Gastro-Soothe Forte

Nchi: Nyuzilandi

Lugha: Kiingereza

Chanzo: Medsafe (Medicines Safety Authority)

Viambatanisho vya kazi:

Hyoscine butylbromide 20mg;  ;  ;  

Inapatikana kutoka:

AFT Pharmaceuticals Ltd

INN (Jina la Kimataifa):

Hyoscine butylbromide 20 mg

Kipimo:

20 mg

Dawa fomu:

Film coated tablet

Tungo:

Active: Hyoscine butylbromide 20mg       Excipient: Colloidal silicon dioxide Hypromellose Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Methylcellulose Microcrystalline cellulose Purified talc Purified water Sodium starch glycolate Titanium dioxide

Dawa ya aina:

Restricted

Viwandani na:

Alchem International Ltd

Matibabu dalili:

For the relief of stomach ache and pain due to cramps or spasm.

Bidhaa muhtasari:

Package - Contents - Shelf Life: Blister pack, PVDC/PVC/Al foil - 10 tablets - 36 months from date of manufacture stored at or below 30°C

Idhini ya tarehe:

2014-02-11

Taarifa za kipeperushi

CONSUMER MEDICINE INFORMATION
GASTRO-SOOTHE & GASTRO-SOOTHE FORTE
_HYOSCINE BUTYLBROMIDE _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Gastro-Soothe &
Gastro-Soothe Forte
tablets. It does not contain all available information. It does not
take the place of talking to
your doctor or pharmacist. Keep this information with your tablets.
You may need to read it
again later.
TO FIND OUT MORE ABOUT GASTRO-SOOTHE & GASTRO-SOOTHE FORTE
You should ask your doctor or pharmacist if you have any questions
about your medicine or if
you have any concerns about taking Gastro-Soothe or Gastro-Soothe
Forte.
WHAT GASTRO-SOOTHE & GASTRO-SOOTHE FORTE ARE USED FOR
Gastro-Soothe & Gastro-Soothe Forte anticholinergic medicines.
Anticholinergic medicines
relieve pain caused by stomach and bowel cramps by helping your
digestive system to relax.
Always consult your doctor or pharmacist if the pain does not improve
within 48 hours or if
pain worsens after treatment.
BEFORE TAKING GASTRO-SOOTHE OR GASTRO-SOOTHE FORTE
_WHEN NOT TO TAKE GASTRO-SOOTHE OR GASTRO-SOOTHE FORTE _
Do
not
take
Gastro-Soothe
or
Gastro-Soothe
Forte
if
you
are
allergic
to
hyoscine
butylbromide or any of the other ingredients in Gastro-Soothe or
Gastro-Soothe Forte. These
ingredients are listed in full at the end of this leaflet (See
Ingredients).
If you are uncertain as to whether you have such an allergy you should
raise this concern with
your doctor or pharmacist.
Do not take Gastro-Soothe or Gastro-Soothe Forte if you have
myasthenia gravis, glaucoma,
porphyria or a condition of the bowel known as megacolon.
Seek advice from your doctor or pharmacist if you have, or have had, a
prostate or heart
condition. This is because Gastro-Soothe & Gastro-Soothe Forte should
not be used in some
types of prostate disease and a certain type of heart complaint.
Gastro-Soothe & Gastro-Soothe Forte should not be used when there is a
blockage in the
stomach or bowel, or in certain conditions when there is reduced bowel
activity. These
conditions are best

Tabia za bidhaa

Page 1 of 5
NEW ZEALAND DATA SHEET
1 GASTRO-SOOTHE
® (HYOSCINE-N-BUTYLBROMIDE 10MG FILM COATED
TABLET)
(Gastro-Soothe) 10 mg Hyoscine-N-butylbromide film coated tablet
GASTRO-SOOTHE FORTE
® (HYOSCINE-N-BUTYLBROMIDE 20MG FILM COATED
TABLET)
(Gastro-Soothe Forte) 20 mg Hyoscine-N-butylbromide film coated tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Gastro-Soothe
Each tablet contains 10 mg Hyoscine-N-butylbromide.
Gastro-Soothe Forte
Each tablet contains 20 mg Hyoscine-N-butylbromide.
For the list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
White, circular 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
Gastro-Soothe and Gastro-Soothe Forte are for oral administration
only.
Gastro-Soothe and Gastro-Soothe Forte should be swallowed whole with
adequate water.
Gastro-Soothe 10 mg/tablet
Adults and children over 6 years: 2 tablets (two 10 mg tablets = 20
mg) four times a day.
Gastro-Soothe Forte 20 mg/tablet
Adults and children over 6 years: 1 tablet (20 mg) four times a day.
4.3
CONTRAINDICATIONS
Gastro-Soothe & Gastro-Soothe Forte are contraindicated in myasthenia
gravis, megacolon, and
narrow glaucoma. In addition, they should not be given to patients who
have demonstrated prior
sensitivity to the product.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Gastro-Soothe and Gastro-Soothe Forte should be used with caution in
conditions characterised by
tachycardia such as thyrotoxicosis, cardiac insufficiency or failure
and in cardiac surgery where it
may further accelerate the heart rate. Due to the risk of
anticholinergic complications, caution should
be used in patients susceptible to intestinal or urinary outlet
obstructions.
Page 2 of 5
Because of the possibility that anticholinergics may reduce sweating,
Gastro-Soothe and Gastro-
Soothe Forte should be administered with caution to patients with
pyrexia
Elevation of intraocular pressure may be produced by the
administrat