Package leaflet: Information for the user

Tormentalum
Ointment
(Tormentillae unguentum compositum FP)
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
physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult a pharmacist.
If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
If there is no improvement or if the patient feels worse, contact a doctor.

Leaflet contents:

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

1. What Tormentalum is and what it is used for

Tormentalum ointment is a compound preparation prepared according to the monograph of the Polish Pharmacopoeia for unguentum tormentillae compositum.
The product contains 3 active substances: liquid extract of tormentil rhizome, ichthammol, and zinc oxide.
Tormentalum ointment is intended for external application to the skin. The medicine has astringent and anti-inflammatory properties.
Indications for use of Tormentalum:

treatment of minor skin injuries such as superficial abrasions, scratches.

2. Important information before using Tormentalum

When not to use Tormentalum
Do not use the medicine:

if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
on open wounds or significantly damaged skin,
on skin reactions occurring after vaccination (also known as local post-vaccination reactions),
on skin lesions caused by chickenpox.

Warnings and precautions
The medicine is intended for topical application on the skin only.
Due to its dark colour, Tormentalum may cause staining of clothing.
Do not apply the medicine near mucous membranes.
Avoid contact with eyes.
Tormentalum and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
Do not use Tormentalum simultaneously with other topical medicines applied to the skin.
If concomitant use of other topical medicines is necessary, it is recommended to apply them between successive applications of Tormentalum.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
There are no data available on the safety of using this medicine during pregnancy and breastfeeding.
Driving and operating machinery
No influence of the medicine on the ability to drive or operate machinery, or on psycho-physical performance, has been observed.
Tormentalum contains lanolin (wool fat)
Due to the presence of lanolin, the medicine may cause local skin reactions (e.g. contact dermatitis).

3. How to use Tormentalum

This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a physician or pharmacist.
This medicine is intended for topical application on the skin.
Recommended dosage
Unless otherwise advised by a physician, apply a thin layer of the ointment to the affected areas of
skin 3 to 4 times daily.
If there is no improvement or if the patient feels worse, consult a physician.
Use of more Tormentalum than recommended
There is no data available regarding overdose when using the medicine as described in the leaflet.
In case of accidental oral ingestion, consult a physician.
Missed dose of Tormentalum
Apply the ointment as soon as possible, then continue with the next dose at the usual time. Do not
apply a double dose to make up for a missed dose.
Sudden discontinuation of Tormentalum does not cause adverse effects.
If you have any further questions about the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
When using the ointment, skin irritation may occur, manifesting as redness and burning.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 Tormentalum

Keep this medicine out of sight and reach of children. Store below 25°C in the original packaging. 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.
Tormentalum may be used for up to 6 months after the date of first use of the medicine, provided this does not extend beyond the expiry date printed on the packaging.
Enter the date of first use of the medicine in this box:
Medicines must 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 package and other information

What Tormentalum contains

The active substances are: liquid extract of rhizome of Potentilla, ichthammol, zinc oxide. 100 g of the ointment contains: 3.0 g of liquid extract of rhizome of Potentilla, 2.0 g of ichthammol, 20.0 g of zinc oxide.
Other ingredients: lanolin, yellow vaseline.

What Tormentalum looks like and contents of the pack
The medicine is in the form of a light brown ointment.
Packaging:

An aluminium tube with a polyethylene cap containing 20 g of ointment, placed in a cardboard box with a leaflet,
An aluminium tube with a polyethylene cap containing 30 g of ointment, placed in a cardboard box with a leaflet.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne „UNIA” Spółdzielnia Pracy
Chłodna 56/60, 00-872 Warsaw
tel.: 22 620 90 81 ext. 190
fax: 22 654 92 40
e-mail: [email protected]
The Tormentalum package leaflet is available in the Audio Leaflet system via a nationwide free telephone number: 800 706 848.