Femodette tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gestodene; Ethinylestradiol

Available from:

Bayer Plc

ATC code:

G03AA10

INN (International Name):

Gestodene; Ethinylestradiol

Dosage:

75microgram ; 20microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07030100; GTIN: 5016703005902

Patient Information leaflet

Page
1
of
20
v022_0
Due to regulatory changes, the content of the following Patient
Information Leaflet may vary from the one found in your medicine pack.
Please compare the 'Leaflet prepared/revised date' towards the end of
the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please
contact
your doctor or pharmacist.
Package booklet: Information for the user
Femodette
®
Gestodene
Ethinylestradiol
IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES
(CHCS):
▪
They are one of the most reliable reversible methods of contraception
if used
correctly.
▪
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.
▪
Please be alert and see your doctor if you think you may have symptoms
of a
blood clot (see section 2.3 ‘Blood clots’).
▪
The Pill may reduce your risk of cancer of the ovary and womb if used
in the long
term.
▪
The Pill will not protect you against sexually transmitted diseases.
▪
This medicine can increase your risk of problems such as blood clots
and breast
cancer.
▪
Some women should not take the Pill because of current medical
problems or
illnesses. Please read this booklet to make sure Femodette is right
for you.
▪
To prevent pregnancy it is important to take Femodette 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 BOOKLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
▪
Keep this booklet. You may need to read it again.
▪
If you have any questions or need more advice, ask your doctor, family
planning
nurse or pharmacist.
▪
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them.
▪
IF ANY OF THE SIDE EFFECTS GETS SEVERE, or if you notice any not
listed in this
booklet, please tell your doctor, family planning nurse or

Summary of Product characteristics

OBJECT 1
FEMODETTE TABLETS
Summary of Product Characteristics Updated 21-Nov-2022 | Bayer plc
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Femodette
®
2. Qualitative and quantitative composition
Each tablet contains 0.075mg gestodene and 0.02mg ethinylestradiol.
Excipients with known effect:
Lactose
37.155 mg per tablet.
Sucrose
19.660 mg per tablet.
For the 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 Femodette should take into consideration the
individual woman's current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with Femodette
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 for 21 days,