Bysimin 20mg/ml solution for injection

Pajjiż: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Ingredjent attiv:

HYOSCINE BUTYLBROMIDE

Disponibbli minn:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

Kodiċi ATC:

A03BB01

INN (Isem Internazzjonali):

HYOSCINE BUTYLBROMIDE 20 mg/ml

Għamla farmaċewtika:

SOLUTION FOR INJECTION

Kompożizzjoni:

HYOSCINE BUTYLBROMIDE 20 mg/ml

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2017-03-24

Fuljett ta 'informazzjoni

PAGE 1 OF 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
BYSIMIN 20MG/ML SOLUTION FOR INJECTION
Hyoscine butylbromide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Bysimin is and what it is used for
2.
What you need to know before you use Bysimin
3.
How to use Bysimin
4.
Possible side effects
5.
How to store Bysimin
6.
Contents of the pack and other information
1.
WHAT BYSIMIN IS AND WHAT IT IS USED FOR
Bysimin contains the active substance hyoscine butylbromide. This
belongs to a group of medicines
called antispasmodics.
Bysimin is used to relieve cramps of your:
- Gastrointestinal tract
- Biliary tract
- Pancreas
- Urogenital tract
Bysimin can also be used in diagnostic medical procedures.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BYSIMIN
DO NOT USE BYSIMIN:
-
If you are allergic to hyoscine butylbromide or any of the other
ingredients of this medicine (listed
in section 6).
-
If you have glaucoma (eye disease).
-
If you have megacolon (abnormally enlarged bowel).
-
If you have myasthenia gravis (muscle weakness).
-
If you have tachycardia (abnormally rapid heartbeats).
-
If you have difficulty or pain passing water (urine) such as men with
prostate problems.
-
If you have gut blockage problems or a totally inactive gut.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Bysimin if:
PAGE 2 OF 4
-
You are being treated with anticoagulant drugs, intramuscular
injection should not be given since
intramuscular haematoma may occur. You can receive slow subcutaneous
or intravenous i

Karatteristiċi tal-prodott

PAGE 1 OF 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bysimin 20mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml ampoule contains 20 mg hyoscine butylbromide.
Excipient with known effect: Contains less than 1 mmol of sodium (23
mg) per dose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear, colourless or almost colourless solution free from visible
particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acute spasm of the gastrointestinal tract, biliary tract, pancreas and
urogenital tract.
As antispasmodic agent in radiology in different diagnostic procedures
where spasm may be a problem.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
1-2 ampoules (20-40 mg) intramuscularly, subcutaneously or
intravenously slowly.
Maximum daily dose: 100mg (5 vials).
Hyoscine butylbromide injection should not be taken on a continuous
daily basis or for extended periods
without investigating the cause of abdominal pain.
_Elderly _
No specific information on the use of this product in the elderly is
available. Clinical trials have included
patients over 65 years and no adverse reactions specific to this age
group have been reported.
_Paediatric population _
Not recommended for children.
Method of administration
For intramuscular, subcutaneous or slow intravenous injection.
4.3
CONTRAINDICATIONS
PAGE 2 OF 6
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Hyoscine butylbromide injection should not be administered to patients
with myasthenia gravis,
megacolon,
narrow
angle
glaucoma,
tachycardia,
prostatic
enlargement
with
urinary
retention,
mechanical stenoses in the region of the gastrointestinal tract or
paralytic ileus.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Hyoscine butylbromide injection should not be given by intramuscular
injection to patients being
treated with anticoagulant drugs since intramuscular haematoma may
occur. These patients can receiv