Recreol

Package Leaflet: Information for the User

RECREOL, 50 mg/g, ointment

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 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 not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement after 14 days or the patient feels worse, a doctor should be consulted.

Table of Contents of the 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 pack and other information

1. What is Recreol and what is it 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 into pantothenic acid in the tissues. Pantothenic acid restores skin elasticity and promotes wound healing.

Recreol ointment is used for:

Treating 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 ointment can be used in children, adolescents, and adults.

2. Important information before using Recreol

When not to use Recreol ointment

• -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 ointment should be stopped in case of an allergic reaction.

contact between Recreol ointment and the eyes should be avoided.

Using Recreol ointment in the anogenital area may affect the durability of condoms.

Particular caution should be exercised when using Recreol

When using Recreol ointment, one should not smoke or approach an open flame due to the risk of severe burns. Fabric (clothing, bedding, dressings, etc.) that has come into contact with this medicine is more easily ignited and poses a significant fire hazard. Washing clothing and bedding may reduce the accumulation of the medicine, but not completely remove it.

Recreol and other medicines

The doctor or pharmacist should be informed 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 on the occurrence of interactions between the ointment and other medicines.

Pregnancy, breastfeeding, and fertility

Recreol ointment can be used during pregnancy and breastfeeding after a doctor's recommendation.

Local application on the breast should be avoided to prevent contact between the medicine and the child's mouth.

No studies have been conducted on the effect of dexpanthenol on human fertility.

Driving and using machines

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

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 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 ointment 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 after 14 days or the patient feels worse, a doctor should be consulted.

Use in children

Recreol ointment can be used in children.

If it is felt that the effect of Recreol ointment 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 occur in less than 1 in 10,000 patients):allergic reactions, hypersensitivity reactions (e.g., skin inflammation/allergy and skin reactions resulting from irritation).

Reporting side effects

If any side effects occur, including any not listed in the 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

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 allow more information to be collected on the safety of the medicine.

5. How to store Recreol

Do not store above 25°C.

The medicine should be stored 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 month stated.

Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines no longer required. 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:
• stearyl alcohol,
• cetyl alcohol,
• white wax,
• protegin XN (liquid paraffin, petroleum jelly, ozokerite, monoolein glyceride, lanolin alcohol mixture),
• purified almond oil,
• white petroleum jelly,
• liquid paraffin,
• lanolin,
• purified water.

What Recreol ointment looks like and contents of the pack

Yellowish ointment of uniform consistency and specific smell.

Aluminum tube containing 30 g or 50 g of ointment, closed with an aluminum membrane and equipped with a white screw cap with a puncture device, 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

Tel.: +371 67083205

Fax: +371 67083505

Email: grindeks@grindeks.lv

This medicine is authorized in the Member States of the European Economic Area 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

Date of last revision of the leaflet: