Country: Ísrael
Tungumál: enska
Heimild: Ministry of Health
BETAMETHASONE
DEVRIES & CO. LTD
H02AB01
TABLETS
BETAMETHASONE 0.5 MG
PER OS
Required
ALFASIGMA S.P.A., ITALY
BETAMETHASONE
BETAMETHASONE
Diseases responsive to oral glucocorticosteroid therapy.
2021-11-30
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only BETNESOL TABLETS ACTIVE INGREDIENT Each tablet contains 0.5 mg betamethasone as sodium phosphate Inactive ingredients and allergens: see section 2 under ‘Important information about some of this medicine’s ingredients’, and section 6 ‘Additional information'. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Betnesol is used to treat diseases that respond to oral glucocorticosteroid therapy. If necessary, this treatment can be given in addition to the basic treatment. THERAPEUTIC GROUP: a group of medicinal products called corticoids (cortisone derivatives). Corticoids are used in many inflammatory and allergic processes due to their anti-inflammatory effect. Cortisone is an endogenous substance that is produced in the adrenal cortex and plays an important part in various processes in our body. These also include the regulation of inflammatory processes. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: you are sensitive (allergic) to the active ingredient or to any of the other ingredients in this medicine (listed in section 6). SPECIAL WARNINGS ABOUT USING THIS MEDICINE EXCEPT FOR SHORT-TERM EMERGENCY THERAPY, DO NOT USE BETNESOL IN THE FOLLOWING CASES: • internal mycotic diseases that affect the whole body • gastric or intestinal ulcers • severe bone loss (osteoporosis) • severe muscle disorder (except myasthenia gravis) • viral diseases such as chicken pox, ocular herpes, shingles (herpes zoster) • polio (poliomyelitis) • enlargement of lymph nodes (lymphoma) after tub Lestu allt skjalið
1 1. NAME OF THE MEDICINAL PRODUCT Betnesol tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 tablet contains 0.5 mg betamethasone (as sodium phosphate) Excipient with known effect: Each tablet contains 22 mg of sodium and 6 mg of sodium benzoate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. Appearance: Pink, round, on both sides, tablet with beveled edges, with a breakline on one side and embossed with "BETNESOL" on the other side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Diseases responsive to oral glucocorticosteroid therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Glucocorticoids should only be administered at lowest therapeutic required doses and as long as it is absolutely necessary to achieve and maintain the desired therapeutic effect. The dosage must be adjusted to the specific situation of the patient, considering severity of disease of the occurred effect and glucocorticoid tolerance. Posology ADULTS AND ADOLESCENTS _OVER_ 12 YEARS _ OF AGE_ The daily dose is administered usually in the morning and at once as this will less affect the rhythm of adrenal cortex-secretion. _Short-term treatment_ Acute asthma attacks, pollinosis or other allergic diseases of the respiratory tract, generalised eczema, urticaria, dermatitis medicamentosa, and various inflammatory skin diseases. 6 tablets in the morning for 2 days, followed by 1 tablet in the morning for 2 days, followed by ½ tablet in the morning for 2 days. _Arthritis rheumatica:_ 1-4 tablets (0,5 mg to 2 mg) daily in the morning for 1-2 weeks, then a gradual withdrawal of treatment, starting with one tablet less a day, later half a tablet less, by keeping each dosage for one week. Thus it is possible to evaluate the minimum effective dose. _Other diseases:_ Betnesol effervescent tablets is indicated particularly for patients with nephrosis since it shows nearly no sodium chloride and water retention effect. In this disease the usual dose is 1-8 tablets (0,5 m Lestu allt skjalið