VIMCOSA lacosamide 50 mg tablet bottle

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

lacosamide, Quantity: 50 mg

Հասանելի է:

Pharmacor Pty Ltd

Դեղագործական ձեւ:

Tablet, film coated

Կազմը:

Excipient Ingredients: colloidal anhydrous silica; hyprolose; magnesium stearate; microcrystalline cellulose; crospovidone; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black; indigo carmine aluminium lake

Կառավարման երթուղին:

Oral

Միավորները փաթեթում:

56 tablets

Ռեկվիզորի տեսակը:

(S4) Prescription Only Medicine

Թերապեւտիկ ցուցումներ:

Lacosamide film-coated tablets are indicated as: ? monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. ? add-on therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older. ? add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older.

Ապրանքի ամփոփագիր:

Visual Identification: Pink, oval shaped, film coated tablets debossed with "LAC" on one side and "50" on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

2022-02-08

Տեղեկատվական թերթիկ

VIMCOSA
1
VIMCOSA
_lacosamide _
_ _
_ _
_ _
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor
or pharmacist.
VIMCOSA film-coated tablets contains the active ingredient lacosamide.
VIMCOSA
work by controlling
brain chemicals which send signals to nerves so that seizures do not
happen.
For more information, see Section 1. Why am I using VIMCOSA? In the
full CMI.
Do not use if you have ever had an allergic reaction to VIMCOSA 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
VIMCOSA? In the full CMI
.
Some medicines may interfere with VIMCOSA 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.
Your doctor will tell you how much VIMCOSA you will need to take each
day. This may depend on your
condition, your body weight, and whether or not you are taking any
other medicines.
More instructions can be found in Section 4. How do I use VIMCOSA? In
the full CMI.
THINGS
YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
VIMCOSA.
•
If you are about to be started on any new medicine, remind your doctor
and pharmacist that
you are taking LACOSAMIDE.
•
Stop taking VIMCOSA and contact your doctor immediately if you become
pregnant while
you are taking VIMCOSA.
THINGS
YOU
SHOULD NOT DO
•
Do not give this medicine to anyone else, even if their condition
seems similar to yours.
•
Do not use it to treat any other complaints unless your doctor tells
you to.
DRIVING
OR
USING MACHINES
•
Be careful before you drive or use any machines or tools until you
know how VIMCOSA
affects you.
•
VIMCOSA cause problems with your ability to drive a car or operate
machinery.
DRINKING
ALCOHOL
•
Tell your doctor if you drink alcohol.
LOOKING
AFT

Ապրանքի հատկությունները

AUSTRALIAN PRODUCT INFORMATION
VIMCOSA (LACOSAMIDE) TABLETS
1.
NAME OF THE MEDICINE
Lacosamide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
VIMCOSA
film-coated
tablets
are
available
in
strengths
of
50
mg,
100 mg, 150 mg and 200 mg lacosamide.
For the full list of excipients, see section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
Film-coated tablets
VIMCOSA film coated tablets 50 mg
Pink, oval shaped, film coated tablets debossed with "LAC" on one side
and "50" on other
side.
VIMCOSA film coated tablets 100 mg
Dark yellow, oval shaped, film coated tablets debossed with "LAC" on
one side and "100" on
other side.
VIMCOSA film coated tablets 150 mg
Peach, oval shaped, film coated tablets debossed with "LAC" on one
side and "150" on other
side.
VIMCOSA film coated tablets 200 mg
Blue, oval shaped, film coated tablets debossed with "LAC" on one side
and "200" on other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VIMCOSA film-coated tablets are indicated as:

monotherapy in the treatment of partial-onset seizures with or without
secondary
generalisation in patients with epilepsy aged 16 years and older.

add-on therapy in the treatment of partial-onset seizures with or
without secondary
generalisation in patients with epilepsy aged 4 years and older.

add-on therapy in the
treatment of primary
generalised tonic-clonic
seizures in
patients with idiopathic generalised epilepsy aged 4 years and older.
4.2
DOSE AND METHOD OF ADMINISTRATION
_Lacosamide oral solution and injection are unavailable in this brand
however are available _
_in other brands. Where correct dosing requires lacosamide oral
solution and injection _
_formulations refer to the specific product information for these
formulations for their _
_complete dosage and administration instructions. _
VIMCOSA therapy can be initiated with either oral or IV
administration. The film-coated
tablets may be taken with or without food. The film-coated tablets
must not be divided.
Conversion to or from oral and IV administration can be done directl