Mashh propolisova 3%

Patient Information Leaflet

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Read the leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet, or
according to the doctor's, pharmacist's or nurse's instructions.

• keep this leaflet, so you can read it again if you need to,
• adverse reactions not listed in the leaflet, they should inform their doctor,pharmacist or nurse. See section 4.
• contact your doctor.

Propolis Ointment 3%

Propolis extractum, 30 mg/g, ointment

Composition

100 g of ointment contains:
Active substance: propolis extractum – ethanol extract of propolis 3 g ,
Excipients: euceryn (white petrolatum, cetyl alcohol, cholesterol), propylene glycol, purified water

Available Packaging

Tube containing 20 g of ointment.

Responsible Entity and Manufacturer

Responsible entity:
Farmina sp. z o.o.
ul. Lipska 44
30-721 Kraków
Manufacturer:
Farmina sp. z o.o., Myślenice Plant
ul. Cegielskiego 2
32-400 Myślenice
Table of contents of the leaflet:

• 1. What is Propolis Ointment 3% and what is it used for;
• 2. Before using Propolis Ointment 3%
• 3. How to use Propolis Ointment 3%
• 4. Possible side effects;
• 5. Storage of Propolis Ointment 3%;
• 6. Other necessary information about Propolis Ointment 3%;

1. What is Propolis Ointment 3% and what is it used for

Propolis Ointment 3% is a preparation based on a water-emulsion base, containing propolis extract (ethanol condensed extract of bee glue) as an active substance. It is assumed that the active ingredients of the propolis extract, responsible for its antimicrobial properties, are primarily phenolic acids: benzoic, cinnamic, coffee and ferulic; alcohols: benzyl and cinnamic, and their esters.
It is believed that Propolis Ointment 3% has antimicrobial and anti-inflammatory effects, and shortens the healing time of skin damage, accelerates tissue regeneration, especially the processes of epithelialization and granulation.
Indications:
Propolis Ointment 3% is used for minor skin damage, skin abrasions, mild skin inflammation, first-degree burns (redness), inflammatory conditions and swelling after insect bites. The product is used traditionally for the mentioned indications, and its effectiveness is based solely on a long period of use and experience.

• 2. Before using Propolis Ointment 3%Do not use Propolis Ointment 3% in people allergic to bee products (honey, pollen, royal jelly), in people prone to allergies, suffering from allergic skin diseases and other diseases with an allergic background, as well as in people allergic to benzoic acid derivatives. Do not use in case of hypersensitivity to any component of the product, including excipients. Before using Propolis Ointment 3%it is recommended to perform an allergy test, which involves applying a small amount of ointment to the elbow fold. If within 3-24 hours, swelling, redness, and itching of the skin occur, you should stop using Propolis Ointment 3%. Particular cautionshould be exercised in people prone to allergies.

Children:Due to the lack of sufficient data, it is not recommended to use in children under 6 years of age.

Fertility, Pregnancy, and Breastfeeding

Well-controlled studies of the preparation have not been conducted in pregnant and breastfeeding women, therefore, it is not recommended to use the preparation.
Do not use in women with a tendency to allergies.

Driving and Operating Machines

There are no data available. So far, no effect on the ability to drive vehicles and operate machinery has been observed.

Using Other Medicines

In the case of using Propolis Ointment 3% on a doctor's prescription, you should inform about all recently taken medicines, even those that are available without a prescription.

3. How to use Propolis Ointment 3%

Adults, adolescents, and children over 6 years: apply a thin layer to the affected areas, as needed, up to several times a day.
Children under 6 years: It is not recommended to use.

• 4. Possible Side EffectsLike all medicines, this medicine can cause side effects, although they may not occur in everyone.

So far, in the course of spontaneous monitoring, after using Propolis Ointment 3%, no side effects have been reported.

In case of occurrence of any of the following symptoms, you should immediately stop using the medicine, inform your doctor or go to the

nearest hospital:swelling of hands, feet, face, lips, mouth, throat causing difficulty swallowing or breathing. These are severe side effects, if they occur, it may indicate the possibility of an allergic reaction (hypersensitivity) to Propolis Ointment 3%.
The occurrence of severe side effects may necessitate immediate medical attention and hospital treatment. Severe side effects occur rarely (≥1/10 000 to <1>In people allergic to other bee products (honey, pollen, royal jelly), the following may occur: rash, redness, increased swelling, or other symptoms of an allergic reaction. In such cases, you should stop using the medicine.
Propylene glycol contained in the ointment may cause skin irritation.
Reporting Side Effects
If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, 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
{current address, phone number, and fax of the above Department}
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the responsible entity.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. Storage of Propolis Ointment 3%

Store at a temperature below 25°C.
Store in a place inaccessible and invisible to children.
Do not use after the expiration date stated on the packaging.

6. Other Information:

To obtain more detailed information, you should contact the responsible entity.
Date of preparation of the leaflet: 31.07.2017