OSPOLOT sulthiame 200 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sulthiame, Quantity: 200 mg

Available from:

Phebra Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: purified talc; macrogol 4000; maize starch; lactose monohydrate; titanium dioxide; Gelatin; hypromellose; colloidal anhydrous silica; magnesium stearate

Administration route:

Oral

Units in package:

200 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 01 JANUARY 1991 : Behavioural disorders associated with epilepsy; hyperkinetic behaviour; temporal lobe epilepsy; myoclonic seizures; grand mal attacks; Jacksonian seizures.

Product summary:

Visual Identification: white filmcoated round tablets debossed "200" on one side and scored on the reverse side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

1991-10-08

Patient Information leaflet

Ospolot
®
Page 1 of 4
_Version 07 _
OSPOLOT
®
_Sulthiame _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ospolot. It does not
contain all 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 risks of
you taking Ospolot against the benefits
they expect it will 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 OSPOLOT IS USED
FOR
Ospolot is used to control epilepsy.
Epilepsy is a condition where you have
repeated seizures or fits. There are
many different types of seizures,
ranging from mild to severe.
_ _
This medicine belongs to a group of
medicines called sulphonamides.
These medicines are thought to work
by controlling brain chemicals that
send signals to nerves so that seizures
do not happen.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
BEFORE YOU TAKE
OSPOLOT
_WHEN YOU MUST NOT TAKE IT_
_ _
DO NOT TAKE OSPOLOT IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing sulthiame
•
any of the ingredients listed at the
end of this leaflet
•
any other similar medicines such as
sulphonamides
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.
DO NOT DRINK ALCOHOL WHILE YOU ARE
BEING TREATED WITH OSPOLOT.
YOU SHOULD NOT TAKE THIS MEDICINE
AFTER THE EXPIRY DATE PRINTED ON THE
PACK, OR IF THE PACKAGING IS TORN OR
SHOWS SIGNS OF TAMPERING.
If it has expired or is damaged, return it
to your pharmacist for disposal.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START TAKING THIS MEDICINE,
TALK TO YOUR
DOCTOR
.
_BEFORE YOU START TO TAKE IT _
TELL YOUR DOCTOR IF YOU HAVE ALLERGIES
TO

Summary of Product characteristics

PRODUCT INFORMATION
Australian Product Information – Ospolot
®
50 mg and 200 mg Tablets
Page 1 of 9
Version 10
OSPOLOT
®
(SULTHIAME) TABLETS
1
NAME OF THE MEDICINE
Sulthiame
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ospolot film-coated tablets contain 50 mg or 200 mg of sulthiame.
Excipients of known effect: sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Ospolot 50 mg tablets are white film-coated round tablets, debossed
"50" on one side and plain on the reverse
side.
Ospolot 200 mg tablets are white film-coated round tablets debossed
"200" on one side and scored on the reverse
side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Ospolot is indicated as an anticonvulsant for behavioural disorders
associated with epilepsy; hyperkinetic
behaviour; temporal lobe epilepsy; myoclonic seizures; grand mal
attacks; Jacksonian seizures.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Caution should be used when establishing dosage in the presence of
renal or hepatic impairment.
Treatment should start with a low dosage which is gradually increased
until clinical response is satisfactory. This
may require four weeks. Ospolot tablets should preferably be swallowed
whole with a little fluid after meals.
ADULTS
Initially 100 mg twice daily or 50 mg three times daily (optimum: 200
mg three times daily).
CHILDREN
Initially 3-5 mg/kg daily in equal divided doses (optimum: 10-15 mg/kg
daily in equal divided doses).
PRODUCT INFORMATION
OSPOLOT
®
Australian Product Information – Ospolot
®
50 mg and 200 mg Tablets
Page 2 of 9
Version 10
4.3
C
ONTRAINDICATIONS
Ospolot may not be used in cases of
•
known hypersensitivity to sulthiame, other sulfonamides or to any of
the excipients listed in
Section 6.1 List of Excipients.
Sulthiame should not be used in patients with
•
known acute porphyria
•
hyperthyroidism or arterial hypertension.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
Ospolot should be administered to patients with a history of
psychiatric disorders or