FINGOLIS fingolimod (as hydrochloride) 0.5 mg capsules blister pack

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

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

Dostępny od:

Cipla Australia Pty Ltd

Forma farmaceutyczna:

Capsule, hard

Skład:

Excipient Ingredients: Gelatin; fumaric acid; stearic acid; pregelatinised maize starch; titanium dioxide; purified water; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Droga podania:

Oral

Sztuk w opakowaniu:

28, 84, 7

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

Fingolis is indicated for the treatment of Relapsing Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis with superimposed relapses to delay the progression of physical disability and reduce the frequency of relapse.

Podsumowanie produktu:

Visual Identification: White to off white powder in size 3 hard gelatin capsules with a white opaque body imprinted with 'MF' and a white opaque cap imprinted with '0.5 mg'; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status autoryzacji:

Registered

Data autoryzacji:

2019-04-09

Ulotka dla pacjenta

FINGOLIS
1
FINGOLIS
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 subject to additional monitoring. This will allow
quick identification of new safety information. You can
help by reporting any side effects you may get. You can report side
effects to your doctor, or directly at
www.tga.gov.au/reporting‐problems.
1.
WHY AM
I
USIN
G
FING
OL
IS
?
FINGOLIS contains the active ingredient fingolimod. FINGOLIS is used
to alter the way the body's immune system works and is
used to treat relapsing remitting multiple sclerosis (MS) and relapses
in patients with secondary progressive
M
S
For more information, see Section 1. Why am I using FINGOLIS? in the
full CMI.
2.
WHAT
SHOULD
I
KNOW BEFORE
I
USE
FING
OL
IS
?
Do not use if you have ever had an allergic reaction to FINGOLIS 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
FINGOLIS? in the full CMI.
3.
WHAT IF
I AM
TAKIN
G
OTH
ER ME
DICIN
ES?
Some medicines may interfere with FINGOLIS 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
FING
OL
IS
?
•
The usual dose is one capsule per day (0.5 mg of fingolimod).
More instructions can be found in Section 4. How do I use FINGOLIS? in
the full CMI.
5.
WHAT
SHOULD
I
KNOW W
HILE
USIN
G
FING
OL
IS
?
THINGS YOU
SHOULD DO
• Remind any doctor, dentist or pharmacist you visit that you are
using FINGOLIS.
• You should avoid becoming pregnant while taking FINGOLIS.
• Tell your doctor about any changes in your vision, in case of any
infection, flu, skin nodules, patches or
open sores.
THINGS YOU
SHOULD NOT DO
• Do not stop using this medicine suddenly
• You should not rec

Charakterystyka produktu

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 PRODUCT INFORMATION – FINGOLIS (FINGOLIMOD) CAPSULES
1. NAME OF THE MEDICINE
FINGOLIMOD.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each fingolimod capsule contains 0.56 mg fingolimod hydrochloride
(equivalent to 0.5 mg fingolimod).
Fingolimod hydrochloride is a white to off white crystalline powder
which is freely soluble in water.
Fingolimod is a base with pKa of 6.70. 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.
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
White to off white powder in size 3 hard gelatin capsules. Capsules
comprise a white opaque body
imprinted in black ink with ‘MF’ and white opaque cap imprinted in
black ink with ‘0.5mg’.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
FINGOLIS is indicated for the treatment of Relapsing Remitting
Multiple Sclerosis and Secondary
Progressive Multiple Sclerosis with superimposed relapses to delay the
progression of physical disability
and reduce the frequency of relapse.
4.2. DOSE AND METHOD OF ADMINISTRATION
The recommended dose of fingolimod is one 0.5 mg capsule taken orally
once daily, which can be taken
with or without food. If a dose is missed, treatment should be
continued with the next dose as planned.
On initiation of fingolimod treatment, after the first dose, it is
recommended that all patients be observed,
with hourly pulse and blood pressure measurement, for a period of 6
hours for signs and symptoms of
bradycardia. All patients should have an electrocardiogram performed
prior to dosing and at the end of the
6-hour monitoring period (see section 4.4 Spe