Hascovir Lipozhel

Package Leaflet: Information for the Patient

Hascovir LIPOŻEL

50 mg/g, gel
Aciclovirum

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 for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 10 days or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

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

1. What is Hascovir LIPOŻEL and what is it used for

Hascovir LIPOŻEL contains the active substance acyclovir. Acyclovir has a strong antiviral effect against herpes simplex virus when applied to the skin.
Hascovir LIPOŻEL is used for the local treatment of symptoms of cold sores (herpes labialis) and herpes simplex infections on the face.

2. Important information before using Hascovir LIPOŻEL

When not to use Hascovir LIPOŻEL:

• 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 to use Hascovir LIPOŻEL, the patient should discuss it with their doctor or pharmacist.
Hascovir LIPOŻEL should only be used on cold sores located on the lips and face. It should not be used on mucous membranes, such as the eyes or genitals, or for the treatment of genital herpes.
Caution should be exercised to avoid contact of the medicine with the eyes.
Patient with particularly severe recurrent cold sores should consult their doctor.
People with weakened immune systems should not use the medicine without consulting their doctor.
To minimize the risk of infection, others should not touch the cold sore area.
1/4

Hascovir LIPOŻEL and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to use.
No interactions between Hascovir LIPOŻEL and other medicines are known.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before using this medicine.
The medicine may be used in pregnant women if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
During breastfeeding, the patient should consult their doctor before using the medicine .

Driving and using machines

Hascovir LIPOŻEL has no effect on the ability to drive or operate machines.

3. How to use Hascovir LIPOŻEL

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The medicine is intended for use on the skin.
The medicine should be applied 5 times a day to the affected areas on the lips and face, at approximately 4-hour intervals, with a night break.
The medicine works best if treatment is started as soon as possible after the first symptoms of herpes appear, such as burning, itching, or redness. Treatment can also be started later, when blisters or vesicles appear.
Treatment should last for at least 4 days. If the skin lesions have not healed, treatment can be extended to 10 days. If the lesions do not disappear after 10 days of using the medicine, the patient should consult their doctor.
To prevent the worsening or spread of infection, the patient should wash their hands before and after applying the medicine and avoid unnecessary rubbing of the affected areas or touching them with a towel.

Using more than the recommended dose of Hascovir LIPOŻEL

No symptoms of overdose are known when using this form of the medicine.
It can be expected that no toxic symptoms will occur, even after accidental ingestion of the entire contents of a 3g tube of Hascovir LIPOŻEL. However, if a large amount of the medicine is swallowed, the patient should consult their doctor.

Missing a dose of Hascovir LIPOŻEL

The patient should not use a double dose to make up for a missed dose.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Hascovir LIPOŻEL can cause side effects, although not everybody gets them.
2/4
Common(in 1 to 10 patients out of 100):
mild skin dryness or flaking.
Uncommon(in 1 to 10 patients out of 1,000):
transient burning or tingling sensation,
itching.
Rare(in 1 to 10 patients out of 10,000):
redness,
contact dermatitis.
Very rare(occurring in less than 1 patient out of 10,000):
sudden hypersensitivity reactions, including angioedema.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Hascovir LIPOŻEL

Store in a temperature below 25°C.
Shelf life after first opening the tube – 2 years.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
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 use. This will help protect the environment.

6. Contents of the pack and other information

What Hascovir LIPOŻEL contains

The active substance of the medicine is acyclovir. 1g of gel contains 50mg of acyclovir.
The other ingredients (excipients) are: purified phosphatidylcholine, glycerol formal, disodium edetate, copolymer of acryloyldimethyltaurine ammonium and N-vinylpyrrolidone, dimethicone, purified water.

What Hascovir LIPOŻEL looks like and contents of the pack

The medicine is a homogeneous gel with a yellowish color.
The packaging of the medicine is an aluminum tube with a PE nozzle, closed with a PE cap, containing 3g of gel.
3/4

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Medicine information

phone: (22) 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

Date of last revision of the leaflet:

4/4