Microgynon 30 tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ethinylestradiol; Levonorgestrel

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

G03AA07

INN (International Name):

Ethinylestradiol; Levonorgestrel

Dosage:

30microgram ; 150microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07030100

Patient Information leaflet

PACKAGING TECHNOLOGY BERLIN SGSMZ
page 1
Bayer AG
client: 0021,GV15,JS86 material-no.: 87251195
PZ: 2589W-3B
code-no.:
name: LF-INS-MICROGYNON 30 SCT 21
country: GB/-/BAG
colors: BLACK
version: 04.05.2020/01
Restricted Document
dimension: 594 X 297 MM
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 Microgynon 30 is right for
you.
R To prevent pregnancy it is
important to take Microgynon
30 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 Microgynon 30 does
2. What you need to know before
you use Microgynon 30
3. Taking Microgynon 30
3.3 A missed pill
4. Possible side effects
5. How to store Mi

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,