Betnesol 500 microgram Soluble Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
03-02-2022
Summary of Product characteristics
(SPC)
03-02-2022
Active ingredient:
BETAMETHASONE SODIUM PHOSPHATE
Available from:
RPH Pharmaceuticals AB
ATC code:
H02AB; H02AB01
INN (International Name):
BETAMETHASONE SODIUM PHOSPHATE
Dosage:
500 microgram(s)
Pharmaceutical form:
Soluble tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Glucocorticoids; betamethasone
Authorization status:
Not marketed
Authorization date:
1993-08-13
Patient Information leaflet
BETNESOL® 500 MICROGRAM SOLUBLE TABLETS
BETAMETHASONE
PATIENT INFORMATION LEAFLET
•
BETNESOL TABLETS IS A STEROID MEDICINE
, prescribed for many different conditions, including serious
illnesses.
•
YOU NEED TO TAKE IT REGULARLY
to get the maximum benefit.
•
DON’T STOP TAKING THIS MEDICINE
without talking to your doctor – you may need to reduce the dose
gradually.
•
BETNESOL TABLETS CAN CAUSE SIDE EFFECTS IN SOME PEOPLE
(read section on side effects below). Some
problems such as mood changes (feeling depressed or ‘high’) , or
stomach problems can happen
straight away. If you feel unwell in any way, keep taking your
medicine, but
SEE YOUR DOCTOR STRAIGHT
AWAY
.
•
SOME SIDE EFFECTS ONLY HAPPEN AFTER WEEKS OR MONTHS
. These include weakness of arms and legs,
or developing a rounder face (read section on side effects for more
information).
•
IF YOU TAKE IT FOR MORE THAN 3 WEEKS, YOU WILL GET A BLUE ‘STEROID
CARD’
: always keep it with you
and show it to any doctor or nurse treating you.
•
KEEP AWAY FROM PEOPLE WHO HAVE CHICKEN POX OR SHINGLES
, if you have never had them. They
could affect you severely. If you do come into contact with chicken
pox or shingles,
SEE YOUR DOCTOR
STRAIGHT AWAY
.
NOW READ THE REST OF THIS LEAFLET
. It includes other important information on the safe and effective
use of this medicine that might be especially important for you.
THIS LEAFLET WAS LAST UPDATED JUNE
2009
.
If you have any questions about this medicine, ask your doctor or
pharmacist.
WHAT IS YOUR MEDICINE?
Betnesol 500 micrograms Soluble Tablets are round, pink soluble
tablets, scored one side and with
‘Betnesol Evans’ engraved on the other.
Each tablet contains 500 micrograms (0.5mg) betamethasone as
betamethasone sodium phosphate.
The tablets also contain sodium hydrogen carbonate (E500), sodium acid
citrate, saccharin sodium,
povidone, Erythrosine (E127) and sodium benzoate (E211). Betnesol
Tablets are supplied in strip
packs of 100 tablets.
The marketing authorisation holder is RPH Pharmaceutic
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
02 February 2022
CRN00CRZ3
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betnesol 500 microgram Soluble Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 micrograms (0.5 mg) betamethasone as
betamethasone sodium phosphate.
Excipients: contains 20.9mg sodium per tablet
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Soluble Tablet
Small, soluble, pink tablet engraved Betnesol Evans on one side and
scored on the reverse.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A wide variety of diseases may sometimes require corticosteroid
therapy. Some of the principal indications are as follows.
Bronchial asthma, severe hypersensitivity reactions, anaphylaxis,
rheumatoid arthritis, systemic lupus erythematosus,
dermatomyositis, mixed connective tissue disease (excluding systemic
sclerosis), polyarteritis nodosa; inflammatory skin
disorders, including pemphigus vulgaris, bullous pemphigoid and
pyoderma gangrenosum; minimal change nephrotic
syndrome, acute interstitial nephritis; ulcerative colitis, Crohn’s
disease; sarcoidosis; rheumatic carditis; haemolytic anaemia
(auto-immune), acute lymphoblastic and chronic lymphocytic leukaemias,
malignant lymphoma, multiple myeloma, idiopathic
thrombocytopenic purpura; immunosuppression in transplantation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Betnesol Tablets are best taken dissolved in water, but they can be
swallowed whole without difficulty. The lowest dosage that
will produce an acceptable result should be used; when it is possible
to reduce the dosage, this must be accomplished by
stages. During prolonged therapy, dosage may need to be increased
temporarily during periods of stress or in exacerbations of
illness (see “Special Warnings and Special Precautions for Use”).
Adults
The dose used will depend upon the disease, its severity, and the
clini
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