Liquid powder dermopur
Poland
Table of Contents
Package leaflet: Information for the patient
DERMOPUR LIQUID POWDER, 15 mg/g, cutaneous suspension
Benzocaine
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or
as directed by a doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or further information, please contact your pharmacist.
- If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
- If there is no improvement or if the patient feels worse, consult a doctor.
Table of contents
- What Dermopur Liquid Powder is and what it is used for
- Important information before using Dermopur Liquid Powder
- How to use Dermopur Liquid Powder
- Possible side effects
- How to store Dermopur Liquid Powder
- Contents of the pack and other information
1. What Dermopur Liquid Powder is and what it is used for
Dermopur Liquid Powder is a cutaneous suspension.
This medicine has local anesthetic, protective, and astringent properties.
Indications
Exudative and inflammatory skin conditions associated with painful and itchy lesions.
Supportive treatment and symptom relief in conditions such as rashes, diaper dermatitis,
vesicular eruptions in chickenpox, shingles, exudative diathesis, prurigo, miliaria, urticaria,
insect bite reactions, and acne vulgaris.
2. Important information before using Dermopur Liquid Powder
When not to use Dermopur Liquid Powder:
- if the patient is allergic to benzocaine or any of the other ingredients of this medicine (listed in section 6),
- on mucous membranes,
- on open wounds,
- on ulcers,
- on skin areas devoid of epidermis,
- in patients treated with sulfonamides.
In children under 12 years of age, this medicine should be used only after consultation with a doctor.
Warnings and precautions
Before starting treatment with Dermopur Liquid Powder, discuss it with your doctor or
pharmacist.
If allergic reactions occur (e.g. increased itching, skin redness), discontinue use and contact your doctor.
Do not use this medicine for prolonged periods. There is a risk of methemoglobinemia (blood disorders) during treatment, especially in children.
Avoid contact of the medicine with the eyes.
Children and adolescents
In children under 12 years of age, this medicine should be used only after consultation with a doctor.
Dermopur Liquid Powder and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
Avoid concomitant use with phenazone, camphor, resorcinol, polyoxyethylene glycols (suppositories, ointments), strongly acidic or alkaline substances, sulfonamides, and oxytetracycline.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
This medicine may be used during pregnancy and breastfeeding only if, in the opinion of the doctor, the benefits outweigh the risks.
Driving and operating machinery
This medicine has no effect on the ability to drive or operate machinery.
3. How to use Dermopur Liquid Powder
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is for topical application to the skin.
Shake the medicine well before use. Apply a thin layer of the suspension to the affected skin area several times (3 or 4) daily.
Use in children and adolescents
Dermopur Liquid Powder should only be used in children under 12 years of age after consultation with a doctor.
Missed application of Dermopur Liquid Powder
If a dose of Dermopur Liquid Powder is missed, continue treatment as usual according to the recommendations.
Use of more than the recommended dose of Dermopur Liquid Powder
If too much medicine is applied, wash it off the skin with water and contact a doctor.
In case of accidental ingestion, seek immediate medical advice, as systemic adverse effects may occur, such as gastrointestinal disturbances, vomiting, convulsions, increased heart rate, loss of consciousness, and methemoglobinemia.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Allergic symptoms such as itching, rash, or erythema may occur. In hypersensitive individuals, there is a risk of more severe reactions, such as local allergic reactions, urticaria, or contact dermatitis.
If any of the above adverse reactions occur, the medicine should be discontinued and advice from a dermatologist should be sought.
There is a risk that the medicine may cause methemoglobinemia (blood disorders) due to absorption through the skin when applied to extensive exuding skin lesions, during prolonged use, or when used in children.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of 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 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 the medicine.
5. How to store the Dermopur Liquid Powder medicine
Keep the medicine out of the sight and reach of children.
Store the medicine at a temperature below 25°C.
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 in use. This will help protect the environment.
6. Contents of the packaging and other information
What Dermopur Liquid Powder contains
- The active substance is benzocaine. 1 g of the skin suspension contains 15 mg of benzocaine.
- The other ingredients are: zinc oxide, talc, levomenthol, glycerol 86%, ethanol, purified water.
What Dermopur Liquid Powder looks like and contents of the pack
Dermopur Liquid Powder is a skin suspension.
Packaging
Aluminium tube internally lacquered with a membrane and a screw cap, or laminate tube with an inner layer of polyethylene and a polypropylene screw cap, or polyethylene container with a screw cap, or amber glass bottle with a screw cap, containing 40 g or 60 g of the medicinal product, placed in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Poznańskie Zakłady Zielarskie „Herbapol” S.A.
ul. Towarowa 47/51, 61-896 Poznań
tel. +48 61 886 18 00
Manufacturer
Poznańskie Zakłady Zielarskie „Herbapol” S.A.
Paterek, ul. Przemysłowa 3, 89-100 Nakło nad Notecią
tel. 52 386 73 10 fax 52 386 73 23
For further information, please contact the Marketing Authorisation Holder.
Poznańskie Zakłady Zielarskie „Herbapol” S.A.
ul. Towarowa 47/51, 61-896 Poznań
tel. +48 61 886 18 00