Heviran Comfort Max

Patient Information Leaflet: Information for the Patient

Heviran Comfort MAX, 400 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 information leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 1 month there is no improvement or you feel worse, contact your 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 pack 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 aciclovir, which inhibits the multiplication of pathogenic viruses for humans in the Herpesgroup.
Heviran Comfort is used to prevent:

• recurrences of genital herpes in adults with normal immunity.

Heviran Comfort can only be used in patients who have been previously diagnosed with genital herpes infection.
If after 1 month there is no improvement or you feel worse, contact your doctor.

2. Important information before taking Heviran Comfort

When not to take Heviran Comfort

• if you are allergicto aciclovir, valaciclovir, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Heviran Comfort, discuss it with your doctor or pharmacist.
Do not take Heviran Comfort without consulting your 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 (see section "Pregnancy, breastfeeding, and fertility")
• in patients with severe recurrent genital herpes
• in patients with severe recurrent cold sores
• in case of frequent (more than 6 per year) and prolonged (after 5 days of therapy, no positive treatment effects) recurrences of herpes, with more severe clinical symptoms (e.g., when new foci of infection appear after 3-4 days of therapy). This may indicate an immune deficiency or absorption disorders requiring diagnosis and a different dosage of the medicine.

Patients who experience herpes during prophylactic use of Heviran Comfort should contact their doctor.
Heviran Comfort should not be taken by people with reduced immunity (e.g., after bone marrow transplantation, HIV-infected). People with reduced immunity should consult their doctor about the treatment of any infection.
During treatment, 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, especially:

• probenecid - a medicine used in gout
• cimetidine - a medicine used mainly in gastric and duodenal ulcer disease
• mycophenolate mofetil - a medicine used after organ transplants
• theophylline - a medicine used in the treatment of asthma and other respiratory diseases.

Heviran Comfort with food and drink

The medicine can be taken regardless of meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
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.
Aciclovir passes into breast milk. Due to the risk of side effects in the breastfed child, after consulting a doctor, decide whether not to take the medicine or stop breastfeeding during treatment.

Driving and using machines

There is no data on the effect of the medicine on the ability to drive and use machines.
However, consider the possibility of side effects of aciclovir, such as dizziness, disorientation, seizures. Do not drive or operate machines unless you are sure you feel well.

Heviran Comfort contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium 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 this patient information leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
During treatment, drink plenty of fluids to avoid the risk of kidney damage and reduce the likelihood of side effects.
Swallow the tablets with water.

Adults

The medicine should be taken orally in a dose of 1 tablet(400 mg) twice a day, every 12 hours.
Without consulting a doctor, the medicine can be taken for a maximum of 1 month, especially during periods of exposure to factors that trigger herpes recurrences (e.g., increased sun exposure, stress, fever).

Use 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 patients with severe kidney function disorders, with a creatinine clearance of less than 10 ml/min, the dosage of aciclovir should be decided by a doctor.

Use in elderly patients

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

Overdose of Heviran Comfort

It is unlikely that accidental ingestion of an overdose of the medicine will cause serious problems. Single ingestion of a dose of aciclovir up to 20 g usually does not cause symptoms of poisoning. Unintentional, repeated oral overdose of aciclovir over several days was associated with gastrointestinal symptoms (nausea, vomiting) and neurological symptoms (headache, confusion).
In case of an overdose, tell your doctor or pharmacist or contact the nearest hospital emergency department for further advice.

Missed dose of Heviran Comfort

If you miss a dose, take it as soon as possible. If it is already time for the next dose, do not take the missed dose.
Do not take a double dose to make up for the missed dose.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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, contact your 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, low blood pressure, rapid heartbeat).

The following side effects may also occur during treatment:

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 aciclovir is uncertain.

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 fluid supplementation in the patient and (or) after reducing the dose or discontinuing the medicine.

Heviran Comfort may cause changes in blood test results, and your 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 you experience bruising or red or purple spots on the skin of unknown cause, tell your doctor.
• decreased white blood cell count or anemia.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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 medicine.

5. How to store Heviran Comfort

Keep the medicine out of the sight and reach of children.
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.
Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Heviran Comfort contains

• The active substance of the medicine is aciclovir. Each tablet contains 400 mg of aciclovir.
• The other ingredients are: microcrystalline cellulose, povidone, sodium carboxymethylcellulose (type A), magnesium stearate.

What Heviran Comfort looks like and contents of the pack

The 400 mg tablets are white, round, and biconvex.
The pack contains 30 or 60 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: