ropinirole hydrochloride 1 mg
INDICATIONS & USAGE Parkinson’s Disease Ropinirole Tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. The effectiveness of Ropinirole Tablets were demonstrated in randomized, controlled trials in patients with early Parkinson’s disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials). Restless Legs Syndrome Ropinirole Tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with moderate-to-severe RLS.
Alembic Pharmaceuticals Limited
ROUND GREEN H 123
H 123 ROUND GREEN
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HOW SUPPLIED Tablets Each circular, biconvex, film-coated tablet contains ropinirole as follows: 0.25 mg: white tablets debossed with “H” on one side and “121” on other side NDC 46708-030-30 bottle of 30 tablets NDC 46708-030-31 bottle of 100 tablets 0.5 mg: yellow tablets debossed with “H” on one side and “122” on other side NDC 46708-031-30 bottle of 30 tablets NDC 46708-031-31 bottle of 100 tablets 1 mg: green tablets debossed with “H” on one side and “123” on other side NDC 46708-032-30 bottle of 30 tablets NDC 46708-032-31 bottle of 100 tablets 2 mg: peach tablets debossed with “H” on one side and “124” on other side NDC 46708-033-30 bottle of 30 tablets NDC 46708-033-31 bottle of 100 tablets 3 mg: purple tablets debossed with “H” on one side and “125” on other side NDC 46708-034-30 bottle of 30 tablets NDC 46708-034-31 bottle of 100 tablets 4 mg: Pale brown tablets debossed with “H” on one side and “126” on other side NDC 46708-035-30 bottle of 30 tablets NDC 46708-035-31 bottle of 100 tablets 5 mg: blue tablets debossed with “H” on one side and “127” on other side NDC 46708-036-30 bottle of 30 tablets NDC 46708-036-31 bottle of 100 tablets STORAGE: Protect from light and moisture. Close container tightly after each use. Store at controlled room temperature 20°-25°C (68°-77°F) [see USP]. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Village Panelav, P. O. Tajpura, Near Baska, Taluka-Halol, Panchmahal, Gujarat, India. Revision Date: 09/2019
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