Package leaflet: Information for the user

RECREOL, 50 mg/g, cream
Dexpanthenolum
Please read all of this leaflet carefully before using this medicine, because 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 doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 14 days of treatment, or if you feel worse, consult your doctor.

Contents of the leaflet

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

1. What Recreol is and what it is used for

Recreol cream contains the active substance dexpanthenol, which belongs to a group of medicines used in the treatment of wounds and ulcers. Dexpanthenol is converted in tissues into pantothenic acid. Pantothenic acid restores elasticity to the skin and promotes wound healing.
Recreol cream is used for:
Supportive treatment of superficial skin lesions of various origins. It helps moisturize the outer layer of the skin and supports healing, subsequently exerting anti-inflammatory and anti-pruritic effects.
Recreol cream may 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 haemophilia due to the risk of severe bleeding.

Warnings and precautions

The use of Recreol cream should be discontinued if an allergic reaction occurs.

Avoid contact of Recreol medicine with the eyes.

Recreol and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.

There are no data available regarding interactions between Recreol and other medicines.

Pregnancy, breastfeeding and fertility

Recreol cream may be used during pregnancy and breastfeeding if recommended by a doctor.

Studies on the effect of dexpanthenol on fertility in humans have not been conducted.

Local application on the breast should be avoided to prevent contact of the medicine with the infant's mouth.

Driving and operating machinery

Recreol cream has no influence on the ability to drive and operate machinery.

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 patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is intended for topical use on the skin.
Unless otherwise directed by a physician, adults and children should apply a thin layer of the cream to the affected area of skin once or several times daily, depending on need.
The duration of treatment depends on the type and course of the condition. If there is no improvement after 14 days of treatment, or if symptoms worsen, consult a doctor.
Use in children
Dexpanthenol may be used in children.
If the effect of Recreol cream seems too strong or too weak, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Very rare (may occur in less than 1 in 10,000 patients): allergic reactions, hypersensitivity reactions (e.g. skin inflammation/allergic skin reactions due to irritation).
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in the leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Recreol

Keep this medicine out of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 pack
A white or yellowish, homogeneous cream with a specific odour.

Aluminium tube containing 30 g or 50 g of cream, closed with an aluminium membrane and fitted with a white cap, placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS GRINDEKS
Krustpils iela 53
Rīga, LV-1057
Latvia
Tel.: +371 67083205
Fax: +371 67083505
E-mail: [email protected]

This medicinal product is authorised in the European Economic Area countries 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