Recreol

Package Leaflet: Information for the User

RECREOL, 50 mg/g, cream

Dexpanthenol

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 directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse after 14 days, a doctor should be consulted.

Table of Contents of the Package Leaflet

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

1. What is Recreol and what is it used for

Recreol cream contains the active substance dexpanthenol, which belongs to a group of medicines used to treat wounds and ulcers. Dexpanthenol is converted into pantothenic acid in the tissues. Pantothenic acid restores skin elasticity and promotes wound healing.
Recreol cream is used for:
Supportive treatment of superficial skin changes of various origins. It helps to moisturize the outer layer of the skin and supports healing, and then has anti-inflammatory and anti-itching effects.
Recreol cream can be used in children, adolescents, and adults.

2. Important information before using Recreol

When not to use Recreol cream

• -if the patient is allergic to dexpanthenol or any of the other ingredients of this medicine (listed in section 6);
• -on wounds in patients with hemophilia due to the risk of severe bleeding.

Warnings and precautions

Use of Recreol cream should be stopped in case of an allergic reaction.
Contact between Recreol and the eyes should be avoided.

Recreol and other medicines

The doctor or pharmacist should be informed about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to use.
There are no data on the occurrence of interactions between Recreol and other medicines.

Pregnancy, breastfeeding, and fertility

Recreol cream can be used during pregnancy and breastfeeding after consultation with a doctor.
No studies have been conducted on the effect of dexpanthenol on human fertility.
Local application to the breast should be avoided to prevent contact between the medicine and the child's mouth.

Driving and using machines

Recreol cream has no effect on the ability to drive and use machines.

Recreol cream contains cetyl alcohol, stearyl alcohol, lanolin, and propylene glycol

Cetyl alcohol, stearyl alcohol, and lanolin may cause local skin reactions (e.g., contact dermatitis). This medicine contains propylene glycol, which may cause skin irritation.

3. How to use Recreol

This medicine should always be used exactly as described in this package leaflet for the patient, or as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.
The medicine is intended for use on the skin.
Unless otherwise directed by a doctor, in adults and children, a thin layer of cream should be applied to the affected skin surface once or several times a day, depending on the needs.
The duration of treatment depends on the type and course of the disease. If there is no improvement or the patient feels worse after 14 days, a doctor should be consulted.

Use in children

Dexpanthenol can be used in children.
If it is felt that the effect of Recreol cream is too strong or too weak, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare (may affect up to 1 in 10,000 patients):allergic reactions, hypersensitivity reactions (e.g., skin inflammation/allergic skin reactions due to irritation).

Reporting side effects

If any side effects occur, including any possible side effects not listed in the package leaflet, the doctor or pharmacist, or nurse should be informed. 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
Phone: +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 Recreol

The medicine should be stored out of sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not freeze.
Do not use this medicine after the expiry date stated on the carton after "Expiry date (EXP)". The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Recreol cream contains

• The active substance is dexpanthenol. 1 g of cream contains 50 mg of dexpanthenol.
• The other ingredients are:
• DL-pantolactone,
• phenoxyethanol,
• potassium cetyl phosphate,
• lanolin,
• propylene glycol,
• stearyl alcohol,
• cetyl alcohol,
• isopropyl myristate,
• purified water.

What Recreol cream looks like and contents of the package

White or yellowish cream with a uniform consistency and specific odor.
Aluminum tube containing 30 g or 50 g of cream, closed with an aluminum membrane and equipped with a white cap, and placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

AS GRINDEKS
Krustpils iela 53
Rīga, LV-1057
Latvia
Phone: +371 67083205
Fax: +371 67083505
Email: [email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Estonia
RECREOL
Latvia
RECREOL 50 mg/g krēms
Lithuania
RECREOL 50 mg/g kremas
Czech Republic
RECREOL
Slovakia
RECREOL 50 mg/g krém
Hungary
RECREOL 50 mg/g krém
Finland
Recreol 50 mg/g kerma
Poland
Recreol
Romania
Recreol 50 mg/g cremă
Portugal
Recreol 50 mg/g creme
Slovenia
Recreol 50 mg/g krema
Austria
Recreol 50 mg/g Creme
Germany
Dexpanthenol Grindeks 50 mg/g Creme

Date of last revision of the package leaflet: