Triadene tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Available from:

Bayer Plc

ATC code:

G03AB06

Pharmaceutical form:

Not applicable

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 07030100; GTIN: 5016703003038

Patient Information leaflet

Page 1 of 18
V020_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 LEAFLET: Information for the user
Triadene
®
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 leaflet to make sure Triadene is right for
you.

To prevent pregnancy it is important to take Triadene 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.

Keep this leaflet. 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
leaflet, please tell your doctor, family planning nurse or

Summary of Product characteristics

OBJECT 1
TRIADENE
Summary of Product Characteristics Updated 06-Oct-2017 | Bayer plc
1. Name of the medicinal product
TRIADENE ®
2. Qualitative and quantitative composition
The memo pack holds six beige tablets containing 30 micrograms
ethinylestradiol and 50 micrograms
gestodene, five dark brown tablets containing 40 micrograms
ethinylestradiol and 70 micrograms
gestodene, and ten white tablets containing 30 micrograms
ethinylestradiol and 100 micrograms
gestodene.
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 Triadene should take into consideration the
individual woman's current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with Triadene
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 Triadene 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 Triadene 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):_
Triadene should be started after taking the last active tablet from
the Every Day Pill pack. The first
Triadene tablet is taken the next day. Additional contraceptive
precautions are not then required.
_Changing from a progestogen-only pill (POP):_
The first tablet of Triadene 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
require