Primidone 50mg tablets

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Primidone

থেকে পাওয়া:

Alliance Healthcare (Distribution) Ltd

এটিসি কোড:

N03AA03

INN (আন্তর্জাতিক নাম):

Primidone

ডোজ:

50mg

ফার্মাসিউটিকাল ফর্ম:

Oral tablet

প্রশাসন রুট:

Oral

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 04080100

তথ্য লিফলেট

B. PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
MYSOLINE
50mg and 250mg Tablets
Primidone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Primidone is and what it is used for
2.
What you need to know before you take MYSOLINE
3.
How to take MYSOLINE
4.
Possible side effects
5.
How to store MYSOLINE
6.
Contents of the pack and other information
1.
WHAT MYSOLINE IS AND WHAT IT IS USED FOR
MYSOLINE contains primidone as the active ingredient; this belongs to
a group of medicines used to
treat seizures.
MYSOLINE is used for the treatment of certain types of epilepsy,
seizures (fits) or shaking attacks
(essential tremor).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYSOLINE
DO NOT TAKE MYSOLINE:

If you are allergic to primidone, phenobarbital, or to any of the
other ingredients of this medicine
(these are listed in Section 6: Further information).

If you have porphyria (a rare inherited disorder of metabolism) or
anyone in your family has it.
WARNINGS AND PRECAUTIONS
This medication is not effective in certain forms of epilepsy. Your
doctor will assess the need to
prescribe you this medicine depending on the form of epilepsy you are
suffering from.
Consult your doctor immediately if the frequency of your seizures
increases or if seizures of a
different type appear.
Talk to your doctor or pharmacist before taking MYSOLINE:

If you have ever had respiratory, kidneys or liver problems;

If you are pregnant or are trying to become pregnant (see beneath for
further information).
I

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Primidone Auden 50 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg primidone.
Each tablet also contains 11.05 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Primidone 50 mg Tablets are white to off white, circular uncoated
tablets,
diameter 6 mm with ‘PR’ embossed on one side of the break line and
‘50’ on
the other side of the break line.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Primidone is indicated in the 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.
Management of essential tremor.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Epilepsy_: Treatment must always be planned on an individual basis.
In many
patients it will be possible to use Primidone alone, but in some,
Primidone will
need to be combined with other anticonvulsants or with supporting
therapy.
Primidone is usually given twice daily. Begin with 125 mg once daily
late in
the evening. Every 3 days increase the daily dosage by 125 mg until
the
patient is receiving 500 mg daily. Thereafter, every 3 days increase
the daily
dosage by 250 mg in adults or 125 mg in children under 9 years - until
control
is obtained or the maximum tolerated dosage is being given. This may
be as
much as 1.5 g a day in adults; 1 g a day in children.
Average daily maintenance doses:
Tablets (250mg)
Milligrams
Adults and children
over 9 years
3 to 6
750 to 1500
Children 6 to 9 years
3 to 4
750 to 1000
Children 2 to 5 years
2 to 3
500 to 750
Children up to 2 years
1 to 2
250 to 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: 1) if the attacks are nocturnal then all or
most of the
da