Bedicort salic
Poland
Table of Contents
Package leaflet: Information for the patient
Bedicort salic, 0.5 mg/g + 30 mg/g, ointment
Betamethasone + Salicylic acid
Please read the following leaflet carefully before using this medicine, as it contains
important information for the patient.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm other people, even if their symptoms are the same.
- If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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 pack and other information
1. What Bedicort salic is and what it is used for
Bedicort salic ointment contains two active substances: betamethasone dipropionate and
salicylic acid.
Betamethasone dipropionate is a synthetic, fluorinated corticosteroid with potent activity.
When applied topically, it exerts anti-inflammatory and antipruritic effects, as well as vasoconstriction.
Topically applied salicylic acid softens keratin and the stratum corneum, and promotes desquamation of the skin, thereby facilitating penetration of betamethasone dipropionate into the skin.
Indications
Bedicort salic is indicated for the topical treatment of subacute and chronic skin disorders,
such as: psoriasis, more severe forms of atopic dermatitis, localized prurigo ( neurodermitis ), lichen planus, and severe forms of eczema (including nummular eczema, contact dermatitis).
2. Important information before using Bedicort salic
When not to use Bedicort salic
- if the patient is allergic to betamethasone dipropionate and salicylic acid or any of the other ingredients of this medicine (listed in section 6);
- in bacterial infections (e.g. tuberculosis, syphilis), viral (e.g. herpes simplex, herpes zoster, varicella), fungal or parasitic (e.g. scabies) 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 treatment with Bedicort salic, discuss it with your doctor or pharmacist.
Avoid applying the medicine over a large area of the body, especially in children.
If symptoms of irritation, allergy or excessive skin dryness occur during treatment with Bedicort salic, discontinue use immediately and contact your doctor.
If a bacterial infection occurs, the doctor will initiate appropriate antibacterial treatment.
Adverse effects similar to those associated with systemic corticosteroids, including suppression of adrenal cortex function, may occur during treatment. Therefore, avoid applying the medicine over large skin areas, wounds, or damaged skin, using large amounts of the product, or prolonged treatment. If treatment in such cases is necessary, special precautions should be taken.
Particular caution is required when using the medicine in psoriasis. Treatment in psoriasis may lead to disease recurrence due to development of tolerance, generalized pustular psoriasis, or systemic toxic effects related to impaired skin integrity.
Do not use under occlusive dressings, as this may increase percutaneous absorption of the corticosteroid.
Do not apply to the eyes.
Avoid contact of the medicine with eyes and mucous membranes.
If blurred vision or other visual disturbances occur, contact your doctor.
Children
Do not use in children under 12 years of age.
Use with caution in children over 12 years of age. In children, suppression of the hypothalamic-pituitary-adrenal (HPA) axis and corticosteroid-related adverse effects may occur more easily than in adults.
In children treated with topical corticosteroids, suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, growth retardation, weight gain impairment, and intracranial hypertension have been reported.
Other medicines and Bedicort salic
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
No data available.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not use Bedicort salic during pregnancy, except for short-term treatment of a single, small skin area.
Oral formulations (e.g. tablets) of this class of products may cause adverse effects in the unborn child. It is unknown whether the same risk applies to Bedicort salic when applied topically.
It is unknown whether topically applied corticosteroids pass into human milk. The doctor will decide whether to discontinue breastfeeding or to discontinue treatment with Bedicort salic, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.
Driving and operating machinery
Bedicort salic has no influence 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. If in doubt, consult a 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 area of skin twice daily (morning and evening).
Use in children under 12 years of age
This medicine should not be used in children under 12 years of age.
Duration of treatment
In some cases, the physician may recommend less frequent application.
Treatment should not last longer than 14 days. If symptoms recur, the physician will decide whether treatment may be repeated.
Consult a doctor if you feel that the effect of Bedicort salic is too strong or too weak.
Use of a higher than recommended dose of Bedicort salic
Prolonged use of the medicine may lead to suppression of the hypothalamic-pituitary-adrenal axis and consequently to secondary adrenal insufficiency, as well as adrenal cortical hyperactivity, including Cushing's syndrome.
In addition, prolonged use of the medicine or use in high doses may cause salicylic acid poisoning.
In case of overdose, the physician will prescribe appropriate symptomatic treatment. Acute symptoms of adrenal corticosteroid overdose are usually reversible. If necessary, the physician will correct electrolyte levels and, in case of chronic poisoning, will recommend gradual, stepwise discontinuation of the medicine.
In case of salicylic acid poisoning, the physician will take actions aimed at rapid removal of salicylates from the patient's body.
Missed dose of Bedicort salic
If a dose is missed at the scheduled time, apply the medicine as soon as remembered. Then continue treatment as before. Do not use a double dose to make up for a missed dose.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur during the use of Bedicort salic:
Frequency unknown (frequency cannot be estimated from the available data):
Eye disorders: blurred vision.
Skin disorders: burning, itching, irritation, dryness of the skin, folliculitis,
hypertrichosis, acneiform eruptions, depigmentation of the skin, perioral dermatitis,
allergic contact dermatitis, contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae
and sweat gland disorders.
Due to the presence of salicylic acid, prolonged use of the product may lead to skin inflammation.
Systemic adverse reactions of betamethasone (typical of corticosteroids) and salicylic acid may also occur as a result of absorption of the active substances into the bloodstream.
Systemic adverse effects may occur primarily with prolonged use of the medicine, application over large areas of skin, or use in children.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions 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, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 betamethasone (as betamethasone dipropionate) and 30 mg salicylic acid.
- Other ingredients are: liquid paraffin and white soft paraffin.
What Bedicort salic looks like and contents of the pack
Bedicort salic ointment is a white or almost white, semi-transparent, greasy, soft mass.
Aluminium tube containing 15 g or 30 g of ointment.
Marketing Authorisation 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
07.02.2025