Package leaflet: Information for the user

Alantan
20 mg/g, ointment
Allantoinum
It is important to read this leaflet before using the medicine, because it contains information important for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, consult a pharmacist.
If the patient experiences any adverse reactions, including any 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.

Contents of the leaflet

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

1. What Alantan is and what it is used for

Alantan is an ointment for topical application to the skin.
The medicine contains the active substance allantoin, which has keratolytic and protective effects on the skin. Allantoin improves skin hydration and supports wound healing by stimulating the growth of new tissue.
Regular use of allantoin in conditions involving excessive skin keratosis may prevent excessive deposition of keratin (a type of protein).

Indications for Alantan:

Treatment of slowly healing wounds, burns (including sunburn),
Treatment of chronic inflammatory skin conditions associated with excessive scaling and keratosis (atopic dermatitis, eczema, psoriasis, and other skin diseases),
Treatment of superficial ulcers, skin defects, and mucosal lesions.

2. Important information before using Alantan

When not to use Alantan

if the patient is allergic to allantoin or to any of the other ingredients of this medicine (listed in section 6),
in the eyes,
for acute inflammatory skin conditions accompanied by exudation.

Warnings and precautions

If any signs of hypersensitivity (such as redness, itching) occur at the site of application, treatment should be discontinued and medical advice should be sought from a doctor or pharmacist.

Alantan and other medicines

Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to use.
No interactions have been reported between Alantan and other topical medicines used on the skin.

Pregnancy and breastfeeding

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.
There is no available data on the safety of Alantan use in pregnant or breastfeeding women.

Driving and operating machinery

Alantan has no known influence on the ability to drive vehicles or operate machinery or on psycho-physical performance.

Alantan contains lanolin (wool fat), propylene glycol, and ethyl parahydroxybenzoate

Due to the presence of lanolin (wool fat), this medicine may cause local skin reactions (e.g. contact dermatitis).
The medicine contains 50 mg of propylene glycol per 1 g of product. Due to the presence of propylene glycol, the medicine may cause skin irritation.
The medicine contains ethyl parahydroxybenzoate and may cause allergic reactions (including delayed-type reactions).

3. How to use Alantan

This medicine should always be used exactly as described in this patient leaflet or as directed by a physician or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is intended for topical application on the skin.
Apply the ointment gently to the affected areas 2 to 3 times daily, unless otherwise directed by a physician.
A small amount of ointment may be applied to a sterile dressing and placed on a cleaned wound. The dressing should be changed once or twice daily.
If there is no improvement or if the patient feels worse, consult a doctor.
Use of more than the recommended dose of Alantan
There is no data available regarding overdose when the medicine is used as described in this leaflet.
In case of accidental oral ingestion, contact a doctor immediately.
Missed dose of Alantan
Do not use a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this product may cause adverse reactions, although not everyone experiences them.
Hypersensitivity reactions and skin irritation may occur (see also section 2: Important information before using Alantan – Warnings and precautions).
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your 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
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the responsible entity.
Reporting adverse reactions enables further collection of information on the safety of the medicine's use.

5. How to store Alantan

The medicine should be stored in a place inaccessible and out of sight 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.
Shelf-life after first opening of the container – 6 months.
Alantan medicine may be used for 6 months from the date of first use of the medicine, without exceeding
the expiry date indicated on the packaging.
The date of first use of the medicine should be entered in this box:
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Alantan contains

The active substance is allantoin. 1 g of the cream contains 20 mg of allantoin.
Other ingredients: lanolin (wool fat), liquid paraffin, white soft paraffin, ethyl parahydroxybenzoate (E 214), propylene glycol (E 1520), purified water.

What Alantan looks like and contents of the pack

Alantan is a yellowish cream with a uniform consistency.
Packaging: An internally lacquered aluminium tube with a membrane and a PE cap, containing 30 g or 100 g of cream, placed in a cardboard box together with the package leaflet.

Marketing Authorisation Holder and Manufacturer

Zakłady Farmaceutyczne „UNIA” Spółdzielnia Pracy
ul. Chłodna 56/60
00-872 Warsaw
tel.: 22 620 90 81 ext. 190
fax: 22 654 92 40
e-mail: [email protected]

The Alantan package leaflet is available in the Audio Leaflet system via a nationwide, toll-free telephone number: 800 706 848.