Heviran Comfort

Leaflet attached to the packaging: patient information

Heviran Comfort, 200 mg, tablets

Aciclovir

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 5 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Heviran Comfort and what is it used for

Heviran Comfort is an antiviral medicine.
The active substance of Heviran Comfort is acyclovir, which inhibits the multiplication of pathogenic viruses for humans in the Herpesgroup.
Heviran Comfort is used to treat:

• recurrent herpes labialis and facial herpes caused by the herpes simplex virus in adults;
• recurrent genital herpes caused by the herpes simplex virus in adults.

Heviran Comfort can only be used in patients who have been previously diagnosed with a herpes simplex virus infection.
If there is no improvement after 5 days or the patient feels worse, they should consult their doctor.

2. Important information before taking Heviran Comfort

When not to take Heviran Comfort

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

Warnings and precautions

Before starting treatment with Heviran Comfort, the patient should discuss it with their doctor or pharmacist.
The patient should not take Heviran Comfort without prior consultation with a doctor:

• in patients with kidney function disorders
• in patients taking other medicines that may damage the kidneys
• in elderly patients (65 years or older)
• in pregnant or breastfeeding women
• in patients with impaired immune systems (e.g., after bone marrow transplantation, with HIV infection). Patients with impaired immune systems should consult their doctor about treating any infection.
• in patients with severe recurrent herpes labialis
• in patients with severe recurrent genital herpes
• if the patient notices frequent (more than 6 per year) and prolonged (after 5 days of treatment, no positive effects) recurrences of herpes, with more severe clinical symptoms (e.g., when new foci of infection appear after 3-4 days of treatment). This may indicate an immune deficiency or absorption disorders requiring diagnosis and a different dosage of the medicine.

During treatment, the patient should drink plenty of fluids to avoid kidney damage.

Children and adolescents

Heviran Comfort should not be used in children and adolescents under 18 years of age.

Heviran Comfort and other medicines

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

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

Heviran Comfort with food and drink

The medicine can be taken regardless of meals.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
The patient should avoid taking the medicine during pregnancy. The medicine can only be used during pregnancy if, in the doctor's opinion, 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, after consulting their doctor, decide whether to stop taking the medicine or stop breastfeeding during treatment.

Driving and operating machinery

There is no data on the effect of the medicine on the ability to drive and operate machinery.
However, the patient should consider the possibility of side effects of acyclovir, such as dizziness, disorientation, and seizures. The patient should not drive or operate machinery unless they are sure they feel well.

Heviran Comfort contains sodium

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

3. How to take Heviran Comfort

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
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.

Adults

Heviran Comfort should be taken orally in a dose of 200 mg five times a day, every 4 hours (with a night break), for 5 days.
In the case of recurrent infections, it is especially important to start treatment during the prodromal period, i.e., itching, burning, tension, or immediately after the first changes appear.

Dosage in patients with kidney function disorders

During treatment with Heviran Comfort, patients with kidney function disorders should drink plenty of fluids (see also section 2 "Warnings and precautions").
In the case of patients with severe kidney function disorders, with a creatinine clearance of less than 10 ml/min, the dosage of acyclovir should be determined by the doctor. In such patients, the doctor may recommend reducing the dose of the medicine to 1 tablet (200 mg) taken twice a day, approximately every 12 hours.

Dosage in elderly patients

In elderly patients, the possibility of kidney function disorders should be considered.
In the case of patients with severe kidney function disorders, with a creatinine clearance of less than 10 ml/min, the dosage of acyclovir should be determined by the doctor, who will adjust the dose of the medicine accordingly (see: Dosage in patients with kidney function disorders).
During treatment, the patient should drink plenty of fluids.

Taking a higher dose of Heviran Comfort than recommended

It is unlikely that accidentally taking a higher dose of the medicine will cause serious problems. A single dose of acyclovir up to 20 g usually does not cause symptoms of poisoning. Unintentional, repeated oral overdose of acyclovir over several days was associated with gastrointestinal symptoms (nausea, vomiting) and neurological symptoms (headache, confusion).
If the patient has taken a higher dose of the medicine than recommended, they should inform their doctor or pharmacist or contact the nearest hospital emergency department for further advice.

Missing a dose of Heviran Comfort

If a dose of the medicine is missed, it should be taken as soon as possible. If it is already time for the next dose, the missed dose should not be taken. The patient should not take a double dose to make up for the missed dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Heviran Comfort can cause side effects, although not everybody gets them.
If the patient experiences any of the following rare(occurring in less than 1 in 1,000 patients) symptoms, they should contact their doctor immediately:

• shortness of breath, angioedema (e.g., swelling of the face, tongue, and larynx, causing breathing difficulties)
• anaphylactic reaction (often manifested as itching, hives, shortness of breath, decreased blood pressure, rapid heartbeat).

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 photosensitivity)
• fatigue, fever.

Uncommon(occurring in less than 1 in 100 patients)

• hives
• accelerated, widespread hair loss. Since accelerated, widespread hair loss can be associated with many diseases and the use of many medicines, its relationship to the action of acyclovir is uncertain.

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

• excitement, 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 associated with kidney failure. Kidney function disorders usually resolve quickly after the patient is given fluids and (or) the dose is reduced or the medicine is discontinued.

Heviran Comfort may cause changes in blood test results, and the doctor may recommend regular blood tests. During treatment, the following may occur:

Rare

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

Very rare

• decreased platelet count, which may affect blood clotting. If unexplained bruising or red or purple spots appear on the skin, 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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Heviran Comfort

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Heviran Comfort contains

• The active substance of Heviran Comfort is acyclovir. Each tablet contains 200 mg of acyclovir.
• The other ingredients are: microcrystalline cellulose, povidone, sodium carboxymethylcellulose (type A), magnesium stearate.

What Heviran Comfort looks like and what the packaging contains

The 200 mg tablets are white, round, and biconvex.
The packaging contains 25 tablets.

Marketing authorization holder and manufacturer

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

Date of last update of the leaflet: