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 Down’s 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 Parkinson’s 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 25°C
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 25°C
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

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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