Tormentiol

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Tormentiol

Combined product
Ointment

Please read carefully the contents of the leaflet 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 directed by a doctor or pharmacist.

• This leaflet should be kept, so that it can be re-read if necessary.
• If advice or additional information is needed, a doctor or 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 after 7-10 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is Tormentiol and what is it used for

Tormentiol ointment is a medicine for use on the skin.
Tormentiol is used as an agent with anti-inflammatory, antibacterial, and astringent properties.

Indications for use of Tormentiol:

Minor skin damage such as abrasions, scratches.
As an auxiliary in purulent changes and inflammatory conditions of the skin.

2. Important information before using Tormentiol

When not to use Tormentiol:

• on wounds or significantly damaged skin.

Warnings and precautions

Tormentiol should not be used for longer than the recommended treatment time, due to the risk of possible accumulation of boric acid in the body and the occurrence of symptoms of poisoning.
During use, contact between Tormentiol and the eyes should be avoided. It should not be applied to large areas of skin.
Due to its dark color, Tormentiol may stain clothing.
The medicine contains lanolin, which may cause local skin reactions (e.g., contact dermatitis).

Children

In children under 12 years of age, due to increased absorption through the skin, during the use of Tormentiol, there is a risk of greater toxic effects of boric acid. Boron may negatively affect the fertility of children in the future.
Due to the lack of data confirming the safety of use, Tormentiol should not be used in children under 12 years of age.

Tormentiol and other medicines:

No interactions between Tormentiol and other medicines have been reported, however, it should not be used simultaneously with other medicines applied directly to the skin.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Due to the lack of data, the medicine may be used during pregnancy only in cases where, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
Due to the lack of data, the medicine may be used during breastfeeding only in cases where, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the child.
In children under 12 years of age, Tormentiol, due to its boron content, may cause fertility disorders.

Driving and using machines:

The medicine does not limit psychomotor abilities, does not impair the ability to drive vehicles or operate machinery.

3. How to use Tormentiol

Unless otherwise directed by a doctor, on diseased areas of the skin, squeeze out a dose of ointment the size of a pea and apply a thin layer of the medicine to the skin. The ointment should be applied several times a day for 7 to 10 days.
If symptoms worsen or do not improve after 7-10 days, a doctor should be consulted.
This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Sometimes local redness, burning, skin irritation may occur.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Tormentiol

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C.
Store in the original packaging.
Do not use this medicine after the expiry date stated on the outer packaging after: Expiry date (EXP). The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. A pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Tormentiol contains

• In 100 g of ointment, the active substances are: Tormentillae rhizomae extractum fluidum(Fluid extract of tormentil rhizome) 2g Ichthammolum(Ichthammol) 2g Borax(Borax) 1g Zincum oxydatum(Zinc oxide) 20 g
• The other ingredients are: white petrolatum, lanolin, vanillin.

What Tormentiol looks like and what the packaging contains

Ointment of uniform consistency, beige-brown color, and characteristic odor, packaged in an aluminum tube in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Perrigo Poland Sp. z o.o.
ul. Domaniewska 48
02-672 Warsaw
phone: +48 (22) 852 55 51
{logo Perrigo}

Manufacturer

Medgenix Benelux NV
Vliegveld 21
8560 Wevelgem
Belgium

Date of last update of the leaflet: August 2024