Primidone 50mg tablets

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Primidone

Dostupné s:

SERB

ATC kód:

N03AA03

INN (Mezinárodní Name):

Primidone

Dávkování:

50mg

Léková forma:

Oral tablet

Podání:

Oral

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 04080100; GTIN: 5060311320032

Informace pro uživatele

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

Charakteristika produktu

OBJECT 1
PRIMIDONE 50MG TABLET
Summary of Product Characteristics Updated 18-Aug-2014 | SERB
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
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 and may be administered using
either the 50 mg or 250 mg
strength tablets.
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:
Milligrams
Adults and children over 9 years
750 to 1500
Children 6 to 9 years
750 to 1000
Children 2 to 5 years
500 to 750
Children up to 2 years
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 give