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

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 Lucette, 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 Lucette”.

The following is a list of the side effects that have been linked with the use of Lucette:

Common side effects (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, vaginal yeast infection.

Uncommon side effects (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
• body weight changes

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

• 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 targetshaped 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)

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 at: 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 lucette

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

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

Do not store above 30°C. Store in the original package in order to protect from light.

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.

If your medicine becomes discoloured or shows signs of any deterioration, consult your pharmacist who will tell you what to do.

6. contents of the pack and other information

What Lucette contains

• Each film-coated tablet contains 0.03 mg ethinylestradiol and 3 mg drospirenone.
• The other ingredients are:

Tablet core: lactose monohydrate, pregelatinised maize starch, maize starch, povidone K-25, magnesium stearate

Film-coating: polyvinyl alcohol, titanium dioxide (E171), talc (E553b), macrogol 3350, lecithin (soya).

What Lucette looks like and contents of the pack

The tablets are white or almost white, round, biconvex film-coated tablet. Engraving on one side: “G63”, other side is without engraving.

Lucette is packaged in PVC/PVDC/AI calendar blister pack of 63 tablets (3 blisters of 21 tablets) or 21 tablets.

The blisters are packed into folding box with patient leaflet and etui storage wallet is enclosed in each box.

PL: 15814/1424 |POM|

Lucette is manufactured by Gedeon Richter Plc., Gyomroi ut 19–21, 1103 Budapest, Hungary.

Procured from within the EU and repackaged by the Product Licence holder: O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.

Leaflet revision and issue date (Ref.): 15.06.2020.

LUCETTE is a registered trademark of Richter Gedeon Nyrt, Hungary.

To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

PACKAGE LEAFLET: INFORMATION FOR THE USER LUCETTE® 0.03 mg/3 mg film-coated tablets

(ethinylestradiol I drospirenone)

This medicine is available as the above name but will be referred to as Lucette throughout the remainder of this leaflet.

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”).
• 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.
• If you get any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

• 1. What Lucette is and what it is used for

• 2. What you need to know before you use Lucette

• 3. How to take Lucette

• 4. Possible side effects

• 5. How to store Lucette

• 6. Contents of the pack and other information

1.what lucette is and what it is used for

• Lucette is a contraceptive pill and is used to prevent pregnancy.
• Each tablet contains a small amount of two different female hormones, namely ethinylestradiol and drospirenone.
• Contraceptive pills that contain two hormones are called “combination” pi­lls.

2.WHAT YOU NEED TO KNOW BEFORE YOU USE LUCETTE

General notes

Before you start using Lucette 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 Lucette, 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 Lucette, or where the reliability of Lucette 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 Lucette alters the monthly changes of body temperature and cervical mucus.

Lucette, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Do not use Lucette

You should not use Lucette 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-lll 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) 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.
• Lucette contains lecithin which may contain soya oil. If you are allergic to peanut or soya, do not use this medicinal product.

Do not use Lucette if you have hepatitis C and are taking the medicinal products containing ombitasvir/pa­ritaprevir/ri­tonavir and dasabuvir (see also in section Other medicines and Lucette).

Children and adolescents

Lucette is not intended for use in females whose periods have not yet started.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lucette.

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”.

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

In some situations you need to take special care while using Lucette or any other combination pill, and your doctor may need to examine you regularly. If the condition develops, or gets worse while you are using Lucette, you should also tell your doctor:

• if a close relative who has ever had breast cancer.
• if you have a disease of the liver or the gallbladder.
• if you have diabetes.
• if you have depression or mood changes.
• if you have epilepsy (see “Other medicines and Lucette”).
• 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, yellowing of the skin or eyes (jaundice), itching of the whole body (pruritus), skin rash with blisters during pregnancy (gestational herpes), a nerve disease causing sudden movements of the body (Sydenham’s cho­rea)).
• if you have ever had chloasma (a discolouration of the skin especially on 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.
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease).
• if you have systemic lupus erythematosus (SLE – a disease affecting your natural defence system).
• 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 Lucette.
• if you have an inflammation in the veins under the skin (superficial thrombophlebitis).
• if you have varicose veins.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Lucette 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’ orVTE)
• 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 Lucette 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 Lucette 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 Lucette 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 Lucette 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 Lucette is small but some conditions will increase the risk. Your risk is higher:

• if you are very overweight (body mass index or BMI over 30 kg/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 Lucette may need to be stopped several weeks before surgery or while you are less mobile. If you need to stop Lucette 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 Lucette needs to be stopped.

If any of the above conditions change while you are using Lucette, 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 Lucette is very small but can increase:

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

Lucette 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.

Psychiatric disorders

Some women using hormonal contraceptives including Lucette 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.

Bleeding between periods

During the first few months that you are taking Lucette, you may have unexpected bleeding (bleeding outside the seven pill-free days). If this bleeding occurs for more than a few months, or if it begins after some months, contact your doctor as they must 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 Lucette

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 use Lucette. 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.

Do not use Lucette if you have Hepatitis C and are taking the medicinal products containing ombitasvir/pa­ritaprevir/ri­tonavir and dasabuvir 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. Lucette can be restarted approximately 2 weeks after completion of this treatment. See section “Do not use Lucette”.

• Some medicines can have an influence on the blood levels of Lucette and can make it less effective in preventing pregnancy, or can cause unexpected bleeding. These include medicines used for the treatment of epilepsy (e.g. barbiturates, carbamazepine, phenytoin, primidone, felbamate, oxcarbazepine, topiramate)
• 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)
• high blood pressure in the blood vessels in the lungs (bosentan);
• fungal infection (e.g. griseofulvin, ketoconazole)
• the symptomatic treatment of arthrosis (etoricoxib)
• the herbal remedy St. John’s wort (Hypericum perforatum). If you want to use herbal products containing St. John’s wort while you are already using Lucette you should consult your doctor first.

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

• ciclosporin (medicine used for the treatment of suppression of tissue rejection following transplant surgery)
• the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures)

tizanidine (medicine used for the treatment of muscle spasticity) theophyllin (a medicine for the treatment of asthma).

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

Lucette with food and drink

Lucette 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 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.

Pregnancy

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

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

Breast-feeding

Use of Lucette 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.

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

Driving and using machines

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

Lucette contains lactose and soya lecithin

Lucette contains 48.17 mg lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Lucette also contains 0.070 mg soya lecithin. If you are allergic to peanut or soya, do not use this medicinal product.

3. how to take lucette

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 Ethinylestradiol / Drospirenone tablet, 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 tablet”.

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

Common side effects (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, vaginal yeast infection.

Uncommon side effects (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
• body weight changes

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

• 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 targetshaped 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)

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 at: 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 tablet

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

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

Do not store above 30°C. Store in the original package in order to protect from light.

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.

If your medicine becomes discoloured or shows signs of any deterioration, consult your pharmacist who will tell you what to do.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Ethinylestradiol / Drospirenone tablet contains

• Each film-coated tablet contains 0.03 mg ethinylestradiol and 3 mg drospirenone.
• The other ingredients are:

Tablet core: lactose monohydrate, pregelatinised maize starch, maize starch, povidone K-25, magnesium stearate

Film-coating: polyvinyl alcohol, titanium dioxide (E171), talc (E553b), macrogol 3350, lecithin (soya).

What Ethinylestradiol / Drospirenone tablet looks like and contents of the pack

The tablets are white or almost white, round, biconvex film-coated tablet. Engraving on one side: “G63”, other side is without engraving.

Ethinylestradiol / Drospirenone tablet is packaged in PVC/PVDC/Al calendar blister pack of 63 tablets (3 blisters of 21 tablets) or 21 tablets.

The blisters are packed into folding box with patient leaflet and etui storage wallet is enclosed in each box.

PL: 15814/1424 |POM|

Ethinylestradiol / Drospirenone tablet is manufactured by Gedeon Richter Plc., Gyomroi ut 19–21, 1103 Budapest, Hungary.

Procured from within the EU and repackaged by the Product Licence holder: O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.

Leaflet revision and issue date (Ref.): 15.06.2020.

To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

PACKAGE LEAFLET: INFORMATION FOR THE USER Ethinylestradiol / Drospirenone 0.03 mg/3 mg film-coated tablets

This medicine is available as the above name but will be referred to as Ethinylestradiol / Drospirenone tablet throughout the remainder of this leaflet.

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”).
• 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.
• If you get any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

• 1. What Ethinylestradiol / Drospirenone tablet is and what it is used for

• 2. What you need to know before you use Ethinylestradiol / Drospirenone tablet

• 3. How to take Ethinylestradiol / Drospirenone tablet

• 4. Possible side effects

• 5. How to store Ethinylestradiol / Drospirenone tablet

• 6. Contents of the pack and other information

1. what ethinylestradiol / drospirenone tablet is and what it is used for

• Ethinylestradiol / Drospirenone tablet is a contraceptive pill and is used to prevent pregnancy.
• Each tablet contains a small amount of two different female hormones, namely ethinylestradiol and drospirenone.
• Contraceptive pills that contain two hormones are called “combination” pi­lls.

2. what you need to know before you use ethinylestradiol / drospirenone tablet

General notes

Before you start using Ethinylestradiol / Drospirenone tablet 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 tablet, 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 tablet, or where the reliability of Ethinylestradiol / Drospirenone tablet 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 tablet alters the monthly changes of body temperature and cervical mucus.

Ethinylestradiol / Drospirenone tablet, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Do not use Ethinylestradiol / Drospirenone tablet

You should not use Ethinylestradiol / Drospirenone tablet 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) 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.
• Ethinylestradiol / Drospirenone tablet contains lecithin which may contain soya oil. If you are allergic to peanut or soya, do not use this medicinal product.

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

Children and adolescents

Ethinylestradiol / Drospirenone tablet is not intended for use in females whose periods have not yet started.

Warnings and precautions

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

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”.

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

In some situations you need to take special care while using Ethinylestradiol / Drospirenone tablet or any other combination pill, and your doctor may need to examine you regularly. If the condition develops, or gets worse while you are using Ethinylestradiol / Drospirenone tablet, you should also tell your doctor:

• if a close relative who has ever had breast cancer.
• if you have a disease of the liver or the gallbladder.
• if you have diabetes.
• if you have depression or mood changes.
• if you have epilepsy (see “Other medicines and Ethinylestradiol / Drospirenone tablet”).
• 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, yellowing of the skin or eyes (jaundice), itching of the whole body (pruritus), skin rash with blisters during pregnancy (gestational herpes), a nerve disease causing sudden movements of the body (Sydenham’s cho­rea)).
• if you have ever had chloasma (a discolouration of the skin especially on 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.
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease).
• if you have systemic lupus erythematosus (SLE – a disease affecting your natural defence system).
• 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 tablet.
• if you have an inflammation in the veins under the skin (superficial thrombophlebitis).
• if you have varicose veins.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Ethinylestradiol / Drospirenone tablet 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 a harmful blood clot due to Ethinylestradiol / Drospirenone tablet 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 tablet 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 tablet 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 tablet 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 Ethinylestradiol / Drospirenone tablet is small but some conditions will increase the risk. Your risk is higher:

• if you are very overweight (body mass index or BMI over 30 kg/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 tablet may need to be stopped several weeks before surgery or while you are less mobile. If you need to stop Ethinylestradiol / Drospirenone tablet 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 tablet needs to be stopped.

If any of the above conditions change while you are using Ethinylestradiol / Drospirenone tablet, 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 tablet 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 tablet 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 tablet, 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 tablet 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.

Psychiatric disorders

Some women using hormonal contraceptives including Ethinylestradiol / Drospirenone tablet 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.

Bleeding between periods

During the first few months that you are taking Ethinylestradiol / Drospirenone tablet, you may have unexpected bleeding (bleeding outside the seven pill-free days). If this bleeding occurs for more than a few months, or if it begins after some months, contact your doctor as they must 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 tablet

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 use Ethinylestradiol / Drospirenone tablet. 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.

Do not use Ethinylestradiol / Drospirenone tablet if you have Hepatitis C and are taking the medicinal products containing ombitasvir/pa­ritaprevir/ri­tonavir and dasabuvir 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 tablet can be restarted approximately 2 weeks after completion of this treatment. See section “Do not use Ethinylestradiol / Drospirenone tablet”.

Some medicines can have an influence on the blood levels of Ethinylestradiol / Drospirenone tablet and can make it less effective in preventing pregnancy, or can cause unexpected bleeding. These include medicines used for the treatment of

• epilepsy (e.g. barbiturates, carbamazepine, phenytoin, primidone, felbamate, oxcarbazepine, topiramate)
• 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)
• high blood pressure in the blood vessels in the lungs (bosentan);
• fungal infection (e.g. griseofulvin, ketoconazole)
• the symptomatic treatment of arthrosis (etoricoxib)
• the herbal remedy St. John’s wort (Hypericum perforatum). If you want to use herbal products containing St. John’s wort while you are already using Ethinylestradiol / Drospirenone tablet you should consult your doctor first.

Ethinylestradiol / Drospirenone tablet may influence the effect of other medicines, e.g.

• ciclosporin (medicine used for the treatment of suppression of tissue rejection following transplant surgery)
• the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures)

tizanidine (medicine used for the treatment of muscle spasticity) theophyllin (a medicine for the treatment of asthma).

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

Ethinylestradiol / Drospirenone tablet with food and drink

Ethinylestradiol / Drospirenone tablet 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 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.

Pregnancy

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

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

Breast-feeding

Use of Ethinylestradiol / Drospirenone tablet 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.

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 tablet affects driving or the use of machines.

Ethinylestradiol / Drospirenone tablet contains lactose and soya lecithin

Ethinylestradiol / Drospirenone tablet contains 48.17 mg lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Ethinylestradiol / Drospirenone tablet also contains 0.070 mg soya lecithin. If you are allergic to peanut or soya, do not use this medicinal product.

3. HOW TO TAKE ETHINYLESTRADIOL / DROSPIRENONE TABLET

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 tablet of 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 “WE” 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 tablet 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 tablet on the first day of your cycle (that is, the first day of your period). If you start Ethinylestradiol / Drospirenone tablet 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 tablet 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 (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 Ethinylestradiol / Drospirenone tablet.

• After a miscarriage

Follow the advice of your doctor.

• After having a baby

You can start taking Ethinylestradiol / Drospirenone tablet 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 tablet.

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

• If you are breast-feeding and want to start Ethinylestradiol / Drospirenone tablet 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 tablet 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 feel sick or vomit or you may bleed from the vagina.

Even girls who have not yet started to menstruate but have accidentally taken this medicine may experience such bleeding.

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 tablet

• 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 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.