BIO-CARBAMAZEPINE 200 TABLET

Ülke: Güney Afrika

Dil: İngilizce

Kaynak: South African Health Products Regulatory Authority (SAHPRA)

Mevcut itibaren:

Biotech Laboratories (Pty) Ltd

Doz:

See ingredients

Farmasötik formu:

TABLET

Kompozisyon:

EACH TABLET CONTAINS CARBAMAZEPINE 200,0 mg

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

2000-02-07

Bilgilendirme broşürü

BIOTECH LABORATORIES (PTY) LTD
BIO-CARBAMAZEPINE 200 (TABLETS)
Date of approval: 7 November 2022
Each tablet contains 200 mg carbamazepine
Approved PIL
Page 1 of 13
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S3
BIO-CARBAMAZEPINE 200 TABLETS
CARBAMAZEPINE
Sugar free.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
BIO-CARBAMAZEPINE 200.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care
provider.
•
BIO-CARBAMAZEPINE 200 has been prescribed for you personally and you
should not share
your medicine with other people. It may harm them, even if their
symptoms are the same as
yours.
WHAT IS IN THIS LEAFLET
1.
What BIO-CARBAMAZEPINE 200 is and what it is used for
2.
What you need to know before you take BIO-CARBAMAZEPINE 200
3.
How to take BIO-CARBAMAZEPINE 200
4.
Possible side effects
5.
How to store BIO-CARBAMAZEPINE 200
6.
Contents of the pack and other information
1.
WHAT BIO-CARBAMAZEPINE 200 IS AND WHAT IT IS USED FOR
Carbamazepine, the active ingredient in BIO-CARBAMAZEPINE 200, can
affect the body in
several different ways. It is an anti-convulsant medicine (prevents
fits). It can also modify some
types of pain.
BIOTECH LABORATORIES (PTY) LTD
BIO-CARBAMAZEPINE 200 (TABLETS)
Date of approval: 7 November 2022
Each tablet contains 200 mg carbamazepine
Approved PIL
Page 2 of 13
BIO-CARBAMAZEPINE 200 is used:
•
To treat some forms of epilepsy.
•
To treat a painful condition of the face called trigeminal neuralgia.
•
To treat a painful condition occurring in the back of the throat,
tongue and ear called idiopathic
glossopharyngeal neuralgia.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BIO-CARBAMAZEPINE 200
DO NOT TAKE BIO-CARBAMAZEPINE 200:
•
If you are allergic (hypersensitive) to carbamazepine, similar
medicines such as tricyclic
antidepressants (used to treat mood disorders) or to any of the other
ingredients of BIO-
CARBAMAZEPINE 200 (listed in section 6).
•
If you have ever had problems wit

Ürün özellikleri

BIOTECH LABORATORIES (PTY) LTD
BIO-CARBAMAZEPINE 200 (TABLETS)
Date of approval: 7 November 2022
Each tablet contains 200 mg carbamazepine
Approved PI
Page 1 of 26
PROFESSIONAL INFORMATION FOR BIO-CARBAMAZEPINE 200
SCHEDULING STATUS
S3
1.
NAME OF THE MEDICINE
BIO-CARBAMAZEPINE 200 tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg carbamazepine.
Sugar free.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
White, flat, round bevelled edge tablet. One side scored. Other side
engraved TARO 11.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Epilepsy: Psychomotor or temporal-lobe epilepsy; grand mal; mixed
forms; focal seizures.
Trigeminal neuralgia.
Idiopathic glossopharyngeal neuralgia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Dosage should be adjusted to the needs of the individual patient. A
low initial daily dose with a
gradual increase is advised. As soon as adequate control is achieved
the dosage may be gradually
reduced to the minimum effective level. The tablets should be taken
with meals. Monitoring of
plasma levels may be useful.
BIOTECH LABORATORIES (PTY) LTD
BIO-CARBAMAZEPINE 200 (TABLETS)
Date of approval: 7 November 2022
Each tablet contains 200 mg carbamazepine
Approved PI
Page 2 of 26
_EPILEPSY _
Adults and children over 12 years: Initially 200 mg twice daily.
Increase at weekly intervals by
adding up to 200 mg per day until the optimum response is obtained,
usually 400 mg twice or three
times daily. Doses up to 1 600 mg daily have been used in adults (in
divided doses).
Children: 10 to 20 mg /kg per day. Dosage should not exceed 1 000 mg
daily.
_ _
Age up to 1 year:
100 – 200 mg per day
1 to 5 years:
200 – 400 mg per day
5 to 10 years:
400 – 600 mg per day
10 to 15 years:
600 – 1000 mg per day
_TRIGEMINAL NEURALGIA _
The initial dose of 100 mg once or twice daily should be increased
gradually until a satisfactory
clinical response is obtained. Control of pain is achieved in most
patients with 400 to 800 mg daily
in 2