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Package leaflet: Information for the user

Cleosensa 0.03mg/3mg Film-coated Tablets

Ethinylestradiol/Drospirenone

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 Cleosensa is and what it is used for

2.    What you need to know before you take Cleosensa

3.    How to take Cleosensa

4.    Possible side effects

5.    How to store Cleosensa

6.    Contents of the pack and other information

1. What Cleosensa is and what it is used for

Cleosensa is a contraceptive pill and is used to prevent pregnancy.

Each tablet contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol.

Contraceptive pills that contain two hormones are called "combination” pills.

2. What you need to know before you take Cleosensa

Do not take Cleosensa:

•    if you have (or have ever had) a blood clot in a blood vessel of the leg (thrombosis), of the lung (pulmonary embolism) 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 an indicator of a heart attack in the future (for example, angina pectoris which causes severe pain in the chest) or of a stroke (for example, a passing slight stroke with no residual effects)

•    if you have a disease that may increase the risk of a blood clot in the arteries.

This applies to the following diseases:

-    diabetes with damaged blood vessels

-    very high blood pressure

-    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) a liver disease and your liver function is still not normal

•    if your kidneys are not working well (renal failure)

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

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

•    if you have any unexplained bleeding from the vagina

•    if you are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of this medicine (listed in section 6). This may cause itching, rash or swelling.

Warnings and precautions

In some situations you need to take special care while using Cleosensa or any other combination pill, and your doctor may need to examine you regularly. If any of the following conditions applies to you, tell your doctor before starting to use Cleosensa. Also, if any of the following applies or if any of the conditions develops or worsens while you are using Cleosensa consult your doctor:

•    if a close relative has or has ever 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 inflammatory bowel disease (ulcerative colitis)

•    if you have a blood disease called HUS (haemolytic uraemic syndrome) which causes kidney damage

•    if you have a blood disease called sickle cell anaemia

•    if you have epilepsy (see also "Other medicines and Cleosensa”)

•    if you have a disease of the immune system called SLE (systemic lupus erythematosus)

•    if you have a disease that first appeared during pregnancy or earlier use of sex hormones (for example, hearing loss, a blood disease called porphyria, skin rash with blisters during pregnancy (gestational herpes), a nerve disease causing sudden movements of the body (Sydenham's chorea))

•    if you have or have ever had chloasma (a discolouration of the skin especially of the face or neck known as "pregnancy patches”). If so, avoid direct sunlight or ultraviolet light

•    if you have hereditary angioedema, products containing oestrogens may cause or worsen the symptoms. You should see your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue and/or throat and/or difficulty swallowing or hives together with difficulty breathing.

Cleosensa and venous and arterial blood clots

The use of any combination pill, including Cleosensa, increases a woman's risk of developing a venous blood clot (venous thrombosis) compared with women who do not take any contraceptive pill.

The risk of venous blood clots in users of combination pills increases:

•    with increasing age

•    if you are overweight

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

•    if you have to have surgery, if you have had a serious accident or if you are immobilised for a long time. It is important to tell your doctor that you are using Cleosensa as you may have to stop taking it. Your doctor will tell you when to start again. This is usually about two weeks after you are back on your feet.

Your chances of having a blood clot are increased by taking the Pill.

•    Of 100,000 women who are not on the Pill and not pregnant, about 5-10 may have a blood clot in a year.

•    Of 100,000 women taking a Pill like Cleosensa, between 30-40 may have a blood clot in a year, the exact number is unknown.

•    Of 100,000 women who are pregnant, around 60 may have a blood clot in a year.

A blood clot in the veins may travel to the lungs and may block blood vessels (called a lung embolus). Formation of blood clots in the veins may be fatal in 1-2 % of cases.

The level of risk may vary according to the type of pill you take. Discuss with your doctor the available options.

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

The risk of an arterial blood clot in users of combination pills increases:

•    if you smoke. You are strongly advised to stop smoking when you use Cleosensa, especially if you are older than 35 years

•    if the fat content of your blood is increased (cholesterol or triglycerides)

•    if you are overweight

•    if one of your close relatives ever had a heart attack or stroke at a young age

•    if you have high blood pressure

•    if you suffer from migraine

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

Cleosensa and cancer

Breast cancer has been observed slightly more often in women using combination 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 on combination 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 check your breasts and you should 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 unusually severe abdominal pain.

Bleeding between periods

During the first few months that you are taking Cleosensa you may have unexpected bleeding (bleeding outside the gap week). If this bleeding occurs for more than a few months, or if it begins after some months, your doctor must find out what is wrong.

What to do if no bleeding occurs during the gap week

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

If the expected bleeding does not happen twice in succession, 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 Cleosensa

Some medicines can make Cleosensa less effective in preventing pregnancy, or can cause unexpected bleeding. These include:

•    medicines used for the treatment of

-    epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)

-    tuberculosis (e.g. rifampicin)

-    HIV infections (ritonavir, nevirapine) or other infections (antibiotics such as griseofulvin, penicillin, tetracycline)

-    high blood pressure in the blood vessels in the lungs (bosentan)

•    the herbal remedy St John's wort.

Cleosensa may influence the effect of other medicines, e.g.

•    medicines containing ciclosporin

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

Ask your doctor or pharmacist for advice before taking any medicine. Cleosensa with food and drink

Cleosensa may be taken with or without food, if necessary with a small amount of water.

Laboratory tests

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

Pregnancy and breast-feeding Pregnancy

If you are pregnant, do not take Cleosensa. If you become pregnant while taking Cleosensa stop immediately and contact your doctor. If you want to become pregnant, you can stop taking Cleosensa at any time (see also "If you stop taking Cleosensa”).

Breast-feeding

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

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.

Driving and using machines

There is no information suggesting that use of Cleosensa affects driving or use of machines.

Cleosensa contains lactose

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

3. How to take Cleosensa

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

Take one tablet of Cleosensa every day, if necessary with a small amount of water. You may take the tablets with or without food, but you should take the tablets every day around the same time.

The strip contains 21 tablets. Next to each tablet is printed the day of the week that it should be taken. If, for example you start on a Wednesday, take a tablet with "WED” next to it. Follow the direction of the arrow on the strip until all 21 tablets have been taken.

Then take no tablets for 7 days. In the course of these 7 tablet-free days (otherwise called a stop or gap week) bleeding should begin. This so-called "withdrawal bleeding”, usually starts on the 2nd or 3rd day of the gap week.

On the 8th day after the last Cleosensa tablet (that is, after the 7-day gap week), you should start with the following strip, whether your bleeding has stopped or not. This means that you should start every strip on the same day of the week and that the withdrawal bleed should occur on the same days each month.

If you use Cleosensa in this manner, you are also protected against pregnancy during the 7 days when you are not taking a tablet.

When can you start with the first strip?

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

Begin with Cleosensa on the first day of the cycle (that is the first day of your period). If you start Cleosensa on the first day of your period 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 a combination hormonal contraceptive, or combination contraceptive vaginal ring or patch

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

Changing from a progestogen-only-method (progestogen-only pill, injection, implant or a progestogen-releasing IUD)

You may switch any day from the progestogen-only pill (from an implant or an IUD on the day of its removal, from an injectable when the next injection would be due) but in all of these cases 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

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

If, after having a baby, you have had sex before starting Cleosensa (again), be sure that you are not pregnant or wait until your next period.

If you are breast-feeding and want to start Cleosensa (again) after having a baby

Read the section on "Breast-feeding”.

Ask your doctor what to do if you are not sure when to start.

If you take more Cleosensa than you should

There are no reports of serious harmful results of taking too many Cleosensa tablets.

If you take several tablets at once then you may have symptoms of nausea or vomiting. Young girls may have bleeding from the vagina.

If you have taken too many Cleosensa tablets, or you discover that a child has taken some, ask your doctor or pharmacist for advice.

If you forget to take Cleosensa

•    If you are less than 12 hours late taking a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and then take the following tablets again at the usual time.

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

The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the beginning or at the end of the strip. Therefore, you should keep to the following rules (see the diagram below):

More than one tablet forgotten in this strip

Contact your doctor.

One tablet forgotten in week 1

Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue taking the tablets at the usual time and use extra precautions for the next 7 days, for example, a condom. If you have had sex in the week before forgetting the tablet you may be pregnant. In that case, contact your doctor.

One tablet forgotten in week 2

Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue taking the tablets at the usual time. The protection against pregnancy is not reduced, and you do not need to take extra precautions.

One tablet forgotten in week 3

You can choose between two possibilities:

1.    Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue taking the tablets at the usual time. Instead of taking the tablet-free period start the next strip.

Most likely, you will have a period at the end of the second strip but you may have light or menstruation-like bleeding during the second strip.

2.    You can also stop 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 the day you always start, make the tablet-free period less than 7 days.

If you follow one 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 a bleeding during the first tablet-free period, you may be pregnant. Contact your doctor before you start the next strip.

Changing the first day of your period: what you need to know

If you take the tablets according to the instructions, then your period will begin during the tablet-free week. If you have to change this day, reduce the number of tablet-free days (but never increase them - 7 is the maximum!). For example, if your tablet-free days normally begin on a Friday, and you want to change this to a Tuesday (3 days earlier) start a new strip 3 days earlier than usual. If you make the tablet-free interval very short (for example, 3 days or less) you may not have any bleeding during these days. You may then experience light or menstruation-like bleeding.

If you are not sure what to do, consult your doctor.

If you stop taking Cleosensa

You can stop taking Cleosensa whenever you want. If you do not want to become pregnant, ask your doctor for advice about other reliable methods of birth control.

If you want to become pregnant, stop taking Cleosensa and wait for a period before trying to become pregnant. You will be able to calculate the expected delivery date more easily.

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

4. Possible side effects

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

The following is a list of the side effects that have been linked with the use of Cleosensa.

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

•    menstrual disorders, bleeding between periods, breast pain, breast tenderness

•    headache, depressive mood

•    migraine

•    nausea

•    thick, whitish vaginal discharge and vaginal yeast infection.

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

•    breast enlargement, changes in interest in sex

•    high blood pressure, low blood pressure

•    vomiting, diarrhoea

•    acne, skin rash, severe itching, hair loss (alopecia)

•    infection of the vagina

•    fluid retention and body weight changes.

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

•    allergic reactions (hypersensitivity), asthma

•    breast secretion

•    hearing impairment

•    blockage of a blood vessel by a clot formed elsewhere in the body

•    the skin conditions erythema nodosum (characterised by painful reddish skin nodules) or erythema multiforme (characterised by rash with target-shaped reddening or sores).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 Cleosensa

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. 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.

What to do in the case of vomiting or severe diarrhoea

If you vomit within 3-4 hours after taking a tablet or you have severe diarrhoea, there is a risk that the active substances in the pill will not be fully taken up by your body. The situation is almost the same as forgetting a tablet. After vomiting or diarrhoea, 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 that is not possible or 12 hours have passed, you should follow the advice given under "If you forget to take Cleosensa”

Delaying your period: what you need to know

Even though it is not recommended, you can delay your period by going straight to a new strip of Cleosensa instead of the tablet-free period and finishing it. You may experience light or menstruation-like bleeding while using this second strip. After the usual tablet-free period of 7 days, start the next strip.

You might ask your doctor for advice before deciding to delay your menstrual period.

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