Glycopyrronium Bromide Oral Solution 1mg/5ml

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

GLYCOPYRRONIUM BROMIDE

Prieinama:

Colonis Pharma Limited Quantum House, Hobson Industrial Estate, Burnopfield, Country, Durham NE16 6EA, United Kingdom

ATC kodas:

A03AB02

INN (Tarptautinis Pavadinimas):

GLYCOPYRRONIUM BROMIDE 1 mg/5ml

Vaisto forma:

ORAL SOLUTION

Sudėtis:

GLYCOPYRRONIUM BROMIDE 1 mg/5ml

Recepto tipas:

POM

Gydymo sritis:

DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

Autorizacija statusas:

Withdrawn

Leidimo data:

2016-07-25

Pakuotės lapelis

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GLYCOPYRRONIUM BROMIDE 1 MG/5 ML ORAL SOLUTION
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 5 ml dose of oral solution contains 1 mg 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 h

Prekės savybės

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
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.
Page 2 of 8
_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 active substance(s) or to any of the
excipients listed in section