RUZURGI amifampridine 10 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amifampridine, Quantity: 10 mg

Available from:

Lacuna Pharma Pty Ltd

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: magnesium stearate; colloidal anhydrous silica; sodium starch glycollate type A; calcium hydrogen phosphate dihydrate; microcrystalline cellulose

Administration route:

Oral

Units in package:

100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

RUZURGI is indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and children aged 6 years and above.

Product summary:

Visual Identification: Scored, oval, white to off-white, debossed with '10 | 110' on one side and 'JACOBUS' on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2021-09-14

Patient Information leaflet

Ruzurgi®
1
RUZURGI®
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. Please report side effects. See the full CMI for
further details.
1.
WHY AM I TAKING RUZURGI?
RUZURGI contains the active ingredient amifampridine. RUZURGI is used
to treat Lambert-Eaton myasthenic syndrome (LEMS) in
adults and children aged 6 years and above.
For more information, see Section 1. Why am I taking RUZURGI?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE RUZURGI?
Do not take if you have ever had an allergic reaction to
amifampridine, fampridine or other aminopyridines, or any of the
ingredients listed at the end of the CMI. Do not take if you have a
history of seizures, fits or convulsions.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS,
INCLUDING PROBLEMS WITH YOUR KIDNEYS OR LIVER, HEART, 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 take
RUZURGI?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with RUZURGI and increase the side
effects of RUZURGI when taken together.
See Section 3. What if I am taking other medicines?
in the full CMI.
4.
HOW DO I TAKE RUZURGI?
•
Follow the instructions provided and use until your doctor tells you
to stop.
•
How much RUZURGI you should take will depend upon your weight and
whether you have any other medical conditions such
as problems with your liver or kidneys. Your doctor will determine the
right dose for you and how often you should take it.
•
You may need to split the tablets or prepare an oral suspension of
RUZURGI tablets to get the right dose for you.
•
If you have problems taking tablets or require a feeding tube, you may
need to prepare an oral suspension of RUZURGI
tablets.
More instructions can be found in Section 4. How do I take RUZURGI?
in the full CMI.
5.
WHAT

Summary of Product characteristics

RUZURGI PI September 2022 version 1.1
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
https://www.tga.gov.au/reporting-problems
AUSTRALIAN PRODUCT INFORMATION – RUZURGI
(AMIFAMPRIDINE) TABLETS
1
NAME OF THE MEDICINE
Amifampridine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each RUZURGI tablet contains 10 mg of amifampridine.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Tablets
Each tablet is functionally scored, oval, white to off-white, and
debossed with “10 | 110” on
one side and “JACOBUS” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
RUZURGI is indicated for the treatment of Lambert-Eaton myasthenic
syndrome (LEMS) in
adults and children aged 6 years and above.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
Dosing should be individualised based on clinical circumstances,
patient response, and
patient population. The dose should be gradually titrated to the
optimal effective dose with
the minimum of side effects. Once achieved, this optimal dose should
be maintained, and
dosing frequency should be adjusted, as needed.
The recommended oral dose is based on body weight (see Table 1).
▼
RUZURGI PI September 2022 version 1.1
2
Safety and effectiveness in paediatric patients below the age of 6
years have not been
established.
If a dose is missed by a few hours, patients who experience weakness
should take their usual
dose as soon as possible. If it is close to their next dose, they
should take their medication at
the next regular interval. Patients should not take double or extra
doses.
TABLE 1: RECOMMENDED DOSE FOR PATIENTS 6 YEARS OF AGE AND OLDER
AGE
INITIAL DOSE
TITRATION
REGIMEN
MAXIMUM
RECOMMENDED
SINGLE DOSE
MAXIMUM TOTAL
DAILY MAINTENANCE
DOSE
All patients
weighing less
than 45 kg
5 mg to 10 mg
daily, in divided
doses (2 to 3
times per day)
Increase daily in
2.5 mg