Lesiplus

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Lesiplus (Drospirenone/Ethinylestradiol 3/0.02 mg 24+4 Theramex)
3 mg + 0.02 mg, film-coated tablets
Drospirenonum + Ethinylestradiolum
Lesiplus and Drospirenone/Ethinylestradiol 3/0.02 mg 24+4 Theramex are different brand names
of the same medicine.
Important information about combined hormonal contraceptives

• When used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of blood clots in veins and arteries, especially during the first year of use or after restarting following an interval of 4 weeks or more.
• Be vigilant and consult your doctor if you suspect symptoms of blood clots (see section 2 "Blood clots (thrombosis)").

Please read the entire leaflet before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, so you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm someone else.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Lesiplus is and what it is used for

• Lesiplus is a contraceptive medicine used to prevent pregnancy.
• Each of the 24 pink film-coated tablets contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol.
• The 4 white film-coated tablets without active substances are also called placebo tablets.
• Contraceptive tablets containing two hormones are known as "combined" tablets.

2. Important information before using Lesiplus

General notes
Before starting to take Lesiplus, you should read the information about
blood clots (thrombosis) in section 2. It is particularly important to be aware of the symptoms
of blood clots (see section 2 "Blood clots (thrombosis)").
Before you can start taking Lesiplus, your doctor will ask you several questions about your health
and the health of your close relatives. Your doctor will also measure your blood pressure and, depending on
your individual situation, may carry out some additional tests.
This leaflet describes several situations in which you should stop taking Lesiplus, or
in which the effectiveness of Lesiplus may be reduced. In such situations, you should either avoid
sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. Do not use the calendar method or temperature monitoring. These methods may be unreliable because Lesiplus alters the monthly changes in body temperature and cervical mucus.
Lesiplus, like other hormonal contraceptives, does not protect against infection
with HIV (AIDS) or other sexually transmitted diseases.

When not to use Lesiplus
Do not take Lesiplus if you have any of the conditions listed below.
If you have any of the conditions listed below, inform your doctor. Your doctor will discuss with you which other contraceptive method may be more suitable.

• if you currently have (or have ever had) a blood clot in a vein of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have blood clotting disorders — for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you are undergoing surgery or will be immobile for a prolonged period (see section "Blood clots (thrombosis)");
• if you have had a heart attack or stroke;
• if you have (or have had in the past) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following conditions that may increase the risk of arterial blood clots: o severe diabetes with blood vessel damage; o very high blood pressure; o very high levels of fats in the blood (cholesterol or triglycerides); o a condition called hyperhomocysteinemia;
• if you currently have (or have ever had in the past) a type of migraine called "migraine with aura";
• if you currently have (or have ever had in the past) liver disease and liver function remains abnormal;
• if you have kidney function disorders (kidney failure);
• if you currently have (or have ever had in the past) liver tumour;
• if you currently have (or have ever had in the past) or are suspected of having breast cancer or cancer of the genital organs;
• if you have any unexplained vaginal bleeding;
• if you are allergic to ethinylestradiol or drospirenone or any of the other ingredients of Lesiplus (listed in section 6). This allergy may cause itching, rash or swelling;
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also section "Lesiplus with other medicines").

Additional information for special populations
Children and adolescents
Lesiplus is not intended for use in girls who have not yet started menstruating.
Older women
Lesiplus is not intended for use after menopause.
Women with liver function disorders
Do not take Lesiplus if you have liver disease. See also sections "When not to use Lesiplus" and "Warnings and precautions".
Women with kidney function disorders
Do not take Lesiplus if you have kidney failure or acute kidney failure. See also sections "When not to use Lesiplus" and "Warnings and precautions".

Warnings and precautions
When should you contact a doctor?
You should contact your doctor immediately

• if you notice possible symptoms of blood clots, which may indicate that you have blood clots in the leg (deep vein thrombosis), in the lungs (pulmonary embolism), heart attack or stroke (see section below "Blood clots (thrombosis)").

For a description of the symptoms of these serious adverse effects, see "How to recognize blood clots".
In certain situations, special caution is required when using Lesiplus or any other combined hormonal contraceptive, and regular medical check-ups may be necessary.
You should tell your doctor if you have any of the following conditions.
If any of these conditions appear or worsen during treatment with Lesiplus, you should also inform your doctor.

• if there is currently or has ever been breast cancer in your close family;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you have depression;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease affecting the natural immune system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridaemia) or have a positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots (thrombosis)");
• if you are immediately postpartum, as you are then at increased risk of blood clots. Consult your doctor for advice on how soon you can start taking Lesiplus after delivery;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see "Lesiplus with other medicines");
• if you have a condition that first occurred during pregnancy or previous use of sex hormones (for example, hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (pemphigoid gestationis), a neurological disorder with involuntary body movements (Sydenham's chorea));
• if you currently have or have ever had in the past golden-brown skin discoloration (chloasma), also known as melasma, mainly on the face. If so, you should avoid direct exposure to sunlight or ultraviolet radiation;
• if you experience symptoms of angioedema such as swelling of the face, tongue and (or) throat and (or) difficulty swallowing, or urticaria that may cause breathing difficulties, you should contact your doctor immediately. Medicines containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

Before starting Lesiplus, discuss this with your doctor or pharmacist.

Blood clots (thrombosis)
Using combined hormonal contraceptives such as Lesiplus is associated with an increased risk of
blood clots, compared to not using hormonal contraception.
In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

• in veins (referred to below as "venous thrombosis" or "venous thromboembolic disease"),
• in arteries (referred to below as "arterial thrombosis" or "arterial thromboembolic events").

Recovery after a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots associated with taking Lesiplus is low.

How to recognize blood clots
Seek immediate medical attention if you notice any of the following symptoms.

Blood clots in veins
What can happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thrombosis). Although these adverse events are rare, they most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of first-time use of combined hormonal contraceptives. The risk may also be increased when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than in women who do not use combined hormonal contraceptives.
If a woman stops taking Lesiplus, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of developing blood clots?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Lesiplus is low.

• In one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In one year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Lesiplus, will develop blood clots.
• The risk of developing blood clots depends on the individual's medical history (see "Factors that increase the risk of blood clots" below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Lesiplus is small, but certain factors may increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years). In such cases, the patient may have an inherited tendency to clotting disorders;
• if the patient requires surgery, will be immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue Lesiplus several weeks before surgery or immobilization. If the patient must stop taking Lesiplus, she should consult her doctor about when it is safe to resume treatment.
• with increasing age (particularly over 35 years);
• if the patient has given birth within the last few weeks.

The risk of developing blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor listed above.
It is important to inform the doctor if any of the listed risk factors apply to the patient, even if uncertain. The doctor may decide to discontinue the use of Lesiplus.
The patient should inform her doctor if any of the above conditions change during treatment with Lesiplus, for example, if a close family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.

Arterial blood clots
What can happen if blood clots form in the arteries?
As with venous blood clots, arterial clots can lead to serious consequences, such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with the use of Lesiplus is very low, but it may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Lesiplus, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In such cases, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valve problems, heart rhythm disorders such as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of blood clots may be further increased.
The patient should inform her doctor if any of the above conditions change during treatment with Lesiplus, for example, if she starts smoking, if a close family member is diagnosed with unexplained thrombosis, or if she gains significant weight.

Lesiplus and cancer
In women using combined hormonal contraceptives, breast cancer is observed slightly more frequently, but it is not known whether this is caused by the use of the drug. For example, more cancers may be detected in women using combined hormonal contraceptives because these women are examined more frequently by doctors. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives.
It is important to examine the breasts regularly and to contact a doctor if any lump is detected.

Benign liver tumours have been reported, rarely, and malignant liver tumours have been reported even more rarely in women using combined hormonal contraceptives. If the patient experiences an unusual, severe abdominal pain, she should contact her doctor.

Intermenstrual bleeding
During the first few months of taking Lesiplus, unexpected bleeding (bleeding outside the placebo tablet period) may occur. If such bleeding persists for longer than a few months, or if it starts after several months of use, the doctor should investigate the cause.

What to do if withdrawal bleeding does not occur during the placebo tablet period
If all the pink active tablets have been taken correctly, without vomiting, severe diarrhoea, or use of other medications, it is very unlikely that the patient is pregnant.
If withdrawal bleeding does not occur twice in succession, this may indicate pregnancy. The patient should contact her doctor immediately. She should not start the next pack until pregnancy has been ruled out.

Psychiatric disorders
Some women using hormonal contraceptives, including Lesiplus, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, the patient should contact her doctor as soon as possible for further medical advice.

Lesiplus and other medicines
Always inform the doctor or pharmacist about all medicines or herbal products currently or recently taken, as well as any medicines the patient plans to take. The patient should also inform any other doctor or dentist prescribing a new medicine (or a pharmacist) that she is using Lesiplus. They may advise whether additional contraceptive methods (e.g. condoms) are needed, for how long, or whether other medicines need to be adjusted.

Do not administer Lesiplus to patients with hepatitis C virus infection who are taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may lead to increased liver test results (elevated liver enzyme AlAT activity).
The doctor will prescribe another type of contraception before starting treatment with these drugs.
Lesiplus may be restarted approximately 2 weeks after completion of this treatment.
See section "When not to use Lesiplus".

• Some medicines may affect the blood levels of Lesiplus and may cause Lesiplus to be less effective 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 infection (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
  • fungal infections (griseofulvin, ketoconazole);
  • arthritis, osteoarthritis (etoricoxib);
  • pulmonary hypertension (bosentan);
  • herbal products containing St John's wort (Hypericum perforatum).

• Lesiplus may affect the action of other medicines, for example:

  • medicines containing cyclosporine;
  • antiepileptic medicines;
  • theophylline (used for breathing problems);
  • tizanidine (used to treat muscle pain and/or muscle spasms);
  • medicines containing lamotrigine (may lead to increased frequency of epileptic seizures).

Always consult a doctor or pharmacist before taking any medicine.

Lesiplus with food and drink
Lesiplus may be taken with or without food and, if needed, with a small amount of water.

Laboratory tests
If a blood test is required, the patient should inform the doctor or laboratory staff that she is using hormonal contraceptives, as the hormones may affect the results of certain tests.

Pregnancy
Lesiplus must not be used during pregnancy. If the patient becomes pregnant while taking Lesiplus, she must stop taking it immediately and contact her doctor.
If the patient plans to become pregnant, she may stop taking Lesiplus at any time (see also "Discontinuing Lesiplus").

Before taking any medicine, consult your doctor or pharmacist.

Breast-feeding
Lesiplus is generally not recommended during breast-feeding. If the patient wishes to use a contraceptive during breast-feeding, she should consult her doctor.

Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines
There is no information suggesting that Lesiplus affects the ability to drive or operate machinery.

Lesiplus contains lactose
If the patient has been diagnosed with an intolerance to certain sugars, she should consult her doctor before taking this medicine.

Lesiplus contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is considered "sodium-free".

3. How to use Lesiplus

This medicine should always be used according to the instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Each blister contains 24 pink coated tablets and 4 white placebo tablets.
The Lesiplus tablets in two different colours are arranged in a specific order within the blister.
One blister contains 28 tablets.
Take one Lesiplus tablet daily, with or without a small amount of water.
You may take the tablets with or without food, but they should be taken daily at approximately the same time.

Do not confuse the tablets: take the pink tablets for the first 24 days, followed by the white placebo tablets for the next 4 days. Start a new blister immediately (first 24 pink tablets, then 4 white tablets). Therefore, there is no break between two blisters.

Due to differences in tablet composition, it is essential to start from the first tablet in the upper left corner of the blister and continue taking one tablet each day. To maintain the correct order, follow the direction of the arrows printed on the blister.

Preparing the blister
To help remember how to take the contraceptive, each Lesiplus blister is supplied with 7 self-adhesive strips printed with the days of the week. Choose the appropriate self-adhesive strip according to the day of the week on which you started taking the tablets. For example, if the first day of use was Wednesday, select the strip where the first day is marked "Wed".

Apply the label along the top edge of the blister where it says "Plaats het etiket hier" ("Place the label here"), so that the first day of the week is positioned above the tablet marked "1" on the reverse side of the blister. This way, each tablet is associated with the correct day of the week, allowing you to check whether a tablet has been taken. The arrows indicate the order in which the tablets should be taken.

During the 4 days when the white placebo tablets are taken (placebo days), withdrawal bleeding should occur (so-called withdrawal bleed). This bleeding usually starts on the 2nd or 3rd day after taking the last active pink tablet of Lesiplus. After taking the last white placebo tablet, start the next blister immediately, regardless of whether bleeding is still occurring. This means that each new blister will begin on the same day of the week, and bleeding should occur approximately on the same days each month.

If the patient takes Lesiplus as directed above, she is protected against pregnancy also during the 4 days when taking the placebo tablets.

When to start the first blister

• If no hormonal contraceptive has been used in the previous month
  Start taking Lesiplus on the first day of the menstrual cycle (i.e. the first day of menstruation). If the patient starts taking Lesiplus on the first day of her period, she is immediately protected against pregnancy. Alternatively, the tablets may be started between days 2–5 of the cycle, but in this case, an additional contraceptive method (e.g. a condom) must be used for the first 7 days.

• Switching from a combined hormonal contraceptive or a combined contraceptive vaginal system or transdermal system
  Start taking Lesiplus the day after taking the last active tablet (last tablet containing active ingredients) from the previous pack, but no later than the day after completing the tablet-free interval of the previous contraceptive (or after the last inactive tablet of the previous contraceptive). When switching from a combined contraceptive vaginal system or transdermal patch, follow your doctor’s advice.

• Switching from a progestogen-only method (progestogen-only minipill, injection, implant, or intrauterine system releasing progestogen)
  You may switch on any day from progestogen-only minipills (on the day of removal of an implant or intrauterine system, or on the scheduled date of the next injection), but in all these cases, an additional contraceptive method (e.g. a condom) must be used for the first 7 days of tablet taking.

• After miscarriage
  Follow your doctor’s advice.

• After childbirth
  After childbirth, you may start taking Lesiplus between day 21 and day 28 postpartum. If you start taking the medicine later than on day 28, use a barrier method (e.g. a condom) for the first seven days of taking Lesiplus. If sexual intercourse has occurred after childbirth, before (re)starting Lesiplus, the patient should first confirm she is not pregnant or wait until the next menstrual bleeding occurs.

• If breastfeeding and wishing to (re)start taking Lesiplus after childbirth
  Please read section "Breastfeeding".

If the patient is unsure when to start taking the medicine, she should consult her doctor.

Taking more than the recommended dose of Lesiplus

There are no reports of serious harmful effects following overdose with Lesiplus tablets.

If several tablets are taken at once, nausea, vomiting or vaginal bleeding may occur. Such bleeding may even occur in girls who have not yet started menstruating but have accidentally taken this medicine.

If too many Lesiplus tablets have been taken or if a child has swallowed them, consult a doctor or pharmacist immediately.

Missed dose of Lesiplus

The last four tablets in the fourth row of the blister are placebo tablets. If a patient misses one of these, the contraceptive efficacy of Lesiplus is maintained. Discard the missed placebo tablet.

If a pink tablet containing active ingredients (tablets 1–24 of the blister) is missed, follow the instructions below:

• If less than 24 hours have passed since the missed tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as possible, then continue taking the following tablets at the usual time.

• If more than 24 hours have passed since the missed tablet, protection against pregnancy may be reduced. The more tablets missed, the greater the risk of pregnancy. The risk of incomplete protection is greatest if a pink tablet is missed at the beginning or end of the blister. Therefore, follow the rules below (see also the chart below):

• Missing more than one tablet in a blister
  Contact your doctor.

• Missing one tablet between days 1–7 (first row)
  Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the remaining tablets at the usual time and use additional protection (e.g. a condom) for the next 7 days. If sexual intercourse occurred in the week before the missed tablet, there is a risk of pregnancy. In this case, consult your doctor.

• Missing one tablet between days 8–14 (second row)
  Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the remaining tablets at the usual time. Protection against pregnancy is not reduced and no additional protection is needed.

• Missing one tablet between days 15–24 (third and fourth rows)
  There are two options:

  1. Take the missed tablet as soon as possible, even if this means taking two tablets at once. Continue taking the remaining tablets at the usual time. Discard the white placebo tablets from this blister and immediately start taking tablets from the next blister (the starting day will be different).

Bleeding will most likely occur at the end of taking tablets from the second blister, during the placebo tablets, but breakthrough bleeding or spotting may also occur during the second blister.

2. Alternatively, stop taking the active pink tablets and go directly to the 4 white placebo tablets (before starting the placebo tablets, note the day on which the tablet was missed). If the patient wishes to start the next blister on her usual starting day, the placebo tablets should be taken for a period shorter than 4 days.

If either of these two options is followed, protection against pregnancy will be maintained.

• If a patient has missed any tablet from the blister and no bleeding occurs during the placebo tablet period, this may indicate pregnancy. In this case, consult a doctor before starting the next blister.

Missed more than 1 pink tablet from 1 blister
Consult your doctor

Missed only 1 pink tablet (taken more than 24 hours late)

Days 1–7
Did sexual intercourse occur in the week before the missed tablet?
Yes

• Take the missed tablet
• Use a barrier method (condom) for the next 7 days
• Finish the tablets in the blister

No

• Take the missed tablet
• Finish the tablets in the blister

Days 8–14

• Take the missed tablet
• Finish the tablets in the blister

Days 15–24
Option 1:

• Take the missed tablet
• Finish the active pink tablets
• Discard the 4 white placebo tablets
• Start the next blister immediately

Option 2:

• Immediately stop taking the active pink tablets
• Go directly to the 4 white placebo tablets
• Start the next blister

What to do if vomiting or severe diarrhoea occurs

If vomiting occurs within 3 to 4 hours after taking a pink active tablet, or if severe diarrhoea occurs, there is a risk that the active ingredients have not been completely absorbed. This situation is similar in effect to missing a tablet. After vomiting or diarrhoea, take another pink tablet from a spare pack as soon as possible. If possible, take it within 24 hours of the usual tablet-taking time. If this is not possible or more than 24 hours have passed, follow the advice given under "Missed dose of Lesiplus".

Delaying the onset of withdrawal bleeding: what you should know

Although not recommended, it is possible to delay the onset of withdrawal bleeding by skipping the white placebo tablets in the 4th row and immediately starting a new Lesiplus blister, continuing until it is finished. Breakthrough bleeding or spotting may occur during the second blister. Complete the second blister by taking the 4 white placebo tablets from the 4th row. Then start the next blister.

Consult your doctor for advice before deciding to delay the onset of bleeding.

Changing the first day of bleeding: what you should know

If the patient takes the tablets as instructed, bleeding will start during the placebo tablet week. If it is necessary to change this day, this can be done by shortening the placebo tablet period (when the white placebo tablets are taken) – but never by extending it – by up to 4 days.

For example, if the placebo tablet period starts on Friday, and the patient wishes to change it to Tuesday (3 days earlier), start the new blister 3 days earlier than usual. Bleeding may not occur during these days. As a result, spotting or breakthrough bleeding may occur.

If the patient is unsure how to proceed, she should contact her doctor.

Stopping use of Lesiplus

You may stop taking Lesiplus at any time. If the patient does not wish to become pregnant, she should consult her doctor about other effective methods of birth control. If the patient wishes to become pregnant, stop taking Lesiplus and wait for a menstrual period before trying to conceive. This makes it easier to calculate the expected due date.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any adverse reactions occur, especially severe and persistent ones, or changes in health status that the patient considers related to the use of Lesiplus, medical advice should be sought from a physician.
All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before using Lesiplus".

Serious adverse reactions
Seek immediate medical attention if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and (or) throat and (or) difficulty swallowing, or hives, which may lead to breathing difficulties (see also section "Warnings and precautions").

The following adverse reactions have been associated with the use of Lesiplus

• Common adverse reactions (may occur in up to 1 in 10 people): mood swings, headache, nausea, breast pain, menstrual disorders such as irregular menstruation, absence of menstruation.
• Uncommon adverse reactions (may occur in up to 1 in 100 people): depression, nervousness, drowsiness, dizziness, "tingling and numbness" sensations, migraine, varicose veins, high blood pressure, abdominal pain, vomiting, indigestion, flatulence, gastritis, diarrhoea, acne, itching, rash, pain, for example back, limb pain, painful muscle cramps, vaginal candidiasis, pelvic pain, breast enlargement, benign breast nodules, uterine and (or) vaginal bleeding (which usually resolves during treatment), vaginal discharge, hot flushes, vaginal inflammation (vaginitis), menstrual disorders, painful menstruation, scanty menstruation, very heavy menstruation, vaginal dryness, abnormal Pap smear results according to Papanicolaou classification, decreased libido, lack of energy, increased sweating, fluid retention, weight gain.
• Rare adverse reactions (may occur in up to 1 in 1000 people): candidiasis (fungal infection), anaemia, increased platelet count, allergic reactions, endocrine disorders, increased appetite, loss of appetite, abnormally high potassium levels in blood, abnormally low sodium levels in blood, inability to achieve orgasm, insomnia, dizziness, tremor, eye disorders, for example blepharitis, dry eye syndrome, abnormally fast heart rhythm, phlebitis, nosebleeds, fainting, abdominal distension, intestinal disease, feeling of fullness, abdominal hernia, oral candidiasis, constipation, dry mouth, pain in the biliary tract or gallbladder, cholecystitis, yellow-brown skin patches, eczema, abnormal hair growth (hirsutism), acneiform skin inflammation, dry skin, nodular skin inflammation, excessive hair loss (alopecia), skin disorders, striae, dermatitis, photosensitive dermatitis, skin nodules, painful and difficult sexual intercourse, vulvovaginitis, intermenstrual bleeding, withdrawal bleeding, breast cysts, increased number of breast cells (hyperplasia), malignant breast tumours, abnormal growth of the cervical mucosa, constriction or thinning of the endometrium, ovarian cysts, uterine enlargement, general malaise, weight loss, harmful blood clots in veins or arteries, for example:
  in the leg or foot (e.g. deep vein thrombosis),
  in the lungs (e.g. pulmonary embolism),
  heart attack,
  stroke,
  mini-stroke or transient stroke-like symptoms, known as transient ischaemic attack (TIA),
  blood clots in the liver, stomach and intestine, kidneys or eye.
  The likelihood of developing blood clots may be higher if the patient has any other factors increasing this risk (see section 2 for further information on factors increasing the risk of blood clots and symptoms of blood clot formation).

The following adverse reactions have been reported, but their frequency cannot be determined from available data: hypersensitivity, erythema multiforme (a rash with red, painful rings).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Lesiplus

Keep Lesiplus out of the sight and reach of children.
Do not use Lesiplus after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Translation of some information on the immediate packaging:
Plaats het etiket hier - Place the self-adhesive strip here.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Lesiplus contains
The active substances in this medicine are ethinylestradiol and drospirenone.
Each pink coated tablet contains the active substances: 0.02 milligrams of ethinylestradiol and 3
milligrams of drospirenone.
The white coated tablets do not contain any active substances.

Other ingredients are:
Pink coated tablets – containing active substances:
Monohydrate lactose, pregelatinized corn starch, povidone K 30, sodium croscarmellose,
polysorbate 80, magnesium stearate.
Tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).
White coated tablets (placebo):
Lactose, povidone K 30, magnesium stearate.
Tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc.

What Lesiplus looks like and contents of the pack

• Each Lesiplus blister pack contains 24 pink coated tablets containing active substances in rows 1, 2, 3 and 4, and 4 white coated tablets (placebo) in row 4.
• Lesiplus tablets, both pink and white, are coated tablets; the tablet core is film-coated.
• Lesiplus is available in cartons containing 1 or 3 blisters, each blister containing 28 tablets (24 + 4).

For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Netherlands, country of export:
Theramex Ireland Limited, 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1
D01 YE64, Ireland
Manufacturer:
Laboratorios León Farma, S.A., C/ La Vallina s/n, Pol Ind, Navatejera, 24008- León, Spain
Parallel importer:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorisation number in the Netherlands, country of export: RVG 109940
Parallel import authorisation number: 400/15