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Numient - patient leaflet, side effects, dosage

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Patient leaflet - Numient

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5. How to store Numient

Keep this medicine out of the sight and reach of children.

Store below 30 °C. Store the medicine in the original package, in order to protect from light and moisture.

Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP. The expiry date refers to the last day of that month. After opening the bottle, use within 90 days.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other informationWhat Numient contains- The active substances of Numient are levodopa and carbidopa

  • – Each 95 mg/23.75 mg modified-release hard capsule contains 95 mg levodopa and 23.75 mg carbidopa (as monohydrate)

  • – Each 145 mg/36.25 mg modified-release hard capsule contains 145 mg levodopa and

  • 36.25 mg carbidopa (as monohydrate)

  • – Each 195 mg/48.75 mg modified-release hard capsule contains 195 mg levodopa and

  • 48.75 mg carbidopa (as monohydrate)

  • – Each 245 mg/61.25 mg modified-release hard capsule contains 245 mg levodopa and

  • 61.25 mg carbidopa (as monohydrate)

  • – The other ingredients are cellulose, microcrystalline, mannitol, tartaric acid, ethylcellulose, hypromellose, sodium starch glycolate, sodium laurilsulfate, povidone, talc, methacrylic acid -methyl methacrylate copolymers (1:1), methacrylic acid – methyl methacrylate copolymers (1:2), triethyl citrate, croscarmellose sodium and magnesium stearate

What Numient looks like and contents of the pack

Numient is a modified-release hard capsule.

95 mg/23.75 mg modified-release hard capsule

White body and a blue cap of 18 × 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 × 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 × 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 × 9 mm imprinted with “IPX066” and “245” in blue ink.

es of 25,


Numient capsules are supplied in plastic bottles with a dessicant and a plastic cap, availa 100 or 240 hard capsules. Not all pack sizes may be marketed.

edicine is available on the European Medicines Agency web site:


Marketing Authorisation Holder

Amneal Pharma Europe Ltd 70 Sir John Rogerson’s Quay Dublin 2

Ireland

Manufacturer


Central Pharma Contract Packing Limited

Caxton Road, Bedford, Bedfordshire

MK41 0XZ

United Kingdom

44(0) 1234 227816

This leaflet was last revised in

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