Marvelon

This leaflet is designed to help you take Marvelon. Please read it carefully. If you still have any doubts about how to take Marvelon, please ask your doctor.

Introduction

There are several means of preventing a pregnancy. One of these is by taking the pill. When taken correctly, the pill has several important advantages over other methods of contraception.

  • It is one of the most reliable methods.
  • Once you stop taking the pill you will be able to become pregnant.
  • You can have sex without having to take other contraceptive measures directly beforehand.
  • Period pains may become less severe or may completely disappear.
  • Some disorders appear less frequently in pill users such as anaemia, pelvic infections, pregnancies occurring outside the womb, and certain disorders of the womb, ovaries and breasts.

N.B. The information in this leaflet only concerns Marvelon.

For information on any other contraceptive pill read the leaflet about that pill.

How Marvelon works

You take Marvelon once a day for 21 days on the run. This provides a small amount of female sex hormones. These hormones are intended to prevent the monthly release of an egg from the ovaries. If an egg is not released you cannot become pregnant. The first 21 days are followed by 7 days when you don-t take a pill. During these pill-free days your regular 'monthly period' occurs. However, this period may be lighter and shorter than usual.

How effective is Marvelon?

Marvelon is one of the most reliable methods of contraception if taken correctly. To make Marvelon as effective as it can be remember:

  • To take it at about the same time every day (See the section 'What to do . . . if you forget to take a pill').
  • To use another contraceptive method as well if you miss a pill or are sick, have severe diarrhoea, or are taking medicines (especially antibiotics) which may interfere with the way the pill works. (See the section 'What to do ... if you have a stomach upset or diarrhoea', and the section 'What to do . . . if you have to take other medicines').

Starting your first Marvelon pack

If you are not taking the pill at present

If your period has not yet begun read section 1.

If your period has begun in the last 5 days read section 2

If it is more than 5 days since your period began read section 3.

  1. Wait for your next period to begin. (Until then take extra contraceptive precautions). On the first day of this period take your first Marvelon pill marked with the corresponding day of the week. Continue to take the pills as instructed in the section 'How to take Marvelon' below. As long as you do this, you don't need to take any other contraceptive precautions.

If you don't have this period, consult your doctor to make sure you are not pregnant. Until the result of the pregnancy test arrives, do not take Marvelon but take extra contraceptive precautions.

Read the section 'Extra contraceptive precautions' carefully.

  1. Count the first day of your period as day 1. If it is now day 2, day 3 or day 4 of your period, you should begin taking your pills on day 5, regardless of whether bleeding has stopped or not. Take your first pill as instructed in the section 'How to take Marvelon' below.

You will not be protected against pregnancy for the first 7 days of pill taking; you must take extra contraceptive precautions. Read the section 'Extra contraceptive precautions' carefully.

  1. If your period started more than 5 days ago, wait until the first day of your next period before starting to take Marvelon. In the meantime you must take extra contraceptive precautions. Read the section 'Extra contraceptive precautions' carefully.

How to take Marvelon

The Marvelon pack contains 21 white pills. On the day you start a new pack of Marvelon, take a pill marked with the corresponding day of the week. For example, if it is Wednesday, take the pill marked Wednesday on the upper row of the pack. Follow the direction of the arrows and continue taking one pill each day until the pack is empty - that is for 21 days in all. Take your pill at the same time each day, preferably in the evening. Swallow each pill whole, with water if necessary.

Your next packs

When you have finished all 21 pills, don-t take any more for 7 days. You will probably have a period during these 7 days. Start your next pack on the 8th day. Do this whether or not you are still bleeding or even if you have not had a period. Providing you take Marvelon correctly, you will always start each new pack on the same day of the week. You will not become pregnant during the 7 day break from taking the pill, as long as you have taken your pills correctly, and start the next Marvelon pack on time.

When you change from other pills

1. Changing to Marvelon from a 22-day pill with 6 days break or from another 21 -day pill with 7 days break.

Finish all the pills in your old pack. Take your first Marvelon pill the next day. Do not leave a gap between packs and do not wait for your period to begin. Continue taking Marvelon as instructed in the section 'How to take Marvelon', above. You don't need extra contraceptive precautions.

You will not have a period until the end of the Marvelon pack, but this is not harmful, nor does it matter if you notice some bleeding while taking the pills.

  1. Changing from a combined every-day (ED) pill (28 pills) to Marvelon. Each every-day pack contains either 21 or 22 active pills followed by either 7 or 6 dummy (inactive) pills.

When you have taken all the active pills in your every day pack (21 or 22 pills) start taking Marvelon the next day. Do not leave a gap between taking your every day pill and starting Marvelon. Throw away the remaining inactive pills (6 or 7). Continue taking Marvelon as instructed in the section 'How to take Marvelon', above. You don't need extra contraceptive precautions.

You will not have a period until the end of the Marvelon pack, but this is not harmful, nor does it matter if you notice some bleeding while taking the pills.

3. Changing from a progestogen-only pill (POP or mini-pill) to Marvelon. (POP pills are taken every day without a break).

Start taking Marvelon on the first day of your period, even if you have taken a mini-pill on that day. Throw away the remaining pills in the POP pack. Continue to take Marvelon as instructed in the section 'How to take Marvelon', above. You don't need to take extra contraceptive precautions.

You may not have a period while taking the mini-pill, especially if you are breast-feeding. Start taking Marvelon the day after you stop taking the mini-pills. Throw away all the remaining mini-pills. You must take extra contraceptive precautions for the first 2 days of taking Marvelon .

Read the section 'Extra contraceptive precautions' carefully.

EXTRA CONTRACEPTIVE PRECAUTIONS

When you need extra contraceptive precautions, either:

  • don't have sex; or
  • use a cap plus spermicide or a condom

Don't use rhythm methods as extra contraceptive precautions. This is because the pill disrupts the usual menstrual cycle changes such as changes in temperature and cervical mucus.

continued

After a baby

If you have just had a baby and you are not breastfeeding, your doctor may advise you to start taking Marvelon 21 or 28 days after delivery. If so, you don't need any extra contraceptive precautions. Read the section 'How to take Marvelon', above.

If you have had sex in the 21 to 28 days since the baby was born you must not start Marvelon until the first day of your first period.

If you start Marvelon more than 28 days after delivery you will not be protected against pregnancy for the first 7 days of taking pills. For these 7 days, take extra contraceptive precautions. Read the section 'Extra contraceptive precautions', carefully.

If you are breast feeding you can still become pregnant, and so you should take contraceptive precautions. Your doctor may advise you not to use the pill- it may reduce the amount of breast-milk you produce, especially if you start taking it shortly after delivery.

You might be able to use the mini-pill (POP). Ask your doctor for advice.

After a miscarriage or abortion

If you have just had a miscarriage or an abortion you should start taking Marvelon immediately. You are then fully protected against pregnancy and don't need any extra contraceptive precautions. Read the section 'How to take Marvelon'.

What to do

If your periods seem different at first

This is normal when you start the pill. You will probably have less bleeding and it may be a different shade of red. You may have a little bleeding from time to time while taking the pills but this should stop within a few months. If your periods seem different, don't stop taking your pills, just mention it to your doctor at your next visit.

If bleeding occurs on any of the 21 pill-taking days

If you have been taking Marvelon correctly for a few months and you see sudden spotting or break-through bleeding (not seen in previous cycles), this may mean that the pill is not working fully as a contraceptive. You should consult your doctor.

If you forget to take a pill

  • If you are less than 12 hours late in taking a pill, you are still protected against pregnancy. Take the pill as soon as you remember, and take the next one at your normal time. This may mean taking 2 pills in one day.
  • If you are more than 12 hours late in taking one or more pills you will not be protected. As soon as you remember take the last missed pill. This may mean taking 2 pills in one day. Continue to take the pills at your normal time. You will not be protected for the next 7 days, and you must take extra contraceptive precautions, and must follow the 7-day rule.

THE 7-DAY RULE

If:

  • you are more than 12 hours late in taking any pill; or
  • you have a stomach upset or diarrhoea for more than 12 hours; or
  • your doctor advises you to follow the 7-day rule because you are taking certain medicines

then continue to take your pills as usual.

However take extra contraceptive precautions for the next 7 days.

Read the section 'Extra contraceptive precautions' carefully.

BUT- If these 7 days run beyond the end of your pack, start the next pack as soon as you have finished the present one.

Do not leave a gap between packs.

You may not have a period until the end of 2 packs but this does you no harm. Nor does it matter if you see some bleeding on pill-taking days.

If you have a stomach upset or diarrhoea

If you have vomiting or diarrhoea the pill may not work. Continue taking it, but you may not be protected from

the first day of vomiting or diarrhoea. If the symptoms disappear within 12 hours after you've taken a pill, take an extra pill from a spare pack and continue with the rest of the pack as usual Marvelon should still give you contraceptive protection during this cycle. However, if the symptoms continue after those 12 hours you must take extra contraceptive precautions during the stomach upset or diarrhoea and for the next 7 days. (Read the sections on the '7-day rule' and 'Extra contraceptive precautions carefully). If your stomach upset or diarrhoea continues for some time, consult your doctor.

If you have to take other medicines

Several medicines may interfere with the way the pill works. These include some drugs that treat acne, epilepsy and tuberculosis and some antibiotics. Other less common medicines might also have this effect.

If you are diabetic, the pill may alter the amount of insulin or other antidiabetic drugs which you need to take. You should consult your doctor for specific advice.

Always tell your doctor if you plan to use other medicines.

Remember to tell any doctor you consult that you are on this pill before they prescribe other medicines.

If you want to skip a period

Sometimes you may want to skip a period, such as during holidays, exams or other special occasions. You can do this with Marvelon but there are certain limits.

To skip your period entirely, don't leave a gap between packs. Start a new pack on the day after finishing your old pack. Use the pack in the normal way for 21 days. During the use of the second pack you may notice slight spotting or breakthrough bleeding but you will still have full contraceptive protection provided you have not forgotten any pills. Start your next pack of Marvelon after 7 pill-free days.

If you miss a period

If you have taken all your pills correctly you are very unlikely to be pregnant. Take your next pack as normal. If you have not taken them correctly, or if you miss a second period, see your doctor at once.

If you are having an operation. treatment for varicose veins or have to stay in bed

If you are planning to have an operation, surgery to the legs or medical treatment for varicose veins that will mean Iying in bed afterwards, it may be best for you to stop taking the pill at least four to six weeks beforehand. You will need to take extra contraceptive precautions. If you have an accident, emergency surgery or long illness that means Iying in bed for some time your doctor may advise you to stop taking the pill. You will need to take extra contraceptive precautions. You can usually start taking the pill again two weeks after you are fully mobile. Ask your doctor for advice.

What to do

If you smoke

Smoking increases the risks to your health and increases some of the risks of taking the pill It is best to stop smoking anyway. Older women, who continue to smoke, may be advised to change to another contraceptive method.

If you want to have a baby

If you want to have a baby you should stop taking the pill it is not harmful to get pregnant straight after this. However, it is helpful to wait until you have had two periods before you try to get pregnant. This makes it easier to work out when the baby is due. You can use another contraceptive method such as a cap plus spermicide or a condom until then. Occasionally regular periods do take some time to return, but this is rare.

Important tips

  • Make sure that any doctor you consult knows that you are taking Marvelon.
  • Keep your Marvelon pills out of reach of children.
  • Keep extra Marvelon packs in a cool, dry and dark place (not in the fridge). continued

More about Marvelon

You may find some of the medical words used difficult to understand. If so ask your doctor or a medically qualified member of your family planning clinic to explain.

Absolute contraindications (Reasons for not taking the pill)

Your doctor will decide whether there are any medical reasons why you should not take the pill. Therefore you should inform your doctor about your state of health.

Marvelon is a 'combined' contraceptive pill, because it contains two hormones, an oestrogen and a progestogen. Don't take Marvelon if any of the following apply:

  • If you are, or could be pregnant.
  • If you are breast feeding.
  • If you suffer from disorders of the blood circulation (or a history of these disorders, e.g. thrombosis or phlebitis) such as blockage of a blood vessel by a blood clot or fatty deposits in the arteries. The signs or symptoms of a blood clot are listed under the Warnings and Precautions Section.
  • If you have more than one of the factors which may increase the risk of a blood clot listed under Serious Adverse Reactions.
  • If you have moderate to severe hypertension (high blood pressure).
  • If you have severe disorders of the liver or a history of these disorders, such as jaundice of pregnancy or jaundice during previous use of hormones, and a rare metabolic liver disease called porphyria.
  • If you have gallstones.
  • If you have known or suspected tumours of the breast or the sex organs, overgrowth of the lining of the womb or vaginal bleeding which has not been explained by your doctor.
  • If you suffer from a rare disorder called lupus erythematosus which may affect many organs in your body, or a history of this condition.
  • If you have a history, during pregnancy or previous use of hormones, of:
  • itching of the whole body (pruritus of pregnancy);

or

  • the rash known as herpes gestationalis; or
  • an appearance or deterioration of otosclerosis (an inherited form of deafness).

If you develop any of the conditions above whilst you

are taking the pill, stop taking it and see your doctor immediately.

Relative contraindications

If you have any of the following conditions your doctor will tell you whether you can use the pill. If your doctor agrees to prescribe the pill, you should ask for regular check-ups during the time you take it. If any of the following conditions apply, or if you have any of them at present and they get worse, your doctor may advise you to stop taking the pill.

y if the risk of having blood clots (thrombosis) in the veins is increased, by, for example, a major operation or during long-term immobilisation or severe varicose veins.

  • If you have any of the risk factors for arterial disease (heart attack or stroke) listed under the Serious Adverse Reactions section.
  • If you have (or suspect that you have) a weak heart, disturbed kidney function, migraine, epilepsy or high blood pressure (or if you have a history of any of these conditions) .
  • If you have a history of gallstones.
  • If you have any risk factors for oestrogen-dependent tumours or certain disorders of the womb.
  • If you have diabetes.
  • If you suffer severe depression or have a history of this condition.
  • If you have sickle cell trait.

Warnings and precautions

Medical supervision/consultation

When you are using the pill, you should arrange for regular check-ups by your doctor. He or she should pay special attention to your blood pressure and your breasts

and give you a regular examination of the pelvic organs

(including a cervical smear).

Consult your doctor promptly if any of the following happen:

  • If you have the following signs or symptoms of a blood clot:
  • Sudden severe pain in the chest. whether it reaches to the arm or not.
  • If you suddenly become breathless.
  • If you have an unusual, severe or prolonged headache.
  • If you suddenly lose vision, partially or completely, or if you see double.
  • If your normal speech is disturbed. - If you experience dizziness.
  • If you have a bad fainting attack or you collapse.
  • If one side, or part of your body suddenly becomes very weak or numb.
  • If you suffer severe pain in one of your calves.
  • If you have sudden stomach ache or develop jaundice (yellowing of the skin).
  • If you can feel a lump in your breast.
  • If you miss a period or experience sudden spotting or break-through bleeding not seen in earlier cycles.
  • If you have persistent vomiting or diarrhoea.
  • If you have any other complaints that you cannot explain but think might be due to the pill.
  • If you plan to use other medicines.
  • If having stopped using the pill, you wish to restart.
  • if you wish to change your method of contraception.

Adverse reactions

Various adverse reactions have been associated with contraceptive pills that contain oestrogen or progestogen. They can be classified as mild, more annoying or serious. if any signs or symptoms appear that make you think that you may have a serious adverse reaction, you should stop using the pill and consult your doctor immediately.

Mild reactions

A variety of complaints have been reported in women who use the pill. However these complaints are not necessarily caused by the pill. They are not normally dangerous and are not likely to damage your health.

  • During the first few months, you may experience bleeding between your periods (see More Annoying Reactions), nausea, vomiting, headaches, breast tenderness and mood swings. These symptoms usually get less or disappear after a few months. However, if bleeding is heavy or prolonged consult your doctor.
  • You may gain a little weight. You should control this by dieting.
  • Occasionally you may not have a period, especially if you use a low-dose pill.
  • Your blood pressure may go up a little.

More Annoying Reactions

During the first few months, while your body is adjusting itself to the pill, some bleeding may occur between your periods, especially if you use low-dose pills. This may be just slight staining ('spotting') which may not even require a pad, or heavier 'break-through' bleeding, which looks rather like a scanty period and requires sanitary protection. In either case keep taking the pill. The bleeding, which usually stops in a day or two, is not serious and will not harm you. It does not mean that the pill does not suit you or that the pill is not giving you contraceptive protection. it may simply mean that your body is adjusting itself to the pill.

Occasionally the following conditions may occur.

  • worsening of fibroids or endometriosis (disorders of the womb)
  • chloasma (yellow brownish patches on the skin). Chloasma can be reduced by avoiding too much exposure to the sun
  • rash, erythema nodosum (red swellings on the legs)
  • discomfort of the eyes if contact lenses are used
  • increased need for insulin or other antidiabetics in diabetic patients
  • milky discharge from the breast
  • pain or enlargement of the breast
  • vaginal infections, with or without vaginal discharge.

continued

Serious reactions

Thrombosis (formation of blood clots in the blood vessels of the legs, lungs brain, heart or elsewhere). With the pill, and especially with earlier pills which contained higher quantities of oestrogen and progestogen, the risk of blood clots occurring in veins and arteries has been reported to be slightly greater than for women who don't use the pill.

Veins

In a very small number of women, clots broke away from the calf veins, and lodged in the arteries of the lungs causing 'pulmonary embolism'.

Arteries

It was reported that older women (35 40 years of age) who continued to smoke while taking the pill were more likely to suffer heart attacks and strokes. However, it has been shown that this is almost entirely due to the smoking habits of the women involved. You should stop smoking.

You should go for regular careful blood pressure checks. if you yet high blood pressure stop using the pill.

People don't always recover fully from a thrombosis and very occasionally they are fatal. Thrombosis has hardly ever been reported to occur in veins or arteries of the liver, the gut, the kidney or the eye.

With modern low-dose pills there are reasons to believe that the events mentioned above may occur less often than with the earlier pills.

Other risk factors, apart from smoking, such as being greatly overweight, having fatty deposits in the arteries, high blood pressure diabetes, a major operation, long-term immobilisation and severe varicose veins may also increase the risk of contracting either thrombosis, heart attack or stroke.

Signs and symptoms of a blood Cot are given under the Warnings Section.

On rare occasions, using the pill may lead to liver diseases such as jaundice and gall-stones, and very rarely it has been associated with certain liver tumours.

Oestrogen-dependent tumours.

Some studies have shown an increased risk of cervical and/or breast cancer on long term use of the combined contraceptive pill, however, this evidence is not conclusive. This possible risk, though small, may be expected to be less with low dose pills.

A rare disease of the skin and blood vessels called Lupus erythematosus.

A rare disease called Sydenham's Chorea.

Beneficial effects

The following beneficial effects have been associated with oestrogen/progestogen containing oral contraceptives.

Your periods

Your periods may become shorter, more regular and may be less painful.

You may bleed less and be less likely to have iron deficiency anaemia.

You may also suffer less from pre-menstrual tension.

Reproductive organs

Some disorders are not as common in women who use the pill, such as pelvic infections, pregnancies occurring outside the womb, and certain disorders of the womb, ovaries and breasts.

Overdose

There have been no reports of serious harmful effects from taking an overdose of Marvelon. However, if (for example) you discover that a child has taken a lot of pills in the last few hours, ask your doctor for advice.

How to take care of your pills

Keep your pills out of the reach of children.

Store your pills below 25C in a dry place (not in the fridge) and protect them from light.

Package quantities

Pack of 3 strips of 21 Marvelon pills.

Each pill contains: desogestrel (a progestagen) 150 micrograms, ethinyloestradiol BP (an oestrogen) 30 micrograms.

Marvelon tablets are white, round, biconvex tablets with a diameter of 6 mm. They have TR5 on one side and 'Organon' and a star on the other.

They also contain di-alpha-tocopherol, potato starch, povidone, stearic acid. aerosil and lactose.

Legal category POM.

Product licence number 0065/0071

Manufactured by N.V. Organon, Oss, The Netherlands.

The Product Licence is held by: Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 4FL. Telephone: Cambridge (01223) 423445.