Intuniv
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
16-02-2023
Charakterystyka produktu
(SPC)
16-02-2023
Sprawozdanie z oceny publicznego
(PAR)
06-10-2015
Składnik aktywny:
guanfacine hydrochloride
Dostępny od:
Takeda Pharmaceuticals International AG Ireland Branch
Kod ATC:
C02AC02
INN (International Nazwa):
guanfacine
Grupa terapeutyczna:
Antiadrenergic agents, centrally acting, Antihypertensives,
Dziedzina terapeutyczna:
Attention Deficit Disorder with Hyperactivity
Wskazania:
Intuniv is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. Intuniv must be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures.,
Podsumowanie produktu:
Revision: 12
Status autoryzacji:
Authorised
Data autoryzacji:
2015-09-17
Ulotka dla pacjenta
36
B. PACKAGE LEAFLET
37
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
INTUNIV 1 MG PROLONGED-RELEASE TABLETS
INTUNIV 2 MG PROLONGED-RELEASE TABLETS
INTUNIV 3 MG PROLONGED-RELEASE TABLETS
INTUNIV 4 MG PROLONGED-RELEASE TABLETS
guanfacine
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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, pharmacist or
nurse.
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.
This leaflet has been written as though the person taking the medicine
is reading it. If you are
giving this medicine to your child, please replace “you” with
“your child” throughout.
WHAT IS IN THIS LEAFLET:
1.
What Intuniv is and what it is used for
2.
What you need to know before you take Intuniv
3.
How to take Intuniv
4.
Possible side effects
5.
How to store Intuniv
6.
Contents of the pack and other information
1.
WHAT INTUNIV IS AND WHAT IT IS USED FOR
WHAT INTUNIV IS
Intuniv contains the active substance guanfacine. This medicine
belongs to a group of medicines
which affects brain activity. This medicine can help improve your
attention, concentration and make
you less impulsive and hyperactive.
WHAT INTUNIV IS USED FOR
This medicine is used to treat ‘attention deficit hyperactivity
disorder’ (ADHD) in children and
adolescents 6-17 years old for whom current stimulant medication is
not appropriate and/or current
medication does not adequately control ADHD symptoms.
The medicine is given a
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Intuniv 1 mg prolonged-release tablets
Intuniv 2 mg prolonged-release tablets
Intuniv 3 mg prolonged-release tablets
Intuniv 4 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Intuniv 1 mg prolonged-release tablet
Each tablet contains guanfacine hydrochloride equivalent to 1 mg of
guanfacine.
_Excipient(s) with known effect_
Each tablet contains 22.41 mg of lactose (as monohydrate).
Intuniv 2 mg prolonged-release tablet
Each tablet contains guanfacine hydrochloride equivalent to 2 mg of
guanfacine.
_Excipient(s) with known effect_
Each tablet contains 44.82 mg of lactose (as monohydrate).
Intuniv 3 mg prolonged-release tablet
Each tablet contains guanfacine hydrochloride equivalent to 3 mg of
guanfacine.
_Excipient(s) with known effect_
Each tablet contains 37.81 mg of lactose (as monohydrate).
Intuniv 4 mg prolonged-release tablet
Each tablet contains guanfacine hydrochloride equivalent to 4 mg of
guanfacine.
_Excipient(s) with known effect_
Each 4 mg tablet contains 50.42 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet
Intuniv 1 mg prolonged-release tablet
7.14 mm round, white to off-white tablets debossed with ‘1MG’ on
one side and ‘503’ on the other
side.
3
Intuniv 2 mg prolonged-release tablet
12.34 mm x 6.10 mm oblong shaped, white to off-white tablets debossed
with ‘2MG’ on one side and
“503” on the other side.
Intuniv 3 mg prolonged-release tablet
7.94 mm round, green tablets debossed with ‘3MG’ on one side and
‘503’ on the other side.
Intuniv 4 mg prolonged-release tablet
12.34 mm x 6.10 mm oblong shaped, green tablets debossed with
‘4MG’ on on
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