GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Methylphenidate Hydrochloride Extended-Release Capsules 10mg
2. Methylphenidate Hydrochloride Extended-Release Capsules 15mg
3. Methylphenidate Hydrochloride Extended-Release Capsules 20mg
4. Methylphenidate Hydrochloride Extended-Release Capsules 30mg
5. Methylphenidate Hydrochloride Extended-Release Capsules 40mg
6. Methylphenidate Hydrochloride Extended-Release Capsules 50mg
7. Methylphenidate Hydrochloride Extended-Release Capsules 60mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Methylphenidate Hydrochloride Extended-Release Capsules 10mg v Each hard gelatin extended-Release capsule contains:
Methylphenidate Hydrochloride……………10mg
Excipients………………………………………………q. s
Approved Colors are used in capsule shells.

2. Methylphenidate Hydrochloride Extended-Release Capsules 15mg
Each hard gelatin extended-Release capsule contains:
Methylphenidate Hydrochloride……………15mg
Excipients………………………………………………q. s
Approved Colors are used in capsule shells.

3. Methylphenidate Hydrochloride Extended-Release Capsules 20mg
Each hard gelatin extended-Release capsule contains:
Methylphenidate Hydrochloride……………20mg
Excipients………………………………………………q. s
Approved Colors are used in capsule shells.

4. Methylphenidate Hydrochloride Extended-Release Capsules 30mg
Each hard gelatin extended-Release capsule contains:
Methylphenidate Hydrochloride……………30mg
Excipients……………………………………………q. s
Approved Colors are used in capsule shells

5. Methylphenidate Hydrochloride Extended-Release Capsules 40mg
Each hard gelatin extended-Release capsule contains:
Methylphenidate Hydrochloride……………40mg
Excipients………………………………………………q. s
Approved Colors are used in capsule shells

6. Methylphenidate Hydrochloride Extended-Release Capsules 50mg
Each hard gelatin extended-Release capsule contains:
Methylphenidate Hydrochloride……………50mg
Excipients………………………………………………q. s
Approved Colors are used in capsule shells

7. Methylphenidate Hydrochloride Extended-Release Capsules 60mg
Each hard gelatin extended-Release capsule contains:
Methylphenidate Hydrochloride……………60mg
Excipients………………………………………………q. s
Approved Colors are used in capsule shells

THERAPEUTIC INDICATIONS:

Methylphenidate is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years of age and older and for the treatment of narcolepsy.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Dispense in container with child resistant closure.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH THE CAPSULES OR BEADS INSIDE THE CAPSULES.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from light and moisture.
Dosage: As directed by the Psychiatrists.
Attach dispensing label as per end country.

Methylphenidate Hydrochloride Extended-Release Capsules 50mg Technical Specification:

Product Name: Methylphenidate Hydrochloride Extended-Release Capsules
Brand Name: Generic
Strength: (10mg), (15mg), (20mg), (30mg), (40mg), (50mg), (60mg)
Dosage Form: Capsules (Hard-gelatin)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use: Central Nervous System Stimulants.
Indication: Methylphenidate is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years of age and older and for the treatment of narcolepsy.
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Methylphenidate Hydrochloride Extended-Release Capsules 10mg
2. Methylphenidate Hydrochloride Extended-Release Capsules 15mg
3. Methylphenidate Hydrochloride Extended-Release Capsules 20mg
4. Methylphenidate Hydrochloride Extended-Release Capsules 30mg
5. Methylphenidate Hydrochloride Extended-Release Capsules 40mg
6. Methylphenidate Hydrochloride Extended-Release Capsules 50mg
7. Methylphenidate Hydrochloride Extended-Release Capsules 60mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Methylphenidate Hydrochloride Extended-Release Capsules 10mg
Each hard gelatin extended-Release capsule contains:
Methylphenidate Hydrochloride……………10mg
Excipients………………………………………………q. s
Approved Colors are used in capsule shells.

2. Methylphenidate Hydrochloride Extended-Release Capsules 15mg
Each hard gelatin extended-Release capsule contains:
Methylphenidate Hydrochloride……………15mg
Excipients………………………………………………q. s
Approved Colors are used in capsule shells.

3. Methylphenidate Hydrochloride Extended-Release Capsules 20mg
Each hard gelatin extended-Release capsule contains:
Methylphenidate Hydrochloride……………20mg
Excipients………………………………………………q. s
Approved Colors are used in capsule shells.

4.Methylphenidate Hydrochloride Extended-Release Capsules 30mg
Each hard gelatin extended-Release capsule contains:
Methylphenidate Hydrochloride……………30mg
Excipients……………………………………………q. s
Approved Colors are used in capsule shells

5. Methylphenidate Hydrochloride Extended-Release Capsules 40mg
Each hard gelatin extended-Release capsule contains:
Methylphenidate Hydrochloride……………40mg
Excipients………………………………………………q. s
Approved Colors are used in capsule shells

6. Methylphenidate Hydrochloride Extended-Release Capsules 50mg
Each hard gelatin extended-Release capsule contains:
Methylphenidate Hydrochloride……………50mg
Excipients………………………………………………q. s
Approved Colors are used in capsule shells

7. Methylphenidate Hydrochloride Extended-Release Capsules 60mg
Each hard gelatin extended-Release capsule contains:
Methylphenidate Hydrochloride……………60mg
Excipients………………………………………………q. s
Approved Colors are used in capsule shells

THERAPEUTIC INDICATIONS:

Methylphenidate is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years of age and older and for the treatment of narcolepsy.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Dispense in container with child resistant closure.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH THE CAPSULES OR BEADS INSIDE THE CAPSULES.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from light and moisture.

Dosage: As directed by the Psychiatrists.

Attach dispensing label as per end country.