Package leaflet: Information for the user

Maexeni 150/30 microgram film-coated tablets

levonorgestrel / ethinylestradiol

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, pharmacist or family planning nurse.

•    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, pharmacist or family planning nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Maexeni is and what it is used for

2.    What you need to know before you take Maexeni

3.    How to take Maexeni

4.    Possible side effects

5.    How to store Maexeni

6.    Contents of the pack and other information

1.    What Maexeni is and what it is used for

Maexeni is a combined oral contraceptive pill (‘the Pill’).

Maexeni is a 21-day Pill - you take one tablet each day for 21 days, followed by 7 days when you take no tablets.

Combined oral contraceptives contain two types of female hormones, an estrogen, ethinylestradiol and a progestogen, levonorgestrel. When used as instructed it is very unlikely that you will become pregnant.

Take Maexeni as directed in order to prevent pregnancy.

2.    What you need to know before you take Maexeni

It is important that you understand the benefits and risks of taking the Pill before you start taking it, or when deciding whether to carry on taking it. Although the Pill is suitable for most healthy women it is not suitable for everyone. Tell your doctor if you have any of the illnesses or risk factors mentioned in this leaflet.

Before you start taking the Pill

Your doctor will ask about you and your family’s medical problems, check your blood pressure and exclude the likelihood of being pregnant. You may also need other checks, such as a breast examination, but only if these examinations are necessary for you, or if you have any special concerns.

Maexeni will not protect you against sexually transmitted infections, such as Chlamydia or HIV. Only condoms can help to do this.

Do not take Maexeni:

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

•    if you have (or have ever had) a blood clot (thrombosis) in a blood vessel of the leg, lung (embolus) or other organs

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

•    if you    have (or    have    ever    had)    a disease that can be a predictor of a heart attack    (for    example,

angina pectoris, which causes severe pain in the chest) or of a stroke (for example, a transient slight stroke with no residual effects)

•    if you have a disease that may increase the risk of a thrombosis in the arteries, such as: o Diabetes mellitus with damaged blood vessels

o Very high blood pressure

o A very high level of fat in the blood (cholesterol or triglycerides)

•    if you have a disturbance of blood clotting (for example, protein C deficiency)

•    if you have (or have ever had) a certain form of migraine (with so-called focal neurological symptoms)

•    if you    have (or    have    ever    had)    an inflammation of the pancreas (pancreatitis)

•    if you    have (or    have    ever    had)    a liver disease and your liver function is still not    normal

•    if you have (or have ever had) a tumour in the liver

•    if you have (or have ever had) or if you are suspected to having breast cancer or cancer of the genital organs

•    if you have any unexplained bleeding from the vagina

•    if you have absence of menstrual period and the cause is unknown.

Warnings and precautions

In some situations you need to take special care while using Maexeni or any other combined hormonal contraceptive, and it may be necessary that you are regularly checked by your doctor. If any of the following conditions applies to you, you must inform your doctor before starting to use Maexeni. Also if any of the following conditions develops or worsens during the use of Maexeni you must consult your doctor.

•    If a close relative has or has had breast cancer

•    If you have a disease of the liver or the gallbladder

•    If you have diabetes

•    If you have depression

•    If you have Crohn’s disease or ulcerative colitis (inflammatory bowel disease)

•    If you have HUS (haemolytic uraemic syndrome; a blood disease that causes kidney damage)

•    If you have epilepsy (see “Other medicines and Maexeni”)

•    If you have SLE (systemic lupus erythematosus; a disease of the immune system)

•    If you have a disease that first appeared during pregnancy or earlier use of sex hormones (for example, hearing loss, porphyria (a disease of the blood), gestational herpes (skin rash with vesicles during pregnancy), Sydenham’s chorea (a disease of the nerves in which sudden movements of the body occur)

•    If you have or have ever had chloasma (golden brown pigment patches, so called “pregnancy patches”, especially on the face). If this is the case, avoid direct exposure to sunlight or ultraviolet light

•    If you have hereditary angioedema, products containing estrogens may induce or worsen symptoms of angioedema. Contact your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue and/or pharynx and/or difficulty swallowing or hives together with difficulty breathing

•    If a pre-existing high blood pressure condition worsens

•    If a pre-existing high level of fat in your blood worsens.

Maexeni and thrombosis

Venous thrombosis

The use of any combination pill, including Maexeni, increases a woman’s risk of developing a venous thrombosis (formation of a blood clot in vessels) compared with a woman who does not take any (contraceptive) pill.

The risk of venous thrombosis in users of combined pills increases:

•    with age

•    if you are overweight

•    if one of your close relatives has had a blood clot (thrombosis) in the leg, lung, or other organ at a young age

•    if you must have an operation (surgery), any prolonged period of immobilization, or if you have had a serious accident. It is important to tell your doctor in advance that you are using Maexeni as you may have to stop using it. Your doctor will tell you when to start again. This is usually about two weeks after you are back on your feet.

Arterial thrombosis

The use of combination pills has been connected with an increase of the risk of arterial thrombosis (obstruction of an artery), for example, in the blood vessels of the heart (heart attack) or the brain (stroke).

The risk of arterial thrombosis in users of combined pills increases:

•    with age

•    if you smoke; you are strongly advised to stop smoking when you use Maexeni, especially if you are older than 35 years

•    if you have an increased fat content in your blood (cholesterol or triglycerides)

•    if you have high blood pressure

•    if you have migraine

•    if you have a problem with your heart (valve disorder, a disturbance of the heart rhythm).

Stop taking Maexeni and tell your doctor immediately if you notice possible signs of thrombosis, such as:

•    any unusual, severe or long-lasting headache or worsening of migraine

•    partial or complete blindness or double vision

•    sudden pain and/or swelling in one of your legs

•    sudden breathlessness

•    sudden cough without an obvious cause

•    sudden severe pain in the chest which may reach the left arm

•    difficulty in speaking or inability to speak

•    weakness, strange feeling, or numbness in any part of the body

•    a feeling of dizziness or spinning

•    collapse with or without focal seizure

•    motor (movement) disturbances

•    sudden severe abdominal pain.

Maexeni and cancer

Breast cancer has been observed slightly more often in women using combined pills, but it is not known whether this is caused by the treatment. For example it may be that more tumours are detected in women using combined pills because they are examined by their doctor more often. The occurrence of breast tumours becomes gradually less after stopping the combination hormonal contraceptives. It is important to regularly checkyour breasts and contact your doctor if you feel any lump.

In rare cases, benign liver tumours, and in even fewer cases malignant liver tumours have been reported in pill users. Contact your doctor if you have unusual severe abdominal pain.

Bleeding between periods

During the first few months that you are taking Maexeni, you may have unexpected bleeding (bleeding outside the gap week). If this bleeding lasts longer than a few months, or if it begins after some months, talk to your doctor who will investigate the cause.

What to do if no bleeding occurs in the gap week

If you have taken all the tablets correctly, have not vomited or had severe diarrhoea, and you have not taken any other medicines, it is highly unlikely that you are pregnant.

If your period (withdrawal bleeding) does not happen twice in a row, you may be pregnant. Contact your doctor immediately. Do not start the next strip until you are sure that you are not pregnant.

Other medicines and Maexeni

Tell your doctor if you are using, have recently used or might use any other medicines, including herbal products. Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that you are using Maexeni. They can tell you if you need to take additional contraceptive precautions (for example condoms) and if so, for how long.

Some medicines can make Maexeni less effective in preventing pregnancy, or can cause unexpected bleeding. They include medicines used for the treatment of:

•    epilepsy (for example, primidone, phenytoin, barbiturates, carbamazepine, oxcarbamazepine, topiramate, felbamate)

•    tuberculosis (for example, rifampicin),

•    HIV infections (ritonavir, nevirapine)

•    other infectious diseases (griseofulvin, penicillin, tetracycline),

•    medicines that increase the motility of your intestines (metoclopramide),

•    the herbal remedy St. John’s wort.

Maexeni may influence the effect of other medicines, for example:

•    medicines containing cyclosporine,

•    or the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures).

Effect on laboratory tests

If you need a blood test, tell your doctor or the laboratory staff that you are taking the pill, because oral contraceptives can affect the results of some tests.

Pregnancy and breast-feeding

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

If you become pregnant while taking Maexeni you must stop using the pill immediately and contact your doctor.

Use of Maexeni is generally not advisable when a woman is breast-feeding. If you want to take the pill while you are breast-feeding contact your doctor.

Driving and using machines

Maexeni does not have any known effect on your ability to drive or use machines.

Maexeni contains lactose

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

3. How to take Maexeni

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

Take Maexeni every day for 21 days

Maexeni comes in strips of 21 tablets, each marked with a day of the week.

•    Take your tablet at the same time every day.

•    Start by taking a tablet marked with the correct day of the week.

•    Follow the direction of the arrows on the strip. Take one tablet each day, until you have finished all 21 tablets.

•    Swallow each tablet whole, with water if necessary. Do not chew the tablet.

Then have seven tablet-free days

After you have taken all 21 tablets in the strip, you have seven days when you take no tablets (the so called “gap week”). So if you take the last tablet of one pack on a Friday, you will take the first tablet of your next pack on the Saturday of the following week.

Within a few days of taking the last tablet from the strip, you should have a withdrawal bleed like a period. This bleed may not have finished when it is time to start your next strip of tablets. You do not need to use extra contraception during these seven tablet-free days - as long as you have taken your tablets correctly and start the next strip of tablets on time.

Then start your next strip

Start taking tablets from your next strip of Maexeni after the seven tablet-free days - even if you are still bleeding. Always start the new strip on time.

As long as you take Maexeni correctly, you will always start each new strip on the same day of the week.

Starting Maexeni

As a new user or starting the Pill again after a break

•    If you have not used a contraceptive with hormones in the previous month

Start taking Maexeni on the first day of the cycle (that is the first day of your menstruation). If you start Maexeni on the first day of your menstruation you are immediately protected against pregnancy. You may also begin on day 2-5 of the cycle, but then you must use extra protective measures (for example, a condom) for the first 7 days.

•    Changing from another combined hormonal contraceptive, or combined contraceptive, vaginal ring or patch

You can start taking Maexeni preferably on the day after the last active tablet (the last tablet containing the active substance) of your previous pill, but at the latest on the day after the tablet-free days of your previous pill finish (or after the last inactive tablet of your previous pill). When changing from a combined contraceptive vaginal ring or patch, follow the advice of your doctor.

•    Changing from a progestogen-only-method (progestogen-only pill “POP” or “mini pill”, injection, implant or a progestogen-releasing intrauterine device - IUD)

You may switch any day from the progestogen-only pill (from an implant or the IUD on the day of its removal, from an injectable when the next injection would be due) but in all of these cases you must use extra protective measures (for example, a condom) for the first 7 days of tablet-taking.

•    After a miscarriage

Follow the advice of your doctor.

•    After having a baby

After having a baby, you can start Maexeni between 21 and 28 days later. If you start later than day 28, you must use a so-called barrier method (for example, a condom) during the first seven days of Maexeni use.

If, after having a baby, you have had intercourse before starting Maexeni (again), you must first be sure that you are not pregnant or you must wait until the next menstrual bleed.

Your doctor will advise you in case you are not sure when to start.

•    If you are breast-feeding and want to start Maexeni after having a baby Read the section on “Pregnancy and breast-feeding”.

If you take more Maexeni than you should

There are no reports of serious harmful results of taking too many Maexeni tablets. If you take several tablets at once, you may have symptoms of nausea or vomiting. Young girls may have bleeding from the vagina. If you have taken too many Maexeni tablets, or you discover that a child has taken some, ask your doctor or pharmacist for advice.

If you forget to take Maexeni

If you are less than 12 hours late in taking your tablet, the protection from pregnancy is not reduced. Take the tablet as soon as you remember, and then continue to take the following tablets at the usual time.

If you are more than 12 hours late taking a tablet, the protection from pregnancy may be reduced. The greater the number of tablets that you have forgotten, the greater is the risk that the protection from pregnancy is reduced.

The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the beginning or the end of the strip. Therefore, follow the instructions below (also see the diagram below):

•    If you forgot more than one tablet in this strip

Contact your doctor.

•    If you forgot one tablet in week 1

Take the forgotten tablet as soon as you remember, even if that means taking two tablets at the same time. Take the following tablets at the usual time and use extra precautions for the next 7 days, for example, a condom. If you have had intercourse in the week before the oversight or you have forgotten to start a new strip after the tablet-free period, you must realize that there is a risk of pregnancy. In that case, contact your doctor.

•    If you forgot one tablet in week 2

Take the forgotten tablet as soon as you remember, even if that means taking two tablets at the same time. Take the following tablets at the usual time. If you have taken the tablets correctly for the last seven days, your protection from pregnancy is not reduced. If you did not use the tablets correctly, use extra precaution for the next 7 days.

•    If you forgot one tablet in week 3 You can choose between two options:

1.    Take the forgotten tablet as soon as you remember, even if that means taking two tablets at the same time. Take the following tablets at the usual time. Instead of the tablet-free period go straight on to the next strip.

Most likely, you will have a period (withdrawal bleed) at the end of the second strip but you may also have spotting or breakthrough bleeding during the second strip.

2.    You can also stop taking tablets from the strip and go directly to the tablet-free period of 7 days (record the day on which you forgot your tablet). If you want to start a new strip on your fixed start day, make the tablet-free period less than 7 days.

If you follow either of these two recommendations, you will remain protected against pregnancy. If you have forgotten any of the tablets in a strip, and you do not have bleeding in the first tablet-free period, this may mean that you are pregnant. You must contact your doctor before you go on to the next strip.

A lost tablet

If you lose a tablet,

Either take the last tablet of the strip in place of the lost tablet. Then take all the other tablets on their proper days. Your cycle will be one day shorter than normal, but your contraceptive protection will not be affected. After your seven tablet-free days you will have a new starting day, one day earlier than before.

Or if you do not want to change the starting day of your cycle, take a tablet from a spare strip if you have one. Then take all the other tablets from your current strip as usual. You can then keep the opened spare strip in case you lose any more tablets.

If you are sick or have diarrhoea

If you vomit within 3-4 hours of taking a tablet or you have severe diarrhoea, there is a risk that the active substances in the pill are not fully adsorbed into your body. The situation is similar what happens to if you forget a tablet. After vomiting or having diarrhoea, you must take another tablet from a reserve strip as soon as possible. If possible take it within 12 hours of when you normally take your pill. If this is not possible or 12 hours have passed, follow the advice given under “If you forget to take Maexeni”.

If you have any further questions on the use of this medicine ask your doctor, pharmacist or family planning nurses.

4. Possible side effects

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

Tell your doctor, pharmacist or family planning nurse if you are worried about any side effects which you think may be due to Maexeni.

Possible side effects include:

Very common (may affect more than 1 in 10 users):

•    headache

Common (may affect up to 1 in 10 users):

•    mood swings,

•    depression,

•    abdominal pain (stomach ache),

•    breast pain,

•    breast tenderness,

•    weight gain,

•    nausea,

•    rash

Uncommon (may affect up to 1 in 100 users):

•    vomiting,

•    diarrhoea,

•    fluid retention,

•    migraine,

•    decreased libido (interest in sex),

•    breast enlargement,

•    itchy red rash of the skin (urticaria)

Rare (may affect up to 1 in 1,000 users):

•    contact lens intolerance,

•    allergic reactions,

•    weight loss,

•    increased libido (interest in sex),

•    breast discharge,

•    vaginal discharge,

•    allergic reactions which can sometimes be severe with swelling of the skin and/or mucous membranes (erythema nodosum and eruthema multiforme)

Other serious side effects you should be aware off are also mentioned in section 2 of this leaflet (“Do not take Maexeni” and “Warnings and precautions”). These include:

-    Blood clotting disorders

-    High blood pressure

-    Liver tumours

-    Swelling of the skin (angioedema)

-    Occurrence or deterioration of conditions such as: Crohn’s disease, epilepsy, migraine etc. Reporting of side effects

If you get any side effects, talkto your doctor, pharmacist or family planning nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme, website: 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 Maexeni

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

Do not use this medicine after the expiry date which is printed on the carton and blister. The expiry date refers to the last day of that month.

Store below 25°C.

Do not throw away any medicines via waste water or household waste. Askyour 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 Maexeni contains

•    The active substances are levonorgestrel and ethinyl estradiol. One (1) film-coated tablet contains 150 micrograms of levonorgestrel and 30 micrograms of ethinyl estradiol.

•    The other ingredients are:

Tablet core: lactose anhydrous, microcrystalline cellulose, povidone K30, croscarmellose sodium, magnesium stearate (E470b).

Film-coating: hypromellose (HPMC, E464), titanium dioxide (E171), macrogol 400 (PEG 400, E1521), iron oxide yellow (E172).

What Maexeni looks like and contents of the pack

Maexeni film-coated tablets are yellow, round biconvex, debossed with ‘LE4’ on one side and plain on other side. Maexeni film-coated tablets are packed in blister strips. Each blister contains 21 tablets.

Maexeni is available in packs of 21 (1x21), 63 (3x21), 126 (6x21) and 273 (13x21) tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Lupin (Europe) Limited

Victoria Court

Bexton Road

Knutsford

Cheshire

WA160PF

United Kingdom

This leaflet was revised in 09/2013

Code No. MP/DRUGS/28/6/2010

ID#: 233609