EPIRAMAX 25 topiramate 25 mg tablets blister pack

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

topiramate, Quantity: 25 mg

Disponibbli minn:

Arrotex Pharmaceuticals Pty Ltd

INN (Isem Internazzjonali):

Topiramate

Għamla farmaċewtika:

Tablet, film coated

Kompożizzjoni:

Excipient Ingredients: microcrystalline cellulose; sodium starch glycollate; pregelatinised maize starch; lactose; saccharin sodium; magnesium stearate; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin; Flavour

Rotta amministrattiva:

Oral

Unitajiet fil-pakkett:

blister pack 60 tablets

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

Epilepsy (adults and children 2 years and over),? Monotherapy in patients with newly diagnosed epilepsy,? conversion to monotherapy in patients with epilepsy,? Add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with Lennox-Gastaut syndrome.,Migraine (adult),Prophylaxis of migraine headache in adults. The usefulness of topiramate in the acute treatment of migraine headache has not been studied.

Sommarju tal-prodott:

Visual Identification: White, round, coated tablet debossed with 'T1' on one side and plain on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2008-01-14

Fuljett ta 'informazzjoni

EPIRAMAX- Consumer Medicine Information
Page 1 of 5
EPIRAMAX
®
_TOPIRAMATE _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about EPIRAMAX.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the expected benefits of you taking
EPIRAMAX against the risks this
medicine could have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT EPIRAMAX IS USED FOR
EPIRAMAX is used for the
treatment of various types of
epilepsy in adults and children over
2 years of age, and for the
prevention of migraines in adults.
It prevents seizures and migraines
by acting on the nerves and
chemicals in the brain.
Your doctor may have prescribed
this medicine on its own or in
addition to another medicine for
controlling your seizures or
migraines.
Your doctor may have prescribed
EPIRAMAX for another reason. Ask
your doctor if you have any
questions about why this medicine
has been prescribed for you.
There is no evidence that
EPIRAMAX is addictive.
EPIRAMAX is only available with a
doctor's prescription.
BEFORE YOU TAKE IT
_When you must not take it _
DO NOT TAKE EPIRAMAX IF YOU
HAVE AN ALLERGY
(HYPERSENSITIVITY) TO:
•
topiramate
•
any of the ingredients. See
Product Description at the
end of this leaflet for a list of
ingredients.
•
if the tablets or capsules are
not as described under
Product Description at the
end of this leaflet.
Symptoms of an allergic or
hypersensitivity reaction
may include:
•
rash, itching or hives on the
skin
•
shortness of breath,
wheezing or difficulty
breathing
•
swelling of the face, lips,
tongue or other parts of the
body
_BEFORE YOU START TO TAKE IT _
YOU MUST TELL YOUR DOCTOR IF YOU:
•
are pregnant or planning to
become pregnant. EPIRAMAX
has caused harm to the
developing foetus when
administere

Karatteristiċi tal-prodott

1
AUSTRALIAN PRODUCT INFORMATION -
EPIRAMAX (TOPIRAMATE) TABLETS
1
NAME OF THE MEDICINE
Topiramate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Epiramax tablets come in four strengths and contain 25 mg, 50 mg, 100
mg or 200 mg of Topiramate.
Excipients of known effect: Lactose and Saccharin.
For the full list of excipients, SEE SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
EPIRAMAX 25
White, round, coated tablet debossed with ‘TI’ on one side and
plain on the
other side.
EPIRAMAX 50 Yellow, round, coated tablet debossed with ‘TI’ over ‘50’ on
one side and
plain on the other side.
EPIRAMAX 100 Yellow, round, coated tablet debossed with ‘TI’ over ‘100’ on
one side and
plain on the other side.
EPIRAMAX 200
Pink, round, coated tablet debossed with ‘TI’ over ‘200’ on
one side and
plain on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
EPILEPSY (ADULTS AND CHILDREN 2 YEARS AND OVER)
•
Monotherapy in patients with newly diagnosed epilepsy
•
conversion to monotherapy in patients with epilepsy
•
Add-on therapy in partial onset seizures (with or without secondary
generalised seizures),
primary generalised tonic-clonic seizures or drop attacks associated
with Lennox-Gastaut
syndrome.
2
MIGRAINE (ADULT)
Prophylaxis of migraine headache in adults. The usefulness of
topiramate in the acute treatment of
migraine headache has not been studied.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Epiramax tablets should be swallowed whole. It can be taken without
regard to meals.
EPILEPSY
For optimum seizure control in both adults and children, it is
recommended that therapy should be
initiated at a low dose followed by slow titration to an effective
dose. Dose titration should be guided
by clinical outcome. The recommended dosages of Epiramax in adults and
children for epilepsy are
summarised in Table 1.
MONOTHERAPY
In newly diagnosed epileptic patients, monotherapy should be initiated
at a low dose (see Table 1).
In patients who are being converted to Epiramax monotherapy,
consider