Microgynon 30 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: 5016703003939

Patient Information leaflet

Page 1 of 19
V029_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
Microgynon
®
30 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 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 Microgynon 30 ED is
right for
you.
▪
To prevent pregnancy it is important to take Microgynon 30 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 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 GET SEVERE, or if you notice any not listed
in this
booklet, please tell your doctor,

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Microgynon 30
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Actives:
Levonorgestrel
150 mcg
Ethinylestradiol
30 mcg
Excipients:
Lactose
32.820 mg
Sucrose
19.371 mg
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Sugar-coated tablets
Each tablet is beige
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception and the recognised gynaecological indications for
such oestrogen-
progesterone combinations.
The decision to prescribe Microgynon 30 should take into consideration
the individual
woman’s current risk factors, particularly those for venous
thromboembolism (VTE),
and how the risk of VTE with Microgynon 30 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 21 days, starting on the
first day of the
menstrual cycle. Contraceptive protection begins immediately_. _
_ _
_Subsequent cycles:_ Tablet-taking from the next pack of Microgynon 30
is continued
after a 7-day tablet-free interval, beginning on the same day of the
week as the first
pack. A withdrawal bleed usually occurs during the tablet-free
interval.
_Changing from 21-day combined oral contraceptives:_ The first tablet
of Microgynon
30 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):_
Microgynon 30 should be started after taking the last active tablet
from the Every Day
Pill pack. The first Microgynon 30 tablet is taken the next day.
Additional
contraceptive precautions are not then required.
_Changing from a progestogen-only pill (POP):_
The first tablet of Microgynon 30 should be taken on the first day of
bleeding,