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LOETTE®

Levonorgestrel and Ethinylestradiol Tablets


Consumer Medicine Information
thrombosis (DVT)), lungs
What is in this leaflet Ask your doctor if you have any
(pulmonary embolism) or eyes
questions about why Loette has
This leaflet answers some common been prescribed for you.  Heart valve or heart rhythm
questions about Loette. It does not Your doctor may have prescribed disorders that may be
Loette for another reason. associated with the formation
contain all the available
of blood clots
information. It does not take the This medicine is available only
 Heart attack or stroke
place of talking to your doctor or with a doctor's prescription.
pharmacist.  Chest pain (angina pectoris)
Loette is not habit-forming.  High blood pressure which is
All medicines have risks and This medicine is not expected to uncontrolled
benefits. Your doctor has weighed affect your ability to drive a car or  Some severe types of headache
the risks of you taking Loette operate machinery. or migraine, including migraine
against the benefits this medicine with partial paralysis
is expected to have for you.  Diabetes with blood vessel
If you have any questions about damage
taking this medicine, ask your Before you take  Breast cancer or cancer of the
doctor or pharmacist. lining of the womb, cervix or
Loette vagina, or you think you have
Keep this leaflet with the
medicine. these conditions
When you must not take  Unexplained vaginal bleeding
You may need to read it again.
Loette  Liver tumour or liver disease
Do not take Loette if you have an  Inflammation of the pancreas,
allergy to: which is associated with very
high blood levels of
What Loette is used  Any medicine containing triglycerides (fatty substances)
ethinylestradiol or
for levonorgestrel
 Yellowing of the whites of the
eyes or of the skin (jaundice)
Loette is an oral contraceptive,  Any of the ingredients listed at during pregnancy or during
the end of this leaflet previous use of an oral
commonly known as a “birth
control pill” or “the Pill”. Loette  Any other similar medicines contraceptive.
(such as other oral  High blood levels of
tablets contain two hormones
contraceptives) cholesterol or triglycerides
(levonorgestrel and
Some of the symptoms of an  Changes in vision, such as
ethinylestradiol), which prevent
allergic reaction may include: blurring.
you from becoming pregnant if
taken correctly. They are similar  shortness of breath Do not take Loette if you have
to the hormones that your body  wheezing or difficulty Hepatitis C and are taking the
normally produces. breathing combination drug regimen
 swelling of the face, lips, ombitasvir/paritaprevir/ritonavir
Loette prevents pregnancy in
tongue or other parts of the and dasabuvir with or without
several ways:
body ribarivin as this may cause
 It inhibits the egg release by  rash, itching or hives on the increases in liver function blood
stopping it maturing skin. test results (increase in ALT liver
 It changes the cervical mucus Do not take Loette if you have or enzyme). Loette can be restarted
consistency making it difficult have had any of the following approximately 2 weeks after
for the sperm to reach the egg medical conditions: completion of treatment with the
 It changes the lining of the
 Blood clots in the legs combination drug regimen.
uterus making it less suitable
for implantation. (thrombophlebitis or deep vein If you are not certain whether
these may apply to you, or you

LOETTE® PAGE 1 OF 8
are worried by anything in this  Heart disease a rare occurrence and can develop
list, tell your doctor.  High cholesterol or blood fats whether or not you are taking an
Do not take this medicine if you  High blood pressure, a history oral contraceptive. They can also
are pregnant or you think you of high blood pressure or high happen during pregnancy. The
are pregnant. blood pressure during risk of having a blood clot is
Pregnancy must be excluded pregnancy higher in oral contraceptive users
before you start taking Loette.  Migraine or other headaches than in non-users, but not as high
Do not give this medicine to a  Epilepsy as during pregnancy.
child.  Depression Tell your doctor if you plan to
Do not take this medicine if you  Gallbladder disease become pregnant or are
have already experienced  Kidney disease breastfeeding.
menopause.  Asthma Your doctor can discuss the risks
Do not take this medicine after  Fibroids and benefits involved with you.
the expiry date (EXP) printed on  Yellowing of the whites of the If you have not told your doctor
the pack or the packaging is torn eyes or skin (jaundice) during about any of the above, tell
or shows signs of tampering. pregnancy or during previous him/her before you start taking
If it is expired or damaged, oral contraceptive use Loette.
return it to your pharmacist for  Lupus (Systemic lupus
disposal. erythematosus) Taking other medicines
If you are not sure whether you  The hearing problem known as Tell your doctor if you are
otosclerosis taking any other medicines,
should start taking this
medicine, talk to your doctor.  Sickle cell anaemia including:
 A history of a skin condition  All prescription medicines
Before you start to take called herpes gestationis found  All medicines, vitamins, herbal
in pregnant women and not supplements or natural
Loette caused by the herpes virus therapies you buy without a
You must have a thorough  Multiple sclerosis prescription from a pharmacy,
medical check-up, including a  Hereditary angioedema. supermarket, naturopath or
Pap smear, breast check, blood health food shop.
If you have any of these conditions
pressure check and urine test. Some medicines may be affected
you should have regular check-ups
Tell your doctor if you are by Loette or may affect how well it
with your doctor to make sure that
allergic to any foods, dyes, works. You may need different
taking Loette is not making the
preservatives or any other amounts of your medicines, or you
conditions worse.
medicines. may need to take different
Tell your doctor if anyone in medicines. Your doctor will
Tell your doctor if you smoke.
your family has had blood clots
Oral contraceptives increase your advise you.
in the deep veins of the legs, a
risk of having a stroke or heart stroke or heart attack or you Tell your doctor or pharmacist if
attack. The risk of serious side have any of the following you are taking any of the
effects on the heart and blood conditions: following:
vessels is even greater if you  Obesity  Rifampicin and rifabutin for
smoke and take oral  Recent surgery or trauma the treatment of tuberculosis
contraceptives. The risk increases  Recently had a baby  Antibiotics such as ampicillin,
with age and with heavy smoking other penicillins and
 Lost a baby in the second tetracyclines
(15 or more cigarettes per day), trimester
especially in women older than 35  Anti-fungal agents such as
 Confined to bed rest for long griseofulvin
years. If you take Loette, you periods.
should not smoke.  Barbiturates (certain types of
The risk of developing blood clots medicines prescribed for
Tell your doctor if you have any in the deep veins of your legs, epilepsy, such as
other health problems, which can break away and block a phenobarbitone)
especially: blood vessel elsewhere in your  Medicines for epilepsy (such as
 Breast lumps, abnormal breast body, are increased if you have phenytoin, primidone
X-ray or mammogram any of these conditions and use an carbamazepine and topiramate)
 Diabetes oral contraceptive. Blood clots are

LOETTE® PAGE 2 OF 8
 Ritonavir for the treatment of be careful with or avoid while you Starting a hormonal
HIV infection are taking this medicine. contraceptive for the first
 Modafinil used to treat time
Do not take Loette, and tell your
excessive daytime sleepiness
doctor if you are taking the
 St. John’s wort, an ingredient To start taking Loette follow these
combination drug regimen
in many medicines you can buy steps:
without a prescription from a ombitasvir/paritaprevir/ritonavir
and dasabuvir with or without 1. On the first day of your
pharmacy, health food shop or
ribarivin for the treatment of menstrual period, take a pink tablet
supermarket
Hepatitis C. Treatment with Loette that matches the day of the week
 Corticosteroids such as
should be stopped when you are from the pink shaded section of the
dexamethasone.
taking this combination of blister pack. For example, if your
While you are taking any of
treatment regimen and can be period commences on a Friday,
these medicines and for the next
restarted approximately 2 weeks then take a pink tablet marked
7 days after stopping them, you
must also use an additional non- after completion of this treatment. Friday.
hormonal method of 2. Then take one pink tablet each
contraception (such as condoms day, following the arrows so that
or a diaphragm, but not the you are taking the correct tablet for
rhythm or temperature How to take it the day of the week until all 21
methods). If you come to the end pink tablets have gone.
of the pink tablets during these 7
Follow all directions given to you 3. Then take one white tablet each
days, start the next pack straight
by your doctor or pharmacist day for the next 7 days.
away. Skip the 7 white tablets.
carefully.
If you take rifampicin and some 4. You will have a ‘withdrawal’
other medicines, you may need to They may differ from the bleed, similar to having a period,
use additional non-hormonal information contained in this during the week of white tablets.
contraception for four weeks after leaflet.
Loette is effective from the first
finishing the course of treatment. If you do not understand the day of use if begun as instructed.
Ask your doctor or pharmacist instructions on the box, ask your
If you do not have a period while
about how long you need to use doctor or pharmacist for help.
you are taking the white tablets,
additional non-hormonal
and there is any chance that you
contraception. How to take Loette have not followed all the
Tell your doctor or pharmacist if Swallow tablets whole with a full instructions in this leaflet,
you are taking any of the glass of water. contact your doctor to check if
following: you are pregnant.
 Atorvastatin used to treat high
When to take Loette
cholesterol Going on to further blister
 Indinavir for the treatment of You must take Loette every day,
packs
HIV infection regardless of how often you have
 Anti-fungal medicines such as sex. On the day after your last white
itraconazole and fluconazole Loette will work best if you do not tablet, begin the next pack with a
 Paracetamol and ascorbic acid miss any tablets and take it at the pink tablet from the pink shaded
(Vitamin C) same time each day. Taking section of the blister pack that
 Cyclosporin used to prevent Loette at the same time each day matches the day of the week. Do
organ rejection will also help you remember when this even if you are still bleeding.
 Theophyllines used for asthma to take the tablets. If you start your new pack late,
and other breathing difficulties It does not matter if you take you must also use an additional
 Corticosteroids Loette before or after food. non-hormonal method of
 Lamotrigine for seizures. contraception (such as condoms
If you are concerned about this,
or a diaphragm, but not the
If you have not told your doctor please speak to your doctor or
rhythm or temperature
or pharmacist about any of the pharmacist.
methods) until a pink tablet has
above, tell them before you start
been taken daily for 7 days
taking Loette.
without a break.
Your doctor and pharmacist have
more information on medicines to

LOETTE® PAGE 3 OF 8
Switching from a different Switching from a protecting you from becoming
combined oral progestogen-only pregnant.
contraceptive contraceptive Do not try to make up for missed
doses by taking more than one
When changing from a different You can stop taking a
tablet at a time.
combined oral contraceptive to progestogen-only contraceptive
Loette, it is important to follow tablet any day and start taking Forgetting one pink tablet
the instructions below carefully. Loette the next day, at the same
1. If you forget one pink tablet but
Loette works best if you do not time.
it is less than 12 hours late, take
miss any tablets and take it at the If you have been using a the missed tablet immediately.
same time each day. progestogen implant, start Take the next tablet at your usual
Follow these steps if your taking Loette on the day the
time, even if this means taking two
current oral contraceptive implant is removed.
pink tablets in one day.
contains an estrogen and a If you have been using a
progestogen: progestogen injection, start If you do not take the missed tablet
1. Stop taking your current oral taking Loette on the day the next within 12 hours, Loette may not
contraceptive after you have taken injection would be due. work as well in protecting you
the last active tablet. If your In all cases start Loette by taking a from becoming pregnant.
current oral contraceptive pack pink tablet from the pink shaded 2. If one pink tablet is missed and
also contains inactive or reminder section that matches the day of the it is more than 12 hours late, take
tablets, do not take them. week. the missed tablet as soon as you
2. The next day, take the first pink You must also use an additional remember and the next pink tablet
Loette tablet from the pink shaded non-hormonal method of at the usual time, even if this
section that matches the day of the contraception (such as condoms means taking two tablets in one
or a diaphragm, but not the day.
week.
rhythm or temperature
You must also use an additional 3. Continue to take tablets at your
methods) until a pink tablet has
non-hormonal method of been taken daily for 7 days usual time but you must also use
contraception (such as condoms without a break. an additional non-hormonal
or a diaphragm, but not the method of contraception (such as
rhythm or temperature After having a baby condoms or a diaphragm but not
methods) until a pink tablet has the rhythm or temperature
been taken daily for 7 days If you have just had a baby, talk to methods) until a pink tablet has
without a break. your doctor before you start taking been taken daily for 7 days without
3. Then take one pink tablet each Loette. a break. If you come to the end of
day following the direction of the the pink tablets during the 7 days
arrows until all 21 pink tablets After a miscarriage or after a missed tablet, start the next
have gone. abortion pack straight away. Skip the 7
4. Then take one white tablet each Your doctor will advise you how white tablets.
day for the next 7 days. to take Loette after a miscarriage Forgetting more than one
5. You will have a ‘withdrawal’ or abortion. pink tablets
bleed, similar to having a period,
Contact your doctor for advice
during the week of white tablets. How long to take it
on what to do.
If you do not have a period while Continue taking your medicine
you are taking the white tablets, for as long as your doctor tells Forgetting a white tablet
and there is any chance that you you. 1. If you miss one or more white
have not followed all the Your doctor may prescribe Loette tablets, leave them in the pack and
instructions in this leaflet, for long periods, until you no do not worry.
contact your doctor to check if longer need or want contraception. 2. However, if you miss white
you are pregnant.
tablets and then forget to start the
If you forget to take your next pack on time, start as soon as
tablets you remember by taking a pink
If you forget to take Loette every tablet that matches the day of the
day, it may not work as well in week from the pink shaded section.

LOETTE® PAGE 4 OF 8
You must also use an additional the end of the pink tablets If you are about to have any
non-hormonal method of during these 7 days, start the blood tests, tell your doctor you
contraception (such as condoms or next pack straight away. Skip are taking Loette.
a diaphragm but not the rhythm or the 7 white tablets. It may interfere with the results of
temperature methods) until a pink The tablet may not have time to be some tests.
tablet has been taken daily for 7 absorbed properly and may not
protect you from becoming If you miss a period and you
days without a break. have taken your tablets
pregnant.
If you are not sure what to do, correctly, continue taking your
ask your doctor or pharmacist. If you have vomiting or tablets as you would normally.
If you are having trouble diarrhoea after taking a white Sometimes you might not have a
tablet, do not worry. menstrual period while taking
remembering to take Loette, ask
your pharmacist for some hints. Loette.
If you take too much
If you miss a period and you
If you wish to delay a (overdose) have not taken your tablets
period Immediately telephone your correctly, keep taking your
doctor or the Poisons tablets and see your doctor
1. After you have finished the last Information Centre on 0800 immediately.
pink tablet in your pack, skip the 7 POISON or 0800 764 766 for Not taking your tablets correctly
white tablets. advice, or go to Accident and includes missing one or more
2. Start the next pack the Emergency at the nearest tablets or starting a new pack later
following day by taking a pink hospital if you think you or than you should have.
tablet from the pink shaded anyone else may have taken too
If you miss two menstrual
much Loette.
section, which matches the day of periods, stop taking your tablets
the week. Do this even if there are no signs and see your doctor, even if you
of discomfort or poisoning. You have taken the tablets correctly.
3. Then take one pink tablet each may need urgent medical You must use a non-hormonal
day, following the arrows so that attention. method of contraception, (such
you are taking the correct tablet for
Symptoms of an overdose may as condoms or a diaphragm)
the day of the week until all 21 during this time.
include:
pink tablets have been taken. Your doctor should make sure you
 Feeling sick or vomiting
4. Then take one white tablet each are not pregnant before you start
 Dizziness
day for the next 7 days. taking Loette again.
 Feeling sleepy or tired
Whilst taking the second pack you Have regular checkups from
 Women may also experience
may have some breakthrough your doctor, including a Pap
menstrual bleeding.
bleeding or spotting. You will not smear.
have a ‘withdrawal bleed’ or Oral contraceptives should not be
period until the end of the second prescribed for longer than one year
pack when the white tablets are without your doctor carrying out a
While you are taking check-up. Your doctor will advise
taken.
Loette you how often you need a Pap
If you vomit or have smear. A Pap smear can detect
diarrhoea after taking Things you must do abnormal cells lining the cervix.
Loette Sometimes abnormal cells can
Tell any other doctors, dentists
progress to cervical cancer. The
If you have vomiting or and pharmacists who are
treating you that you are taking most important risk factor for
diarrhoea within 3 to 4 hours cervical cancer is persistent human
after taking a pink tablet, you Loette.
papillomavirus (HPV) infection.
must use an additional non- If you are about to start taking
However, cervical cancer has been
hormonal method of any new medicines, tell the
doctor or pharmacist that you reported to occur more often in
contraception (such as condoms
or a diaphragm, but not the are taking Loette. women using an oral contraceptive
rhythm or temperature for a long time. This finding may
If you become pregnant while
methods) until a pink tablet has not be caused by the oral
taking Loette, see your doctor
been taken daily for 7 days immediately. contraceptive, but may be related
without a break. If you come to

LOETTE® PAGE 5 OF 8
to sexual behaviour and other contraception such as condoms  Missed periods, but if you have
reasons. or a diaphragm. not taken Loette as directed
you should check whether you
Perform regular breast self- are pregnant
examination. Things you must not do
 Changes in mucus from the
Risk factors for the development Do not take Loette to treat any vagina
of breast cancer include increasing other complaints unless your  Vaginal thrush (Candida)
age, family history, obesity, never doctor tells you to.
 Breast pain, tenderness,
having had a baby, and late age for Do not give your medicine to enlargement, possible milk
first full-term pregnancy. Breast anyone else even if they have the secretion
cancer has also been found slightly same condition as you.  Changes in sex drive
more often in women who use oral Do not stop taking Loette, or  Nausea or vomiting
contraceptives than in women of change the dosage, without  Abdominal pain, cramps or
the same age who do not use them. checking with your doctor. bloating
This slight increase in the number If you stop taking Loette or do not
 Mood changes, including
of breast cancer cases gradually take a tablet every day, without depression
disappears during the course of the using another form of
 Headache, including migraines
10 years after stopping use of oral contraception, you may become
contraceptives. It is not known  Nervousness
pregnant.
whether the oral contraceptive  Dizziness
causes the difference. It may be  Contact lenses becoming
that the women were examined uncomfortable to wear.
 Weight change (increase or
more often, so that the breast Side Effects decrease)
cancer was noticed earlier.
Tell your doctor or pharmacist  Changes in appetite
If you are concerned about
contracting a sexually as soon as possible if you do not  Swelling of the hands, ankles
transmitted disease (STD), ask feel well while taking Loette. or feet
your partner to wear a condom All medicines can have side  Acne
when having sexual intercourse effects. Sometimes they are  Rash
with you. serious, most of the time they are  Darkening of the skin, which
Loette will not protect you from not. You may need medical may persist after stopping your
HIV-AIDS or any other sexually attention if you get some of the medicine
transmitted diseases (STDs) such side effects.  Loss of scalp hair
as chlamydia, genital herpes, It can be difficult to tell whether  Increase in body hair.
genital warts, gonorrhoea, hepatitis side effects are the result of taking The above list includes the more
B, human papilloma virus and Loette or are side effects of common side effects of your
syphilis. To help protect yourself another medicine you are taking. medicine.
from STDs, you need to use a
Do not be alarmed by the list of
barrier contraceptive such as a Tell your doctor as soon
side effects.
condom. as possible if…
You may not experience any of
Tell your doctor you are taking them. Tell your doctor as soon as
Loette at least 4 weeks before possible if you notice any
any planned hospitalisation or Ask your doctor or pharmacist
to answer any questions you worsening of conditions that you
surgery. may already have such as:
have.
Your doctor may tell you to stop  Chorea (involuntary muscle
taking Loette several weeks before spasm)
Tell your doctor if…
surgery or at the time of  Porphyria
Tell your doctor if you notice
immobilisation. Your doctor will  Systemic lupus erythematosus
any of the following and they
tell you when you can start taking (lupus)
worry you:
Loette after you are back on your  Changes in bleeding patterns,  Varicose veins
feet. including breakthrough  Gallbladder disease
To avoid pregnancy during this bleeding/spotting  Hereditary angioedema
time you must use a non-  Painful periods (swelling of the face, lips,
hormonal method of mouth, tongue or throat).

LOETTE® PAGE 6 OF 8
The above list includes serious  Swelling around eyes or mouth the car on hot days or on
side effects that may require  Bloody diarrhoea, abdominal window sills.
medical attention. Serious side pain or tenderness, fever, Heat and dampness can destroy
effects are rare. nausea or vomiting. some medicines.
Whilst these side effects are rare, Keep it where children cannot
Go to hospital if…
they are serious. You may need reach it.
Tell your doctor immediately, or
urgent medical attention or A locked cupboard at least one-
go to Accident and Emergency at
hospitalisation. and-a-half metres above the
the nearest hospital if you notice
any of the following: Other side effects not listed ground is a good place to store
 Sharp chest pain, coughing of above may also occur in some medicines.
blood, or sudden shortness of patients. Tell your doctor if you
breath notice anything else that is Disposal
 Pain in the calf muscle area making you feel unwell, even if it
If your doctor tells you to stop
is not on this list.
 Crushing chest pain or taking Loette, or the expiry date
heaviness in the chest has passed, ask your pharmacist
 Sudden severe headache or
After stopping Loette what to do with any left over.
vomiting, dizziness or fainting, If your periods do not return
disturbances of vision or within 2 to 3 months of stopping
speech, weakness, or numbness Loette tell your doctor.
in an arm or leg Some women have short-term Product description
 Sudden changes or loss of problems getting pregnant after
vision stopping Loette, especially if they
 Breast lumps What it looks like
had irregular menstrual cycles
 Severe pain or tenderness in the before starting to use an oral Loette comes in a 4 week sample
stomach area contraceptive. pack containing 1 blister pack and
 Jaundice or a yellowing of the a 12 week box containing 3 blister
If you are planning to become
skin or eyeballs, often with packs. Each blister pack contains
pregnant after stopping Loette,
fever, fatigue, loss of appetite, 21 pink hormone tablets and 7
use a non-hormonal method of
dark coloured urine or light white non-hormonal tablets. The
coloured bowel movements. contraception, such as condoms
or a diaphragm for 3 months blister pack is marked with days of
Taking oral contraceptives has
been associated with an before trying to get pregnant. the week next to each tablet.
increased risk of having a Ask your doctor or pharmacist
benign liver tumour and in very for advice about taking folate if Ingredients
rare cases, liver cancer. The you plan to become pregnant.
risk appears to increase the Each pink tablet contains 100
longer oral contraceptives are micrograms of levonorgestrel and
taken 20 micrograms of ethinylestradiol
 Migraine headaches for the as the active ingredients.
first time
After taking Loette
White tablets do not contain active
 More frequent migraines if you ingredients.
already suffer from them Storage
The pink tablets contain the
 Itchy rash Keep your tablets in the blister following inactive ingredients:
 You are an epileptic and your pack until it is time to take them.
fits become more frequent If you take the tablets out of the  Microcrystalline cellulose
 Rise in blood pressure. You blister pack they may not keep  Lactose monohydrate
may experience headache, well.  Polacrilin potassium
blurred vision or palpitations. Keep your tablets in a cool, dry  Magnesium stearate
Sometimes your blood pressure place where the temperature  Macrogol
may rise without you stays below 25C and is away  Hypromellose
from light.
experiencing any of these  Titanium dioxide
symptoms. It is important to Do not store Loette or any other
 Iron Oxide Red CI 77491.
keep your routine doctor's medicine, in a bathroom or near
a sink. Do not leave Loette in The white tablets contain:
appointments so that your
blood pressure can be checked  Lactose monohydrate

LOETTE® PAGE 7 OF 8
 Maize starch
 Magnesium stearate
 Macrogol
 Hypromellose
 hyprolose
 Titanium dioxide.
Loette does not contain gluten,
tartrazine or any other azo dyes.

Supplier
Loette is supplied in New Zealand
by:
Pfizer New Zealand Limited
PO Box 3998
Auckland, New Zealand
Toll Free number: 0800 736 363

Date of preparation
This leaflet was prepared in March
2017.
® Registered Trade Mark.
© Pfizer New Zealand Ltd 2017.

LOETTE® PAGE 8 OF 8

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