Loette Tablets 84 (3 x 28)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Loette. it does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Loette against the benefits this medicine is expected to have for you.

If you have any questions about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Loette is used for

Loette is an oral contraceptive. Loette tablets contain two hormones (levonorgestrel and ethinyloestradiol), which prevent you from becoming pregnant if taken correctly. They are similar to the hormones that your body normally produces.

Loette prevents pregnancy in several ways:
It inhibits the egg release by stopping it maturing
It changes the cervical mucus consistency making it difficult for the sperm to reach the egg
It changes the lining of the uterus making it less suitable for implantation.

Loette is also used to treat moderate acne that is not responsive to topical acne treatments in women who also accept contraception.

Your doctor may have prescribed Loette for another reason. Ask your doctor if you have any questions about why Loette has been prescribed for you.

Loette is not habit-forming.

This medicine is available only with a doctor's prescription.

Before you take Loette

When you must not take Loette

Do not take Loette if:
1. You are allergic to any of the ingredients found in Loette

The ingredients found in Loette are listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or troubled breathing.
2. You have or have had any medical conditions, especially the following:
Blood clots in the legs (thrombophlebitis or deep vein thrombosis), lungs (pulmonary embolism) or eyes
Heart valve or heart rhythm disorders that may be associated with the formation of blood clots
Heart attack or stroke
Chest pain (angina pectoris)
High blood pressure which is uncontrolled
Some severe types of headache or migraine, including migraine with partial paralysis
Diabetes with blood vessel damage
Breast cancer or cancer of the lining of the womb, cervix or vagina, or you think you have these conditions
Unexplained vaginal bleeding
Liver tumour or liver disease
Yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of an oral contraceptive
High blood levels of cholesterol or triglycerides (fatty substances)

If you are not certain whether these may apply to you, or you are worried by anything in this list, tell your doctor.
3. If you are pregnant or you think you are pregnant.

Pregnancy must be excluded before you start taking Loette.
4. Loette is not for use in children.
5. The expiry date (EXP) printed on the pack has passed.

Loette may have no effect at all, or worse, an entirely unexpected effect, if you take it after the expiry date.
6. The packaging is torn or shows signs of tampering.

If this is the case, take the tablets back to your pharmacist.

Before you start to take Loette

You must have a thorough medical check-up, including a Pap smear, breast check, blood pressure check and urine test.

You must tell your doctor if:
1. You are allergic to any foods, dyes, preservatives or any other medicines.
2. You smoke.

Oral contraceptives increase your risk of having a stroke or heart attack. The risk of serious side effects on the heart and blood vessels is even greater if you smoke and take oral contraceptives. The risk increases with age and with heavy smoking (15 or more cigarettes per day), especially in women older than 35 years. If you take Loette, you should not smoke.
3. You have any other health problems, especially:
Breast lumps, abnormal breast X-ray or mammogram
Diabetes
Heart disease
High cholesterol or blood fats
High blood pressure or you have a history of high blood pressure, including high blood pressure during pregnancy
Migraine or other headaches
Epilepsy
Depression
Gallbladder disease
Kidney disease
Asthma
Fibroids
Yellowing of the whites of the eyes or skin (jaundice) during pregnancy or during previous oral contraceptive use
Lupus (systemic lupus erythematosus)
The hearing problem known as otosclerosis
Sickle cell anaemia
A history of a skin condition called herpes gestationis found in pregnant women and not caused by the herpes virus.
Multiple sclerosis.

If you have any of these conditions you should have regular check-ups with your doctor to make sure that taking Loette is not making the conditions worse.
4. Anyone in your family has had blood clots in the deep veins of the legs, a stroke or heart attack or you have any of the following conditions:
Obesity
Recent surgery or trauma
Recently had a baby
Lost a baby in the second trimester
Confined to bed rest for long periods.

The risk of developing blood clots in the deep veins of your legs, which can break away and block a blood vessel elsewhere in your body, are increased if you have any of these conditions and use an oral contraceptive. Blood clots are a rare occurrence and can develop whether or not you are taking an oral contraceptive. They can also happen during pregnancy. The risk of having a blood clot is higher in oral contraceptive users than in non- users, but not as high as during pregnancy.
5. You plan to become pregnant or you think you are pregnant.

Like most medicines, Loette is not recommended during pregnancy.
6. You are breast-feeding or plan to breast-feed

Like most medicines, Loette is not recommended while you are breast-feeding. Small amounts of oral contraceptives have been found in breast milk. It is not known what effect this may have on the baby. A decrease in milk supply may also occur.

If you have not told your doctor about any of the above, tell them before you start taking Loette.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may stop Loette from working properly. These include medicines such as:
Rifampicin and rifabutin for the treatment of tuberculosis
Antibiotics such as ampicillin, other penicillins and tetracyclines
Anti- fungal agents such as griseofulvin
Barbiturates (phenobarbitone)
Medicines for epilepsy (such as phenytoin, primidone, carbamazepine and topiramate)
Ritonavir for the treatment of HIV infection
Modafinil used to treat excessive daytime sleepiness
St. John's wort, an ingredient in many medicines you can buy without a prescription from a pharmacy, health food shop or supermarket
Corticosteroids such as dexamethasone.

While you are taking any of these medicines and for the next 7 days after stopping them, you must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods). If you come to the end of the pink tablets during these 7 days, start the next pack straight away. Skip the 7 white tablets. If you take rifampicin and some other medicines, you may need to use additional non-hormonal contraception for four weeks after finishing the course of treatment.

Ask your doctor or pharmacist about how long you need to use additional non-hormonal contraception. Some medicines may increase the levels of Loette in your blood, which may lead to unwanted side effects.

These medicines include:
Atorvastatin used to treat high cholesterol
Indinavir for the treatment of HIV infection
Anti-fungal agents such as itraconazole and fluconazole
Paracetamol and ascorbic acid (Vitamin C).

Loette may also affect how well some other medicines work. These medicines include:
Cyclosporin used to prevent organ rejection
Theophyllines used for asthma and other breathing difficulties
Corticosteroids
Lamotrigine for seizures.

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Loette.

If you are scheduled for any laboratory tests, tell your doctor you are taking Loette. Some blood tests may be affected by taking Loette.

How to take Loette

For both contraception and treatment of acne, follow the directions on the blister pack.

If your doctor has prescribed Loette for some other purpose than contraception, follow their directions closely, even if they are not the same as on the pack.

When to take Loette

You must take Loette every day, even if you do not have sex very often. Loette will work best if you do not miss any tablets and take it at the same time each day. Taking your tablet at the same time each day will also help you remember when to take the tablets.

It does not matter if you take Loette before or after food.

If you are concerned about this, please speak to your doctor or pharmacist.

How to take Loette

Swallow Loette with a glass of water.

Starting a hormonal contraceptive for the first time

To start taking Loette follow these steps:
1. On the first day of your menstrual bleed, take a pink tablet that matches the day of the week from the pink shaded section of the blister pack.
2. Then take one pink tablet each day, following the arrows so that you are taking the correct tablet for the day of the week until all 21 pink tablets have gone.
3. Then take one white tablet each day for the next 7 days.
4. You will have a 'withdrawal' bleed, similar to having a period, during the week of white tablets.

Loette is effective from the first day of use if begun as instructed.

If you do not bleed and there is any chance that you have not followed all the instructions in this leaflet, contact your doctor to check if you are pregnant.

Going on to further blister packs
1. On the day after your last white tablet, begin the next pack with a pink tablet from the pink shaded section of the blister pack that matches the day of the week. Do this even if you are still bleeding.
2. Each new pack is started with a pink tablet on the same day as the first pack, so that you have 21 days on pink tablets, then 7 days on white tablets. There is no break between packs.
3. If you start the new pack later than the day after your last white tablet, you may have started a normal fertile cycle.

If you start late, you must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) until a pink tablet has been taken daily for 7 days without a break.

Changing from a different combined oral contraceptive

When changing from a different combined oral contraceptive to Loette, it is important to follow the instructions below carefully.

Loette works best if you do not miss any tablets and take it at the same time each day.

Follow these steps if your current oral contraceptive contains an oestrogen and a progestogen:
1. Stop taking your current oral contraceptive after you have taken the last active tablet. If your current oral contraceptive pack also contains reminder tablets, do not take them.
2. The next day, take the first pink Loette tablet from the pink shaded section that matches the day of the week.

You must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) until a pink tablet has been taken daily for 7 days without a break.
3. Then take one pink tablet each day following the direction of the arrows until all 21 pink tablets have gone.
4. Then take one white tablet each day for the next 7 days.
5. You will have a 'withdrawal' bleed, similar to having a period, during the week of white tablets.

If you do not bleed and there is any chance that you have not followed all the advice in this leaflet, contact your doctor to check if you are pregnant.

Changing from a progestogen-only contraceptive

You can stop taking a progestogen-only contraceptive tablet any day and start taking Loette the next day, at the same time.

If you have been using a progestogen implant, start taking Loette on the day the implant is removed.

If you have been using a progestogen injection, start taking Loette on the day after the next injection would be due.

In all cases start Loette by taking a pink tablet from the pink shaded section that matches the day of the week.

You must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) until a pink tablet has been taken daily for 7 days without a break.

After having a baby

If you have just had a baby, talk to your doctor before you start taking Loette.

After a miscarriage or abortion

Your doctor will advise you how to take Loette after a miscarriage or abortion.

How long to take Loette

For contraception:
Your doctor may prescribe Loette for long periods, until you no longer need or want contraception.

If you are not sure how long you should be taking Loette, ask your doctor.

For treatment of acne:
Your doctor will advise how long to take Loette for the treatment of acne.

If you forget to take your tablets

If you forget to take Loette every day it may not work as well in protecting you from becoming pregnant.

Do not try to make up for missed doses by taking more than one tablet at a time.

Forgetting one pink tablet
1. If you forget one pink tablet but it is less than 12 hours late, take the missed tablet immediately. Take the next tablet at your usual time, even if this means taking two tablets in one day.

If you do not take the missed tablet within 12 hours, Loette may not work as well in protecting you from becoming pregnant.
2. If one pink tablet is missed and is more than 12 hours late, take the last tablet as soon as you remember and the next tablet at the usual time.
3. Continue to take tablets at your usual time but you must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm but not the rhythm or temperature methods) until a pink tablet has been taken daily for 7 days without a break. If you come to the end of the pink tablets during the 7 days after a missed tablet, start the next pack straight away. Skip the 7 white tablets.

Forgetting more than one pink tablet

Contact your doctor for advice on what to do.

Forgetting a white tablet
1. If you miss one or more white tablets, leave them in the pack and do not worry.
2. However, if you miss white tablets and then forget to start the next pack on time, start as soon as you remember by taking a pink tablet that matches the day of the week from the pink shaded section. You must also use an additional non- hormonal method of contraception (such as condoms or a diaphragm but not the rhythm or temperature methods) until a pink tablet has been taken daily for 7 days without a break.

If you are not sure what to do, ask your doctor or pharmacist.

If you are having trouble remembering to take Loette, ask your pharmacist for some hints.

If you wish to delay a period
1. After you have finished the last pink tablet in your pack, skip the 7 white tablets.
2. Start the next pack the next day by taking a pink tablet from the pink shaded section, which matches the day of the week.
3. Then take one pink tablet each day, following the arrows so that you are taking the correct tablet for the day of the week until all 21 pink tablets have gone.
4. Then take one white tablet each day for the next 7 days.

Whilst taking the second pack you may have some breakthrough bleeding or spotting. You will not have a 'withdrawal bleed' until the end of the second pack when the white tablets are taken.

If you vomit or have diarrhoea after taking Loette

If you have vomiting or diarrhoea within 3 to 4 hours after taking a pink tablet, you must use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) until a pink tablet has been taken daily for 7 days without a break. If you come to the end of the pink tablets during these 7 days, start the next pack straight away. Skip the 7 white tablets.

The tablet may not have time to be absorbed properly and may not protect you from becoming pregnant.

If you have vomiting or diarrhoea after taking a white tablet, do not worry.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital if you think you or anyone else may have taken too much Loette. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too much Loette, some of the symptoms you may have include:
feeling sick or vomiting,
dizziness
feeling sleepy or tired.

Women may also experience menstrual bleeding.

While you are taking Loette

Things you must do

Tell all doctors, dentists and pharmacists who are treating you that you are taking Loette.

If you are about to start taking any new medicines, tell the doctor or pharmacist that you are taking Loette.

If you become pregnant while taking Loette, see your doctor immediately.

If you miss a period and you have taken your tablets correctly, continue taking your tablets as you would normally. Sometimes you might not have a menstrual period while taking Loette.

If you miss a period and you have not taken your tablets correctly, keep taking your tablets and see your doctor immediately. Not taking your tablets correctly includes missing one or more tablets or starting a new pack later than you should have.

If you miss two menstrual periods, stop taking your tablets and see your doctor, even if you have taken the tablets correctly. You must use a non-hormonal method of contraception, (such as condoms or a diaphragm) during this time. Your doctor should make sure you are not pregnant before you start taking Loette again.

Have regular check ups from your doctor, including a Pap smear. Oral contraceptives should not be prescribed for longer than one year without your doctor carrying out a check-up. Your doctor will advise you how often you need a Pap smear. A Pap smear can detect abnormal cells lining the cervix. Sometimes abnormal cells can progress to cancer. Cervical cancer has been reported to occur more often in women using an oral contraceptive for a long time. This finding may not be caused by the oral contraceptive, but may be related to sexual behaviour and other reasons.

Perform regular breast self-examination. Breast cancer has been found slightly more often in women who use oral contraceptives than in women of the same age who do not use them. This slight increase in the number of breast cancer cases gradually disappears during the course of the 10 years after stopping use of oral contraceptives. It is not known whether the oral contraceptive causes the difference. It may be that the women were examined more often, so that the breast cancer was noticed earlier.

If you are concerned about contracting a sexually transmitted disease (STD), ask your partner to wear a condom when having sexual intercourse with you. Loette will not protect you from HIV-AIDS or any other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B, human papilloma virus and syphilis. To help protect yourself from STDs, you need to use a barrier contraceptive such as a condom.

Tell your doctor you are using Loette at least 4 weeks before any planned hospitalisation or surgery. Your doctor may tell you to stop taking Loette several weeks before surgery or at the time of immobilisation. Your doctor will tell you when you can start taking Loette after you are back on your feet.

To avoid pregnancy during this time you must use a non-hormonal method of contraception such as condoms or a diaphragm.

Things you must not do

Do not give Loette to anyone else even if they have the same condition as you.

Do not use Loette to treat any other complaints unless your doctor tells you to.

Do not stop taking Loette, or change the dosage, without checking with your doctor. If you stop taking Loette or do not take a tablet every day, without using another form of contraception, you may become pregnant.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while taking Loette. When used correctly, Loette is an effective contraceptive, but may have unwanted side effects in some people. All medicines can have side effects. Sometimes they are serious, most of the time they are not.

Ask your doctor or pharmacist to answer any questions you have.

Tell your doctor immediately, or go to accident and emergency at your nearest hospital if you notice any of the following:
Sharp chest pain, coughing of blood, or sudden shortness of breath
Pain in the calf muscle area
Crushing chest pain or heaviness in the chest
Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg
Sudden changes or loss of vision
Breast lumps
Severe pain or tenderness in the stomach area
Jaundice or a yellowing of the skin or eyeballs, often with fever, fatigue, loss of appetite, dark coloured urine or light coloured bowel movements. Taking oral contraceptives has been associated with an increased risk of having a benign liver tumour, and in very rare cases, liver cancer. The risk appears to increase the longer oral contraceptives are taken.
Migraine headaches for the first time
More frequent migraines if you already suffer from them
Itchy rash
You are an epileptic and your fits become more frequent
Rise in blood pressure
Swelling around eyes or mouth
Bloody diarrhoea, abdominal pain or tenderness, fever, nausea or vomiting.

Whilst these side effects are rare, they are serious. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following and they worry you.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Reproductive or breast problems such as:
Changes in bleeding patterns, including breakthrough bleeding/spotting
Painful periods
Missed periods, but if you have not taken Loette as directed you should check whether you are pregnant
Changes in mucus from the vagina
Changes in the cervix
Vaginal thrush (candida)
Breast pain, tenderness, enlargement, possible milk secretion
Changes in sex drive.

Stomach problems such as:
Nausea or vomiting
Abdominal pain, cramps or bloating.

Difficulties thinking or working because of:
Mood changes, including depression
Headache, including migraines
Nervousness
Dizziness
Contact lenses becoming uncomfortable to wear.

Changes to your appearance such as:
Weight change (increase or decrease) or changes in appetite
Swelling of the hands, ankles or feet
Acne
Rash
Darkening of the skin, which may persist after stopping Loette
Loss of scalp hair
Increase in body hair.

Worsening of conditions you may already have such as:
Chorea
Porphyria
Systemic lupus erythematosus
Varicose veins
Gallbladder disease.

Other side effects not listed abovemay also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

After stopping Loette

If your periods do not return within 2 to 3 months of stopping Loette tell your doctor.

Some women have short-term problems getting pregnant after stopping Loette, especially if they had irregular menstrual cycles before starting to use an oral contraceptive.

If you are planning to become pregnant after stopping Loette, use a non-hormonal method of contraception such as condoms or a diaphragm for 3 months before trying to get pregnant.

Ask your doctor or pharmacist for advice about taking folate if you plan to become pregnant.

After taking Loette

Storage

Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the blister pack they may not keep well.

Keep Loette in a cool, dry place where the temperature stays below 25 degrees C and is away from light.

Do not store Loette or any other medicine, in a bathroom or near a sink.

Do not leave Loette in the car on hot days or on window sills. Heat and dampness can destroy some medicines.

Keep Loette where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking Loette, or the tablets have passed their expiry date, ask your pharmacist what to do with any left over.

Product description

What it looks like

Loette comes in a 4- week sample pack containing one blister and a 12- week box containing 3 blister packs. Each blister pack contains 21 pink hormone tablets and 7 white non-hormonal tablets. The blister pack is marked with days of the week next to each tablet.

Ingredients

Each pink tablet contains 100 micrograms of levonorgestrel and 20 micrograms of ethinyloestradiol as the active ingredients.

Each white tablet contains no active ingredients.

The pink and white tablets also contain the following inactive ingredients:
Microcrystalline cellulose
Lactose
Polacrilin potassium
Magnesium stearate
Macrogol 1450
Glycol montanate
Hypromellose
Titanium dioxide.

The pink tablets also contain the colouring agent:
Iron Oxide Red CI 77491.

Loette does not contain gluten, tartrazine or any other azo dyes.

Supplier

Loette is supplied by:

Wyeth Australia Pty Limited,
ABN 16 000 296 211
17-19 Solent Circuit,
Norwest Business Park,
Baulkham Hills NSW 2153

For further information please contact Wyeth on toll-free 1800 500 498 or E-mail: [email protected]

Australian Registration Number: AUST R 61771

This leaflet was prepared on 28 November 2008.

® Registered Trade Mark