Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4 HF, United Kingdom
Risperidone 0.5 mg Film-coated Tablets.
Risperidone 1 mg Film-coated Tablets.
Risperidone 2 mg Film-coated Tablets.
Risperidone 3 mg Film-coated Tablets.
Risperidone 4 mg Film-coated Tablets.
Risperidone 6 mg Film-coated Tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Risperidone Accord 0.5 mg film-coated tablets are brick red coloured, round, biconvex, film-coated tablet, plain on both sides. Risperidone Accord 1 mg film-coated tablets are white to off white, capsule shaped, biconvex film-coated tablet, plain on both sides. Risperidone Accord 2 mg film-coated tablets are light orange coloured, capsule shaped, biconvex film-coated tablet, plain on both sides. Risperidone Accord 3 mg film-coated tablets are light yellow coloured, oval shaped, biconvex film-coated tablet with a break line on one side and plain on other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Risperidone Accord 4 mg film-coated tablets are green coloured, capsule shaped, biconvex film-coated tablet plain on both sides. Risperidone Accord 6 mg film-coated tablets are yellow coloured, round, biconvex, film-coated tablet plain on both sides. |
Each film-coated tablet contains 0.5 mg of risperidone.
Excipient with known effect: Each film-coated tablet contains 63.65 mg lactose (as lactose monohydrate).
Each film-coated tablet contains 1 mg of risperidone.
Excipient with known effect: Each film-coated tablet contains 127.30 mg lactose (as lactose monohydrate).
Each film-coated tablet contains 2 mg of risperidone.
Excipients with known effect: Each film-coated tablet contains 126.35 mg lactose (as lactose monohydrate), and 0.02 mg of lake of sunset yellow (E110).
Each film-coated tablet contains 3 mg of risperidone.
Excipient with known effect: Each film-coated tablet contains 189.53 mg lactose (as lactose monohydrate).
Each film-coated tablet contains 4 mg of risperidone.
Excipient with known effect: Each film-coated tablet contains 124.45 mg lactose (as lactose monohydrate).
Each film-coated tablet contains 6 mg of risperidone.
Excipients with known effect: Each film-coated tablet contains 122.55 mg lactose (as lactose monohydrate) and 0.01 mg of lake of sunset yellow (E110).
For a full list of excipients see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Risperidone |
Risperidone is a selective monoaminergic antagonist with unique properties. Although risperidone is a potent D2 antagonist, which is considered to improve the positive symptoms of schizophrenia, it causes less depression of motor activity and induction of catalepsy than classical antipsychotics. |
| List of Excipients |
|---|
|
Tablet Core: Lactose monohydrate Tablet coating (for 0.5 mg): Hypromellose (E464) Tablet coating (for 1 mg): Hypromellose (E464) Tablet coating (for 2 mg): Hypromellose (E464) Tablet coating (for 3 mg): Hypromellose (E464) Tablet coating (for 4 mg): Hypromellose (E464) Tablet coating (for 6 mg): Hypromellose (E464) |
Risperidone is packed in PVC/PVdC/Al blister of 20, 28, 30, 50, 60, 90, 100 and 120 tablets.
Not all pack sizes may be marketed.
Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4 HF, United Kingdom
Risperidone 0.5 mg Film-coated Tablets: PL 20075/0007
Risperidone 1 mg Film-coated Tablets: PL 20075/0008
Risperidone 2 mg Film-coated Tablets: PL 20075/0009
Risperidone 3 mg Film-coated Tablets: PL 20075/0010
Risperidone 4 mg Film-coated Tablets: PL 20075/0011
Risperidone 6 mg Film-coated Tablets: PL 20075/0012
16/09/2008
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