Scaldex

Leaflet attached to the packaging: Patient Information

SCALDEX, ointment

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by
your doctor.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor. See section 4.
• The medicine Scaldex should be used for no longer than 7 days. If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Scaldex and what is it used for

Scaldex ointment is a combination of natural origin substances, a broad-spectrum antibiotic, and vitamin A. The joint action of several active substances contained in the propolis extract, calendula tincture, and bacitracin determines the antibacterial and anti-inflammatory properties of the medicine.
The medicine acts as a disinfectant, contributing to faster cleansing of wounds from metabolic products and necrotic elements. Vitamin A accelerates the renewal processes of damaged tissue.

Scaldex is used to treat:

• thermal burns of I and II degree,
• mild frostbites of I and II degree,
• difficult-to-heal superficial wounds,
• bedsores of I and II degree,
• purulent minor wounds.

Scaldex is intended for use on a small skin surface.
Scaldex is intended for adults and adolescents over 12 years of age.
The medicine may be used in children under 12 years of age only under the supervision of a doctor.

2. Important information before using Scaldex

When not to use Scaldex

If the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).
If the patient is allergic to plants of the Asteraceae family (formerly Compositae), such as chamomile, yarrow, or calendula. If the patient has kidney function disorders.
Scaldex should not be used in third- and fourth-degree burns, as well as on deep and extensive wounds.

Warnings and precautions

Before starting to use Scaldex, you should consult a doctor or pharmacist and exercise caution if any of the following information raises concerns:

• if an allergic reaction occurs during the use of Scaldex, including severe and sudden reactions (rash around the burn wound, swelling of the burn wound and its surroundings, acute contact dermatitis, contact urticaria, erythema), you should immediately discontinue the use of the medicine and consult a doctor.
• patients allergic to neomycin or bee products (honey, pollen, royal jelly) may also be allergic to Scaldex.
• you should avoid using Scaldex in patients with atopic dermatitis.
• Scaldex can only be used on a small skin surface or wounds. You should not use the medicine in large doses, as one of the active substances of the medicine may cause kidney damage after absorption into the blood.
• in case of concurrent use of other medicines that may damage the kidneys (e.g., aminoglycoside antibiotics), you should consult a doctor before using Scaldex.
• during the use of the medicine, superinfection with resistant microorganisms (especially fungi) may occur, so in case of worsening symptoms, you should consult a doctor.
• if the patient has kidney function disorders, you should consult a doctor before using this medicine.
• you should exercise caution when using Scaldex on the face, as getting the product into the eye will cause conjunctival irritation, manifested by burning. In case the medicine gets into the eye, it should be rinsed with clean water, preferably boiled and cooled.
• Scaldex is intended for use on a small skin surface, do not use in third- and fourth-degree burns, do not use on deep and extensive wounds.
• Scaldex should be used for no longer than 7 days. In case of no improvement, you should consult a doctor.

Children

The use of the product is allowed in children under 12 years of age, only under the supervision of a doctor.

Scaldex and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
In particular, you should inform your doctor if you are to receive general anesthetics, muscle relaxants, or medicines that can damage the kidneys, such as aminoglycoside antibiotics.
If you are unsure whether you are taking any of the above medicines, you should ask your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before using this medicine.
In pregnant and breastfeeding women, the possibility of absorption of the medicinal product Scaldex into the blood should be considered.
When using Scaldex during pregnancy, caution is advised, as there are reports that vitamin A, one of the components of Scaldex, in high doses may have a harmful effect on fetal development.
Scaldex should not be used in inflammatory conditions of the nipples during breastfeeding.

Driving and using machines

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

Scaldex contains lanolin

1 g of ointment contains 364.5 mg of lanolin.
The medicine may cause local allergic reactions (e.g., contact dermatitis, manifested by redness, itching, blistering).

3. How to use Scaldex

This medicine should always be used exactly as advised by your doctor or pharmacist. If you are unsure, you should consult a doctor or pharmacist.
The medicine is intended for topical use on the skin, on a small skin surface.

Usual dose for adolescents over 12 years of age and adults:

• In the first days of treatment, the ointment should be applied to the wound surface every 2-3 hours.
• In subsequent days of treatment, apply 3 times a day.
• In case of accompanying purulent discharge, additionally rinse twice a day with 0.1% potassium permanganate solution.

Do not use in occlusive or closed dressings that prevent air access.
In case of burns larger than 2% of the body surface, apply the preparation to the burned skin and consult a doctor.
Note: 1% of the patient's body surface corresponds to the size of their hand without fingers.
Scaldex should be used for no longer than 7 days. In case of no improvement, you should consult a doctor.
If you feel that the effect of Scaldex is too strong or too weak, you should consult a doctor.

Using a higher dose of Scaldex than recommended

In case of using a higher dose of the medicine than recommended, you should immediately consult a doctor or pharmacist.

Missing a dose of Scaldex

You should not use a double dose to make up for a missed dose.

Stopping the use of Scaldex

In case of any further doubts regarding the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Scaldex can cause side effects, although not everybody gets them.
Scaldex is generally well-tolerated, and any side effects usually disappear within a few days of stopping the medicine.
The most common side effect of Scaldex is local allergic reactions, which may manifest as itching, rash around the burn wound, swelling of the burn wound and its surroundings.
In most cases, there is a lack of available data to estimate the frequency of side effects, which may also vary depending on the indications for treatment. Side effects with an unknown frequency (frequency cannot be determined from available data):

• superinfections with resistant strains of bacteria or fungi;
• severe allergic reaction (so-called anaphylactic reaction, which may manifest in various ways, from generalized itching, swelling of the lips and face, excessive sweating, chest tightness to hypotension, loss of consciousness, breathlessness, and cardiac arrest);
• allergic reactions such as rash around the burn wound, swelling of the burn wound and its surroundings, acute contact dermatitis, contact urticaria, erythema, itching;
• harmful effects on the kidneys;
• muscle weakness.

In case of such symptoms, you should discontinue the medicine and consult a doctor.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor. 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,
Jerozolimskie Avenue 181 C, 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.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Scaldex

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Store at a temperature below 25°C.
After completing the treatment, any unused product should be discarded. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Scaldex contains

The active substances of Scaldex are:

• •calendula flower tincture Calendula officinalisL. flos(1:5), extraction solvent - 70% (V/V) ethanol (Calendulae tinctura)
• propolis extract (Propolis extractum)
• bacitracin (Bacitracinum)
• synthetic vitamin A, oily concentrate (Vitaminum A syntheticum densatum oleosum)(vitamin A stabilized with tocopherol, 1 g contains: vitamin A - 990 mg, α-tocopherol - 10 mg).

1 g of Scaldex ointment contains: 90 mg of calendula flower tincture; 30 mg of propolis extract; 10 mg of bacitracin; 0.3 mg of synthetic vitamin A, oily concentrate.
The other ingredients are: linseed oil, cholesterol, paraffin, white petrolatum, lanolin.

What Scaldex looks like and what the packaging contains

Scaldex is a homogeneous ointment with a color ranging from yellow-beige to dark brown, with a characteristic propolis smell.
The packaging of the medicine is an aluminum tube with a membrane, internally coated with epoxy-phenolic lacquer, with an HDPE screw cap, in a cardboard box. Packaging size: 25 g of ointment.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Solinea Sp. z o.o.
Elizówka, Szafranowa 6
21-003 Ciecierzyn
Poland

Manufacturer:

CHEMA-ELEKTROMET Spółdzielnia Pracy
Przemysłowa 9, 35-105 Rzeszów
To obtain more detailed information about this medicine, you should contact the representative of the marketing authorization holder.

Date of the last update of the leaflet: