Lusinelle

PATIENT LEAFLET: INFORMATION FOR THE USER

Lusinelle 0,02 mg/3 mg film-coated tablets

Ethinylestradiol/Drospirenone
Generic medicine
Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods when used correctly
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks
• Be alert and contact your doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”)

Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:
1. What Lusinelle is and what it is used for
2. What you need to know before taking Lusinelle
3. How to take Lusinelle
4. Possible side effects
5. How to store Lusinelle
6. Contents of the pack and other information

1. What Lusinelle is and what it is used for
Lusinelle is a contraceptive pill used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones, drospirenone and ethinylestradiol.
Contraceptive pills containing two hormones are known as “combined” pills.

2. What you should know before taking Lusinelle

General information
Before starting to use Lusinelle, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).
Before taking Lusinelle, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out other examinations.
This leaflet describes various conditions that require you to stop taking Lusinelle or situations in which the effectiveness of Lusinelle may be reduced. In such cases, you must avoid sexual intercourse or use additional non-hormonal contraceptive measures, such as condoms or another barrier method. Do not use the rhythm method or basal body temperature method. These methods may be unreliable, as Lusinelle alters the monthly fluctuations in body temperature and cervical mucus.
Lusinelle, like all hormonal contraceptives, does not protect against infection with HIV (AIDS) or other sexually transmitted diseases.

Do not use Lusinelle:
Do not use Lusinelle if you have any of the conditions listed below. If you have any of the conditions listed below, consult your doctor. Your doctor will discuss with you other methods of birth control that might be more suitable for your situation.

• if you have (or have had in the past) a blood clot in a blood vessel of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are due to undergo surgery or will be bedridden for a prolonged period (see section “Blood clots”);
• if you have had a heart attack or stroke in the past;
• if you have (or have had in the past) angina pectoris (a condition causing severe chest pain and which may be an early sign of a heart attack) or a transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following conditions, which may increase the risk of blood clots forming in the arteries:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats (cholesterol or triglycerides) in the blood
  • a condition known as hyperhomocysteinaemia
• if you have (or have had in the past) a type of migraine called “migraine with aura”;
• if you have (or have had in the past) liver disease and liver function is still abnormal
• if your kidneys do not work properly (renal failure)
• if you have (or have had in the past) a liver tumour
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir (also see section “Other medicines and Lusinelle”)
• if you have (or have had in the past) or are suspected of having breast or genital organ cancer
• if you have unexplained vaginal bleeding
• if you are allergic to ethinylestradiol or drospirenone or to any of the excipients of this medicine (listed in section 6). This condition may manifest as itching, skin rash, or swelling.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lusinelle.
When to be particularly careful with Lusinelle
When should you contact a doctor?
Contact a doctor urgently

• if you notice signs of a possible blood clot which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see the following section "Blood clot (thrombosis)"). For a description of the symptoms of these serious side effects, go to section “How to recognize a blood clot”.

In certain situations, you must be particularly cautious when using Lusinelle or any other combined oral contraceptive, and regular medical check-ups may be necessary.
Inform your doctor if any of the following conditions apply to you.
If any of these conditions develop or worsen while you are using Lusinelle, inform your doctor:

• if a close relative has or has had breast cancer
• if you have liver or gallbladder disease
• if you have diabetes
• if you suffer from depression
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)
• if you have systemic lupus erythematosus (SLE, a disease affecting the body’s natural defence system)
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure)
• if you have sickle cell anaemia (an inherited red blood cell disorder)
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas)
• if you are due to undergo surgery or will be bedridden for a prolonged period (see section 2 “Blood clots”)
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after giving birth you can start taking Lusinelle
• if you have inflammation of veins near the skin surface (superficial thrombophlebitis)
• if you have varicose veins
• if you suffer from epilepsy (see section "Taking Lusinelle with other medicines")
• if you have a condition that first occurred during pregnancy or previous use of sex hormones (e.g. hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (herpes gestationis), a nerve disorder causing sudden body movements (Sydenham’s chorea))
• if you have or have had chloasma (skin pigmentation changes, especially on the face or neck, known as “melasma” or “pregnancy mask”). In this case, avoid direct exposure to sunlight or ultraviolet light
• if you have hereditary angioedema, products containing oestrogens may induce or worsen symptoms. If you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with breathing difficulties, contact your doctor immediately.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Lusinelle increases the risk of developing a blood clot compared to not using one. In rare cases, a blood clot may

It is important to remember that the overall risk of a harmful blood clot associated with
Lusinelle is low.
HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical advice if you notice any of the following signs or symptoms.
Are you experiencing any of these signs? What might you
be suffering from?

• Swelling in one leg or along a vein in the leg or Deep vein thrombosis of the foot, especially if accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking
• increased warmth in the affected leg
• change in skin color of the leg, such as paleness, redness, or bluish discoloration
• sudden and unexplained shortness of breath; Pulmonary embolism
• sudden cough without an obvious cause, possibly with coughing up blood;
• sharp chest pain that may worsen when breathing deeply;
• severe dizziness or lightheadedness;
• rapid or irregular heartbeat;
• severe stomach pain

If you are unsure, inform your doctor, as some of these
symptoms, such as cough or shortness of breath, may be
mistaken for a milder condition such as a respiratory
tract infection (e.g. a "common cold").
Retinal vein thrombosis
Symptoms occurring more frequently in one eye:
(blood clot

• sudden loss of vision in one eye)
• painless blurring of vision that may progress to vision loss
• pain, discomfort, pressure, or heaviness in the chest; Heart attack
• squeezing or fullness sensation in the chest, arm, or behind the breastbone;
• feeling of fullness, indigestion, or choking;
• discomfort in the upper body spreading to the back, jaw, throat, arms, or stomach;
• sweating, nausea, vomiting, or dizziness;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat
• sudden numbness or weakness of the face, one arm, or one leg, especially on one side of the body; Stroke
• sudden confusion, difficulty speaking or understanding speech;
• sudden difficulty seeing in one or both eyes;
• sudden difficulty walking, dizziness, loss of balance or coordination;
• sudden, severe, or prolonged headache with no known cause;
• loss of consciousness or fainting with or without seizures.

Sometimes stroke symptoms may be brief, with almost
immediate and complete recovery, but you should still
seek urgent medical attention as you may be at risk
of another stroke.

• swelling and pale blue discoloration of a limb; Blood clots blocking other blood vessels
• severe abdominal pain (acute abdomen)

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of developing blood clots in veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, the clot may form 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 when you
start 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 or a different drug) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not using a combined hormonal contraceptive.
When you stop taking Lusinelle, the risk of developing a blood clot returns
to normal levels 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 developing a blood clot in the leg or lung (DVT or PE) with
Lusinelle is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year. Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Lusinelle, about 9–12 will develop a blood clot in one year.
• The risk of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Lusinelle is low, but certain conditions can increase this risk. Your risk is higher:

• if you are very overweight (body mass index or BMI over 30 kg/m²);
• if a close relative has had a blood clot in a leg, lung, or another organ at a young age (under approximately 50 years). In this case, you might have an inherited blood clotting disorder;
• if you are scheduled for surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a plaster cast on your leg. You may need to stop taking Lusinelle several weeks before surgery or during periods of reduced mobility. If you need to stop taking Lusinelle, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years of age);
• if you have given birth less than a few weeks ago. The risk of developing a blood clot increases the more of these conditions you have. Air travel (lasting >4 hours) may temporarily increase the risk of blood clot formation, especially if you have some of the other risk factors listed. It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to have you stop taking Lusinelle. If any of the above conditions change while you are using Lusinelle—for example, if a close relative develops thrombosis without a known cause or if you gain significant weight—contact your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems—for example, they may lead to a heart attack or stroke.
Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of Lusinelle is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Lusinelle, it is advisable to stop smoking. If you are unable to stop smoking and you are over 35 years old, your doctor may recommend using a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke;
• if you or a close relative have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes. If you have more than one of these conditions, or if one is particularly severe, the risk of developing a blood clot may be even higher. If any of the above conditions change while you are using Lusinelle—for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.

Lusinelle and cancer
Breast cancer is observed slightly more frequently in women who use combined oral contraceptives, but it is not known whether this is due to the treatment. For example, women using combined pills may be diagnosed with more tumors simply because they undergo more frequent medical check-ups. The incidence of breast cancer gradually decreases after stopping treatment with combined hormonal contraceptives. It is important that you regularly examine your breasts and contact your doctor if you feel any lumps.
Benign liver tumors have been observed rarely in women using oral contraceptives, and malignant liver tumors even more rarely. Contact your doctor if you experience unusual and severe abdominal pain.

Intermenstrual bleeding
During the first few months of taking Lusinelle, unexpected bleeding (bleeding outside the pill-free week) may occur. If this bleeding continues for more than a few months, or starts after several months, your doctor should investigate the cause.

What to do if you do not get your period during the pill-free week
If you have taken all tablets correctly, have not vomited or had severe diarrhea, and have not taken other medications, it is highly unlikely that you are pregnant.
If you miss two consecutive periods, you may be pregnant. Contact your doctor immediately. Do not start the next pack until you are certain you are not pregnant.

Psychiatric disorders
Some women using hormonal contraceptives, including Lusinelle, have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or depressive symptoms, consult your doctor as soon as possible for further medical advice.

Other medicines and Lusinelle
Inform your doctor if you are taking any other medicines, including herbal products. Also inform any other doctor or dentist who prescribes you a medicine (or your pharmacist) that you are taking Lusinelle. They may advise you whether you need to use additional contraceptive measures (for example, condoms) and for how long.
Some medicines can affect the blood levels of Lusinelle and may reduce its effectiveness in preventing pregnancy or may cause unexpected bleeding. These include medicines used to treat:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
• tuberculosis (e.g., rifampicin)
• HIV and hepatitis C virus infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz) or other infections (griseofulvin)
• high blood pressure in the pulmonary vessels (bosentan)
  • St. John’s wort (Hypericum perforatum)

Lusinelle may affect the action of other medicines, for example:

• medicines containing cyclosporine
• the antiepileptic lamotrigine (this may lead to an increased frequency of epileptic seizures).

Do not use Lusinelle if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, as this may cause increases in liver function blood test results (elevated levels of the liver enzyme ALT).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
Lusinelle may be restarted approximately 2 weeks after completing this treatment.
See section “Do not use Lusinelle”.

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

Lusinelle with food and drink
Lusinelle may be taken with or without food, if necessary with a little water.

Laboratory tests
If you are scheduled for a blood test, inform your doctor or laboratory staff that you are taking the pill, as hormonal contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

Pregnancy
If you are pregnant, you must not use Lusinelle. If you become pregnant while taking Lusinelle, stop taking the pill immediately and contact your doctor. If you wish to become pregnant, you may stop taking Lusinelle at any time (see also section “If you wish to stop taking Lusinelle”).

Breastfeeding
The use of Lusinelle is not recommended during breastfeeding. If you wish to take the pill while breastfeeding, you must consult your doctor.

Driving and use of machines
There is no evidence to suggest that Lusinelle affects the ability to drive or operate machinery.

Lusinelle contains lactose.
If your doctor has informed you that you are intolerant to certain sugars, contact him before taking this medicine.

3. How to take Lusinelle

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Take one Lusinelle tablet every day, with or without water. You may take the
tablets with or without food, but you must take them at approximately the same time each day.
The blister pack contains 21 tablets. Next to each tablet, the day of the week
on which it should be taken is printed. For example, if you start on Wednesday, take the tablet next to the
abbreviation "WED". Follow the direction of the arrow on the blister pack until all 21
tablets have been taken.
Then, do not take any tablets for 7 days. During these 7 tablet-free days (also
known as the "pill-free week"), your menstrual period will occur. This so-called
"withdrawal bleeding" usually starts on the second or third day of the
pill-free week.
Start the new blister pack on the eighth day after taking the last Lusinelle tablet (i.e. after the 7 days of the
pill-free week), regardless of whether your menstrual bleeding has stopped or not.
In this way, you will always start a new Lusinelle blister pack on the same day of the week, and your periods will occur on the same days each month.
When taking Lusinelle as described above, you are protected against pregnancy even during the 7 days when you do not take a tablet.

When can you start the first blister pack?

• If you have not used a hormonal contraceptive in the previous month Start taking Lusinelle on the first day of your cycle (i.e. the first day of your menstrual period). If you start taking Lusinelle on the first day of your period, contraceptive protection is immediate. You may also start taking Lusinelle between day 2 and day 5 of your cycle, but in this case you must use additional contraceptive measures (e.g. a condom) for the first 7 days.
• Switching from a combined hormonal contraceptive, a combined vaginal ring, or a contraceptive patch You may start taking Lusinelle preferably the day after the last active tablet (the last tablet containing active ingredients) of your previous pill, or at the latest the day after the end of the pill-free interval of your previous pill (or after the last inactive tablet of your previous pill). When switching from a combined vaginal ring or contraceptive patch, follow your doctor's advice.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or progestogen-releasing IUS) You may switch on any day from the progestogen-only pill (from an implant or IUS on the day of its removal, from an injectable when the next injection is due), but in all these cases you must use additional contraceptive measures (e.g. a condom) for the first 7 days of tablet intake.
• After an abortion Follow your doctor's advice.
• After childbirth You may start taking Lusinelle between day 21 and day 28 after delivery. If you start later than day 28, you must use a so-called barrier method (e.g. a condom) during the first 7 days of taking Lusinelle. If, after childbirth, you have had sexual intercourse before starting (or restarting) Lusinelle, you must first ensure that you are not pregnant or wait for your menstrual period.
• If you are breastfeeding and wish to start (or restart) taking Lusinelle after childbirth Read the section on "Breast-feeding".

Consult your doctor if you are unsure about when to start.

If you take more Lusinelle than you should
There have been no reports of serious harmful effects following an overdose of
Lusinelle tablets.
If you take several tablets at once, you may experience symptoms such as nausea or vomiting. Young girls may experience vaginal bleeding.
If you have taken too many Lusinelle tablets or if you find that a child has taken any of the tablets, contact your doctor or pharmacist immediately.

If you forget to take Lusinelle

• If the delay in taking a tablet is less than 12 hours, contraceptive protection is not reduced. Take the missed tablet as soon as you remember and continue taking the following tablets at your usual time.
• If the delay in taking a tablet is more than 12 hours, contraceptive protection may be reduced. The greater the number of tablets missed, the higher the risk that contraceptive effectiveness may be reduced.

This risk is greatest if you miss a tablet at the beginning or end of the blister pack. Therefore,
follow the instructions below (see also the diagram below):

• If you have missed more than 1 tablet in this blister pack Consult your doctor.
• If you missed 1 tablet in the first week Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time and use additional contraceptive measures for the next 7 days, e.g. a condom. If you had sexual intercourse in the previous week, pregnancy may have occurred. In this case, consult your doctor.
• If you missed 1 tablet in the second week Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. Contraceptive protection is not reduced, so no additional precautions are necessary.
• If you missed 1 tablet in the third week You have two options:
  1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. Skip the pill-free interval and immediately start the next blister pack.

Your menstrual period will most likely occur at the end of the second blister pack, but you may experience light bleeding or spotting similar to menstruation during the second blister pack.

2. You may also stop taking tablets from the current cycle and go directly to the 7-day pill-free interval (note the day on which you forgot to take the tablet). If you wish to start the next blister pack on your usual day, observe a pill-free interval of less than 7 days.

If you follow either of these two recommendations, you will remain protected against pregnancy.

• If you have missed any of the tablets in the blister pack and do not have a menstrual period during the first pill-free interval, you may be pregnant. Consult your doctor before starting a new blister pack.

What to do in case of vomiting or severe diarrhoea
If you vomit within 3–4 hours after taking a tablet or have severe diarrhoea, the active ingredients of the pill may not be fully absorbed by your body. This situation is similar to missing a tablet. After vomiting or severe diarrhoea, take another tablet from a reserve blister pack as soon as possible. If possible, take it within 12 hours of your usual pill-taking time. If this is not possible or if more than 12 hours have passed, follow the instructions in the section "If you forget to take Lusinelle".

Delaying your period: what you need to know
Although not recommended, it is possible to delay your period by starting a new blister pack of Lusinelle immediately, without observing the usual 7-day pill-free interval. During the use of this second blister pack, you may experience light bleeding or spotting. Start the next blister pack after the usual 7-day pill-free interval.
You may wish to consult your doctor before deciding to delay your period.

Changing the day your period starts: what you need to know
If you take the tablets as instructed, your periods will start during the pill-free week. If you wish to change the day your period starts, you may shorten (but never lengthen – 7 days is the maximum!) the number of pill-free days. For example, if your pill-free interval normally starts on Friday and you wish to move it to Tuesday (3 days earlier), you should start the next blister pack 3 days earlier. If you make the pill-free interval very short (e.g. 3 days or less), you may not have a menstrual period during that interval. You may subsequently experience light bleeding or spotting.
Consult your doctor if you are unsure what to do.

If you wish to stop taking Lusinelle
You may stop taking Lusinelle at any time. If you wish to avoid pregnancy, consult your doctor for advice on other reliable methods of birth control. If you wish to become pregnant, stop taking Lusinelle and wait for your menstrual period before trying to conceive. This will allow you to calculate your expected due date more easily.
If you have any doubts about using this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lusinelle can cause side effects, although not everyone experiences them. If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think could be due to Lusinelle, inform your doctor.

An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) exists in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2, "What you should know before using Lusinelle".

The following side effects have been reported with the use of Lusinelle:

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

• mood swings
• headache
• abdominal pain (stomach ache)
• acne
• breast tenderness, breast enlargement, painful or irregular menstruation
• weight gain

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

• candidiasis (fungal infection)
• cold sores (herpes simplex)
• allergic reactions
• increased appetite
• depression, nervousness, sleep disturbances
• tingling, dizziness
• vision disorders
• irregular heartbeat or unusually rapid heartbeat
• high blood pressure, low blood pressure, migraine, varicose veins
• sore throat
• nausea, vomiting, inflammation of the stomach and/or intestine, diarrhoea, constipation
• sudden swelling of the skin and/or mucous membranes (e.g. tongue and throat) and/or difficulty swallowing or hives with breathing difficulties (angioedema), hair loss (alopecia), eczema, itching, skin rashes, dry skin, problems with oily skin (seborrhoeic dermatitis)
• neck pain, limb pain, muscle cramps
• bladder infection
• breast lump (benign and cancer), milk production despite not being pregnant (galactorrhea), ovarian cysts, hot flushes, absence of menstruation, very heavy menstrual bleeding, vaginal discharge, vaginal dryness, lower abdominal (pelvic) pain, abnormal Pap test (Papanicolaou test or Pap test), decreased sexual desire
• fluid retention, lack of energy, excessive thirst, increased sweating
• weight loss

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

• asthma
• hearing loss
• erythema nodosum (characterised by red, painful skin nodules)
• erythema multiforme (skin rash with target-like lesions or ulcers)
• harmful blood clots in a vein or artery, for example: in a leg or foot (DVT - Deep Vein Thrombosis), or in a lung (PE - Pulmonary Embolism), or heart attack, or stroke, or transient ischaemic attack (TIA), also known as mini-stroke or temporary stroke-like symptoms, or blood clots in the liver, stomach/intestine, kidneys, or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system: segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lusinelle

Keep Lusinelle out of the sight and reach of children.
This medicine does not require any special storage conditions.
Expiry date
Do not use this medicine after the expiry date stated on the packaging after the wording
"Do not use after:" or "EXP:".
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lusinelle contains
The active substances are ethinylestradiol and drospirenone.
Each tablet contains 0.02 mg of ethinylestradiol and 3 mg of drospirenone.
The other components are:
Tablet core: monohydrate lactose, pregelatinized starch (maize), povidone,
sodium croscarmellose, polysorbate 80, magnesium stearate.
Coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350,
talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
Description of the appearance of Lusinelle and package contents
Pink, round, film-coated tablets.
Lusinelle is available in packs containing 1, 2, 3, 6 and 13 blisters, each blister containing 21 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Theramex Ireland Limited
Kilmore House, Park Lane, Spencer Dock
Dublin 1, D01 YE64
Ireland
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milan
Italy
Manufacturer
Laboratorios León Farma, S.A.
Pol. Ind. Navatejera.
C/ La Vallina s/n
24008 - Villaquilambre, León.
Spain
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany