Millinette 20microgram/75microgram tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gestodene; Ethinylestradiol

Available from:

Gedeon Richter (UK) Ltd

ATC code:

G03AA10

INN (International Name):

Gestodene; Ethinylestradiol

Dosage:

75microgram ; 20microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07030100; GTIN: 5391512451134

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MILLINETTE® 20/75
MICROGRAM COATED TABLETS
ethinylestradiol / gestodene
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 “Blood clots”).
WHAT IS IN THIS LEAFLET
1. What Millinette is and what it is used for
2. What you need to know before you use Millinette
3. How to take Millinette
4. Possible side effects
5. How to store Millinette
6. Contents of the pack and other information
1. WHAT MILLINETTE IS AND WHAT IT IS USED FOR
Millinette is a combined oral contraceptive, one of a group of drugs
often referred
to as the Pill. It contains two types of hormone: an oestrogen,
ethinylestradiol, and
a progestogen, gestodene. These hormones stop the ovary from releasing
an egg
each month (ovulation). They also thicken the fluid (mucus) at the
neck of the
womb (cervix) making it more difficult for the sperm to reach the egg,
and alter
the lining of the womb to make it less likely to accept a fertilised
egg.
Medical research and vast experience have shown that, if taken
correctly, the Pill is
an effective reversible form of contraception.
Remember, combined hormonal contraceptive pills like Millinette will
not protect
you against sexually-transmitted diseases (such as AIDS). Only condoms
can help
to do this.
YOU AND THE PILL
HOW YOUR BODY GETS READY FOR PREGNANCY (the menstrual cycle).
You can usually become pregnant (conceive) from the time you start to
have periods (usually in your teens), until your periods stop (the
menopause).
Every menstrual cycle takes about 28 days. About halfway through this
cycle, an
egg is released from one of your ovaries into a F

Summary of Product characteristics

OBJECT 1
MILLINETTE 20/75 MICROGRAM COATED TABLETS
Summary of Product Characteristics Updated 02-Oct-2017 | Consilient
Health Ltd
1. Name of the medicinal product
Millinette 20/75 microgram coated tablets
2. Qualitative and quantitative composition
Each tablet contains 20 micrograms ethinylestradiol and 75 micrograms
gestodene.
Excipients with known effect: each tablet contains 35.3068 mg lactose
(as lactose monohydrate), 19.6600
mg sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Coated tablets.
Pale yellow, round, biconvex sugar-coated tablets, both sides are
without imprinting.
4. Clinical particulars
4.1 Therapeutic indications
Contraception.
The decision to prescribe Millinette should take into consideration
the individual woman's current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with Millinette
compares with other combined hormonal contraceptives (CHCs) (see
sections 4.3 and 4.4).
4.2 Posology and method of administration
Do not start or continue with Millinette in case of known or suspected
pregnancy.
Posology
_How is Millinette taken?_
To patients who use a package with 21 active tablets:
The tablets 1-21 contain active substances (active tablets).
The tablets must be taken in the order given on the blister pack,
every day at approximately the same
point. One tablet is taken daily for 21 consecutive days. Every
subsequent blister pack is started after a 7
day tablet-free interval during which time a withdrawal bleeding
usually occurs. This bleeding usually
starts on the 2
nd
or 3
rd
day after taking the last tablet has been taken and it may not have
stoped, before
the next blister pack is started.
_How to start Millinette_
_No preceding hormonal contraceptive use in the past month _
The tablets should be started on day 1 in the woman's normal cycle
(i.e. on the first day the woman has a
menstrual bleeding). It is acceptable to start the tablets on day 2-5,
but during the first cycle the
concomitant use of non-hormonal contra