Alantan-plus

Package leaflet: Information for the user

Alantan Plus
(20 mg + 50 mg)/g, ointment
Allantoinum + Dexpanthenolum
Please read this 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 patient leaflet or as directed by the physician 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 your condition does not improve or worsens, consult your doctor.

Table of contents

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

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

Alantan Plus is an ointment for topical 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) deposition.
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 use of Alantan Plus:

• prevention of diaper rash in infants,
• treatment of various types of wounds, such as abrasions, minor cuts and skin fissures,
• treatment of sunburns and burns following radiotherapy and phototherapy,
• care of irritated and dry skin,
• excessive keratosis of the palms and soles,
• supportive treatment in atopic dermatitis, allergic eczema, nasal mucositis, and leg ulcers.

2. 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,
• on acutely inflamed skin areas with exudation.

Warnings and precautions
If any signs of skin irritation (such as redness, itching) occur at the site of application, discontinue use of the medicine and consult a doctor or pharmacist.

Alantan-Plus and other medicines
Inform your doctor or pharmacist about any medicines currently used, recently used, or planned to be used.
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 lack of data regarding the safety of Alantan-Plus during pregnancy and breastfeeding.

Driving and operating machinery
No influence of the medicine on the ability to drive or operate machinery and on psycho-physical performance has been observed.

Alantan-Plus 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 Plus

This medicine should always be used exactly as described in this patient leaflet or as directed by a physician or pharmacist. In case of doubt, consult a doctor or pharmacist.
This medicine is intended for topical application on the skin.
Affected areas should be treated, unless otherwise directed by a physician, usually once or several times daily.
Care of infants:
apply to areas at risk of diaper rash (after each diaper change). Before applying the ointment, the skin should be washed and dried.
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 regarding overdose when the medicine is used as described in the leaflet.
In case of accidental oral ingestion, consult a doctor.
Missed dose of Alantan Plus
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 all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Hypersensitivity reactions and skin irritation may occur (see also section 2: Important information
before use of 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 may also be reported to the marketing authorization holder.
By reporting adverse reactions, you help provide more information on the safety of this medicinal product.

5. How to store Alantan-Plus

Keep the medicine out of the 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.
Usable period after first opening of the container – 6 months.
Alantan-Plus may be used for 6 months from the date of first use of the medicine,
without exceeding the expiry date indicated 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 in use. This will help protect
the environment.

6. Contents of the pack and other information

What Alantan Plus contains

• The active substances are: alantoin and dexpanthenol. 1 g of cream contains 20 mg of alantoin and 50 mg of dexpanthenol (50% solution of panthenol in propylene glycol).
• Other ingredients: lanolin (wool fat), liquid paraffin, white soft paraffin, ethyl parahydroxybenzoate (E 214), purified water.

What Alantan Plus looks like and contents of the pack
Alantan Plus is a cream of yellowish colour and uniform consistency.
Packaging:
Aluminium tube internally lacquered, with a membrane and a polyethylene cap, containing 30 g or 100 g of cream, placed in a cardboard box with the leaflet.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne „UNIA” Spółdzielnia Pracy
Chłodna Street 56/60
00-872 Warsaw
Phone: +48 22 620 90 81 ext. 190
Fax: +48 22 654 92 40
e-mail: [email protected]

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