Package leaflet: Information for the patient

Bedicort salic
Betamethasone + Salicylic acid
(0.5 mg + 20 mg)/g, solution for the skin
Read the entire leaflet before using the medicine, as it contains
important information for the patient.

Keep this leaflet to be able to read it again if necessary.
If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

What Bedicort salic is and what it is used for
Important information before using Bedicort salic
How to use Bedicort salic
Possible side effects
How to store Bedicort salic
Contents of the packaging and other information

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

Bedicort salic contains two active substances, betamethasone and salicylic acid.
Betamethasone is a corticosteroid medicine with strong anti-inflammatory activity. When applied locally, it reduces inflammatory skin symptoms such as redness, swelling, and itching.
Salicylic acid softens the outer layer of the skin and causes desquamation of the epidermis, allowing betamethasone dipropionate to penetrate into the skin.
Bedicort salic is indicated for local treatment of scalp psoriasis, severe forms of seborrheic dermatitis, lichen planus, severe forms of allergic dermatitis, allergic contact dermatitis affecting the scalp, and discoid lupus erythematosus.

2. Important information before using Bedicort salic

When not to use Bedicort salic:

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

Warnings and precautions
Before starting to use Bedicort salic, discuss it with your doctor, pharmacist, or nurse.
If irritation worsens, or symptoms of allergy or skin dryness occur, discontinue use of the medicine and contact your doctor immediately.
If the patient experiences blurred vision or other visual disturbances, contact your doctor.
Avoid prolonged use, application over large areas of skin, or application to damaged skin, especially in children. In such cases, the medicine should be used with particular caution, as adverse effects similar to those of systemic corticosteroids (e.g. taken orally) may occur, including suppression of adrenal cortex function.
If an infection develops at the site of application, the doctor may prescribe additional antibacterial or antifungal treatment, or decide to interrupt therapy until the infection resolves.
Do not apply the medicine to the armpits, groin, or under occlusive dressings (airtight coverings), due to the risk of increased absorption of the medicine through the skin into the body.
Bedicort salic should be used with particular caution in psoriasis.
Avoid contact of the medicine with eyes and mucous membranes.

Children and adolescents
Do not use in children under 12 years of age.
Use with caution in children over 12 years of age and in adolescents. In children, suppression of the hypothalamic-pituitary-adrenal axis and adverse effects typical of corticosteroids, including disturbances in growth and development, may occur more easily than in adults.

Bedicort salic and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
The safety of topical use of this medicine in pregnant women has not been established.
Bedicort salic may be used only when, in the opinion of the doctor, the potential benefit to the mother outweighs the possible risk to the fetus.
It is not known whether topically applied corticosteroids pass into human breast milk.
The doctor will decide whether breastfeeding should be discontinued or treatment with Bedicort salic should be stopped, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and operating machinery
Bedicort salic solution has no effect on the ability to drive or operate machinery.

3. How to use Bedicort salic

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
This medicine is intended for topical use on the skin.
Adults and children over 12 years of age:
Apply a small amount of the medicine (approximately 0.5 ml of solution per 0.5 ml of solution per 10 cm of skin surface) to the affected skin areas—usually twice daily (morning and evening).
In some cases, the physician may recommend less frequent application.
If symptoms recur, the physician will consider whether treatment may be repeated.
Duration of treatment
Treatment should not last longer than 2 weeks continuously (without interruption).
Children under 12 years of age
Do not use in children under 12 years of age.
If you feel that the effect of Bedicort salic is too strong or too weak, consult your doctor.
Use of more than the recommended dose of Bedicort salic
If the patient accidentally uses more solution than recommended or unintentionally swallows the medicine, contact a doctor immediately or go to the nearest hospital.
Prolonged use of the medicine may cause suppression of the hypothalamic-pituitary-adrenal axis and the appearance of Cushing's syndrome symptoms. In case of overdose, the physician will administer appropriate symptomatic treatment, and in cases of chronic intoxication, will recommend gradual discontinuation of the medicine.
Long-term use of the medicine may also lead to salicylic acid poisoning. In such a case, the physician will take measures aimed at rapid elimination of salicylates from the patient's body.
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Local adverse effects with unknown frequency (frequency cannot be determined from available data):

blurred vision
burning, itching, irritation, dryness of the skin
folliculitis
hypertrichosis
acneiform skin changes
skin depigmentation
perioral dermatitis
allergic contact dermatitis
skin maceration
secondary infections, skin atrophy, striae
miliaria (small blisters on the skin)

Systemic adverse effects with unknown frequency (frequency cannot be determined from available data):

Due to absorption of the active substances into the bloodstream, systemic adverse effects of betamethasone (typical of corticosteroids) and salicylic acid may also occur. Systemic adverse effects occur primarily with prolonged use of the medicine, application over large skin areas, and in children.

Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult a doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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]
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the package and other information

What Bedicort salic contains

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

What Bedicort salic looks like and contents of the pack
Bedicort salic solution is a colourless, clear liquid with the smell of isopropyl alcohol.
Packaging
Polyethylene bottle with dropper and cap, containing 30 ml, 50 ml, 60 ml or 100 ml of solution, placed in a cardboard box.
Marketing Authorisation 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