GERICARB SR 400mg Milligram Tablets

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

CARBAMAZEPINE

Հասանելի է:

McDermott Laboratories Ltd t/a Gerard Laboratories

INN (Միջազգային անվանումը):

CARBAMAZEPINE

Դոզան:

400mg Milligram

Դեղագործական ձեւ:

Tablets

Ռեկվիզորի տեսակը:

Product subject to prescription which may be renewed (B)

Լիազորման կարգավիճակը:

Authorised

Հաստատման ամսաթիվը:

0000-00-00

Տեղեկատվական թերթիկ

PACKAGE LEAFLET: INFORMATION FOR THE USER
GERICARB SR 200MG PROLONGED RELEASE TABLETS
GERICARB SR 400MG PROLONGED RELEASE TABLETS
CARBAMAZEPINE
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 symptoms 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.
WHAT IS IN THIS LEAFLET:
1. What Gericarb SR is and what it is used for
2. What you need to know before you take Gericarb SR
3. How to take Gericarb SR
4. Possible side effects
5. How to store Gericarb SR
6. Contents of the pack and other information.
1. WHAT GERICARB SR IS AND WHAT IT IS USED FOR
Gericarb SR are specially formulated to release the active ingredient
gradually.
Carbamazepine, the active ingredient, can affect the body in several
different ways. It is an 
anticonvulsant medicine (prevents fits), it can also modify some
types of pain and can control 
mood disorders.
Gericarb SR are used
• To treat some forms of epilepsy
• To treat a painful condition of the face called trigeminal
neuralgia
• To help control serious mood disorders when some other medicines
don’t work.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GERICARB SR
A small number of people being treated with anti-epileptics such as
carbamazepine have had 
thoughts of harming or killing themselves. If at any time you have
these thoughts, 
immediately contact your doctor.
Serious skin rashes (Stevens- Johnson syndrome, toxic epidermal
necrolysis) have been 
reported with the use of carbamazepine. Frequently, the rash can
involve ulcers of the mouth, 
throat, nose, genitals and conjunctivitis (red and swollen eyes).
These serious skin rashes are 

Ապրանքի հատկությունները

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gericarb SR 400 mg, prolonged-release tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release tablet contains 400 mg carbamazepine
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release tablets
White to yellowish, round, flat, cloverleaf shaped tablets with bevelled edge, double-sided cross break-mark, 4 notches
on the band.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Epilepsy
generalised tonic-clonic
partial seizures
•
For the paroxysmal pain of trigeminal neuralgia.
•
For the prophylaxis of manic or hypomanic phases of manic-depressive psychosis in patients unresponsive or with
contraindications to lithium therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment is started with a low dose set individually according to the type and severity of symptoms. The dose is then
slowly increased to the optimal maintenance dose to suit the patient.
Doses should be based on seizure control and the development of clinical intolerance. Plasma levels are indicative
whether a patient is within or outside the therapeutic range in order to explain a lack of seizure control or development
of intolerance. This may be particularly useful, if combination therapy is used. Therapeutic plasma levels of
carbamazepine are typically between 4 - 12 µg/l corresponding to a dosage of 400 - 1200 mg per day.
A maximum daily dose of 1600-2000 mg may be required in adults.
When patients are transferred from an immediate-release carbamazepine product, the same total daily dose will
generally be suitable. In a few patients, it may be necessary to increase the total daily dose, particularly when it is used
with other antiepileptics