FAMPYRA fampridine 10mg modified release tablets bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fampridine, Quantity: 10 mg

Available from:

Biogen Australia Pty Ltd

INN (International Name):

Fampridine

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; hypromellose; titanium dioxide; macrogol 400

Administration route:

Oral

Units in package:

14 tablets per bottle; 4 bottles per carton

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

FAMPYRA modified release tablets are indicated for the symptomatic improvement of walking ability in adult patients with Multiple Sclerosis who have shown improvement after 8 weeks of treatment

Product summary:

Visual Identification: White to off-white bi-convex oval shaped tablet with flat edge and debossed on one side with 'A10'; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-05-24

Patient Information leaflet

FAMPYRA
®
(FAM-PEER-A)
_Fampridine (fam-pri-deen)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FAMPYRA. It does
not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
benefits FAMPYRA is expected to
have for you, against the risks of
taking it.
IF YOU HAVE ANY QUESTIONS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST OR CONTACT
THE MULTIPLE SCLEROSIS (MS) SOCIETY
IN YOUR STATE OR REGION.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT FAMPYRA IS
USED FOR
FAMPYRA is used in adult patients
with Multiple Sclerosis (MS) to
improve walking. It belongs to a
group of medicines called potassium
channel blockers. They work by
stopping potassium leaving the nerve
cells which have been damaged by
MS.
This medicine is thought to work by
letting signals pass down the nerve
more normally, which allows you to
walk better.
Your doctor may prescribe
FAMPYRA for another purpose. Ask
your doctor if you have any questions
about why FAMPYRA has been
prescribed for you.
There is no information on the use of
this medicine in those below 18 years
of age.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
FAMPYRA
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE FAMPYRA IF:
1.
YOU HAVE AN ALLERGY TO
FAMPYRA OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET
Some of the symptoms of an
allergic reaction may include,
shortness of breath, wheezing or
difficulty breathing, swelling of
the face, lips, tongue or other
parts of the body, rash, itching or
hives on the skin.
2.
YOU ARE CURRENTLY TAKING OTHER
FORMS OF FAMPRIDINE (4-AMINO
PYRIDINE).
Taking FAMPYRA with other
forms of fampridine may increase
the risk of seizures, fits or
convulsions. ASK YOUR DOCTOR OR PHARMACIST
IF YOU ARE NOT SURE IF YOU HAVE
BEEN TAKING ONE OF THESE
MEDICINES.
3.
YOU HAVE EVER HAD A SEIZURE, OR
YOU HAVE BEEN TOLD BY YOUR
DOC

Summary of Product characteristics

FAMPYRA PI (version 020921)
1
AUSTRALIAN PRODUCT INFORMATION
FAMPYRA
® (FAMPRIDINE) 10 MG MODIFIED RELEASE (MR) TABLET
1
NAME OF THE MEDICINE
Fampridine, also known by its chemical name, 4-aminopyridine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FAMPYRA is a potassium channel blocker, available in a 10 mg tablet
strength. Each tablet
contains 10 mg fampridine, formulated as a modified release tablet for
twice-daily oral
administration. Each tablet also contains hypromellose,
microcrystalline cellulose, silicon
dioxide, magnesium stearate and the film coat (Opadry White Y-1-7000
E171) contains
hypromellose, titanium dioxide and macrogol 400.
3
PHARMACEUTICAL FORM
Modified release tablet.
FAMPYRA (fampridine) is a 10 mg modified release white to off-white,
film coated, oval
shaped, biconvex, non-scored tablet with flat edge, debossed with
"A10" on one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
FAMPYRA modified release tablets are indicated for the symptomatic
improvement of
walking ability in adult patients with Multiple Sclerosis (MS) who
have shown improvement
after 8 weeks of treatment.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended dosage of FAMPYRA for adults is one 10 mg tablet,
twice daily, taken
approximately 12 hours apart.
Tablets must be swallowed whole. As the tablets are modified release
tablets, doses cannot
be divided, crushed, dissolved, sucked or chewed. The tablets can be
taken with or without
food.
The usual dosing regime of one tablet in the morning and one tablet in
the evening taken 12
hours apart should always be followed. A double dose should not be
taken if a dose is
missed.
Patients with moderate to severe renal impairment (Creatinine
clearance <50 mL/min or
eGFR less than 59 mL/min/1.73m
2
) should be excluded from treatment (see Section 4.3
Contraindications).
FAMPYRA PI (version 020921)
2
As with all medicines, physicians should review the individual
benefit/risk of FAMPYRA
treatment with the individual patient to ensure continuing positive
benefit/risk. Prescri