Country: European Union
Language: English
Source: EMA (European Medicines Agency)
levodopa, carbidopa
Amneal Pharma Europe Ltd
N04BA02
levodopa, carbidopa
Anti-Parkinson drugs
Parkinson Disease
Symptomatic treatment of adult patients with Parkinson’s disease
Revision: 3
Withdrawn
2015-11-19
31 B. PACKAGE LEAFLET 32 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NUMIENT 95 MG/23.75 MG MODIFIED-RELEASE HARD CAPSULES NUMIENT 145 MG/36.25 MG MODIFIED-RELEASE HARD CAPSULES NUMIENT 195 MG/48.75 MG MODIFIED-RELEASE HARD CAPSULES NUMIENT 245 MG/61.25 MG MODIFIED-RELEASE HARD CAPSULES Levodopa/Carbidopa READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Numient is and what it is used for 2. What you need to know before you take Numient 3. How to take Numient 4. Possible side effects 5. How to store Numient 6. Contents of the pack and other information 1. WHAT NUMIENT IS AND WHAT IT IS USED FOR Numient contains two different medicines called levodopa and carbidopa in one hard capsule. - levodopa turns into a material called ‘dopamine’ in your brain. The dopamine helps to improve the symptoms of your Parkinson’s disease. - carbidopa belongs to a group of medicines called ‘aromatic amino acid decarboxylase inhibitors’. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body. Numient is used to improve the symptoms of Parkinson’s disease in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NUMIENT _ _ DO NOT TAKE NUMIENT: - if you are allergic to levodopa or carbidopa, or any of the other ingredients of this medicine (listed in section 6); - if you have narrow-angle glaucoma (an eye disorder); - if you have phaeochromocytoma (a rare tumour of the adrenal gland); - if you are taking certain medicines for treating depression [non-selective Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Numient 95 mg/23.75 mg modified-release hard capsules Numient 145 mg/36.25 mg modified-release hard capsules Numient 195 mg/48.75 mg modified-release hard capsules Numient 245 mg/61.25 mg modified-release hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 95 mg/23.75 mg modified-release hard capsules Each capsule contains 95 mg levodopa and 23.75 mg carbidopa (as monohydrate) 145 mg/36.25 mg modified-release hard capsules Each capsule contains 145 mg levodopa and 36.25 mg carbidopa (as monohydrate) 195 mg/48.75 mg modified-release hard capsules Each capsule contains 195 mg levodopa and 48.75 mg carbidopa (as monohydrate) 245 mg/61.25 mg modified-release hard capsules Each capsule contains 245 mg levodopa and 61.25 mg carbidopa (as monohydrate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Modified-release hard capsule 95 mg/23.75 mg modified-release hard capsule White body and a blue cap of 18 x 6 mm imprinted with “IPX066” and “95” in blue ink. 145 mg/36.25 mg modified-release hard capsule Light blue body and a blue cap of 19 x 7 mm imprinted with “IPX066” and “145” in blue ink. 195 mg/48.75 mg modified-release hard capsule Yellow body and a blue cap of 24 x 8 mm imprinted with “IPX066” and “195” in blue ink. 245 mg/61.25 mg modified-release hard capsule Blue body and a blue cap of 23 x 9 mm imprinted with “IPX066” and “245” in blue ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of adult patients with Parkinson’s disease. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Numient is recommended to be dosed orally, approximately every 6 hours. Dosing this medicinal product more than 5 times per day is not recommended. 3 Each capsule strength may be used alone, or in combination with other capsule strengths as required. Use of this medicinal product with other levodopa containing medicinal products has not been studied. Dose recommen Read the complete document