Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Hyoscine hydrobromide may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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:
This medicine is an injection which will be given to you by a doctor. Your doctor will determine the dose you require. It will be given under the skin or into a muscle. Adults Treatment of nausea (feeling sick), vomiting (being sick), vertigo (feeling dizzy and light headed), loss of balance and motion sickness:
Stop taking your medicine and see a doctor immediately if you notice any of the following side effects as you may need urgent medical treatment:
Other side effects include:
Hyoscine Injection Keep this medicine out of the sight and reach of children. You should not be given this medicine if it has passed the expiry date shown on the label. The expiry date refers to the last day of that month. The doctor or nurse will check this. Protect from light. Do not throw away any medicines via wastewater or household waste . Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Hyoscine Injection contains The active ingredient is Hyoscine Hydrobromide 0.04% w/v and 0.06% w/v. The other ingredients are sodium chloride, dilute hydrobromic acid and water for injections. What Hyoscine Injection looks like and contents of the pack Hyoscine Injection is a clear, colourless solution supplied in clear glass 1ml ampoules. It is supplied in cartons containing ten ampoules. Marketing Authorisation Holder and Manufacturer: Martindale Pharma Bampton Road, Harold Hill, Romford, Essex, RM3 8UG This leaflet was last revised in: September 2017 Product License Numbers: PL 01883/6175R PL 01883/6135R If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at the above address.
D0386200000
Hyoscine 400 micrograms/ml Solution for Injection comes as injection containing 400micrograms/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Hyoscine 400 micrograms/ml Solution for Injection is hyoscine hydrobromide.
This leaflet reproduces the patient information leaflet approved for Hyoscine 400 micrograms/ml Solution for Injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
a. Nausea, vomiting, vertigo, labyrinthine disorders, motion sickness
b. To prevent excessive bronchial salivary secretions during the use of general anaesthesia.
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.
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, acute porphyria, prostatic enlargement with urinary retention, gastrointestinal obstruction, mechanical stenosis in the region of the gastrointestinal tract, and the onset of labour or paralytic ileus.
Hyoscine should not be given by intramuscular injection to patients being treated with anticoagulant drugs since intramuscular haematoma may occur.
• Urinary Retention
• Caution is necessary in treating patients with cardiovascular disease (e.g. acute myocardial infarction, hypertension and conditions associated with tachycardia (including hyperthyroidism, cardiac insufficiency, and cardiac surgery)),
• Down's Syndrome, renal or hepatic impairment.
• Increased seizure frequency in epileptic patients.
• Use in caution with patients with diarrhoea. Hyoscine should be used with caution in patients with ulcerative colitis as use may lead to ileus or megacolon.
• Hyoscine may aggravate gastro-oesophageal reflux.
• In case severe unexplained abdominal pain persists or worsens or occurs together with symptoms like fever, nausea, vomiting, changes in bowel movements, abdominal tenderness, decreased blood pressure, fainting or blood in stool, appropriate diagnostic measures are needed to investigate the aetiology of the symptoms.
• Heat prostration can occur at high ambient temperatures, due to decreased sweating. Hyoscine should be administered with caution to patients with pyrexia.
• Elevation of intraocular pressure may be produced by the administration of anticholinergic agents such as hyoscine in patients with undiagnosed and therefore untreated angle-closure glaucoma.
• Urgent ophthalmological advice should be sought in case patients should develop a painful, red eye with loss of vision after the injection of hyoscine.
• After parenteral administration of hyoscine, cases of anaphylaxis including episodes of shock have been observed. As with all drugs causing such reactions, patients receiving hyoscine by injection should be kept under observation.
• Children: Use with caution in children as they may be more susceptible to adverse effects.
This medicinal product contains 3.54mg/ml of sodium per dose. To be taken into consideration by patients on a controlled sodium diet
• Anticholinergics/antimuscarinics: Many drugs have anticholinergic effects; concomitant use of two or more such drugs can increases side-effects such as dry mouth, urine retention and constipation; concomitant use can also lead to confusion in the elderly.Anticholinergic (antimuscarinic) side-effects may be intensified by concomitant use of hyoscine with drugs such as tricyclic and tetracyclic antidepressants, monoamine oxidase inhibitors (MAOIs), antihistamines, quinidine, amantadine, antipsychotics (e.g. phenothiazines, butyrophenones, clozapine), disopyramide and other anticholinergics (e.g. tiotropium, ipratropium, atropine-like compounds) may be intensified by hyoscine.
• Nitrates: Reduced effect of sub-lingual nitrates (failure to dissolve under the tongue due to dry mouth).
• Beta-adrenergic agents: The tachycardic effects of beta-adrenergic agents maybe enhanced by hyoscine.
• Metoclopramide and Domperidone – Dopamine antagonist: Although hyoscine is not indicated for gastrointestinal treatment, concomitant treatment with dopamine antagonists such as metoclopramide or domperidone may result in diminution of the effects of both drugs on the gastrointestinal tract.
• Dopaminergics: Hyoscine may reduce absorption of levopdopa
• Alcohol: Patients should be advised to avoid alcohol prior to having any procedure which requires administration of hyoscine as an increased sedative effect has been reported when hyoscine is given with alcohol.
• Parasympathomimetics: Hyoscine antagonises the effects of parasympathomimetics
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Pregnancy:
There are limited data from the use of hyoscine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. Hyoscine crosses the placenta. Use of hyoscine during pregnancy may cause respiratory depression in the neonate. As a precautionary measure hyoscine is not recommended during pregnancy.
Breast-feeding:
There is insufficient information on the excretion of hyoscine and its metabolites in human milk. A risk to the breastfeeding child cannot be excluded. Use during breastfeeding is not recommended.
Fertility:
No studies on the effects of human fertility due to hyoscine have been conducted
Hyoscine may cause drowsiness, dizziness or blurred vision. If affected, patients must not drive or operate machinery.
Many of the listed undesirable effects can be assigned to the anticholinergic properties of hyoscine.
• Immune system disorders: anaphylactic shock including cases with fatal outcome, anaphylactic or anaphylactoid reactions, dyspnoea, skin reactions (e.g. urticaria, rash, erythema, pruritus) and other hypersensitivity
• Psychiatric disorders: mental confusion or excitement, psychotic disorder, delirium, hallucinations
• Nervous system disorders: drowsiness, dizziness, headache, loss consciousness, neuroleptic malignant syndrome
• Eye disorders: blurred vision, dilation of the pupils, with loss of accommodation, photophobia, angle-closure glaucoma
• Cardiac disorders: transient bradycardia, tachycardia, palpitations, arrhythmias
• Vascular disorders: blood pressure decreased, flushing
• Gastrointestinal disorders: dry mouth, constipation, nausea, vomiting, difficulty in swallowing
• Skin and subcutaneous tissue disorders: dyshidrosis, skin dryness, and rashes
• Renal and urinary disorders: difficulty with micturition
• General disorders and administration site conditions: idiosyncratic reactions, injection site pain, particularly after intramuscular use, occurs, thirst
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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Symptoms:
In the early stages the symptoms would be excitement, delirium, dilated pupils, rapid pulse, hot flushes, dry skin, dry mouth and thirst, (see also section 4.8).
Symptomatic and supportive treatment should be instituted (in the case of oral ingestion, gastric lavage should be included). Many of the symptoms are related to the anticholinergic nature of hyoscine: urinary retention, reddening of the skin, tachycardia, inhibition of gastrointestinal motility and transient visual disturbances may occur. Cheynes-Stokes respiration has been reported. Other symptoms may include: hyperthermia, hyperpyrexia, hypertension, nausea and vomiting. Toxic doses may also cause CNS stimulation marked by restlessness, confusion, ataxia, incoordination, paranoid and psychotic reactions, hallucinations, and occasionally seizures. In severe over-dosage, central stimulation may give way to CNS depression, coma, circulatory/respiratory failure and death. Treatment:
Physostigmine by slow intravenous injection in a dose of 1 to 4mg has been used to reverse the anticholinergic effects, however, such use is hazardous and is not generally recommended. Diazepam may be given to control excitement. For patients with glaucoma, pilocarpine should be given locally. Cardiovascular complications should be treated according to usual therapeutic principles. In cases of respiratory paralysis, intubation and artificial respiration should be undertaken. Catheterisation may be required for urinary retention.
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Hyoscine hydrobromide. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Hyoscine 400 micrograms/ml Solution for Injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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