BETNESOL TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BETAMETHASONE

Available from:

DEVRIES & CO. LTD

ATC code:

H02AB01

Pharmaceutical form:

TABLETS

Composition:

BETAMETHASONE 0.5 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ALFASIGMA S.P.A., ITALY

Therapeutic group:

BETAMETHASONE

Therapeutic area:

BETAMETHASONE

Therapeutic indications:

Diseases responsive to oral glucocorticosteroid therapy.

Authorization date:

2021-11-30

Patient Information leaflet

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

Summary of Product characteristics

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