Loette® Tablets(Levonorgestrel 0.100 mg/Ethinyloestradiol 0.020 mg)
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 Loette is and what it is used for
2. What you need to know before you take Loette
3. How to take Loette
4. Possible side effects
5. How to store Loette
6. Contents of the pack and other information
1. WHAT LOETTE IS AND WHAT IT IS USED FOR
Pharmacotherapeutic group
Loette is a monophasic combined oral hormonal contraceptive (pill).
Each tablet contains two female hormones: levonorgestrel (a progestin) andethinyloestradiol (an oestrogen). Each blister contains 21 tablets, each containing thesame amount of progestin and oestrogen. This pill should be taken for 21 days,
followed by a break for 7 days. These hormones prevent the release of an ova so that
pregnancy does not occur.
Therapeutic indications
Prevention of pregnancy, when the product is used in accordance with the
instructions.
Treatment of mild to moderate acne vulgaris in women of childbearing potential andwho take contraceptives.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOETTE
Do not take Loette:
If you have or have had a venous thrombosis (a blood clot) in the blood vesselsof the legs (deep vein thrombosis), lungs (pulmonary embolism) and eyes (seealso the section entitled “Blood clots”);
If you have had a disease of the blood vessels (arteries), such as a heart attack or
a stroke (see also the section entitled “Blood clots”);
If you have a hereditary predisposition to one of the diseases mentioned above;

Page 1 of 11-If you suffer from headaches or migraines accompanied by neurologicalsymptoms such as aura (i.e., with an unusual sensation such as bursts of light);
If you have damage to the heart valves or some heart rhythm disorders;If you have high blood pressure, which is not improved when you take bloodpressure medicines;
If you have chest pain (angina pectoris);
If you have diabetes with blood vessel damage;If you have, or have had, cancer of the breast, uterus or liver (see also the section
entitled “Cancer”);
If you have serious liver disease;
If you have vaginal bleeding of unknown origin;
If you are pregnant or think you may be;
If you are allergic to levonorgestrel, ethinyloestradiol or any of the otheringredients of this medicine (listed in section 6)
If you have or have had an inflammation of the pancreas, which was associatedwith severe increase of the lipids in your blood.

Do not use Loette if you have hepatitis C and you are taking medicines that containthe
combinationofombitasvir/paritaprevir/ritonavir,
dasabuvir,
glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (also see section“Other medicines and Loette”).
If any of the situations listed above applies to you, you must stop Loette and you
should talk to your doctor BEFORE you start taking it.
If any of the situations appears for the first time while taking Loette, you must contact
your doctor immediately.
Warnings and precautions
Talk to your doctor before taking Loette.
If you smoke (especially if you are over 35 years old);If someone in your immediate family has had a disease caused by blood clots,
such as deep vein thrombosis, pulmonary embolism, heart attack, or stroke;If your weight is excessive;
If you are diabetic;
If you have high blood pressure;If you suffer from headaches or migraines;
If you have, or have had, one or more breast cysts and someone in yourimmediate family has had breast cancer;
If you have a uterine fibroid;
If you have liver disease or gallbladder disease (gallstones);
If you have had a biliary problem when previously taking a contraceptive pill or
during a pregnancy;
If you suffer from a hypersensitivity reaction - called angioedema;
If you have a high level of fats in the blood (cholesterol or triglyceride);If you are, or have been, severely depressed;
If you have or have had a chloasma (brown spots on the skin, called “mask ofpregnancy”, particularly on the face). In this case, you must avoid excessive
exposure to the sun or to ultraviolet radiation;

Page 2 of 11-If you suffer from haemolytic uraemic syndrome (a blood disease that causes
renal insufficiency).

Also, careful consideration should be given to certain disorders, which can beexacerbated when taking the pill, such as systemic lupus erythematosus (skin damage
extending to the whole body), varicose veins, asthma, epilepsy, pemphigoid
gestationis (herpes occurring during a pregnancy), hyperprolactinaemia, a disordercalled "Saint Vitus Dance" or chorea and otosclerosis (disease of the inner ear).
If you develop symptoms of angioedema, such as swelling of the face, tongue and/or
throat and/or difficulties swallowing or hives with potential difficulties breathing, talkto your doctor immediately. Products containing oestrogens can trigger or worsen
symptoms of hereditary or acquired angioedema.
Consult your doctor if any of the warnings mentioned above apply to you, or appliedin the past. If any of these situations appear for the first time while taking Loette orworsens while taking Loette, you must contact your doctor.
As all contraceptive pills, Loette does not protect against HIV infections (AIDS), or
against the other sexually transmitted diseases.
Psychiatric disorders
Some women who take hormonal contraceptives including Loette have reported
depression or depressed mood. Depression can be serious and may sometimes lead tosuicidal thoughts. If you experience mood changes and depressive symptoms contact
your doctor for medical advice as soon as possible.
Potentially serious situations
Blood clots
Thrombosis is the formation of a blood clot that can block a blood vessel (vein orartery). If a blood clot forms in the deep veins of the leg (deep vein thrombosis), it
could detach and block arteries in the lungs (pulmonary embolism). Deep veinthrombosis is a rare phenomenon, which may occur whether the woman takes the pillor not. The risk is a little higher for women who take the pill than for those who do
not take it, but remains lower than the risk of thrombosis during pregnancy.
The risk of deep vein thrombosis increases temporarily after surgery, childbirth,second trimester termination of pregnancy and in case of prolonged immobilization(for example if you have a leg in plaster), and all the more if you take simultaneously
the pill. Your doctor may advise you to stop the pill several weeks before any surgery
or for the time of immobilization. He/she will also tell you when you can start taking
the pill again after return to full mobility and after childbirth or second trimester
termination of pregnancy.
In rare cases, a blood clot may also form in the arteries, such as those of the heart(heart attack) or brain (stroke), as well as the liver, gut, kidneys or eyes.
The risk of heart attack or stroke increases with age and smoking. You must stopsmoking if you take the pill, especially if you are 35 years and older and smoke
more than 15 cigarettes per day.

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Thrombosis does not always heal completely. It can sometimes cause a permanent
disability or even be fatal. If you notice signs of a potential thrombosis, you should
contact your doctor immediately (see also the section entitled “When should you
contact your doctor”).
CancerEstablished risk factors for development of breast cancer include older age, family
history, obesity, not having had children and having had a first pregnancy andchildbirth at an older age.
Breast cancer has been diagnosed slightly more often in women taking the pill than inwomen of the same age who do not take it. This slight increase in the number ofbreast cancer diagnoses gradually disappears 10 years after stopping the pill. It is notknown whether this difference is caused by the pill. It also may be that the women
have been examined more carefully and more often, so that breast cancer had been
detected earlier. The pill could also increase the risk of cervical cancer, but this has
not been scientifically proven.
In rare cases, non-cancerous liver tumours, and even more rarely, malignant liver
tumours have been reported in users of the pill. The risk of developing such tumours
increases with the duration of taking the pill, but remains low overall.
When should you contact your doctor?
Regular check-ups
Your doctor will ask you to return for periodic regular medical examinations. In
general, the frequency and nature of these examinations will depend on various
personal medical factors. Your doctor will need to assess the different aspects andwill provide you with the necessary explanations.
Contact your doctor as soon as possible in the following cases:
If you feel possible signs of thrombosis, as for example:o Pain or tightness in the chest, possibly irradiating in the left armo Severe pain or abnormal swelling of a lego Severe and sudden headacheo Sudden vision or speech alteration (partial or total loss of sight or difficulty
talking)o Vomiting, dizziness or faintingo Sudden weakness or numbness of one side or half of the bodyo Severe and intolerable abdominal paino Sudden coughIf you feel a lump in your chest;
At least four weeks in advance, if you must undergo surgery or remain bedridden for some time (see also the section entitled “Blood clots”);
After childbirth or second trimester termination of pregnancy (see also thesection entitled “Blood clots”);
If you notice abundant unusual vaginal bleeding;If you think you may be pregnant;If your period does not appear during the week not taking the pill.

Page 4 of 11Other medicines and Loette
Tell your doctor or pharmacist if you are taking, have recently taken or might takeany other medicines.
When your doctor or your dentist wants to prescribe you a new medicine, you must
always tell them that you take Loette. Your doctor will tell you if you need totemporarily use another form of contraception while taking this medicine.
Several medicines may interfere with the way the pill works. Medicines that
increase the activity of your liver enzymes may prevent your pill from working,and may cause breakthrough bleeding and irregular periods. These may be:Some medicines used to treat epilepsy (primidone, phenytoin, barbiturates,
topiramate, phenylbutazone, carbamazepine, felbamate)
Griseofulvin (a product used to treat fungal infections)
Some treatments against HIV (AIDS) and other viral infections (ritonavir)
Rifampicin (to treat tuberculosis)
Products containing St. John's Wort (Hypericum perforatum)
Modafinil (mood-brightening substance)
Dexamethasone (substance used to treat various inflammatory and autoimmune
diseases)
Such drugs include drugs that increase the activity of your liver enzymes.
Other medicines that do not affect your liver enzymes may also have this effect.
These include drugs that speed up the passage of food through your body and certain
antibiotics.
Women on short term treatment with any of these medicines should temporarily use abarrier method, such as the condom, in addition to the pill or choose anothernon-hormonal method of contraception. The barrier method should be used during
time of concomitant drug administration and for 28 days after their discontinuation.
If you are receiving long-term therapy with drugs that make the Pill less effective,
another method of contraception should be used.
Oral contraceptives may influence the outcome of certain laboratory tests. Tell yourdoctor that you take Loette if you must undergo a blood test.
Do not use Loette if you have hepatitis C and you are taking medicines that containthe
combinationofombitasvir/paritaprevir/ritonavir,
dasabuvir,
glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir as these products canresult in elevations in liver function blood tests ( elevated ALT liver enzyme).
Your doctor will prescribe a different type of contraceptive before starting treatment
with these medicines.
Loette may be resumed approximately two weeks after the end of this treatment. See
section “Do not take Loette”.
Loette with food and drink
Loette can be taken with food and drink.

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Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning tohave a baby, ask your doctor or pharmacist for advice before taking this medicine.
Loette cannot be used if you are pregnant or if you think you might be.
Loette cannot be used if you are breast-feeding.
Driving and using machines
The effect on driving or using machines has not been studied for Loette.
Loette contains lactose
If your doctor has informed you of intolerance to some sugars, contact them before
taking this medicine.
3. HOW TO TAKE LOETTE
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
When and how to take the tablets
The Loette blister contains 21 tablets. The day of the week when it must be taken isshown on the blister for each tablet. Take one tablet each day, in the order shown on
the blister, preferably at the same time for 21 consecutive days. During the 7 days
following the 21 days do not take any tablets. Your period should start during these 7days without tablets (usually on the 3rd day). After this 7 days period without tablets,
start a new blister on the 8th day, even if your period is not finished.
Accordingly, you will always start a new blister on the same day of the week, and you
will have your period on about the same days every 4 weeks.
Taking the pill is not indicated before the appearance of the first period and in postmenopausal women.
When to start the first blister
If you have not used contraceptive pills the previous monthTake the first tablet on the first day of your period.
If you take another combined pill
Take the first tablet the day that follows taking the last active tablet of the previous
contraceptive.
If you take an only progestin pill (“mini pill”)
Take the first tablet at any time of your cycle, the day that follows stopping the mini
pill. You must use an additional non-hormonal mechanical contraceptive method(such as a condom or spermicide) during the first 7 days of treatment.
If you are using an injectable contraceptive or an implant or an IUD
Take the first tablet the day the implant or the IUD is removed or the day planned foryour next injection. You must use an additional non-hormonal mechanicalcontraceptive method (such as a condom or spermicide) during the first 7 days oftreatment.

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If you have had a first trimester termination of pregnancy
You can start Loette immediately.
If you have just given birth or if you had a second trimester termination ofpregnancy
Your doctor may advise you to start taking Loette from the 28th day after childbirth orafter a second trimester termination of pregnancy. You must use an additional nonhormonal mechanical contraceptive method (such as a condom or spermicide) during
the first 7 days of treatment. If you have already had sexual intercourse, you must
exclude pregnancy before starting to take the pill or wait until the next period.
What to do if you have an unexpected bleeding
Unexpected vaginal bleeding may appear between the periods (spotting), especiallyduring the first months of use. In general, the irregular bleeding ceases once yourbody has become accustomed to the pill (after about three blisters). However, if the
bleeding persists or appears for the first time after prolonged use of Loette, see yourdoctor immediately.
What to do if your period does not appear
If you do not have your period after 7 days without the pill and if you havescrupulously respected the instructions, pregnancy is unlikely. Start the new blister on
the 8th day. However, if you still do not have a period after two complete 21 days
cycles of treatment, see your doctor immediately and do not start the next blister
before having his/her agreement.
If you take more Loette than you should
We do not know of cases where there have been serious adverse effects after taking asignificant quantity of Loette pills.
Symptoms:
If you have taken several Loette tablets at once, you can have nausea, vomiting,stomach pain, dizziness, somnolence, fatigue, tense breasts or light vaginal bleeding.
Treatment:
Specific treatment is probably not necessary.
If you discover that a child has taken Loette, you must immediately inform yourdoctor.
If you used or taken too much Loette, contact immediately your doctor or pharmacist.
If you forget to take Loette
If you missed taking one tablet for less than 12 hours, the contraceptive
reliability of the pill is maintained. Take the missed dose as soon as you
remember and take the next tablet at the usual time.
If you missed taking one tablet for more than 12 hours or if you have forgotten
more than one tablet, the contraceptive reliability of the pill may becompromised. In this case:o Take the last forgotten tablet immediately, even if 2 tablets must be taken on
the same day and continue the contraceptive treatment until the end of theblister;

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oAt the same time use an additional non-hormonal mechanical contraceptive
method (such as a condom or spermicide) during the next 7 days; if thissafety period of 7 days with condom extends beyond the last tablet of theblister, do not take a break between the two blisters and start the next blister
immediately after taking the last tablet.

However, it is recommended to ask the advice of your doctor.
What to do if you vomit or have significant diarrhoea
If you vomit or if you have significant diarrhoea in the 4 hours after taking a tablet, it
is possible that the active components of Loette had not been sufficiently absorbed byyour body. You must then follow the instructions in the section entitled “If you forget
to take Loette” by taking a tablet from the backup blister. If diarrhoea or vomiting
persists, see your doctor.
If you stop taking Loette
When you stop taking Loette it may be that your period does not return spontaneously(post-therapeutic amenorrhoea). In this case, you should contact your doctor.
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 getsthem.
Serious side effects
The serious side effects associated with the use of the contraceptive pill are describedin the sections entitled “Blood clots” and “Cancer”. Please read these sections formore information in section 2. “Potentially serious situations”.
Angioedema
Talk to your doctor immediately if you develop any symptoms of angioedema, suchas swelling of the face, tongue and/or throat and/or difficulties swallowing or hives
with potential difficulties breathing (also see “Warnings and precautions”)
The other side effects are listed by category of frequency as follows:
Very common:
more than one in 10 users
Common:between one in 10 users and one in 100 users
Uncommon:between one in 100 users and one in 1,000 users
Rare:
between one in 1,000 users and one in 10,000 users
Very rare:
fewer than one in 10,000 users
Frequency not known (cannot be estimated from the available data)
System/organ class
Infections and infestations
CommonSide effectVaginal infection, including vaginal candidiasis (yeast
infection)

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System/organ classSide effect
Neoplasms
benign,malignant and unspecified(inc. cysts and polyps)
Very rare
An increased risk of benign liver tumours, malignant
liver tumours
Immune system disorders
Rare
Hypersensitivity reactions, including very rare cases ofurticaria, allergic oedema affecting the face (angiooedema), severe breathing and circulation disorders
Very rare
Aggravation of disseminated lupus erythematosus
Metabolism and nutrition
disorders
UncommonIncreased or decreased appetite
Rare
Glucose intolerance
Very rare
Worsening of porphyria (accumulation of porphyrin in
the tissues)
Psychiatric disorders
CommonChanges in mood and libido (sexual desire),
depression.
Nervous system disorders
Very common
Headache, migraine
CommonNervousness, dizziness
Very rare
Worsening of the Saint Vitus Dance (chorea)
Eye disorders
Rare
Contact lens intolerance
Very rare
Inflammation of the optic nerve*, thrombosis (bloodclot) of vessels of the retina
Cardiac and vasculardisorders
Very rare
Worsening of varicose veins
Gastrointestinal disorders
CommonNausea, vomiting, stomach pain
UncommonCramps in the stomach, bloating
Very rare
Inflammation of the pancreas, inflammation of thecolon due to a lack of oxygen
Frequency not known
Inflammatory bowel disease (Crohn's disease,ulcerative colitis)
Hepatobiliary disorders
Rare
Jaundice by obstruction of the bile ducts
Very rare
Gallstones, decrease of biliary secretion**
Frequency not known
Hepatic injury (e.g., inflammation of the liver,abnormal liver function)
Skin and subcutaneous
tissue disorders
CommonAcne
UncommonRash, appearance of persistent brown spots on theface, abnormal development of hairiness, hair loss
Rare
Rash with nodules (nodular erythema)
Very rare
Vesiculobullous rashes (erythema multiforme)
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System/organ classSide effect
Renal
and
urinary
disorders
Very rare
Haemolytic uraemic syndrome (specific tendency to
bleeding)
Reproductive system andbreast disorders
Very common
Bleeding between periods (spotting)CommonPain and tension in the breasts, increase in the volumeof the breasts and secretions, painful periods, change
in the volume of the periods, absence of periods,
changes in cervical secretions
General disorders andadministration
site
conditions
CommonWater retention, oedema
Investigations
CommonChange in body weight (increase or decrease)
UncommonIncrease in blood pressure, change in the level of fatsin the bloodRare
Decrease in the level of folates*** in the blood* Inflammation of the optic nerve can cause partial or total loss of sight.
** The pill can aggravate an existing gallbladder disease or may enable the development of such a
disease.
*** The level of folates in the blood can decrease if you take the pill. This can be important if you fall
pregnant quickly after stopping the pill.

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. By reporting side effects you can help
provide more information on the safety of this medicine.
5. HOW TO STORE LOETTE
Please refer to the outer package for storage condition.
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 outer package.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
Loette Tablets
Active substances are levonorgestrel 100 mcg and ethinyloestradiol 20 mcg.
Other ingredients are lactose monohydrate, microcrystalline cellulose, polacrilin
potassium, magnesium stearate, macrogol 1450, hypromellose, titanium dioxide
E171, red iron oxide E172 and montan glycol wax.
Pfizer Corporation Hong Kong Limited
DEC 2023
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Version approved: 11 JUL 2024

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