Mysoline 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Primidone

Available from:

SERB

ATC code:

N03AA03

INN (International Name):

Primidone

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04080100; GTIN: 5060033040058

Patient Information leaflet

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).

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
‘Mysoline 50mg Tablets’
“Primidone SERB 50mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50mg primidone.
For full list of excipients see section 6.1
3
PHARMACEUTICAL FORM
Tablet
White or virtually white, round, biconvex, uncoated tablets
intagliated with a
single M on one side and plain on the reverse.
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