Brevinor 500microgram/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:

500microgram ; 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: 5013457025194

Patient Information leaflet

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
BREVINOR
® 0.5 MILLIGRAM (MG)/35 MICROGRAMS (ΜG) TABLETS
norethisterone/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 or pharmacist.

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 or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Brevinor is and what it is used for
2. What you need to know before you take Brevinor
3. How to take Brevinor
4. Possible side effects
5. How to store Brevinor
6. Contents of the pack and other information
1. WHAT BREVINOR IS AND WHAT IT IS USED FOR
Brevinor is one of a group of medicines called combined oral
contraceptives or “the Pill” for
short.
Brevinor contains two hormones - a progestogen hormone called
norethisterone and an
oestrogen hormone called ethinylestradiol. These two hormones act
together to prevent
pregnancy from occurring.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BREVINOR
Important things that you SHOULD know about your medicine:

Brevinor 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 Brevinor 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 “What if I forget to take a tablet?”

Most people do not have serious problems when taking Brevinor but side
effects can
occur – see Section 4 for details. If any of the side effects gets
serious, or if you
notice any side effects not listed in this leaflet, please tell your
doctor, nurse or
pharmacist.

Taking som

Summary of Product characteristics

OBJECT 1
BREVINOR TABLETS
Summary of Product Characteristics Updated 19-Jun-2017 | Pfizer
Limited
1. Name of the medicinal product
Brevinor 0.5 milligram (mg)/35 micrograms (μg) Tablets.
2. Qualitative and quantitative composition
Each tablet contains 0.5 milligrams norethisterone and 35 micrograms
ethinylestradiol.
Excipients with known effect:
Each tablet contains lactose.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Tablet.
Blue, flat, circular, bevel-edged tablet inscribed 'SEARLE' on one
side and 'BX' on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Brevinor 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 Brevinor 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 Brevinor 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 co