Loestrin 30 tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Norethisterone acetate; Ethinylestradiol

Available from:

Galen Ltd

ATC code:

G03AA05

INN (International Name):

Norethisterone acetate; Ethinylestradiol

Dosage:

1.5mg ; 30microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07030100; GTIN: 5016298110395

Patient Information leaflet

1.3.1 Package Leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LOESTRIN* 20 TABLETS
LOESTRIN* 30 TABLETS
(NORETHISTERONE ACETATE AND ETHINYLESTRADIOL)
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, ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Loestrin is and what it is used for
2. What you need to know before you take Loestrin
3. How to take Loestrin
4. Possible side effects
5. How to store Loestrin
6. Contents of the pack and other information
1.
WHAT LOESTRIN IS AND WHAT IT IS USED FOR
The name of your medicine is Loestrin tablets. Loestrin contains two
types of medicine:
•
Norethisterone acetate – this is a hormone known as a
‘progestogen’
•
Ethinylestradiol – this is a hormone known as an ‘estrogen’.
These hormones are similar to those produced naturally by your body
during pregnancy.
WHAT LOESTRIN IS USED FOR
Loestrin is a contraceptive pill used to stop you becoming pregnant.
•
It is called a ‘combined contraceptive pill’
•
This is because it contains two types of medicine.
HOW LOESTRIN WORKS
The hormones in your pill help stop you from getting pregnant in the
following ways:
•
Stopping eggs being released for fertilisation
•
Thickening the fluid present in the neck of the womb. This makes it
more difficult for sperm
to enter the womb
•
The lining of the womb does not thicken enough for a fertilised egg to
become embedded in
it.
1.3.1 Package Leaflet
2
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOESTRIN
DO NOT TAKE LOESTRIN:
•
if you are allergic to norethisterone acetate, ethin

Summary of Product characteristics

OBJECT 1
LOESTRIN 30
Summary of Product Characteristics Updated 29-Jan-2018 | Galen Limited
1. Name of the medicinal product
Loestrin 30
2. Qualitative and quantitative composition
Each Loestrin 30 tablet contains:
Norethisterone acetate
Ethinylestradiol
1.5mg
0.03mg
Excipients with known effect
Each tablet contains sunset yellow FCF (E110), 22.01mg of lactose and
38.76mg of sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Pale green convex film-coated tablet.
4. Clinical particulars
4.1 Therapeutic indications
Loestrin 30 is indicated for the prevention of pregnancy in women who
elect to use oral contraceptives.
The efficacy of any contraceptive method, except sterilisation,
depends upon the reliability with which it
is used. Correct and consistent use of methods can result in lower
failure rates.
4.2 Posology and method of administration
Posology
One Loestrin 30 tablet should be taken daily at approximately the same
time of day for three weeks and
then an interval of one week allowed before commencing the second
course of tablets. Second and
subsequent courses should be taken for three weeks with one week
without tablets between courses. Thus
each new course of tablets is always started on the same day of the
week. It is important that the tablets
are taken as directed and should be taken without regard to menstrual
bleeding except in the initial cycle.
_Pill initiation_
Provided that it is reasonably certain that a woman is not pregnant:
• COCs can be started at any time within 5 days of the start of
menstrual bleeding without additional
contraceptive precautions;
• COCs can be started at any other time in the cycle, or by women
who are not menstruating, with
additional contraceptive precautions for the first 7 days;
• a switch can be made from other methods of contraception, whether
hormonal or not, at any time in the
cycle. Additional contraceptive precautions are required for the first
7 days if changing from a non-
hormonal method outside the first 5 days of the menst