RITALIN SR 20 MG TABLETS

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

METHYLPHENIDATE HYDROCHLORIDE

Διαθέσιμο από:

NOVARTIS ISRAEL LTD

Φαρμακολογική κατηγορία (ATC):

N06BA04

Φαρμακοτεχνική μορφή:

TABLETS

Σύνθεση:

METHYLPHENIDATE HYDROCHLORIDE 20 MG

Οδός χορήγησης:

PER OS

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

PATHEON INC., CANADA

Θεραπευτική περιοχή:

METHYLPHENIDATE

Θεραπευτικές ενδείξεις:

Attention deficit hyperactivity disorders . Narcolepsy.

Ημερομηνία της άδειας:

2013-10-31

Φύλλο οδηγιών χρήσης

.ﺀﺎﻤﻟﺍ ﻦﻣ ﺔﺌﻴﻠﻣ ﺱﺄﻛ ﻊﻣ
ﺹﺮﻘﻟﺍ ﻊﻠﺑ ﺐﺠﻳ
.ﻎﻠﻣ 10 ﻦﻴﻟﺎﺘﻳﺭ ﺹﺍﺮﻗﺃ ﺮﻄﺷ
ﻥﺎﻜﻣﻹﺎﺑ
ﻰﻠﻋ ﻱﺬﻟﺍ ﺮﻄﺸﻟﺍ ﻂﺨﺑ
ﺔﻧﺎﻌﺘﺳﻹﺍ ﺐﺠﻴﻓ ،ﺹﺮﻗ ﻒﺼﻧ ﻦﻋ
ﺓﺭﺎﺒﻋ ﻲﺋﺍﻭﺪﻟﺍ ﺭﺍﺪﻘﻤﻟﺍ ﻥﺎﻛ
ﺍﺫﺇ
.ﻲﺋﺍﻭﺪﻟﺍ ﺭﺍﺪﻘﻤﻟﺍ ﺔﻗﺩ ﻥﺎﻤﻀﻟ
ﺹﺍﺮﻗﻷﺍ ﺮﻄﺷ ﺓﺍﺩﺃ ﻝﺎﻤﻌﺘﺳﺇ
ﻥﺎﻜﻣﻹﺎﺑ .ﻩﺮﻄﺸﻟ ﺹﺮﻘﻟﺍ
_:ﺹﺍﺮﻗﺃ ﻎﻠﻣ 20 _
_SR_
_ ﻦﻴﻟﺎﺘﻳﺭ ﻝﻭﺎﻨﺗ ﺔﻴﻔﻴﻛﻭ ﻰﺘﻣ_
ﺔﺒﺟﻭ ﺪﻌﺑ ﻞﻀﻔﻳﻭ ﻡﺎﻌﻄﻟﺍ ﺔﺒﺟﻭ
ﺪﻌﺑ
ﹰ
ﻻﺎﺣ ﻎﻠﻣ 20
SR
ﻦﻴﻟﺎﺘﻳﺭ ﺹﺍﺮﻗﺃ ﻝﻭﺎﻨﺗ ﺐﺠﻳ
.ﺔﻴﻨﻏ ﺭﻮﻄﻓ
.ﺀﺎﻤﻟﺍ ﻊﻣ ﻞﻣﺎﻜﻟﺍ ﻪﻠﻜﺸﺑ
ﺹﺮﻘﻟﺍ ﻊﻠﺑ ﺐﺠﻳ
.ﺹﺮﻘﻟﺍ ﻖﺤﺳ ﻭﺃ ﻎﻀﻣ ﺯﻮﺠﻳ ﻻ
.ﻎﻠﻣ 20
SR
ﻦﻴﻟﺎﺘﻳﺭ ﺹﺍﺮﻗﺃ ﺮﻄﺷ ﻥﺎﻜﻣﻹﺎﺑ
ﺲﻴﻟ
ﺐﺠﻳ ﻦﻜﻟ ،ﻡﺎﻌﻄﻟﺍ ﻊﻣ ﺎﻬﻟﻭﺎﻨﺗ
ﻥﺎﻜﻣﻹﺎﺒﻓ ،ﻦﻄﺒﻟﺍ ﻲﻓ ﺝﺎﻋﺰﻧﺇ
ﻚﻟ ﺐﺒﺴﺗ ﺹﺍﺮﻗﻷﺍ ﺖﻧﺎﻛ ﺍﺫﺇ
.(ﻡﺎﻌﻃ ﻥﻭﺩ ﻦﻣ
ﹰ
ﺎﻤﺋﺍﺩ ﻭﺃ ﻡﺎﻌﻃ ﻊﻣ
ﹰ
ﺎﻤﺋﺍﺩ :ﻱﺃ) ﺔﻘﻳﺮﻄﻟﺍ ﺲﻔﻨﺑ
ﹰ
ﺎﻤﺋﺍﺩ ﺎﻬﻟﻭﺎﻨﺗ ﻰﻠﻋ ﺹﺮﺤﻟﺍ
.ﻡﺍﻭﺪﻟﺍ ﻰﻠﻋ
ﹰ
ﻼﺛﺎﻤﺘﻣ ﺀﺍﻭﺪﻟﺍ ﺮﻴﺛﺄﺗ ﻥﻮﻜﻴﺳ
ﺍﺬﻜﻫﻭ
ﺖﻴﻗﻮﺘﻟﺍ ﻝﻮﺣ ﺐﻴﺒﻄﻟﺍ ﺮﺸﺘﺳﺇ
.ﻡﻮﻨﻟﺍ ﺔﻠﻗ ﺐﺒﺴﻳ ﻥﺃ ﻦﻴﻟﺎﺘﻳﺭ
ﻥﺄﺷ ﻦﻣ ﻰﺿﺮﻤﻟﺍ ﺾﻌﺑ ﻯﺪﻟ
.ﻦﻴﻟﺎﺘﻳﺭ ﻦﻣ ﺮﻴﺧﻷﺍ ﻲﺋﺍﻭﺪﻟﺍ
ﺭﺍﺪﻘﻤﻟﺍ ﻝﻭﺎﻨﺘﻟ ﻡﻮﻴﻟﺍ ﻝﻼﺧ
ﺢﻴﺤﺼﻟﺍ
_:ﺝﻼﻌﻟﺍ ﺓﺮﺘﻓ_
.ﺐﻴﺒ�

Αρχείο Π.Χ.Π.

Page 1
RIT API MAY20 V11
New Zealand Data Sheet March 2020
PRESCRIBING INFORMATION
1. PRODUCT NAME
RITALIN
® 10 MG TABLETS
RITALIN
® SR 20 MG TABLETS
RITALIN
® LA 10MG, 20 MG, 30 MG AND 40 MG MODIFIED-RELEASE CAPSULES
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
The active substance is methylphenidate hydrochloride (INN for
alpha-phenyl-2-piperidine
acetic acid methyl ester).
Ritalin tablet contains 10 mg methylphenidate hydrochloride.
Ritalin SR tablet contains 20 mg methylphenidate hydrochloride.
Ritalin LA capsule contains 10mg, 20 mg, 30 mg and 40 mg
methylphenidate hydrochloride.
3. PHARMACEUTICAL FORM
TABLET 10 MG:
Immediate release 10mg tablets (divisible). A round, flat, white
tablet with bevelled edges
containing 10mg methylphenidate. Imprinted CG on one side and A/B with
a score on the
other.
SR TABLET:
Sustained release 20mg tablets (non-divisible). White to off-white,
round, biconvex, bevel-
edged, film-coated tablet, containing 20 mg of methylphenidate.
Branded with CIBA on one
side and 16 on the other side in black ink.
LA CAPSULE 10 MG:
Modified-release hard capsule. White to off white beads that are
roughly spherical in shape in
a light brown and white capsule with imprint NVR and R10 in
tan-coloured ink.
LA CAPSULE 20 MG:
Modified-release hard capsule. White to off-white beads that are
roughly spherical in shape in
a white capsule with imprint NVR and R20 in tan-coloured ink.
LA CAPSULE 30 MG:
Modified-release hard capsule. White to off-white beads that are
roughly spherical in shape in
a yellow capsule with imprint NVR and R30 in tan-coloured ink.
LA CAPSULE 40 MG:
Modified-release hard capsule. White to off-white beads that are
roughly spherical in shape in
a light brown capsule with imprint NVR and R40 in tan-coloured ink.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD):
Page 2
RIT API MAY20 V11
New Zealand Data Sheet March 2020
Ritalin 10 mg, Ritalin SR 20 mg, Ritalin LA 10mg, 20mg, 30mg, 40mg.
NARCOLEPSY:
Ritalin 10 mg a