Glycopyrronium bromide 2mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
01-01-2019
Summary of Product characteristics
(SPC)
12-02-2019
Public Assessment Report
(PAR)
20-04-2020
Active ingredient:
Glycopyrronium bromide
Available from:
A A H Pharmaceuticals Ltd
ATC code:
A03AB02
INN (International Name):
Glycopyrronium bromide
Dosage:
2mg
Pharmaceutical form:
Oral tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 01020000; GTIN: 5025903081029
Patient Information leaflet
FRONT SIDE
000
USE IN ADULTS
- If you feel the effect of your medicine is too weak or strong,
do not change the dose yourself, but ask your doctor.
One tablet of Glycopyrronium Bromide 2mg tablet, three times
- The length of your treatment will depend on how serious
your condition is.
daily (in the morning, early afternoon and at bedtime).
One tablet of Glycopyrronium Bromide 1mg tablet, three times
daily (in the morning, early afternoon and at bedtime).
TAKING THIS MEDICINE
DRIVING AND USING MACHINES
PREGNANCY, BREAST-FEEDING AND FERTILITY
- medicines for depression (isocarboxazid, linezolid,
methylene blue, moclobemide, phenelzine, procarbazine,
rasagiline, selegiline, tranylcypromine).
If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicinal
product.
Always take this medicine exactly as described in this leaflet or
as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
3. HOW TO TAKE GLYCOPYRRONIUM BROMIDE TABLETS
- Take this medicine by mouth.
If your doctor has prescribed a medical test, tell your doctor that
you are taking Glycopyrronium Bromide tablets, as this may
interfere with some test results.
HOW MUCH TO TAKE
- Your doctor will decide on how many Glycopyrronium
Bromide tablets you should take.
- The dose will depend on your condition and its severity.
Do not take this medicine if you are pregnant or breast-feeding,
think you may be pregnant or are planning to have a baby.
- Swallow the tablets whole with a drink of water.
You may get side effects after taking this medicine, including
blurred vision and feeling dizzy. Some of these side effects can
affect you being able to concentrate and your reaction speed. If
this happens, do not drive or carry out any work that requires a
high level of attention.
- The tablets may be taken just before or with meals or food.
- reserpine (used to treat high blood pressure and mental
disorders),
Glycopyrronium Bromide tablets contains lactose
monohydrate.
GLYCOPY
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Glycopyrronium Bromide 2mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2mg of Glycopyrronium bromide (or
Glycopyrrolate).
Contains lactose monohydrate
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablets
White to off-white, round flat beveled tablet (nominal diameter 7mm)
debossed “2”
on one side and break line on other side without any visible defects.
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
Use in adults:
One tablet three times daily (in the morning, early afternoon and at
bedtime)
The dosage of Glycopyrronium Bromide 2mg tablets should be adjusted to
the need
of the individual patient to assure symptomatic control with a minimum
of adverse
reactions. The recommended maximum daily dose of Glycopyrronium
bromide is
8mg.
Dose adjustment may be required in elderly and in patients with renal
impairment
Dosage needs to be adjusted as needed as tolerated
Glycopyrronium Bromide tablets are not recommended for use in
children.
Method of administration
Glycopyrronium Bromide 2mg tablets are administered orally
4.3
CONTRAINDICATIONS
_Glycopyrronium Bromide tablets _must not be used
•
In Glaucoma, obstructive uropathy (for example bladder neck
obstruction due to
prostatic hypertrophy); obstructive disease of the gastrointestinal
tract (as in
achalasis, pyloroduodenal stenosis, etc.); paralytic ileus; intestinal
atony of the
elderly or debilitated patient; unstable cardiovascular status in
acute hemorrhage;
severe ulcerative colitis; toxic megacolon complicating ulcerative
colitis;
myasthenia gravis.
•
In those patients with a hypersensitivity to Glycopyrronium bromide
or, any other
excipient(s) listed in section 6.1.
•
In patients taking solid oral dosage forms of potassium chloride.
Slower
gastrointestinal time produced by Glycopyrronium bromide may increase
th
Read the complete document
