MEDABON CO TABLET

Land: Zuid-Afrika

Taal: Engels

Bron: South African Health Products Regulatory Authority (SAHPRA)

Beschikbaar vanaf:

Ranbaxy (SA) (Pty) Ltd

Dosering:

See ingredients

farmaceutische vorm:

TABLET

Samenstelling:

EACH COMBIPACK CONTAINS MIFEPRISTONE 200,0 mg (ORAL TAB) MISOPROSTOL 0,2 mg (VAGINAL TAB)

Autorisatie-status:

Registered

Bijsluiter

Ranbaxy Pharmaceuticals (Pty) Ltd
Medabon Co, oral and vaginal tablets
Response to Clinical Evaluation Queries (dated 3 June 2021)
Date submitted: 17 June 2021
Date of CC approval: 07 September 2021
1.3.2
Initials:
Page 1 of 11
PROPOSED PATIENT INFORMATION LEAFLET FOR MEDABON CO
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
MEDABON CO ORAL AND VAGINAL TABLETS
MIFEPRISTONE
MISOPROSTOL
Sugar free
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING MEDABON CO:

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.

MEDABON CO 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 MEDABON CO is and what it is used for
2.
What you need to know before you use MEDABON CO
3.
How to use MEDABON CO
4.
Possible side effects
5.
How to store MEDABON CO
6.
Contents of the pack and other information
Ranbaxy Pharmaceuticals (Pty) Ltd
Medabon Co, oral and vaginal tablets
Response to Clinical Evaluation Queries (dated 3 June 2021)
Date submitted: 17 June 2021
Date of CC approval: 07 September 2021
1.3.2
Initials:
Page 2 of 11
1.
WHAT MEDABON CO IS AND WHAT IT IS USED FOR
MEDABON CO is a combination therapy containing two medicines called
mifepristone and
misoprostol.
MEDABON CO is recommended for the medical termination of a pregnancy
no later than 63 days
after the first day of your last menstrual period.
Mifepristone is an anti-hormone that acts by blocking the effects of
progesterone, a hormone which
is needed for pregnancy to continue. Misoprostol is a prostaglandin,
which is a substance that
increases contraction of the womb that will help expel the pregnancy.
The two medicines can
therefore cause termination of pregnancy and must be used one after
the other to give the best
possible chance for the treatment to work.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MEDABON CO
DO NO

Productkenmerken

Ranbaxy Pharmaceuticals (Pty) Ltd
Medabon Co, oral and vaginal tablets
Response to Clinical Evaluation Queries1 (dated 3 June 2021)
Date submitted: 17 June 2021
Date of CC Approval: 07-Sept-2021
1.3.1.1
Initials:
Page 1 of 18
PROPOSED PROFESSIONAL INFORMATION FOR MEDABON CO
SCHEDULING STATUS
S4
1.
NAME OF THE MEDICINE
MEDABON CO ORAL AND VAGINAL TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each combipack of MEDABON CO contains one mifepristone oral tablet and
four misoprostol
vaginal tablets.
Each mifepristone oral tablet contains 200 mg mifepristone.
Each misoprostol vaginal tablet contains 0,2 mg misoprostol.
Sugar free.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORMS
_MIFEPRISTONE: _
Tablet (for oral use).
Light yellow, circular, biconvex, uncoated tablet, debossed with
“S” on one side and plain on the
other side. Diameter: 11,0 mm.
_MISOPROSTOL: _
Vaginal tablet.
White to off-white, rectangular shaped, uncoated tablet, debossed with
a square on either side of
the break line on one side and plain on the other side. Diameter: 11,6
mm x 6,3 mm.
4.
CLINICAL PARTICULARS
Ranbaxy Pharmaceuticals (Pty) Ltd
Medabon Co, oral and vaginal tablets
Response to Clinical Evaluation Queries1 (dated 3 June 2021)
Date submitted: 17 June 2021
Date of CC Approval: 07-Sept-2021
1.3.1.1
Initials:
Page 2 of 18
4.1
THERAPEUTIC INDICATIONS
MEDABON CO is indicated for medical termination of developing
intra-uterine pregnancy of up to
63 days of amenorrhoea.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
200 mg of mifepristone (one tablet) is taken in a single oral dose,
followed 36 to 48 hours later by
the administration of misoprostol 0,8 mg (i.e. 4 vaginal tablets of
0,2 mg each) vaginally in a single
dose. If the patient vomits shortly after administration of
mifepristone, she should inform the doctor.
MEDABON CO has only been studied in women over the age of 18.
MEDABON CO has not been evaluated for use in children and
adolescents._ _
METHOD OF ADMINISTRATION:_ _
The mifepristone tablet is f