Yaz Plus 3 mg/0,02 mg/0,451 mg Film-Coated Tablets

• YAZ PLUS is used to prevent pregnancy and to improve the folate status in women who decide to use oral contraception.

• YAZ PLUS is used for the treatment of moderate acne vulgaris in women seeking oral contraception.

• YAZ PLUS is also used for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraceptive as their method of birth control. The efficacy of YAZ PLUS for PMDD was not assessed beyond 3 cycles.

Each of the 24 pink film-coated tablets contains a small amount of the female hormones ethinylestradiol and drospirenone and the vitamin levomefolate calcium (which is also contained in the 4 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 YAZ PLUS, or where the reliability of YAZ 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 YAZ PLUS alters the monthly changes of body temperature and cervical mucus.

YAZ PLUS does not protect against HIV infection (AIDS) or any other sexually transmitted infections (STI). Additional barrier contraceptive measures are needed to prevent transmission of STIs and HIV.

Do not take YAZ PLUS

Do not use YAZ PLUS if you have any of the conditions listed below. If any of these apply to you, tell your doctor before starting to use YAZ 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 YAZ 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 “YAZ PLUS and blood clots” and consult your doctor who will decide whether you may use the Pill)
• if you have (or have ever had) a certain kind 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 damaged blood vessels
• if you have (or have ever had) 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

Warnings and precautions

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

Do not share medicines prescribed for you with others.

Always take YAZ PLUS exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The YAZ PLUS pack contains 28 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. Usually a period will start on day 2 to 3 after the last hormone-containing pink YAZ PLUS tablet (i.e. while you are taking the last 4 hormone-free light orange tablets). Do not leave a gap between packs, i.e. start taking your next pack on the day after you have finished the current one, 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 every month.

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.

When can you start with the first pack?

If you have not used a contraceptive with hormones during the previous month:

Start taking YAZ PLUS on the first day of the cycle (that is, the first day of your period). Then follow the days in order. YAZ PLUS will work immediately, it is not necessary to use an additional contraceptive method.

If you take more YAZ PLUS than you should

There are no reports of serious harmful effects of taking too many YAZ 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 may experience such bleeding. If you have taken too many YAZ PLUS tablets, or you discover that a child has taken some, ask your doctor or pharmacist for advice.

If you forget to take YAZ PLUS

Depending on the day of the cycle on which one tablet has been missed, you may need to take additional contraceptive precautions, for example a barrier method such as a condom. Take the tablets according to the following principles. See also the ‘missed pill chart’ for details. In case of doubt, contact your doctor.

• If you forgot to take any of the 4 hormone-free light orange film-coated tablets (the last 4 tablets in the blister), you are still protected against pregnancy because they do not contain any hormones. However, to make sure that you do not change your pill taking rhythm, which is important for the contraceptive reliability of your Pill, you should proceed with your next tablet at the normal time and discard the forgotten hormone-free light orange film-coated tablet(s) to avoid any confusion. If you forgot the last hormone-free light orange tablet of your current pack it is important that you still take the first tablet from the next pack at the correct time.
• The following advice refers to the pink tablets (those containing hormones) (tablets 1 - 24 of your blister):
• If you are less than 24 hours late when taking a 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 24 hours late in taking any of pink tablets your protection against pregnancy may be reduced. The more pink 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 24 pink tablets). Therefore, you should follow the rules given below (see also the diagram below).
• More than one tablet forgotten in a pack Contact your doctor.

YAZ PLUS can have side effects. Not all side effects reported for YAZ 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”, “YAZ PLUS and blood clots” and “YAZ PLUS and cancer” for side effects, including serious reactions, associated with the use of YAZ PLUS. Please read these sections carefully and consult your doctor at once where appropriate.

The following side effects were reported in studies with Yaz or with Yaz Plus:

Frequent side effects

• Emotional lability (mood swings), depression/depressive mood
• Migraine
• Nausea
• Breast pain, unscheduled uterine bleeding (bleeding between periods), genital tract bleeding (vaginal bleeding) not further specified

Less frequent side effects

• Decrease and loss of libido (reduced or loss of sex drive)
• 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

Side effects that have been reported with the use of the Pill, without knowing their precise frequency: 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 YAZ 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 characterised by tender red nodules)
• women with hypertriglyceridaemia (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 uraemic 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 YAZ 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 YAZ PLUS’.

If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 YAZ PLUS.

STORE ALL MEDICINES OUT OF 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 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).