Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Hyoscine 400 micrograms/ml Solution for Injection

⚠ This medicine appears to have been discontinued

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.

Active substance: Hyoscine hydrobromide
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

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 move­ ments, stomach tenderness, fainting or blood in your stool. If any of the above statements applies to you, please speak to your doctor or nurse before being given Hyoscine Injection. After receiving Hyoscine Injection, you may be kept under observation. This is a normal procedure. If after receiving an injection of hyoscine you develop a painful, red eye with loss of vision please contact your doctor or nurse immediately. Other medicines and Hyoscine Injection Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular:
  • medicines used to treat an irregular heart beat e.g. disopyramide and quinidine.
  • medicines use to treat respiratory conditions such as COPD (Chronic Obstructive Pulmonary Disease) and asthma e.g. tiotropium and ipratropium.
  • medicines used to treat depression such as tricyclic and tetracyclic antidepressants.
  • medicines used to treat hay fever and other allergies e.g. antihistamines.
  • medicines used to relieve the symptoms of nausea and vomiting e.g. metoclopramide and domperidone.
  • medicines used to control nausea ( feeling sick) and vomiting (being sick) and to treat mental illness e.g. phenothiazines, butyrophenones and clozapine.
  • medicines used for Parkinson's disease and influenza e.g. amantadine. Hyoscine Injection may also reduce the effects of the following medicines:
  • levodopa – Used to treat Parkinson's disease
  • Nitrate (GTN)tablets – Used under the tongue for angina
  • Parasympathomimetics – Used to treat conditions such as glaucoma, depression, asthma, heart conditions and retention of urine. Hyoscine Injection and alcohol You are advised not to drink alcohol whilst being treated with Hyoscine Injection, as it may cause drowsiness. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine Use of Hyoscine Injection during pregnancy may cause breathing problems in the newborn infant. Use during pregnancy and breast feeding is not recommended. Driving and using machines Hyoscine Injection may cause drowsiness, dizziness or blurred vision. If affected, do not drive or operate any tools or machinery after you have been given Hyoscine Injection. Hyoscine contains Sodium This medicinal product contains 3.54mg/ml of sodium per dose. To be taken into consideration by patients on a controlled sodium diet

How to take it

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:

  • 200 micrograms as a single dose. Preventing excessive production of saliva if you have been given a general anaesthetic:
  • 200-600 micrograms given 30-60 minutes before the anaesthetic. Children over 4 months of age Treatment of nausea (feeling sick), vomiting (being sick), vertigo (feeling dizzy and light headed), loss of balance and motion sickness:
  • 6 micrograms per kg of body weight as a single dose. Preventing excessive production of saliva if you have been given a general anaesthetic:
  • 15 micrograms per kg of body weight given 30-60 minutes before the anaesthetic. Children (under 4 months) Not recommended. If you think you have been given too much Hyoscine Injection This medicine is given to you by your doctor so it is unlikely you will receive too much. Your doctor has information on how to recognise and treat an overdose. If you experience any of the following please speak to your doctor or nurse immediately:
  • dilated pupils
  • a rapid heartbeat
  • rapid breathing
  • abnormally high temperature
  • restlessness
  • excitement
  • confusion
  • hallucinations (seeing or hearing things that aren't there)

Possible side effects

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:

  • Serious allergic reaction, signs include skin rash, itching or hives, swelling of the face, lips, tongue or other parts of the body, difficulty breathing, feeling faint or dizzy. Cases including anaphylactic shock with a fatal outcome have been reported.
  • collapse in hot weather due to decreased sweating The most common side effects associated wIth hyoscine are:
  • drowsiness
  • dry mouth
  • dizziness
  • blurred vision
  • difficulty passing water.

Other side effects include:

  • headache
  • loss of consciousness
  • slow heart beat
  • excitement
  • psychotic disorder; this is an illness affecting mental health. You may experience delusions (believing things which are not true), hallucinations (seeing and possibly hearing or smelling things that are not really there) or lose touch with reality.
  • confusion/delirium
  • hallucinations
  • dilation of the pupils
  • sensitivity to light
  • angle-closure glaucoma (red, painful eye)
  • heart problems
  • racing heart, and/or palpitations
  • irregular heart beat
  • flushing
  • decrease in blood pressure
  • constipation
  • nausea
  • vomiting
  • difficulty in swallowing
  • dyshidrosis: also known as 'pompholyx' or 'dyshidrotic eczema', is a skin condition which small, fluid-filled blisters appear on the fingers, palms of the hand, and sometimes on the soles of the feet. The blisters can be very itchy and painful and when they begin to heal and dry up, the skin can become cracked or scaly
  • skin dryness
  • pain at the site of injection (particularly after intramuscular use)
  • thirst
  • Neuroleptic malignant syndrome: this is a serious and potentially life-threatening condition. The signs may include a high fever, fast heartbeat, unstable blood pressure, sweating and tremor. Other signs are faster breathing, muscle stttfness, agitation and reduced consciousness. The level of an enzyme called creatine phosphokinase may be raised in your blood which suggests damage to muscles. 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 a www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

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.

Contents of the pack and other information

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

Frequently asked questions about Hyoscine 400 micrograms/ml Solution for Injection

How do I take Hyoscine 400 micrograms/ml Solution for Injection?

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.

What is the active substance in Hyoscine 400 micrograms/ml Solution for Injection?

The active substance in Hyoscine 400 micrograms/ml Solution for Injection is hyoscine hydrobromide.

Where does this information come from?

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.

Can I get Hyoscine 400 micrograms/ml Solution for Injection without a prescription?

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.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Hyoscine hydrobromide (5 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

a. Nausea, vomiting, vertigo, labyrinthine disorders, motion sickness

b. 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, 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.

4.4. Special warnings and precautions for use

• 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

4.5. Interaction with other medicinal products and other forms of interaction

• 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

.

4.6. Fertility, pregnancy and lactation

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

4.7. Effects on ability to drive and use machines

Hyoscine may cause drowsiness, dizziness or blurred vision. If affected, patients must not drive or operate machinery.

4.8. Undesirable effects

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.

.

4.9. Overdose

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.

🇵🇱 Known in Poland as

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.

  • Buscolysin partial — not the same combinationHyoscini butylbromidum · injection / infusion
  • Scopolamine butylbromide Kalceks partial — not the same combinationHyoscini butylbromidum · injection / infusion
  • Buscopan Compositum Vet partial — not the same combinationHyoscini butylbromidum (Scopolamini butylbromidum) + Metamizolum natricum · injection / infusion
  • Spasmalgan compositum partial — not the same combinationMetamizolum natricum monohydricum + Hyoscini butylbromidum · injection / infusion
  • Sympagesic partial — not the same combinationMetamizolum natricum monohydricum + Hyoscini butylbromidum · injection / infusion
  • Spasmium comp. partial — not the same combinationMetamizolum natricum + Hyoscini butylbromidum · injection / infusion

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 about this leaflet

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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