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HYOSCINE 600 MICROGRAMS/ML SOLUTION FOR INJECTION

Active substance(s): HYOSCINE HYDROBROMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Hyoscine 400 micrograms/ml Solution for Injection
Hyoscine 600 micrograms/ml Solution for Injection

Hyoscine Hydrobromide

(Referred to as Hyoscine Injection in this leaflet)

D0386200000

Read all of this leaflet carefully before you are given
Hyoscine Injection
• Keep this leaflet, you may need to read it again
• If you have any further questions, please ask your doctor
or nurse
• If you get any side effects, talk to your doctor, pharmacist or
nurse . This includes any possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Hyoscine Injection is and what it is used for
What you need to know before Hyoscine Injection is given
How Hyoscine Injection is given
Possible side effects
How to store Hyoscine Injection
Contents of the pack and other information

1. What Hyoscine Injection is and what it is
used 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

3. How Hyoscine Injection is given
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)

4. 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.

5. How to store 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.

6. 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

Expand Transcript

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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