Tormentiol

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Tormentiol
Compound preparation
Ointment
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 the
physician or pharmacist.

• Keep this leaflet so that it can be read again if necessary.
• If advice or further information is needed, consult a physician or pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform the physician or pharmacist. See section 4.
• If there is no improvement or if the patient feels worse after 7–10 days, consult a physician.

Contents of the leaflet:

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

1. What Tormentiol is and what it is used for

Tormentiol ointment is a medicine intended for topical application to the skin.
Tormentiol is used as an agent with anti-inflammatory, antibacterial, and astringent properties.
Indications for Tormentiol:
Minor skin injuries such as abrasions and scratches.
Adjunctive treatment in purulent skin lesions and inflammatory skin conditions.

2. Information before using Tormentiol

When not to use Tormentiol:

• if the patient is allergic to any of the active substances or to any of the other ingredients of the medicine;
• in case of intolerance to boric acid and its derivatives;
• in newborns and infants;
• in local post-vaccination reactions;
• in skin lesions caused by chickenpox;
• on wounds or significantly damaged skin.

Warnings and precautions
Tormentiol should not be used for longer than the recommended treatment duration due to the risk of possible accumulation of boric acid in the body and the occurrence of poisoning symptoms.
During use, avoid contact of Tormentiol with the eyes. Do not apply on large areas of skin.
Due to its dark colour, 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 skin absorption during use of Tormentiol, there is a risk of greater toxic effects of boric acid. Boron may negatively affect children's future fertility.
Due to lack of data confirming safety, 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 effects on 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.
Due to lack of data, Tormentiol may be used during pregnancy only if, in the opinion of the physician, the benefit to the mother outweighs the potential risk to the fetus.
Due to lack of data, Tormentiol may be used during breastfeeding only if, in the opinion of the physician, the benefit to the mother outweighs the potential risk to the infant.
In children under 12 years of age, Tormentiol, due to its boron content, may cause fertility disorders.

Driving and operating machinery:
Tormentiol does not impair psychomotor abilities and does not affect the ability to drive motor vehicles or operate moving machinery.

3. How to use Tormentiol

Unless otherwise advised by your doctor, squeeze a pea-sized amount of the ointment onto the affected skin area and spread a thin layer of the medicine over the skin. Apply the ointment several times daily for 7 to 10 days.
If symptoms worsen or do not improve after 7–10 days, consult your doctor.
This medicine should always be used exactly as described in this patient information leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everyone will experience them.
Occasionally, local redness, burning, or skin irritation may occur.
Reporting of adverse reactions
If any adverse effects occur, including any 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 49 21 301
Fax: + 48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables better assessment of the safety of the medicine.

5. How to store Tormentiol

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Keep 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Tormentiol medicinal product contains

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

What Tormentiol looks like and contents of the pack
An ointment of homogeneous consistency, beige-brown in colour, with a characteristic odour, packed in an aluminium tube placed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Perrigo Poland Sp. z o.o.
ul. Domaniewska 48
02-672 Warszawa
tel.: +48 (22) 852 55 51
{Perrigo logo}

Manufacturer
Medgenix Benelux NV
Vliegveld 21
8560 Wevelgem
Belgium