Package leaflet: Information for the user

RECREOL, 50 mg/g, ointment
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 a doctor or pharmacist.

Keep this leaflet for future reference.
If advice or further information is needed, consult a pharmacist.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.
If there is no improvement after 14 days of treatment, or if the patient feels worse, consult a doctor.

Table of contents

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 ointment 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 to pantothenic acid. Pantothenic acid restores elasticity to the skin and promotes wound healing.
Recreol ointment 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 ointment may be used in children, adolescents, and adults.

2. Important information before using Recreol ointment

When not to use Recreol ointment

if the patient is allergic to dexpanthenol or to 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

Treatment with Recreol ointment should be discontinued if an allergic reaction occurs.

Avoid contact of Recreol ointment with the eyes.
Application of Recreol ointment in the anogenital area may affect the integrity of condoms.

Special caution must be observed when using Recreol ointment
Smoking or approaching open flames should be avoided while using Recreol ointment due to the risk of severe burns. Fabrics (clothing, bed linen, dressings, etc.) that have come into contact with this medicine are more flammable and pose a serious fire hazard. Washing clothes and bed linen may reduce the accumulation of the medicine, but will not completely remove it.

Recreol and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
There are no data available on potential interactions between this ointment and other medicines.

Pregnancy, breastfeeding and fertility
Recreol ointment may be used during pregnancy and breastfeeding if recommended by a doctor.
Local application on the breasts should be avoided to prevent contact of the medicine with the infant's mouth.
No studies on the effect of dexpanthenol on fertility in humans have been conducted.

Driving and operating machinery
Recreol ointment has no influence on the ability to drive and operate machinery.

Recreol ointment contains cetyl alcohol, stearyl alcohol and lanolin
Cetyl alcohol, stearyl alcohol and lanolin may cause local skin reactions (e.g. contact dermatitis).

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 your doctor or pharmacist.
This medicine is intended for topical use on the skin.
Unless otherwise advised by a doctor, adults and children should apply a thin layer of the ointment 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, or if the patient feels worse, consult a doctor.
Use in children
Recreol ointment may be used in children.
If there is a feeling that the effect of Recreol ointment is 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 everybody will get them.
Very rare (may occur in less than 1 in 10,000 patients): allergic reactions, hypersensitivity reactions (e.g. skin inflammation/allergy and skin reactions due to irritation).
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in the leaflet, please 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 may 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 Recreol

Do not store above 25 °C.
Keep the medicine in a place out of sight and reach of children.
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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Recreol ointment contains

The active substance is dexpanthenol. 1 g of ointment contains 50 mg of dexpanthenol.
The other ingredients are:
cetyl alcohol,
stearyl alcohol,
white wax,
Protegin XN (liquid paraffin, petroleum jelly, ozokerite, monoglyceride of oleic acid, mixture of lanolin alcohols),
purified almond oil,
white petroleum jelly,
liquid paraffin,
lanolin,
purified water.

What Recreol ointment looks like and contents of the pack
A yellowish, homogeneous ointment with a characteristic odour.

Aluminium tube containing 30 g or 50 g of ointment, sealed with an aluminium membrane and fitted with a white cap with a piercing device, 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 ziede
Lithuania RECREOL 50 mg/g tepalas
Czech Republic RECREOL
Slovakia RECREOL 50 mg/g masť
Hungary RECREOL 50 mg/g kenőcs
Finland Recreol 50 mg/g voide
Poland Recreol
Romania Recreol 50 mg/g unguent
Portugal Recreol 50 mg/g pomada
Slovenia Recreol 50 mg/g mazilo
Austria Recreol 50 mg/g Salbe
Germany Dexpanthenol Grindeks 50 mg/g Salbe