Glycopyrronium bromide 1mg/5ml oral solution sugar free

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Glycopyrronium bromide

Available from:

Colonis Pharma Ltd

ATC code:

A03AB02

INN (International Name):

Glycopyrronium bromide

Dosage:

200microgram/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01020000; GTIN: 5060380960139

Patient Information leaflet

Read all of this leaflet carefully before you
start taking 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 or pharmacist.
■
This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the
same as yours.
■
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Glycopyrronium Bromide oral solution
is and what it is used for
2. What you need to know before you take
Glycopyrronium Bromide oral solution
3. How to take Glycopyrronium Bromide
oral solution
4. Possible side effects
5. How to store Glycopyrronium Bromide
oral solution
6. Contents of the pack and other information
1. What Glycopyrronium Bromide oral
solution is and what it is used for
This medicine is called Glycopyrronium Bromide
and belongs to a group of medicines called
anticholinergic or antimuscarinic drugs. It
contains the active substance glycopyrronium
bromide. Each 5ml dose of oral solution
contains 1mg of glycopyrronium bromide.
■
Glycopyrronium Bromide is used, in
combination with other medicines, to treat
peptic (stomach) ulcers in adults.
2. What you need to know before
you take Glycopyrronium
Bromide oral solution
DO NOT TAKE GLYCOPYRRONIUM BROMIDE ORAL
SOLUTION IF:
■
you are allergic (hypersensitive) to
glycopyrronium bromide or any of the other
ingredients of this medicine (listed in
section 6)
■
you have glaucoma (increased pressure in
the eye)
■
you have a condition called myasthenia
gravis which leads to muscle weakness
and fatigue
■
you have obstruction of the stomach
(pyloric stenosis) or bowel causing vomiting,
abdominal pain and swelling (paralytic ileus)
■
you have an enlarged prostate gland
(prostatic hypertrophy)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Glycopyrronium B

Summary of Product characteristics

OBJECT 1
GLYCOPYRRONIUM BROMIDE 1 MG/5 ML ORAL
SOLUTION
Summary of Product Characteristics Updated 28-Jun-2018 | Colonis
Pharma Ltd
1. Name of the medicinal product
Glycopyrronium Bromide 1 mg/5 ml Oral Solution
2. Qualitative and quantitative composition
Each 5 ml of oral solution contains 1 mg of glycopyrronium bromide
Excipient(s) with known effect:
Sorbitol (E420)
Sodium methyl parahydroxybenzoate (E219)
Sodium propyl parahydroxybenzoate (E217)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution
Glycopyrronium Bromide 1 mg/5 ml oral solution is a clear, colourless,
strawberry flavoured liquid.
4. Clinical particulars
4.1 Therapeutic indications
For use in adults as an add-on therapy in the treatment of peptic
ulcer.
4.2 Posology and method of administration
Posology
The dosage of Glycopyrronium Bromide 1 mg/5 ml oral solution should be
adjusted to the needs of the
individual patient to assure symptomatic control with a minimum of
adverse reactions. The recommended
maximum daily dosage of Glycopyrronium Bromide is 8 mg (40 ml).
The recommended initial dosage of Glycopyrronium Bromide oral solution
for adults is 1 mg (5 ml) three
times daily (in the morning, early afternoon, and at bedtime). Some
patients may require 2 mg (10 ml) at
bedtime to assure overnight control of symptoms. For maintenance, a
dosage of 1 mg (5 ml) twice a day
is recommended.
The presence of high fat food reduces the oral bioavailability of
Glycopyrronium Bromide if taken shortly
after a meal. Therefore it should be taken at least one hour before or
two hours after meals.
_Paediatric population_
Glycopyrronium Bromide oral solution is not recommended for use in
children.
Method of administration
For oral use only.
The correct quantity of Glycopyrronium Bromide oral solution should be
measured and administered
using the dosage cup provided and then swallowed. The dosage cup
should be washed after each use with
clean water (do not put it in a dishwasher).
4.3 Contraindications
• Hypersensitivity to the a