Consumer medicine information

Yaz

Drospirenone + Ethinylestradiol

BRAND INFORMATION

Brand name

Yaz

Active ingredient

Drospirenone + Ethinylestradiol

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Yaz.

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about YAZ. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking YAZ against the benefits they expect it will have for you.

If you have any concerns, or are unsure about taking this medicine, ask your doctor or pharmacist for more advice.

Keep this leaflet with the medicine. You may need to read it again.

WHAT YAZ IS USED FOR

YAZ is a combined oral contraceptive, commonly known as a ‘birth control pill’ or ‘the Pill’.

YAZ is used to prevent pregnancy.

It is also used to treat moderate acne and symptoms of premenstrual dysphoric disorder (PMDD) in women seeking oral contraception.

You may also experience the following benefits:

  • more regular and lighter periods – potentially resulting in a decrease in anaemia (iron deficiency)
  • a decrease in period pain
  • improvement in symptoms like bloating, swelling or weight gain related to fluid retention

Some conditions such as pelvic inflammatory disease, ovarian cysts, ectopic pregnancy (where the foetus is carried outside of your womb), lumpy breasts and cancer of the uterus (womb), and ovaries may be less common in women taking the Pill.

When taken correctly, it prevents you from becoming pregnant in several ways, including:

  • inhibiting the egg release by stopping it maturing
  • changing the cervical mucus consistency, making it more difficult for the sperm to reach the egg.

YAZ has 24 active (hormone) tablets and 4 inactive tablets, rather than the traditional 21 active tablets and 7 inactive tablets. This means that with YAZ, you take the active (hormone) tablets for three more days. This helps your hormone levels to stay even.

When the Pill is taken by women under close observation in clinical trials, it is more than 99% effective in preventing pregnancy.

However, in real life the Pill is around 92% effective. This is because pills might be missed, or taken with medicines that may interfere with their effectiveness, or may not be absorbed due to vomiting and diarrhoea.

Like all oral contraceptives, YAZ is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted infections.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

BEFORE YOU TAKE YAZ

When you must not take it

Do not take YAZ if you have an allergy to

  • drospirenone and/or ethinylestradiol, the active ingredients in YAZ
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty in breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

Do not take YAZ if you are taking antiviral medicines which contain glecaprevir, pibrentasvir, sofosbuvir, velpatasvir, voxilaprevir, 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).

Do not take YAZ if you have or have had a blood clot in:

  • the blood vessels of the legs (deep vein thrombosis - DVT)
  • the lungs (pulmonary embolism - PE)
  • the heart (heart attack)
  • the brain (stroke)
  • other parts of the body.

Do not take YAZ if you have or are concerned about an increased risk of blood clots. Blood clots are rare. Very occasionally blood clots may cause serious permanent disabilities, or may even be fatal.

You are more at risk of having a blood clot when you take the Pill. But the risk of having a blood clot when taking the Pill is less than the risk during pregnancy.

Do not take YAZ if you are concerned about an increased risk of blood clots because of age or smoking. The risk of having a heart attack or stroke increases as you get older. It also increases if you smoke. You should stop smoking when taking the Pill, especially if you are older than 35 years of age.

Do not take YAZ if you have, or have had:

  • any blood clotting disorders such as Protein C deficiency, Protein S deficiency, Leiden Factor V mutation, Antithrombin III deficiency or other inherited blood clotting conditions
  • a confirmed blood test showing:
    - increased levels of homocysteine
    - antiphospholipid antibodies (APLAs) e.g. anticardiolipin-antibodies and lupus anticoagulant. These may increase your risk for blood clots or pregnancy losses (miscarriage)
  • major surgery after which you have not been able to move around for a period of time
  • angina (chest pain)
  • mini stroke (also known as TIA or transient ischaemic attack)
  • severe kidney insufficiency or an acute failure of your kidney
  • migraine, where you have also had problems with seeing, speaking or had weakness or numbness in any part of your body
  • high risk of blood clots due to conditions such as diabetes with blood vessel damage, severe high blood pressure or severe high or low level of fats in your blood
  • pancreatitis (an inflammation of the pancreas) associated with high levels of fatty substances in your blood
  • severe liver disease and your liver function has not returned to normal
  • cancer that may grow under the influence of sex hormones (e.g. of the breast or the genital organs)
  • a benign or malignant liver tumour
  • unexplained vaginal bleeding.

If any of these conditions appear for the first time while using the Pill, stop taking it at once and tell your doctor. In the meantime use non-hormonal (barrier) methods of contraception (such as condoms or a diaphragm).

Do not take this medicine if you are pregnant or think you might be pregnant.

Do not give this medicine to a child.

Do not take this medicine after the expiry date printed on the pack and blister. The expiry date is printed on the carton and on each blister after “EXP” (e.g. 11 18 refers to November 2018). The expiry date refers to the last day of that month. If it has expired return it to your pharmacist for disposal.

Do not take this medicine if the packaging is torn or shows signs of tampering. If the packaging is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if:

  • you smoke
  • you or anyone in your immediate family has had blood clots in the legs (DVT) or lungs (PE), a heart attack, a stroke, breast cancer or high cholesterol.

Tell your doctor if you have, or have had any of the following medical conditions:

  • diabetes
  • high blood pressure
  • heart valve disorders or certain heart rhythm disorders
  • migraine
  • an increased potassium blood level (e.g. due to problems with your kidney/s) and also use diuretics or other drugs that may increase the potassium in your blood
  • cancer
  • hyperhomocysteinaemia, a condition characterised by high levels of the amino acid homocysteine in the blood.

Ask your doctor to check if you:

  • are overweight
  • have any hereditary or acquired conditions that may make it more likely for you to get blood clots
  • have high cholesterol or triglycerides
  • have liver disease
  • have kidney disease
  • have high potassium in your blood
  • have jaundice (yellowing of the skin) and/or pruritus (itching of the skin) related to cholestasis (condition in which the flow of bile from the liver stops or slows)
  • have gall bladder disease
  • have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)
  • have systemic lupus erythematosus (SLE – a disease affecting the skin all over the body)
  • have haemolytic uraemic syndrome (HUS– a disorder of blood coagulation causing failure of the kidneys)
  • have sickle cell disease
  • 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)
  • have chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face) – if so, avoid exposure to the sun or ultraviolet radiation
  • have hereditary angio-oedema – you should see your doctor immediately if you experience symptoms of angio-oedema, such as swollen face, tongue and/or pharynx and/or difficulty swallowing, or hives together with difficulty in breathing.

If any of the above conditions appear for the first time, recur or worsen while taking YAZ, you should tell your doctor.

Tell your doctor if you are breastfeeding. YAZ is generally not recommended if you are breastfeeding.

YAZ contains lactose monohydrate. If you have an intolerance to some sugars, tell your doctor before you start taking YAZ.

If you have not told your doctor about any of the above, tell him/her before you start taking YAZ.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and YAZ may interfere with each other. These include:

  • medicines used to treat tuberculosis such as rifampicin, rifabutin
  • macrolide antibiotics (e.g. clarithromycin, erythromycin)
  • medicines used to treat fungal infections, such as griseofulvin, ketoconazole
  • medicines used to treat HIV, such as ritonavir or nevirapine
  • some medicines used to treat Hepatitis C Virus (HCV) such as boceprevir, telaprevir, glecaprevir, pibrentasvir, ombitasvir, paritaprevir, dasabuvir
  • medicines used to treat epilepsy such as phenytoin, primidone, barbiturates (e.g. phenobarbitone), carbamazepine, oxcarbazepine, topiramate, felbamate, lamotrigine
  • cyclosporin, an immunosuppressant medicine
  • medicines used to treat high blood pressure, chest pain and/or irregular heartbeats such as diltiazem, verapamil
  • etoricoxib, an anti-inflammatory medicine used to treat pain
  • tizanidine, melatonin or midazolam which are medicines that relax the body
  • theophylline, a medicine that helps with breathing
  • herbal medicines containing St John’s Wort
  • grapefruit juice.

These medicines may be affected by YAZ, or may affect how well it works. Your doctor may need to alter the dose of these medicines, or prescribe a different medicine.

Some medicines

  • can have an influence on the blood levels of YAZ
  • can make it less effective in preventing pregnancy
  • can cause unexpected bleeding.

You might have an increase in potassium in the blood if you are taking YAZ with medicines that may increase potassium levels in the blood. These include:

  • medicines used to treat high blood pressure, such as ACE inhibitors, angiotensin-II-receptor antagonists and diuretics
  • certain anti-inflammatory medicines, such as indomethacin
  • aldosterone antagonists, such as spironolactone and eplerenone.

In a study of women taking drospirenone together with an ACE inhibitor, no significant differences were observed in the potassium levels when compared to the placebo.

You may need to use additional barrier methods of contraception (such as condoms or a diaphragm) while you are taking any of these medicines and for some time after stopping them. Your doctor will be able to tell you how long you will need to use additional contraceptive methods.

Your doctor and pharmacist have more information on medicines that you need to be careful with or avoid while taking this medicine.

HOW TO TAKE YAZ

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack ask your doctor or pharmacist for help.

How to take it

Take one tablet daily at about the same time each day. You must take YAZ every day regardless of how often you have sex. This will also help you remember when to take it.

Swallow the tablet whole with a full glass of water. It does not matter if you take it before or after food.

Each blister pack is marked with the day of the week.

Take your first tablet from the green area on the blister pack corresponding to the day of the week.

Follow the direction of the arrows on the blister pack until all the tablets have been taken.

A period should begin 2-3 days after starting to take the white inactive tablets and may not have finished before the next pack is started.

Always start a new blister pack on the same day of the week as your previous pack.

Taking YAZ for the first time

If you are starting YAZ after a natural cycle, and you have not used a hormonal contraceptive in the past month, start on the first day of your period, i.e. on the first day of your menstrual bleeding.

You may also start on days 2-5 of your period, but in that case make sure you also use additional barrier contraceptive precautions (e.g. condom) for the first 7 days of tablet-taking.

Your doctor will advise you when to start if you:

  • are taking YAZ after having a baby
  • have had a miscarriage or an abortion.

Changing from another contraceptive

Changing from a combined oral contraceptive:
Start taking YAZ on the day after taking the last active tablet in your previous Pill pack. Bleeding may not occur until the end of the first pack of YAZ

You can also switch to YAZ after taking one or more inactive tablets in your previous Pill pack, but no later than the day after taking the last inactive tablet.

If you are not sure which were the active/inactive tablets in your previous Pill pack, ask your doctor or pharmacist. Your previous Pill pack may have different colour tablets to those of YAZ.

Changing from a progestogen-only pill (‘minipill’):
Stop taking the minipill on any day and start taking YAZ at the same time the day after you took your last minipill.

You must also use additional barrier contraceptive precautions (e.g. condoms or a diaphragm) for the first 7 days of tablet-taking when having intercourse.

Changing from a progestogen-only injection, implant or intrauterine system (IUS):
Start taking YAZ when your next injection is due, or on the day that your implant or IUS is removed.

You must also use additional barrier contraceptive precautions (e.g. condoms or a diaphragm) for the first 7 days of tablet-taking when having intercourse.

Changing from a vaginal ring:
Start on the day of removal of the ring but at the latest when the next application would have been due.

Stopping YAZ

You can stop taking YAZ at any time. If you are considering becoming pregnant, it is recommended that you begin taking a vitamin supplement containing folic acid. It is best that you start taking folic acid tablets before you stop taking YAZ and not stop until your doctor advises this. Ask your doctor or pharmacist about suitable supplements. It is both safe and recommended that you take folic acid during pregnancy.

If you want to delay a period

To delay your period,

  • continue taking the light pink active tablets in the current blister,
  • skip the white placebo tablets in the last row of the same blister, and
  • start a new blister by taking the light pink active tablet from the green area corresponding to the day of the week (to ensure that you take your tablets on the corresponding day of the week as marked on the pack, you may have some extra tablets left over in your current blister which you can discard).

You can continue to delay your period by skipping the white placebo tablet in the second blister. The delay can be extended until the last light pink active tablet in the third blister is taken.

If you wish for your period to begin at any time during the extension, stop taking the light pink active tablets and start taking the white placebo tablets instead.

You should get your period approximately 2 – 3 days after you start taking the white placebo tablet. After taking the last white placebo tablet, start a new blister by taking the light pink active tablet.

During the extension, you may have some breakthrough bleeding or spotting on active tablet-taking days.

If you forget to take it

If you are late taking a tablet but still take it within 24 hours, contraception is maintained. If you are more than 24 hours late, this is called a missed pill. Follow these detailed instructions:

For YAZ to be most effective, light pink active tablets need to be taken uninterrupted for 7 days.

If you have been taking the light pink active tablets for 7 uninterrupted days and miss a light pink active tablet, take the missed tablet as soon as you remember, then go back to taking your medicine as you would normally, even if this means taking two tablets in one day. You will not need to use additional barrier contraceptive precautions.

The chance of pregnancy after missing a light pink active tablet depends on when you missed the tablet. There is a higher risk of becoming pregnant if you miss a tablet at the beginning or end of a pack.

If after taking your missed tablet you have less than 7 days of light pink active tablets left in a row, you should finish the active tablets in your pack but skip the white inactive tablets and start a new pack. This is the best way to maintain contraceptive protection. However, you may not have a period until the end of the light pink active tablets of the second pack. You may have spotting or breakthrough bleeding on tablet-taking days.

If you have been taking the light pink active tablets for less than 7 days and miss a light pink active tablet, take the missed tablet as soon as you remember, then go back to taking your medicine as you would normally, even if this means taking two tablets in one day. In addition, you must also use additional barrier contraceptive precautions (e.g. condoms or a diaphragm) for the next 7 days. If you have had sexual intercourse during that time, there is a possibility of pregnancy and you may need emergency contraception.

If you forget to take more than one light pink active tablet, seek advice from your doctor or pharmacist about what to do.

If you have had sexual intercourse in the week before missing your tablets, there is a possibility of becoming pregnant.

If you miss a white inactive tablet, you do not need to take them later because they do not contain any active ingredients. However, it is important that you discard the missed white tablet(s) to make sure that the number of days between taking active tablets is not increased as this would increase the risk of pregnancy. Continue with the next tablet at the usual time.

Please see the diagram at the end of this leaflet for “Summary of advice if you missed a light pink active tablet more than 24 hours ago”.

Ask your doctor or pharmacist to answer any questions you may have.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (Australia: 13 11 26 or New Zealand: 0800 POISON or 0800 764 766) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much YAZ.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take several light pink active 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.

WHILE YOU ARE TAKING YAZ

Things you must do

Tell any doctors, dentists and pharmacists who treat you that you are taking this medicine.

If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.

Have regular check-ups with your doctor. When you are taking the Pill, your doctor will tell you to return for regular check-ups, including getting a Cervical Screening Test. Your doctor will advise how often you need a Cervical Screening Test. A Cervical Screening Test can detect abnormal cells lining the cervix. Sometimes abnormal cells can progress to cancer.

If you are about to start on any new medicine, remind your doctor and pharmacist that you are taking YAZ.

Stop taking YAZ and see your doctor immediately if you notice the following signs:

  • one-sided swelling of the leg and/or foot or along a vein in the leg
  • pain or tenderness in the leg which may be felt only when standing or walking
  • increased warmth in the affected leg; red or discoloured skin on the leg
  • sudden onset of unexplained shortness of breath or rapid breathing
  • sudden coughing or coughing up of blood
  • sharp chest pain or sudden severe pain in the chest which may increase with deep breathing
  • severe light headedness or dizziness
  • rapid or irregular heartbeat
  • sudden pain, swelling and slight blue discoloration of an extremity
  • sudden numbness or weakness of the face, arm or leg, especially on one side of the body
  • sudden trouble walking, dizziness, loss of balance or coordination
  • sudden confusion, slurred speech or aphasia; sudden partial or complete loss of vision, double vision, painless blurring of vision which can progress to loss of vision
  • sudden, severe or prolonged headache with no known cause
  • loss of consciousness or fainting with or without seizure
  • pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the chest arm, or below the breastbone
  • discomfort radiating to the back, jaw, throat, arm, stomach
  • feeling of being full, having indigestion or choking
  • sweating, nausea, vomiting
  • extreme weakness and anxiety.

If you are going to have surgery, tell the surgeon or anaesthetist beforehand that you are taking this medicine. The risk of having blood clots is temporarily increased as a result of major surgery, any surgery to the legs or pelvis, neurosurgery or major trauma. In women who take YAZ, the risk may be higher.

In women at risk of prolonged immobilisation (including major surgery, any surgery to the legs or pelvis, neurosurgery, or major trauma), your doctor may tell you to stop taking (in the case of elective surgery at least four weeks in advance) and not resume until two weeks after complete remobilisation. Another method of contraception should be used to avoid unintentional pregnancy. Your doctor may prescribe other treatment (e.g. treatment for blood clots) if YAZ has not been discontinued in advance.

Other risk factors for blood clotting include temporary immobilisation including air travel of greater than 4 hours, particularly in women with other risk factors. Consult your doctor if you plan to air travel for greater than 4 hours.

Consult your doctor if you develop high blood pressure while taking YAZ – you may be told to stop taking it.

If you become pregnant while taking this medicine, tell your doctor immediately.

If you vomit within 3-4 hours or have severe diarrhoea after taking a light pink active tablet, the active ingredients may not have been completely absorbed. This is like missing a tablet. Follow the advice for missed tablets.

If you have unexpected bleeding and it continues, becomes heavy, or occurs again, tell your doctor. When taking these tablets for the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) between your periods. You may need to use sanitary products, 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 months.

If you have missed a period, but you have taken all your tablets, it is very unlikely that you are pregnant, as long as:

  • you have taken the light pink active tablets at the right time
  • you have not been taking medicine(s) that may interfere with YAZ
  • you have not vomited or had severe diarrhoea during this cycle.

If this is so, continue to take YAZ as usual. If you have any concerns consult your doctor or pharmacist.

If you miss your period twice in a row, you may be pregnant even if you have taken the Pill correctly. Stop taking YAZ and seek advice from your doctor. You must use a non-hormonal method of contraception, (such as condoms or a diaphragm) until your doctor rules out pregnancy.

If you choose to delay your period while taking YAZ, your regular bleeding is not expected to occur during the extension period when the intake of the light pink active tablet is uninterrupted. Therefore, the absence of regular bleeding cannot be used as a sign of an unexpected pregnancy and as such, unexpected pregnancy may be difficult to recognise. Although pregnancy is unlikely if YAZ is taken as directed, if for any reason you think you might be pregnant, contact your doctor and do a pregnancy test. This may be of particular importance if you are also using other medications, since some medications are known to be harmful to the foetus.

YAZ will not protect you from HIV-AIDS or any other Sexually Transmitted Infections (STIs), such as chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B, human papilloma virus and syphilis.

To protect yourself from STIs, you will need to use additional barrier contraceptives (e.g. condoms).

Things you must not do

Do not take YAZ to treat any other conditions, unless your doctor tells you to.

Do not give your medicine to anyone else.

Do not stop taking your medicine or change the dosage without checking with your doctor. You may become pregnant if you are not using any other contraceptive and you stop taking YAZ, or do not take a tablet every day.

SIDE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking YAZ.

This medicine helps most people, but it may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

The following list includes the more common side effects of your Pill. These are usually mild and lessen with time.

If you notice any of the following side effects and they worry you, tell your doctor or pharmacist:

  • nausea
  • headache, including migraines
  • mood changes, including depression
  • unscheduled vaginal bleeding
  • abnormal periods
  • irregular bleeding between periods
  • breast tenderness or pain.

The following list includes very serious but rare side effects. You may need urgent medical attention or hospitalisation.

If you experience any of the following, tell your doctor immediately, or go to the Emergency Department at your nearest hospital:

  • pain in the chest, arm or below the breastbone
  • pain or discomfort that goes to your back
  • breathlessness and/or difficulty breathing
  • swelling, pain or tenderness of one leg
  • sudden weakness, numbness or bad ‘pins and needles’ of the face, arm or leg, especially on one side of the body
  • sudden trouble walking, dizziness, loss of balance or coordination
  • severe, sudden stomach pains
  • a fainting attack, or you collapse
  • unusual headaches or migraines that are worse than usual
  • sudden problems with speech, understanding or eyesight

The side effects listed above are possible signs of a blood clot (thrombosis).

  • jaundice (yellowing skin or yellowing eyes)
  • you cough up blood
  • breast lumps
  • unexplained vaginal bleeding.

Tell your doctor or pharmacist if you feel unwell. Other side effects not listed may also occur in some people.

Blood clots and the Pill

Blood clots may block blood vessels in your body. This type of blood clot is also called thrombosis.

Blood clots sometimes occur in the deep veins of the legs (DVT). If a blood clot breaks away from the veins where it has formed, it may reach and block the blood vessels of the lungs, causing pulmonary embolism (PE).

Blood clots can also occur in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke).

Blood clots are a rare occurrence and can develop whether or not you are taking the Pill. They can also happen during pregnancy. The risk of having blood clots is higher in Pill users than in non users, but not as high as during pregnancy.

The excess risk of a blood clot is highest during the first year after a woman takes the Pill for the first time or after having a break from the Pill for 4 weeks or more.

If you notice possible signs of a blood clot, stop taking YAZ and consult your doctor immediately.

To prevent pregnancy, you must also use additional barrier contraceptive precautions (e.g. condoms or a diaphragm).

If you are concerned about an increased risk of blood clots while on YAZ, speak to your doctor.

Cancer and the Pill

Breast cancer has been diagnosed slightly more often in women who take the Pill than in women of the same age who do not take the Pill.

This slight increase in the numbers of breast cancer diagnoses gradually disappears during the course of the 10 years after women stop taking the Pill.

It is not known whether the difference is caused by the Pill. It may be that these women were examined more often, so that the breast cancer was noticed earlier.

It is important that you check your breasts regularly and contact your doctor if you feel any lumps.

In rare cases benign liver tumours 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 who have been taking 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.

AFTER TAKING YAZ

Storage

Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the pack they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 30°C.

Do not store it or any other medicine in the bathroom, near a sink, or on a window-sill. Do not leave it in the car. Heat and damp can destroy some medicines.

Keep YAZ where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Return any unused medicine to your pharmacist.

PRODUCT DESCRIPTION

What it looks like

YAZ active tablets are light pink round tablets marked on one side with the letters "DS" in a regular hexagon.

YAZ inactive tablets are white round tablets marked on one side with the letters "DP" in a regular hexagon.

YAZ comes in a box containing either 1 or 3 blister packs. Each blister pack contains 24 light pink active tablets and 4 white inactive tablets.

Ingredients

Each YAZ light pink active tablet contains:

Active ingredients:

  • 3 milligram of drospirenone
  • 20 microgram of ethinylestradiol (as betadex clathrate)

Inactive ingredients:

  • Lactose monohydrate
  • maize starch
  • hypromellose
  • magnesium stearate
  • purified talc
  • titanium dioxide
  • iron oxide red

Each white inactive tablet contains:

  • lactose monohydrate
  • microcrystalline cellulose
  • magnesium stearate
  • hypromellose
  • purified talc
  • titanium dioxide

Tablets do not contain gluten. Tablets also do not contain tartrazine or any other azo dyes.

Supplier

Made in Germany for:

Bayer Australia Ltd
ABN 22 000 138 714
875 Pacific Highway
Pymble NSW 2073

Bayer New Zealand Limited
P O Box 2825
Shortland Street
Auckland 1140
New Zealand

Australian Registration Number

YAZ - AUST R 226241

Date of Preparation

April 2023

See TGA website (www.ebs.tga.gov.au) for latest Australian Consumer Medicine Information.

See MEDSAFE website (www.medsafe.govt.nz) for latest New Zealand Consumer Medicine Information.

Missed a pill?
See the end of this leaflet

® Registered Trademark of the Bayer group, Germany

© Bayer Australia Ltd

All rights reserved.

Published by MIMS May 2023

BRAND INFORMATION

Brand name

Yaz

Active ingredient

Drospirenone + Ethinylestradiol

Schedule

S4

 

1 Name of Medicine

Yaz (drospirenone and ethinylestradiol).

2 Qualitative and Quantitative Composition

Each light pink active tablet contains drospirenone 3 mg and ethinylestradiol (as betadex clathrate) 20 microgram.
Excipients with known effect:
Each light pink active tablet contains 48.18 mg of lactose monohydrate.
Each white placebo tablet contains 23.21 mg of lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Each Yaz active tablet is light pink in colour, marked on one side with the letters "DS" in a regular hexagon.
Each Yaz placebo tablet is white in colour, marked on one side with the letters "DP" in a regular hexagon.

4 Clinical Particulars

4.9 Overdose

There has not yet been any clinical experience of overdose with Yaz. On the basis of general experience with COCs, symptoms that may occur in case of overdose of active tablets are: nausea, vomiting and withdrawal bleeding. The last may even occur in girls before their menarche, if they have accidentally taken the medicinal product. There are no antidotes and further treatment should be symptomatic.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. There is limited evidence available in the literature suggesting that estrogens may be weakly genotoxic at high doses. Ethinylestradiol was negative in studies for DNA adduct formation in cultured human liver slices and in assays for gene mutations (bacterial or mammalian cells in vitro) and gave equivocal results in assays for chromosomal damage in vitro (clastogenic effects were not consistently seen and occurred at high concentrations). In vivo studies did not confirm these results.
Drospirenone was found to induce chromosome aberrations in human peripheral lymphocytes. However, drospirenone was not mutagenic in bacterial and mammalian cell gene mutation assays in vitro, and was not clastogenic in mouse micronucleus assays in vivo. Interactions between drospirenone and the DNA of liver cells which indicate a genotoxic potential were found in in vitro and in vivo studies in rats. No such finding was observed in human liver cells in vitro.
Carcinogenicity. Long-term carcinogenicity studies were performed in mice and rats with drospirenone, ethinylestradiol and with a combination of both products. After 2 years oral treatment of mice and rats with drospirenone alone there were no increases in the incidence of neoplastic lesions. Exposure to drospirenone (based on AUC) was up to 3-fold (mice) and 8-fold (rats) than that anticipated in humans at the recommended clinical dose. In contrast, treatment with the combination of drospirenone and ethinylestradiol resulted in an increased rate of neoplastic lesions in the mammary glands and uteri of mice and rats and in the pituitary glands of mice. The tumour pattern was similar but the incidence increased even further in animals receiving ethinylestradiol alone, indicating that ethinylestradiol was responsible for the increase in neoplastic lesions. Coadministration of drospirenone decreased the carcinogenic potential of ethinylestradiol in the mouse pituitary and in the mouse and rat uterus and mammary gland.
The ethinylestradiol induced tumours in rodents have previously been seen with other ethinylestradiol containing products, and are considered attributable to species specific effects of estrogens on prolactin secretion in rodents.
Although long-term animal studies did not definitively indicate a tumourigenic potential for the clinical use of either drospirenone or ethinylestradiol, it should be borne in mind that sex steroids can promote the growth of certain hormone dependent tissues and tumours.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Drospirenone. The chemical name for drospirenone is 6β, 7β, 15β, 16β-dimethylene-3-oxo-17α-pregn4-ene-21, 17-carbolactone. Chemical formula: C24H30O3. Molecular weight: 366.50.
Chemical structure. It has the following structural formula:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSDROSPI.gif CAS number. 67392-87-4.
Drospirenone is a white to off-white crystalline powder. It is freely soluble in methylene chloride, soluble in acetone and methanol, sparingly soluble in ethylacetate and ethanol 96% (v/v), and practically insoluble in hexane and water.
Ethinylestradiol. The chemical name for ethinylestradiol is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17β-diol. Chemical Formula: C20H24O2. Molecular Weight: 296.41.
Chemical structure. It has the following structural formula:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSETHEST.gif CAS number. 57-63-6.
Ethinylestradiol betadex clathrate is an inclusion complex of the compendially described substances ethinylestradiol and betadex and, when dissolved in water, it dissociates into the active moiety ethinylestradiol and the ligand betadex.
Ethinylestradiol is a white to creamy white, odourless, crystalline powder. It is insoluble in water and soluble in alcohol, chloroform, ether, vegetable oils and aqueous solutions of alkali hydroxides.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/YAZST.gif

References

1. Dinger JC, Heinemann LA, Kuhl-Habich D. The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance Study on oral contraceptives based on 142,475 women-years of observation. Contraception 2007; 75:344-54.
2. Long-term Active Surveillance Study for oral contraceptives (LASS), 2nd update report based on study status May 2009.
3. Seeger JD, Loughlin J, Eng PM, Clifford CR, Cutone J, Walker AM. Risk of thromboembolism in women taking ethinlyestradiol/ drospirenone and other oral contraceptives. Obstet Gynecol 2007; 100: 587-593.
4. Heit JA, Kobbervig CE, James AH, Petterson TM, Bailey KR, Melton LJ. Trends in the incidence of venous thromboembolism during pregnancy or postpartum: a 30 year population based study. Ann Intern Med 2005; 143:697-706.
5. Lidegaard O, Lokkegaard E, Svendsen AL, Agger C. Hormonal contraception and risk of venous thromboembolism: national follow up. BMJ 2009; 339:b2890.
6. Van Hylckama Vlieg A, Helmerhorst FM, Vandenbroucke JP, Doggen CJM, Rosendaal FR. Effects of estrogen dose and progestogen type on venous thrombotic risk associated with oral contraceptives: results of the MEGA case-control study. BMJ 2009; 339:b2921.
7. Parkin L, Sharples K, Hernandez RK, Jick SS. Risk of venous thromboembolism in users of oral contraceptives containing drospirenone or levonorgestrel nested case-control study based on UK General Practice Research Database. BMJ 2011; 340:d2139.
8. Jick SS, Hernandez RK. Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data. BMJ 2011; 340:d2151.
9. Lidegaard O, Nielsen LH, Skovlund CW, Skjeldestad FE, Lokkegaard, E. Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and estrogen doses: Danish cohort study, 2001-9. BMJ 2011; 343:d6423.
10. FDA 2011 Ouellet-Hellstrom R, Graham DJ, Staffa JA, Sidney S, Cheetham TC, Cooper WO, Connell, F. Combined hormonal contraceptives (CHCs) and the risk of cardiovascular disease endpoints. CHC-CVD Final Report 111022v2 (available at http://www.fda.gov/downloads/drugs/drugsafety/ucm277384.pdf, addendum available at http://www.fda.gov/downloads/drugs/drugsafety/ucm287762.pdf).
11. Dinger J, Bardenheuer K, Heinemann K. Cardiovascular and general safety of a 24-day regimen of drospirenone-containing combined oral contraceptives: Final results from the international active surveillance study of women taking oral contraceptives. Contraception 2014; 89(4):253-63.