ETHINYLESTRADIOL 0.03 MG / DROSPIRENONE 3 MG TABLETS - patient leaflet, side effects, dosage

2. what you need to know before you take ethinylestradiol/drospirenone tablets

Before you start using Ethinylestradi­ol/Drospireno­ne Tablets you should read the information on blood clots in section 2. It is particularly important to read the symptoms of a blood clot – see Section 2 “Blood clots”.

Before you can begin taking Ethinylestradi­ol/Drospireno­ne Tablets, your doctor will ask you some questions about your personal health history and that of your close relatives. The doctor will also measure your blood pressure and, depending upon your personal situation, may also carry out some other tests.

In this leaflet, several situations are described where you should stop using

Ethinylestradi­ol/Drospireno­ne Tablets, or where the reliability of Ethinylestradi­ol/Drospireno­ne Tablets may be decreased. In such situations you should either not have sex or you should take extra non-hormonal contraceptive precautions, e.g. use a condom or another barrier method. Do not use rhythm or temperature methods. These methods can be unreliable because

Ethinylestradi­ol/Drospireno­ne Tablets alter the monthly changes of body temperature and cervical mucus. Ethinylestradi­ol/Drospireno­ne Tablets, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Do not take Ethinylestradi­ol/Drospireno­ne Tablets

You should not use Ethinylestradi­ol/Drospireno­ne Tablets 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 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’);
• 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 inflammation of the pancreas (pancreatitis);
• 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.

Do not use Ethinylestradi­ol/Drospireno­ne Tablets if you have hepatitis C and are taking the medicinal products containing ombitasvir/pa­ritaprevir/ri­tonavir and dasabuvir or glecaprevir / pibrentasvir (see also in section “Other medicines and Ethinylestradi­ol/Drospireno­ne Tablets”).

Additional information on special populations

Use in children

Ethinylestradi­ol/Drospireno­ne Tablets are not intended for use in females whose periods have not yet started.

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”.

Talk to your doctor or pharmacist or nurse before taking Ethinylestradi­ol/Drospireno­ne Tablets.

In some situations you need to take special care while using Ethinylestradi­ol/Drospireno­ne Tablets or any other combination pill, and your doctor may need to examine you regularly.

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

If the condition develops, or gets worse while you are using Ethinylestradi­ol/Drospireno­ne Tablets, you should also tell 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 ulcerative colitis (chronic inflammatory bowel disease);
• if you have haemolytic uraemic syndrome (HUS – a disorder of blood clotting causing failure of the kidneys);
• if you have sickle cell anaemia (an inherited disease of the red blood cells);
• 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);
• if you need an operation, or you are off your feet for a long time (see in section 2 ‘Blood clots’);
• if you have 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 Ethinylestradi­ol/Drospireno­ne Tablets;

• if you have an inflammation in the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have epilepsy (see section “Other medicines and Ethinylestradi­ol/Drospireno­ne Tablets”);
• if you have systemic lupus erythematosus (SLE – a disease affecting your natural defence system);
• 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 disease of the nerves in which sudden movements of the body occur (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 experience symptoms of angioedema such as swollen face, tongue and/or throat and/or difficulty swallowing, or hives potentially with difficulty breathing contact a doctor immediately. Products containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema.

Psychiatric disorders:

Some women using hormonal contraceptives including Ethinylestradiol/Drospirenone Tablets have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Ethinylestradi­ol/Drospireno­ne Tablets increase 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 a harmful blood clot due to Ethinylestradi­ol/Drospireno­ne Tablets 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 Ethinylestradi­ol/Drospireno­ne Tablets 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 Ethinylestradi­ol/Drospireno­ne Tablets 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 drospirenone, such as Ethinylestradi­ol/Drospireno­ne Tablets, 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).

  	Risk of developing a blood clot in a year
  Women who are not using a combined hormonal pill/patch/ring and are not pregnant	About 2 out of 10,000 women
  Women using a combined hormonal contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5–7 out of 10,000 women
  Women using Ethinylestradi­ol/Drospireno­ne Tablets	About 9–12 out of 10,000 women

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

The risk of a blood clot with Ethinylestradi­ol/Drospireno­ne Tablets 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 Ethinylestradi­ol/Drospireno­ne Tablets may need to be stopped several weeks before surgery or while you are less mobile. If you need to stop Ethinylestradi­ol/Drospireno­ne Tablets 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 Ethinylestradi­ol/Drospireno­ne Tablets need to be stopped.

If any of the above conditions change while you are using Ethinylestradi­ol/Drospireno­ne Tablets, 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 Ethinylestradi­ol/Drospireno­ne Tablets is very small but can increase:

• with increasing age (beyond about 35 years);
• if you smoke. When using a combined hormonal contraceptive like Ethinylestradi­ol/Drospireno­ne Tablets 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 Ethinylestradi­ol/Drospireno­ne Tablets, 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.

Ethinylestradi­ol/Drospireno­ne Tablets 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 risk 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 Ethinylestradi­ol/Drospireno­ne Tablets, 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, contact your doctor so that they can find out if anything is wrong.

What to do if no bleeding occurs during the seven pill-free days

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. Only start the next strip if you are sure that you are not pregnant.

Other medicines and Ethinylestradi­ol/Drospireno­ne Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist) that you are taking this medicine. They can tell you if you need to take additional contraceptive precautions (for example condoms) and if so, for how long, or, whether the use of another medicine you need must be changed.

Some medicines

• can have an influence on the blood levels of Ethinylestradi­ol/Drospireno­ne Tablets
• can make it less effective in preventing pregnancy
• can cause unexpected bleeding

These include medicines used for the treatment of:

• epilepsy (e.g. barbiturates, carbamazepine, phenytoin, primidone, oxcarbazepine)
• tuberculosis (e.g. rifampicin)
• HIV and Hepatitis C Virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)),
• fungal infections (griseofulvin, ketoconazole)
• arthritis, arthrosis (etoricoxib)
• high blood pressure in the blood vessels in the lungs (bosentan),
• the herbal remedy St. John’s wort.

Ethinylestradi­ol/Drospireno­ne Tablets 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)
• theophylline (used to treat breathing problems)
• tizanidine (used to treat muscle pain and/or muscle cramps).

Do not use Ethinylestradi­ol/Drospireno­ne Tablets if you have hepatitis C and are taking the medicinal products containing ombitasvir/pa­ritaprevir/ri­tonavir and dasabuvir or glecaprevir / pibrentasvir as this may cause increases in liver function blood test results (increase in ALT liver enzyme). Your doctor will prescribe another type of contraceptive prior to start of the treatment with these medicinal products. Ethinylestradi­ol/Drospireno­ne Tablets can be restarted approximately 2 weeks after completion of this treatment. See section “Do not use Ethinylestradi­ol/Drospireno­ne Tablets”.

Ask your doctor or pharmacist for advice before taking any medicine.

Taking Ethinylestradi­ol/Drospireno­ne Tablets with food and drink

Ethinylestradi­ol/Drospireno­ne Tablets 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 hormonal contraceptives can affect the results of some tests.

Pregnancy breast-feeding and fertility

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.

Pregnancy

If you are pregnant, do not take Ethinylestradi­ol/Drospireno­ne Tablets. If you become pregnant while taking Ethinylestradi­ol/Drospireno­ne Tablets stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Ethinylestradi­ol/Drospireno­ne Tablets at any time (see also “If you want to stop taking Ethinylestradi­ol/Drospireno­ne”).

Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding

Use of Ethinylestradi­ol/Drospireno­ne Tablets is generally not advisable when a woman is breastfeeding.

If you want to take the pill while you are breast-feeding you should contact your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

There is no information suggesting that use of Ethinylestradi­ol/Drospireno­ne Tablets affects driving or use of machines.

Ethinylestradi­ol/Drospireno­ne Tablets contain lactose monohydrate. If your doctor has told you that you have intolerance to sugars, contact the doctor before taking this medicinal product.

Ethinylestradi­ol/Drospireno­ne Tablets also contains E110, sunset yellow FCF and E102, tartrazine which may cause allergic reactions.

3. how to take ethinylestradiol/drospirenone tablets

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

Take one Ethinylestradi­ol/Drospireno­ne tablet 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 Ethinylestradi­ol/Drospireno­ne 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 Ethinylestradi­ol/Drospireno­ne Tablets 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 Ethinylestradi­ol/Drospireno­ne Tablets on the first day of your cycle (that is the first day of your period). If you start Ethinylestradi­ol/Drospireno­ne Tablets 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 combined hormonal contraceptive, or combined contraceptive vaginal ring or patch.

You can start Ethinylestradi­ol/Drospireno­ne Tablets 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 finish (or after the last inactive tablet of your previous pill). When changing from a combined contraceptive vaginal ring or a transdermal patch, follow the advice of your doctor.

• Changing from a progestogen-only-method (progestogen only pill, injection, implant or a progestogen-releasing intrauterine system (IUS))

You may switch any day from the progestogen-only pill (from an implant or an IUS 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 taking Ethinylestradi­ol/Drospireno­ne Tablets.

• After a miscarriage or abortion

Follow the advice of your doctor.

• After having a baby

You can start taking Ethinylestradi­ol/Drospireno­ne Tablets 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 taking Ethinylestradi­ol/Drospireno­ne Tablets.

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

• If you are breast-feeding and want to start Ethinylestradi­ol/Drospireno­ne Tablets 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 Ethinylestradi­ol/Drospireno­ne Tablets than you should

There are no reports of serious harmful results of taking too many Ethinylestradi­ol/Drospireno­ne 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 Ethinylestradi­ol/Drospireno­ne Tablets, or you discover that a child has taken some, ask your doctor or pharmacist for advice.

If you forget to take Ethinylestradi­ol/Drospireno­ne Tablets

• 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 also the diagram below):

• More than one tablet forgotten in this strip

Contact your doctor.

• One tablet is 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 is 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. If you forget more than one tablet use an additional barrier method such as a condom for 7 days.

• One tablet is 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 having seven pill-free days start the next strip as soon as you have taken the last tablet.

Most likely, you will have a period at the end of the second strip – but you may also 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 (record the day on which you forgot your tablet). If you want to start a new strip 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 bleeding in the first tablet-free period, you may be pregnant. Contact your doctor before you start the next strip.

What to do in case of vomiting or severe 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 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 Ethinylestradi­ol/Drospireno­ne Tablets”.

Delaying your period: what you need to know

Although it is not recommended, you can delay your period by skipping the seven pill-free days and going straight to a new strip of Ethinylestradi­ol/Drospireno­ne Tablets and finishing it. You may experience light or menstruation like bleeding while using this second strip. After the usual pill-free period of 7 days start your next strip.

It is advisable to consult your doctor for advice before deciding to delay your menstrual period.

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 seven pill-free days. If you have to change this day, make the pill-free period shorter – (but never longer – 7 days is the maximum!). For example, if you start the seven pill-free days 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 pill-free period very short (for example 3 days or less) you may not have any bleeding during this time. You may then experience light or menstruation-like bleeding.

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

If you want to stop taking Ethinylestradi­ol/Drospireno­ne Tablets

You can stop taking Ethinylestradi­ol/Drospireno­ne Tablets 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 Ethinylestradi­ol/Drospireno­ne Tablets and wait for a menstrual 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, Ethinylestradi­ol/Drospireno­ne Tablets 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 Ethinylestradi­ol/Drospireno­ne Tablets, 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 Ethinylestradi­ol/Drospireno­ne Tablets”.

The following is a list of the side effects that have been linked with the use of Ethinylestradi­ol/Drospireno­ne Tablets:

Serious side effects:

Contact a doctor immediately if you experience any of the following symptoms of angioedema: swollen face, tongue and /or throat and/ or difficulty swallowing or hives potentially with difficulty breathing (see also section ‘Warnings and precautions’).

Signs of breast cancer include:

• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel.

Signs of cancer of the cervix include:

• vaginal discharge that smells and/or contains blood
• unusual vaginal bleeding
• pelvic pain
• painful sex

If you think you may have any of these, see a doctor straight away. You may need to stop taking Ethinylestradi­ol/Drospireno­ne Tablets.

Common side effects (between 1 and 10 in every 100 users may be affected):

• menstrual disorders, bleeding between periods, breast pain, breast tenderness
• headache, depressive mood
• migraine
• nausea
• thick, whitish vaginal discharge and vaginal yeast infection

Uncommon side effects (between 1 and 10 in every 1,000 users may be affected):

• 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 side effects (between 1 and 10 in every 10,000 users may be affected):

• allergic reactions (hypersensitivity), asthma
• breast secretion
• hearing impairment
• the skin conditions erythema nodosum (characterized by painful reddish skin nodules) or erythema multiforme (characterized by rash with target-shaped reddening or sores)
• 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 risk for blood clots and the symptoms of a blood clot).

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

Reporting 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: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store ethinylestradiol/drospirenone tablets

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

This medicinal product 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 to protect the environment.

6. contents of the pack and other information

What Ethinylestradi­ol/Drospireno­ne Tablets contain

• – The active substances are drospirenone and ethinylestradiol.

• – The other ingredients are

What Ethinylestradiol/Drospirenone Tablets look like and contents of the pack

Ethinylestradi­ol/Drospireno­ne Tablets are round, yellow, uncoated biconvex tablets with ‘143’ debossed on one side and other side plain.

They are supplied in blister packs containing 21, 63, 126 or 273 tablets. Each carton contains blisters packed separately in an aluminium laminated sachet.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Morningside Healthcare Ltd

Unit C, Harcourt Way

Leicester, LE19 1WP, UK

Manufacturer

Morningside Pharmaceuticals Ltd

5 Pavilion Way

Loughborough, LE11 5GW, UK

This leaflet was last revised in August 2021.

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