the Leaflet: