Synphase tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Available from:

Pfizer Ltd

ATC code:

G03AB04

Pharmaceutical form:

Not applicable

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 07030100; GTIN: 5012882007676

Patient Information leaflet

12:27
N/A
Piramal Healthcare
N/A
8 pt
United Kingdom
01
Leaflet
FPO
N/A
84 x 52 mm
N/A
PAR-2019-0004984
PROFILE
BLACK
BARCODE Nº
PHARMA CODE
DATE:
22 APR 2019
TIME:
SMALLEST
BODY TEXT
SIZE
MARKET
PROOF Nº
COMPONENT
DRAWING Nº
DIMENSIONS
NOTES
PAR NUMBER
COLOURS
PRINTING
NON-PRINTING
20190418A
NEW COMPONENT Nº
OLD COMPONENT Nº
PACKAGING SITE
1
PACKAGE LEAFLET:
INFORMATION FOR THE USER
SYNPHASE
®
500 MICROGRAM / 35 MICROGRAM TABLETS
AND 1 MILLIGRAM / 35 MICROGRAM TABLETS
norethisterone / ethinylestradiol
2
Important things that you SHOULD know about your medicine:
• Synphase is an oral contraceptive medicine for use by women.
• You should take Synphase regularly as instructed by your
doctor or nurse, in order for it to be effective. When taken as
instructed, it is a very effective contraceptive. See section 3,
‘ If you forget to take Synphase’.
• Taking some other medicines may stop Synphase from working
properly. See section 2 for details. Check with your doctor,
nurse or pharmacist before taking any other medicines while
you are taking Synphase.
3
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, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if their signs of illness are the
same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
See
section 4.
4
WHAT IS IN THIS LEAFLET
1.
What Synphase is and what it is used for
2. What you need to know before you take Synphase
3.
How to take Synphase
4.
Possible side effects
5.
How to store Synphase
6. Contents of the pack and other information
1.
WHAT SYNPHASE IS AND WHAT IT IS USED FOR
Synphase is one of a group of medicines called combined oral
contraceptives or “the Pill” for short.
5
Synphase contains t

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Synphase 500 microgram / 35 microgram tablets and 1 milligram / 35
microgram tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
7 blue tablets containing norethisterone 500 micrograms and
ethinylestradiol 35 micrograms; 9
white tablets containing norethisterone 1.0 milligram and
ethinylestradiol 35 micrograms; 5 blue
tablets containing norethisterone 500 micrograms and ethinylestradiol
35 micrograms.
Excipients with known effect:
Each tablet contains lactose.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet.
Synphase consists of 7 blue tablets marked 'BX' on one side and
'SEARLE' on the other; 9 white
tablets marked 'SEARLE' on one face and 'BX' on the other; 5 blue
tablets marked 'BX' on one
side and 'SEARLE' on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Synphase is indicated for oral contraception, with the benefit of a
low intake of estrogen.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage of Synphase for the initial cycle of therapy is 1 tablet
taken at the same time each day from
the first day of the menstrual cycle. For subsequent cycles, no
tablets are taken for 7 days, then a new
course is started of 1 tablet daily for the next 21 days. This
sequence of 21 days on treatment, seven days
off treatment is repeated for as long as contraception is required.
Patients unable to start taking Synphase tablets on the first day of
the menstrual cycle may start treatment
on any day up to and including the 5th day of the menstrual cycle.
Patients starting on day 1 of their period will be protected at once.
Those patients delaying therapy up to
day 5 may not be protected immediately and it is recommended that
another method of contraception is
used for the first 7 days of tablet-taking. Suitable methods are
condoms, caps plus spermicides and intra-
uterine devices.
The rhythm, temperature and cervical-mucus methods should not be
relied upon.
Tablet omissions
Tablets must be taken daily in or