headache
bruising
abdominal pain
anxiety
These are not all of the possible side effects of FYCOMPA. For more information ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store FYCOMPA?
Store FYCOMPA tablets at room temperature between 68°F to 77°F (20°C to 25°C).
Store FYCOMPA oral suspension below 86°F (30°C). Do not freeze.
Replace the cap tightly after opening.
Use FYCOMPA oral suspension within 90 days after the bottle is first opened.
Keep FYCOMPA and all medicines out of the reach of children.
General information about the safe and effective use of FYCOMPA.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about FYCOMPA that is written for health professionals. Do not use FYCOMPA for a condition for which it was not prescribed. Do not give FYCOMPA to other people, even if they have the same symptoms you have. It may harm them.
What are the ingredients in FYCOMPA?
Active ingredient: perampanel
Inactive ingredients (tablets): lactose monohydrate, low substituted hydroxypropyl cellulose, povidone, microcrystalline cellulose, magnesium stearate, hypromellose, polyethylene glycol, talc, and titanium dioxide. Tablets of different strengths also may contain yellow ferric oxide (10 mg and 2 mg), red ferric oxide (2 mg, 4 mg, 6 mg, 8 mg), black ferric oxide (8 mg), and FD&C blue # 2 (indigo carmine) aluminum lake (10 mg and 12 mg).
Inactive ingredients (oral suspension): sorbitol, microcrystalline cellulose, carboxymethylcellulose sodium, poloxamer, simethicone, citric acid, sodium benzoate, and purified water.
Marketed by Eisai Inc., Woodcliff Lake, NJ 07677
FYCOMPA® is a trademark owned by Eisai R&D Management Co. Ltd. For more information, go to www.FYCOMPA.com or 1-888-274-2378.
This Medication Guide has been approved by the U.S. Food and Drug Administration Revised April 2016
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INSTRUCTIONS FOR USE
Instructions for Use
FYCOMPA® (fī-COM-puh)
(perampanel)
Oral Suspension
Read this Instructions for Use before you start using FYCOMPA Oral Suspension and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.
Prepare the FYCOMPA Oral Suspension dose
You will need the following supplies: See Figure A
FYCOMPA Oral Suspension bottle
Bottle adapter
Dosing syringe (2 dosing syringes are included in the FYCOMPA Oral Suspension box)
Step 1. Remove the FYCOMPA Oral Suspension bottle, bottle adapter, and 2 syringes from the box. See Figure A
Step 2. Shake the bottle well before each use. See Figure B
Step 3. Uncap the bottle and insert the bottle adapter into the bottle by pressing downward. See Figure C and Figure D
After the bottle adapter is in place, it cannot be removed.
Step 4. Check the dose in milliliters (mL) as prescribed by your healthcare provider. Find this number on the syringe. See Figure E
Step 5. Push the plunger of the syringe all the way down then insert the syringe into the upright bottle through the opening in the bottle adapter. See Figure F
Step 6. With the syringe in place, turn the bottle upside down. Pull the plunger to withdraw the dose pre |
