Numient

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

levodopa, carbidopa

Available from:

Amneal Pharma Europe Ltd

ATC code:

N04BA02

INN (International Name):

levodopa, carbidopa

Therapeutic group:

Anti-Parkinson drugs

Therapeutic area:

Parkinson Disease

Therapeutic indications:

Symptomatic treatment of adult patients with Parkinson’s disease

Product summary:

Revision: 3

Authorization status:

Withdrawn

Authorization date:

2015-11-19

Patient Information leaflet

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

Summary of Product characteristics

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