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GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS/ML SOLUTION FOR INJECTION

Active substance(s): GLYCOPYRROLATE / GLYCOPYRRONIUM BROMIDE

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Package leaflet: information for the user

Glycopyrronium Bromide 200 micrograms/ml Solution for Injection
Glycopyrronium Bromide
(referred to as Glycopyrronium Injection in this leaflet)

D02428

Read this leaflet carefully before you are given
this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or nurse.
• If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects not
listed in this leaflet

What is in this leaflet:
1. What Glycopyrronium Injection is and what it is
used for
2. What you need to know before you are given
Glycopyrronium Injection.
3. How Glycopyrronium Injection is given.
4. Possible side effects.
5. How to store Glycopyrronium Injection.
6. Contents of the pack and other information

1. What Glycopyrronium Injection is and
what it is used for
Glycopyrronium Bromide belongs to a group of
medicines called anticholinergic drugs.
Glycopyrronium Injection may be used:
• To protect against some of the unwanted effects
of drugs such as Neostigmine or Pyridostigmine,
which are used to reverse the effects of certain
types of muscle-relaxing drugs used during
operations (called non-depolarising muscle
relaxants).
• Before an operation, to reduce saliva and other
secretions and to reduce the acidity of the
stomach contents.
• Before or during an operation, to reduce or
prevent slowing of the heartbeat during surgery.

2. What you need to know before you are
given Glycopyrronium Injection.
You should not be given Glycopyrronium
Injection if:
• you are allergic to Glycopyrronium Bromide or to
any of the other ingredients in this medicine, listed
in section 6 of this leaflet
Warnings and precautions
Take special care with Glycopyrronium Injection. Tell
your doctor if:
• you are pregnant or breast feeding.
• you suffer from myasthenia gravis (a disease
resulting in severe muscle weakness and fatigue).
• you have an abnormally high heart rate
associated with an over-active thyroid gland, poor
heart function, heart failure or have had cardiac
surgery.
• you have a history of high blood pressure,
coronary artery disease or irregular heartbeat
• you have a fever.

Other medicines and Glycopyrronium Injection
Tell your doctor or nurse if you are taking, have
recently taken or might take any other medicines.
Medicines which may interact with Glycopyrronium
Injection include:
• other anticholinergic drugs, such as those used to
treat Parkinson’s disease, spasm of the intestine
or a ‘weak bladder’, or some inhalers to relieve
wheeziness
• drugs used to treat depression known as tricyclic
antidepressants
• drugs used to stabilise your mood, or to
treat nausea, vomiting or vertigo known as
phenothiazines
• medicines used to treat heart conditions such as
digoxin tablets or disopyramide
• procainamide and quinidine, used to treat an
irregular heartbeat).
• antihistamines (medicines used to treat allergic
conditions).
• corticosteroids (used to reduce inflammation or to
relieve asthma).
• pethidine (a strong pain reliever).
Pregnancy and breast-feeding.
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 being given this medicine.
Driving and using machines.
After having Glycopyrronium Injection you should
not drive or operate machinery until you have been
advised that it is safe to do so.
Important information about some of the
ingredients of Glycopyrronium Injection.
This medicinal product contains less than 1mmol
Sodium (23mg) per dose, i.e. essentially ‘Sodiumfree’.

3. How Glycopyrronium Injection is given
Glycopyrronium Injection is given by injection into a
muscle or into a vein.
Dosage when used before an operation:
Adults and older patients:
You doctor may inject 200 to 400 micrograms (0.2
to 0.4mg) into a vein or into a muscle before the
anaesthetic is given. Alternatively, they may give you
a dose of 4 to 5 micrograms per kilogram of body
weight (0.004 to 0.005mg per kg), up to a maximum
dose of 400 micrograms (0.4mg).
Children:
Your doctor will give your child 4 to 8 micrograms
per kilogram of body weight (0.004 to 0.008mg
per kg) injected into a vein or into a muscle before
the anaesthetic is given, up to a maximum of 200
micrograms (0.2mg).
Continued overleaf

Dosage when used during an operation:
Adults and older patients:
Your doctor will give you a single dose of 200 to
400 micrograms (0.2 to 0.4mg) by injection into a
vein. Alternatively, they may give you a single dose
of 4 to 5 micrograms per kilogram of body weight
(0.004 to 0.005mg per kg), up to a maximum of 400
micrograms (0.4mg). This dose may be repeated if
necessary.

Also you can help to make sure that medicines
remain as safe as possible by reporting any
unwanted side effects via the internet at www.
mhra.gov.uk/yellowcard. Alternatively you can call
Freephone 0808 100 3352 (available from 10 a.m.
to 2 p.m. Mondays to Fridays) or fill in a paper form
available from your local pharmacy.

Children:
Your doctor will give your child a single dose of
200 micrograms (0.2mg) by injection into a vein.
Alternatively they may give them a single dose of 4
to 8 micrograms per kilogram of body weight (0.004
to 0.008mg per kg) by injection into a vein, up to a
maximum of 200 micrograms (0.2mg). This dose may
be repeated if necessary.

Keep out of the sight and reach of children.
This medicinal product does not require any special
storage conditions. You should not be given this
medicine after the expiry date which is stated on
the label and carton after EXP, or if it shows signs of
deterioration. The expiry date refers to the last day
of that month. The doctor or nurse will check this.
If only part of an ampoule is used the remaining
solution should be discarded.

Dosage when reversing the effects of nondepolarising muscle relaxants:
Adults and older patients:
Your doctor will give you 200 micrograms (0.2mg)
per 1,000 micrograms (1mg) of Neostigmine or the
equivalent dose of Pyridostigmine, by injection into
a vein. Alternatively, they may give you a dose of 10
to 15 micrograms per kilogram of body weight (0.01
to 0.015 mg per kg) into a vein with 50 micrograms
per kg (0.05 mg per kg) of Neostigmine or equivalent
dose of Pyridostigmine.
Glycopyrronium Injection may be given at the same
time and from the same syringe as the Neostigmine
or Pyridostigmine.
Children:
Your doctor may give your child 10 micrograms
per kg of body weight (0.01mg per kg) injected
into a vein with 50 micrograms per kg (0.05mg
per kg) of Neostigmine or the equivalent dose of
Pyridostigmine. Glycopyrronium Injection may be
given at the same time and from the same syringe as
the Neostigmine or Pyridostigmine.
If you are given too much Glycopyrronium
Injection
This medicine will be given to you in hospital so it is
unlikely you will receive too much, however if you
are concerned you may have been given too much
you should speak to your doctor or nurse.

5. How to store Glycopyrronium Injection.

6. Contents of the pack and other
information
What Glycopyrronium Injection contains.
The active substance is Glycopyrronium Bromide.
Each 1ml of solution contains 200 micrograms of
Glycopyrronium Bromide.
The other ingredients are sodium chloride, dilute
hydrochloric acid and water for injections.
What Glycopyrronium Injection looks like and
contents of the pack.
Glycopyrronium Injection is a clear, colourless
solution for injection. Glycopyrronium Injection is
available in glass ampoules containing either 1ml
or 3ml of solution. Each carton supplied contains 10
ampoules.
Marketing Authorisation Holder and
Manufacturer
Martindale Pharmaceuticals, Bampton Road, Harold
Hill, Romford, Essex, RM3 8UG, UK.
Date of revision: November 2012
Marketing Authorisation Number: PL 00156/0115

If you have any further questions about this
medicine, ask your doctor or nurse.

4. Possible side effects
Like all medicines Glycopyrronium Injection can
cause side effects, although not everybody gets
them. Tell your doctor or nurse if you notice any of
the following symptoms:
• a dry mouth or absence of sweating
• difficulty in passing urine
• blurred vision
• palpitations or an unusually fast heartbeat.
If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects not
listed in this leaflet.

D02428

Text: 9.5pt

100mm Measurement Verification Bar

2428-C

For intramuscular or intravenous injection
Each ampoule contains:
200 micrograms of Glycopyrronium Bromide, Sodium Chloride,
diluted Hydrochloric Acid and Water for Injections
Use as directed by the physician.
See enclosed patient information leaflet for more details.
Once opened any unused product must be discarded.
Keep out of the reach and sight of children.
This medicinal product contains Sodium.
See leaflet for further information.
Martindale Pharmaceuticals, Romford, Essex RM3 8UG, UK.
PL 00156/0115

200 micrograms per ml Solution for Injection

Component Code: D01444
Nominal dimensions (mm):
76.5 x 94.5 x 32.5
Cutter Profile: MAL 23
Version Control

Date

By

Version A created:

28/09/10

AC

Version B:

21/03/11

AC

Version C:

30/03/11

AC

Version D:

10 x 1ml ampoules

Version E:

Glycopyrronium Bromide
200 micrograms per ml
Solution for Injection

Version F:
D01444

5 026468 170920

Version G:
Version H:
Version I:

200 micrograms in 1ml

Version J:
Version K:

Glycopyrronium Bromide
200 micrograms per ml
Solution for Injection
For intramuscular or intravenous injection

POM
10 x 1ml ampoules

200 micrograms in 1ml
Glycopyrronium Bromide
200 micrograms per ml
Solution for Injection
10 x 1ml ampoules

Version L:
Version M:
Version N:
Version O:
Version P:

Glycopyrronium Bromide

200 micrograms
in 1ml

200 micrograms in 1ml

Lot:

Exp:

Glycopyrronium Bromide
200 micrograms per ml
Solution for Injection

10 x 1ml ampoules

200 micrograms in 1ml

Colour Specifications
Pantone Ref:
PMS Black C
PMS 380 C
PMS 361 C
PMS
Varnish free areas:

Swatch:

Component Code: D01456
Nominal dimensions (mm):
H: 20

W: 32

Cutter Profile:
Version Control

Date

By

Version A created:

01/10/10

AC

Version B:

21/03/11

AC

Version C:

30/03/11

AC

Version D:
Version E:
200 micrograms
in 1ml

Version F:

Martindale Pharmaceuticals

Version G:

For IV or IM use only
1ml
PL00156/0115
Lot:

Version H:
Version I:
D01456

Glycopyrronium
Bromide
200 micrograms
per ml Solution
for Injection POM

Version J:
Version K:

Exp:

Version L:
Version M:
Version N:
Version O:
Version P:
Colour Specifications
Pantone Ref:
PMS Black C
PMS 380 C
PMS 361 C
PMS
Varnish free areas:

Swatch:

Component Code: D01457
Nominal dimensions (mm):
H:44

W:30

Cutter Profile:
Date

Version A created:

01/10/10

AC

Version B:

21/03/11

AC

Version C:

30/03/11

AC

Version D:
Version E:
Version F:
Version G:
Version H:
Version I:

600 micrograms
in 3ml

Version J:

Martindale Pharmaceuticals

Glycopyrronium
Bromide
200 micrograms
per ml Solution
for Injection POM
PL00156/0115

Version K:
Version L:
Version M:
Version N:
Version O:

D01457

For IV or IM use only

Version P:

Lot:
Exp:

By

Version Control

Colour Specifications
Pantone Ref:
PMS Black C
PMS 380 C
PMS 144 C
PMS
Varnish free areas:

Swatch:

Expand view ⇕

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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