Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Fycompa Oral suspension
Sorbitol (E420) liquid (crystallising), Microcrystalline cellulose (E460), Carmellose sodium (E466), Citric acid, anhydrous (E330), Sodium benzoate (E211), Poloxamer 188, Simethicone emulsion 30% (containing: purified water, silicone oil, polysorbate 65, methylcellulose, silica gel, macrogol stearate, sorbic acid, benzoic acid (E210) and sulfuric acid) and Purified water.

2 mg tablet
Core
Lactose monohydrate, Low-substituted hydroxypropyl cellulose, Povidone, Magnesium stearate
Film coating
Hypromellose 2910; Talc; Macrogol 8000; Titanium dioxide; Ferric oxide, yellow; Ferric oxide, red


4 mg tablet
Core
Lactose monohydrate, Low-substituted hydroxypropyl cellulose, Povidone , Magnesium stearate
Film coating
Hypromellose 2910; Talc; Macrogol 8000; Titanium dioxide ; Ferric oxide, red 
6 mg tablet
Core
Lactose monohydrate, Low-substituted hydroxypropyl cellulose, Povidone , Microcrystalline cellulose, Magnesium stearate
Film coating
Hypromellose 2910; Talc; Macrogol 8000; Titanium dioxide ; Ferric oxide, red 

8 mg tablet
Core
Lactose monohydrate, Low-substituted hydroxypropyl cellulose, Povidone, Microcrystalline cellulose, Magnesium stearate
Film coating
Hypromellose 2910; Talc; Macrogol 8000; Titanium dioxide; Ferric oxide, red; Ferric oxide, black

10 mg tablet
Core
Lactose monohydrate, Low-substituted hydroxypropyl cellulose, Povidone, Microcrystalline cellulose, Magnesium stearate
Film coating
Hypromellose 2910; Talc; Macrogol 8000; Titanium dioxide; Ferric oxide, yellow; FD&C Blue #2 Indigo carmine aluminium lake

12 mg tablet
Core
Lactose monohydrate, Low-substituted hydroxypropyl cellulose, Povidone, Microcrystalline cellulose, Magnesium stearate
Film coating
Hypromellose 2910; Talc; Macrogol 8000; Titanium dioxide; FD&C Blue #2 Indigo carmine aluminium lake

6.2   Incompatibilities

Not applicable.
6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.

Fycompa Oral suspension
After first opening: Use within 90 days and not later than the expiry date indicated on the packaging materials.

6.4   Special precautions for storage

Store below 30°C. Do not freeze.

6.5   Nature and contents of container

Fycompa Oral suspension
Polyethylene terephthalate (PET) bottle with a child-resistant (CR) polypropylene (PP) closure; each bottle contains 340 ml of suspension in an outer cardboard carton.
Each carton contains one bottle, two 20 mL graduated oral dosing syringes and an LDPE press-in bottle adapter (PIBA). The oral dosing syringes are graduated in 0.5 ml increments.

Film-coated tablets
PVC/aluminium blisters
2 mg – pack of 7, 10, 14, 28, 84, 98
4 mg – packs of 7, 10, 14, 28, 84, 98
6 mg – packs of 7, 10, 14, 28, 84, 98
8 mg – packs of 7, 10, 14, 28, 84, 98
10 mg – packs of 7, 10, 14, 28, 84, 98
12 mg – packs of 7, 10, 14, 28, 84, 98

Not all pack sizes may be marketed.
6.6   Special precautions for disposal

No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


7.    MANUFACTURER:
Eisai Manufacturing Limited, Hatfield, Hertfordshire, UK