Lucille

PACKAGE LEAFLET

Package leaflet: Information for the user

Lucille, film-coated tablets

Desogestrel/Ethinylestradiol
Important information 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 blood clots forming 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 may be experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Please read this leaflet carefully before using 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, pharmacist, or nurse.
• 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 effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Lucille is and what it is used for
2. What you need to know before using Lucille

When you should contact your doctor

3. How to use Lucille
4. Possible side effects
5. How to store Lucille
6. Contents of the pack and other information

1. What Lucille is and what it is used for

Composition and type of Pill
Lucille is a combined oral contraceptive ("the combined pill"). Each tablet contains a small amount of two different female hormones. These are desogestrel (a progestogen) and ethinylestradiol (an oestrogen). Due to its low hormone content, Lucille is considered a low-dose oral contraceptive. Since the two hormones are used at different dosages in tablets of three different colours, Lucille is considered a triphasic oral contraceptive.
Why use Lucille?
Lucille is used to prevent pregnancy.
When used correctly (without forgetting to take the tablets), the likelihood of pregnancy is very low.

2. What you should know before using Lucille

General information
Before starting to use Lucille, 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”).
This patient information leaflet describes various situations in which you should stop using the pill or in which the reliability of the pill may be reduced. In these situations, you must refrain from sexual intercourse or use additional non-hormonal contraceptive measures, such as a condom or another barrier method. Do not use methods based on biological rhythms or body temperature. These methods may be ineffective because the pill alters the normal variations in body temperature and cervical mucus that occur during the menstrual cycle.
Lucille, like all hormonal contraceptive pills, does not protect against HIV (AIDS) or other sexually transmitted infections.
Lucille has been prescribed for you only. Do not give it to other people.
Lucille should normally not be used to delay a menstrual period. However, if in exceptional cases you need to delay a period, contact your doctor.
Do not use Lucille
Do not use Lucille 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 birth control methods that might be more suitable for your situation. See also section “Warnings and precautions”.

• if you have (or have ever had) a blood clot in a vein 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 about to undergo surgery or will be bedridden for a prolonged period (see section “Blood clots”);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain that may be an early sign of heart attack) or transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following conditions, which may increase the risk of developing clots 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 ever had) a type of migraine called “migraine with aura”;
• if you have (or have ever had) pancreatitis (inflammation of the pancreas) associated with high levels of fatty substances in the blood;
• if you have jaundice (yellowing of the skin) or have (or have had) severe liver disease and liver function has not returned to normal;
• if you have (or have ever had) a cancer that can grow under the influence of sex hormones (e.g. breast or genital organs);
• if you have (or have ever had) a liver tumour;
• if you have any type of unexplained vaginal bleeding;
• if you have endometrial hyperplasia (abnormal growth of the inner lining of the uterus);
• if you are pregnant or suspect you may be pregnant;
• if you are allergic to desogestrel or ethinylestradiol, or to any of the other ingredients of this medicine (listed in section 6);
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Lucille”).

If any of these conditions occur for the first time while you are taking the pill, stop using it immediately and consult your doctor. In the meantime, use non-hormonal contraceptive methods. See also “General information” above.
Warnings and precautions
When should you contact a doctor?
Seek urgent medical advice

• if you notice possible signs of a 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, refer to the section “How to recognize a blood clot”.

Consult your doctor or pharmacist before using Lucille.
Inform your doctor if any of the following conditions apply to you.
If such a condition occurs or worsens while you are using Lucille, inform your doctor.
If you notice symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible breathing difficulties, contact a doctor immediately. Medicinal products containing estrogens can cause or worsen symptoms of hereditary or acquired angioedema.
if you smoke;
if you have diabetes;
if you are overweight;
if you have high blood pressure;
if you have a heart valve disorder or certain heart rhythm disorders;
if you have inflammation of veins under the skin (superficial thrombophlebitis);
if you have varicose veins;
if you have a family history of thrombosis, heart attack, or stroke in close relatives;
if you suffer from migraine;
if you suffer from epilepsy;
if you have high levels of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
if you are about 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 delivery you can start taking Lucille;
if any of your close relatives have had breast cancer;
if you have liver or gallbladder disease;
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 conditions that first appeared or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, a disease called porphyria, a skin condition called herpes gestationis, a condition called Sydenham’s chorea);
if you have (or have ever had) chloasma (brownish-yellow patches on the skin, especially on the face). In this case, avoid excessive exposure to sunlight or ultraviolet rays.
Psychiatric disorders
Some women using hormonal contraceptives, including Lucille, have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor as soon as possible for further medical advice.
If any of the above conditions occur for the first time, recur, or worsen during use of the pill, you should consult your doctor.
Pill and Thrombosis
BLOOD CLOTS
Using a combined hormonal contraceptive such as Lucille increases the risk of developing a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, serious long-term effects may occur, and very rarely, such effects may be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with Lucille is low.
HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical advice if you notice any of the following signs or symptoms.
Do you have one of these signs? What might you be suffering from?

• swelling in one leg or along a vein in the leg or 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 colour of the leg, such as paleness, redness, or bluish discoloration
• sudden and unexplained shortness of breath or rapid breathing
• sudden cough without an obvious cause, possibly with coughing up blood
• sharp chest pain that may worsen when breathing deeply
• severe dizziness or vertigo
• 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”).

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. Most cases 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 of first-time use of a combined hormonal contraceptive. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same medication or a different one) 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 Lucille, 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 venous thromboembolism (VTE) and on 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 Lucille 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 desogestrel, such as Lucille, about 9–12 will develop a blood clot in one year.
• The likelihood 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 Lucille is low, but certain conditions can increase it. Your risk is higher:

• if you are very overweight (body mass index or BMI above 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 may have an inherited blood clotting disorder;
• if you are due to undergo surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in a cast. You may need to stop taking Lucille several weeks before surgery or during periods of reduced mobility. If you need to stop taking Lucille, 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 when you have more than one of these conditions.
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 above.
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 stop your use of Lucille.
If any of the conditions listed above change while you are using Lucille—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 can 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 Lucille is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Lucille, it is advisable to stop smoking. If you cannot 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 of them is particularly severe, the risk of developing a blood clot may be even higher.
If any of the conditions listed above change while you are using Lucille—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.

The Pill and Cancer
Breast cancer has been diagnosed slightly more frequently in women using the Pill compared to women of the same age who do not use it. This slight increase in breast cancer diagnoses gradually disappears within 10 years after stopping the Pill. It is not known whether the Pill causes this difference. It may be that women are examined more frequently, leading to earlier detection of breast cancer.
Benign liver tumors have been reported rarely in women taking the Pill, and malignant liver tumors even more rarely. These tumors may cause internal bleeding. Consult your doctor immediately if you experience severe abdominal pain.
Cervical cancer is caused by infection with human papillomavirus (HPV). It has been reported to occur more frequently in women who use the Pill for long periods. It is not known whether this is due to hormonal contraceptive use or to sexual behavior and other factors (such as more frequent cervical screening).

Children and adolescents
There are no clinical data on efficacy and safety in adolescents under 18 years of age.

Other medicines and Lucille
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines:

• can affect the levels of Lucille in the blood;
• can make it less effective in preventing pregnancy;
• cause unexpected bleeding. These include medicines used to treat:
  • epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
  • tuberculosis (e.g., rifampicin, rifabutin);
  • HIV or Hepatitis C virus infections (known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nelfinavir, nevirapine, efavirenz) and/or combinations with medicines against hepatitis C virus (HCV) (e.g., boceprevir, telaprevir) or other infections (griseofulvin, rifabutin);
  • fungal infections (griseofulvin, ketoconazole);
  • arthritis, osteoarthritis (etoricoxib);
  • high blood pressure in the blood vessels of the lungs (bosentan);
  • herbal preparations containing St. John's wort ( Hypericum perforatum ), used mainly for the treatment of depressed mood.

Lucille can also affect the action of other medicines (e.g., cyclosporine, the antiepileptic lamotrigine—this could lead to an increase in the frequency of epileptic seizures).
Also inform any other doctors or dentists who prescribe other medicines (or the pharmacist) that you are using Lucille, so they can advise whether and for how long you need to use additional contraceptive methods.
Do not use Lucille if you have Hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or
sofosbuvir/velpatasvir/voxilaprevir, as this may cause increases in blood tests for liver function (increase in liver enzyme ALT).
Your doctor will prescribe another type of contraceptive before starting treatment with these medicines.
Lucille may be restarted approximately 2 weeks after completion of this treatment. See section “Do not use Lucille”.

Laboratory tests
If you are undergoing blood or urine tests, inform healthcare professionals that you are taking Lucille, as it may affect the results of some tests.

Pregnancy and breastfeeding
Pregnancy
Lucille must not be used during confirmed or suspected pregnancy. If you suspect pregnancy while taking Lucille, consult your doctor as soon as possible.
Breastfeeding
Lucille is generally not recommended during breastfeeding. If you wish to use the Pill during breastfeeding, consult your doctor.

Driving and use of machinery
No effects have been observed.

Lucille contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

When should you contact your doctor?
Regular check-ups
While using the Pill, your doctor will ask you to attend regular check-up visits. Generally, you should have a check-up once a year.

Contact your doctor as soon as possible if:

• you notice possible signs of a blood clot, which may indicate you have a blood clot in the leg (deep vein thrombosis), in the lungs (pulmonary embolism), a heart attack, or a stroke (see BLOOD CLOTS in the section above). For a description of symptoms of these serious side effects, see “HOW TO RECOGNIZE A BLOOD CLOT”.
• you notice any change in your health status, particularly related to the conditions mentioned in this patient information leaflet (see also section 2 and more specifically the subsection “Do not use”; do not forget references to changes in the health status of close family members);
• you detect a lump in your breast;
• you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives together with breathing difficulties;
• you need to take other medicines (see also section 2 “Other medicines and Lucille”);
• you are immobile or need to undergo surgery (consult your doctor at least four weeks in advance);
• you have heavy and unusual vaginal bleeding;
• you have forgotten to take tablets during the first week of the pack and have had sexual intercourse in the previous seven days;
• you have severe diarrhea;
• you miss two periods in a row or suspect pregnancy (do not start a new pack until you have consulted your doctor).

3. How to use Lucille

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
When and how to take the tablets
The Lucille pack contains 21 tablets: 7 yellow tablets (numbered 1 to 7), 7 red
tablets (numbered 8 to 14) and 7 white tablets (numbered 15 to 21).
Take one tablet every day at the same time, with water if necessary. Each
time you start a new pack of Lucille, take the yellow tablet marked number 1,
located in the top left corner of the blister. Choose from the seven adhesive labels with the days of the week the one corresponding to the day you start taking Lucille. Attach the label with the day of the week to the blister, directly above the row of yellow tablets. This way you can easily check whether you have taken the daily tablet. Follow the direction of the arrows until all 21 tablets have been taken, starting with the yellow ones, then the red ones and finally the white ones. For the next 7 days, do not take any tablets. During these 7 days, vaginal bleeding (withdrawal bleeding) should begin. This usually starts 2–3 days after the last tablet of Lucille. Start the new pack on the eighth day, even if withdrawal bleeding is still occurring. This means that each new pack will always be started on the same day of the week, and withdrawal bleeding will occur approximately on the same days each month.
Starting the first pack of Lucille

• When no hormonal contraceptive has been used in the previous month. Start taking Lucille on the first day of your cycle, that is, the first day of menstrual bleeding. Lucille is effective immediately, and no additional contraceptive method is needed. You may also start between day 2 and day 5 of the cycle, but in this case you must use an additional contraceptive method (barrier method) for the first 7 days of tablet-taking in the first cycle.
• Switching from another combined hormonal contraceptive (combined oral contraceptive pill (COC), vaginal ring, or transdermal patch). You may start taking Lucille the day after taking the last tablet of the previous contraceptive (i.e. without any pill-free interval). If the previous contraceptive pack contains inactive tablets, you may start Lucille the day after taking the last active tablet (in case of doubt, consult your doctor or pharmacist). You may also start later, but never later than the day after the pill-free interval of the previous contraceptive (or the day after the last inactive tablet of the previous contraceptive). If switching from a vaginal ring or transdermal patch, start Lucille preferably on the day of removal of the ring or patch, or at the latest on the day when the next ring or patch would have been due.

If you have used the pill, patch, or ring consistently and correctly and are sure you are not
pregnant, you may stop taking the pill or remove the ring or patch on any day and start Lucille immediately.
If you follow these instructions, no additional contraceptive method is needed.

• Switching from a progestogen-only pill (mini-pill). You may stop the mini-pill on any day and start taking Lucille the next day at the same time. However, if you have sexual intercourse, make sure to use an additional contraceptive method (barrier method) for the first 7 days of taking Lucille.
• Switching from a progestogen-only injectable contraceptive, implant, or intrauterine device (IUD). Start using Lucille on the day when the next injection would have been due, or on the day the implant or intrauterine device is removed. However, if you have sexual intercourse, make sure to use an additional contraceptive method (barrier method) for the first 7 days of taking Lucille.
• After childbirth. After childbirth, your doctor may advise waiting until after your first normal menstrual cycle before starting Lucille. Sometimes it is possible to start earlier. Follow your doctor’s recommendations. If you are breastfeeding and wish to take Lucille, you must discuss this with your doctor first.
• After a spontaneous or induced abortion. Follow your doctor’s advice.

If you take more Lucille than you should
No serious harmful effects have been reported from taking too many Lucille tablets at once. If more tablets have been taken at once, nausea, vomiting or vaginal bleeding may occur. If you find out that a child has taken Lucille, consult your doctor.
If you forget to take Lucille

• If less than 12 hours have passed since the usual time of taking the tablet, the reliability of the pill is maintained. Take the missed tablet as soon as you remember, and take the following tablets as usual.
• If more than 12 hours have passed since the usual time of taking the tablet, the reliability of the pill may be reduced. The greater the number of consecutive tablets missed, the higher the risk that contraceptive protection is reduced. The risk of pregnancy is particularly high if yellow tablets at the beginning of the pack or white tablets at the end of the pack are missed. Follow the instructions below (see also the following scheme).

More than one tablet missed in a pack
Consult your doctor.
1 tablet missed during the first week (yellow tablets)
Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and continue taking the following tablets as usual. Use additional contraceptive methods (barrier method) for the next 7 days.
If you had sexual intercourse during the week before the missed tablet, there is a possibility of pregnancy. Inform your doctor immediately.
1 tablet missed during the second week (red tablets)
Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and continue taking the following tablets as usual.
The reliability of the pill is maintained. No additional contraceptive precautions are needed.
1 tablet missed during the third week (white tablets)
You may choose one of the following alternatives, without needing additional contraceptive precautions.

1. Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and continue taking the following tablets as usual. Start the new pack immediately after finishing the current one, without any interval between the two packs. Withdrawal bleeding may not occur until the end of the second pack, and you may experience spotting or breakthrough bleeding during tablet-taking.

Or

2. Stop taking the tablets in the current pack, observe a pill-free interval of 7 days or less ( including the day of the missed tablet ), and then start a new pack. If you choose this option, you can start the new pack on the same day of the week as you usually do.

If you have missed tablets in a pack and do not have your period during the first normal pill-free interval, pregnancy may have occurred. Consult your doctor before starting the new pack.
If you suffer from gastrointestinal disorders (e.g. vomiting, severe diarrhoea)
If vomiting or severe diarrhoea occurs, the active ingredients of Lucille tablets may not have been completely absorbed. If vomiting occurs within 3–4 hours after taking a tablet, it is as if the tablet had been missed. In this case, follow the instructions for missed tablets. In case of severe diarrhoea, consult your doctor.
If you wish to change the day when your period starts
If tablets are taken correctly, menstruation will occur approximately on the same day every 4 weeks. If you wish to shift the onset of menstruation, you should shorten (never extend) the next pill-free interval. For example, if your period usually starts on Friday and you wish it to start on Tuesday (3 days earlier), you should start the next pack 3 days earlier than usual. If the pill-free interval is made very short (e.g. 3 days or less), bleeding may not occur during the interval. You may experience breakthrough bleeding or spotting during the intake of tablets from the next pack.
If you have unexpected bleeding
In the first few months of taking the pill, irregular vaginal bleeding (spotting or breakthrough bleeding) between periods may occur with all oral contraceptives. You may need to use sanitary protection, but you should continue taking the tablets as usual. Irregular vaginal bleeding usually stops once your body has adapted to the pill (usually after about 3 months).
Consult your doctor if bleeding persists, becomes heavy, or recurs.
If you do not have your periods
If all tablets have been taken correctly and there has been no vomiting or use of other medicines, it is very unlikely that you are pregnant. Continue using Lucille as usual.
If you do not have your period for two consecutive months, pregnancy may have occurred. Consult your doctor immediately. Do not start a new pack of Lucille until your doctor has ruled out pregnancy.
If you wish to stop using Lucille
You may stop using Lucille at any time. If you do not wish to become pregnant, consult your doctor about other methods of birth control.
If you stop using Lucille because you wish to become pregnant, wait until you have had a natural menstrual period before trying to conceive. This helps to calculate the expected date of delivery.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lucille 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 may be due to Lucille, inform your doctor.
All women taking combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism, VTE) or blood clots in the arteries (arterial thromboembolism, ATE). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you should know before using Lucille”. Other serious reactions observed with the Pill are described in section 2 “Warnings and precautions”.

Serious side effects
Contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible difficulty breathing (see also “Warnings and precautions”).

Common: may affect more than 1 in 10 women

• Depressed mood, mood changes
• Headache
• Nausea, abdominal pain
• Breast pain, breast tenderness
• Weight gain

Uncommon: may affect more than 1 in 100 women

• Fluid retention
• Decreased sexual desire
• Migraine
• Vomiting, diarrhoea
• Skin rash, urticaria
• Breast enlargement

Rare: may affect more than 1 in 1,000 women

• Harmful blood clots in a vein or an artery, for example: in a leg or foot (DVT), in a lung (PE), heart attack, stroke, mini-stroke, or temporary symptoms similar to stroke known as transient ischaemic attack (TIA), 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).
• Hypersensitivity reactions
• Increased sexual desire
• Intolerance to contact lenses
• Erythema nodosum, erythema multiforme (these are skin disorders)
• Breast discharge, vaginal discharge
• Weight loss

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lucille

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack.
Store below 30°C. Keep in the original packaging.
Do not use this medicine if you notice, for example, any change in the tablet's colour,
tablet crumbling, or any other visible signs of deterioration.
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 Lucille contains
The active substances are:
yellow tablets: desogestrel (0.050 mg) and ethinylestradiol (0.035 mg)
red tablets: desogestrel (0.100 mg) and ethinylestradiol (0.030 mg)
white tablets: desogestrel (0.150 mg) and ethinylestradiol (0.030 mg)
The other components are:
tablet core:
all-rac-alpha-tocopherol;
lactose monohydrate;
potato starch;
povidone;
anhydrous colloidal silica;
stearic acid.
coating:
yellow, red and white tablets:
hypromellose;
macrogol 400;
talc;
titanium dioxide (E171).
yellow tablets:
yellow iron oxide (E172).
red tablets:
red iron oxide (E172).

Description of the appearance of Lucille and package contents
Lucille is available in packs of 1, 3 and 6 strips of 21 tablets (7 yellow tablets, 7 red tablets and 7 white tablets), packaged in a cardboard carton.
The tablets are biconvex, round and 5 mm in diameter. The tablets are marked “VR 4” (yellow tablets), “VR 2” (red tablets), “TR 5” (white tablets) on one side and are smooth on the other side.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24, Ireland
Tel: 0039 0687502429

Manufacturer
N.V. Organon, PO Box 20, 5340 BH, Kloosterstraat 6, Oss, Netherlands

Alternative manufacturer for packaging and final control
Cyndea Pharma, S.L, Polígono Industrial Emiliano Revilla Sanz, Avenida de Ágreda, 31 Ólvega
42110 (Soria), Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Czech Republic/Finland/Greece/Portugal: Laurina
Germany: Novial
Italy: LUCILLE