Primidone 250mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Primidone

Tilgjengelig fra:

Teva UK Ltd

ATC-kode:

N03AA03

INN (International Name):

Primidone

Dosering :

250mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Caution - AMP level prescribing advised

Produkt oppsummering:

BNF: 04080100; GTIN: 5060311320025

Informasjon til brukeren

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.

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Primidone Auden 250 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg primidone.
Each tablet also contains 55.25 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Primidone 250 mg Tablets are white to off white, circular uncoated
tablets, diameter
11.5 mm with ‘PR’ embossed on one side of the break line and
‘250’ 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.
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 day's dose may be
given in the