Alantan

Package Leaflet: Information for the User

Alantan

20 mg/g, ointment

Allantoin
Read the package leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this package leaflet for the patient or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, ask your pharmacist.
• If the patient experiences any undesirable effects, including any not listed in this 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

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

1. What is Alantan and what is it used for

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

Indications for use of Alantan:

• treatment of difficult-to-heal wounds, burns (including sunburns),
• treatment of chronic skin conditions with excessive scaling and keratinization (atopic dermatitis, eczema, psoriasis, and other skin diseases),
• treatment of superficial ulcers, skin defects, and mucous membranes.

2. Important information before using Alantan

When not to use Alantan

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

Warnings and precautions

If any signs of hypersensitivity (such as redness, itching) occur at the site of application, the use of the medicine should be discontinued and a doctor or pharmacist consulted.

Alantan and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interaction between Alantan and other topically applied medicines has been found.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
There are no data on the safety of using the medicine in pregnant and breastfeeding women.

Driving and using machines

No effect of the medicine on the ability to drive and use machines, as well as on psychophysical fitness, has been found.

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

• Due to the presence of lanolin (wool fat), the 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 (possible late reactions).

3. How to use Alantan

This medicine should always be used exactly as described in this package leaflet for the patient or as advised by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The medicine is intended for topical use on the skin.
The medicine should be applied gently to the affected areas 2 to 3 times a day, unless otherwise advised by the doctor.
A small amount of ointment can be applied to a sterile dressing and applied to the cleaned wound. The dressing should be changed once or twice a day.
If there is no improvement or the patient feels worse, they should contact their doctor.

Using more than the recommended dose of Alantan

There are no data on overdose when using the medicine as described in the leaflet.
In case of accidental ingestion, the patient should contact their doctor.

Missing a dose of Alantan

The patient should not use a double dose to make up for a missed dose.
In case of any further doubts related to 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.
Hypersensitivity reactions, skin irritation (see also section 2: Important information before using Alantan - Warnings and precautions) may occur.

Reporting side effects

If any undesirable effects occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products 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
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Alantan

The medicine should be stored out of sight and reach of children.
Store in a temperature 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 month stated.
Shelf-life after first opening: 6 months.
Alantan can be used for 6 months from the date of first use, without exceeding the expiry date stated on the packaging.
In this window, the date of first use should be entered:
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. Contents of the pack and other information

What Alantan contains

• The active substance of the medicine is allantoin. 1 g of ointment contains 20 mg of allantoin.
• The other ingredients are: lanolin (wool fat), liquid paraffin, white petrolatum, ethyl parahydroxybenzoate (E 214), propylene glycol (E 1520), purified water.

What Alantan looks like and contents of the pack

Alantan is a yellow ointment of uniform consistency.
Packaging:
An internally lacquered aluminum tube with a membrane and a PE cap, containing 30 g or 100 g of ointment, placed in a cardboard box with a leaflet.

Marketing authorization 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: unia@uniapharm.pl
The content of the Alantan leaflet is available in the Ulotka Audio system at the national, free phone number: 800 706 848.

Date of last revision of the leaflet: