Glycopyrronium bromide 1mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Glycopyrronium bromide

Saadav alates:

P.I.E. Pharma Ltd

ATC kood:

A03AB02

INN (Rahvusvaheline Nimetus):

Glycopyrronium bromide

Annus:

1mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 01020000; GTIN: 05050114912534

Infovoldik

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 Tablets are and what they are
used for
2. What you need to know before you take Glycopyrronium
Bromide Tablets
3. How to take 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
Glycopyrronium bromide (the active substance in Glycopyrronium
Bromide
Tablets)
belongs
to
a
group
of
medicines
called
anticholinergics or antimuscaranics.
It is used together with other medicines to make the stomach
contents less acidic and to help treat peptic (stomach) ulcers in
adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
GLYCOPYRRONIUM BROMIDE TABLETS
DO NOT TAKE GLYCOPYRRONIUM BROMIDE TABLETS AND TALK
TO YOUR DOCTOR IF:
•
you are allergic to glycopyrronium bromide or any of the
ingredients of this medicine (listed in section 6 at the end of
the leaflet)
•
you suffer from:
o
glaucoma (increased pressure in the eye)
o
an enlarged prostate gland (prostatic hypertrophy)
o
obstruction of the stomach (pyloric stenosis) or bowel
causing vomiting, abdominal pain and swelling (paralytic
ileus)
o
myasthenia
gravis
(leading
to
muscle
weakness
and
fatigue).
Tell your doctor if you are not sure about any of the above.
WARNINGS AND PRECAUTIONS
TALK
TO
YOUR
DOCTOR
OR
PHARMACIST
before
taking
Glycopyrronium Bromide Tablets if you:
•
are over 60 years of age
•
are a child or thi

Toote omadused

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