Package leaflet: Information for the patient

GEMIDERMA
5 mg/g, ointment
Boric acid
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, as you may need to read it again.
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 your condition does not improve or if you feel worse, you should contact your doctor.

Contents of the leaflet:

What Gemiderma is and what it is used for
Important information before use of Gemiderma
How to use Gemiderma
Possible side effects
How to store Gemiderma
Contents of the pack and other information

1. What Gemiderma is and what it is used for

Gemiderma contains boric acid as the active substance, which has weak bacteriostatic and fungistatic properties. This medicine slightly acidifies the skin surface, has an astringent, drying effect and weak antiseptic (antibacterial, antifungal) activity.
Indications
As an adjunctive treatment in inflammatory skin conditions.

2. Important information before use of Gemiderma

When not to use Gemiderma

if you are allergic to the active substance (boric acid) or to any of the other ingredients of this medicine (listed in section 6);
on extensive wounds;
on mucous membranes or near the eyes;
over large areas of skin;
on damaged skin;
in children under 3 years of age.

Warnings and precautions
Before starting to use this ointment, discuss it with your doctor or pharmacist.
This medicine should be used externally on the skin only.
Use for the shortest possible duration. If symptoms do not improve within 3 days of using the medicine, consult your doctor.
Children and adolescents
Do not use in children under 3 years of age.
Gemiderma with other medicines
Tell your doctor or pharmacist about any other medicines you are currently using, have recently used, or plan to use.
No data available.
Pregnancy, breastfeeding and fertility
Use during pregnancy and breastfeeding only on the advice of a doctor.
If using this medicinal product during breastfeeding, care should be taken to avoid contact of the product with the skin of the breast, to prevent accidental ingestion by the infant and/or accidental contact of the medicine with the infant’s skin.
Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.
Gemiderma contains anhydrous lanolin, which may cause local skin reactions (e.g. contact dermatitis).

3. How to use Gemiderma

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.
Apply a thin layer of ointment to the affected areas of skin and spread gently. Use once or twice daily.
Children and adolescents
Do not use in children under 3 years of age.
If you feel the medicine’s effect is too strong or too weak, consult your doctor.
Use of more than the recommended dose of Gemiderma
No data available.
If you use more than the recommended dose, consult your doctor or pharmacist.
Missed dose of Gemiderma
Take the next dose as scheduled. Do not use a double dose to make up for a missed dose.
Stopping Gemiderma
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Local skin reactions (e.g. contact dermatitis) may occur.
Prolonged use over large areas of damaged skin may lead to accumulation of boric acid in the body, which may result in boric acid poisoning.
Reporting of adverse reactions
If you experience any adverse reactions, including any not listed in this 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
e-mail: [email protected]
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Gemiderma

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.
Usable period after first opening of the tube – 1 year.
Store below 25°C. Keep the tube tightly closed.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Gemiderma contains

The active substance is boric acid. 1 g of ointment contains 5 mg of boric acid.
Other ingredients: anhydrous lanolin, yellow soft paraffin, purified water.

What Gemiderma looks like and contents of the pack
Gemiderma is a light yellow ointment with a faint lanolin odour.
The pack consists of an aluminium tube with a polyethylene cap containing 20 g of ointment, placed in a cardboard box with the patient leaflet.

Marketing authorisation holder and manufacturer:
Pharmaceutical Production Enterprise „GEMI” Grzegorz Nowakowski
ul. Mickiewicza 36
05-480 Karczew
tel. +48 22 780 83 05 ext. 70
e-mail: [email protected]