mpanied by nausea, vomiting and sensitivity to light (signs of migraine)
weakness
itchy, red, burning rash (signs of eczema)
hair loss
itching
weight loss
breathlessness
abnormal lung function test results starting after one month of treatment, remaining stable after that and reversible after treatment discontinuation
abnormal liver function test results
depression
eye pain
hypertension (Gilenya may cause a mild increase in blood pressure).
The above effects are common and non-serious. If any of these affects you severely, tell your doctor.
Tell your doctor immediately or go to Accident and Emergency if you notice any of the following:
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
sudden onset of rash or hives
yellow skin or eyes, light-coloured or darkening of the urine, unexplained nausea, vomiting, abdominal pain, tiredness or loss of appetite. Your doctor may request blood tests to check and to monitor your liver function and may consider stopping treatment if your liver problem is serious.
Tell your doctor if you notice anything else that is making you feel unwell.
Some people may have other side effects not yet known or mentioned in this leaflet.
After using Gilenya
Storage
Keep your medicine in the original container until it is time to take it.
Store it in a cool dry place where the temperature stays below 30°C.
Do not store Gilenya or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sills.
Keep the medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any capsules you have left over.
Product description
What it looks like
Gilenya 0.5 mg capsules are white opaque body and bright yellow opaque cap; radial imprint with black ink, "FTY 0.5 mg" on cap and two radial bands imprinted on the body with yellow ink, containing white to almost white powder.
Gilenya capsules are available in boxes containing 7 or 28 capsules.
Ingredients
Each Gilenya capsule contains 0.56 mg of fingolimod hydrochloride (equivalent to 0.5 mg of fingolimod) as the active ingredient. It also contains the following inactive ingredients:
mannitol
magnesium stearate
titanium dioxide
gelatin
Gilenya does not contain gluten, tartrazine or any other azo dyes.
Sponsor
Gilenya is supplied in Australia by:
NOVARTIS Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
North Ryde NSW 2113
Telephone: 1 800 671 203
Web site: www.novartis.com.au
® = Registered Trademark
This leaflet was prepared in
April 2011.
Australian Registration Number:
0.5 mg capsule - AUST R 169890
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