AdiraMedica Hyoscine Butylbromide 20 mg

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Hyoscine butylbromide 20mg

Available from:

AdiraMedica Pty Ltd.

Dosage:

20 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Hyoscine butylbromide 20mg Excipient: Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry white 85G18490 Povidone

Prescription type:

Restricted

Therapeutic indications:

AdiraMedica Hyoscine butylbromide provides relief from stomach cramps and spasms.

Product summary:

Package - Contents - Shelf Life: Blister pack, Al/PVC - 10 tablets - 24 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2019-02-25

Summary of Product characteristics

NEW ZEALAND DATA SHEET
AdiraMedica Hyoscine Butylbromide New Zealand Data Sheet v 1.0 11 Oct
2021
Page 1 of 9
ADIRAMEDICA HYOSCINE BUTYLBROMIDE
1 PRODUCT NAME
-
ADIRAMEDICA HYOSCINE BUTYLBROMIDE 10 mg film-coated tablets
-
ADIRAMEDICA HYOSCINE BUTYLBROMIDE 20 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hyoscine-N-butylbromide 10 mg film-coated tablet, and 20 mg film
coated
tablet.
Excipient with known effect: Lactose Monohydrate For
the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Oral, Film-Coated Tablet
Presentation
ADIRAMEDICA HYOSCINE BUTYLBROMIDE 10 mg and ADIRAMEDICA HYOSCINE
BUTYLBROMIDE 20 mg tablets are both: White to off-white coloured,
round, biconvex, film
coated tablet plain on both sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Muscle spasm of the gastrointestinal tract.
4.2
DOSE AND METHOD OF ADMINISTRATION
AdiraMedica Hyoscine Butylbromide 10 mg:
Adults and children over 6 years:
2 tablets four times a day
ADIRAMEDICA HYOSCINE BUTYLBROMIDE 10 mg tablets should be swallowed
whole with a
glass of water.
NEW ZEALAND DATA SHEET
AdiraMedica Hyoscine Butylbromide New Zealand Data Sheet v 1.0 11 Oct
2021
Page 2 of 9
ADIRAMEDICA HYOSCINE BUTYLBROMIDE 10 mg should not be taken on a
continuous daily
basis or for extended periods without investigating the cause of
abdominal pain.
AdiraMedica Hyoscine Butylbromide 20 mg:
Adults and children over 6 years:
1 tablet four times a day.
ADIRAMEDICA
HYOSCINE
BUTYLBROMIDE
20
mg
tablets
and
ADIRAMEDICA
HYOSCINE
BUTYLBROMIDE 20 mg tablet should be swallowed whole with a glass of
water.
ADIRAMEDICA HYOSCINE BUTYLBROMIDE 20 mg tablets should not be taken on
a continuous
daily basis or for extended periods without investigating the cause of
abdominal pain.
4.3
CONTRAINDICATIONS
ADIRAMEDICA
HYOSCINE
BUTYLBROMIDE
10
mg
and
ADIRAMEDICA
HYOSCINE
BUTYLBROMIDE 20 mg are contraindicated in myasthenia gravis,
mechanical stenosis in the
gastrointestinal tract, paralytical or obstructive ileus, megacolon
and in patients who have
d