Active ingredient
- glycopyrronium bromide
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00156/0115 .
Glycopyrronium Bromide 200 micrograms/ml Solution for Injection
Package leaflet: information for the user
Glycopyrronium Bromide 200 micrograms/ml Solution for Injection
Glycopyrronium Bromide
(referred to as Glycopyrronium Injection in this leaflet)
Read all of this leaflet carefully before you are given this medicine because it contains important information for you
What is in this leaflet:
1. What Glycopyrronium Injection is and what it is used for
2. What you need to know before you use Glycopyrronium Injection.
3. How to use Glycopyrronium Injection.
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 Injection contains the active substance glycopyrronium bromide.
Glycopyrronium Bromide belongs to a group of medicines called anticholinergic drugs.
Glycopyrronium Injection may be used:
2. What you need to know before you use Glycopyrronium Injection
You should not be given Glycopyrronium Injection if:
Warnings and precautions
Take special care with Glycopyrronium Injection. Tell your doctor if:
Always tell your doctor or nurse about any of these conditions before having your injection.
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:
Glyceryl trinitrate tablets (used to treat angina) may not dissolve under the tongue as well as usual owing to the dry mouth which glycopyrronium bromide causes.
Pregnancy, 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 machines because this medicine can cause blurred vision, dizziness and other effects that may affect your ability to do so. Do not drive or use machinery until these effects have gone.
Glycopyrronium Injection contains sodium
This injection contains less than 1mmol (23mg) of sodium per 2ml (essentially ‘sodium-free’).
3. How to use Glycopyrronium Injection
Glycopyrronium Injection is given by injection into a muscle (intramuscularly) or into a vein (intravenously).
Dosage when used before an operation:
Adults, adolescents over 12 years old and elderly 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:
The child will be given 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).
Dosage when used during an operation:
Adults, adolescents over 12 years old and elderly patients:
The recommended 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.
Children:
The recommended 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.
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. If you have any further questions about this medicine, ask your doctor or nurse.
Dosage when reversing the effects of non-depolarising muscle relaxants:
Adults, adolescents over 12 years old and elderly 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.
Dosage in patients with impaired kidney function:
If you have impaired kidney function, your doctor will decide upon a dose that suits your condition.
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).
Tell your doctor or nurse if you notice any of the following symptoms:
Very common side effect (affects more than 1 in 10 people):
Common (may affect up to 1 in 10 people)
Very rare (may affect up to 1 in 10,000 people)
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: 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 Injection
Keep out of the sight and reach of children.
This medicinal product does not require any special storage conditions. 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.
If only part of an ampoule is used the remaining solution should be discarded. The injection should not be used if particles are present. Do not use this medicine if you notice the ampoule is damaged or if the contents are discoloured.
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 Glycopyrronium Injection contains.
The active substance is Glycopyrronium Bromide.
Each 1ml glass ampoule contains 200 micrograms of glycopyrronium bromide.
Each 3ml glass ampoule contains 600 micrograms of glycopyrronium bromide.
The other ingredients are sodium chloride, hydrochloric acid (for pH adjustment) 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
Manufacturer
Marketing Authorisation Number: PL 00156/0115
The leaflet was last revised in February 2018
D04150
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