Femodene tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gestodene; Ethinylestradiol

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

G03AA10

INN (International Name):

Gestodene; Ethinylestradiol

Dosage:

75microgram ; 30microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07030100

Patient Information leaflet

THIS AREA MUST BE IDENTICAL ON BOTH SIDES!
IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL
CONTRACEPTIVES (CHCS):
R They are one of the most reliable reversible methods of
contraception if used correctly.
R They slightly increase the risk of having a blood clot in the
veins and arteries, especially in the first year or when
restarting a combined hormonal contraceptive following a
break of 4 or more weeks.
R Please be alert and see your doctor if you think you may have
symptoms of a blood clot (see section 2.3 ‘Blood clots’).
R The Pill may reduce your risk of cancer of the ovary and womb
if used in the long term.
R The Pill will not protect you against sexually transmitted
diseases.
R This medicine can increase your risk of problems such as
blood clots and breast cancer.
R Some women should not take the Pill because of current
medical problems or illnesses. Please read this leaflet to make
sure Femodene is right for you.
R To prevent pregnancy it is important to take Femodene as
instructed and start each pack on time. Please make sure that
you understand what to do if you miss a pill or if you think
you are pregnant.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
R Keep this leaflet. You may need to read it again.
R If you have any questions or need more advice, ask your
doctor, family planning nurse or pharmacist.
R This medicine has been prescribed for you. Do not pass it on to
others. It may harm them.
R IF ANY OF THE SIDE EFFECTS GETS SEVERE, or if you notice any not
listed in this leaflet, please tell your doctor, family planning
nurse or pharmacist.
IN THIS LEAFLET
1.
WHAT FEMODENE DOES
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FEMODENE
2.1 When you should not use Femodene
2.2 When to take special care with Femodene
2.3 Blood clots
2.4 The Pill and cancer
2.5 Psychiatric disorders
2.6 Taking other medicines
2.7 Taking Femodene with food and drink
2.8 Pregnancy and breast-feeding
2.9 Driving and using machines
2.10 Femodene contains lactose and sucrose
3.
TAKING FEMODENE
3.1 How

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Femodene ®
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Actives:
Gestodene
75 micrograms
Ethinylestradiol
30 micrograms
Excipients:
Lactose
37.43 mg
Sucrose
19.66 mg
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Sugar-coated tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception and the recognised gynaecological indications for
such oestrogen-
progestogen combinations.
The decision to prescribe Femodene should take into consideration the
individual
woman’s current risk factors, particularly those for venous
thromboembolism (VTE),
and how the risk of VTE with Femodene compares with other combined
hormonal
contraceptives (CHCs) (see sections 4.3 and 4.4).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_First treatment cycle: _1 tablet daily for 21 days, starting on the
first day of the
menstrual cycle. Contraceptive protection begins immediately.
_Subsequent cycles:_ Tablet taking from the next pack of Femodene is
continued after a
7-day interval, beginning on the same day of the week as the first
pack.
_Changing from 21-day combined oral contraceptives:_ The first tablet
of Femodene
should be taken on the first day immediately after the end of the
previous oral
contraceptive course. Additional contraceptive precautions are not
required.
_Changing from a combined Every Day pill (28 day tablets):_
Femodene should be started after taking the last active tablet from
the Every Day Pill
pack. The first Femodene tablet is taken the next day. Additional
contraceptive
precautions are not then required.
_Changing from a progestogen-only pill (POP):_
The first tablet of Femodene should be taken on the first day of
bleeding, even if a
POP has already been taken on that day. Additional contraceptive
precautions are not
then required. The remaining progestogen-only pills should be
discarded.
_Post-partum and post-abortum use: _ After pregnancy, oral
contraception can be
started 21 days after a vagina