Primidone Auden 250mg Tablets

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: myHealthbox

Ակտիվ բաղադրիչ:

primidone

Հասանելի է:

Auden Mckenzie (Pharma Division) Ltd

ATC կոդը:

N03AA03

INN (Միջազգային անվանումը):

primidone

Դոզան:

250mg

Դեղագործական ձեւ:

Tablets

Կառավարման երթուղին:

Oral use

Միավորները փաթեթում:

Pack size of 100 tablets

Ռեկվիզորի տեսակը:

POM - Prescription Only Medicine

Պատրաստված է:

Tiofarma

Թերապեւտիկ խումբ:

Antiepileptics (barbiturates and derivatives)

Թերապեւտիկ ցուցումներ:

It 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.

Լիազորման կարգավիճակը:

Authorised

Հաստատման ամսաթիվը:

2015-05-22

Տեղեկատվական թերթիկ

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. If you are not sure if any 
of the above applies to you, talk to your doctor or 
pharmacist before taking this medicine. 

TAKING OTHER MEDICINES 
Please tell your doctor or pharmacist if you are taking or 
have recently taken any other medicines, including medicines 
obtained without a prescription.  Taking some medicines 
together can be harmful. 

In particular, tell your doctor or pharmacist if you are taking 
any

Ապրանքի հատկությունները

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 amou