Yasmin 0,03 mg/3 mg Film-Coated Tablets

YASMIN is a combined oral contraceptive (“the combined Pill”) consisting of 21 light yellow hormone-containing tablets and 7 white hormone-free tablets (bottom row of the blister pack). Each hormone-containing tablet contains a small amount of two different female hormones. These are drospirenone (a progestogen) and ethinylestradiol (an estrogen). Contraceptive pills that contain two hormones are called “combined oral contraceptives”. YASMIN is used to prevent pregnancy.

General notes 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 sexual intercourse or you should take extra non-hormonal contraceptive precautions, e.g. use a condom or another barrier method. Do not use the 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 does not protect against HIV infections (AIDS) and other sexually transmitted diseases (STDs). Additional barrier contraceptive measures are needed to prevent transmission of STDs and HIV infection. Do not take 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 contraceptive pill or an entirely different (non-hormonal) method of birth control.

• If you are hypersensitive (allergic) to ethinylestradiol or drospirenone or any of the other ingredients of YASMIN (listed in section 6). This may cause, for example, itching, rash or swelling.
• If you have, or have ever had a disorder affecting the blood circulation: in particular, those conditions relating to thrombosis (the formation of a blood clot) in the blood vessels of the legs (deep vein thrombosis), the lungs (pulmonary embolism), or other parts of the body. (See also the section later in this leaflet called “YASMIN and blood clots”).
• If you have a high risk of venous or arterial blood clots (see “YASMIN and blood clots” and consult your doctor who will decide whether you may use YASMIN).
• If you have or have had a heart attack or stroke (caused by a blood clot or a rupture of a blood vessel in the brain).
• 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 ischaemic attack or small reversible stroke).
• If you have a history of migraine accompanied by e.g. visual symptoms, speech disability, or weakness or numbness in any part of your body.
• If you have diabetes mellitus with blood vessel damage.
• If you have jaundice (yellowing of the skin) or severe liver disease.
• If you are taking any antiviral medicines which contain ombitasvir, paritaprevir, or dasabuvir, and combinations of these. These antiviral medicines are used to treat chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
• If you have or have had a cancer that may grow under the influence of sex hormones (e.g. of the breast or the genital organs).
• If you have a severe kidney insufficiency or an acute failure of your kidney.
• If you have or have had a benign or malignant liver tumour.
• If you have any unexplained vaginal bleeding.
• If you are pregnant or think you might be pregnant. 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. See also “General notes”.

Warnings and precautions

In some situations you need to take special care while taking YASMIN and your doctor may need to examine you regularly. Consult your doctor before starting to use YASMIN if any of the following conditions apply to you or if any of them develop or worsen while you are taking YASMIN:

• If you smoke
• If you have diabetes
• If you are overweight
• If you have high blood pressure
• If you have a heart valve disorder or a certain heart rhythm disorder
• If you have an inflammation of your veins (superficial phlebitis)
• If you have varicose veins
• If anyone in your immediate family has had a blood clot (thrombosis in the leg, lung ‘pulmonary embolism’, or elsewhere), a heart attack or a stroke at a young age
• If you suffer from migraine
• If you suffer from epilepsy (see “Other medicines and YASMIN”)
• If you have an increased potassium blood level (e.g. due to problems with your kidneys) and also use diuretics that may increase the potassium in your blood (ask your doctor if you are not sure)
• If you or someone in your immediate family has or has ever had high blood levels of cholesterol or triglycerides (fatty substances)
• If anyone in your immediate family has ever had breast cancer
• If you have a disease of the liver or gallbladder
• If you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)
• If you have systemic lupus erythematosus (SLE, a disease of the immune system affecting the skin all over the body)
• If you have haemolytic uraemic syndrome (HUS, a disorder of blood coagulation causing failure of the kidneys)
• If you have sickle cell disease (for example, sickle cell anaemia, or other sickle cell conditions)
• If 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)
• If you have or have ever 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 you have hereditary angioedema. Consult your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue or throat and/or difficulty swallowing, or hives, together with difficulty breathing. Products containing estrogens may induce or worsen symptoms of angioedema. If any of the above conditions appear for the first time, recur or worsen while using the pill, you should contact your doctor.

Do not share medicines prescribed for you with any other person. Always take YASMIN exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The YASMIN pack contains 28 tablets (21 light yellow hormone-containing tablets and 7 white hormone-free tablets). The first course of YASMIN is started on the first day of the menstrual period (day 1 of the cycle) from the silver section of the pack by selecting the appropriate tablet for that day of the week (e.g. “MO” for Monday). The tablet is swallowed whole with some liquid. Thereafter one tablet must be taken daily for 28 days following the direction shown by the arrows. It does not matter at what time of the day the tablet is taken, but once you have selected a particular time, the tablet should be taken as near as possible at the same time each day. Withdrawal bleeding usually starts on day 2 or 3 after starting the hormone-free tablets and may not have finished before the next pack is started. Each subsequent pack is started in the silver section the day after the last tablet of the current pack. If you start YASMIN during the latter part of the week, the very first cycle may be slightly shortened.

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 the tablet marked with that day of the week from the silver section of the pack. For example, if your period starts on a Friday, take the tablet marked “FR”. Then take 1 tablet every day following the directions shown by the arrows. During the first cycle an additional barrier method is recommended for the first 7 days of tablet-taking.

When changing from another combined pill, vaginal ring or transdermal (contraceptive) patch

You should start with YASMIN preferably on the day after the last hormone-containing tablets of your previous combined oral contraceptive, but at the latest on the day following the usual tablet-free or hormone-free tablet interval of your previous combined oral contraceptive. In case you have used a vaginal ring or transdermal patch, you should start using YASMIN preferably on the day of removal of the last ring or patch of a cycle, but at the latest when the next application would have been due. If you follow these instructions, it is not necessary to use an additional contraceptive method.

When changing from a progestogen-only method (minipill, injection, implant) or from a progestogen-releasing intrauterine system (IUS)

You may switch any day from the minipill, from an implant or the IUS on the day of its removal, and from an injectable when the next injection would be due, but in all these cases you are advised to use an additional barrier method for the first 7 days of tablet-taking.

After having a baby

If you are breastfeeding and want to take YASMIN, you should discuss this first with your doctor, who will advise you. After a miscarriage or an abortion your doctor will advise you.

If you take more YASMIN than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. 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. Even girls who have not yet started to menstruate but have accidentally taken this medicine may experience such bleeding. If you discover that a child has taken YASMIN, ask your doctor for advice. Taking the white tablets from the bottom row of the blister is harmless because they do not contain hormone ingredients.

If you forget to take YASMIN

If you are less than 12 hours late in taking a light yellow hormone-containing tablet, the reliability of the pill is maintained. Take the tablet as soon as you remember and take the next tablet at the usual time. If you are more than 12 hours late in taking any light yellow hormone-containing tablet, the reliability of the pill may be reduced. The more consecutive hormone-containing 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 in the week before or in the week after the white hormone-free tablets. Therefore, you should follow the rules given below.

• More than one tablet forgotten in a pack: Ask your doctor for advice.
• 1 tablet missed in the first 7 days of hormone-containing tablet-taking (Day 1 to 7): Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablet at the usual time. Use extra contraceptive precautions (barrier method) for the next 7 days. If you have 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 the second 7 days of hormone-containing tablet-taking (Day 8 to 14): Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablet at the usual time. Provided that you have taken all your tablets correctly in the 7 days before the missed tablet, the reliability of the pill is maintained and you need not use extra contraceptive precautions. If this is not the case use extra precautions for 7 days.
• 1 tablet missed in the third 7 days of hormone-containing tablet-taking (Day 15 to 21): 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 until the hormone-containing tablets are used up. The 7 hormone-free tablets must be discarded, (i.e. discard the current pack after taking the last light yellow tablet). Start the next pack right away, with the first light yellow tablet from the silver section. You may not have a withdrawal bleed until the end of the hormone-containing tablets in the second pack, but you may have spotting or breakthrough bleeding on hormone-containing 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 then continue with the next pack, starting in the silver section with the light yellow hormone-containing tablet for the appropriate day of the week. If you have forgotten tablets in a pack and you do not have your period as expected, you may be pregnant. Consult your doctor before you start the next pack.

YASMIN can have side effects. Not all side effects reported for YASMIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking YASMIN, please consult your health care provider for advice.

Serious side effects

Serious reactions associated with the use of the pill, as well as the related symptoms, are described in the following sections: “YASMIN and blood clots / YASMIN 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 were not necessarily 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.

Frequent side effects

• emotional lability (mood swings), depression/ depressive mood
• decrease and loss of libido (reduced or loss of sex drive)
• migraine
• nausea
• breast pain, unscheduled uterine bleeding (bleeding between periods), genital tract bleeding (vaginal bleeding) not further specified

Less frequent side effects

• any blockage or clot in a deep peripheral vein, clots which travel through the venous blood system (e.g. to the lung known as pulmonary embolism or as pulmonary infarction), heart attack caused by blood clots, stroke caused by blockage of the blood supply to or in the brain

Description of selected adverse reactions

Adverse reactions with very low frequency or with delayed onset of symptoms which are considered to be related to the group of combined oral contraceptives are listed below (see also sections ‘Do not take YASMIN’, and ‘Warnings and precautions’):

Tumours

• The frequency of diagnosis of breast cancer is very slightly increased among users of oral contraceptives. As breast cancer is rare in women under 40 years of age the excess number is small in relation to the overall risk of breast cancer. It is not known whether there is a direct link to users of combined oral contraceptives.
• liver tumours (benign and malignant)

Other conditions

• erythema nodosum (a skin condition characterized by tender red nodules)
• women with hypertriglyceridemia (increased blood fats resulting in an increased risk of pancreatitis when using combined oral contraceptives)
• high blood pressure
• occurrence or worsening of conditions for which a link to combined oral contraceptives is not definite: jaundice and/or itching related to cholestasis (blocked bile flow); gallstone formation; a metabolic condition called porphyria; systemic lupus erythematosus (a chronic autoimmune disease); haemolytic uremic syndrome (a blood clotting disease); a neurological condition called Sydenham’s chorea; herpes gestationis (a type of skin condition that occurs during pregnancy); otosclerosis - related hearing loss
• In women with hereditary angioedema (characterized by sudden swelling of e.g. the eyes, mouth, throat etc.) external estrogens may induce or worsen symptoms of angioedema.
• disturbed liver function
• changes in glucose tolerance or effect on peripheral insulin resistance
• Crohn’s disease, ulcerative colitis
• chloasma
• hypersensitivity (including symptoms such as rash, urticaria)

If you notice any side effect not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of reach and sight of children. Store at or below 30 ºC. Keep the blister strip in the original carton until required for use. Do not use after expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).