Medikinet MR 5mg Hard Capsules

Țară: Malaezia

Limbă: engleză

Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredient activ:

Methylphenidate

Disponibil de la:

HYPHENS PHARMA SDN. BHD.

INN (nume internaţional):

Methylphenidate

Unități în pachet:

30 capsule Capsules

Produs de:

MEDICE Arzneimittel PÃ?Â?tter GmbH

Prospect

MEDIKINET MR
®
HARD CAPSULES
Methylphenidate Hydrochloride 5mg, 10mg, 20mg, 30mg & 40mg
_Consumer Medication Information Leaflet (RiMUP)_
1
WHAT IS IN THIS LEAFLET
1.
What Medikinet MR is used for
2.
How Medikinet MR works
3.
Before you use Medikinet MR
4.
How to use Medikinet MR
5.
While you are using Medikinet
MR
6.
Side effects
7.
Storage
and
disposal
of
Medikinet
MR
8.
Product description
9.
Manufacturer
and
product
registration
holder
10.
Date of revision
1.
WHAT MEDIKINET MR IS USED FOR
Medikinet
MR
contains
active
substance
_methlyphenidate_
_ _
_hydrochloride._
It is a mild stimulant
acting
on
central
nervous
system(CNS).
Medikinet
MR
is
used
to
treat
_attention_
_ _
_deficit hyperactivity disorder_
(ADHD).
-
It is used in children and young
people between the ages of 6 to
18
and in adults from the age of
18 years
on.
-
It
is
used
only
after
trying
treatments
which
do
not
involve
medicines.
Such
as
counselling
and
behavioural
therapy.
Medikinet
MR
is
not
for
in
treatment
for
ADHD
in
children
under 6
years of age as safety and
benefits is unknown.
2.
HOW MEDIKINET MR WORKS
Medikinet MR improves the activity
of
certain parts of the brain which are
under-
active.
The medicine
can
help
improve
attention
(attention
span),
concentration
and
reduce
impulsive behaviour.
The medicine is given as part of a
treatment programme, which usually
includes:
_-_
_ _
Psychological
_-_
_ _
Educational and
_-_
_ _
Social therapy
Medikinet MR treatment must only
be
initiated by, and used under the
supervision
of,
a
specialist
in
behavioural
disorders.
A
very
thorough assessment of the ailments
is
necessary.
The
accompanying
treatment
programmes
can
contribute
to
an
improved
management of the disorder.
3.
BEFORE YOU USE MEDIKINET
MR
When you must not use it
Do not take Medikinet MR if you or
your child has the followings:
-
Allergic
(hypersensitive)
to
_methylphenidate_
or any of
the
other
ingredients
of
Medikinet
MR
(refer to
section
‘ Other
information’).
-
Thyroid
problem
-
Increased
pressure
in
the
eye
(glaucoma)
-
Tum

Caracteristicilor produsului

1
PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
MEDIKINET MR 5 MG
hard capsules
MEDIKINET MR 10 MG
hard capsules
MEDIKINET MR 20 MG
hard capsules
MEDIKINET MR 30 MG
hard capsules
MEDIKINET MR 40 MG
hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MEDIKINET MR 5 MG
hard capsules
Each hard capsule contains 5 mg methylphenidate hydrochloride,
corresponding to 4.325 mg
methylphenidate.
Excipient with known effect: 63.57 mg – 72.71 mg sucrose/hard
capsule
MEDIKINET MR 10 MG
hard capsules,
Each hard capsule contains 10 mg methylphenidate hydrochloride,
corresponding to 8.65 mg
methylphenidate.
Excipient with known effect: 127.14 mg – 145.42 mg sucrose/ hard
capsule
MEDIKINET MR 20 MG
hard capsules
Each hard capsule contains 20 mg methylphenidate hydrochloride,
corresponding to 17.30 mg
methylphenidate.
Excipient with known effect: 114.65 mg – 131.13 mg sucrose/ hard
capsule
MEDIKINET MR 30 MG
hard capsules
Each hard capsule contains 30 mg methylphenidate hydrochloride,
corresponding to 25.95 mg
methylphenidate.
Excipient with known effect: 69.60 mg – 79.61 mg sucrose/ hard
capsule
MEDIKINET MR 40 MG
hard capsules
Each hard capsule contains 40 mg methylphenidate hydrochloride,
corresponding to 34.60 mg
methylphenidate.
Excipient with known effect: 92.80 mg – 106.14 mg sucrose/ hard
capsule
For
the
full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsules
FOR SPECIALIST’S USE ONLY
2
MEDIKINET MR 5 MG
hard capsules
White opaque capsules size 3 with a black imprint containing white and
blue pellets.
MEDIKINET MR 10 MG
hard capsules
Amethyst-white opaque capsules size 3 with a black imprint containing
white and blue
pellets.
MEDIKINET MR 20 MG
hard capsules
Amethyst opaque capsules size 3 with a black imprint containing white
and blue pellets.
MEDIKINET MR 30 MG
hard capsules
Hard capsules size 3 with a dark violet opaque cap with a white
imprint and a light grey opaque body
with a black imprint containing white and blue pellets.
MEDIKINET MR 40 MG
hard capsules
Hard capsules size