Hascovir lipogel
Poland
Table of Contents
Package leaflet: Information for the patient
Hascovir LIPOGEL
50 mg/g, gel
Aciclovirum
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or further information, please 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:
- What Hascovir LIPOGEL is and what it is used for
- Important information before using Hascovir LIPOGEL
- How to use Hascovir LIPOGEL
- Possible side effects
- How to store Hascovir LIPOGEL
- Contents of the pack and other information
1. What Hascovir LIPOGEL is and what it is used for
Hascovir LIPOGEL contains the active substance aciclovir. When applied to the skin, aciclovir has a strong action against the herpes simplex virus.
Hascovir LIPOGEL is used in the local treatment of symptoms of cold sores (herpes labialis) and herpes lesions on the face.
2. Important information before using Hascovir LIPOZEL
When not to use Hascovir LIPOZEL:
- if the patient is allergic to aciclovir, valaciclovir, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting treatment with Hascovir LIPOZEL, discuss it with your doctor or
pharmacist.
Hascovir LIPOZEL should be used only for cold sores located on the lips and face. The medicine must not be applied to mucous membranes, e.g. inside the mouth or eyes, and must not be used to treat genital herpes. Care must be taken to avoid contact of the medicine with the eyes.
Patients who experience particularly severe recurrent cold sores should consult a doctor.
Immunocompromised individuals should not use this medicine without consulting a doctor.
To reduce the risk of infection, other people should avoid touching the herpes-affected skin areas.
Hascovir LIPOZEL and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
No interactions between Hascovir LIPOZEL and other medicines are known.
Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, is planning to become pregnant, or is breastfeeding, she should consult a doctor or pharmacist before using this medicine.
This medicine may be used during pregnancy if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the fetus.
During breastfeeding, consult a doctor before using this medicine.
Driving and operating machinery
Hascovir LIPOZEL has no effect on the ability to drive or operate machinery.
3. How to use Hascovir LIPOGEL
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
This medicine is for topical use on the skin.
Apply the medicine 5 times daily to the affected areas on the lips and facial skin, at approximately four-hour intervals, with a break at night.
The medicine works most effectively if treatment is started as soon as possible after the first symptoms of herpes appear, such as burning, itching, or redness. Treatment may also be started at a later stage of the disease, when blisters or nodules appear.
Treatment should last for at least 4 days. If skin lesions have not healed, treatment may be extended up to 10 days. If the lesions have not resolved after 10 days of using the medicine, consult your doctor.
To prevent worsening or spreading of the infection, wash your hands before and after applying the medicine, and avoid unnecessary rubbing of the affected areas or touching them with a towel.
Use of a higher than recommended dose of Hascovir LIPOGEL
Symptoms of overdose are not known when using this formulation.
Toxic symptoms are not expected, even after accidental ingestion of the entire contents of the 3 g tube of Hascovir LIPOGEL. However, if a large amount of the medicine is swallowed, consult your doctor.
Missed dose of Hascovir LIPOGEL
Do not use a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
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Common (in 1 to 10 patients out of 100):
mild skin dryness or desquamation.
Uncommon (in 1 to 10 patients out of 1,000):
transient sensation of burning or tingling,
itching.
Rare (in 1 to 10 patients out of 10,000):
erythema,
contact dermatitis.
Very rare (occurring in less than 1 patient out of 10,000):
sudden hypersensitivity reactions, including angioedema.
Reporting of adverse reactions
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: +48 22 4921 301, fax: +48 22 4921 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 the medicine.
5. How to store Hascovir LIPOŽEL
Store below 25 °C.
Shelf life after first opening of the tube – 2 years.
Keep this medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
6. Contents of the pack and other information
What Hascovir LIPOŽEL contains
The active substance is aciclovir. 1 g of gel contains 50 mg of aciclovir.
The other ingredients (excipients) are: purified phosphatidylcholine, glycerol formal,
disodium edetate, copolymer of acryloyldimethyltaurine and N-vinylpyrrolidone,
dimethicone, purified water.
What Hascovir LIPOŽEL looks like and contents of the pack
The medicine is a homogeneous yellowish gel.
The medicine is packed in an aluminium tube with a PE cannula, closed with a PE cap, containing 3 g of gel.
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Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicinal product information
tel.: (22) 742 00 22
e-mail: [email protected]
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