Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50–58 Baggot Street Lower, Dublin 2, IRELAND
Intuniv 1 mg prolonged-release tablets.
Intuniv 2 mg prolonged-release tablets.
Intuniv 3 mg prolonged-release tablets.
Intuniv 4 mg prolonged-release tablets.
| Pharmaceutical Form |
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Prolonged-release tablet. Intuniv 1 mg tablet: 7.14mm round, white to off-white tablets debossed with ‘1MG’ on one side and ‘503’ on the other side. Intuniv 2 mg tablet: 12.34mm x 6.10mm oblong shaped, white to off-white tablets debossed with ‘2MG’ on one side and “503” on the other side. Intuniv 3 mg tablet: 7.94mm round, green tablets debossed with ‘3MG’ on one side and ‘503’ on the other side. Intuniv 4 mg tablet: 12.34mm x 6.10mm oblong shaped, green tablets debossed with ‘4MG’ on one side and ‘503’ on the other side. |
Intuniv 1 mg tablet: Each tablet contains guanfacine hydrochloride equivalent to 1 mg of guanfacine.
Intuniv 2 mg tablet: Each tablet contains guanfacine hydrochloride equivalent to 2 mg of guanfacine.
Intuniv 3 mg tablet: Each tablet contains guanfacine hydrochloride equivalent to 3 mg of guanfacine.
Intuniv 4 mg tablet: Each tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacine.
Excipient(s) with known effect:
Each 1 mg tablet contains 22.41 mg of lactose (as monohydrate).
Each 2 mg tablet contains 44.82 mg of lactose (as monohydrate).
Each 3 mg tablet contains 37.81 mg of lactose (as monohydrate).
Each 4 mg tablet contains 50.42 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Guanfacine |
Guanfacine is a selective alpha2A-adrenergic receptor agonist in that it has 15-20 times higher affinity for this receptor subtype than for the alpha2B or alpha2C subtypes. Guanfacine is a non-stimulant. The mode of action of guanfacine in ADHD is not fully established. |
| List of Excipients |
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Hypromellose 2208 3 mg and 4 mg prolonged-release tablets also include: Indigo carmine aluminium lake (E132) |
The blister strips comprise of 2 layers, a clear thermoformable rigid film which is laminated with PCTFE to a PVC backing to which a push-through aluminium foil is adhered. The blisters are contained in cardboard cartons.
Intuniv 1 mg prolonged-release tablet: pack sizes: 7 or 28 tablets.
Intuniv 2 mg prolonged-release tablet: pack sizes: 7, 28 or 84 tablets.
Intuniv 3 mg prolonged-release tablet: pack sizes: 28 or 84 tablets.
Intuniv 4 mg prolonged-release tablet: pack sizes: 28 or 84 tablets.
Not all pack sizes may be marketed.
Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50–58 Baggot Street Lower, Dublin 2, IRELAND
Intuniv 1 mg tablet: EU/1/15/1040/001-002
Intuniv 2 mg tablet: EU/1/15/1040/003-005
Intuniv 3 mg tablet: EU/1/15/1040/006-007
Intuniv 4 mg tablet: EU/1/15/1040/008-009
Date of first authorisation: 17/09/2015
| Drug | Countries | |
|---|---|---|
| INTUNIV | Austria, Australia, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Japan, Lithuania, Netherlands, Poland, United Kingdom, United States |
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