BEDICORT 0.5 mg/20 mg Solution

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Bedicort Salic
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
3. What is Bedicort Salic and what is it used for
4. Important information before using Bedicort Salic
   1. When not to use Bedicort Salic:
   2. Warnings and precautions
   3. Children and adolescents
   4. Bedicort Salic and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
5. How to use Bedicort Salic
   1. Using a higher dose of Bedicort Salic than recommended
6. Possible side effects
   1. Reporting side effects
7. How to store Bedicort Salic
8. Package contents and other information
   1. What Bedicort Salic contains
   2. What Bedicort Salic looks like and what the package contains
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Bedicort Salic

Betamethasone + Salicylic Acid
(0.5 mg + 20 mg)/g, skin solution

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or
• nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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. Package contents and other information

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

Bedicort Salic contains two active substances, betamethasone and salicylic acid.
Betamethasone is a strong corticosteroid. When applied locally, it reduces symptoms of skin inflammation, such as redness, swelling, and itching.
Salicylic acid softens the outer layer of the skin and exfoliates the skin, allowing betamethasone dipropionate to penetrate the skin.
Bedicort Salic is indicated for the local treatment of scalp psoriasis, severe forms of seborrheic dermatitis, lichen planus, severe forms of allergic contact dermatitis, and contact eczema (allergic) on the scalp, and rosacea.

2. Important information before using Bedicort Salic

When not to use Bedicort Salic:

• if the patient is allergic to betamethasone or salicylic acid, or any other component of this medicine (listed in section 6);
• in case of bacterial (e.g., tuberculosis, scrofula), viral (e.g., herpes, shingles, chickenpox), or fungal skin infections;
• in acne vulgaris;
• in rosacea;
• in perioral dermatitis;
• on facial skin;
• in diaper dermatitis;
• in pruritus of the anal and genital area;
• in children under 12 years of age.

Warnings and precautions

Before starting to use Bedicort Salic, the patient should discuss it with their doctor, pharmacist, or nurse.
If irritation or symptoms of hypersensitivity or dry skin occur, the patient should stop using the medicine and contact their doctor immediately.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
The patient should avoid long-term use of the medicine, on a large skin surface, or on damaged skin, especially in children. In such cases, the medicine should be used with particular caution, as side effects similar to those of systemic corticosteroids (e.g., oral) may occur, including suppression of adrenal cortex function.
If an infection occurs at the site of application, the doctor will prescribe additional antibacterial or antifungal medications or decide to discontinue treatment until the infection is cured.
The medicine should not be applied to the skin of the armpits or groin or under an occlusive dressing (sealing), due to the risk of increased absorption of the medicine through the skin into the body.
The medicine should be used with particular caution in psoriasis.
Contact between the medicine and the eyes or mucous membranes should be avoided.

Children and adolescents

Do not use in children under 12 years of age.
Use with caution in children over 12 years of age and adolescents. In children, it is easier than in adults for the hypothalamic-pituitary-adrenal axis to be suppressed and for side effects characteristic of corticosteroids to occur, including growth and development disorders.

Bedicort Salic and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to use.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
The safety of using Bedicort Salic in pregnant women has not been established.
Bedicort Salic can only be used if the potential benefit to the mother outweighs the possible risk to the fetus.
It is not known whether topical corticosteroids pass into breast milk.
The doctor will decide whether to discontinue breastfeeding or stop using Bedicort Salic, considering the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and using machines

Bedicort Salic solution has no effect on the ability to drive or operate machines.

3. How to use Bedicort Salic

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
This medicine is intended for use on the skin.
Adults and children over 12 years of age:
A small amount of the medicine (about 0.5 ml of liquid per 10 cm of skin surface) should be applied to the affected areas of the skin - usually twice a day (morning and evening).
In some cases, the doctor may recommend less frequent use of the medicine.
In case of recurrence of the disease, the doctor will consider whether treatment can be repeated.
Duration of treatment
Treatment should not last longer than 2 weeks without interruption.
Children under 12 years of age
Do not use in children under 12 years of age.
If the patient feels that the effect of Bedicort Salic is too strong or too weak, they should consult their doctor.

Using a higher dose of Bedicort Salic than recommended

If the patient accidentally uses a larger amount of the solution than recommended or unintentionally swallows the medicine, they should contact their doctor or go to the nearest hospital immediately.
Long-term use of the medicine may cause suppression of the hypothalamic-pituitary-adrenal axis and the occurrence of Cushing's syndrome symptoms. In case of overdose, the doctor will provide appropriate symptomatic treatment, and in case of chronic poisoning, they will recommend gradual withdrawal of the medicine.
Long-term use of the medicine may also cause salicylic acid poisoning. In such a case, the doctor will take actions to quickly remove salicylates from the patient's body.
In case of any further doubts about using this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Bedicort Salic can cause side effects, although not everybody gets them.
Local side effects of unknown frequency (frequency cannot be determined from available data):

• blurred vision
• burning, itching, irritation, dryness of the skin,
• folliculitis,
• hypertrichosis,
• acne-like changes on the skin,
• skin depigmentation,
• perioral dermatitis,
• allergic contact dermatitis,
• skin maceration,
• secondary infections, skin atrophy, skin striae
• dyshidrotic eczema (small blisters on the skin),

Systemic side effects of unknown frequency (frequency cannot be determined from available data):

• 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 occur mainly in case of long-term use of the medicine, use on a large skin surface, and in children.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should consult their doctor or pharmacist.
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, e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Bedicort Salic

Do not store above 25°C. Do not freeze.
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 month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Bedicort Salic contains

• The active substances of the medicine are betamethasone and salicylic acid. 1 g of the solution contains 0.5 mg of betamethasone (as betamethasone dipropionate) and 20 mg of salicylic acid.
• Other ingredients are: disodium edetate, hypromellose, sodium hydroxide, isopropyl alcohol, purified water.

What Bedicort Salic looks like and what the package contains

Bedicort Salic solution is a colorless, clear liquid with the smell of isopropyl alcohol.
Package
A polyethylene bottle with a dropper and screw cap, containing 30 ml, 50 ml, 60 ml, or 100 ml of the solution, placed in a cardboard box.

Marketing authorization holder

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

Manufacturer

Przedsiębiorstwo Farmaceutyczne Jelfa SA
ul. Wincentego Pola 21
58-500 Jelenia Góra

Date of last revision of the leaflet: