Package leaflet: Information for the user

Alantan Plus
(20 mg + 50 mg)/g, cream
Allantoinum + Dexpanthenolum
Please read this leaflet carefully before using the medicine, as it contains important information for you.
Always use this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, consult your doctor.

Leaflet contents

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

1. What Alantan Plus is and what it is used for

Alantan Plus is a topical cream for application to the skin.
The medicine contains two active substances: allantoin and dexpanthenol. Allantoin has keratolytic and protective effects on the skin, improves skin hydration, and supports wound healing by stimulating the growth of new tissue. Regular use of allantoin in cases of excessive skin keratosis may prevent excessive keratin (a type of protein) accumulation.
Dexpanthenol penetrates deeply into the skin, where it is converted into pantothenic acid. Increased demand for pantothenic acid occurs in skin injuries and various skin disorders. Dexpanthenol has water-binding properties, thereby increasing skin elasticity.

Indications for Alantan Plus:

Care of irritated and dry skin,
Treatment of various types of wounds, such as abrasions, minor cuts and skin fissures,
Treatment of sunburns and radiation- or phototherapy-induced burns,
Prevention of diaper rash in infants,
Excessive keratosis of the palms and soles,
Supportive treatment in atopic dermatitis, allergic eczema, rhinitis, and leg ulcers.

2. Important information before using Alantan Plus

When not to use Alantan Plus

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

Warnings and precautions
If any symptoms of hypersensitivity (such as redness, itching) occur at the site of application, use of the medicine should be discontinued and the patient should consult a doctor or pharmacist.
Alantan Plus and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use.
No interactions have been reported between Alantan Plus and other topical skin medications.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
There is no available data on the safety of Alantan Plus during pregnancy and breastfeeding.
Driving and operating machinery
Alantan Plus has no known effect on the ability to drive or operate machinery or on psycho-physical performance.
Alantan Plus contains lanolin (wool fat), cetostearyl alcohol, propylene glycol, polysorbate 60, ethyl parahydroxybenzoate, methyl parahydroxybenzoate, and propyl parahydroxybenzoate

Due to the presence of lanolin (wool fat) and cetostearyl alcohol, this medicine may cause local skin reactions (e.g. contact dermatitis).
This medicine contains 50 mg of propylene glycol per 1 g of product. Due to the presence of propylene glycol, this medicine may cause skin irritation.
This medicine contains polysorbate 60. Polysorbates may cause allergic reactions.
This medicine contains ethyl parahydroxybenzoate, methyl parahydroxybenzoate, and propyl parahydroxybenzoate, which may cause allergic reactions (delayed-type reactions possible).

3. How to use Alantan-Plus

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
This medicine is intended for topical application to the skin.
Affected areas should be treated, unless otherwise advised by a doctor, usually once or several times daily.
Baby care:
apply to areas at risk of diaper rash (after each diaper change). Before applying the cream, clean and dry the skin thoroughly.
If there is no improvement or if the patient feels worse, consult a doctor.
Use of a higher than recommended dose of Alantan-Plus
There is no data available on overdose when the medicine is used according to the instructions in the leaflet.
In case of accidental oral ingestion, contact a doctor.
Missed application of Alantan-Plus
Do not apply a double dose to make up for a missed application.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Hypersensitivity reactions and skin irritation may occur (see also section 2: Important information before using Alantan Plus - Warnings and precautions).
Reporting of adverse reactions
If any adverse effects 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 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 Alantan-Plus

Keep this medicine out of sight and reach of children.
Store below 25°C in the original packaging.
Do not store in the refrigerator.
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 the container – 6 months.
Alantan-Plus may be used within 6 months from the date of first use of the medicine,
provided the expiry date printed on the packaging is not exceeded.
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 will help
protect the environment.

6. Contents of the packaging and other information

What Alantan Plus contains
The active substances in the medicine are: allantoin and dexpanthenol. 1 g of cream contains 20 mg of allantoin and
50 mg of dexpanthenol (50% solution of panthenol in propylene glycol).
Other components are: lanolin (wool fat), liquid paraffin, cetostearyl alcohol, ethyl parahydroxybenzoate (E 214), methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), purified water, polawax NF (cetostearyl alcohol containing polyoxyethylene derivatives of fatty acid esters and sorbitan, including polysorbate 60 (E 435)).
What Alantan Plus looks like and contents of the pack
Alantan Plus is a white, homogenous cream.
Packaging:
Aluminium tube internally lacquered, with a membrane and a polyethylene cap, containing 35 g or 100 g of cream, placed in a cardboard box with a leaflet.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne „UNIA” Spółdzielnia Pracy
Chłodna 56/60
00-872 Warsaw
Phone: +48 22 620 90 81 ext. 190
Fax: +48 22 654 92 40
e-mail: [email protected]
The Alantan Plus package leaflet content is available in the Audio Leaflet system via a nationwide free phone number: 800 706 848.