Logynon ED tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Available from:

Bayer Plc

ATC code:

G03AA07

Pharmaceutical form:

Not applicable

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 07030100; GTIN: 5016703004127

Patient Information leaflet

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Page 1 of 15
PACKAGE LEAFLET: INFORMATION FOR THE USER
Logynon
®
ED
Levonorgestrel
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
‘Blood clots’ in Section 2).

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 Logynon ED is right for you.

To prevent pregnancy it is important to take Logynon ED 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 BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions or need more advice, ask your
doctor, family planning nurse
or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them.

If you get any side effects, talk to your doctor, family planning
nurse or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
1.
What Logynon ED is and what it is used for
2.
What you need to know before you use Logynon ED
3.
How to use Logynon ED
4.
Possible side effects
5.
How to store Logynon ED
6.
Contents of the pack and other information
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Page 2

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Logynon
®
ED
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Calendar pack containing 6 light brown tablets, 5 white tablets and 10
ochre-coloured
tablets containing the following ingredients.
_ _
_Each Light Brown Tablet contains: _
Actives
Levonorgestrel
50 micrograms
Ethinylestradiol
30 micrograms
Excipients
Lactose
32.87 mg
Sucrose
19.297 mg
_ _
_Each White Tablet contains: _
_ _
Actives
Levonorgestrel
75 micrograms
Ethinylestradiol
40 micrograms
Excipients
Lactose
32.835 mg
Sucrose
19.660 mg
_ _
_Each Ochre Tablet contains: _
Actives
Levonorgestrel
125 micrograms
Ethinylestradiol
30 micrograms
Excipients
Lactose
32.795 mg
Sucrose
19.223 mg
Loygnon ED also contains 7 large white placebo tablets.
Each placebo tablet contains:
Excipients
Lactose
48.250 mg
Sucrose
33.980 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-
progesterone combinations.
The decision to prescribe Logynon ED should take into consideration
the individual
woman’s current risk factors, particularly those for venous
thromboembolism (VTE),
and how the risk of VTE with Logynon ED compares with other combined
hormonal
contraceptives (CHCs) (see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Tablets must be taken orally in the order directed on the blister
package at about the
same time every day, with some liquid if necessary.
_First treatment cycle: _1 tablet daily for 28 days, starting on the
first day of the
menstrual cycle. 21 (small) active tablets are taken followed by 7
(larger) placebo
tablets. Contraceptive protection begins immediately.
_Subsequent cycles:_ Tablet taking is continuous, which means that the
next pack of
Logynon ED follows immediately without a break. A withdrawal bleed
usually
occurs when the white placebo tablets are being taken.
_Changing from 21-day combined o