Yasmin Plus 3 mg/0,03 mg/0,451 mg Film-Coated Tablets

YASMIN PLUS is a contraceptive pill and it is used to prevent pregnancy and to improve the folate status in women who decide to use oral contraception. Each of the 21 orange film-coated tablets contains a small amount of the female hormones ethinylestradiol and drospirenone and levomefolate calcium (which is also contained in the 7 light orange hormone-free film-coated tablets). Contraceptive pills that contain two hormones are called “combined pills” or “combined oral contraceptives”.

General notes In this leaflet, several situations are described where you should stop using YASMIN PLUS, or where the reliability of YASMIN PLUS may be decreased. In such situations you should either 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 rhythm or temperature methods. These methods can be unreliable because YASMIN PLUS alters the monthly changes of body temperature and cervical mucus. YASMIN PLUS does not protect against HIV infection (AIDS) or any other sexually transmitted infections (STIs). Additional barrier contraceptive measures are needed to prevent transmission of STIs and HIV. Do not take YASMIN PLUS if you have any of the conditions listed below. If any of these apply to you, tell your doctor before starting to use YASMIN PLUS. Your doctor may advise you to use a different type of pill or an entirely different (non-hormonal) method of birth control.

• If you are allergic (hypersensitive) to ethinylestradiol, drospirenone, levomefolate calcium or any of the other ingredients in YASMIN PLUS (listed in section 6). This may cause, for example, itching, rash or swelling.
• If you have (or have ever had) a blood clot in a blood vessel of the leg (thrombosis), of the lung (pulmonary embolism) or other parts of the body.
• If you have (or have ever 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 disease that can be an indicator (i) of a future heart attack (for example, angina pectoris which causes severe chest pain which may spread to the left arm) or (ii) of a stroke (for example, a minor stroke with no residual effects, a so-called transient ischaemic attack).
• If you have a high risk of venous or arterial blood clots (see ‘The Pill and blood clots’ and consult your doctor who will decide whether you may use YASMIN PLUS).
• If you have (or have ever had) a certain kind of migraine (with so-called focal neurological symptoms such as visual symptoms, speech disability, or weakness or numbness in any part of your body).
• If you have diabetes mellitus with damaged blood vessels.
• If you have (or have ever had) a liver disease (symptoms of which may be yellowing of the skin or itching over the whole body) and your liver is still not working normally.
• 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 ever 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 acute kidney failure.
• If you have (or have ever had) a benign or malignant tumour of the liver.
• If you have any unexplained bleeding from the vagina.
• If you are pregnant or think you might be pregnant; If any of these conditions appear for the first time while using YASMIN PLUS, stop taking it at once and consult your doctor. In the meantime, use non-hormonal contraceptive measures (e.g. condom).

Warnings and precautions

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

• 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 ever 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 have epilepsy (see ‘Other medicines and YASMIN PLUS’);
• 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're not sure);
• if you or someone in your immediate family has ever had high blood levels of cholesterol or triglycerides (fatty substances);
• if a close relative has or has ever had breast cancer;
• if you have a disease of the liver or gall bladder;
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (or SLE, a disease of the immune system);
• if you have haemolytic uremic syndrome (or HUS, a disorder of blood coagulation causing failure of the kidneys);
• if you have sickle-cell disease;
• 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, or a neurological disease called Sydenham's chorea);
• if you have or have ever had golden brown pigment patches so-called “pregnancy patches” especially on the face (chloasma). If this is the case, avoid direct exposure to sunlight or ultraviolet light;
• if you suffer from vitamin B12 deficiency (for example due to a reduced B12 diet such as a strict vegetarian diet, due to a history of gastrointestinal surgery or certain types of gastritis) tell your doctor that you use YASMIN PLUS because folates may hide vitamin B12 deficiency;
• 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 YASMIN PLUS, you should contact your doctor.

YASMIN PLUS and depression

Some women using hormonal contraceptives including YASMIN have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.

YASMIN PLUS and blood clots (thrombosis)

A thrombosis is the formation of a blood clot, which may block a blood vessel. A thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis). If a blood clot breaks away from the vein where it has formed, it may reach and block the arteries of the lungs, causing a so-called “pulmonary embolism”. Blood clots can also occur very rarely in the blood vessels of the heart (causing a heart attack). Blood clots or a ruptured blood vessel in the brain may cause a stroke. The risk of venous thromboembolism is highest during the first year of use. This increased risk is present after initially starting the combined Pill or restarting (following a 4 week or greater pill-free interval) the same or a different combined Pill. Data from a large study suggest that this increased risk is mainly present during the first 3 months. Overall the risk for venous thromboembolism in users of low estrogen dose pills is two to threefold higher than for non-users of combined oral contraceptives who are not pregnant. Venous or arterial thromboembolic events may cause serious permanent disabilities or may even be fatal. Blood clots can occur in other parts of the body including the liver, gut, kidney, brain or eye.

Do not share medicines prescribed for you with any other person. Always take YASMIN PLUS exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The YASMIN PLUS pack contains 28 tablets (21 hormone-containing orange tablets and 7 hormone-free light orange tablets). Take your tablet at about the same time each day, with some liquid if necessary. Follow the direction of the arrows until all 28 tablets have been taken. The first course of YASMIN PLUS 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). 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 inactive 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. When taken correctly, combined oral contraceptives have a failure rate of approximately 1% per year. The failure rate may increase when pills are missed or taken incorrectly.

Starting your first pack of YASMIN PLUS

If you have not used a contraceptive with hormones during the previous month Start taking YASMIN PLUS on the first day of the cycle (that is, the first day of your period). For example, if your period starts on a Friday, start with the tablet marked “FR”. Then follow the days in order. It is not necessary to use an additional contraceptive method, if initiated and taken as directed above.

If you take more YASMIN PLUS than you should

There are no reports of serious harmful effects of taking too many YASMIN PLUS tablets. If you take several hormone-containing tablets at once, you may feel sick or vomit or may bleed from the vagina. Even girls who have not yet started to menstruate but have accidentally taken this medicine may experience such bleeding. If you have taken too many YASMIN PLUS tablets, or you discover that a child has taken some, ask your doctor or pharmacist for advice.

If you forget to take YASMIN PLUS

If you forgot to take any of the 7 hormone-free light orange film-coated tablets (the last 7 tablets in the blister), you are still protected against pregnancy because they do not contain any hormones. The following advice refers to the orange tablets (those containing hormones) (tablets 1 to 21 of your blister):

• If you are less than 12 hours late when taking any hormone-containing tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and then continue taking the tablets again at the usual time.
• If you are more than 12 hours late in taking any of the orange tablets your protection against pregnancy may be reduced. The more orange tablets you have forgotten, the greater the risk that the protection from pregnancy is reduced. There is a particularly high risk of becoming pregnant if you miss tablets at the beginning of the pack or at the end (the last of the 21 orange tablets). Therefore, you should follow the rules given below (see also the diagram below).
• More than one tablet forgotten in a pack: Ask your doctor for advice.

YASMIN PLUS can have side effects. Not all side effects reported for YASMIN PLUS are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice. Tell your doctor if you notice any side 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 See also section ‘Warnings and precautions’, ‘YASMIN PLUS and blood clots’ and ‘YASMIN PLUS and cancer’ for side effects, including serious reactions, associated with the use of YASMIN PLUS. Please read these sections carefully and consult your doctor at once where appropriate. The following side effects were reported in studies with Yasmin and are also regarded as being representative for YASMIN PLUS:

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

• venous and arterial thromboembolic events*

* Estimated frequency, from epidemiological studies encompassing a group of combined oral contraceptives. Frequency was borderline to Very Rare. The term venous and arterial thromboembolic events covers the following: 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.

Other side effects

that have been reported are: erythema multiforme (a skin condition characterised by itchy red blotches or swollen patches of skin). Description of selected side effects side effects 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 PLUS’, ‘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 (characterised by sudden swelling of e.g. the lips, tongue, 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)

Interactions

Unexpected bleeding and/or contraceptive failure may result from interactions of other medicines with YASMIN PLUS (e.g. the herbal remedy St. John’s wort, or medicines for epilepsy, tuberculosis, HIV and Hepatitis C Virus infections and other infections). See section ‘Other medicines and YASMIN PLUS’.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of YASMIN PLUS.

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN. Store at or below 30 °C. Keep the blister strip in the pouch, in the original carton until required for use. Do not use after the expiry date stated on the carton and the blister strip. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).