MEDIKINET MR CAPSULES 5MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Methylphenidate 4.35mg eqv Methylphenidate Hydrochloride

Available from:

HYPHENS PHARMA PTE. LTD.

ATC code:

N06BA04

Pharmaceutical form:

CAPSULE, DELAYED RELEASE PELLETS

Composition:

Methylphenidate 4.35mg eqv Methylphenidate Hydrochloride 5mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

MEDICE Arzneimittel Pütter GmbH & Co. KG

Authorization status:

ACTIVE

Authorization date:

2015-03-16

Summary of Product characteristics

1
PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
MEDIKINET MR
5 mg capsules
MEDIKINET MR
10 mg capsules
MEDIKINET MR
20 mg capsules
MEDIKINET MR
30 mg capsules
MEDIKINET MR
40 mg capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MEDIKINET
MR
5 mg capsules
Each capsule contains 5 mg methylphenidate hydrochloride,
corresponding to 4.35 mg
methylphenidate.
Excipients: 63.57 mg – 72.71 mg sucrose/capsule
MEDIKINET MR
10 mg capsules
Each capsule contains 10 mg methylphenidate hydrochloride,
corresponding to 8.65
mg methylphenidate.
Excipients: 127.14 mg – 145.42 mg sucrose/capsule
MEDIKINET MR
20 mg capsules
Each capsule contains 20 mg methylphenidate hydrochloride,
corresponding to 17.30
mg methylphenidate.
Excipients: 114.65 mg – 131.13 mg sucrose/capsule
MEDIKINET MR
30 mg capsules
Each capsule contains 30 mg methylphenidate hydrochloride,
corresponding to 25.95
mg
methylphenidate.
Excipients: 69.60 mg – 79.61 mg sucrose/capsule
MEDIKINET MR
40 mg capsules
Each
modified-release
capsule
contains
40
mg
methylphenidate
hydrochloride,
corresponding to 34.60 mg methylphenidate.
Excipients: 92.80 mg – 106.14 mg sucrose/capsule
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified-release capsules, hard
MEDIKINET MR 5 MG
capsules
White opaque capsules size 3 with a black imprint containing white and
blue pellets.
MEDIKINET MR 10 MG
capsules
Amethyst-white opaque capsules size 3 with a black imprint containing
white and blue
pellets.
MEDIKINET MR 20 MG
capsules
Amethyst opaque capsules size 3 with a black imprint containing white
and blue pellets.
MEDIKINET MR 30 MG
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
capsules
Hard capsules size 2 with dark violet opaque cap with a white imprint
and a grey opaque
body with a black imprint containing white and blue pellets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ATTENTION-DEFICIT/HYPERACTIVIT