Mirelle 0,015 mg/0,06 mg Film-Coated Tablets

MIRELLE is a contraceptive pill and is used to prevent pregnancy. Each pale yellow film-coated tablet contains a small amount of the female hormones ethinylestradiol and gestodene. Contraceptive pills that contain two hormones are called ‘combined pills’ or ‘combined oral contraceptives’.

General notes
Before you can begin taking MIRELLE, your doctor will ask you some questions about your personal health history and that of your close relatives. The doctor will also measure your blood pressure and, depending upon your personal situation, may also carry out some other tests. In this leaflet, several situations are described where you should stop using MIRELLE, or where the reliability of MIRELLE may be decreased. In such situations you should either 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 MIRELLE alters the monthly changes of body temperature and cervical mucus. MIRELLE, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Do not take MIRELLE if you have any of the conditions listed below. If any of these apply to you, tell your doctor before starting to use MIRELLE. Your doctor may advise you to use a different type of pill or an entirely different (including non-hormonal) method of birth control.

• if you are hypersensitive (allergic) to ethinylestradiol, gestodene or any of the other ingredients in MIRELLE. 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 ‘MIRELLE 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 (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) 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, ritonavir, 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 (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 MIRELLE, 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 MIRELLE, and your doctor may need to examine you regularly. Consult your doctor before starting to use MIRELLE if any of the following conditions apply to you or if any of them develop or worsen while you are taking MIRELLE:

• 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 MIRELLE’)
• 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 uraemic 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 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, contact your doctor.

Do not share medicines prescribed for you with any other person. The MIRELLE 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 2-3 after the last hormone-containing pale yellow MIRELLE tablet (i.e. while you are taking the last 4 hormone-free white 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 can you start with the first pack?
If you have not used a contraceptive with hormones during the previous month, start taking MIRELLE on the first day of the cycle (that is, the first day of your period). Then follow the days in order. MIRELLE will work immediately, it is not necessary to use an additional contraceptive method. 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 taking the tablets in the first cycle.

Changing from another combined hormonal contraceptive pill, or combined contraceptive vaginal ring or patch.
You can start taking MIRELLE 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 hormone-free tablets you can start MIRELLE on the day after taking the last tablet containing hormones (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 hormone-free tablet of your present Pill). In case you have used a vaginal ring or transdermal patch, start using MIRELLE preferably on the day of removal of the last ring or patch of a cycle pack, 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.

Changing from a progestogen-only method (progestogen-only pill, injection, implant or a progestogen-releasing ‘IUS’, intrauterine system). You may switch from the progestogen-only pill any day (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due) but in all of these cases you must use extra protective measures (for example, a condom) during the first 7 days of MIRELLE use.

After a miscarriage. Follow the advice of your doctor.

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 MIRELLE. Sometimes it is possible to start sooner. Your doctor will advise you. If, after having a baby, you have had sex before starting MIRELLE, be sure that you are not pregnant or wait until the next menstrual period.

If you want to start MIRELLE after having a baby and are breastfeeding, discuss this first with your doctor.

Ask your doctor what to do if you are not sure when to start.

If you take more MIRELLE than you should
There are no reports of serious harmful effects of taking too many MIRELLE 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. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take MIRELLE
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 white 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 white film-coated tablet(s) to avoid any confusion. If you forgot the last hormone-free white 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 pale yellow tablets (those containing hormones) (tablets 1-24 of your blister):
• If you are less than 12 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 12 hours late in taking any of pale yellow tablets your protection against pregnancy may be reduced. The more pale yellow 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 pale yellow 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. Do not take more than 2 tablets on a given day, to make up for missed pills. If you have forgotten tablets in a pack, and you do not have the expected bleeding that should start at the end of the blister (while taking the last 4 hormone-free white tablets), you may be pregnant. Contact your doctor before you start the next pack.

1 tablet missed during day 1 - 7
If you have forgotten to start a new pack, or if you have missed tablet(s) during the first 7 days of your pack, there is a risk that you are already pregnant (if you had sex in the 7 days before forgetting the tablet). In that case, contact your doctor before you start the next pack. See also the ‘missed pill chart’ for details. If you had no sex in the 7 days before the oversight, take the missed pale yellow 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.

1 tablet missed during day 8 - 14
Take the missed pale yellow 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 during day 15 - 24
You may choose either of the following options, without the need for extra contraceptive precautions.

1. Take the missed pale yellow tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next pale yellow tablets at the usual time (unless there are no pale yellow tablets left in the current pack). Discard your current pack as soon as the pale yellow tablets are finished (do not take the remaining 4 white hormone-free tablets) and start the next pack so that no gap is left between packs. You may not have a withdrawal bleed until you have finished the pale yellow tablets of the second pack but you may have spotting or breakthrough bleeding while taking the tablets.
2. Stop taking tablets from your current pack, have a tablet-free break of 4 days or less (also count the day you missed your tablet) and continue with the next pack.

MIRELLE can have side effects. Not all side effects reported for MIRELLE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MIRELLE, please consult your health care provider for advice. Tell your doctor if you notice any of the following:

Frequent side effects:

• nausea
• abdominal pain
• weight gain
• headache
• depressed or altered mood
• breast pain including breast tenderness

Less frequent side effects:

• vomiting
• diarrhoea
• fluid retention
• migraine
• reduced interest in sex
• breast enlargement
• rash
• urticaria (hives)
• contact lens intolerance
• allergic reactions (hypersensitivity)
• weight loss
• increased interest in sex
• vaginal discharge
• breast discharge
• erythema nodosum or multiforme (skin disorders)
• venous and arterial thromboembolic events*

* Estimated frequency, from epidemiological studies encompassing a group of combined oral contraceptives. 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.

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 MIRELLE’ 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

• 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 (chronic inflammatory bowel disease)
• chloasma (golden brown pigment patches, so-called “pregnancy patches”, especially on the face)

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

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 MIRELLE.

Keep out of the reach and sight of children. Store at or below 25 °C. Protect from light. Store in the blister in the outer carton.