WHY USE YASMIN?

To prevent pregnancy. You may also experience the following additional benefits: Improvement in symptoms like bloating, swelling or weight-gain, related to fluid retention. Improvement in acne, and reduction in greasiness of the skin and hair. Oral contraceptives are a very effective method of birth control. When taken correctly (without missing tablets), the chance of becoming pregnant is very low.

Do not use the combined Pill 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 Pill or an entirely different (non-hormonal) method of birth control.

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. (See also
the section later in this leaflet called "The Pill and Thrombosis").

If 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 ischemic attack or small
reversible stroke).

If you have diabetes mellitus with blood vessel damage.

If you have jaundice (yellowing of the skin) or severe liver disease.

If you have or have had cancer of the breast or the genital organs.

If your have a severe kidney insufficiency or an acute failure of your kidney

If you have or have had a benign or malignant liver tumor.

If you have any unexplained vaginal bleeding.

If you are pregnant or think you might be pregnant

If you are allergic to any of the ingredients of Yasmin.

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


WHAT DO YOU NEED TO KNOW BEFORE USING YASMIN?

General notes

In this leaflet, several situations are described where you should stop taking the Pill, or where the reliability of the Pill 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 the Pill alters the usual changes in temperature and cervical mucus that occur during the menstrual cycle.

Yasmin, like all contraceptive Pills, does not protect against HIV infection (AIDS) or any
other sexually transmitted disease.

Yasmin has been prescribed for you personally. Do not share it with others.
Before you start to use Yasmin
If the combined Pill is used in the presence of any of the conditions listed below you may need to be kept under close observation. Your doctor can explain this to you. Therefore, if any of these apply to you, tell your doctor before starting to use Yasmin.
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 a thrombosis, a heart attack or a stroke;
you suffer from migraine
you suffer from epilepsy;
you have an increased potassium blood level (e.g. due to problems with your kidney) and additionallly use diuretics that may increase the potassium in your blood (ask your doctor);
you or someone in your immediate family have or have had high blood levels of cholesterol or triglycerides (fatty substances);
anyone in your immediate family has had breast cancer;
you have liver or gallbladder disease
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 hemolytic uremic syndrome (HUS; a disorder of blood coagulation causing failure of the kidneys);
you have sickle cell disease;
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.

If any of the above conditions appear for the first time, recur or worsen while using the Pill, you
should contact your doctor.

The Pill 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 lopulmonary embolismlr. Deep venous thrombosis is a rare occurrence. It 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 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 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 the Pill you should stop smoking, especially if you are older than about 35 years of age.
If you develop high blood pressure while using the Pill, 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 immobilization (for example, when you have your leg or legs in plaster or splints). In women who use the Pill the risk may be yet higher. Tell your doctor you are using the Pill well in advance of any expected hospitalization or surgery. Your doctor may tell you to stop taking the Pill several weeks before surgery or at the time of immobilization. Your doctor will also tell you when you can start taking the Pill 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 (See also "When should you contact your doctor?")

The Pill 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 10 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 liver tumors and even more rarely, malignant liver tumors have been reported in users of the Pill. These tumors 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 behavior and other factors.

Some medicines may stop the Pill from working properly. These include medicines used for the treatment of epilepsy (e.g. primidone, phenytoin, barbiturates) and tuberculosis (e.g. rifampicin); and antibiotics (e.g. ampicillin, tetracyclines, griseofulvin) for some other infectious diseases. Some medicines (e.g. ketoconazole, erythromycin, cyclosporin) may inhibit the metabolism of Yasmin. Always tell the doctor who prescribes the Pill 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 drugs 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 is generally not recommended for use during breastfeeding. If you wish to take the Pill while breastfeeding, please seek the advice of your doctor.

Yasmin must not be used by women who are pregnant, or who think they may be pregnant.

There are no observed effects.

When and how to take the tablets?
The Yasmin pack contains 21 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 21 tablets have been taken.

During the next 7 days you take no tablets. A period should begin during these 7 days (the withdrawal bleed). Usually it will start on day 2-3 after the last Yasmin tablet. Start taking your next pack on the 8 th day even if your period continues. This means that you will always start new packs on the same day of the week, and also that you have your withdrawal bleed on about the same days, 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. For example, if your period starts on a Friday, take a tablet marked Friday. Then follow the days in order. You may also start on days 2-5 of your cycle, but in that case make sure you also use an additional contraceptive method (barrier method) for the first 7 days of tablet-taking in the first cycle.

When changing from another 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). If your present Pill pack also contains inactive tablets you can start Yasmin on the day after taking the last active tablet (if you are not sure which this is, ask your doctor or pharmacist). You can also start later, but never later than the day following the tablet-free break of your present Pill (or the day after the last inactive tablet of your present Pill).

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. 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.
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.

If too many Yasmin tablets are taken (overdose)
There has not yet been any clinical experience of overdose with Yasmin. There have been no reports of serious harmful effects from overdose in preclinical studies. 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 you want to stop taking Yasmin
You can stop taking Yasmin at any time you want. If you do not want to become pregnant, ask your doctor about other methods of birth control.

If you stop taking Yasmin because you want to get pregnant, it is generally recommended that you wait until you have had a natural period before trying to conceive. This helps you to work out when the baby will be due.

If you are less than 12 hours late in taking a tablet, the reliability of the Pill is maintained. Take the tablet as soon as you remember and take the next tablets at the usual times.

If you are more than 12 hours late in taking any tablet, the reliability of the Pill may be reduced. The more consecutive tablets you have missed the higher the risk that the contraceptive effect is decreased. There is a particularly high risk of becoming pregnant if you miss tablets at the beginning or at the end of the pack. Therefore, you should follow the rules given below.

1 tablet missed in week 1 - Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. Use extra contraceptive precautions (barrier method) for the next 7 days. If you had sexual intercourse in the week before missing the tablet, there is a possibility of becoming pregnant. So tell your doctor immediately.

1 tablet missed in week 2 - Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. The reliability of the Pill is maintained. You need not use extra contraceptive precautions.

1 tablet missed in week 3 - You may choose either of the following options, without the need for extra contraceptive precautions.

1. Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. Start the next pack as soon as the current pack is finished so that no gap is left between packs. You may not have a withdrawal bleed until the end of the second pack but you may have spotting or breakthrough bleeding on tablet-taking days.

or

2. Stop taking tablets from your current pack, have a tablet-free break of 7 days or less (also count the day you missed your tablet) and continue with the next pack. When following this method, you can always start your next pack on the same day of the week as you usually do.

If you have forgotten tablets in a pack and you do not have the expected period in the first normal tablet-free break, you may be pregnant. Consult your doctor before you start the next pack.

If you vomit within 3 to 4 hours after taking your Yasmin tablet, the active ingredients may not have been completely absorbed. This is like missing a tablet. Therefore, follow the advice for missed tablets.

You can delay your period if you start with your next pack of Yasmin immediately after finishing your current pack. You can continue with this pack for as long as you wish, until this pack is empty. When you wish your period to begin, just stop tablet-taking. While using the second pack you may have some breakthrough bleeding or spotting on tablet-taking days. Start with your next pack after the usual 7-day tablet-free break.

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 next tablet-free break. For example, if your period usually starts on a Friday and in future you want it to start on Tuesday (3 days earlier) you should now start your next pack 3 days sooner than you usually do. If you make your tablet-free break 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.

With all Pills, for the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) 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 the Pill (usually after about 3 tablet-taking cycles). If it continues, becomes heavy or starts again, tell your doctor.

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.

WHAT SIDE EFFECTS MIGHT YOU HAVE WHILE TAKING YASMIN ?

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 the Pill.

Serious Side Effects
Serious reactions associated with the use of the Pill, as well as the related symptoms, are described in the following sections: "The Pill and Thrombosis/The Pill and Cancer". Please read these sections for additional information and consult your doctor at once where appropriate.

Other possible side effects
The following side effects have been reported by users of the Pill, although they need not be
caused by the Pill. These side effects may occur in the first few months that you are using the
Pill and usually lessen with time.

• breast tenderness, pain and secretion;
• headache;
• changes in sexual drive;
• depressive moods;
• contact lens intolerance;
• nausea, vomiting and feeling sick;
• changes in vaginal secretion;
• various skin reactions;
• fluid retention;
• changes in body weight;
• hypersensitivity reactions.

MORE ABOUT THE PILL

The combined Pill may also have non-contraceptive health benefits.
Your period may be lighter and shorter. As a result, the risk of anemia may be lower. Your period pains may become less severe or may completely disappear.
In addition, some serious disorders have been reported to occur less frequently in users of the Pills containing 50 ìg of ethinylestradiol (‚high-dose 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 uterus) and cancer of the endometrium (lining of the womb) and ovaries. This may also be the case for low-dose
Pills but this has not been confirmed

One of the hormones in Yasmin, drospirenone, has special properties leading to beneficial effects in addition to contraception. Drospirenone can prevent weight-gain, and other symptoms like bloating and swelling, related to fluid retention caused by hormones both in oral contraceptives and at certain times in the menstrual cycle. Drospirenone also has antiandrogenic activity which can help to reduce acne (pimples) and greasiness of the skin and hair. These special properties make drospirenone similar to the natural progesterone hormone produced by your body.

Packs and Tablets
Yasmin is presented as a blister pack containing 21 tablets.
Yasmin tablets are contained in blister packs consisting of transparent films made of polyvinyl chloride and metallic foils made of aluminum (matt side hot sealable).
Yasmin may be sealed in a pouch made of aluminum foil.

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

Composition in Full
Yasmin tablets contain:
active substances - drospirenone (3 mg), ethinyl estradiol (30 micrograms)
other substances - lactose monohydrate, maize starch (corn starch), modified starch (pregelatinized starch), polyvidone 25000, magnesium stearate, hydroxypropylmethyl cellulose, macrogol 6000, talc, titanium dioxide, ferric oxide pigment, yellow.

IF YOU HAVE ANY FURTHER QUESTIONS PLEASE CONSULT YOUR DOCTOR OR
PHARMACIST.