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GLYCOPYRRONOIUM BROMIDE 200 MICROGRAMS/ML SOLUTION FOR INJECTION

Active substance(s): GLYCOPYRRONIUM BROMIDE

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Robinul® 200 micrograms/ml
Solution for Injection

2899
30.09.16[3]

(glycopyrronium bromide)
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist 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).
Your medicine is available using the above name but will be referred to as
Robinul Injection throughout this leaflet.
What is in this leaflet
1. What Robinul Injection is and what it is used for
2. What you need to know before you use Robinul Injection
3. How to use Robinul Injection
4. Possible side effects
5. How to store Robinul Injection
6. Contents of the pack and other information
1. WHAT ROBINUL INJECTION IS AND WHAT IT IS USED FOR
Robinul Injection belongs to a group of medicines called anticholinergic
drugs. Its purpose is to dry up the secretions in your mouth and airways and
to reduce the acidity of your stomach before an operation. It is also used to
block some of the unwanted effects that may occur during an operation or
from other medicines that may be used, such as slowing the heart rate or
excess production of saliva.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ROBINUL
INJECTION
Do not use Robinul Injection:
- if you are allergic to Glycopyrronium bromide or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist or nurse before using Robinul Injection:
- if you are suffering from heart disease, heart failure, irregular heart beats
or high blood pressure
- if you have an overactive thyroid gland
- if you have a high temperature (fever)
- if you have been administered inhalation anaesthesia
- if you suffer from glaucoma (increased pressure in the eye)
- if you suffer from myasthenia gravis (leading to muscle weakness and
fatiguability)
- if you have an enlarged prostrate gland
- if you suffer from obstruction of the stomach (pyloric stenosis) or bowel
causing vomiting abdominal pain and swelling (paralytic ileus)
- if you are pregnant or are breast feeding (see section Pregnancy and
breast-feeding and fertility below).
Other medicines and Robinul Injection
Tell your doctor or pharmacist if you are taking, have recently taken, or
might take any other medicines. A number of drugs can interact with Robinul
Injection which can significantly alter their effects.
These drugs include:
- Drugs for depression known as Tricyclic Antidepressants and Monoamine
Oxidase Inhibitors (MAOIs)
- Clozapine which is used to treat severe mental disorders
- Strong pain relievers such as Nefopam
- Amantadine which is used to treat Parkinson's disease or viral infection.
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
using this medicine.
Driving and using machines
You should not drive or use machines after being given this medicine until
the doctor advises you that you are safe to do so.
Robinul Injection contains sodium
Robinul Injection contains less than 1mmol (23mg) of sodium per 2 ml
(essentially ‘sodium-free’).

3. HOW TO USE ROBINUL INJECTION
Robinul Injection should be administered by a qualified healthcare
professional.
Method of administration:
Robinul Injection is administered by injection into a vein or muscle.
Your doctor will decide the correct dose for you depending on your
circumstances. Your dose may be calculated according to your weight.
The injection may need to be repeated depending on your response.
If you use more Robinul Injection than you should
This is unlikely because the dose will be administered by a health
professional.
If you have any further questions on the use of this medicine ask your
doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines this medicine can cause side-effects, although not
everybody gets them.
Consult a doctor straight away if you notice any of the following
symptoms - you may need urgent medical treatment:
Swelling mainly of the face, lips or throat which makes it difficult to
swallow or breathe, itching and rashes. This could be a sign of a
severe allergic reaction or angioedema (frequency not known, cannot
be estimated from the available data).
All medicines can cause allergic reactions although serious allergic
reactions are very rare.
Other side effects have also been reported under the following frequency
Very rare (may affect up to 1 in 10,000 people)
glaucoma (increased pressure in the eyes).
Not known (frequency cannot be estimated from the available data)
- a dry mouth
- blurred vision or reduced ability to sweat
- palpitations (an awareness of strong, thumping heart beats)
- fear of bright light
- confusion
- vomiting
- difficulty in passing water (urinating)
- a faster heart rate than normal
- difficulty in passing stools (constipation)
- reduced lung secretion
- redness and dryness of the skin
- feeling unwell
- feeling giddy.
If any of the side effects become serious, or you notice any side
effects not listed in this leaflet, please tell your doctor.
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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE ROBINUL INJECTION
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label
and carton. The expiry date refers to the last day of that month.
Do not store above 25°C.
If only part used, discard the remaining solution.
If the solution becomes discoloured or show any other signs of deterioration,
consult your pharmacist who will tell you what to do.
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 to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Robinul Injection contains
- The active substance is glycopyrronium bromide.
- Each 1ml of solution contains 200 micrograms glycopyrronium bromide.
- The other ingredients are sodium chloride, water for injections and
hydrochloric acid.
What Robinul Injection looks like and contents of pack
Robinul Injection is a clear, colourless, sterile solution for injection filled in
transparent 1 ml glass ampoules. The ampoules have a blue scored dot and
green neck ring.
Each 1ml glass ampoule contains 200 micrograms (0.2mg) of
glycopyrronium bromide.
Robinul Injection is available in pack size of 10 x 1ml ampoules.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Meda Pharma GmbH & Co KG, Benzstrasse 1, D –61352
Bad Homburg, Germany.
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.

POM

PL 20636/2899

Leaflet revision and issue date (Ref) 30.09.16[3]
Robinul is a trademark of Wyeth LLC.

Glycopyrronium Bromide
200 micrograms/ml Solution
for Injection

2899
30.09.16[3]

PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist 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).
Your medicine is available using the above name but will be referred to as
Glycopyrronium Bromide Injection throughout this leaflet.
What is in this leaflet
1. What Glycopyrronium Bromide Injection is and what it is used for
2. What you need to know before you use Glycopyrronium Bromide Injection
3. How to use Glycopyrronium Bromide Injection
4. Possible side effects
5. How to store Glycopyrronium Bromide Injection
6. Contents of the pack and other information
1. WHAT GLYCOPYRRONIUM BROMIDE INJECTION IS AND WHAT IT
IS USED FOR
Glycopyrronium bromide belongs to a group of medicines called
anticholinergic drugs. Its purpose is to dry up the secretions in your mouth
and airways and to reduce the acidity of your stomach before an operation.
It is also used to block some of the unwanted effects that may occur during
an operation or from other medicines that may be used, such as slowing the
heart rate or excess production of saliva.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
GLYCOPYRRONIUM BROMIDE INJECTION
Do not use Glycopyrronium Bromide Injection:
- if you are allergic to Glycopyrronium bromide or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist or nurse before using Glycopyrronium
Bromide Injection:
- if you are suffering from heart disease, heart failure, irregular heart beats
or high blood pressure
- if you have an overactive thyroid gland
- if you have a high temperature (fever)
- if you have been administered inhalation anaesthesia
- if you suffer from glaucoma (increased pressure in the eye)
- if you suffer from myasthenia gravis (leading to muscle weakness and
fatiguability)
- if you have an enlarged prostrate gland
- if you suffer from obstruction of the stomach (pyloric stenosis) or bowel
causing vomiting abdominal pain and swelling (paralytic ileus)
- if you are pregnant or are breast feeding (see section Pregnancy and
breast-feeding and fertility below).
Other medicines and Glycopyrronium Bromide Injection
Tell your doctor or pharmacist if you are taking, have recently taken, or
might take any other medicines. A number of drugs can interact with
Glycopyrronium Bromide Injection which can significantly alter their effects.
These drugs include:
- Drugs for depression known as Tricyclic Antidepressants and Monoamine
Oxidase Inhibitors (MAOIs)
- Clozapine which is used to treat severe mental disorders
- Strong pain relievers such as Nefopam
- Amantadine which is used to treat Parkinson's disease or viral infection.
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
using this medicine.
Driving and using machines
You should not drive or use machines after being given this medicine until
the doctor advises you that you are safe to do so.
Glycopyrronium Bromide Injection contains sodium
Glycopyrronium Bromide Injection contains less than 1mmol (23mg) of
sodium per 2 ml (essentially ‘sodium-free’).

3. HOW TO USE GLYCOPYRRONIUM BROMIDE INJECTION
Glycopyrronium Bromide Injection should be administered by a qualified
healthcare professional.
Method of administration:
Glycopyrronium Bromide Injection is administered by injection into a vein or
muscle.
Your doctor will decide the correct dose for you depending on your
circumstances. Your dose may be calculated according to your weight.
The injection may need to be repeated depending on your response.
If you use more Glycopyrronium Bromide Injection than you should
This is unlikely because the dose will be administered by a health
professional.
If you have any further questions on the use of this medicine ask your
doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines this medicine can cause side-effects, although not
everybody gets them.
Consult a doctor straight away if you notice any of the following
symptoms - you may need urgent medical treatment:
Swelling mainly of the face, lips or throat which makes it difficult to
swallow or breathe, itching and rashes. This could be a sign of a
severe allergic reaction or angioedema (frequency not known, cannot
be estimated from the available data).
All medicines can cause allergic reactions although serious allergic
reactions are very rare.
Other side effects have also been reported under the following frequency
Very rare (may affect up to 1 in 10,000 people)
glaucoma (increased pressure in the eyes).
Not known (frequency cannot be estimated from the available data)
- a dry mouth
- blurred vision or reduced ability to sweat
- palpitations (an awareness of strong, thumping heart beats)
- fear of bright light
- confusion
- vomiting
- difficulty in passing water (urinating)
- a faster heart rate than normal
- difficulty in passing stools (constipation)
- reduced lung secretion
- redness and dryness of the skin
- feeling unwell
- feeling giddy.
If any of the side effects become serious, or you notice any side
effects not listed in this leaflet, please tell your doctor.
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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE GLYCOPYRRONIUM BROMIDE INJECTION
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label
and carton. The expiry date refers to the last day of that month.
Do not store above 25°C.
If only part used, discard the remaining solution.
If the solution becomes discoloured or show any other signs of deterioration,
consult your pharmacist who will tell you what to do.
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 to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Glycopyrronium Bromide Injection contains
- The active substance is glycopyrronium bromide.
- Each 1ml of solution contains 200 micrograms glycopyrronium bromide.
- The other ingredients are sodium chloride, water for injections and
hydrochloric acid.
What Glycopyrronium Bromide Injection looks like and contents of
pack
Glycopyrronium Bromide Injection is a clear, colourless, sterile solution for
injection filled in transparent 1 ml glass ampoules. The ampoules have a
blue scored dot and green neck ring.
Each 1ml glass ampoule contains 200 micrograms (0.2mg) of
glycopyrronium bromide.
Glycopyrronium Bromide Injection is available in pack size of 10 x 1ml
ampoules.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Meda Pharma GmbH & Co KG, Benzstrasse 1, D –61352
Bad Homburg, Germany.
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2899

Leaflet revision and issue date (Ref) 30.09.16[3]

+ 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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