Logynon tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Available from:

Waymade Healthcare 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

Patient Information leaflet

THIS AREA MUST BE IDENTICAL ON BOTH SIDES!
Levonorgestrel
Ethinylestradiol
!
!
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 Logynon ED is right for you.
R 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.
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 Logynon ED does
2. What you need to know before you use
Logynon ED
3. Taking Logynon ED
3.3 A missed pill
4. Possible side effects
5. How to store Logynon ED
6. What is in Logynon ED and who makes it
1. WHAT LOGYNON ED DOES
Logynon ED is a combined oral contraceptive
pill (‘the Pill’). YOU TAKE IT TO STOP YOU GETTING
PREGNANT.
This contraceptive contains two typ

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
33.07 mg
Sucrose
19.297 mg
_Each White Tablet contains: _
_ _
Actives
Levonorgestrel
75 micrograms
Ethinylestradiol
40 micrograms
Excipients
Lactose
33.035 mg
Sucrose
19.660 mg
_Each Ochre Tablet contains: _
Actives
Levonorgestrel
125 micrograms
Ethinylestradiol
30 micrograms
Excipients
Lactose
32.995 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 oral contrace