Primidone 50mg tablets

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Primidone

থেকে পাওয়া:

Teva UK 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; GTIN: 5060311320032

তথ্য লিফলেট

PATIENT INFORMATION LEAFLET
PRIMIDONE AUDEN 50 MG & 250 MG TABLETS
_ _
_ _
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.
IN THIS LEAFLET:
_ _
1. What PRIMIDONE is and what it is used for
2. What you need to know before you take PRIMIDONE Tablets
3. How to take PRIMIDONE Tablets
4. Possible side effects
5. How to store PRIMIDONE Tablets
6. Contents of the pack and other information
1. WHAT PRIMIDONE IS AND WHAT IT IS USED FOR
Primidone Tablets belongs to a group of medicines used to treat
seizures.
Primidone 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 PRIMIDONE TABLETS
DO NOT TAKE PRIMIDONE IF YOU:
•
Are allergic (hypersensitive) to primidone, a substance called
phenobarbitone, or to any
of the other ingredients of Primidone (these are listed in Section 6:
Further
information).
•
Have porphyria (a rare inherited disorder of metabolism) or anyone in
your family has
it.
SPECIAL PRECAUTIONS
Check with your doctor or pharmacist before taking your medicine if
any of the following applies
to you:
•
Have ever had problems with your breathing, kidneys or liver.
•
Are pregnant or are trying to become pregnant (see beneath for further
information)
If you go into hospital, tell the medical staff that you are taking
Primidone.
A small number of people being treated with anti-epileptics such as
primidone have had
thoughts of harming or killing themselves. If at any time you have
these thoughts, immediately
contact your doctor.

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