FINGOLIMOD SANDOZ fingolimod (as hydrochloride) 0.5 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fingolimod hydrochloride, Quantity: 0.56 mg (Equivalent: fingolimod, Qty 0.5 mg)

Available from:

Sandoz Pty Ltd

INN (International Name):

Fingolimod hydrochloride

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: mannitol; iron oxide yellow; magnesium stearate; Gelatin; titanium dioxide

Administration route:

Oral

Units in package:

84, 28, 7

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

FINGOLIMOD SANDOZ is indicated for the treatment of adult and paediatric patients of 10 years of age and above with relapsing forms of multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

Product summary:

Visual Identification: Size 3 capsule with 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.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 18 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2017-05-26

Patient Information leaflet

FINGOLIMOD SANDOZ®
1
FINGOLIMOD SANDOZ®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.

This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING FINGOLIMOD SANDOZ?
Fingolimod Sandoz contains the active ingredient fingolimod
hydrochloride. Fingolimod Sandoz is used to treat relapsing forms of
multiple sclerosis in adults, children and adolescents (10 years of
age and above). For more information, see Section
1. Why am I
using Fingolimod Sandoz? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE FINGOLIMOD SANDOZ?
Do not use if you have ever had an allergic reaction to fingolimod
hydrochloride or any of the ingredients listed at the end of the
CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS,
TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO
BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see
Section
2. What should I know before I use Fingolimod
Sandoz? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Fingolimod Sandoz and affect how it
works. A list of these medicines is in Section 3. What if I
am taking other medicines? in the full CMI.
4.
HOW DO I USE FINGOLIMOD SANDOZ?
ADULTS: The usual dose is one 0.5 mg capsule taken once a day.
CHILDREN AND ADOLESCENTS: The dose is dependent on body weight.
More instructions can be found in Section 4. How do I use Fingolimod
Sandoz?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING FINGOLIMOD SANDOZ?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Fingolimod Sandoz.
•
Tell your doctor about any changes in your vision.
•
Tell your doctor straight away if you think you have an infection,
fever, or feel like you have the flu.
•
Talk to your doctor straight away if you notice any skin nodules (e.g.
shiny pearly nodules), patches
or open sores that d

Summary of Product characteristics

1
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PI – FINGOLIMOD SANDOZ
® (FINGOLIMOD) CAPSULES
1
NAME OF THE MEDICINE
The active ingredient of FINGOLIMOD SANDOZ is fingolimod.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fingolimod hydrochloride is a white to almost white crystalline powder
which is freely soluble in
water. Fingolimod is a base with pKa of 7.82. Therefore, it has high
solubility at low pH and very low
solubility at high pH (e.g. < 0.01 mg/mL at pH 6.8). Relevant
distribution coefficients are 22.3 in _n_-
Octanol/water and 1290 in _n_-Octanol/hydrochloric acid 0.1N.
0.25 mg hard capsules: Each FINGOLIMOD SANDOZ capsule contains 0.28 mg
fingolimod
hydrochloride (equivalent to 0.25 mg fingolimod), mannitol, hyprolose,
hydroxypropylbetadex,
magnesium stearate, gelatin, titanium dioxide and iron oxide yellow.
0.5 mg hard capsules: Each FINGOLIMOD SANDOZ capsule contains 0.56 mg
fingolimod
hydrochloride (equivalent to 0.5 mg fingolimod), mannitol, magnesium
stearate, titanium dioxide,
iron oxide yellow and gelatin.
Excipients with known effect: Gelatin may contain residual sulfites.
3
PHARMACEUTICAL FORM
FINGOLIMOD SANDOZ 0.25 mg capsule: white to almost white powder in
ivory opaque (body and cap),
size 3, with black radial imprint “FTY 0.25mg” on cap and black
radial band on body.
FINGOLIMOD SANDOZ 0.5 mg capsule: white to almost white powder in
white opaque body and bright
yellow opaque cap gelatin capsules, size 3, radial imprint with black
ink “FTY 0.5 mg” on cap and two
radial bands imprinted on body with yellow ink.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
FINGOLIMOD SANDOZ is indicated for the treatment of adult and
paediatric patients of 10 years of
age and above with relapsing forms of multiple sclerosis to reduce the
frequency of relapses and to
delay the progres