Marvelon® 28

Marvelon® 28

Active ingredient(s): ethinylestradiol and desogestrel

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Marvelon 28. It does not contain all the available information. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Marvelon 28. Read this information carefully before you start taking Marvelon 28 tablets and keep this leaflet as you may need to read it again.

Where to find information in this leaflet:

1. Why am I using Marvelon 28?
2. What should I know before I use Marvelon 28?
3. What if I am taking other medicines?
4. How do I use Marvelon 28?
5. What should I know while using Marvelon 28?
6. Are there any side effects?
7. Product details

1. Why am I using Marvelon 28?

Marvelon 28 contains the active ingredients ethinylestradiol and desogestrel.

Marvelon 28 is an oral contraceptive, commonly known as a “Birth Control Pill” or “The Pill” that has been prescribed to prevent you from getting pregnant.

Marvelon 28 prevents pregnancy in several ways:

• It inhibits the egg release by stopping it maturing.
• Changing the cervical mucus consistency making it difficult for the sperm to reach the egg.
• Changing the lining of the uterus making it less suitable for implantation.

Marvelon 28 consists of 21 large white tablets, each containing 2 active ingredients: 30 micrograms of ethinylestradiol (an estrogen) and 150 micrograms of desogestrel (a progestogen) and 7 small white inactive tablets (first row of the blister pack).

Because of the small amounts of different female hormones in the active tablets, Marvelon 28 is considered a low-dose combined oral contraceptive.

Oral contraceptives are a very effective method of birth control. When taken correctly (without missing tablets) the chance of becoming pregnant is very low.

The following non-contraceptive health benefits have been associated with the combined Pill:

• Your periods may be lighter and shorter. As a result, the risk of anaemia may be lower.
• Your period pains may become less severe or may completely disappear.
• In addition, some serious disorders have been reported to occur less frequently in users of Pills containing 50 micrograms of ethinylestradiol (‘high-dose Pills’). These are benign breast disease, ovarian cysts, pelvic infections (pelvic inflammatory disease), ectopic pregnancy (pregnancy in which the embryo implants outside of the womb) and cancer of the endometrium (lining of the womb) and ovaries. This may also be the case for low-dose Pills but so far this has only been confirmed for endometrial and ovarian cancer.

2. What should I know before I use Marvelon 28?

Warnings

Do not use Marvelon 28 if you have an allergy to:

• any medicine containing desogestrel or ethinylestradiol
• 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 troubled breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin

Check with your doctor if you:

• have any other medical conditions
• take any medicines for any other condition

Do not use the combined Pill if you have or have had any of the conditions listed below. If any of these conditions apply to you, tell your doctor before starting to use Marvelon 28. Your doctor may advise you to use a different type of Pill or an entirely different (non-hormonal) method of birth control.

• 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 (see also the section later in this leaflet called ‘2. What should I know before I use Marvelon 28?: The Pill and Thrombosis’)
• a stroke (caused by a clot in or a rupture of a blood vessel in the brain)
• a condition that may be the first sign of a heart attack (such as angina pectoris or chest pain) or stroke (such as transient ischaemic attack or small reversible stroke)
• a serious risk factor or several risk factors for developing a blood clot
• very high blood pressure
• a very high level of fat in the blood (cholesterol or triglycerides)
• if you have major surgery (e.g., an operation) and your ability to move around is limited for a long period of time (see also the section later in this leaflet called ‘2. What should I know before I use Marvelon 28?: The Pill and Thrombosis’)
• a disorder affecting your blood clotting – for instance Activated Protein C resistance, antithrombin-III, protein C or protein S deficiencies
• a history of migraine accompanied by e.g. visual symptoms, speech disability, or weakness or numbness in any part of the body
• diabetes mellitus with blood vessel damage
• pancreatitis (an inflammation of the pancreas) associated with high levels of fatty substances in your blood
• jaundice (yellowing of the skin) or severe liver disease and your liver is not yet working normally
• a cancer that may grow under the influence of sex hormones (e.g. of the breast or of the genital organs)
• a benign or malignant liver tumour
• any unexplained vaginal bleeding
• you are pregnant or think you might be pregnant.

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 contraceptive measures. See also ‘General Notes’ in the next section.

Do not use Marvelon 28 if you have Hepatitis C and are taking the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir and medicinal products including glecaprevir and pibrentasvir (see ‘3. What if I am taking other medicines?‘).

Do not take Marvelon 28 if the expiry date printed on the pack has passed.

Do not take Marvelon 28 if the packaging is torn or shows signs of tampering.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you intend to become pregnant.

Tell your doctor immediately if you are pregnant or think you are pregnant while you are using Marvelon 28.

Like most medicines, Marvelon 28 must not be used during pregnancy

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Marvelon 28 is generally not recommended for use during breastfeeding. If you wish to take the Pill while breastfeeding, please seek the advice of your doctor.

Before you start to use Marvelon 28

General notes

• In this leaflet, several situations are described where you should stop taking the Pill, or where the reliability of the Pill may be decreased. In such situations you should 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 the Pill alters the usual changes in temperature and cervical mucus that occur during the menstrual cycle.
• If you are concerned about contracting a sexually transmitted infection (STI), ask your partner to wear a condom when having sexual intercourse with you.
  Marvelon 28 will not protect you from HIV (AIDS) or any other sexually transmitted infections. To help protect yourself from STIs, you need to use a barrier contraceptive such as a condom, but even barrier contraceptives may not protect you against human papilloma virus (HPV).

You should have a thorough medical check-up, including a Pap smear, breast check, blood pressure check and urine check.

You must tell your doctor if you are allergic to any foods, dyes, preservatives or any other medicines.

You must tell your doctor if you smoke.

The risk of having a heart attack or stroke increases as you get older. It also increases the more you smoke. When using the Pill you should stop smoking, especially if you are older than about 35 years of age.

You must tell your doctor if you have any of the conditions listed below. You may need to be kept under close observation. Your doctor can explain this to you. Tell your doctor if:

• you have diabetes
• you are overweight
• you have high blood pressure
• you have a heart valve disorder or a certain heart rhythm disorder
• you have an inflammation of your veins (superficial phlebitis)
• you have varicose veins
• anyone in your immediate family has had a thrombosis, a heart attack or a stroke
• you suffer from migraine
• you suffer from epilepsy
• you or someone in your immediate family has or has had high levels of cholesterol or triglycerides (fatty substances) in the blood
• anyone in your immediate family has had breast cancer
• you have liver or gall bladder disease
• you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)
• you have systemic lupus erythematosus (SLE, a disease affecting the skin all over the body)
• you have haemolytic uraemic syndrome (HUS; a disorder of blood coagulation causing failure of the kidneys)
• you have sickle cell disease
• 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, a neurological disease called Sydenham’s chorea); hereditary and acquired angioedema (you should see your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue and/or throat and/or difficulty swallowing or hives, potentially with difficulty breathing). Products containing estrogens may cause or worsen hereditary and acquired angioedema.
• you have or have had chloasma (yellow brownish pigmentation patches on the skin, particularly of the face); if so, avoid too much exposure to the sun or ultraviolet radiation.
• You need an operation or if your ability to move around is limited for a long period of time. This includes travelling by plane for greater than 4 hours.
• if you have recently given birth you are at an increased risk of blood clots. You should ask your doctor how soon after delivery you can start using Marvelon 28 (see also the section in this leaflet called ‘2. What should I know before I use Marvelon 28?: The Pill and Thrombosis’);
• you are lactose intolerant.

Tell your doctor if any of the above conditions appear for the first time, recur or worsen while using the Pill.

The Pill and 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 this blood clot breaks away from the veins where it is formed, it may reach and block the arteries of the lungs, causing a so-called ‘pulmonary embolism’. Deep venous thrombosis is a rare occurrence. It can develop whether or not you are taking the Pill. The risk is higher in Pill-users than in non-users. The chance of getting a thrombosis is highest during the first year after you start using the Pill for the very first time. The risk is also higher if you restart using the Pill (the same product or a different product) after a break of 4 weeks or more. Thrombosis can also happen if you become pregnant.

The risk of getting a blood clot in the deep veins of the legs for women using Pills with desogestrel (in Marvelon 28) may be slightly higher than for women using Pills with levonorgestrel, norgestimate or norethisterone. The absolute numbers remain very small.

Blood clots can also occur very rarely in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke). Extremely rarely blood clots can occur in the liver, gut, kidney or eye.

Very occasionally thrombosis may cause serious permanent disabilities or may even be fatal.

If you develop high blood pressure while using the Pill, you may be told to stop using it.

The risk of having deep venous thrombosis is temporarily increased as a result of an operation or immobilisation (for example when you have your leg or legs in plaster or splints). In women who use the Pill, the risk may be yet higher. Tell your doctor you are using the Pill well in advance of any expected hospitalisation or surgery. Your doctor may tell you to stop taking the Pill several weeks before surgery or at the time of immobilisation. Your doctor will also tell you when you can start taking the Pill again after you are back on your feet.

If you notice possible signs of a thrombosis, stop taking the Pill and consult your doctor immediately (See also ‘5. What should I know while using Marvelon 28?’).

The Pill and Cancer

Regularly examine your breasts.

The information given below was obtained from studies of women who used combined oral hormonal contraceptives, such as the combined pill, and from an additional study that included both oral and non-oral hormonal contraceptive-users.

In studies with the combined Pill, breast cancer has been diagnosed slightly more often in women who use the Pill than in women of the same age who do not use the Pill. This slight increase in the numbers of breast cancer diagnoses gradually disappears during the course of the 10 years after stopping use of the Pill.

In the additional study that included both oral and non-oral hormonal contraceptive-users, the occurrence of breast cancer was reported to increase the longer the women used the contraceptive. The difference in the reported risk of breast cancer between women who have never used the contraceptive and those who had used the contraceptive was small: 13 additional cases of breast cancer per 100,000 women-years.

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

Tell your doctor immediately if you have severe pain in your stomach.

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.

Chronic infection with Human Papilloma Virus (HPV) is the single most important risk factor for cervical cancer. HPV is a sexually transmitted infection. In women who use combined oral contraceptives for a long time the chance of getting cervical cancer may be slightly higher. This finding may not be caused by the Pill itself but may be related to sexual behaviour and other factors.

3. What if I am taking other medicines?

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

Also tell any other doctor or dentist who prescribes another medicine (or your pharmacist) that you use Marvelon 28.

Some medicines may interfere with Marvelon 28 and affect how it works.

Medicines that may reduce the effect of Marvelon 28 include:

• medicines for epilepsy (such as phenytoin, primidone, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate)
• medicines for tuberculosis (e.g. rifampicin and rifabutin)
• medicines for HIV infections (e.g. ritonavir, nelfinavir, nevirapine, efavirenz)
• medicines for Hepatitis C virus infection (e.g. boceprevir, telaprevir);
• antifungals (e.g. griseofulvin)
• medicines for high blood pressure in the blood vessels of the lungs (bosentan);
• herbal medicines containing St. John’s Wort primarily for the treatment of depressive moods

If you are taking medicines or herbal products that might make Marvelon 28 less effective, a barrier contraceptive method should also be used. Since the effect of another medicine on Marvelon 28 may last up to 28 days after stopping the medicine, it is necessary to use the additional barrier contraceptive method for that long.

Your doctor will tell you how long you need to take additional contraceptive precautions or whether you should use another contraceptive method altogether.

Marvelon 28 may interfere with the effect of some medicines.

Marvelon 28 may also interfere with how other medicines work, causing either an increase in effect (e.g., ciclosporin) or a decrease in effect (e.g lamotrigine).

Do not use Marvelon 28 if you have Hepatitis C and are taking the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir as this may cause increases in liver function blood test results (increase in ALT liver enzyme). Marvelon 28 can be restarted approximately 2 weeks after completion of treatment with the combination drug regimen. (See ‘2. What should I know before I use Marvelon 28?’).

If you are taking other Hepatitis C drug combinations (such as glecaprevir/pibrentasvir) you may experience increased levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Marvelon 28.

4. How do I use Marvelon 28?

Marvelon 28 pack contains 28 tablets: 21 large white tablets with active substances and 7 small tablets that do not contain active substances.

On the blister each tablet is marked with the day of the week on which it is to be taken. Take your tablet about the same time each day, with some liquid if necessary. Follow the direction of the arrows on the pack until all 28 tablets have been taken. A period should begin during the 7 days that you use the inactive tablets (the withdrawal bleed). Usually it will start on day 2-3 after the last large tablet.

Start taking your next pack immediately after the last small inactive tablet, even if your period continues. This means you will always start new packs on the same day of the week, and also means that you have your period on about the same days, each month.

When no hormonal contraception has been used in the past month

Start taking Marvelon 28 on the first day of your cycle, i.e. the first day of menstrual bleeding. Take a tablet from the green section marked with that day of the week. For example, if your period starts on a Friday, then take a tablet marked Friday. Then follow the days in order. Marvelon 28 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 tablet-taking in the 1st cycle.

When changing from another combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch)

You can start taking Marvelon 28 the day after you take the last tablet from your present Pill pack. If your present Pill pack contains inactive tablets (placebo) tablets you can start Marvelon 28 on the day after taking the last active 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 the present Pill (or the day after the last inactive tablet of your present Pill).

In case you use a vaginal ring or transdermal patch, you should start using Marvelon 28 preferably on the day of removal, but at latest when the next ring or patch would have been applied.

When changing from a progestogen-only method (minipill)

You can stop taking the minipill any day and start taking Marvelon 28 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 changing from an injectable, an implant or a progestogen-releasing intrauterine device (IUD)

Start using Marvelon 28 when your next injection is due or on the day that your implant or your IUD is removed. Make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet-taking.

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 Marvelon 28. Sometimes it is possible to start sooner. Your doctor will advise you. If you are breast-feeding and want to take Marvelon 28, you should discuss this first with your doctor.

After a miscarriage or abortion

Your doctor will advise you.

Additional contraceptive precautions

When additional contraceptive precautions are required you should either abstain from vaginal sex, or use a barrier method of contraception, a condom or a cap (diaphragm) plus spermicide. Rhythm methods are not advised as the Pill disrupts the cyclical changes associated with the natural menstrual cycle e.g. changes in temperature and cervical mucus.

If you forget to use Marvelon 28

What to do if you forget to take your tablets

• If you are less than 12 hours late in taking any tablet, take the tablet as soon as you remember and take further tablets at the usual time.
• If you are more than 12 hours late in taking a large (active) tablet, the reliability of the Pill may be reduced. The more consecutive tablets you have missed, the higher the risk that the contraceptive efficacy is decreased. There is a particularly high risk of becoming pregnant if you miss large (active) tablets at the beginning of the pack or in the 3rd week (the week before you start taking the small tablets). Therefore you should follow the rules given below.

More than one tablet forgotten in a pack

Ask your doctor for advice.

One tablet missed in week 1

Take the missed 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. If you had sexual intercourse in the week before missing the tablets, there is a possibility of becoming pregnant. So tell your doctor immediately.

One tablet missed in week 2

Take the missed 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.

One tablet missed in week 3

You may choose either of the following options, without the need for extra contraceptive precautions.

1. Take the missed 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. Start the next pack as soon as the large (active) tablets in the current pack are finished, so skip the smaller placebo tablets. You may not have a withdrawal bleed until you take the placebo tablets at the end of the second pack but you may have spotting or breakthrough bleeding on active tablet-taking days.

Or

2. Stop taking the large (active) tablets from your current pack and immediately continue with the smaller placebo tablets (a maximum of 6 days, the total number of placebo plus missed tablets may not be more than 7). Then continue with the next pack. When following this method, you can always start your next pack on the same day of the week as you usually do.

One tablet missed in week 4

The reliability of the Pill is maintained. Take the tablet as soon as you remember and take the next tablets at the usual times.

If you have forgotten tablets in a pack and you do not have the expected period in the first normal placebo tablet interval, you may be pregnant. Consult your doctor before you start with the next pack.

If you want to delay your period

You can delay your period if you continue with the large (active) tablets in your next pack of Marvelon 28 immediately after finishing the large tablets in your current pack. You can continue with this pack for as long as you wish, until this pack is empty. When you wish your period to begin, just stop tablet-taking. While using the second pack you may have some breakthrough bleeding or spotting on active tablet-taking days. Start your next pack after the usual 7 day inactive tablet interval.

If you want to change the starting day of your period

If you take your tablets as directed, you will have your period on about the same day every 4 weeks. If you want to change this, just shorten (never lengthen) the next placebo tablet interval. For example, if your period usually starts on a Friday and in future you want it to start on Tuesday (3 days earlier) you should now start your next pack 3 days sooner than you usually do. If you make your placebo tablet interval very short (e.g. 3 days or less), you may not have a bleeding during the interval. You may have some breakthrough bleeding or spotting during the use of the large tablets in the next pack.

If you vomit or have diarrhoea

If you vomit, or have severe diarrhoea, the active ingredients of your Marvelon 28 tablet may not have been completely absorbed. If you vomit within 3 to 4 hours after taking your tablet, this is like missing a tablet. Therefore, follow the advice for missed tablets. If you have severe diarrhoea, please contact your doctor.

If you have unexpected bleeding

With all Pills, for the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) between your periods. You may need to use sanitary protection, but continue to take your tablets as normal. Irregular vaginal bleeding usually stops once your body clock has adjusted to the Pill (usually after about 3 tablet-taking cycles). Tell your doctor if it continues, becomes heavy or starts again.

If you have missed a period

If you have taken all of your tablets at the right time, and you have not vomited, or had severe diarrhoea or used other medicines then you are very unlikely to be pregnant. Continue to take Marvelon 28 as usual.

If you miss your period twice in a row, you may be pregnant. Do not start the next pack of Marvelon 28 until your doctor has checked you are not pregnant.

If you want to stop taking Marvelon 28

You can stop taking Marvelon 28 any time you want to.

If you do not want to get pregnant, use another reliable birth control method after stopping Marvelon 28. Ask your doctor for advice.

If you stop because you want to get pregnant, it is generally recommended that you wait until you have had natural period before trying to conceive. This helps you to work out when the baby will be due.

Ask your doctor or pharmacist for advice about taking folate if you plan to become pregnant.

If you take too much Marvelon 28 (overdose)

There have been no reports of serious harmful effects from taking too many Marvelon 28 tablets at one time. If you take too much Marvelon 28 you may feel sick, vomit or have vaginal bleeding.

If you discover a child has taken Marvelon 28, ask your doctor for advice.

If you are not sure what to do, telephone your doctor or the Poisons Information Centre on 13 11 26 for advice.

5. What should I know while using Marvelon 28?

Things you should do

Regular check-ups

When you are using the Pill, your doctor will tell you to return for regular check-ups. You should have a check-up at least once a year.

Call your doctor straight away if you:

• notice any changes in your own health, especially involving any of the items mentioned in this leaflet (see also ‘2. What should I know before I use Marvelon 28?’); do not forget about the items related to your immediate family
• feel a lump in your breast
• you experience symptoms of angioedema such as swollen face, tongue and/or throat and/or difficulty swallowing or hives potentially with difficulty breathing (see also ‘2. What should I know before I use Marvelon 28?’).
• you are going to use other medicines (see also ‘3. What if I am taking other medicines?’)
• your ability to move around is limited for a long period of time or you are to have surgery (consult your doctor at least 4 weeks in advance)
• you have unusual, heavy vaginal bleeding
• you forgot tablets in the first week of the pack and had intercourse in the seven days before
• you have severe diarrhoea
• you miss your period twice in a row or suspect you are pregnant. Do not start the next pack until told to by your doctor.

Stop taking tablets and see your doctor immediately if you notice possible signs of thrombosis, myocardial infarction or a stroke such as:

• an unusual cough
• severe pain in the chest which may reach the left arm – this discomfort may include the back, jaw, throat, arm, stomach
• feeling of being full, having indigestion or choking
• sweating, nausea, vomiting, anxiety
• breathlessness or rapid breathing
• any unusual, sudden, severe or prolonged headache or migraine attack
• partial or complete loss of vision, or double vision
• confusion, slurring or speech disability
• sudden changes to your hearing, sense of smell or taste
• dizziness or fainting
• fast or irregular heartbeat
• weakness or numbness in any part of your body
• severe pain in your stomach
• severe pain or swelling in either of your legs
• pain or tenderness in the leg which may be felt only when standing or walking
• warmth, red or discoloured skin on the leg
• sudden pain, swelling and slight blue discoloration of an extremity
• sudden trouble walking, loss of balance or coordination

The situations and symptoms mentioned above are described and explained in more detail in the following section 2. ‘What should I know before I use Marvelon 28?’.

Remind any doctor, dentist or pharmacist you visit that you are using Marvelon 28.

Driving or using machines

There have been no observed effects.

Looking after your medicine

Store your tablets below 30°C in a dry place and protect them from light

Follow the instructions in the carton on how to take care of your medicine properly.

Heat and dampness can destroy some medicines. Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

A locked cupboard at least 1.5 meters above the ground is a good place to store medicines.

When to discard your medicine

Do not use the product if you notice, for example, colour change in the tablet, crumbling of the tablet or any other visible signs of deterioration.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date stated on the blister and outer box.

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well while taking Marvelon 28.

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects

What to do

The following side effects have been reported by users of the Pill, although they may not be caused by the Pill. These side effects may occur in the first few months that you are using the Pill and usually lessen with time. Common/uncommon (occurring in more than one per 1000 users): nausea, vomiting, abdominal pain, diarrhoea increase in body weight, fluid retention headache, migraine decreased sexual drive, depressed mood, mood changes breast pain, breast tenderness, breast enlargement rash, hives. Rare (occurring in less than one per 1000 users): contact lens intolerance hypersensitivity reactions decrease in body weight increased sexual drive breast secretion vaginal secretion acne erythema nodosum, erythema multiforme (these are skin conditions) hair loss excessive hair growth Unknown (frequency cannot be estimated from the available data): angioedema, particularly in patients who already have a (family) history of angioedema

Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects	What to do
Serious reactions associated with the use of the Pill, as well as the related symptoms, are described in the following Sections ‘2. What should I know before I use Marvelon 28?: The Pill and Thrombosis/ The Pill and Cancer‘. Please read these sections for additional information.	You should stop taking Marvelon if you experience any signs of thrombosis (headache or pain elsewhere in your body, dizziness, fainting, disturbances in vision, swollen ankles), or jaundice (yellowing of the eyes or skin). Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What Marvelon 28 contains

Large (active) tablets

Active ingredient (main ingredient)	ethinylestradiol 30 micrograms desogestrel 150 micrograms
Other ingredients (inactive ingredients)	colloidal anhydrous silica lactose monohydrate potato starch povidone stearic acid dl-alpha-tocopherol
Potential allergens	lactose

Small (inactive) tablets

Active ingredient (main ingredient)	no active ingredients
Other ingredients (inactive ingredients)	lactose monohydrate potato starch magnesium stearate
Potential allergens	lactose

Do not take this medicine if you are allergic to any of these ingredients.

What Marvelon 28 looks like

Marvelon 28 is presented in a PVC/Aluminium backed blister containing 28 tablets (21 active tablets) and 7 smaller (inactive) tablets packed in a sealed sachet. The sachet is packed in a carton together with the package leaflet.

(Aust R 42894).

Who distributes Marvelon 28

Organon Pharma Pty Limited
Building A, 26 Talavera Road, Macquarie Park, NSW 2113
Australia

This leaflet was prepared in October 2023.

S-CCPPI-OG8276A-TB-112021

RCN 100002842-AU