Lusine

Italy
Brand name Lusine
Form tablets, film-coated
Active substance / Dosage
ETHINYLESTRADIOL
DROSPIRENONE
Prescription type Prescription only
ATC code
G03AA12
Registration number 041716
Manufacturer THERAMEX IRELAND LIMITED
Lusine tablets, film-coated

Table of Contents

Package Leaflet: Information for the User

Lusine 0.03 mg/3 mg film-coated tablets

Ethinylestradiol/Drospirenone
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.

  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, because it may be harmful to them.
  • If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

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

1. What Lusine is and what it is used for

  • Lusine 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 Lusine

General notes
Before starting to use Lusine, you must read the information about blood clots in paragraph 2. It is particularly important that you read about the symptoms of a blood clot (see paragraph 2 “Blood clots”).
Before taking Lusine, your doctor will ask you some questions about your personal medical history and that of your family members. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out additional tests.
This leaflet describes various situations that require discontinuation of Lusine or in which the safety of Lusine may be reduced. In such situations, 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 Lusine alters the monthly fluctuations in body temperature and cervical mucus.
Lusine, like all hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Do not use Lusine
Do not use Lusine 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 case.

  • if you have (or have ever had) a blood clot in a vein in your leg (deep vein thrombosis, DVT), in your lung (pulmonary embolism, PE), or in another organ;

  • 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 ever had a heart attack or a 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 a transient ischemic attack (TIA – temporary stroke-like symptoms);

  • if you have any of the following conditions, which may increase the risk of forming blood clots in the arteries:

    • if you have (or have ever had) a type of migraine called “migraine with aura”;

  • if you have (or have had in the past) a 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 (or have had in the past) or are suspected of having cancer of the breast or genital organs;

  • 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
When to be particularly careful with Lusine
Talk to your doctor or pharmacist before taking Lusine.
In certain situations, you need to be particularly cautious when using Lusine 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 Lusine, 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 defense system);
  • if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder that causes kidney failure);
  • if you have sickle cell anaemia (an inherited red blood cell disorder);
  • if you have high levels of fat 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 delivery you can start taking Lusine;
  • if you have inflammation of veins near the skin surface (superficial thrombophlebitis);
  • if you have varicose veins;
  • if you have epilepsy (see section “Taking Lusine with other medicines”);
  • if you have a disease that first occurred during pregnancy or during 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 involuntary movements (Sydenham’s chorea));
  • if you have or have had chloasma (skin pigmentation changes, especially on the face or neck, also known as “melasma” or “pregnancy mask”). In this case, avoid direct exposure to sunlight or ultraviolet radiation;
  • if you have hereditary angioedema, products containing oestrogens may trigger or worsen angioedema 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, seek immediate medical attention.
  • 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, tell 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 infection (e.g. a "common cold").
Symptoms occurring more frequently in one eye:
 sudden loss of vision or
 painless blurring of vision that may progress to vision loss		Retinal vein thrombosis (blood clot in the eye)
  • sudden pain, discomfort, pressure or heaviness in the chest;
    - squeezing sensation or fullness in the chest, one arm, or below 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
Heart attack
  • sudden numbness or weakness in the face, arm, or leg, especially on one side of the body;
    - sudden confusion, difficulty speaking or understanding speech;
    - sudden trouble 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
Stroke
seek urgent medical attention as you may be at risk of another stroke.
  • swelling and pale blue discoloration of a limb;
    - severe abdominal pain (acute abdomen)
Blood clots blocking other blood vessels

Breast cancer and Lusine
Breast cancer has been observed at a slightly increased frequency in women using combined oral contraceptives, but it is not known whether this is due to the treatment. For example, it is possible that more tumours are diagnosed in women using combined pills because they undergo more frequent medical check-ups. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important that you regularly examine your breasts and contact your doctor if you feel any lumps.

Benign liver tumours have been rarely observed in women taking oral contraceptives, and even more rarely, malignant liver tumours. Contact your doctor if you experience unusual and severe abdominal pain.

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

What to do if menstruation does not occur during the pill-free week
If you have taken all tablets correctly, have not vomited or had severe diarrhoea, and have not taken any other medicines, it is highly unlikely that you are pregnant.

If you do not have a period for two consecutive cycles, you may be pregnant. Contact your doctor immediately. Do not start the next pack until you are certain you are not pregnant.

Other medicines and Lusine
Inform your doctor if you are taking any other medicines, including herbal preparations. Also, tell any other doctor or dentist who prescribes you a medicine (or your pharmacist) that you are taking Lusine. They will advise you whether you need to use additional contraceptive measures (for example, condoms) and for how long.

Some medicines may affect blood levels of Lusine 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 and efavirenz)
    • other infections (griseofulvin)
    • high blood pressure in the blood vessels of the lungs (bosentan)
  • St. John’s wort (Hypericum perforatum)

Lusine may affect the effect of other medicines, for example:

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

Consult your doctor or pharmacist before taking any medicine.

Lusine with food and drinks
Lusine can be taken with or without food, if necessary with a little water.

Laboratory tests
If you are due to have a blood test, inform your doctor or laboratory staff that you are taking the pill, as hormonal contraceptives may influence the results of certain laboratory tests.

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

Consult your doctor or pharmacist before taking any medicine.

Breast-feeding
The use of Lusine is not recommended during breast-feeding. If you wish to take the pill while breast-feeding, you must consult your doctor.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
There is no evidence to suggest that Lusine affects the ability to drive or use machines.

Lusine contains lactose.
If your doctor has told you that you have an intolerance to some sugars, contact him before taking this medicine.

3. How to take Lusine

Take this medicine exactly as directed by your doctor or pharmacist. If you are
unsure, consult your doctor or pharmacist.
Take one Lusine tablet every day, with or without water. You may take the tablets with or without food, but you must take them at about 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 label 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 referred to as the "tablet-free interval" or "hormone-free interval"), your menstrual period will occur. Usually, this so-called "withdrawal bleeding" starts on the second or third day of the tablet-free interval.
Start the next blister pack on the eighth day after taking the last Lusine tablet (i.e., after the 7-day tablet-free interval), regardless of whether your menstrual bleeding has stopped. In this way, you will always start a new Lusine blister pack on the same day of the week, and your periods will occur on the same days each month.
When taking Lusine 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 Lusine on the first day of your cycle (i.e., the first day of your menstrual period). If you start taking Lusine on the first day of your period, contraceptive protection is immediate. You may also start between day 2 and day 5 of your cycle; however, in this case, you must use additional contraceptive precautions (e.g., condoms) for the first 7 days.
  • Switching from a combined hormonal contraceptive or from a combined vaginal ring or contraceptive patch Start taking Lusine 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 tablet-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 (or on the day of removal of an implant or IUS, or when the next injection would have been due in the case of an injectable). However, in all these cases, you must use additional contraceptive precautions (e.g., condoms) for the first 7 days of tablet intake.
  • After an abortion Follow your doctor's advice.
  • After childbirth You may start taking Lusine 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., condoms) during the first 7 days of taking Lusine. If you have had sexual intercourse after childbirth before starting (or restarting) Lusine, you must first ensure that you are not pregnant or wait for your next menstrual period.
  • If you are breastfeeding and wish to start (or restart) taking Lusine after childbirth Read the section "Breast-feeding". Consult your doctor if you are unsure about when to start.

If you take more Lusine than you should
There have been no reports of serious harmful effects following an overdose of Lusine 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 Lusine tablets or if you discover that a child has taken any of the tablets, contact your doctor or pharmacist immediately.

If you forget to take Lusine
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 then 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 missed tablets, 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 pack. Therefore, follow the instructions below (see also the diagram below):

  • If you have missed more than 1 tablet in this pack Contact 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 precautions (e.g., condoms) for the next 7 days. 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 remains effective, and 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 tablet-free interval and start the next blister pack immediately.

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

  2. You may also stop taking tablets from the current pack and go directly into the 7-day tablet-free interval (note the day on which you missed the tablet). If you wish to start the next pack on your usual day, observe a tablet-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 tablets in the pack and do not have a withdrawal bleed during the first tablet-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 of taking a tablet or have severe diarrhoea, the active ingredients may not be completely 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. Ideally, take it within 12 hours of your usual tablet-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 Lusine".

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 Lusine immediately, without observing the 7-day tablet-free interval. During the use of this second pack, you may experience light bleeding or spotting. Start the next pack after the usual 7-day tablet-free interval.
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 begin during the tablet-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 tablet-free days. For example, if your tablet-free interval starts on Friday and you wish it to start on Tuesday (3 days earlier), you should start the next pack 3 days earlier. If you make the tablet-free interval very short (e.g., 3 days or less), you may not have a menstrual period during that interval. You may then experience light bleeding or spotting later.
Consult your doctor if you are unsure what to do.

If you wish to stop taking Lusine
You may stop taking Lusine 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 Lusine 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, Lusine can cause side effects, although not everybody gets 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 Lusine, 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 various risks associated with the use of combined hormonal contraceptives, see section 2 “What you need to know before taking Lusine”.
The following side effects have been reported with the use of Lusine:
Common side effects (may affect up to 1 in 10 people):

  • menstrual disorders, intermenstrual bleeding, breast pain
  • headache, depressed mood
  • migraine
  • nausea
  • thick, whitish vaginal discharge and vaginal yeast infections

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

  • changes in sexual desire
  • high blood pressure, low blood pressure
  • vomiting
  • acne, skin rash, intense itching
  • vaginal infection
  • fluid retention and changes in body weight

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

  • allergic reactions (hypersensitivity), asthma
  • breast discharge
  • hearing loss
  • skin diseases known as nodular erythema (characterized by red, painful skin nodules) or erythema multiforme (characterized by target-like skin lesions or ulcers)

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 Italian Medicines Agency (Agenzia Italiana del Farmaco) website: http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lusine

Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Expiry date
Do not use Lusine after the expiry date stated on the blister and on the packaging after the words "Do not use after:" or "EXP.:".
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Lusine contains
The active substances are ethinylestradiol and drospirenone.
Each tablet contains 0.03 mg ethinylestradiol and 3 mg drospirenone.
The other ingredients are:
Tablet core: monohydrate lactose, maize starch, pregelatinized starch (maize),
crospovidone, povidone, polysorbate 80, magnesium stearate.
Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350,
talc, yellow iron oxide (E172).
Description of the appearance of Lusine and contents of the pack
Yellow, round, film-coated tablets.
Lusine is available in packs of 1, 2, 3, 6 and 13 blisters, each containing 21 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
THERAMEX IRELAND LIMITED,
3RD FLOOR, KILMORE HOUSE, PARK LANE, SPENCER DOCK, DUBLIN 1, D01 YE64, IRELAND
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
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