Sialanar
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
19-06-2023
Karatteristiċi tal-prodott
(SPC)
19-06-2023
Rapport ta 'Valutazzjoni Pubblika
(PAR)
29-09-2016
Ingredjent attiv:
Glycopyrronium bromide
Disponibbli minn:
Proveca Pharma Limited
Kodiċi ATC:
A03AB02
INN (Isem Internazzjonali):
glycopyrronium
Grupp terapewtiku:
Drugs for functional gastrointestinal disorders
Żona terapewtika:
Sialorrhea
Indikazzjonijiet terapewtiċi:
Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.
Sommarju tal-prodott:
Revision: 10
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2016-09-15
Fuljett ta 'informazzjoni
25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE USER
SIALANAR 320 MICROGRAMS/ML ORAL SOLUTION
glycopyrronium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS 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 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 your child gets 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 Sialanar is and what it is used for
2.
What you need to know before you give Sialanar
3.
How to use Sialanar
4.
Possible side effects
5.
How to store Sialanar
6.
Contents of the pack and other information
1.
WHAT SIALANAR IS AND WHAT IT IS USED FOR
Sialanar contains the active substance glycopyrronium.
Glycopyrronium 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.
Sialanar 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 nerves
and muscles. It is mostly caused by poor control of muscles in the
face. Acute sialorrhoea may be
associated with inflammation, dental infections or infections of the
mouth.
Sialanar acts on the salivary glands to reduce production of saliva.
2.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE SIALANAR
DO NOT GIVE SIALANAR IF YOUR CHILD OR ADOLESCENT:
−
is allergic to glycopyrronium or any of the other ingredients of this
medicine (listed in section 6)
−
is pregnant or breast feeding
−
has glaucoma (raised pressure in the eye)
−
is unable
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Sialanar 320 micrograms/ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 400 micrograms of glycopyrronium bromide equivalent
to 320 micrograms of
glycopyrronium.
Excipient(s) with known effect
Each ml contains 2.3 mg sodium benzoate (E211).
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oral solution
Clear, colourless solution.
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
Sialanar should be prescribed by physicians experienced in the
treatment of paediatric patients with
neurological disorders.
Posology
Due to the lack of long term safety data, Sialanar is recommended for
short -term intermittent use (see
section 4.4).
_Paediatric population – children and adolescents aged 3 years and
older _
The dosing schedule for glycopyrronium is based on the weight of the
child, starting with
approximately 12.8 micrograms/kg per dose (equivalent to 16
micrograms/kg per dose
glycopyrronium bromide), three times per day and increasing by the
doses shown in Table 1 below,
every 7 days. Dose titration should be continued until efficacy is
balanced with undesirable effects and
amended up or down as appropriate, to a maximum individual dose of 64
micrograms/kg body weight
glycopyrronium or 6 ml (1.9 mg glycopyrronium, equivalent to 2.4 mg
glycopyrronium bromide) three
times a day, whichever is less. Dose titrations should be conducted in
discussion with the carer to
assess both efficacy and undesirable effects until an acceptable
maintenance dose is achieved.
Undesirable effects may be minimised by using the lowest effective
dose necessary to control
symptoms. It is important that the carer checks the dose volume in the
syringe before administration.
The maximum volume of the highest dose
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