Melodene 0,02 mg/0,075 mg Tablets

• MELODENE is used to prevent pregnancy.

• Each of the 21 white coated tablets 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 MELODENE, 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 MELODENE, or where the reliability of MELODENE 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 MELODENE alters the monthly changes of body temperature and cervical mucus.

MELODENE does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Do not take MELODENE

Do not use the MELODENE if you have any of the conditions listed below. If any of these apply to you, tell your doctor before starting to use it. 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 hypersensitive (allergic) to gestodene or ethinylestradiol or any of the other ingredients of MELODENE (listed in section 6).
• 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, 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), the heart (heart attack), or other parts of the body.
• If you have a high risk of venous or arterial blood clots (see “MELODENE and thrombosis”. Consult your doctor who will decide whether you may use MELODENE).
• 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 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 MELODENE, stop taking it at once and consult your doctor. In the meantime, use non-hormonal contraceptive measures.

Additional information on special populations

Use in children

MELODENE is not intended for use in females whose periods have not yet started.

Use in older women

MELODENE is not intended for use after the menopause.

Women with liver impairment

Do not take MELODENE if you suffer from liver disease. See also “Do not take MELODENE” and “Warnings and precautions”.

Women with kidney impairment

Talk to your doctor. Available data do not suggest a need to change the use of MELODENE.

Do not share medicines prescribed for you with any other person. Always take MELODENE exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

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 white MELODENE tablet (i.e. while you are taking tablets from the last 7 hormone-free pink 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, each month.

MELODENE, when taken correctly, has 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 MELODENE

When no hormonal contraceptive has been used in the past month

Start taking MELODENE on the first day of your cycle, i.e. the first day of menstrual bleeding. Then follow the days in order. You may also start on days 2 to 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 tablet-taking in the first cycle.

When changing from a combined Pill, vaginal ring, or transdermal (contraceptive) patch

You can start taking MELODENE 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 MELODENE on the day after taking the last hormone-containing tablet (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, you should start using MELODENE 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.

When changing from a progestogen-only pill (minipill)

You can stop taking the minipill any day and start taking MELODENE the next day, at the same time. But make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet-taking when having intercourse.

When changing from an injectable, an implant, or a progestogen-releasing intrauterine device (IUD)

Start using MELODENE when your next injection is due or on the day that your implant or your IUD is removed. But make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet-taking when having intercourse.

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 MELODENE. Sometimes it is possible to start sooner. Your doctor will advise you.

If you are breast-feeding and want to take MELODENE, you should discuss this first with your doctor.

After a miscarriage or an abortion

Your doctor will advise you.

If you take more MELODENE than you should

There have been no reports of serious effects from overdose noted. If you take several white 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 unavailable, seek help at the nearest hospital or poison control centre.

If you forget to take MELODENE

If you forgot to take any of the 7 hormone-free pink tablets (the last 7 tablets in the blister), you are still protected against pregnancy because they do not contain any hormones. However, they should be discarded to avoid unintentionally prolonging the hormone-free phase.

The following advice only refers to missed hormone-containing white tablets.

• If you are less than 12 hours late in taking any tablet, contraceptive protection is not reduced. Take the tablet as soon as you remember and continue taking the tablets at the usual time.
• If you are more than 12 hours late in taking any of the white tablets, contraceptive protection against pregnancy may be reduced. The more white 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 white 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 7 hormone-free pink tablets), you may be pregnant. Contact your doctor before you start the next pack.
• 1 tablet missed during the first 7 days: 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 sexual intercourse 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 sexual intercourse in the 7 days before missing one tablet, take the missed white 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 the second 7 days: Take the missed white 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 do not need to use extra contraceptive precautions.
• 1 tablet missed during the third 7 days: You may choose either of the following options, without the need for extra contraceptive precautions.
• 1. Take the missed white tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next white tablet at the usual time (unless there are no white tablets left in the current pack). Complete taking all of the white tablets and discard the 7 pink hormone-free tablets and start the next pack right away so that there is no gap left between packs). You may not have a withdrawal bleed until you have finished the white tablets of the second pack, but you may experience spotting or breakthrough bleeding while taking the tablets.
• 2. Stop taking tablets from the current pack, have a tablet-free break of up to 7 days (also count the day you missed your tablet) and continue with the next pack, starting in the silver section with the tablet for the appropriate day of the week.

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

If any of these side effects continue, are severe or bother you, tell your doctor or pharmacist.

Serious reactions associated with the use of MELODENE, as well as the related symptoms, are described in the following sections: “MELODENE and thrombosis” and “MELODENE and cancer”. Please read these sections for additional information and consult your doctor at once where appropriate.

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 or increased interest in sex
• breast enlargement
• rash
• urticaria (hives)
• allergic reaction (hypersensitivity)
• contact lens intolerance
• weight loss
• 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 MELODENE’ 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
• chloasma

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 MELODENE’.

If you notice any side effects not mentioned in this leaflet, please inform 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/Plublications/Index/8. By reporting side effects, you can help provide more information on the safety of MELODENE.

Store all medicines out of the reach of children.

Store at or below 30 ºC.

Return unused or expired medicines to your pharmacist for safe disposal.