Gemiderma

Leaflet attached to the packaging: patient information

GEMIDERMA

5 mg/g, ointment
Boric acid

Read the leaflet carefully 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 advised by
the doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

What the medicine G is and what it is used for

• 2. Important information before using the medicine G

3. How to use the medicine G

4. Possible side effects

• 5. How to store the medicine G
• 6. Package contents and other information

• 1.

What the medicine G is and what it is used for

Medicine G contains boric acid as the active substance, which has a weak bacteriostatic and fungistatic effect. This medicine slightly acidifies the skin surface, has a drying and slightly antiseptic effect (antibacterial, antifungal).
Indications for use
As an auxiliary in inflammatory skin conditions.

2. Important information before using the medicine G

When not to use the medicine G

• if the patient is allergic to the active substance (boric acid) or any of the other ingredients of the medicine (listed in section 6);
• on extensive wounds;
• on mucous membranes, in the eyes;
• on a large skin surface;
• on damaged skin,
• in children under 3 years of age.

Warnings and precautions

Before starting to use this ointment, the patient should discuss it with their doctor or pharmacist.
The medicine should only be used on the skin.
It should be used for as short a time as possible. If the symptoms of the disease do not disappear after 3 days of using the medicine, the patient should consult their doctor.

Children and adolescents

Not to be used in children under 3 years of age.

G and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No data available.

Pregnancy, breastfeeding, and fertility

Use during pregnancy and breastfeeding only on the advice of a doctor.
When using the medicinal product during breastfeeding, care should be taken to avoid contact between the medicinal product and the breast skin, as this may cause accidental ingestion of the product by the infant and/or accidental contact between the medicine and the infant's skin.

Driving and using machines

The medicine does not affect the ability to drive and use machines.
It contains anhydrous lanolin, so it may cause local skin reactions (e.g., contact dermatitis).

3. How to use the medicine G

This medicine should always be used exactly as described in the patient leaflet or as advised by
the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
A thin layer of ointment should be applied to the affected areas of the skin and rubbed in. It should be used once or twice a day.

Children and adolescents

Not to be used in children under 3 years of age.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Using a higher dose of the medicine G than recommended

No data available.
In case of using a higher dose of the medicine than recommended, the patient should consult their doctor or pharmacist.

Missing a dose of the medicine G

The patient should take the next dose of the medicine. They should not use a double dose to make up for the missed dose.

Stopping the use of the medicine G

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Local skin reactions (e.g., contact dermatitis) may occur.
Prolonged use of the medicine on large areas of damaged skin may cause accumulation of boric acid in the body, which can lead to boric acid poisoning.

Reporting side effects

If the patient experiences
any side effects, including any possible side effects not listed in the leaflet,
they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
e-mail: ndl@urpl.gov.pl.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store the medicine G

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
The shelf life after opening the tube is 1 year.
Store in a temperature below 25°C. Store the tube tightly closed.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What the medicine G contains

• The active substance of the ointment is boric acid. 1 g of the medicine contains 5 mg of boric acid .
• The other ingredients are: anhydrous lanolin, yellow petrolatum, purified water.

What the medicine G looks like and what the package contains

G is a light yellow ointment with a slight lanolin smell.
The medicine packaging consists of an aluminum tube with a polyethylene cap containing 20 g of ointment, placed in a cardboard box with the patient leaflet.

Responsible entity and manufacturer:

Pharmaceutical Production Company "GEMI" Grzegorz Nowakowski
ul. Mickiewicza 36
05-480 Karczew
tel. +48 22 780 83 05 w. 70
e-mail: gemi@gemi.pl

Date of the last update of the leaflet: 14.10.2014