Mysoline 250mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Primidone

Предлага се от:

Sigma Pharmaceuticals Plc

АТС код:

N03AA03

INN (Международно Name):

Primidone

дозиране:

250mg

Лекарствена форма:

Oral tablet

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Caution - AMP level prescribing advised

Каталог на резюме:

BNF: 04080100

Листовка

MYSOLINE 250MG TABLETS
(primidone)
PATIENT INFORMATION LEAFLET
Your medicine is called Mysoline 250mg Tablets, but will be referred
to as
Mysoline throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
*
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. Do not pass it on to
others. It
may harm them, even if their symptoms are the same as yours.
*
If any of the side effects gets serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
What Mysoline is and what it is used for
Before you use Mysoline
How to use Mysoline
Possible side effects
How to store Mysoline
Further information
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).
BEFORE YOU USE MYSOLINE
DO NOT TAKE MYSOLINE IF YOU:
*
are allergic (hypersensitive) to primidone, a substance called
phenobarbitone, or to any of the other ingredients of Mysoline (these
are
listed in Section 6: Further information).
*
have porphyria (a rare inherited disorder of metabolism) or anyone in
your
family has it.
TAKE SPECIAL CARE WITH MYSOLINE IF 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
Mysoline.
A small number of people being treated with anti-epileptics such as
mysoline have had thoughts of harming or killing themselves. If at any
time
you have these thoughts, immediately contact your doctor.
TAKING OTHER MEDICINES
Please tell your doctor if you are taking or have recently taken any
other
medicines, including medicines obtained without a prescription.

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mysoline 250mg Tablets
Primidone SERB 250mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Primidone Ph. Eur. 250 mg
3
PHARMACEUTICAL FORM
White uncoated oral tablets.
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 _
Posology
Primidone should be started at the lowest possible dose in the evening
and thereafter the dose
should be increase in a stepwise manner to minimise adverse reactions.
Epilepsy
Treatment must always be planned on an individual basis. In many
patients primidone
treatment may be given as monotherapy, but in some, Primidone will
need to be combined
with other anticonvulsants or with supporting therapy.
In certain patients, it may be 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 daily dose may
be given in the evening;
2) If the attacks are associated with some particular event such as
menstruation, a slight
increase in the appropriate dose is often beneficial.
•
In adults:
Initial dose: it is usually 125 mg in a single intake in the evening.
Then every 3 days, the daily
dose is increased in a stepwise approach by 125 mg until the patient
is receiving 500 mg daily.
Thereafter, every 3 days, the daily dose (given in 2 divided doses) is
increased by 250 mg,
until control is obtained or until the maximum tolerated dose and may
be up to 1.5 g daily.
Maintenance dose:
Milligrams
Adults
750 - 1500
•
In children:
Initial dose: it is usually 125 mg in a single intake in the evening.
Then every 3 days, the daily
dose is increased in a stepwise approach by 125 mg until the patient
is receiving 500 mg daily.
Thereafter, every 3 days, the daily dose (given in 2