Land: Singapore
Taal: Engels
Bron: HSA (Health Sciences Authority)
Methylphenidate 4.35mg eqv Methylphenidate Hydrochloride
HYPHENS PHARMA PTE. LTD.
N06BA04
CAPSULE, DELAYED RELEASE PELLETS
Methylphenidate 4.35mg eqv Methylphenidate Hydrochloride 5mg
ORAL
Prescription Only
MEDICE Arzneimittel Pütter GmbH & Co. KG
ACTIVE
2015-03-16
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 Lees het volledige document