HYOSCINE HYDROBROMIDE 600 MCG/ML SOLUTION FOR INJECTION
Active substance: HYOSCINE HYDROBROMIDE
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Hyoscine Hydrobromide Solution for Injection Technical Leaflet Draft HYOSCINE HYDROBROMIDE 400 or 600 MICROGRAMS/ML SOLUTION FOR INJECTION Hyoscine hydrobromide solution for injection PACKAGE LEAFLET Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. In this leaflet: 1. What Hyoscine is and what it is used for 2. Before you are given Hyoscine Hydrobromide Solution for Injection 3. How Hyoscine Hydrobromide Solution for Injection is given 4. Possible side effects 5. Storing Hyoscine Hydrobromide Solution for Injection 1. WHAT HYOSCINE IS AND WHAT IT IS USED FOR
Hyoscine belongs to a group of medicines called antispasmodics, which prevent or relieve muscle spasms. You may be given hyoscine injection before surgery to control muscle spasms which could affect your breathing or your heart. 2. BEFORE YOU ARE GIVEN HYOSCINE HYDROBROMIDE SOLUTION FOR INJECTION
You should not be given Hyoscine Hydrobromide Solution for Injection: if you are hypersensitive (allergic) to hyoscine or any of the other ingredients of Hyoscine Hydrobromide injection. if you suffer from an eye problem called narrow angle glaucoma.
Special care should be taken with Hyoscine Hydrobromide Solution for Injection: if you suffer from heart problems if you have a blocked or paralysed gut if you are a man who has an enlarged prostate If you have Downs Syndrome If you suffer from myasthenia gravis (extreme muscle weakness) If you suffer from liver or kidney problems Pregnancy Hyoscine is not normally recommended for use in pregnancy; please ask your doctor or pharmacist for advice.
Hyoscine Hydrobromide Solution for Injection Technical Leaflet Draft
Driving and using machines: Hyoscine may cause drowsiness. Do not drive or operate any tools or machinery after you have been given hyoscine. Taking other medicines: Taking another medicine while you are being given Hyoscine Hydrobromide Solution for Injection can affect how it or the other medicine works. Please inform your doctor if you are taking, or have recently taken, any other medicine, even those not prescribed. Examples of medicines that can affect Hyoscine Hydrobromide Solution for Injection are :Drugs used to treat heart problems such as disopyramide and nitrates. Tricyclic and MAOI drugs, used to treat depression Antihistamines, used to treat hayfever and other allergies Phenothiazines, used to control nausea (feeling sick) and vomiting and to treat mental illness. Amantadine, used for Parkinsons disease and influenza You should not drink alcohol while you are being given hyoscine 3. HOW HYOSCINE HYDROBROMIDE SOLUTION FOR INJECTION IS GIVEN The usual dose in adults is 200 to 600 micrograms injected subcutaneously (under the skin) or intramuscularly (into a muscle) approximately 30 to 60 minutes before you are given your anaesthetic for surgery. In emergencies hyoscine may be injected into a vein so it works more quickly. The dose in children is usually 15 micrograms per kg bodyweight, injected under the skin, into a muscle or a vein. Hyoscine is not recommended for use in the elderly. Your doctor will decide the dose that is best for you. If you do not understand, or are in any doubt, ask your doctor or nurse. 4. POSSIBLE SIDE EFFECTS
Like all medicines, Hyoscine Hydrobromide Solution for Injection can have side effects. The most common side effects associated with hyoscine are drowsiness, dry mouth, dizziness, blurred vision and difficulty passing water.
Hyoscine Hydrobromide Solution for Injection Technical Leaflet Draft Rarely, slow heart beat, mental confusion, excitement and allergic reactions have been reported. If you notice any side effects not mentioned in this leaflet or feel that the medicine has affected you badly in any way, please inform your doctor or pharmacist. 5. STORING HYOSCINE HYDROBROMIDE SOLUTION FOR INJECTION
Keep out of the reach and sight of children Hyoscine hydrobromide should not be stored above 25C It should be stored in the original container in order to protect from light. It should not be used after the expiry date stated on the label. This leaflet was last approved on December 2006 6. FURTHER INFORMATION
Hyoscine Hydrobromide Solution for Injection contains the active ingredient hyoscine hydrobromide. The injection is available in two strengths, 400 micrograms/ml and 600 micrograms/ml. Other ingredients include hydrobromic acid (47%), sodium hydroxide and water for injections. The injection is a sterile solution for injection. Manufactured by Wockhardt UK Holdings Ltd, Ash Road North, Wrexham, LL13 9UF, UK. The Product Licence holder is Wockhardt UK Ltd, Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, UK. For any information about this medicinal product, please contact the Medical Information Department of CP Pharmaceuticals Ltd, Ash Road North, Wrexham LL13 9UF. Tel: 01978 661261 --------------------------------------------------------------------------------------------------SUMMARY OF PRODUCT CHARACTERISTICS Product Summary 1. Trade Name of Medicinal Product Hyoscine Hydrobromide 400 micrograms/ml Solution for Injection Hyoscine Hydrobromide 600 micrograms/ml Solution for Injection 2. Qualitative and quantitative Composition
Hyoscine Hydrobromide Solution for Injection Technical Leaflet Draft
Each 1ml ampoule contains 400 or 600 micrograms of hyoscine hydrobromide. For excipients, see 6.1. 3. Pharmaceutical Form Solution for Injection. A clear colourless solution, practically free from particles. Clinical Particulars 4.1 Therapeutic Indications Due to its anticholinergic activity, hyoscine injection is used as a preoperative medication to control bronchial, nasal, pharyngeal and salivary secretions, to prevent bronchospasm and laryngospasm and to block cardiac vagal inhibiting reflexes during induction of anaesthesia and intubation. 4.2 Posology and Method of Administration Dosage Adults For pre-medication a dose of 200 to 600 micrograms is given by the subcutaneous or intramuscular route 30 to 60 minutes before induction of anaesthesia. The injection may if required also be given by the intravenous route for acute use. Children A dose of 15 micrograms/kg is recommended in children. Elderly Hyoscine is not recommended for use in the elderly. 4.3 Contraindications Hypersensitivity to hyoscine. Narrow angle glaucoma. 4.4 Special Warnings and Precautions for Use
Hyoscine Hydrobromide Solution for Injection Technical Leaflet Draft Caution is necessary in treating patients with cardiovascular disease, gastrointestinal obstruction, paralytic ileus, prostatic enlargement, Down's Syndrome, myasthenia gravis, renal or hepatic impairment. Because hyoscine may cause drowsiness, patients must not drive or operate machinery. Patients should avoid alcohol. Heat prostration can occur at high ambient temperatures, due to decreased sweating. 4.5 Interactions with other medicaments and other forms of interaction The antimuscarinic side-effects can be increased by concomitant administration of disopyramide, tricyclic and MAOI drugs, antihistamines, phenothiazines, amantadine and alcohol. Reduced effect of sub-lingual nitrates. 4.6 Pregnancy and Lactation Use of hyoscine during pregnancy may cause respiratory depression in the neonate, and should only be given during pregnancy when the potential benefit clearly outweighs the foetal hazard. 4.7 Effects on Ability to Drive and Use Machines Because hyoscine may cause drowsiness, patients must not drive or operate machinery. 4.8 Undesirable Effects The most common side effects are drowsiness, dry mouth, dizziness, blurred vision and difficulty with micturition. Other reported effects include bradycardia, idiosyncratic reactions and mental confusion or excitement. 4.9 Overdose Symptoms of overdose may include dilated pupils, tachycardia, rapid respiration, hyperpyrexia, restlessness, excitement, delirium and hallucinations. In the unlikely event of overdosage, supportive therapy should be implemented. Physostigmine by slow intravenous injection in a dose of 1 to 4mg has been used to reverse the anticholinergic effects, but this drug is rapidly metabolised. Neostigmine by slow intravenous injection in a dose of 0.5 to 2 mg antagonises only the peripheral effects. Diazepam may be given to control excitement. Pharmacological Properties 5.1 Pharmacodynamic Properties
Hyoscine Hydrobromide Solution for Injection Technical Leaflet Draft
Hyoscine is an anticholinergic drug which inhibits the muscarinic actions of acetylcholine at post-ganglionic parasympathetic neuroeffector sites including smooth muscle, secretory glands and CNS sites. Small doses effectively inhibit salivary and bronchial secretions and sweating and provide a degree of amnesia. Hyoscine is a more powerful suppressor of salivation than atropine and usually slows rather than increases heart rate. 5.2 Pharmacokinetic Properties Hyoscine is rapidly absorbed following IV or IM injection and is reversibly bound to plasma protein. Hyoscine is reported to cross the placenta and blood brain barrier. Hyoscine is almost completely metabolised by the liver and excreted in the urine. In one study in man, 3.4% of a single dose, administered by subcutaneous injection was excreted unchanged in urine within 72 hours. 5.3 Pre-clinical safety data None stated Pharmaceutical Particulars 6.1 List of Excipients Hydrobromic acid (47%) Sodium hydroxide Water for injections 6.2 Incompatibilities None stated 6.3 Shelf Life 24 months 6.4 Special Precautions for Storage Do not store above 25C Store in the original container. 6.5 Nature and Contents of Container 1ml neutral glass (Type I) ampoules in packs of 5 or 10. 6.6 Instructions for Use/Handling
Hyoscine Hydrobromide Solution for Injection Technical Leaflet Draft
None stated. Administrative Data 7. Marketing Authorisation Holder Wockhardt UK Ltd Ash Road North Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom 8. Marketing Authorisation Number 400mcg : PL 29831/0114 600mcg : PL 29831/0115 9. Date of first authorisation/renewal of authorisation 1 December 2006 10. Date of (partial) Revision of Text 1 December 2006
Hyoscine belongs to a group of medicines called antispasmodics, which prevent or relieve muscle spasms. You may be given hyoscine injection before surgery to control muscle spasms which could affect your breathing or your heart. 2. BEFORE YOU ARE GIVEN HYOSCINE HYDROBROMIDE SOLUTION FOR INJECTION
You should not be given Hyoscine Hydrobromide Solution for Injection: if you are hypersensitive (allergic) to hyoscine or any of the other ingredients of Hyoscine Hydrobromide injection. if you suffer from an eye problem called narrow angle glaucoma.
Special care should be taken with Hyoscine Hydrobromide Solution for Injection: if you suffer from heart problems if you have a blocked or paralysed gut if you are a man who has an enlarged prostate If you have Downs Syndrome If you suffer from myasthenia gravis (extreme muscle weakness) If you suffer from liver or kidney problems Pregnancy Hyoscine is not normally recommended for use in pregnancy; please ask your doctor or pharmacist for advice.
Hyoscine Hydrobromide Solution for Injection Technical Leaflet Draft
Driving and using machines: Hyoscine may cause drowsiness. Do not drive or operate any tools or machinery after you have been given hyoscine. Taking other medicines: Taking another medicine while you are being given Hyoscine Hydrobromide Solution for Injection can affect how it or the other medicine works. Please inform your doctor if you are taking, or have recently taken, any other medicine, even those not prescribed. Examples of medicines that can affect Hyoscine Hydrobromide Solution for Injection are :Drugs used to treat heart problems such as disopyramide and nitrates. Tricyclic and MAOI drugs, used to treat depression Antihistamines, used to treat hayfever and other allergies Phenothiazines, used to control nausea (feeling sick) and vomiting and to treat mental illness. Amantadine, used for Parkinsons disease and influenza You should not drink alcohol while you are being given hyoscine 3. HOW HYOSCINE HYDROBROMIDE SOLUTION FOR INJECTION IS GIVEN The usual dose in adults is 200 to 600 micrograms injected subcutaneously (under the skin) or intramuscularly (into a muscle) approximately 30 to 60 minutes before you are given your anaesthetic for surgery. In emergencies hyoscine may be injected into a vein so it works more quickly. The dose in children is usually 15 micrograms per kg bodyweight, injected under the skin, into a muscle or a vein. Hyoscine is not recommended for use in the elderly. Your doctor will decide the dose that is best for you. If you do not understand, or are in any doubt, ask your doctor or nurse. 4. POSSIBLE SIDE EFFECTS
Like all medicines, Hyoscine Hydrobromide Solution for Injection can have side effects. The most common side effects associated with hyoscine are drowsiness, dry mouth, dizziness, blurred vision and difficulty passing water.
Hyoscine Hydrobromide Solution for Injection Technical Leaflet Draft Rarely, slow heart beat, mental confusion, excitement and allergic reactions have been reported. If you notice any side effects not mentioned in this leaflet or feel that the medicine has affected you badly in any way, please inform your doctor or pharmacist. 5. STORING HYOSCINE HYDROBROMIDE SOLUTION FOR INJECTION
Keep out of the reach and sight of children Hyoscine hydrobromide should not be stored above 25C It should be stored in the original container in order to protect from light. It should not be used after the expiry date stated on the label. This leaflet was last approved on December 2006 6. FURTHER INFORMATION
Hyoscine Hydrobromide Solution for Injection contains the active ingredient hyoscine hydrobromide. The injection is available in two strengths, 400 micrograms/ml and 600 micrograms/ml. Other ingredients include hydrobromic acid (47%), sodium hydroxide and water for injections. The injection is a sterile solution for injection. Manufactured by Wockhardt UK Holdings Ltd, Ash Road North, Wrexham, LL13 9UF, UK. The Product Licence holder is Wockhardt UK Ltd, Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, UK. For any information about this medicinal product, please contact the Medical Information Department of CP Pharmaceuticals Ltd, Ash Road North, Wrexham LL13 9UF. Tel: 01978 661261 --------------------------------------------------------------------------------------------------SUMMARY OF PRODUCT CHARACTERISTICS Product Summary 1. Trade Name of Medicinal Product Hyoscine Hydrobromide 400 micrograms/ml Solution for Injection Hyoscine Hydrobromide 600 micrograms/ml Solution for Injection 2. Qualitative and quantitative Composition
Hyoscine Hydrobromide Solution for Injection Technical Leaflet Draft
Each 1ml ampoule contains 400 or 600 micrograms of hyoscine hydrobromide. For excipients, see 6.1. 3. Pharmaceutical Form Solution for Injection. A clear colourless solution, practically free from particles. Clinical Particulars 4.1 Therapeutic Indications Due to its anticholinergic activity, hyoscine injection is used as a preoperative medication to control bronchial, nasal, pharyngeal and salivary secretions, to prevent bronchospasm and laryngospasm and to block cardiac vagal inhibiting reflexes during induction of anaesthesia and intubation. 4.2 Posology and Method of Administration Dosage Adults For pre-medication a dose of 200 to 600 micrograms is given by the subcutaneous or intramuscular route 30 to 60 minutes before induction of anaesthesia. The injection may if required also be given by the intravenous route for acute use. Children A dose of 15 micrograms/kg is recommended in children. Elderly Hyoscine is not recommended for use in the elderly. 4.3 Contraindications Hypersensitivity to hyoscine. Narrow angle glaucoma. 4.4 Special Warnings and Precautions for Use
Hyoscine Hydrobromide Solution for Injection Technical Leaflet Draft Caution is necessary in treating patients with cardiovascular disease, gastrointestinal obstruction, paralytic ileus, prostatic enlargement, Down's Syndrome, myasthenia gravis, renal or hepatic impairment. Because hyoscine may cause drowsiness, patients must not drive or operate machinery. Patients should avoid alcohol. Heat prostration can occur at high ambient temperatures, due to decreased sweating. 4.5 Interactions with other medicaments and other forms of interaction The antimuscarinic side-effects can be increased by concomitant administration of disopyramide, tricyclic and MAOI drugs, antihistamines, phenothiazines, amantadine and alcohol. Reduced effect of sub-lingual nitrates. 4.6 Pregnancy and Lactation Use of hyoscine during pregnancy may cause respiratory depression in the neonate, and should only be given during pregnancy when the potential benefit clearly outweighs the foetal hazard. 4.7 Effects on Ability to Drive and Use Machines Because hyoscine may cause drowsiness, patients must not drive or operate machinery. 4.8 Undesirable Effects The most common side effects are drowsiness, dry mouth, dizziness, blurred vision and difficulty with micturition. Other reported effects include bradycardia, idiosyncratic reactions and mental confusion or excitement. 4.9 Overdose Symptoms of overdose may include dilated pupils, tachycardia, rapid respiration, hyperpyrexia, restlessness, excitement, delirium and hallucinations. In the unlikely event of overdosage, supportive therapy should be implemented. Physostigmine by slow intravenous injection in a dose of 1 to 4mg has been used to reverse the anticholinergic effects, but this drug is rapidly metabolised. Neostigmine by slow intravenous injection in a dose of 0.5 to 2 mg antagonises only the peripheral effects. Diazepam may be given to control excitement. Pharmacological Properties 5.1 Pharmacodynamic Properties
Hyoscine Hydrobromide Solution for Injection Technical Leaflet Draft
Hyoscine is an anticholinergic drug which inhibits the muscarinic actions of acetylcholine at post-ganglionic parasympathetic neuroeffector sites including smooth muscle, secretory glands and CNS sites. Small doses effectively inhibit salivary and bronchial secretions and sweating and provide a degree of amnesia. Hyoscine is a more powerful suppressor of salivation than atropine and usually slows rather than increases heart rate. 5.2 Pharmacokinetic Properties Hyoscine is rapidly absorbed following IV or IM injection and is reversibly bound to plasma protein. Hyoscine is reported to cross the placenta and blood brain barrier. Hyoscine is almost completely metabolised by the liver and excreted in the urine. In one study in man, 3.4% of a single dose, administered by subcutaneous injection was excreted unchanged in urine within 72 hours. 5.3 Pre-clinical safety data None stated Pharmaceutical Particulars 6.1 List of Excipients Hydrobromic acid (47%) Sodium hydroxide Water for injections 6.2 Incompatibilities None stated 6.3 Shelf Life 24 months 6.4 Special Precautions for Storage Do not store above 25C Store in the original container. 6.5 Nature and Contents of Container 1ml neutral glass (Type I) ampoules in packs of 5 or 10. 6.6 Instructions for Use/Handling
Hyoscine Hydrobromide Solution for Injection Technical Leaflet Draft
None stated. Administrative Data 7. Marketing Authorisation Holder Wockhardt UK Ltd Ash Road North Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom 8. Marketing Authorisation Number 400mcg : PL 29831/0114 600mcg : PL 29831/0115 9. Date of first authorisation/renewal of authorisation 1 December 2006 10. Date of (partial) Revision of Text 1 December 2006
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
