Document: leaflet CONSILIENT HEALTH (UK)_PL 04854-0121 change

• leaflet CONSILIENT HEALTH (UK)_PL 04854-0121
• leaflet MAH BRAND_PL 04854-0121

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MILLINETTE® 30/75

microgram coated tablets

ethinylestradiol and gestodene

Important things to know about combined hormonal contraceptives (CHCs):

•    They are one of the most reliable reversible methods of contraception if used correctly.

•    They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive following a break of 4 or more weeks.

•    Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 "Blood clots”).

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you,

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

See section 4.

What is in this leaflet

1.    What Millinette is and what it is used for

2.    What you need to know before you use Millinette

3.    How to take Millinette

4.    Possible side effects

5.    How to store Millinette

6.    Contents of the pack and other information

1. WHAT MILLINETTE IS AND WHAT IT IS USED FOR

Millinette is a combined hormonal contraceptive, one of a group of drugs often referred to as the Pill. It contains two types of hormone: an oestrogen, ethinylestradiol, and a progestogen, gestodene. These hormones stop the ovary from releasing an egg each month (ovulation). They also thicken the fluid (mucus) at the neck of the womb (cervix) making it more difficult for the sperm to reach the egg, and alter the lining of the womb to make it less likely to accept a fertilised egg. Medical research and vast experience have shown that, if taken correctly, the Pill is an effective reversible form of contraception. Remember, combined hormonal contraceptive pills like Millinette will not protect you against sexually-transmitted diseases (such as AIDS). Only condoms can help to do this.

How your body gets ready for pregnancy (the menstrual cycle).

You can usually become pregnant (conceive) from the time you start to have periods (usually in your teens), until your periods stop (the menopause). Every menstrual cycle takes about 28 days. About halfway through this cycle, an egg is released from one of your ovaries into a Fallopian tube. This is called ovulation. The egg travels down the Fallopian tube towards your womb. When you have sex, your partner's penis releases millions of sperm into your vagina. Some of these sperm travel up through your womb into your Fallopian tubes. If there is an egg in one of these tubes and a sperm reaches it, you can become pregnant. This is called 'conception'.

A fertilised egg settles in the lining of your womb and takes nine months to grow into a baby. As an egg can live for up to two days, and sperm for up to five days, you can become pregnant if you have had sex up to five days before ovulation and for some time afterwards. If a sperm does not fertilise an egg, you will lose the egg at the end of your menstrual cycle along with the lining of your womb. This is called a 'period'.

How do natural hormones work?

Your menstrual cycle is controlled by two sex hormones made by your ovaries: oestrogen and progesterone (which is a progestogen). Your oestrogen levels increase during the first half of your menstrual cycle, and make your womb develop a thick lining, ready to receive the egg if conception happens. Progesterone comes later in your menstrual cycle and changes the lining of the womb to prepare it for pregnancy.

If you don't become pregnant, you will then make less of these hormones and this causes the lining of your womb to break down. As mentioned above, this womb lining leaves your body as a period. If you do become pregnant, your ovaries and placenta (this attaches the growing baby to the womb and gives it food) carry on making progesterone and oestrogen to stop any more eggs being released. This means that while you are pregnant you will not ovulate or have periods.

How does the pill work?

A combined contraceptive pill such as Millinette contains hormones which are like those that your body produces (oestrogen and progestogen). These hormones help to stop you from getting pregnant, just as your natural hormones would stop you conceiving again when you are already pregnant.

The combined contraceptive pill protects you against getting pregnant in three ways.

1.    You won't release an egg to be fertilised by sperm.

2.    The fluid in the neck of your womb thickens so it is more difficult for sperm to enter it.

3.    The lining of your womb does not thicken enough for an egg to grow in it.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE MILLINETTE

General notes

Before you start using Millinette you should read the information on blood clots (thrombosis) in section 2. It is particularly important to read the symptoms of a blood clot - see Section 2 "Blood clots”.

Do not use Millinette

You should not use Millinette if you have any of the conditions listed below. If you do have any of the conditions listed below, you must tell your doctor. Your doctor will discuss with you what other form of birth control would be more appropriate:

•    if you are allergic to ethinylestradiol or gestodene or any of the other ingredients of this medicine (listed in section 6)

•    if you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs

•    if you know you have a disorder affecting your blood clotting - for instance, protein C deficiency, protein S deficiency, antithrombin-III-deficiency, Factor V Leiden or antiphospholipid-antibodies

•    if you need an operation or if you are off your feet for a long time (see section 'Blood clots' (thrombosis and embolus)

•    if you have ever had a heart attack or a stroke

•    if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischaemic attack [TIA - temporary stroke symptoms])

•    if you have any of the following diseases that may increase your risk of a clot in the arteries:

•    severe diabetes with blood vessel damage

•    very high blood pressure

•    a very high level of fat in the blood (cholesterol or triglycerides)

•    a condition known as hyperhomocysteinaemia

•    if you have (or have ever had) a type of migraine called 'migraine with aura'

•    if you have or have ever had an eye disorder due to circulatory disease

•    if you have liver disease or if you have ever had this

•    if you have liver tumours or if you have ever had these

•    if you have breast cancer or other cancer, for example ovarian cancer, cervical cancer, or cancer of the uterus (womb)

•    if you have unusual bleeding from your vagina

•    if you are pregnant or think you might be.

If you get any of these conditions while you are taking Millinette, do not take any more pills and contact your doctor immediately.

In the meantime, use another method of contraception such as a condom or cap plus spermicide.

Warnings and precautions

When should you contact your doctor?

Seek urgent medical attention

• if you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary embolism), a heart attack or a stroke (see 'Blood clots' section below).

For a description of the symptoms of these serious side effects please go to "How to recognise a blood clot”.

Regular check-ups

Before you start taking Millinette, your doctor should take your medical history by asking you some questions about yourself and other members of your family. Your doctor will take your blood pressure and make sure you are not pregnant. Your doctor may also examine you. Once you have started taking Millinette, your doctor will see you again for regular check-ups This will happen when you go back to your doctor for more pills.

Tell your doctor if any of the following conditions apply to you.

If the condition develops, or gets worse while you are using Millinette, you should also tell your doctor.

Your doctor may tell you to stop using Millinette and advise you to use another method of contraception.

If you have:

•    elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history for this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);

•    systemic lupus erythematosus (SLE -;a disease affecting your natural defence system);

•    haemolytic uraemic syndrome (HUS - a disorder of blood clotting causing failure of the kidneys).

If you suffer from:

•    high blood pressure (hypertension);

•    yellowing of the skin (jaundice);

•    itching of your whole body (pruritus);

•    gallstones;

•    the inherited disease called porphyria;

•    the movement disorder called Sydenham's chorea;

•    the rash known as herpes gestationis;

•    the inherited form of deafness known as otosclerosis;

•    disturbed liver function;

•    diabetes;

•    depression;

•    Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);

•    sickle cell anaemia (an inherited disease of the red blood cells);

•    if you need an operation, or you are off your feet for a long time (see in section 2 'Blood clots');

•    just given birth you are at an increased risk of blood clots. You should ask your doctor how soon after delivery you can start taking Millinette;

•    an inflammation in the veins under the skin (superficial thrombophlebitis).

•    varicose veins.

•    brown patches on your face and body (chloasma), which you can reduce by staying out of the sun and not using sunbeds or sunlamps.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Millinette increases your risk of developing a blood clot compared with not using one. In rare cases a blood clot can block blood vessels and cause serious problems.

Blood clots can develop

•    in veins (referred to as a 'venous thrombosis', 'venous thromboembolism' or VTE)

•    in the arteries (referred to as an 'arterial thrombosis', 'arterial thromboembolism' or ATE).

Recovery from blood clots is not always complete. Rarely, there may be serious lasting effects or, very rarely, they may be fatal.

It is important to remember that the overall risk of having a harmful blood clot due to Millinette is small.

HOW TO RECOGNISE A BLOOD CLOT

Seek urgent medical attention if you notice any of the following signs or symptoms:

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

•    The use of combined hormonal contraceptives has been connected with an increase in the risk of blood clots in the vein (venous thrombosis). However, these side effects are rare. Most frequently, they occur in the first year of use of a combined hormonal contraceptive.

•    If a blood clot forms in a vein in the leg or foot it can cause a deep vein thrombosis (DVT).

•    If a blood clot travels from the leg and lodges in the lung it can cause a pulmonary embolism.

•    Very rarely a clot may form in a vein in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?

The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks or more.

After the first year, the risk gets smaller but is always slightly higher than if you were not using a combined hormonal contraceptive.

When you stop Millinette your risk of a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of a blood clot in the leg or lung (DVT or PE) with Millinette is small.

•    Out of 10,000 women who are not using any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.

•    Out of 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate about 5-7 will develop a blood clot in a year.

•    Out of 10,000 women who are using a combined hormonal contraceptive that contains gestodene, such as Millinette between about 9 and 12 women will develop a blood clot in a year.

•    The risk of having a blood clot will vary according to your personal medical history (see "Factors that increase your risk of a blood clot” below)

Factors that increase your risk of a blood clot in a vein

The risk of a blood clot with Millinette is small but some conditions will increase the risk. Your risk is higher:

•    if you are very overweight (body mass index or BMI over 30kg/m²);

•    if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age (e.g. below the age of about 50). In this case you could have a hereditary blood clotting disorder;

• if you need to have an operation, or if you are off your feet for a long time because of an injury or illness, or you have your leg in a cast. The use of Millinette may need to be stopped several weeks before surgery or while you are less mobile. If you need to stop Millinette ask your doctor when you can start using

it again.

•    as you get older (particularly above about 35 years);

•    if you gave birth less than a few weeks ago.

The risk of developing a blood clot increases the more conditions you have.

Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly if you have some of the other factors listed.

It is important to tell your doctor if any of these conditions apply to you, even if you are unsure. Your doctor may decide that Millinette needs to be stopped.

If any of the above conditions change while you are using Millinette, for example a close family member experiences a thrombosis for no known reason; or you gain a lot of weight, tell your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

Factors that increase your risk of a blood clot in an artery

It is important to note that the risk of a heart attack or stroke from using Millinette is very small but can increase:

•    with increasing age (beyond about 35 years);

•    if you smoke. When using a combined hormonal contraceptive like Millinette you are advised to stop smoking. If you are unable to stop smoking and are older than 35 your doctor may advise you to use a different type of contraceptive;

•    if you are overweight;

•    if you have high blood pressure;

•    if a member of your immediate family has had a heart attack or stroke at a young age (less than about 50). In this case you could also have a higher risk of having a heart attack or stroke;

•    if you, or someone in your immediate family, have a high level of fat in the blood (cholesterol or triglycerides);

•    if you get migraines, especially migraines with aura;

•    if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial fibrillation);

•    if you have diabetes.

If you have more than one of these conditions or if any of them are particularly severe the risk of developing a blood clot may be increased even more.

If any of the above conditions change while you are using Millinette, for example you start smoking, a close family member experiences a thrombosis for no known reason or you gain a lot of weight, tell your doctor.

The pill and cancer

Some studies have found that you may have an increased risk of cervical cancer if you use the pill in the long term. This increased risk may not be caused by the pill, because it could be due to the effects of sexual behaviour and other circumstances. Every woman is at risk of breast cancer whether or not she takes the pill. Breast cancer is rare in women under 40. Breast cancer has been found slightly more often in women who take the pill than in women of the same age who don't take the pill. If you stop taking the pill, this reduces your risk, so that 10 years after stopping the pill the risk of finding breast cancer is the same as for women who have never taken the pill.

Since breast cancer is a rare condition in women below 40 years of age, the increase in number of diagnosed cases of breast cancer in current and previous users of the pill is small compared to the risk of breast cancer during their entire life time.

For example:

•    Of 10,000 women who have never taken the Pill, about 16 will have breast cancer by the time they are 35 years old.

•    Of 10,000 women who take the Pill for 5 years in their early twenties, about 17-18 will have breast cancer by the time they are 35 years old.

•    Of 10,000 women who have never taken the Pill, about 100 will have breast cancer by the time they are 45 years old.

•    Of 10,000 women who take the Pill for 5 years in their early thirties, about 110 will have breast cancer by the time they are 45 years old.

Your risk of breast cancer is higher if:

•    you have a close relative (mother, sister or grandmother) who has had breast cancer

•    you are seriously overweight.

See a doctor as soon as possible if you notice any changes in your breasts, such as dimpling of the skin, changes in the nipple or any lumps you can see or feel.

Rarely, using the pill has led to liver diseases such as jaundice and benign liver tumours.

Very rarely, the pill has been associated with some forms of malignant liver tumours (cancer) in long-term users.

Liver tumours may lead to life-threatening intra-abdominal haemorrhage (bleeding in the abdomen). So, if you have pain in your upper abdomen that does not get better, tell your doctor. Also, if your skin becomes yellow (jaundiced), you must tell your doctor.

Other medicines and Millinette

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines may stop Millinette from working properly.

If you are taking any other medicine while you are taking Millinette, be sure to tell your doctor (or dentist, if they have prescribed antibiotics). Your doctor (or dentist) can tell you whether you should use extra contraceptive precautions and for how long.

Medicines which can sometimes stop Millinette from working properly are:

•    antibiotics (such as ampicillin, tetracycline and rifampicin);

•    medicines used to treat epilepsy or other illnesses of nervous system, such as primidone, carbamazepine, oxcarbazepine, topiramate, hydantoins or barbiturates (such as phenobarbitone);

•    ritonavir (a medicine used to treat HIV infections);

•    griseofulvin (a medicine used to treat fungal infections);

•    the herbal remedy commonly known as St John's Wort (hypericum perforatum).

You may have to use another method of contraception as well, such as the condom, while you are taking these medicines - and for a further seven days afterwards. Your doctor may advise you to use these extra precautions for even longer.

If you are taking antibiotics, always ask your doctor's advice about extra precautions.

Always mention you are on the combined pill if you are prescribed any medicines.

The herbal remedy St John's Wort (Hypericum perforatum) may prevent oral contraceptives from working properly and should not be taken at the same time as this medicine. If you are already taking a St John's Wort preparation, stop taking St John's Wort and tell your doctor at your next visit.

Millinette may influence the effect of other medicines, such as cyclosporine, lamotrigine, therefore in such case you should consult your doctor.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

If you think you might be pregnant, stop taking Millinette and talk to your doctor immediately. Until you have spoken to your doctor, use another method of contraception such as a condom or a cap plus spermicide. Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding

Ask your doctor or pharmacist for advice before taking Millinette. Millinette should not be taken during breast-feeding.

Driving and using machines

Millinette has no or only minor influence on the ability to drive and use machines. Millinette contains lactose and sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Before you have any blood tests

Tell your doctor or the laboratory staff that you are taking the pill, because oral contraceptives can affect the results of some tests.

3. HOW TO TAKE MILLINETTE

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

This pack is designed to help you remember to take your pills.

Starting the first pack

Take the first pill on the first day of your period. This is day one of your cycle - the day when bleeding starts.

If you start on day 2-5 of your period, you should use another method of contraception as well, such as the condom, for the first seven pill-taking days, but this is only for the first pack.

You can take your pill at any time, but you should take it about the same time each day. You may find it easiest to take it either last thing at night or first thing in the morning. Take a pill every day in the order shown until you finish all 21 pills in the pack. Once you have taken all 21 pills, stop for seven days. You will probably bleed during some of these seven days.

You do not need to use any other form of contraception during the seven-day break provided you have taken the 21 pills properly and you start the next pack on time.

The next pack

After seven pill-free days, start your next pack. Do this whether or not you are still bleeding. You will always start a new pack on the same day of the week.

Changing to Millinette from another combined hormonal contraceptive

You should start with Millinette on the day after you take the last pill of your present strip (or the day after the last active pill, if your present pill strip also contains dummy pills), but no later than on the day after the usual tablet-free or dummy pill interval with your previous pill.

Changing to Millinette from progestogenonly preparations (progestogen-only pills, injection, implant)

You may change from progestogen-only pills (POPs) on any day. Stop taking the POP and start taking Millinette the next day at the same time point. When changing from injections, Millinette should be started when the next injection is due to be given. When changing from an implant, Millinette should be started on the day the implant is removed. In all these cases you should also use a barrier method for the first 7 days of taking the pills.

Starting after childbirth or miscarriage or abortion

After a birth, abortion or miscarriage, your doctor should advise you about taking the pill.

You can start using Millinette immediately after a miscarriage or abortion which occurs during the first three months of pregnancy. In this case it is not necessary to take further contraceptive measures.

If you have had a delivery or abortion which occurs during the second three months of pregnancy, you can start taking Millinette 21-28 days after giving birth or having an abortion. If you are breast-feeding, the combined pill is not recommended because it can reduce your flow of milk. Alternative contraception (such as the condom) must be used for the first 7 days of pill-taking. If you have had unprotected sex you should not start Millinette until your period starts or you are sure you are not pregnant. If you have any questions about starting Millinette after childbirth or abortion, ask your doctor or pharmacist.

If you take more Millinette than you should

If you take more Millinette than you should, it is not likely that it will do you any harm, but you may feel sick, actually be sick or have some vaginal bleeding. If you have any of these symptoms, you should talk to your doctor who can tell you what, if anything, you need to do.

If you forget to take Millinette

If you forget to take a pill please follow these instructions.

If one pill is 12 hours late or less

Your contraceptive protection should not be affected if you take the late pill at once, and keep taking your next pills at the usual time. This may mean taking two pills in one day.

If you are more than 12 hours late in taking a pill, or have missed more than one pill

If you are more than 12 hours late in taking a pill, or you have missed more than one pill, your contraceptive protection may be lower so you must use extra protection. The more pills you have missed, the more risk there is that your contraceptive protection is reduced. In this case follow the instructions for daily practice:

What to do if you miss the pill during the first week?

You must take the last missed tablet as soon as you remember, even if this means that you have to take 2 tablets at the same time. Thereafter, you should continue taking the tablets at the usual time of the day. You must also use a barrier method of contraception, e.g. a condom, for the next 7 days. If intercourse has taken place during the preceding 7 days the possibility of pregnancy must be considered. The more missed tablets and the closer to the tablet free interval this happens, the greater the risk of pregnancy.

What to do if you miss the pill during the second week?

You must take the last missed tablet as soon as you remember even if this means that you have to take 2 tablets at the same time. Thereafter, you should continue taking the tablets at the usual time of the day. Provided that the tablets have been taken in a correct manner during the 7 days preceding the missed tablet, it is not necessary to take further contraceptive measures. However, if this is not the case, or if more than 1 tablet has been missed, you should use another contraceptive method for 7 days.

What to do if you miss the pill during the third week?

The risk of contraceptive failure is higher because of the approaching tablet-free interval. Reduced contraceptive protection may, however, be prevented by following one of the following two alternatives. It is not necessary to take further contraceptive precautions, provided that all tablets have been taken correctly during the 7 days preceding the first missed tablet.

However, if you have not taken Millinette correctly during the 7 days preceding the first missed tablet, you should follow the first of the two alternatives and additionally use a barrier method (such as a condom) for the next 7 days.

1.    Take the last missed tablet as soon as you remember, even if it means that you have to take 2 tablets at the same time. You should continue taking the tablets at the usual time of the day. Start your next pack immediately after taking the last tablet in the current pack, i.e. without a tablet-free interval between the packs. Withdrawal bleeding is unlikely until the end of the second pack, but there may be some spotting, or breakthrough bleeding, on the days you are taking tablets.

2.    Stop taking tablets from the current pack. You should then have 7 pill-free days, including those when you forgot to take you tablets, before starting your next pack.

If you have missed tablets and then do not get a withdrawal bleeding in the first normal tablet-free interval, the possibility of pregnancy must be considered.

If you have missed taking one (or more) pills, and have had unprotected sexual intercourse; you may be pregnant. Ask your doctor or pharmacist about emergency contraception.

If you stop taking Millinette

If you stop taking Millinette, you can become pregnant. You should discuss other methods of contraception with your doctor to avoid pregnancy.

What to do if you have a stomach upset?

If you have been sick or had diarrhoea within 3-4 hours after taking the pill, the active substances in the pill may not be fully absorbed into your body. In this case the advice concerning missed pills, described above should be followed. In case of vomiting or diarrhoea, use extra contraceptive precautions, such as a condom, for any intercourse during the stomach upset and for the next seven days.

What to do if you want to delay or to shift your period?

If you want to delay or to shift your period, you should contact your doctor for advice.

If you want to delay your period

You should continue the next pack of Millinette after taking the last tablet in the current pack, without a pill-free interval. You can take as many pills from this next pack as you want, until the end of the second blister pack. When you use the second pack, you may have breakthrough bleeding or spotting. Regular intake of Millinette is resumed after the usual 7 days tablet-free interval.

If you want to shift your period to another day of the week

If you take Millinette correctly, you will always have your monthly period on the same day of the month. If you want to shift your period to another day of the week, rather than the one you are used to with the present pill intake, you may shorten (but never lengthen) the forthcoming pill-free interval by as many days as you like. For example, if your monthly period usually starts on Friday and you want it to start on Tuesday (i.e. three days earlier), you should start the next pack of Millinette three days earlier. The shorter the pill-free interval, the greater the possibility that you will not have a withdrawal bleeding, and that you may have breakthrough bleeding or spotting during the second pack.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you get any side effect, particularly if severe and persistent, or have any change to your health that you think may be due to Millinette, please talk to your doctor.

An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or blood clots in your arteries (arterial thromboembolism (ATE)) is present for all women taking combined hormonal contraceptives. For more detailed information on the different risks from taking combined hormonal contraceptives please see section 2 "What you need to know before you use Millinette”.

The following serious adverse event have been reported in women using combined hormonal contraceptives, see section 2 under "Blood clots” and "The pill and cancer”.

•    Cervical cancer (cancer of the neck of the womb).

Reasons for stopping Millinette immediately

If you experience any of the following conditions whilst taking Millinette, take no further tablets and tell your doctor straight away. In the meantime use another non-hormonal method of contraception such as a condom.

•    Your skin becomes yellow (jaundice);

•    A large increase in your blood pressure;

•    The levels of lipids (fats) in your blood change;

•    Pregnancy;

•    Definite worsening of conditions which had got worse during a previous pregnancy or while taking the pill in this past;

•    Severe abdominal pain.

The following side effects have been reported in women using the pill, which can occur in the first few months after starting Millinette, but they usually stop once your body has adjusted to the pill.

The most commonly reported undesirable effects (more than 1 in 10 women) are: irregular bleeding; nausea; weight gain; tender breast; headache.

Common (equal or more than 1 in 100 women, but less than 10 in 100):

Mood changes, including depression and irritability; acne; none, reduced or painful bleeding; breast enlargement and secretion; changes in vaginal secretions; abdominal pain; fluid retention; changes in sexual desire (increased or decreased); nervousness; eye irritation; dizziness; visual disturbances; migraine; increase or decrease in body weight.

Uncommon (equal or more than 1 in 1,000 women, but less than 1 in 100) and rare (equal or more than 1 in 10,000 women, but less than 1 in 1,000):

Allergic reactions; vomiting; brown patches on your face and body (chloasma or melasma); loss of hair; excessive hair growth; rash; rash with tender red lumps on the leg and arms (erythema nodosum); high blood pressure; breast cancer; cervical cancer; enhanced levels of blood fat; decrease in blood folate level; impaired hearing (otosclerosis); abdominal cramps or bloating; abnormal vaginal smears; inflammation of the pancreas; liver tumours; chorea (a movement disease); systemic lupus erythematosus (SLE, a disease of the connective tissue); changes in appetite (increase or decrease); irritation of the eye due to contact lenses.

•    Harmful blood clots in a vein or artery for example:

-    in a leg or foot (i.e. DVT),

-    in a lung (i.e. PE),

-    heart attack,

-    stroke,

-    mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack (TIA),

-    blood clots in the liver, stomach/intestine, kidneys or eye.

The chance of having a blood clot may be higher if you have any other conditions that increase this risk (See section 2 for more information on the conditions that increase the risk for blood clots and the symptoms of a blood clot).

Very rare (less than 1 in 10,000 women):

Worsening of systemic lupus erythematosus (SLE, a disease of the connective tissue); worsening of an inherited disease called porphyria; worsening of chorea (a movement disease); urticaria; angioedema; inflammation of the optic nerve (may lead to partial or complete loss of vision); blood clot in the blood-vessels of the eye; aggravation of varicose veins; inflammation of the walls of the bowel (ischemic colitis); gallbladder disease (including gallstones); fever; rash of the face, arms and legs (erythema multiforme); a blood disorder called haemolytic uraemic syndrome (a disorder where blood clots cause the kidneys to fail).

Unknown frequency: Liver disorders.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme : www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE MILLINETTE

Keep this medicine out of the sight and reach of children.

Store below 25°C. Store in the original package in order to protect from light and moisture.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Millinette contains

The active substances are: 30 micrograms ethinylestradiol and 75 micrograms gestodene in one coated tablet.

The other ingredients are:

Tablet core: Sodium calcium edetate, Magnesium stearate, Silica colloidal anhydrous, Povidone K-30, Maize starch, Lactose monohydrate.

Tablet coat: Quinoline yellow (E104), Povidone K-90, Titanium dioxide (E171), Macrogol 6000, Talc, Calcium carbonate (E170), Sucrose.

What Millinette looks like and contents of the pack

Yellow, round, biconvex sugar-coated tablets, both sides are without imprinting. Packaging:

Blister: PVC/PVDC/aluminium.

Blister: PVC/PVDC/aluminium in PETP/aluminium/PE bag.

Pack sizes: 1 x 21 tablets; 3 x 21 tablets, 6 x 21 tablets, 13 x 21 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Gedeon Richter Plc.,

19-21 Gyomroi ut, 1103 Budapest, Hungary

Distributed by:

Consilient Health (UK) Ltd.,

No.1 Church Road, Richmond Upon Thames, Surrey. TW9 2QE.

This leaflet was last revised in June 2016