Heviran Comfort

Package Leaflet: Information for the Patient

Heviran Comfort, 50 mg/g, Cream

Aciclovir

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

This medicine should always be used exactly as described in this package leaflet or as directed by a doctor, pharmacist, or nurse.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 10 days, they should contact their doctor.

Table of Contents of the Package Leaflet

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

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

Heviran Comfort cream for topical use contains the active substance acyclovir, which has antiviral properties and is effective against the herpes simplex virus.
Heviran Comfort cream is indicated for the local treatment of recurrent herpes labialis (cold sores) and facial herpes caused by the herpes simplex virus.
If there is no improvement or the patient feels worse after 10 days, they should contact their doctor.

2. Important information before using Heviran Comfort

When not to use Heviran Comfort

• if the patient is allergic to 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, pharmacist, or nurse if:

• the patient is unsure if they have herpes simplex lesions.

Heviran Comfort should not be used without consulting a doctor if:

• the patient's immune system is not working properly (e.g., if they have had a bone marrow transplant or have AIDS); patients with impaired immune function should consult their doctor about treating any infection;
• they have experienced a particularly severe recurrence of cold sores.

Do not use the cream:

• for skin infections other than herpes;
• to treat genital herpes;
• on mucous membranes (e.g., eyes, inside the mouth or nose).

Heviran Comfort should only be used for herpes lesions on the lips and face.
If the herpes lesions have not cleared up or have worsened after 10 days, the patient should consult their doctor.
Contact with the eyes should be avoided. If the medicine gets into the eyes, they should be rinsed thoroughly with warm water. If in doubt, the patient should consult their doctor.
Hands should be washed before and after using the medicine to prevent the spread of infection to other areas of the skin. During treatment, the patient should not scratch the blisters or crusts or touch them with a towel.
To minimize the risk of spreading the infection to others, they should not be allowed to touch the herpes lesions, share towels, etc.

Children

This medicine should not be used in children under 6 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.
Interactions between Heviran Comfort and other medicines are not known.

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 using this medicine.

Driving and using machines

Heviran Comfort has no or negligible influence on the ability to drive and use machines.

Heviran Comfort contains propylene glycol (E 1520), cetearyl alcohol, and sodium lauryl sulfate

Each gram of cream contains 400 mg of propylene glycol. Propylene glycol may cause skin irritation.
The medicine contains cetearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).
The medicine contains 7.5 mg of sodium lauryl sulfate per gram of cream.
Sodium lauryl sulfate may cause local skin irritation (such as stinging or burning) or exacerbate skin reactions caused by other medicines used on the same area of skin.

3. How to use Heviran Comfort

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

Adults, adolescents, and children over 6 years of age

The medicine should be applied 5 times a day to the affected areas of skin at approximately 4-hour intervals, with a night-time break. The medicine works best if treatment is started as soon as possible after the first symptoms of herpes appear, such as tingling, itching, or redness. Treatment can also be started later, when blisters or crusts have formed.

Use in children from 6 to 12 years of age

In children from 6 to 12 years of age, the use of the medicine should be supervised by a doctor.
Duration of treatment
Treatment should be continued for at least 4 days.
If the skin lesions have not healed, treatment can be extended up to 10 days. If the lesions have not cleared up after 10 days of treatment, the patient should consult their doctor.
Method of administration
Topical application.
Apply the medicine directly to the herpes lesions on the lips and face without touching them with your hands. Avoid scratching the lesions or touching them with a towel.
This medicine is for use by one person only. After opening the package, it should only be used by one patient.
To prevent the spread of infection, hands should be washed before and after applying the medicine, and the patient should avoid unnecessary rubbing of the lesions or touching them with a towel.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Overdose of Heviran Comfort

In case of accidental ingestion of the cream, the patient should contact their doctor or pharmacist.

Missed dose of Heviran Comfort

A double dose should not be used to make up for a missed dose. If a dose is missed, the patient should apply the cream as soon as they remember and continue treatment as before.
If the patient has any further doubts about using this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Heviran Comfort can cause side effects, although not everybody gets them.

The patient should stop using the medicine and contact their doctor immediately if they experience:

• an allergic reaction with symptoms including swelling of the face, lips, and tongue, and difficulty breathing.

The following side effects may occur:
Uncommon(affecting up to 1 in 100 people)

• mild drying or flaking of the skin
• a transient burning, stinging, or tingling sensation may occur immediately after applying the cream
• itching.

Rare(affecting up to 1 in 1,000 people)

• redness
• contact dermatitis after using the acyclovir cream.

Very rare(affecting less than 1 in 10,000 people)

• sudden hypersensitivity reactions, including severe reactions such as angioedema (a severe allergic reaction that may cause swelling of the hands and feet, face, lips, tongue, and throat, and difficulty breathing) and urticaria (symptoms include itchy blisters and redness on the skin).

Reporting side effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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 to gather more information on the safety of this medicine.

5. How to store Heviran Comfort

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the month.
Do not store above 25°C.
The shelf life after opening the tube is 1 year.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the package and other information

What Heviran Comfort contains

• The active substance is acyclovir. Each gram of cream contains 50 mg of acyclovir.
• The other ingredients are: cetearyl alcohol, liquid paraffin, propylene glycol (E 1520), sodium lauryl sulfate, poloxamer 407, white petrolatum, purified water.

What Heviran Comfort looks like and contents of the package

Heviran Comfort is a white, smooth cream with a characteristic odor.
Heviran Comfort cream is packaged in aluminum tubes with an internal membrane, coated with epoxy-phenolic lacquer, with an HDPE cap and a piercer, in a cardboard box.
Package sizes: 2 g, 5 g, or 10 g.
Not all package sizes may be marketed.

Marketing authorization holder

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

Manufacturer

Medinfar Manufacturing, S.A.
Parque Industrial Armando Martins Tavares, Rua Outeiro da Armada, 5
Condeixa-a-Nova 3150-194 Sebal, Portugal
Date of last revision of the package leaflet:November 2023