Norimin 1mg/35microgram tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Norethisterone; Ethinylestradiol

Available from:

Pfizer Ltd

ATC code:

G03AA05

INN (International Name):

Norethisterone; Ethinylestradiol

Dosage:

1mg ; 35microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07030100; GTIN: 5012882007645

Patient Information leaflet

Page 1 of 11
PACKAGE LEAFLET: INFORMATION FOR THE USER
NORIMIN
® 1 MG/0.035 MG TABLETS
norethisterone/ethinylestradiol
Important things that you SHOULD know about your medicine:

Norimin is an oral contraceptive medicine for use by women.

This medicine has been prescribed for you. Do not pass it on to
others.

You should take Norimin regularly as instructed by your doctor or
nurse, in order
for it to be effective. When taken as instructed, it is a very
effective contraceptive.
See section 3 ‘If you forget to take Norimin’.

Taking some other medicines may stop Norimin from working properly.
See
section 2 for details. Check with your doctor, nurse or pharmacist
before taking any
other medicines while you are taking Norimin.
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 Norimin is and what it is used for
2.
What you need to know before you take Norimin
3.
How to take Norimin
4.
Possible side effects
5.
How to store Norimin
6.
Contents of the pack and other information
1. WHAT NORIMIN IS AND WHAT IT IS USED FOR
Norimin is one of a group of medicines called combined oral
contraceptives or “the Pill” for
short.
Page 2 of 11
Norimin contains two hormones - a progestogen hormone called
norethisterone and an estrogen
hormone called ethinylestradiol. These two hormones act together to
prevent pregnancy from
occurring.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NORIMIN
 DO NOT TAKE NORIMIN:

if you are allergic to norethisterone, ethinylestradiol or any of

Summary of Product characteristics

OBJECT 1
NORIMIN TABLETS
Summary of Product Characteristics Updated 07-Jul-2017 | Pfizer
Limited
1. Name of the medicinal product
Norimin 1 mg/0.035 mg tablets
2. Qualitative and quantitative composition
Each tablet contains 1mg norethisterone and 0.035mg ethinylestradiol.
Excipient(s) with known effect
Each tablet contains 41.71 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
White round flat tablets with bevel-edged tablet inscribed 'SEARLE' on
one side and 'BX' on the other.
4. Clinical particulars
4.1 Therapeutic indications
Norimin is indicated for oral contraception, with the benefit of a low
intake of oestrogen.
4.2 Posology and method of administration
Posology
The dosage of Norimin for the initial cycle of therapy is 1 tablet
taken at the same time each day from the
first day of the menstrual cycle. For subsequent cycles, no tablets
are taken for 7 days, then a new course
is started of 1 tablet daily for the next 21 days. This sequence of 21
days on treatment, seven days off
treatment is repeated for as long as contraception is required.
Patients unable to start taking Norimin tablets on the first day of
the menstrual cycle may start treatment
on any day up to and including the 5th day of the menstrual cycle.
Patients starting on day 1 of their period will be protected at once.
Those patients delaying therapy up to
day 5 may not be protected immediately and it is recommended that
another method of contraception is
used for the first 7 days of tablet-taking. Suitable methods are
condoms, caps plus spermicides and intra-
uterine devices. The rhythm, temperature and cervical-mucus methods
should not be relied upon.
Tablet omissions
Tablets must be taken daily in order to maintain adequate hormone
levels and contraceptive efficacy.
If a tablet is missed within 12 hours of the correct dosage time then
the missed tablet should be taken as
soon as possible, even if this means taking 2 tablets on the same day,
this will ensure that contraceptive
protec