Glycopyrronium bromide 1mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Glycopyrronium bromide

Tilgjengelig fra:

Morningside Healthcare Ltd

ATC-kode:

A03AB02

INN (International Name):

Glycopyrronium bromide

Dosering :

1mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 01020000; GTIN: 5055132714658

Informasjon til brukeren

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,

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Assicco 1mg Tablets
Glycopyrronium Bromide 1mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1mg tablet contains 1mg of Glycopyrronium Bromide
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
The tablets are white to off white capsule shaped, flat, bevelled
edge, scored tablets
engraved with “I 21” (1mg) or “I 22” (2mg) on the scored side
and plain on the other
side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of severe sialorrhoea (chronic pathological
drooling)
in children and adolescents aged 3 years and older with chronic
neurological
disorders.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Glycopyrronium bromide tablets are recommended for short-term
intermittent use
(see section 4.4 and 5.1).
Glycopyrronium bromide tablets should be prescribed by physicians
experienced in
the treatment of patients with neurological disorders.
Posology
The dosing schedule for Glycopyrronium bromide 1mg and 2mg tablets is
based on
the weight of the child with an initial dosing of 0.02 mg/kg to be
given orally three
times daily and titrated in increments of 0.02 mg/kg every 7 days
based on therapeutic
response and adverse reactions. The maximum recommended dose is 0.1
mg/kg three
times daily not to exceed 1.5-3 mg per dose based upon weight (see
Table).
During a four-week titration period, dose should be increased no more
frequently than
weekly
using
the
titration
schedule
to
minimise
anticholinergic
adverse
events.
Increase of dose should occur only after it is clear that the dose
level is well tolerated
and monitoring of the increase is in place. Prior to each dose
increase, a review of the
tolerability of the current dose level should be made with the
patient's caregiver.
Younger children may be more susceptible to adverse events and this
should be kept
in mind when dose adjustments are made.
Following the dose titration period, the child’s