Mysoline Tablets

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

primidone, Quantity: 250 mg

Available from:

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

INN (International Name):

Primidone

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: carmellose calcium; povidone; Gelatin; magnesium stearate; stearic acid

Administration route:

Oral

Units in package:

100 tablets, 200 tablets

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Management of grand mal and psychomotor (temporal lobe) epilepsy. It is also of value in the management of focal or jacksonian seizures, myoclonic jerks and akinetic attacks.

Product summary:

Visual Identification: White or virtually white, round biconvex, uncoated tablets, intagliated with an "M" on each side of a bisecting line on one face and plain on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

1991-07-11

Patient Information leaflet

MYSOLINE®
1
MYSOLINE®
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.
1.
WHY AM I USING MYSOLINE?
MYSOLINE contains the active ingredient Primidone. MYSOLINE is used to
control epilepsy.
For more information, see Section 1. Why am I using MYSOLINE?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE MYSOLINE?
Do not use MYSOLINE if you have ever had an allergic reaction to
Primidone 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
MYSOLINE?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may be affected by MYSOLINE or may affect how well
MYSOLINE works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE MYSOLINE?
•
Your doctor or pharmacist will tell you how many tablets you will need
to take each day
•
Follow the instructions provided and use MYSOLINE until your doctor
tells you to stop
More instructions can be found in Section 4. How do I use MYSOLINE? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING MYSOLINE?
Things you should
do
•
Remind any doctor, dentist or pharmacist you visit that you are using
MYSOLINE
•
Take your MYSOLINE regularly
•
Tell your doctor immediately if you have any thoughts about suicide or
doing harm to yourself
Things you should
not do
•
Do not stop taking MYSOLINE, or lower change the dosage, without
checking with your doctor
Driving or using
machines
•
Be careful before you drive or use any machines or tools until you
know how MYSOLINE affects you
Drinking alcohol
•
Be careful when drinking alcohol while you are using MYSOLINE as it
may increase the effects of
alcohol
Looking after
your medicine
•
Store it in a cool dry place away

Summary of Product characteristics

_Page 1 of 11_
AUSTRALIAN PRODUCT INFORMATION- MYSOLINE
® (PRIMIDONE)
1
NAME OF THE MEDICINE
Primidone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Mysoline tablet contains 250 mg primidone as the active
ingredient.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Tablets BP
White or virtually white, round biconvex, uncoated tablets,
intagliated with an “M” on each side
of a bisecting line on one face and plain on the other.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
Management of grand mal and psychomotor (temporal lobe) epilepsy:
It is also of value in the management of focal or Jacksonian seizures,
myoclonic jerks and
akinetic attacks.
4.2
DOSE
AND
METHOD
OF
ADMINSTRATION
Treatment must always be planned on an individual basis. In many
patients, it will be possible
to use Mysoline alone, but in some patients, Mysoline will need to be
combined with other
anticonvulsants.
Mysoline is usually given twice daily. Begin with 1/2 tablet once
daily late in the evening.
Every three days, increase the daily dosage by 1/2 tablet until the
patient is receiving 2 tablets
daily. Thereafter, every three days, increase the daily dosage by 1
tablet in adults or 1/2 tablet
in children under 9 years, until control is obtained or the maximum
tolerated dosage is being
given. This may be as much as 6 tablets/day in adults or 4 tablets/day
in children. See Table
1.
Table 1:
Average daily maintenance doses
Age Group
Tablets
mg
Children up to 2 years
1-2
250-500
Children 2-5 years
2-3
500-750
Children 6-9 years
3-4
750-1,000
Adults, children over 9
years
3-6
750-1,500
The total daily dose is usually best divided and given in two equal
amounts, one in the
morning and the other in the evening. In certain patients, it may be
considered advisable to
give a larger dose when the seizures are more frequent. For instance,
if the attacks are
nocturnal then all or most of the day's dose may be given in the
evening; or if the attacks are
Product Information - Australia
Page 2 of 11
associ