Glycopyrronium bromide 2mg tablets

Country: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Glycopyrronium bromide

Disponibbli minn:

Drugsrus Ltd

Kodiċi ATC:

A03AB02

INN (Isem Internazzjonali):

Glycopyrronium bromide

Dożaġġ:

2mg

Għamla farmaċewtika:

Oral tablet

Rotta amministrattiva:

Oral

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 01020000; GTIN: 5050114912633

Fuljett ta 'informazzjoni

OTHER MEDICINES AND GLYCOPYRRONIUM BROMIDE TABLETS
Tell your doctor or pharmacist if you or your patient are taking
or have recently taken any other medicines, including
medicines obtained without a prescription. Taking
Glycopyrronium Bromide Tablets with the following medicines
can affect the way Glycopyrronium Bromide Tablets or the
listed medicine works or can increase the risk of side effects:
Ÿ
potassium chloride solid oral dose (see section above “DO
NOT TAKE GLYCOPYRRONIUM BROMIDE TABLETS IF YOU:”)
Ÿ
anticholinergic medicines (see section above “DO NOT
TAKE GLYCOPYRRONIUM BROMIDE TABLETS IF YOU:”)
Ÿ
antispasmodics used to treat sickness or vomiting e.g.,
domperidone and metaclopramide
Ÿ
topiramate, used to treat epilepsy
Ÿ
antihistamines such as promethazine, used to treat some
allergies
Ÿ
neuroleptics/antipsychotics (clozapine, haloperidol,
phenothiazine), used to treat some mental illnesses
Ÿ
skeletal muscle relaxants (botulinum toxin)
Ÿ
antidepressants such as amitriptyline, clomipramine,
lofepramine or imipramine (known as tricyclic
antidepressants)
Ÿ
opioids used to treat severe pain
Ÿ
corticosteroids, used to treat inflammatory disease (e.g.,
prednisolone)
Talk to your doctor or pharmacist for further information about
any medicines to avoid or if you are in doubt about any of the
above medicines.
LONG TERM USE
Long term efficacy and safety of Glycopyrronium Bromide
Tablets has not been studied beyond 24 weeks of use.
Continued use should be discussed with the patient's doctor
every 3 months to check that Glycopyrronium Bromide Tablets
are still right for the patient.
PREGNANCY AND BREAST-FEEDING
Glycopyrronium Bromide Tablets must not be given if the
patient is pregnant or thinks they may be pregnant or is
breastfeeding (see section 2 'Do not take'). Discuss with the
patient's doctor whether there is a need for contraception.
DRIVING AND USING MACHINES
Glycopyrronium Bromide Tablets may affect vision and co-
ordination. This may affect the performance of skilled tasks
such as

Karatteristiċi tal-prodott

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.
The tablet can be divided into equal halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of severe sialorrhoea (chronic pathological
drooling) due to
chronic neurological disorders of childhood onset in patients aged 3
years and older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_Posology _
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.
PAEDIATRIC POPULATION
Children and adolescents aged 3 years and older
The dosing schedule for Glycopyrronium bromide tablets is based on the
weight of
the child with the initial dosing of 0.02 mg/kg to be given orally
three times daily and
titrate in increments of 0.02 mg/kg every 5-7 days based on
therapeutic response and
adverse reactions. The maximum recommended dosage is 0.1 mg/kg three
times daily
not to exceed 1.5-3 mg per dose based upon weight. For greater detail,
see Table 1.
During the four-week titration period, dosing can be increased with
the recommended
dose titration schedule while ensuring that the anticholinergic
adverse events are
tolerable. Prior to each increase in dose, review the tolerability of
the current dose
level 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 carried out.
Following the dose titration period, the child’s sialorrhoea should
be monitored, in
conju