Hyoscine Hydrobromide 600 Mcg/Ml Solution For Injection
PACKAGE LEAFLET: INFORMATION FOR THE USER HYOSCINE HYDROBROMIDE 400 or 600 MICROGRAMS/ML SOLUTION FOR INJECTION
Hyoscine hydrobromide solution for injection Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Hyoscine Hydrobromide Solution for Injection. In the rest of this leaflet, it is called Hyoscine for Injection.
In this leaflet:
1. What Hyoscine for Injection is and what it is used for
2. What you need to know before you use Hyoscine for Injection
3. How to use Hyoscine for Injection
4. Possible side effects
5. How to store Hyoscine for Injection
6. Contents of the pack and further Information
1. WHAT HYOSCINE FOR INJECTION IS AND WHAT IT IS USED FOR
Hyoscine belongs to a group of medicines called anticholinergics. These:
• dry up secretions in your nose, throat and lungs
• prevent muscle spasms in your throat and lungs
• keep your heartbeat steady.
Thus you may be given Hyoscine for Injection before surgery (a pre-med) since it makes being put to sleep easier.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE HYOSCINE FOR INJECTION
You should not be given Hyoscine for Injection:
• if you are allergic to hyoscine 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)
•sufferfrom 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 prostate with urinary retention.
•suffer from an eye problem called angle-closure glaucoma
• are an elderly patient.
Warnings and precautions
Talk to your doctor or nurse before using Hyoscine for 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 •sufferfrom 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.
Product Summary
1. NAME OF THE MEDICINAL PRODUCT
Hyoscine Hydrobromide 400 micrograms/ml Solution for Injection
Hyoscine Hydrobromide 600 micrograms/ml Solution for Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
4. CLINICAL PARTICULARS
4.1 Therapeutic indication
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 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.
4.4 Special warnings and precautions for use
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-oespophageal reflux.
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 blood in your stool.
If any of the above statements applies to you, please speak to your doctor or nurse before being given Hyoscine for Injection.
After receiving hyoscine, you may be kept under observation. This is 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 for Injection
Taking another medicine while you are being given Hyoscine for Injection can increase its side effects. Tell your doctor if you are taking, have recently taken or might take any other medicine.
Examples of medicines that can increase the side effects of Hyoscine for Injection are:
• disopyramide, quinidine, medicines used to treat an irregular heart beat
•tiotropium, ipratropium, (atropine-like compounds); used to treat respiratory conditions such as COPD (Chronic Obstructive Pulmonary Disease) and asthma •tricyclic, and tetracyclic antidepressants plus monoamine oxidase inhibitors (MAOI); used to treat depression •antihistamines; used to treat hay fever and other allergies •metoclopramide and domperidone; used to relieve the symptoms of nausea and vomiting •phenothiazines, butyrophenones, clozapine; used to control nausea (feeling sick) and vomiting (being sick) and to treat mental illness
•amantadine; used for Parkinson’s disease and influenza.
Hyoscine for 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 for Injection may increase your heart rate if you take a drug such as salbutamol (or another beta agonist) for asthma.
Hyoscine for Injection with food, drink and alcohol
You should not drink alcohol while you are being given Hyoscine for Injection as it may cause drowsiness.
Pregnancy and Breastfeeding
Use of hyoscine during pregnancy may cause breathing problems in the newborn infant. Use during pregnancy and breast feeding is not recommended. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Driving and using machines
Hyoscine may cause drowsiness, dizziness or blurred vision. If affected, do not drive or operate any tools or machinery after you have been given Hyoscine for Injection.
3. HOW TO USE HYOSCINE FOR INJECTION
Adults
The recommended dose for adults is 200 to 600 micrograms injected under the skin or into a muscle approximately 30 to 60 minutes before you are given your anaesthetic for surgery.
If needed Hyoscine for Injection may be injected into a vein so it works more quickly.
Use in Children
The dose in children is usually 15 micrograms per kg body-weight (Use with caution in children as children are more susceptible to side effects). 103046/5
...........................>4
In case severe unexplained abdominal pain persists or worsens or occurs together with symptoms like fever, nausea, vomiting, changes in bowl 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.
4.5 Interactions 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 increase 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 may be 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 levodopa
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.
Elderly
Hyoscine is not recommended for use in older people
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.
If you use more Hyoscine for Injection than you should
If you think you have received more Hyoscine for Injection than you should, please tell your doctor or nurse immediately. Signs of an overdose include dilated pupils, a rapid heart beat, rapid breathing, abnormally high temperature, restlessness, excitement, confusion and hallucinations (seeing or hearing things that aren’t there).
If you have missed a dose of Hyoscine for Injection
If you think you have missed a dose of Hyoscine for Injection, please tell your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 for an allergic reaction:
-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 heart beat, unstable blood pressure, sweating and tremor. Other signs are faster
A risk to the breastfeeding child cannot be excluded. Use during breastfeeding is not recommended.
Fertility: No studies on the effects on human fertility 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 of 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
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.
4.9 Overdose
Symptoms:
Serious signs of poisoning following acute overdosage have not been observed in man. In the case of overdosage, anticholinergic symptoms such as urinary retention, dry mouth, 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 dilated pupils, hyperthermia, hyperpyrexia, hypertension, nausea and vomiting.
Toxic doses may also cause CNS stimulation marked by restlessness, confusion, excitement, ataxia, incoordination, paranoid and psychotic reactions, hallucinations, delirium, and occasionally seizures. In severe overdosage, central stimulation may give way to CNS depression, coma circulatory and respiratory failure and death.
Treatment:
In the unlikely event of overdosage, supportive therapy should be implemented. Physostigmineby slow intravenous injection in a dose of 1 to 4mg has been used to reverse the
breathing, muscle stiffness, 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 side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme
Website: http://www.mhra.gov.uk/ yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE HYOSCINE FOR INJECTION
Keep this medicine out of the sight and reach of children
Your doctor or nurse will usually be responsible for storing and preparing Hyoscine for Injection before use and for checking that the vials have not passed their expiry date.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
Hyoscine for Injection should not be stored above 25°C.
It should be stored in the original container in order to 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Hyoscine for Injection contains
Hyoscine for Injection contains the active ingredient hyoscine hydrobromide. Hyoscine for 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.
What Hyoscine for Injection looks like and contents of the pack
Hyoscine for Injection is a dear colourless solution. It is available in packs of 5 or 10 ampoules. Not all pack sizes may be marketed
Other formats
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
|
Product Name |
Reference Number |
|
Hyoscine Hydrobromide 400micrograms/ml Solution for Injection |
29831/0114 |
|
Hyoscine Hydrobromide 600micrograms/ml Solution for Injection |
29831/0115 |
This is a service provided by the Royal National Institute of Blind People.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: is Wockhardt UK Ltd,
Ash Road North, Wrexham LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham LL13 9UF, UK.
Date of leaflet revision: September 2015
fwOCRHARDT
103046/5
...........................->4
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.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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 Preclinical safety data
None stated
6. 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 25°C Store in the original container.
6.5 Nature and contents of container
1 ml neutral glass (Type I) ampoules in packs of 5 or 10.
6.6 Special precautions for disposal
None stated.
7. MARKETING AUTHORISATION HOLDER
Wockhardt UK Ltd Ash Road North Wrexham LL13 9UF UK
8. MARKETING AUTHORISATION NUMBER(S)
PL 29831/0114 PL 29831/0115
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21 April 2007
10. DATE OF REVISION OF THE TEXT
09/2015 fwOCKHARDT