Bedicort salic

Package Leaflet: Information for the Patient

Bedicort Salic, 0.5 mg/g + 30 mg/g, Ointment

Betamethasone + Salicylic Acid

Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• Ask your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Bedicort Salic and what is it used for

Bedicort Salic ointment contains two active substances: betamethasone dipropionate and salicylic acid.
Betamethasone dipropionate is a synthetic, fluorinated corticosteroid with strong potency.
When applied topically, it has anti-inflammatory, antipruritic, and vasoconstrictive effects.
Salicylic acid, when applied topically, softens keratin and thickened skin and exfoliates the skin, allowing betamethasone dipropionate to penetrate the skin.

Indications

Bedicort Salic is indicated for the topical treatment of acute and chronic skin diseases, such as: psoriasis, severe forms of atopic dermatitis, limited neurodermatitis, lichen planus, severe forms of eczema (including nummular eczema and contact eczema).

2. Important information before using Bedicort Salic

When not to use Bedicort Salic

• on the face;

Warnings and precautions

Before starting treatment with Bedicort Salic, discuss it with your doctor or pharmacist.
Avoid applying the medicine to a large area of the body, especially in children.
If symptoms of irritation, allergy, or excessive dryness of the skin occur during treatment with Bedicort Salic, stop using the medicine and consult a doctor.
If a bacterial infection occurs, the doctor will prescribe appropriate antibacterial treatment.
During treatment, side effects similar to those that occur with systemic corticosteroids may occur, including suppression of adrenal function. Therefore, avoid applying the medicine to a large area of skin, wounds, damaged skin, using large amounts, and for a long time. If necessary, use the medicine in these cases with special caution.
Be particularly cautious when using the medicine in psoriasis. Using the medicine in psoriasis may lead to relapse of the disease due to the development of tolerance, generalized pustular psoriasis, and systemic toxic effects related to skin barrier disruption.
Do not use the medicine under occlusive dressings, as this may increase percutaneous absorption of the corticosteroid.
Do not use in the eyes.
Avoid contact of the medicine with the eyes and mucous membranes.
If blurred vision or other visual disturbances occur, consult a doctor.

Children

Do not use the medicine in children under 12 years of age.
Use with caution in children over 12 years of age. In children, it is easier than in adults to suppress the hypothalamic-pituitary-adrenal axis and cause side effects characteristic of corticosteroids.
In children treated with topical corticosteroids, suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, growth retardation, and increased intracranial pressure have been reported.

Other medicines and Bedicort Salic

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
No data available.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Do not use Bedicort Salic during pregnancy, except for short-term treatment of a small area of skin.
Oral forms (e.g., tablets) of this class of products may cause side effects in the unborn child. It is not known whether the same risk applies to Bedicort Salic when used on the skin.
It is not known whether topical corticosteroids pass into breast milk. The doctor will decide whether to stop breastfeeding or stop using Bedicort Salic, considering the benefits of breastfeeding for the baby and the benefits of treatment for the mother.

Driving and using machines

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

3. How to use Bedicort Salic

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

Adults and children over 12 years of age

Usually, a small amount of the medicine (0.2-0.5 cm of ointment per 10 cm of skin surface) should be applied to the affected skin area, twice a day (morning and evening).

Use in children under 12 years of age

Do not use the medicine in children under 12 years of age.

Duration of treatment

In some cases, the doctor may recommend less frequent use of the medicine.
Treatment should not last longer than 14 days. If the disease recurs, the doctor will decide whether treatment can be repeated.
Consult your doctor if you feel that the effect of Bedicort Salic is too strong or too weak.

Using more than the recommended dose of Bedicort Salic

Long-term use of the medicine may lead to suppression of the hypothalamic-pituitary-adrenal axis and, consequently, to secondary adrenal insufficiency, as well as to Cushing's syndrome.
Additionally, long-term use of the medicine or use in large doses may cause salicylic acid poisoning.
In case of overdose, the doctor will provide appropriate symptomatic treatment. Acute symptoms of corticosteroid overdose are usually reversible. If necessary, the doctor will correct electrolyte levels and, in case of chronic poisoning, will gradually discontinue the medicine.
In case of salicylic acid poisoning, the doctor will take actions to quickly remove salicylates from the patient's body.

Missing a dose of Bedicort Salic

If you miss a dose at the scheduled time, use it as soon as you remember. Then continue using the medicine as before. Do not use a double dose to make up for the missed dose.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Bedicort Salic can cause side effects, although not everybody gets them.
The following side effects may occur when using Bedicort Salic:

Frequency not known (frequency cannot be estimated from the available data):

Eye disorders: blurred vision.
Skin disorders: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acne-like changes, skin depigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infections, skin atrophy, striae, and petechiae.
Due to the presence of salicylic acid, long-term use may cause skin irritation.
As a result of the absorption of active substances into the blood, general side effects of betamethasone (characteristic of corticosteroids) and salicylic acid may also occur.
General side effects may occur mainly in case of long-term use, application to a large skin area, and use in children.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 help to gather more information on the safety of this medicine.

5. How to store Bedicort Salic

Do not store above 25°C.
Shelf life after first opening: use within 2 weeks.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the month.
Medicines should 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 pack and other information

What Bedicort Salic contains

• -The active substances are betamethasone and salicylic acid. 1 g of ointment contains 0.5 mg of betamethasone (as betamethasone dipropionate) and 30 mg of salicylic acid.
• -The other ingredients are liquid paraffin and white petrolatum.

What Bedicort Salic looks like and contents of the pack

Bedicort Salic ointment is a white or almost white, semi-transparent, greasy, soft mass.
The aluminum tube contains 15 g or 30 g of ointment.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

Przedsiębiorstwo Farmaceutyczne Jelfa S.A.
ul. Wincentego Pola 21
58-500 Jelenia Góra
Poland

Date of last revision of the leaflet:

• 07.02.2025