BUSCOPAN AMPOULES 20MG/ML

Professional Leaflet

Buscopan® Ampoules
20 mg/ml Solution
for Injection

abcd

(hyoscine butylbromide)
Trade name of the medicinal product
BUSCOPAN Ampoules 20 mg/ml solution for injection.
Qualitative and quantitative composition
Each 1 ml ampoule contains 20 mg hyoscine butylbromide. For
excipients, see List of excipients
Pharmaceutical form
Solution for injection. A colourless or almost colourless, clear
solution.
Clinical particulars
Therapeutic indications
BUSCOPAN Ampoules are indicated in acute spasm, as in renal or
biliary colic, in radiology for differential diagnosis of obstruction
and to reduce spasm and pain in pyelography, and in other
diagnostic procedures where spasm may be a problem, e.g. gastroduodenal endoscopy.
Posology and method of administration
Adults: One ampoule (20 mg) intramuscularly or intravenously,
repeated after half an hour if necessary. Intravenous injection
should be performed ‘slowly’, (in rare cases a marked drop in blood
pressure and even shock may be produced by BUSCOPAN). When
used in endoscopy this dose may need to be repeated more frequently.
Maximum daily dose of 100 mg.
Special populations
Elderly:
No specific information on the use of this product in the elderly is
available. Clinical trials have included patients over 65 years and
no adverse reactions specific to this age group have been reported.
Paediatric population
Not recommended for children
BUSCOPAN Ampoules should not be taken on a continuous daily
basis or for extended periods without investigating the cause of
abdominal pain.
Diluent: BUSCOPAN injection solution may be diluted with
dextrose or with sodium chloride 0.9% injection solutions.
Contraindications
BUSCOPAN Ampoules should not be administered to patients with
myasthenia gravis, megacolon, narrow angle glaucoma, tachycardia,
prostatic enlargement with urinary retention, mechanical stenoses
in the region of the gastrointestinal tract or paralytic ileus.
BUSCOPAN should not be used in patients who have demonstrated
prior hypersensitivity to hyoscine butylbromide or any other
component of the product.
BUSCOPAN Ampoules should not be given by intramuscular
injection to patients being treated with anticoagulant drugs since
intramuscular haematoma may occur.
Special warnings and precautions for use
In case severe, unexplained abdominal pain persists or worsens, or
occurs together with symptoms like fever, nausea, vomiting,
changes in bowel movements, abdominal tenderness, decreased
blood pressure, fainting, or blood in stool, appropriate diagnostic
measures are needed to investigate the etiology of the symptoms.
BUSCOPAN Ampoules can cause tachycardia, hypotension, and
anaphylaxis, therefore use with caution in patients with cardiac
conditions, such as cardiac failure, coronary heart disease, cardiac
arrhythmia or hypertension, and in cardiac surgery. Monitoring of
these patients is advised. Emergency equipment and personnel
trained in its use must be readily available.
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Because of the possibility that anticholinergics may reduce
sweating, BUSCOPAN should be administered with caution to
patients with pyrexia.
Elevation of intraocular pressure may be produced by the
administration of anticholinergic agents such as BUSCOPAN in
patients with undiagnosed and therefore untreated narrow angle
glaucoma. Therefore, patients should seek urgent
ophthalmological advice in case they should develop a painful, red
eye with loss of vision after the injection of BUSCOPAN.
After parenteral administration of BUSCOPAN, cases of
anaphylaxis including episodes of shock have been observed. As
with all drugs causing such reactions, patients receiving
BUSCOPAN by injection should be kept under observation.
Interaction with other medicinal products and other forms
of interaction
The anticholinergic effect of drugs such as tri- and tetracyclic
antidepressants, antihistamines, quinidine, amantadine,
antipsychotics (e.g. phenothiazines, butyrophenones),
disopyramide and other anticholinergics (e.g. tiotropium,
ipratropium, atropine-like compounds) may be intensified by
BUSCOPAN. The tachycardic effects of beta-adrenergic agents may
be enhanced by BUSCOPAN.
Concomitant treatment with dopamine antagonists such as
metoclopramide may result in diminution of the effects of both
drugs on the gastrointestinal tract.
Fertility, pregnancy and lactation
Pregnancy
There are limited data from the use of hyoscine butylbromide in
pregnant women. Animal studies are insufficient with respect to
reproductive toxicity (see Pre-clinical safety data). As a
precautionary measure BUSCOPAN is not recommended during
pregnancy.
Lactation
There is insufficient information on the excretion of hyoscine
butylbromide and its metabolites in human milk. A risk to the
breastfeeding child cannot be excluded. Use of BUSCOPAN during
breastfeeding is not recommended
Fertility
No studies on the effects on human fertility have been conducted.
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines
have been performed. However, patients should be advised that
they may experience undesirable effects such as accommodation
disorder or dizziness during treatment with BUSCOPAN Ampoules.
Therefore, caution should be recommended when driving a car or
operating machinery. If patients experience accommodation
disorder or dizziness, they should avoid potentially hazardous
tasks such as driving or operating machinery.
Undesirable effects
Many of the listed undesirable effects can be assigned to the
anticholinergic properties of BUSCOPAN. Adverse events have
been ranked under headings of frequency using the following
convention:
Very common
Common
Uncommon
Rare
Very rare
Not known


≥ 1/10
≥ 1/100, < 1/10
≥ 1/1,000, <1/100
≥ 1/10,000, <1/1,000
<1/10,000
cannot be estimated
from the available data
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Immune system disorders
Not known*: anaphylactic shock including cases with fatal
outcome, anaphylactic reactions, dyspnoea, skin reactions (e.g.
urticaria, rash, erythema, pruritus) and other hypersensitivity.
Eye disorders
Common: accommodation disorders
Not known*: mydriasis, increased intraocular pressure
Cardiac disorders
Common: tachycardia
Vascular disorders
Common: dizziness
Not known*: blood pressure decreased, flushing
Gastrointestinal disorders
Common: dry mouth
Constipation
Skin and subcutaneous tissue disorders
Not known*: dyshidrosis
Renal and urinary disorders
Not known*: urinary retention
Injection site pain, particularly after intramuscular use, occurs.
Hyoscine butylbromide, the active ingredient of BUSCOPAN, due to
its chemical structure as a quaternary ammonium derivate, is not
expected to enter the central nervous system. Hyoscine
butylbromide does not readily pass the blood-brain barrier.
However, it cannot totally be ruled out that under certain
circumstances psychiatric disorders (e.g. confusion) may also
occur after administration of BUSCOPAN.
*This adverse reaction has been observed in post-marketing
experience. With 95% certainty, the frequency category is not
greater than common, but might be lower. A precise frequency
estimation is not possible as the adverse drug reaction did not
occur in a clinical trial database of 185 patients.
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:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie ; E-mail: [email protected].

Pharmacokinetic properties
Absorption and distribution
After intravenous administration hyoscine butylbromide is rapidly
distributed (t½α = 4 min, t½β = 29 min) into the tissues. The
volume of distribution (Vss) is 128 L (corresponding to approx.
1.7 L/kg). Because of its high affinity for muscarinic receptors and
nicotinic receptors, hyoscine butylbromide is mainly distributed on
muscle cells of the abdominal and pelvic area as well as in the
intramural ganglia of the abdominal organs. Plasma protein
binding (albumin) of hyoscine butylbromide is approximately
4.4%. Animal studies demonstrate that hyoscine butylbromide
does not pass the blood-brain barrier, but no clinical data to this
effect is available. Hyoscine butylbromide (1 mM) has been
observed to interact with the choline transport (1.4 nM) in
epithelial cells of human placenta in vitro.
Metabolism and elimination
The main metabolic pathway is the hydrolytic cleavage of the ester
bond. The half-life of the terminal elimination phase (t½γ) is
approximately 5 hours. The total clearance is 1.2 L/min. Clinical
studies with radiolabeled hyoscine butylbromide show that after
intravenous injection 42 to 61% of the radioactive dose is excreted
renally and 28.3 to 37% faecally.
The portion of unchanged active ingredient excreted in the urine is
approximately 50%. The metabolites excreted via the renal route
bind poorly to the muscarinic receptors and are therefore not
considered to contribute to the effect of the hyoscine butylbromide.
Paediatric population
No particular pharmacokinetic studies concerning hyoscine
butylbromide have been performed in children.
Pre-clinical safety data
In limited reproductive toxicity studies hyoscine butylbromide
showed no evidence of teratogenicity in rats at 200 mg/kg in the
diet or in rabbits at 200 mg/kg by oral gavage or 50 mg/kg by
subcutaneous injection. Fertility in the rat was not impaired at
doses up to 200 mg/kg in the diet.
Pharmaceutical particulars
List of excipients
Sodium chloride
Water for injections
Incompatibilities
None known
Shelf life
Unopened: 5 years
Once opened, use immediately and discard any unused contents.

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, and Cheynes-Stokes respiration has been reported.

Special precautions for storage
Store below 30˚C
Store in the outer carton in order to protect from light.

Therapy: Symptoms of BUSCOPAN overdosage respond to
parasympathomimetics. For patients with glaucoma, pilocarpine
should be given locally. Cardiovascular complications should be
treated according to usual therapeutic principles. In case of
respiratory paralysis, intubation and artificial respiration.
Catheterisation may be required for urinary retention.

Instructions for use/handling
For single use only. Any unused solution should be discarded.

In addition, appropriate supportive measures should be used as
required.

Marketing Authorisation Number
PL 00015/5005R
PA 7/16/2

Pharmacological properties
Pharmacodynamic properties
BUSCOPAN is an antispasmodic agent which relaxes smooth
muscle of the organs of the abdominal and pelvic cavities. It is
believed to act predominantly on the intramural parasympathetic
ganglia of these organs.

Nature and contents of container
1 ml clear glass (Ph. Eur. Type I) ampoules marketed in cartons
containing 10 ampoules.

Marketing Authorisation Holder
Boehringer Ingelheim Limited, Ellesfield Avenue, Bracknell,
Berkshire, RG12 8YS, United Kingdom.

Manufacturer of the product
Boehringer Ingelheim España, S.A.
Prat de la Riba, 50, 08174 Sant Cugat del Vallès, Barcelona, Spain
Legal Category
POM / S1B
Date of revision of the text
This Professional Leaflet was revised in November 2016.
© Boehringer Ingelheim Limited 2016

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Package Leaflet: Information for the user

Buscopan® Ampoules
20 mg/ml Solution
for Injection

abcd

(hyoscine butylbromide)
Read all of this leaflet carefully before you start taking
this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets troublesome or serious,
or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Take special care with BUSCOPAN Ampoules
Check with your doctor or pharmacist before having this
medicine if:
• You have any heart problems
• You have a fever
• You have problems with your thyroid gland such as an
overactive thyroid gland

In this leaflet:
1. What BUSCOPAN Ampoules are and what they are
used for
2. Before you receive BUSCOPAN Ampoules
3. How BUSCOPAN Ampoules will be given
4. Possible side effects
5. How to store BUSCOPAN Ampoules
6. Further information

Check with your doctor or pharmacist straight away if
you have unexplained abdominal pain which persists or
worsens or occurs with:
• fever
• feeling sick
• being sick
• changes in your bowel movements
• abdominal tenderness
• low blood pressure
• feeling faint or,
• blood in your bowel movements

1. WHAT BUSCOPAN AMPOULES ARE AND WHAT
THEY ARE USED FOR
The name of your medicine is BUSCOPAN Ampoules
20 mg/ml Solution for injection (called BUSCOPAN
Ampoules in this leaflet).
BUSCOPAN Ampoules contain a medicine called
‘hyoscine butylbromide’. This belongs to a group of
medicines called ‘antispasmodics’.
BUSCOPAN Ampoules are used to relieve cramps in the
muscles of your:
• Stomach
• Gut (intestine)
• Bladder and the tubes leading to the outside of your
body (urinary system)
BUSCOPAN Ampoules can also be used in some
diagnostic and therapeutic medical procedures where
spasm may be a problem for example barium enema.
2. BEFORE YOU RECEIVE BUSCOPAN AMPOULES
You should not be given BUSCOPAN Ampoules if:
• You are allergic (hypersensitive) to hyoscine
butylbromide or any of the other ingredients
(listed in Section 6)
• You have glaucoma (an eye problem)
• You have megacolon (a very enlarged bowel)
• You have something called ‘myasthenia gravis’
(a very rare muscle weakness problem)
• You have a very fast heart rate
• You have difficulty or pain passing water (urine)
such as men with prostate problems
• You have gut blockage problems or a totally inactive
gut
• You are pregnant, likely to get pregnant or are
breast-feeding
You should not receive this medicine if any of the above
apply to you. If you are not sure, talk to your doctor or
pharmacist before taking this medicine.

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If you are not sure if any of the above apply to you, talk
to your doctor or pharmacist before receiving
BUSCOPAN Ampoules.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines. This includes
medicines obtained without a prescription and herbal
medicines. This is because BUSCOPAN Ampoules can
affect the way some other medicines work. Also some
other medicines can affect the way BUSCOPAN
Ampoules work.
In particular tell your doctor or pharmacist if you are
taking any of the following:
• Medicines for depression called ‘tetracyclic
antidepressants’ or ‘tricyclic antidepressants’ such as
doxepin
• Medicines for allergies and travel sickness called
‘antihistamines’
• Medicines to control your heart beat such as quinidine
or disopyramide
• Medicines for severe mental illness such as haloperidol
or fluphenazine
• Medicines usually used for breathing problems such as
salbutamol, ipratropium, tiotropium or atropine-like
medicines
• Amantadine - for Parkinson’s disease and flu
• Metoclopramide - for feeling sick (nausea)
If you are not sure if any of the above apply to you, talk
to your doctor or pharmacist before receiving
BUSCOPAN Ampoules.
Pregnancy and breast-feeding
You should not be given BUSCOPAN Ampoules if you are
pregnant, likely to get pregnant or are breast-feeding.
Driving and using machines
Some people may have sight problems or feel dizzy while
taking this medicine. If this happens to you, wait until
your sight returns to normal or you stop feeling dizzy
before driving or using any tools or machines.
Important information about some of the ingredients of
BUSCOPAN Ampoules
BUSCOPAN Ampoules contain sodium chloride. The
amount of sodium in a 1 ml ampoule is less than 1 mmol
(23 mg), the total amount of sodium if you are given five
ampoules in 24 hours is less than 1 mmol (23 mg) this
means that your medicine is essentially sodium free.
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3. HOW BUSCOPAN AMPOULES WILL BE GIVEN
BUSCOPAN Ampoules are usually given by a doctor or
nurse. BUSCOPAN Ampoules should not be given every
day for long periods of time.
Receiving the injection
BUSCOPAN Ampoules may be given in two ways:
• By being slowly injected into a vein
• By an injection into a muscle
• BUSCOPAN Ampoules may be diluted with other
solutions if needed
How much will you be given
• You will usually be given one ampoule, but you may be
given a further ampoule after half an hour if required
• If you are being given BUSCOPAN Ampoules as part of
an endoscopy your dose may need to be given more often
• You should not be given more than 5 ampoules in any
24-hour period
BUSCOPAN Ampoules are not recommended for children.
If you have more BUSCOPAN Ampoules than you should
It is unlikely that you will be given too much of this
medicine. However, tell the doctor or nurse if you think
that you have been given too much.
4. POSSIBLE SIDE EFFECTS
Like all medicines, BUSCOPAN Ampoules can cause side
effects although not everybody gets them. The following
side effects may happen with this medicine.
Stop taking your medicine and see a doctor straight away,
if you notice any of the following serious side effects - you
may need urgent medical treatment:
• Allergic reactions such as skin rash, nettle rash, redness
of the skin and itching
• Severe allergic reactions (anaphylaxis) such as difficulty
breathing, feeling faint or dizzy (shock)
• Painful red eye with loss of vision
Other side effects
• Dry mouth (affects fewer than 1 in 10 people)
• Dizziness (affects fewer than 1 in 10 people)
• Blurred vision (affects fewer than 1 in 10 people)
• Increased heart rate (affects fewer than 1 in 10 people)
• Constipation
• Small blisters on hands and feet
• Being unable to pass water (urine)
• Low blood pressure, for example feeling faint
• Flushing
• Dilated pupils
• Increased fluid pressure inside the eye

5. HOW TO STORE BUSCOPAN AMPOULES
• Keep out of the reach and sight of children
• Store below 30°C, keep the ampoules in the outer carton
in order to protect from light
• BUSCOPAN Ampoules should not be used after the
expiry date which is printed on the carton and
ampoules. The expiry date refers to the last day of that
month
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
protect the environment.
6. FURTHER INFORMATION
What BUSCOPAN Ampoules contain
Each ampoule contains 20 mg of the active ingredient
hyoscine butylbromide. The other ingredients are sodium
chloride and water for injections.
What BUSCOPAN Ampoules looks like and contents of
the pack
BUSCOPAN Ampoules are clear glass ampoules containing
a colourless or almost colourless, clear solution.
BUSCOPAN Ampoules are supplied in cartons containing
10 x 1 ml ampoules.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisations are held by:
Boehringer Ingelheim Limited,
Ellesfield Avenue,
Bracknell, Berkshire,
RG12 8YS, United Kingdom
and the ampoules are manufactured at:
Boehringer Ingelheim España, S.A.
Prat de la Riba, 50
08174 Sant Cugat del Vallès,
Barcelona, Spain
This leaflet was revised in June 2014.
© Boehringer Ingelheim Limited 2014

Pain at the place you had the injection may occur if you
have been given BUSCOPAN Ampoules into a muscle.
Although unlikely, in certain circumstances it may be
possible that BUSCOPAN may pass into the brain and
cause side effects, for example confusion.
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 (see
details below). By reporting side effects you can help
provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL – Dublin 2.
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: [email protected]

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