HEVIPOINT

Package leaflet: Information for the patient

HEVIPOINT
50 mg/g, skin patch
Aciclovir
Read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 10 days, or if your condition worsens, contact your doctor.

Contents of the leaflet

1. What HeviPoint is and what it is 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 package and other information

1. What HeviPoint is and what it is used for
HeviPoint in the form of a skin patch contains the active substance aciclovir, which has antiviral activity and acts strongly against the herpes simplex virus.
HeviPoint is used for the treatment of herpes labialis (cold sores) caused by the herpes simplex virus in adults and adolescents aged over 12 years.

2. Important information before using HeviPoint

When not to use HeviPoint:

• if the patient is allergic to the active substance aciclovir or to any of the other ingredients of this medicine (listed in section 6);
• in patients hypersensitive to valaciclovir;
• in children under 12 years of age.

Warnings and precautions
Before starting treatment with HeviPoint, consult your doctor or pharmacist if:

• the patient's immune system is not functioning properly (e.g., if the patient has undergone bone marrow transplantation or has AIDS). Patients with weakened immunity should consult a doctor for treatment of any infection, including cold sores.
• the cold sore has not resolved after 10 days, has not completely healed, or has worsened;
• the patient experiences severe recurrent cold sores.

Do not use HeviPoint:

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

HeviPoint should be used only for the treatment of cold sores located on the lips.
Avoid contact of the medicine with the eyes. If the medicine gets into the eyes, rinse thoroughly with warm water.
Cold sores are contagious. Do not touch the affected areas to avoid spreading the infection. Do not touch, puncture blisters, or scratch scabs, as this may promote virus transmission.
Always wash your hands before and after touching affected areas.

HeviPoint and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
No data available.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
HeviPoint has no effect or negligible effect on the ability to drive or operate machinery.

HeviPoint contains butylhydroxytoluene. This medicine may cause local skin reactions (e.g., contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use HeviPoint

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
Adults and adolescents aged 12 years and above
HeviPoint should be applied five times daily at approximately four-hour intervals, with a break at night. Apply a small amount of the medicine directly to the affected areas.
Do not use doses larger than those recommended.
The medicine should be used for at least five days. If after five days of treatment the symptoms of herpes have not resolved, treatment may be continued for another 5 days (maximum treatment duration – 10 days).
Treatment with HeviPoint should be started immediately upon noticing the first symptoms of herpes (burning, redness, itching). Treatment may also be initiated at a later stage of the disease, when blisters or vesicles appear.
Consult a doctor if cold sores recur, worsen, or do not resolve after 10 days of treatment.
Method of administration
For topical use only.
Apply the medicine directly to the herpes lesions on the lips, avoiding contact with hands. Scratching the lesions or touching them with a towel should be avoided.
This medicine must be used by only one person. After opening the packaging, only one patient should use the medicine.
Use in children
Do not use HeviPoint in children under 12 years of age.
Use of a higher than recommended dose of HeviPoint
If the patient accidentally swallows HeviPoint, they should immediately contact a doctor or go to the nearest hospital for medical assistance.
Missed dose of HeviPoint
If the patient forgets to apply the medicine, they should do so as soon as they remember, then continue using it as before.
Stopping use of HeviPoint
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicinal product may cause adverse reactions, although not everybody will experience them.
You should stop using this medicine and contact your doctor immediately if you experience an allergic reaction with symptoms including facial swelling.

Adverse reactions have been classified according to their frequency of occurrence.

Uncommon (may occur in 1 out of 100 patients):

• transient burning, stinging or tingling sensation after application of the medicine,
• moderate dryness and peeling of the skin,
• itching.

Rare (may occur in 1 out of 1000 patients):

• erythema,
• contact dermatitis.

Very rare (may occur in 1 out of 10,000 patients):

• sudden allergic reaction – including angioedema (a severe allergic reaction – swelling may affect the face, limbs, oral cavity, larynx and cause breathing difficulties) and urticaria.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to 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 mentioned month.
Store below 25°C, in the original packaging to protect from light.
Do not store in the refrigerator.
Keep out of sight and reach of children.
Shelf life after first opening the container: 3 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Hevipoint contains

• The active substance is aciclovir. 1 g of the topical stick contains 50 mg of aciclovir.
• Other ingredients are: castor oil, first cold-pressed, hard fat, carnauba wax, white wax, octyldodecanol, white soft paraffin, butylated hydroxytoluene, vanilla flavour.

What HeviPoint looks like and contents of the pack
HeviPoint is a topical stick.
Pack:
A cylindrical polystyrene container containing 3 g of topical stick, with a slider made of acetal resin,
secured with a polystyrene cap, placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
February 2023