Hyoscine Hydrobromide Martindale Pharma 600 micrograms/ml Solution for Injection

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Hyoscine hydrobromide

Saatavilla:

Martindale Pharmaceuticals Ltd

ATC-koodi:

A04AD

INN (Kansainvälinen yleisnimi):

Hyoscine hydrobromide

Annos:

600 microgram(s)/millilitre

Lääkemuoto:

Solution for injection

Prescription tyyppi:

Product subject to prescription which may not be renewed (A)

Terapeuttinen alue:

Other antiemetics

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

2005-08-26

Pakkausseloste

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 heart burn
• have a fever
• suffer from heart problems(i.e heart attack, high blood
pressure, heart failure or are undergoing cardiac surgery)
• suffer from overactive thyroid
• suffer from inflammation of the bowel (colitis).
CHILDREN:
Use with caution.
Children are more susceptible to side effects.
PLEASE CONTACT YOUR DOCTOR OR NURSE IMMEDIATELY if you
experience severe persistent or worsening stomach pain;
together with, nausea, vomiting, changes in bowel
movements, stomach tenderness, fainting or b

Valmisteyhteenveto

Health Products Regulatory Authority
12 April 2019
CRN008R64
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hyoscine Hydrobromide Martindale Pharma 600 micrograms/ml Solution for
Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml contains 600 micrograms of Hyoscine Hydrobromide.
Excipient with known effect
Contains 3.54 mg/ml of sodium
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection
A clear colourless solution
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.
Health Products Regulatory Authority
12 April 2019
CRN008R64
Page 2 of 5
Hyoscine should not be given by intramuscular injection to patients
being treated with anticoagulant drugs since intramuscular
haematoma may occur.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution is necessary in treating patients with cardiovascular disease
(e.g. acute myocardial infarction, h