Primidone Auden 50mg Tablets

Riik: Suurbritannia

keel: inglise

Allikas: myHealthbox

Toimeaine:

primidone

Saadav alates:

Auden Mckenzie (Pharma Division) Ltd

ATC kood:

N03AA03

INN (Rahvusvaheline Nimetus):

primidone

Annus:

50mg

Ravimvorm:

Tablets

Manustamisviis:

Oral use

Ühikuid pakis:

Pack size of 100 tablets

Retsepti tüüp:

POM - Prescription Only Medicine

Valmistatud:

Tiofarma

Terapeutiline rühm:

Antiepileptics (barbiturates and derivatives)

Näidustused:

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.

Volitamisolek:

Authorised

Loa andmise kuupäev:

2015-05-22

Infovoldik

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

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Primidone Auden 50 mg Tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each tablet contains 50 mg primidone.  

Each tablet also contains 11.05 mg of lactose monohydrate. 

For a full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Tablet 

Primidone 50 mg Tablets are white to off white, circular uncoated
tablets, 
diameter 6 mm with ‘PR’ embossed on one side of the break
line and ‘50’ 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. 

Average daily maintenance doses: 

 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