Hyoscine Injection BP 400 micrograms/ml, Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Hyoscine Hydrobromide

Available from:

Ethypharm

ATC code:

A04AD

INN (International Name):

Hyoscine Hydrobromide

Dosage:

400 microgram(s)/millilitre

Pharmaceutical form:

Solution for injection

Therapeutic area:

Other antiemetics

Authorization status:

Marketed

Authorization date:

2005-08-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
HYOSCINE 400 MICROGRAMS/ML SOLUTION FOR INJECTION
Hyoscine Hydrobromide
(Referred to as Hyoscine Injection in this leaflet)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN HYOSCINE
INJECTION
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please ask your doctor or
pharmacist.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Hyoscine Injection is and what it is used for
2.
What you need to know before Hyoscine Injection is given
3.
How Hyoscine Injection is given
4.
Possible side effects
5.
How to store Hyoscine Injection
6.
Contents of the pack and other information
1.
WHAT HYOSCINE INJECTION IS AND WHAT IT IS USED FOR
Hyoscine Injection is used to treat nausea (feeling sick), vomiting
(being sick), vertigo, loss of balance
and motion sickness. Hyoscine Injection is also used to prevent you
from producing
too much saliva if you have been given a general anaesthetic.
2.
WHAT YOU NEED TO KNOW BEFORE HYOSCINE INJECTION IS GIVEN
YOU SHOULD NOT BE GIVEN HYOSCINE INJECTION IF YOU:
· are allergic to hyoscine hydrobromide or any of the other
ingredients of this medicine listed in section
6.
· suffer from myasthenia gravis (extreme muscle weakness)
· suffer from megacolon (dilated large bowel)
· suffer from blockage of stomach (pyloric stenosis) or bowel
· suffer from an inactive or paralysed bowel (paralytic ileus)
· suffer from a racing heart
· are a man who has an enlarged prostrate with urinary retention.
· suffer from an eye problem called angle-closure glaucoma
· are an elderly patient
WARNINGS AND PRECAUTIONS
TELL YOUR DOCTOR OR NURSE BEFORE BEING GIVEN HYOSCINE
INJECTION IF YOU:
· suffer from epilepsy, as there is an increased seizure frequency in
epileptic patients
· have Down’s Syndrome
· suffer from liver or kidney problems
· suffer from diarrhoea
· suffer from h

Summary of Product characteristics

Health Products Regulatory Authority
30 October 2019
CRN008MV0
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hyoscine Injection BP 400 micrograms/ml, Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains 400 micrograms of Hyoscine Hydrobromide.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection
A clear colourless solution in clear glass ampoules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1. Nausea, vomiting, vertigo, labyrinthine disorders, motion sickness.
2. To prevent excessive bronchial salivary secretions during the use
of general anaesthesia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults
1. 200 micrograms as a single dose.
2. 200 – 600 micrograms, 30 – 60 minutes before induction of
anaesthesia.
Paediatric population
1. 6 micrograms/ kg as a single dose.
2. 15 micrograms/ kg, 30 – 60 minutes before induction of
anaesthesia.
Children (under 4 months)
Not recommended.
Elderly
Hyoscine is not recommended for use in the elderly.
Method of administration
By subcutaneous or intramuscular injection.
In adults, the injection may if required also be given by the
intravenous route for acute use.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
Hyoscine should not be administered to patients with myasthenia
gravis,
megacolon, angle-closure glaucoma, tachycardia, prostatic enlargement
with
urinary retention, gastrointestinal obstruction, mechanical stenosis
in the
region of the gastrointestinal tract or paralytic ileus.
Hyoscine should not be given by intramuscular injection to patients
being treated
with anticoagulant drugs since intramuscular haematoma may occur.
Health Products Regulatory Authority
30 October 2019
CRN008MV0
Page 2 of 5
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Caution is necessary in treating patients with cardiovascular disease
(e.g. acute myocardial infarction, hypertension
and conditions associated with