Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Hyoscine hydrobromide
Ethypharm
A04AD
Hyoscine hydrobromide
600 microgram(s)/millilitre
Solution for injection
Other antiemetics
Marketed
2005-08-26
PACKAGE LEAFLET: INFORMATION FOR THE USER HYOSCINE HYDROBROMIDE 600 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 BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again If you have any further questions, please ask your doctor or nurse If you get any side effects, talk to your doctor, or 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 • suf Read the complete document
Health Products Regulatory Authority 13 June 2019 CRN008YGW 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. Hyoscine should not be given by intramuscular injection to patients being treated with anticoagulant drugs since intramuscular haematoma may occur. Health Products Regulatory Authority 13 June 2019 CRN008YGW 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, hyp Read the complete document