Alantan-plus

Leaflet attached to the packaging: information for the user

Alantan Plus

(20 mg + 50 mg)/g, cream
Allantoin + Dexpanthenol

You should carefully read the contents of the leaflet 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 a doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 Plus and what is it used for
• 2. Important information before using Alantan Plus
• 3. How to use Alantan Plus
• 4. Possible side effects
• 5. How to store Alantan Plus
• 6. Contents of the packaging and other information

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

Alantan Plus is a cream for topical use on the skin.
The medicine contains two active substances: allantoin and dexpanthenol. Allantoin has a keratolytic and protective effect on the skin, improves its hydration, and supports wound healing by stimulating the growth of new tissue. Regular use of allantoin in excessive keratinization of the skin may prevent excessive keratin deposition (a type of protein).
Dexpanthenol penetrates deep into the skin, where it is converted into pantothenic acid. Increased demand for pantothenic acid occurs in the case of skin damage and various skin diseases. Dexpanthenol has the ability to bind water, which increases skin elasticity.

Indications for use of Alantan Plus:

• care of irritated and dry skin,
• treatment of various types of wounds, such as abrasions, minor cuts, and skin cracks,
• treatment of sunburn and burns after radiotherapy and phototherapy,
• prevention of diaper rash in infants,
• excessive keratinization of the skin on the hands and feet,
• supportive treatment in atopic dermatitis, allergic eczema, nasal mucositis, 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,
• on acute inflammatory skin conditions, accompanied by exudation.

Warnings and precautions

If any symptoms 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 should be consulted.

Alantan Plus 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 Plus and other medicines used topically on the skin 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 is no data on the safety of using the medicine in pregnant and breastfeeding women.

Driving and operating machinery

No effect of the medicine on the ability to drive vehicles and operate machinery, as well as on psychophysical fitness, has been found.

Alantan Plus contains lanolin (wool fat), cetearyl alcohol, propylene glycol, polysorbate 60, ethyl parahydroxybenzoate, methyl parahydroxybenzoate, and propyl parahydroxybenzoate

• Due to the presence of lanolin (wool fat) and cetearyl alcohol, 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 polysorbate 60. Polysorbates may cause allergic reactions.
• The medicine contains ethyl parahydroxybenzoate, methyl parahydroxybenzoate, and propyl parahydroxybenzoate and may cause allergic reactions (possible late-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 doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The medicine is intended for topical use on the skin.
Affected areas should be rubbed in, unless otherwise directed by a doctor, usually once or several times a day.
Infant care:
apply to areas prone to diaper rash (after each diaper change). Before applying the cream, the skin should be washed and dried.
If there is no improvement or the patient feels worse, they should contact their doctor.

Using a higher dose of Alantan Plus than recommended

There is 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 Plus

The patient should not use a double dose to make up for a missed dose.
If the patient has any further doubts about using this medicine, they 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 Plus - Warnings and precautions) may occur.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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 gather more information on the safety of the medicine.

5. How to store Alantan Plus

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 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 given month.
Shelf life after first opening the packaging – 6 months.
Alantan Plus can be used for 6 months from the date of first use, without exceeding the expiry date on the packaging.
In this window, the patient should enter the date of first use of the medicine:
Medicines should not be disposed of via wastewater or household waste containers. 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 packaging and other information

What Alantan Plus contains

The active substances of the medicine are: allantoin and dexpanthenol. 1 g of cream contains 20 mg of allantoin and 50 mg of dexpanthenol (50% solution of pantothenol in propylene glycol).
The other ingredients are: lanolin (wool fat), liquid paraffin, cetearyl alcohol, ethyl parahydroxybenzoate (E 214), methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), purified water, Polawax NF (cetearyl alcohol containing polyoxyethylene derivatives of fatty acid esters and sorbitan, including polysorbate 60 (E 435)).

What Alantan Plus looks like and what the packaging contains

Alantan Plus is a white cream, with a uniform consistency.
Packaging:
An internally lacquered aluminum tube, with a membrane and a PE cap, containing 35 g or 100 g of cream, placed in a cardboard box with a patient 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: [email protected]
The content of the Alantan Plus leaflet is available in the Ulotka Audio system under the national, toll-free phone number: 800 706 848.

Date of last update of the leaflet: