Brevinor Tablets - 3 Months Calendar Pack UK

Oral Administration: 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 contraceptive protection is maintained. If one or more tablets are missed for more than 12 hours from the correct dosage time it is recommended that the patient takes the last missed tablet as soon as possible and then continues to take the rest of the tablets in the normal manner. In addition, it is recommended that extra contraceptive protection, such as a condom, is used for the next 7 days.

Patients who have missed one or more of the last 7 tablets in a pack should be advised to start the next pack of tablets as soon as the present one has finished (i.e. without the normal seven day gap between treatments). This reduces the risk of contraceptive failure resulting from tablets being missed close to a 7 day tablet free period.

Changing from another oral contraceptive

In order to ensure that contraception is maintained it is advised that the first dose of Brevinor tablets is taken on the day immediately after the patient has finished the previous pack of tablets.

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 some other medicines may stop Brevinor from working properly. See Section 2 for details. Check with your doctor, nurse or pharmacist before taking any other medicines while you are taking Brevinor.
Please read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important to you. If you have any further questions, ask your doctor, nurse or pharmacist.

BREVINOR® norethisterone/ethinylestradiol 0.5 milligram (mg)/35 micrograms
(μg) Tablets
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
Do not take Brevinor:
• if you are allergic to norethisterone, ethinylestradiol or any of the other ingredients of this medicine (listed in section 6).
• if you are currently pregnant.
• if you have had blood clots in the legs, blood clots in varicose veins, the lungs, the brain or elsewhere (coronary and cerebral thrombotic disorders).
• if you or a member of your family have ever had a problem with blood clots,
including deep vein thrombosis (DVT).
• if you have had swelling (inflammation) of a vein caused by a blood clot.
• if you have had a heart attack or stroke or have had or have angina.
• if you have had or have high levels of fats in your blood (hyperlipidaemia) or other disorders of body fats.
• if you have had or have cancer of the breast, cervix, vagina or womb.
• if you have had the following during pregnancy:
o pruritus (itching of the whole body)
o jaundice (yellowing of the skin or eyes), for which your doctor could not find
the cause
o pemphigoid gestationis (a rash previously known as herpes gestationis typically with blistering of the palms of the hands and the soles of the feet).
• if you have had or have severe chronic liver disease (liver tumours, Dubin
-Johnson or Rotor syndrome).
• if you have had or have vaginal bleeding, for which your doctor could not find the cause.
• if you have had or have bad migraines.
Warnings and precautions
Talk to your doctor or pharmacist before taking Brevinor if you have any of the following conditions. This will help them decide if Brevinor is suitable for you:
• Migraine
• Headaches
• Slow or sudden development of visual disturbances such as complete or partial loss of vision
• Asthma
• Epilepsy (a condition where you suffer from fits)
• Diseases of the heart and blood vessels (cardiovascular disease)
• High blood pressure (hypertension)
• Kidney disease
• Diabetes
• Multiple sclerosis (a problem of the nervous system)
• Tetany (muscle twitches)
• Breast problems of any sort
• Varicose veins (widened or twisted vein usually in the leg)
• Liver dysfunction
• Severe depression
• Fibroids in your uterus
• Irregular periods
• Sharp pain in your abdomen
• Gallstones
• Sickle-cell anaemia
• Otosclerosis (an inherited form of deafness)
• Porphyria (a metabolic disease)

• Chloasma (brown patches on your skin which can happen during pregnancy but may not fade completely)
• Any disease that is likely to get worse during pregnancy.
Possible risk of Thrombosis (Blood Clot)
Some evidence suggests that women who take the Pill are more likely to develop various blood circulation disorders than women who don't take the Pill.
A thrombosis is a blood clot. A thrombosis can develop in veins or in arteries and can cause a blockage. The chance of a thrombosis forming in women taking the Pill and women not taking the Pill is rare. When blood clots form in arteries they can cause chest pain (angina), strokes (blood clots in or bleeding from the blood vessels in the brain) and heart attacks.
If blood clots form in veins they can often be treated, with no long-term danger. On rare occasions a piece of thrombosis may break off. It can travel to the lungs to cause a condition called pulmonary embolism. Therefore in rare cases a thrombosis can cause serious permanent disability or could even be fatal.
It is important to note that a thrombosis can form in people who are not taking the Pill as well as those who are taking it. The risk is higher in women who take the Pill than in women who don't take the Pill, but is not as high as the risk during pregnancy. The excess risk of thrombosis is highest during the first year a woman ever uses a combined oral contraceptive pill.
For healthy non-pregnant women: the chance of having a blood clot is about 5 in 100,000 each year.
For women taking the Pill containing either levonorgestrel or norethisterone (a second generation Pill): the chance of having a blood clot is about 15 in 100,000 each year.
For women taking the Pill containing desogestrel or gestodene (a third generation Pill): the chance of having a blood clot is about 25 in 100,000 each year.
For women who are pregnant: the chance of having a blood clot is about 60 in 100,000 pregnancies.
The risk of heart attacks and strokes for women who use the combined Pill increases with age and smoking. Other conditions also increase the risk of blood clots in the arteries. These include being greatly overweight, having diseased arteries (atherosclerosis), high blood pressure during pregnancy (pre-eclamptic toxaemia), high blood levels of cholesterol, and
diabetes. If you have any of these conditions, you should check with your doctor or nurse to see if the Pill is suitable for you. Smokers over 35 are usually told to stop taking these pills.
Possible risk of Breast Cancer

Every woman is at risk of breast cancer whether or not she takes the Pill. Breast cancer is rare under the age of 40 years, but the risk increases as a woman gets older.
Breast cancer has been found slightly more often in women who take the Pill than in women of the same age who do not take the Pill. If women stop taking the Pill, this reduces the risk so that 10 years after stopping the Pill, the risk of finding breast cancer is the same as for women who have never taken the Pill. Breast cancer seems less likely to have spread when
found in women who take the Pill than in women who do not take the Pill.
It is not certain whether the Pill causes the increased risk of breast cancer. It may be that women taking the Pill are examined more often, so that
breast cancer is noticed earlier. The risk of finding breast cancer is not affected by how long a woman takes the Pill but by the age at which she stops. This is because the risk of breast cancer strongly increases as a woman gets older.
The chart below shows the background chances of breast cancer at various ages for 10,000 women who have never taken the Pill (black bars) and for 10,000 women whilst taking the Pill and during the 10 years after stopping it (
orange bars). The small extra risk of finding breast cancer can be seen for each age group. This small possible additional risk in women  who take the Pill has to be balanced against the fact that the Pill is a very effective
contraceptive and it helps prevent cancer of the womb or ovary.
Estimated number of breast cancers found in 10,000 women who took the
Pill
for 5 years then stopped, or who never tookthe Pill.

Cancers found up to
the age of:
•
There have been some reports on the risk of liver tumors and cervical cancer
associated with the use of oral contraceptives.
•
There is evidence to suggest that the use of combined oral contraceptives offer
s
protection against both ovarian an
d endometrial cancer.
Cervical cancer
Some research suggests an increased risk of getting cancer of the cervix (neck of the uterus or
womb) in women who take combined oral contraceptives for a long time. However, this may
be due to other causes, such as
sexual behaviour.
Liver cancer
Very rarely, tumours of the liver have been seen in women taking combined oral
contraceptives, especially if they have been taken for a long time.
If you are worried about any of these things or if you have had cancer in
the past, talk to your
doctor to see if you should take the combined oral contraceptive pill.
Endometrial and ovarian cancer
Research shows that combined oral contraceptives protect against cancer of the ovary and
cancer of the endometrium (lining of
the womb).
If you are going to have a major operation

Make sure your doctor knows about it. You may need to stop taking Brevinor
about 4 weeks
before the operation until at least 2 weeks after the operation and until you are fully mobile.
Alternatively, your doctor may prescribe an
estrogen
-
free hormonal contraceptive.
Your doctor or nurse will advise whether you can still take
Brevinor.
Medical check-ups
Your doctor or nurse will give you regular checkups while you are taking
Brevinor. Your blood
pressure will be checked before you start
Brevinor
and then at regular intervals whilst
you are on
Brevinor
. You may be required to have an exa
mination of your breasts, abdomen
and pelvis including a cervical smear test at regular intervals, if this is con
sidered necessary
by the doctor.
Sexually transmitted diseases
Brevinor
helps to prevent pregnancy. It will not protect against sexually transmitted diseases
including AIDS. For safer sex, use a condom as well as your usual contraceptive.

Other m
edicines
and
Brevinor
Tell your doctor or pharmacists if you are taking, have recently
taken, or might take any other
medicines.
This includes the following medicines, as the effect of Brevinor may be altered
when they are taken at the same time:
• the herbal remedy St John's wort-
Latin name
Hypericum perforatum
(depression)
•
carbamazepine (epilepsy)
•
oxacarbazepine (epilepsy)
•
phenytoin (epilepsy)
•
phenobarbital (sleeplessness, anxiety, epilepsy)
•
primidone (epilepsy)
•
topiramate (epilepsy)
•
nelfinavir (
HIV
-
Human Immunodeficiency Virus
-
infection)
•
nevirapine (HIV infection and AIDS)
•
ritonavir (HIV infection and AIDS)
•
rifabutin (bacterial infection)
•
rifampicin (bacterial infection)
•
griseofulvin (fungal infection)
•
modafinil (narcolepsy i.e. daytime
sleepiness)
.
If you do need to take any of the medicines listed above,
Brevinor
may not be suitable for
you. Your doctor or nurse will advise you whether to stop taking these medicines or use an
additional contraceptive method, such as a condom whilst taking Brevinor.

Laboratory Tests
Brevinor
may interfere with some tests, tell your doctor or nurse if you need to give samples
for laboratory assessment.

Taking Brevinor
with food and drink
Please refer to section 3.

Pregnancy,breast-feeding and fertility
Do not take
Brevinor
if you are pregnant or trying to become pregnant.
Do not take
Brevinor
if you are breast-feeding.
If you miss a period while you are taking
Brevinor, tell your doctor, nurse or pharmacist.
Your doctor, nurse or pharmacist will inform you about the increased risk to the foetus if you
have become pregnant while taking
Brevinor. You will need to have a pregnancy test before
you continue to take
Brevinor.
Driving and using machines
Brevinor is not known to affect the ability to drive or use machinery.

Brevinor
contains lactose
Lactose is a type of sugar
. If you suffer from diabetes or you have been told by your doctor
that you have an intolerance to some sugars, contact your doctor before taking
this medicine.
3. How to take Brevinor
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Brevinor
can be taken with or without food.
Starting your first blister strip
• Take the first tablet on your first day of bleeding. This is the day when your period starts. If you are not having periods, ask your doctor or clinic when you should start taking your tablets.
• Take the tablet marked with the correct day of the week.
• You will be protected at
once as long as you take a tablet every day.
• You can take the tablet at a time that suits you,
but you must take it at about the
same time every day.
• Take a tablet every day until you finish a blister strip.
• If you cannot start the tablet on the first d
ay of your period you may start to take it on
any day up to the fifth day. However, if you do this, you may not be protected for the first seven days, so you should use another method of contraception such as a condom during those days.
Starting the next
blister strip
• Once you have finished all 21 tablets,
stop for seven days.
You will probably bleed
during some or all of these seven days.
•
Then, start the next blister strip. Do this whether or not you are still bleeding. You will always start the next blister strip on the same day of the week.
• You are protected during the seven day break, but only if you start the next blister strip on time. The first tablet in your blister strip is the worst
pill
of all to miss or take
late.

If you notice a change in
your periods
It is normal that your periods may become irregular and you may notice some bleeding
between periods. Your periods may become lighter and you may occasionally have no bleeding during the tablet free days. Make a note of what happens so that you can tell your doctor or nurse at your next check-up.
If you take more Brevinor than you should
Taking too many tablets at once may make you sick, cause vaginal bleeding or breast swelling. Contact your doctor or go to your nearest hospital casualty department
immediately.
If you forget to take Brevinor
• If you forget to take a tablet take it as soon as you remember and take the next one at your normal time. This may mean taking two tablets on the same day.
• If you are 12 or more hours late in
taking one or more tablets, it may not work. As
soon as you remember, take your last missed tablet and carry on taking them
normally. However, you may not be protected for the next seven days, so either avoid sexual intercourse or use an extra contraceptive method, such as a condom.
• If you have fewer than seven tablets in your blister strip after you have missed taking a dose, you should complete the blister strip and start the next blister strip without a break. This will give you protection from when you took the last missed tablet. You may not have a period until the end of two blister strips, but this will not harm you.
You may also have some bleeding on days when you take the tablets.
If you want to stop taking Brevinor
or want to have a baby?
If you stop taking
Brevinor, this will result in the loss of contraceptive protection and the risk
of pregnancy.
If you wish to become pregnant, you should contact your doctor or nurse about stopping the
tablets. It is advisable to stop taking
Brevinor 3 months before you want to start trying to
have a baby.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you change brands of oral contraceptive
• Take the first tablet of your new blister strip on the day immediately after you have
finished your old blister strip. Your period will usually be delayed until the new
blister strip is finished, but you may have some break-through bleeding during the first few days of the new blister strip. This is quite normal and you will still be protected against pregnancy.
If you have a stomach upset or
you are sick
• Brevinor may not work if you are sick or have severe diarrhoea. You should carry on taking the tablets as normal, but use a condom while you are ill and for the next seven days. If these seven days run beyond the end of the blister strip, start the next pack without a break.
• If you do have a break, ask your doctor or nurse whether you need an extra
contraceptive method, such as a condom. If you have just
had a baby
• If you are breast feeding, you should not take the combined oral contraceptive. This is
because the oestrogen in the tablets may reduce the amount of milk you produce. You
should be able to take another type of contraceptive instead. Ask your doctor or
nurse
for advice.
• If you are not breast feeding, you may start taking
Brevinor
21 days after your baby is
born. This will protect you immediately. If you start later than this, you may not be
protected until you have taken the tablets for seven days.
If you
have just had a miscarriage or abortion
You may be able to start taking
Brevinor
immediately. If you can, you will be protected
straight away. Ask your doctor or nurse
if you should do so.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines,
this medicine
can cause side effects although not everybody gets them.
Tell your doctor
or call an ambulance
immediately
if you experience any of the following
symptoms of an allergic reaction after taking this medicine. Although they are rare, the
symptoms can be severe and you may need urgent medical attention or hospitalisation.
• Sudden wheeziness, difficulty in breathing, chest pain, fever, sudden swellings, rash or itching (especially affecting the whole body).
Stop taking Brevinor
and contact your doctor straight away if you notice any of the
following serious side effects. These may be signs of a blood clot.
• you are coughing up blood
• you have swelling or tenderness in your stomach
• you have a sudden sharp or severe pain in the chest
• you suddenly become short of breath or find breathing is painful
• you have painful or inflamed veins in your legs
• you have a first attack of migraine (a bad headache with sickness)
• you have migraines which get worse, especially if your sight is affected, you see flashing lights, your limbs feel weak, you lose the sensation or feel a different sensation in your limbs, or you have a fit
• you have sudden and unusual severe headaches
• you experience dizziness or you faint
• you develop a problem with your sight or speech.
Other side effects Brevinor may cause are:
• feeling sick
• stomach upset
• weight gain
• changes in appetite
• changes in the way your body breaks down sugars, fats or vitamins
• headache
• high blood pressure 

• depression
• swollen or sore breasts
• change in sex drive
• worsening of womb disorders
• irregular vaginal bleeding.
Taking any medicine carries some risk. You can use the information in this leaflet, and the advice your doctor
or nurse has provided you to weigh up the risks and benefits of taking the
Pill. Don't be embarrassed, ask as many questions as you need to.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
informa
tion on the safety of this medicine.
5. How to store
Brevinor
Keep
this medicine
out of the sight
and reach
of children.
Do not use
this medicine
after the expiry date which is stated on the carton and blister strip after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the blister in the outer carton in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
6. Contents of the pack and other information
What Brevinor contains
The active substances are norethisterone and ethinylestradiol.
Each Brevinor tablet contains
500 micrograms of norethisterone and
35 micrograms of
ethinylestradiol
The other ingredients are maize starch, polyvidone, magnesium stearate, lactose (see section 2 Brevinor contains lactose) and colouring E132.
What Brevinor looks like and contents of the pack
Brevinor tablets are blue and have the word 'SEARLE' on one side and 'BX' on the other side.
They are packed in blister strips of 21 tablets and come in cartons containing either 21 or 63 tablets.
Not all pack sizes maybe marketed.
Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
UK
Manufacturer
Piramal Healthcare UK Limited
Morpeth
Northumberland
NE61 3YA
UK
This leaflet was last revised in08/2014.Ref: BR9_1

Other side-effects known or suspected to occur with oral contraceptives include gastro-intestinal symptoms, changes in libido and appetite, headache, exacerbation of existing uterine fibroid disease, depression, and changes in carbohydrate, lipid and vitamin metabolism.

Spotting or bleeding may occur during the first few cycles. Usually menstrual bleeding becomes light and occasionally there may be no bleeding during the tablet-free days.

Hypertension, which is usually reversible on discontinuing treatment, has occurred in a small percentage of women taking oral contraceptives.