Consumer Medicine Information

YASMIN^®

Drospirenone 3mg and Ethinylestradiol 30mcg tablets

What is in this leaflet

Please read this leaflet carefully before you start using YASMIN. It will advise you about how to take YASMIN properly and when to tell your doctor about health-related conditions. If you have any questions or need more advice, ask your doctor, professional health care provider or pharmacist.
This preparation has been prescribed for you personally and you should not pass it on to others. It may harm them.

What is YASMIN used for and how does it work

YASMIN is a combined oral contraceptive (often called "the Pill"). Each small hormonal tablet contains a small amount of two different female hormones. These are drospirenone (a progestogen hormone) and ethinylestradiol (an estrogen). Because of the small amount of hormones, YASMIN is considered a low-dose combined oral contraceptive preparation. YASMIN also contains 7 small white non-hormonal tablets that do not contain any active ingredients.

How does YASMIN work?

Combined oral contraceptive Pills, such as YASMIN, provide one of the most effective reversible methods of contraception known. Usually, when YASMIN is taken according to the instructions, the egg cells (normally released by the ovary each month) are prevented from maturing to the point where they can be fertilised. In addition, the cervical mucus remains thick, so it is more difficult for a man's sperm to enter the womb. Also, the lining of the womb is not prepared sufficiently for a fertilised egg to grow in.

What is YASMIN used for?

YASMIN is used to prevent pregnancy. Oral contraceptives are a very effective method of birth control. When taken correctly (without missing tablets) the chance of becoming pregnant is very low.
When using YASMIN you may also experience an improvement in symptoms like bloating, swelling or weight gain related to fluid retention. There may also be some improvement in acne and reductions in greasiness of the skin and hair.

Before you use YASMIN

Do not use YASMIN if you have any of the conditions listed below. If any of these apply to you, tell your doctor before starting to use YASMIN. Your doctor may advise you to use a different type of hormonal contraception or an entirely different (non-hormonal) method of birth control.

You must not use YASMIN if:

• you have, or have ever had a disorder affecting the blood circulation. In particular, those conditions relating to thrombosis. Thrombosis is the formation of a blood clot. This may occur in the blood vessels of the legs (deep vein thrombosis), the lungs (pulmonary embolism), the heart (heart attack), the brain (stroke), or other parts of the body
• you have or have had a stroke (caused by a blood clot or a rupture of a blood vessel in the brain)
• you have or have ever had a condition that may be a first sign of a heart attack (such as angina pectoris or chest pain) or stroke (such as transient ischaemic attack or small reversible stroke)
• you have or have had a pancreatitis (an inflammation of the pancreas) associated with high levels of fatty substances in your blood
• you have diabetes mellitus with blood vessel damage
• you or someone in your immediate family have or have had high blood levels of cholesterol or triglycerides (fatty substances)
• you have jaundice (yellowing of the skin) or severe liver disease
• you have or have had cancer of the breast or the genital organs
• you have a severe kidney insufficiency or an acute failure of your kidney
• you have or have had a benign or malignant liver tumour
• you have a history of migraine accompanied by e.g. visual symptoms, speech disability, or weakness or numbness in any part of your body
• you have any unexplained vaginal bleeding
• you are pregnant or think you might be pregnant
• you are allergic to any of the ingredients of YASMIN

If any of these conditions appear for the first time while using YASMIN, stop taking it at once and consult your doctor. In the meantime, use non-hormonal contraceptive measures.

Tell your doctor if:

If YASMIN is used in the presence of any of the conditions listed below or they appear for the first time or recur or worsen during treatment, you may need to be kept under close observation. You doctor can explain this to you. You should tell your doctor if:

• you smoke
• you have diabetes
• you are overweight
• you have high blood pressure
• you have a heart valve disorder or a certain heart rhythm disorder
• you have an inflammation of your veins (superficial phlebitis)
• you have varicose veins
• anyone in your immediate family has had thrombosis, a heart attack or a stroke
• you suffer from migraine
• you suffer from epilepsy
• anyone in your immediate family has had breast cancer
• you have liver, kidney or gallbladder disease
• you have an increased potassium blood level (e.g. due to problems with your kidneys) and additionally use a diuretic or other medicine that may increase the potassium in your blood (ask your doctor)
• you or someone in your immediate family has or has had high blood levels of cholesterol or triglycerides (fatty substances)
• you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease)
• you have systemic lupus erythematosus (SLE; a disease affecting the skin all over the body)
• you have haemolytic uraemic syndrome (HUS; a disorder of blood coagulation causing failure of the kidneys)
• you have sickle cell disease
• you have a condition that occurred for the first time or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, a metabolic disease called porphyria, a skin disease called herpes gestationis, a neurological disease called Sydenham's chorea)
• you have or have had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face); if so, avoid too much exposure to the sun or ultraviolet radiation

What else you should know

YASMIN does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

In this leaflet, several situations are described where you should stop taking YASMIN, or where the reliability of YASMIN may be decreased. In such situations you should not have sex or you should take extra non-hormonal contraceptive precautions, e.g., use a condom or another barrier method. Do not use rhythm or temperature methods. These methods can be unreliable because YASMIN alters the usual changes in temperature and cervical mucus that occur during the menstrual cycle.

YASMIN and thrombosis

Thrombosis is the formation of a blood clot which may block a blood vessel.
Thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis). If this blood clot breaks away from the veins where it is formed, it may reach and block the arteries of the lungs, causing a so-called "pulmonary embolism". Deep venous thrombosis is a rare occurrence. The risk for venous thromboembolism is highest during the first year a woman ever uses the Pill.
Venous thromboembolism can develop whether or not you are taking the Pill. It can also happen if you become pregnant. The risk is higher in Pill users than in non-users but not as high as the risk during pregnancy.
Blood clots can also occur very rarely in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke). Extremely rarely, blood clots can occur in the liver, gut, kidney or eye.
Very occasionally a thrombosis may cause serious permanent disabilities or may even be fatal.
The risk of having a heart attack or stroke increases as you get older. It also increases the more you smoke.

When using YASMIN you should stop smoking, especially if you are older than about 35 years of age.

If you develop high blood pressure while using YASMIN, you may be told to stop using it.
The risk of having deep venous thrombosis is temporarily increased as a result of an operation or immobilisation (for example, when you have your leg or legs in plaster or splints). In women who use the Pill (such as YASMIN) the risk may be even higher. Tell your doctor you are using YASMIN well in advance of any expected hospitalisation or surgery. Your doctor may tell you to stop taking YASMIN several weeks before surgery or at the time of immobilisation. Your doctor will also tell you when you can start taking YASMIN again after you are back on your feet.
If you notice possible signs of a thrombosis, stop taking the Pill and consult your doctor immediately.

YASMIN and cancer

Breast cancer has been diagnosed slightly more often in women who use the Pill than in women of the same age who do not use the Pill. This slight increase in the numbers of breast cancer diagnoses gradually disappears during the course of the ten years after stopping use of the Pill. It is not known whether the difference is caused by the Pill. It may be that the women were examined more often, so that the breast cancer was noticed earlier.
In rare cases, benign, and even more rarely, malignant liver tumours have been reported in users of the Pill. These tumours may lead to internal bleeding. Contact your doctor immediately if you have severe pain in your abdomen.
Cervical cancer has been reported to occur more often in women using the Pill for a long time. This finding may not be caused by the Pill but may be related to sexual behaviour and other factors.

YASMIN and other medicines

Some oral medicines may stop YASMIN from working properly. These include medicines used for the treatment of epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate) and tuberculosis (e.g. rifampicin, rifabutin); and antibiotics (e.g. ampicillin, tetracyclines, griseofulvin) for some other infectious diseases; and the herbal remedy St. John's wort (primarily used for the treatment of depressive moods). Some medicines (e.g. ketoconazole, erythromycin, cyclosporin) may inhibit the metabolism of YASMIN. The Pill may also interfere with the working of other medicines. Always tell the doctor who prescribes YASMIN which medicines you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that you use YASMIN. They can tell you if you need to take additional contraceptive precautions and if so, for how long.
There is a theoretical potential for an increase in serum potassium if you are taking YASMIN with other medicines that may increase serum potassium levels. Such drugs include ACE inhibitors, angiotensin-II-receptor antagonists, certain anti-inflammatory drugs (e.g. indomethacin), diuretics that may increase the potassium in your blood, and aldosterone antagonists. However, in a study in women taking drospirenone together with an ACE inhibitor, no significant difference in the potassium blood level could be observed compared with placebo.

YASMIN and breast-feeding

YASMIN is generally not recommended for use during breast-feeding. If you wish to take the Pill while breast-feeding, please seek the advice of your doctor.

YASMIN and pregnancy

YASMIN must not be used by women who are pregnant, or who think they may be pregnant. If you suspect that you are pregnant while you are already using YASMIN ED, you should consult your doctor as soon as possible.

YASMIN and ability to drive

There are no observed effects.

How to use YASMIN properly

The contraceptive protection provided by YASMIN is continuous. Additional contraceptive precautions are only required when special circumstances (e.g. forgetting tablets) reduce the reliability of the preparation.
Remember that YASMIN has been prescribed for you personally. Do not share it with others. Do not take YASMIN if the packaging is worn or damaged, or the tablets appear different in any way.

When and how to take the tablets

The YASMIN pack contains 21 small round light yellow tablets and 7 small white non-hormonal tablets. On the pack each tablet is marked with the day of the week on which it is to be taken. Take your tablet at about the same time each day, with some water if necessary. Follow the direction of the arrows until all the tablets have been taken. A period (the withdrawal bleed) should begin during the 7 days of taking the small white non-hormonal tablets. Start taking your next pack on the very next day after you have completed your last pack. This means that you will always start new packs on the same day of the week, and also that you will have your withdrawal bleed on about the same day each month.

Starting your first pack of YASMIN

When no hormonal contraceptive has been used in the past month

Start taking YASMIN on the first day of your cycle, i.e. the first day of menstrual bleeding. Take a tablet marked with that day of the week. Take your first tablet from the green section of the pack. For example, if your period starts on a Monday, take the tablet marked Monday from the green section of the pack. Then follow the days in order of the directional arrows. When you start taking YASMIN your very first cycle may be shorter than usual. If you start on the first day of your cycle you will be immediately protected from pregnancy and there is no need to use additional barrier contraceptive methods. You may also start on days 2-5 of your cycle, but in that case make sure you also use an additional contraceptive method for the first 7 days of tablet taking in the first cycle.

When changing from a combined Pill

You can start taking YASMIN the day after you take the last tablet from your present Pill pack (this means no tablet-free break). Take your first tablet from the green section marked with that day of the week. If your present Pill pack also contains non-hormonal tablets you can start YASMIN on the day after taking the last hormonal tablet (if you are not sure which this is, ask your doctor or pharmacist). A withdrawal bleed may not occur until the end of the first pack of YASMIN.

When changing from a progestogen-only Pill (minipill)

You can stop taking the minipill any day and start taking YASMIN the next day, at the same time. Take your first tablet from the green section marked with that day of the week. But make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet taking when having intercourse.

When changing from an injectable or implant

Start using YASMIN when your next injection is due or on the day that your implant is removed. Take your first tablet from the green section marked with that day of the week. But make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet taking when having intercourse.

After having a baby

If you have just had a baby, your doctor may tell you to wait until after your first normal period before you start taking YASMIN. Sometimes it is possible to start sooner. Your doctor will advise you. If you are breast-feeding and want to take YASMIN, you should discuss this first with your doctor.

After a miscarriage or an abortion

Your doctor will advise you.

Special circumstances

The following describes special circumstances that could alter the way you take YASMIN. In all situations where the reliability of YASMIN is reduced (such as missing tablets) additional contraceptive precautions are required following the advice given below. This advice should also be followed in situations where other medicines may stop YASMIN from working properly and in the case of vomiting after taking YASMIN.

If you forget to take your tablets

If you have forgotten more than one tablet in a pack, ask your doctor, pharmacist or healthcare provider for advice.
If you forget to take a tablet, follow the instructions below

If you vomit or have severe diahorrea after taking YASMIN

If you vomit within 3 to 4 hours after taking your YASMIN, the active ingredients may not have been completely absorbed. This is like missing a tablet. Therefore, follow the advice for missed tablets. If you have severe diarrhea, please contact your doctor. Vomiting or diahorrea while taking the non-hormonal tablets does not have an influence on the contraceptive reliability.

If you are taking medicines that affect YASMIN

Some oral medicines may stop YASMIN from working properly. These medicines are listed in an earlier section. For the time that you are taking the medicine and for the next 7 days follow the advice for missed tablets. If you are taking rifampicin, or you are taking these medicines continuously, your doctor will advise you on the length of time you need to take extra contraceptive precautions

If you want to delay a period

You can delay your period if you miss out the white non-hormonal tablets and go straight to the light yellow hormonal tablets in the green section of your next pack. Continue with this pack until this pack is empty. Your period will start while you are taking the white non-hormonal tablets in the next pack. You may have some breakthrough bleeding or spotting while you are taking the light yellow hormonal tablets.

If you want to change the starting day of your period

If you take your tablets as directed, you will have your period on about the same day every 4 weeks. If you want to change this, just shorten, (never lengthen) the duration of taking the white non-hormonal tablets. If you make the duration of taking the white non-hormonal tablets very short (e.g. 3 days or less), you may not have a bleeding during the break. You may have some breakthrough bleeding or spotting during the use of the next pack.

If you have unexpected bleeding

As with other Pills, for the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) with YASMIN between your periods. You may need to use sanitary protection, but continue to take your tablets as normal. Irregular vaginal bleeding usually stops once your body has adjusted to YASMIN (usually after about 3 tablet-taking cycles). If it continues, becomes heavy or starts again, tell your doctor.

If you have missed a period

If you have taken all of your tablets at the right time, and you have not vomited or used other medicines, then you are very unlikely to be pregnant. Continue to take YASMIN as usual.
If you miss your period twice in a row, you may be pregnant. Tell your doctor immediately. Do not start the next pack of YASMIN until your doctor has checked you are not pregnant.

Overdosage

There have been no reports of serious harmful effects from taking too many YASMIN tablets at one time. If you have taken several tablets at a time, you may have nausea, vomiting or vaginal bleeding. If you discover that a child has taken YASMIN, ask your doctor for advice.

When using YASMIN

Tell your doctor immediately if:

You should stop treatment and see your doctor immediately if you get a blood clot while you are taking YASMIN. Warning signs to look out for are:

• an unusual cough
• severe pain in the chest which may reach the left arm
• breathlessness
• any unusual, severe, or prolonged headache or migraine attack
• partial or complete loss of vision, or double vision
• slurring or speech disability
• sudden changes to your hearing, sense of smell, or taste
• dizziness or fainting
• weakness or numbness in any part of your body
• severe pain in your abdomen
• severe pain or swelling in either of your legs

Tell your doctor if:

Contact your doctor as soon as possible if:

• you notice any changes in your own health, especially involving any of the items mentioned in this leaflet; do not forget about the items related to your immediate family
• you feel a lump in your breast
• you are going to use other medications
• you are to be immobilised or are to have surgery (consult your doctor at least four weeks in advance)
• you have unusual, heavy vaginal bleeding
• you forgot tablets in the first week of the pack and had intercourse in the seven days before
• you miss your period twice in a row or suspect you are pregnant (do not start the next pack until told to by your doctor)

Regular check-ups

When you are using YASMIN, your doctor will tell you to return for regular check-ups. In general, you should have a check-up every year.

Side effects

Tell your doctor if you notice any unwanted effect, especially if severe or persistent, or if there is a change in your health that you think might be caused by YASMIN.

Serious side effects

Serious reactions associated with the use of combined oral contraceptives such as YASMIN, as well as the related symptoms, are described in the section "Before you use YASMIN". Please read this section carefully and consult your doctor where appropriate.

Other possible side effects

The following have been reported in users of combined oral contraceptives such as YASMIN, although they may not be caused by the contraceptive Pill. Such undesirable effects that occur in the first few months that you are using YASMIN will probably lessen with time.

• breast tenderness, enlargement, pain and secretion
• dizziness, headache; migraine
• nervousness
• changes in sexual drive; depressive moods/mood changes
• changes in the cornea of the eye, contact lens intolerance, disease of the nerves of the eye (optic neuritis)
• nausea, abdominal pain, vomiting and feeling sick
• changes in vaginal secretion, bleeding between periods, vaginal thrush
• rash, urticaria, certain skin disorders (erythema nodosum or erythema multiforme), acne
• fluid retention
• changes in body weight
• reduced carbohydrate tolerance
• hypertension
• hypersensitivity reactions

Storage

Do not use after the expiry date stated on the package.
Store all drugs properly and keep them out of reach of children.

Further information

Like other combined oral contraceptive Pills, YASMIN may also have non-contraceptive health benefits.

• Your period may be lighter and shorter. As a result, the risk of anaemia may be lower. Your period pains may become less severe or may completely disappear.
• Some serious disorders have been reported to occur less frequently in users of "high-dose" oral contraceptive Pills. These are benign breast disease, ovarian cysts, pelvic infections (pelvic inflammatory disease or PID), ectopic pregnancy (pregnancy in which the embryo implants outside of the womb) and cancer of the endometrium (lining of the womb) and ovaries. This may also be the case for "low-dose" Pills such as YASMIN.

YASMIN tablets contain:

active substances (per tablet)

drospirenone (3mg) and ethinylestradiol (0.03mg)

other substances

lactose monohydrate, maize starch (corn starch), modified starch (pregelatinised starch), povidone 25 000, magnesium stearate, hydroxylpropylmethyl cellulose, macrogol 6000, talc, titanium dioxide, ferric oxide pigment (yellow)

If you have any further questions please consult your doctor or pharmacist.

Name and Address

Bayer New Zealand Limited
3 Argus Place
Hillcrest
North Shore
AUCKLAND 0627

Free Phone:  0800 233 988

Date of Preparation

1st February 2007