Hevipoint

Package Leaflet: Information for the Patient

HEVIPOINT
50 mg/g, stick for the skin
Acyclovir

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 the package leaflet or as advised by
your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should ask your pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If after 10 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

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

1. What is Hevipoint and what is it used for

Hevipoint stick contains the active substance acyclovir, which has antiviral properties,
showing strong effects against the herpes simplex virus (Herpes simplex).
Hevipoint is used to treat herpes simplex virus infection of the lips (recurrent herpes labialis) in adults and adolescents over 12 years of age.

2. Important information before using Hevipoint

When not to use Hevipoint:

• if you are allergic to the active substance acyclovir or any of the other ingredients of this medicine (listed in section 6);
• in people with hypersensitivity to valacyclovir;
• in children under 12 years of age.

Warnings and precautions

Before starting to use Hevipoint, you should discuss it with your doctor or pharmacist if:

• your immune system is not working properly (e.g., if you have had a bone marrow transplant or have AIDS). Patients with reduced immunity should consult their doctor about treating any infection, including cold sores.
• the cold sore has not healed after 10 days or has worsened
• you have had a severe recurrent cold sore.

You should not use Hevipoint:

• for skin infections other than cold sores
• to treat genital herpes
• on mucous membranes of the mouth, nose, or eyes.

Hevipoint is used only to treat cold sores on the lips.
You should avoid contact of the medicine with your eyes. If the medicine gets into your eyes, you should rinse them thoroughly with warm water.
Cold sores are infectious. You should not touch the affected areas to avoid spreading the infection. You should not touch or puncture the blisters or scratch the scabs, as this can spread the virus.
You should always wash your hands before and after touching the affected areas.

Hevipoint and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
No data available.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Hevipoint has no or negligible influence on the ability to drive and use machines.
Hevipoint contains butylhydroxytoluene.The medicine may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.

3. How to use Hevipoint

This medicine should always be used exactly as described in the package leaflet or as advised by
your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
Recommended dose
Adults and adolescents over 12 years of age
Hevipoint should be applied 5 times a day at approximately 4-hour intervals, with a night-time break. A small amount of the medicine should be applied directly to the affected areas.
You should not use more than the recommended dose.
The medicine should be used for at least 5 days. If the symptoms of the cold sore have not resolved after 5 days of treatment, you can continue treatment for another 5 days (maximum treatment period – 10 days).
Treatment with Hevipoint should be started as soon as the first symptoms of the cold sore appear (burning, redness, itching). Treatment can also be started later, when blisters or vesicles appear.
You should contact your doctor if the cold sore recurs, worsens, or does not resolve after 10 days of treatment.
Method of administration
For cutaneous use.
Apply the medicine directly to the cold sore on the lips, without touching it with your hands. You should avoid scratching the blisters or touching them with a towel.
This medicine is for use by one person only. After opening the package, only one patient can use it.

Use in children

Do not use Hevipoint in children under 12 years of age.

Using more than the recommended dose of Hevipoint

If you swallow Hevipoint, you should immediately contact your doctor or go to the nearest hospital for medical help.

Missing a dose of Hevipoint

If you forget to apply the medicine, you should do so as soon as you remember, and then continue using it as before.

Stopping treatment with Hevipoint

If you have any further questions about using this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Hevipoint can cause side effects, although not everybody gets them.
You should stop using this medicine and contact your doctor immediately if you experience an allergic reaction with symptoms including swelling of the face.
Side effects are classified according to their frequency.

• Uncommon (may affect up to 1 in 100 people):
• transient burning, stinging, or tingling sensation after application of the medicine,
• mild drying and flaking of the skin,
• itching.

Rare (may affect up to 1 in 1,000 people):

• redness,
• contact dermatitis.

Very rare (may affect up to 1 in 10,000 people):

• sudden allergic reaction - including angioedema (severe allergic reaction - swelling may affect the face, limbs, mouth, throat, and cause difficulty breathing) and urticaria.

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website:
https://smz.ezdrowie.gov.pl.
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hevipoint

Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the month.
Store in a temperature below 25°C, in the original package to protect from light.
Do not store in the refrigerator.
Keep out of the sight and reach of children.
Shelf life after first opening of the container: 3 months.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Hevipoint contains

• The active substance is acyclovir. 1 g of stick for the skin contains 50 mg of acyclovir.
• The other ingredients are: first-pressing castor oil, solid fat, carnauba wax, white wax, octyldodecanol, white petrolatum, butylhydroxytoluene, vanilla flavor.

What Hevipoint looks like and contents of the pack

Hevipoint is a stick for the skin.
Packaging
A cylindrical polystyrene container containing 3 g of stick for the skin, with a slide made of acetal resin, secured with a polystyrene cap, placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
Manufacturer:
Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice
Poland
Laboratorio Chimico Farmaceutico A. Sella S.r.l.
Via Vicenza 67,
36015 Schio (VI)
Italy

Date of last revision of the leaflet:

February 2023