Glycopyrronium bromide 1mg tablets

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktīvā sastāvdaļa:

Glycopyrronium bromide

Pieejams no:

DE Pharmaceuticals

ATĶ kods:

A03AB02

SNN (starptautisko nepatentēto nosaukumu):

Glycopyrronium bromide

Deva:

1mg

Zāļu forma:

Oral tablet

Ievadīšanas:

Oral

Klase:

No Controlled Drug Status

Receptes veids:

Valid as a prescribable product

Produktu pārskats:

BNF: 01020000

Lietošanas instrukcija

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS TAKING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR
THEM.
!
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 your child only. Do not
pass it on to others. It may harm them, even if their signs of
illness are the same as your child's.
!
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 Tablets are and what they are
used for
2.
What you need to know before you give Glycopyrronium
Bromide Tablets
3.
How to use Glycopyrronium Bromide Tablets
4.
Possible side effects
5.
How to store Glycopyrronium Bromide Tablets
6.
Contents of the pack and other information
1.
WHAT GLYCOPYRRONIUM BROMIDE TABLETS ARE AND WHAT THEY
ARE USED FOR
This medicine is called Glycopyrronium Bromide and belongs to a
group of medicines known as quaternary ammonium
anticholinergics, which are agents that block or reduce the
transmission between nerve cells. This reduced transmission can
de-activate the cells that produce saliva.
Glycopyrronium Bromide is used to treat excessive production of
saliva (sialorrhoea) in children and adolescents aged 3 years and
older. Sialorrhoea (drooling or excessive salivation) is a common
symptom of many diseases of the muscles or nerves. It is mainly
caused by poor control of muscles in the face. Glycopyrronium
Bromide Tablets act on the salivary glands to reduce production of
saliva.
2.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE GLYCOPYRRONIUM
BROMIDE TABLETS
DO NOT GIVE GLYCOPYRRONIUM BROMIDE TABLETS IF THE CHILD OR
ADOLESCENT:
!
is ALLERGIC (hypersensitive) to Glycopyrronium Bromide or any
of the other ingredients of this medicine (listed in section 6),
!
has GLAUCOMA (increased pressure in the eye),
!
has a condition called MYASTHENIA GRAVIS which leads to
muscle weakness and fatigue,

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Glycopyrronium Bromide 1mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1mg of Glycopyrronium Bromide
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
White to off white round scored uncoated tablet engraved with “GP”
& “1” on either
side of score line and plain on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For use in adults as add-on therapy in the treatment of peptic ulcer.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage of Glycopyrronium Bromide 1 mg or 2 mg Tablets should be
adjusted to
the needs of the individual patient to assure symptomatic control with
a minimum of
adverse reactions. The presently recommended maximum daily dosage of
Glycopyrronium Bromide is 8 mg.
Glycopyrronium Bromide 1mg Tablets.
The recommended initial dosage of Glycopyrronium Bromide 1 mg Tablets
for adults
is one tablet three times daily (in the morning, early afternoon, and
at bedtime). Some
patients may require two tablets at bedtime to assure overnight
control of symptoms.
For maintenance, a dosage of one tablet twice a day is frequently
adequate.
Glycopyrronium Bromide 2mg Tablets.
The recommended dosage of Glycopyrronium Bromide 2 mg Tablets for
adults is one
tablet two or three times daily at equally spaced intervals.
Paediatric population
Glycopyrronium Bromide Tablets are not recommended for use in
children.
Method of administration
For oral administration
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section
6.1.
In common with other antimuscarinics: angle-closure glaucoma;
myasthenia gravis
(large doses of quaternary ammonium compounds have been shown to block
end
plate nicotinic receptors); paralytic ileus; pyloric stenosis;
prostatic enlargement.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Glycopyrronium Bromide Tablets should be used with caution in the
elderly.
They should also be used with caution