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HYOSCINE HYDROBROMIDE 400 MCG/ML SOLUTION FOR INJECTION

Active substance(s): HYOSCINE HYDROBROMIDE / HYOSCINE HYDROBROMIDE

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103046/4

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 either 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 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
Caution is necessary in treating patients with cardiovascular disease, gastrointestinal obstruction, paralytic ileus,
prostatic enlargement, Down’s Syndrome, myasthenia
gravis, renal or hepatic impairment. Increased seizure
frequency in epileptic patients.

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 medicinal products 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, hypersensitivity reactions (anaphylactic or anaphylactoid 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.


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.


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Michael.Casingena

Three

22/05/2013

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444215/450394

Pharma 188
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If you sign this proof you are signifying
full approval of design and text.

If needed Hyoscine for Injection may be injected into a vein so
it works more quickly.

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our client’s brief,
t
 he final responsibility must be taken by our client.

Adults
The usual 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.

UK

3. HOW HYOSCINE FOR INJECTION IS GIVEN

Market

You should not be given Hyoscine for Injection if you:
•  re hypersensitive (allergic) to hyoscine or any of the
a
other ingredients of Hyoscine for Injection (see section
‘What Hyoscine for Injection contains’)
• suffer from an eye problem called narrow angle glaucoma
• are an elderly patient.

8.5pt

In addition Hyoscine for Injection may reduce the effect of
nitrates placed under the tongue for heart pain.

Min. Point Size

2. BEFORE YOU ARE GIVEN HYOSCINE FOR
INJECTION

150 x 395mm

Thus you may be given Hyoscine for Injection before surgery (a pre-med) since it makes being put to sleep easier.

Size

Examples of medicines that can increase the side effects of
Hyoscine for Injection are:

-

Taking other medicines
Taking another medicine while you are being given
Hyoscine for Injection can increase its side effects Please
inform your doctor if you are taking, or have recently taken,
any other medicine, including those obtained without a
prescription.

Profile

Driving and using machines
Hyoscine may cause drowsiness. Do not drive or operate
any tools or machinery after you have been given Hyoscine
for Injection.

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Using Hyoscine for Injection with food and drink
You should not drink alcohol while you are being given
Hyoscine for Injection.

Item Code

Pregnancy
Use of hyoscine during pregnancy may cause breathing
problems in the newborn infant. Please ask your doctor or
nurse for advice.

•  isopyramide, a medicine used to treat an irregular
d
heart beat
• tricyclic and monoamine oxidase inhibitors (MAOI),
drugs used to treat depression
• antihistamines, used to treat hay fever and other allergies
•  henothiazines, used to control nausea (feeling sick) and
p
vomiting (being sick) and to treat mental illness
• amantadine, used for Parkinson’s disease and influenza.

Speak to your doctor before being given Hyoscine for
Injection if you:
• suffer from heart problems
• have a blocked or paralysed gut

Black

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 hearbeat steady.

Colours Used

1. WHAT HYOSCINE IS AND WHAT IT IS USED FOR

HYOSCINE HYDROBROMIDE 400 OR 600mg/ml

-  eep this leaflet. You may need to read it again.
K
- f you have further questions, please ask your doctor or
I
your nurse.
-  his medicine has been prescribed for you personally and
T
you should not pass it on to others. It may harm them,
even if their symptoms are the same as yours.

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 is and what it is used for
2. Before you are given Hyoscine for Injection
3. How Hyoscine for Injection is given
4. Possible side effects
5. How to store Hyoscine for Injection
6. Further Information

If any of the above statements applies to you, please speak
to your doctor or nurse before being given Hyoscine for
Injection.

Wockhardt

Read all of this
leaflet carefully
before you start
using this medicine.

Description

Hyoscine hydrobromide solution
for injection

• suffer from epilepsy, as there is an increased seizure
frequency in epileptic patients.
• are a man who has an enlarged prostate
• have Down’s Syndrome
• suffer from myasthenia gravis (extreme muscle weakness)
• suffer from liver or kidney problems

Customer

HYOSCINE HYDROBROMIDE 400 or 600
MICROGRAMS/ML SOLUTION FOR INJECTION

Measure bar should be 150mm at 100% scale

PACKAGE LEAFLET: INFORMATION FOR THE USER

5. HOW TO STORE HYOSCINE FOR INJECTION
Keep out of the reach and sight of children
Your doctor or nurse will usually be responsable for storing
and preparing Hyoscine for Injection before use and for
checking that the vials have not passed their expiry date.

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
1ml 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 29831/0115
PL 239831/0114
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
April 2008
10. DATE OF REVISION OF THE TEXT

Product Name

Reference
Number

Hyoscine Hydrobromide 400
micrograms/ml Solution for Injection

29831/0114

Hyoscine Hydrobromide 600
micrograms/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: May 2013

103046/4

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8.5pt

UK

English

Michael.Casingena

Three

22/05/2013

Min. Point Size

Market

Language

Proof By

Proof No.

Date

Artwork No.

150 x 395mm

444215/450394

Pharma 188
Code

-

-

-

-

-

-

-

Textfree area (Does not print)

Black

Keyline (Does not print)

Size

If you sign this proof you are signifying
full approval of design and text.

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 nurse.

Please be ready to give the following information:

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our client’s brief,
t
 he final responsibility must be taken by our client.

Other side effects include:
• slow heart beat
• mental confusion
• excitement

0800 198 5000 (UK Only)

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The most common side effects associated with hyoscine
are:
• drowsiness
• dry mouth
• dizziness
• blurred vision
• difficulty passing water.

Other formats
To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:

Profile

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
-collapse in hot weather due to decreased sweating

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Like all medicines, Hyoscine for Injection may cause side
effects, although not everybody gets them.

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 clear colourless solution. It is
available in packs of 5 or 10 ampoules. Not all pack sizes
may be marketed

Item Code

4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION

Measure bar should be 150mm at 100% scale

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.

HYOSCINE HYDROBROMIDE 400 OR 600mg/ml

Hyoscine for Injection
should not be stored
above 25°C. It should
Your doctor will decide the dose that is best for you. If you do be stored in the
not understand, or are in any doubt, ask your doctor or nurse. original container in
order to protect from
If you are given more Hyoscine for Injection than you
light.
should
If you think you have received more Hyoscine for Injection
Medicines should not
than you should, please tell your doctor or nurse immedibe disposed of via
ately. Signs of an overdose include dilated pupils, a rapid
wastewater or household waste. Ask your pharmacist
heart beat, rapid breathing, abnormally high temperature,
how to dispose of medicines no longer required. These
restlessness, excitement, confusion and hallucinations
measures will help to protect the environment.
(seeing or hearing things that aren’t there).

Description

Elderly
Hyoscine is not recommended for use in the elderly.

Wockhardt

Colours Used

Hyoscine for Injection should not be used after the expiry
date stated on the label. The expiry date refers to the last
day of that month.

Customer

Children
The dose in children is usually 15 micrograms per kg
bodyweight.

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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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