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The eMC  

Last Updated 31 Jan 2013

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Binovum tablets

Binovum (bi-no-vum) is a medicine which is used in contraception. Binovum contains ethinylestradiol/norethisterone. It is supplied by Janssen-Cilag Ltd.

The information in this Medicine Guide for Binovum varies according to the condition being treated and the particular preparation used.

Binovum tablets

Information specific to Binovum tablets when used in contraception

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Your medicine

Binovum contains two hormones that are similar to the hormones oestrogen and progesterone that are produced by the body. Binovum comes in a strip of 21 tablets. Each strip contains two types of tablets – 7 white and 14 peach coloured tablets. These tablets contain different amounts of oestrogen and progesterone.

Binovum is used to prevent women from becoming pregnant. It works by preventing the release of eggs from the ovary. It may also change the lining of the uterus which makes it difficult for an egg to develop and also increase the thickness of vaginal fluid which can stop a sperm from reaching an egg.

Binovum may increase the chances of developing blood clots or cancers such as breast cancer or cervical cancer. However, it may provide some protection against ovarian and endometrial cancer. You and your prescriber will need to weigh up the benefits and risks of taking Binovum before you start to take it.

Hormonal contraceptives will only prevent a pregnancy if they are taken regularly. It is important you take this medicine at the same time each day. If you want immediate contraceptive cover then start to take Binovum on the first day of your menstrual period. If you do not start taking Binovum on the first day of your menstrual period you will need to take extra contraceptive precautions for at least seven days until Binovum starts to work. For more information about starting Binovum and if you need to take extra contraceptive precautions ask your prescriber, family planning nurse or read the patient information leaflet that comes with your medicine.

Once you have started to take Binovum, you should take it once a day for 21 days. After this you should not take any more tablets for the next seven days. Start a new strip of Binovum immediately after the seven day tablet-free break. During this break you will usually have a withdrawal bleed. If you do not have a withdrawal bleed during the tablet-free break and you have taken all your pills properly, you are very unlikely to be pregnant. However, if you have not taken your tablets properly and you miss a withdrawal bleed or if you miss two withdrawal bleeds in a row you should immediately contact your prescriber or family planning nurse. This is because there is a possibility that you could be pregnant and you must not take Binovum during pregnancy.

In certain situations the effectiveness of Binovum may be reduced and you will need to take extra contraceptive precautions. These situations include: missing a dose by more than 12 hours; taking other medicines that interact with Binovum; having diarrhoea, vomiting or an upset stomach or any medical condition which interferes with the absorption of your medicine. If any of these situations occur during the last seven days of your strip you should not have a tablet-free break between strips of tablets. Start taking the next strip of tablets without a break.

As there is no gap between strips you will not have a withdrawal bleed at the end of the first strip. But you may have some menstrual bleeding while you are taking the second strip and you should have a withdrawal bleed once you finish the second strip. For more information about situations when the effectiveness of Binovum may be reduced and when to take additional contraceptive precautions ask your prescriber, family planning nurse or read the patient information leaflet that comes with your medicine.

Do not share your medicine with other people. It may not be suitable for them and may harm them.

The pharmacy label on your medicine tells you how much medicine you should take. It also tells you how often you should take your medicine. This is the dose that you and your prescriber have agreed you should take. You should not change the dose of your medicine unless you are told to do so by your prescriber.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber.

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When to take your medicine

Some medicines work best if they are taken at a specific time of day. Getting the most from your medicine can also be affected by what you eat, when you eat and the times at which you take other medicines. Make sure you follow any specific instructions given to you by your prescriber or that are in the Patient Information Leaflet that comes with this medicine.

In the case of Binovum:

  • this medicine should be taken at the same time each day. It is best to take Binovum in the evening
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How to take your medicine

Some medicines have specific instructions about how to take them. This is because they work better when taken correctly. These instructions can include getting the right dose and special instructions for preparing the medicine.

In the case of Binovum:

If you are having problems taking this medicine, you should talk to your prescriber or pharmacist. They may be able to give you advice on other ways to take your medicine or other medicines that are easier for you to take.

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Taking too much of your medicine

Taking extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems. If you take extra doses of your medicine, you must get medical advice immediately. You may need a test to assess the effect of taking extra doses. This is because the effects of taking too much medicine are very complex so it is very important that you seek medical advice.

Contact your prescriber, pharmacist, specialist clinic or call 111 for advice.

Make sure you take all of your medicine containers with you if you are advised to go to hospital.

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Stopping your medicine

If you are not having any problems with this medicine, do not stop taking it unless you no longer need this form of contraception or you are advised to stop taking it by your prescriber.

If you are in any doubt, contact your prescriber, pharmacist, specialist clinic or call 111.

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Looking after your medicine

The instructions on how you should keep your medicine are on the pharmacy label. You should keep your medicine in the original container. This will help to keep your medicine in the best condition and also allow you to check the instructions. Do not take the medicine if the packaging appears to have been tampered with or if the medicine shows any signs of damage. Make sure that the medicine is out of the sight and reach of children.

In the case of Binovum:

  • protect your medicine from light
  • do not store in temperatures above 30°C

You must not take the medicine after the expiry date shown on the packaging. If you have any unused medicine, return it to your pharmacist who will dispose of it safely.

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Whether this medicine is suitable for you

Binovum is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

Binovum is not prescribed for post-menopausal women or females who have not started menstruating.

As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:

  • to determine whether or not the medicine is suitable and whether it must be prescribed with extra care
  • to check that this medicine is not having any undesired effects

Over time it is possible that Binovum can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Binovum has become unsuitable, it is important that the prescriber is contacted immediately.

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Side-effects

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

Very common: More than 1 in 10 people who take Binovum:

  • bleeding or spotting between menstrual periods - this may happen within the first few months of starting treatment with Binovum. If this continues to happen once Binovum has been taken for some time you must seek medical advice
  • headaches - seek immediate medical advice if you get an unusually severe headache for the first time, if the symptoms of your headache are different from normal, if your headaches occur more frequently, are persistent or worsen
  • painful menstrual periods
  • pre-menstrual syndrome
  • vomiting - if you vomit within two hours of taking Binovum you may need to take extra contraceptive precautions. For more information speak to your prescriber, family planning nurse or read the patient information leaflet that comes with this medicine

Common: More than 1 in 100 people who take Binovum:

  • acne
  • back pain
  • breast pain
  • breast tenderness
  • cervical problems
  • depression
  • diarrhoea - if you have severe diarrhoea for more than one day after taking Binovum you may need to take extra contraceptive precautions. For more information speak to your prescriber, family planning nurse or read the patient information leaflet that comes with this medicine
  • distension of the stomach
  • feeling dizzy
  • feeling nervous
  • menstrual problems including heavy and long periods, irregular menstrual periods or not having a menstrual period - seek immediate medical advice if you do not have two withdrawal bleeds in a row or if you suddenly have spotting or bleeding in between menstrual periods after taking Binovum for some time
  • muscle spasm
  • pelvic pain
  • raised blood pressure
  • stomach pain
  • vaginal itching
  • vaginal or genital discharge
  • withdrawal bleeding

Uncommon: More than 1 in 1000 people who take Binovum:

  • breast problems including mass or tumours
  • dark patches on the face or neck - this may persist. If you are prone to developing chloasma you should not expose your skin to sunlight or to ultraviolet light while taking Binovum
  • decreased libido
  • feeling anxious
  • feeling irritable
  • fluid retention
  • general feeling of being unwell
  • hair loss
  • hypersensitivity reactions
  • itching
  • loss of appetite
  • migraines - seek immediate medical advice if you get an unusually severe migraine for the first time, if the symptoms of your migraine are different from normal, if your migraines occur more frequently, are persistent or worsen
  • mood changes
  • mood swings
  • nausea
  • oedema
  • oedema of the extremities
  • skin rash or rashes
  • tiredness
  • urticaria
  • vaginal infections
  • weakness
  • weight gain

Rare: More than 1 in 10,000 people who take Binovum:

  • appetite gain
  • difficulty losing weight
  • gallstones
  • hair overgrowth
  • intolerance to contact lenses
  • liver problems such as liver tumours - liver tumours have been reported in women who have taken oral contraceptives for a long time. Seek immediate medical advice if you have pain in the upper part of your stomach
  • weight loss

Very rare: Fewer than 1 in 10,000 people who take Binovum:

  • breast enlargement
  • galactorrhoea
  • hormone dependent tumours such as breast or cervical cancer
  • vaginal dryness

The frequency of these side-effects is unknown:

  • abnormal laboratory test results
  • anaphylactic reactions
  • angioedema
  • decrease in production of breast milk
  • eye or eyesight problems
  • high levels of cholesterol or other lipids in the blood
  • may affect the results for certain tests
  • metabolic problems
  • pancreatitis
  • photosensitivity skin reaction
  • reduced glucose tolerance  - people with diabetes may be advised to adjust their anti-diabetic therapy
  • skin problems
  • some conditions may occur for the first time, return or get worse when taking Binovum. If this happens to you, seek immediate medical advice. Examples include: systemic lupus erythematosus, gallstones, diabetes, otosclerosis, or certain types of autoimmune skin problems that may have occurred during pregnancy
  • thromboembolic problems such as heart attacks, strokes, deep vein thromboses or pulmonary embolisms - seek immediate medical advice if you: have unusual pain, redness or swelling in the calf or leg; suddenly developed chest pain which is spreading to the left arm; suddenly feel breathless or develop a cough; have eye or eyesight problems such as have double vision or loss of vision; have aphasia or slurred speech; have sudden weakness or numbness affecting one side or one part of the body; have vertigo; have problems controlling movements; have a seizure; or if you collapse
  • vaginal bleeding

If you feel unwell or if you have concerns about a side-effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call 111.

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Taking other medicines

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Binovum:

The following types of medicine may interact with Binovum:

If you are taking Binovum and one of the above medicines or types of medicines, make sure your prescriber knows about it.

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Complementary preparations and vitamins

Medicines can interact with complementary preparations and vitamins.

Make sure you tell your prescriber the names of all the complementary preparations and vitamins that you are taking or are planning to take.

Your prescriber can then decide whether it is appropriate for you to take combinations that are known to interact.

In the case of Binovum:

If you have been prescribed Binovum you should only take something on the above list on the specific advice of your prescriber or pharmacist.

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Driving and operating machinery

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

Like all medicines Binovum can cause side effects. You should see how this medicine affects you and then judge if you are safe to drive or operate machinery. If you are in any doubt, talk to your prescriber.

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Diet

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Binovum:

  • there are no specific foods that you must exclude from your diet when taking Binovum
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Alcohol

Alcohol can interact with certain medicines.

In the case of Binovum:

  • there are no known interactions between alcohol and Binovum
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Family planning and pregnancy

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Binovum:

  • if you become pregnant, or think you have become pregnant while taking Binovum, you must contact your prescriber

This medicine is not suitable during pregnancy. Your prescriber will only start your treatment with this medicine once they are certain that you are not pregnant. If you are planning to become pregnant you should discuss with your prescriber or family planning nurse when it is best to stop Binovum. This is because it may take some time for your periods to become regular again.

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Breast-feeding

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Binovum:

  • you should only take this medicine while breast-feeding if your doctor thinks you need it

Before you have your baby you should discuss breast-feeding with your doctor or midwife. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast-feed.

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Ingredients of your medicine

Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. They are also added to improve the medicine's taste and appearance and to make it easier to take. Some may be used to prolong the life of the medicine.

You should check that you are able to take the ingredients in your medicine, especially if you have any allergies.

Binovum contains:

If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Binovum before, do not take Binovum. Talk to your prescriber, pharmacist or nurse as soon as possible.

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Binovum, Version 7, last updated 31 Jan 2013