Lesine(Ethinylestradiol/Drospirenone 0.03 mg/3 mg Theramex)
3 mg + 0.03 mg, coated tablets
Drospirenonum + Ethinylestradiolum
Lesine and Ethinylestradiol/Drospirenone 0.03 mg/3 mg Theramex are different trade names for the same medicine.
Lesine is a contraceptive pill and is used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol.
Contraceptive pills that contain two hormones are called "combined" pills.
Before starting to take Lesine, you should read the information about blood clots (thrombosis) in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots (thrombosis)").
Before you can start taking Lesine, your doctor will ask you a few questions about your health and the health of your close relatives. Your doctor will also measure your blood pressure and, in individual cases, may also perform some other tests.
This leaflet describes several situations in which you should stop taking Lesine, or in which the effectiveness of Lesine may be reduced. In such situations, you should either not have sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. You should not use the calendar method or the temperature measurement method. These methods may be unreliable because Lesine modifies the monthly changes in body temperature and cervical mucus.
You should not take Lesine if you have any of the conditions listed below. If you have any of the conditions listed below, you should inform your doctor. Your doctor will discuss with you which other contraceptive method will be more suitable for you.
Additional information for special populations
Children and adolescents
Lesine is not intended for use in girls who have not yet started their menstrual cycle.
Elderly women
Lesine is not intended for use after menopause.
Women with liver disease
You should not take Lesine if you have liver disease. See also sections "When not to take Lesine" and "Warnings and precautions".
Women with kidney disease
You should not take Lesine if you have kidney failure or acute kidney failure. See also sections "When not to take Lesine" and "Warnings and precautions".
Before starting to take Lesine, you should discuss it with your doctor or pharmacist.
When should you contact your doctor?
You should see your doctor immediately
To find a description of the symptoms of these serious side effects, see "How to recognize a blood clot".
In certain situations, you should be particularly careful when taking Lesine or any other combined hormonal contraceptive, and you may need to have regular check-ups with your doctor.
If these symptoms occur or worsen while taking Lesine, you should also tell your doctor:
Taking combined hormonal contraceptives, such as Lesine, is associated with an increased risk of blood clots compared to not taking them. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur:
Not everyone who has a blood clot will recover completely. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.
You should see your doctor immediately if you notice any of the following symptoms.
Are you experiencing any of these symptoms?
What disease is likely to occur in you?
increased temperature in the affected leg;
| |
Symptoms usually occur in one eye:
| Retinal vein thrombosis (blood clot in the eye) |
| Heart attack |
| Stroke |
The risk of forming a blood clot in a vein is highest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when resuming combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to not taking combined hormonal contraceptives.
If you stop taking Lesine, the risk of blood clots returns to normal within a few weeks.
The risk of blood clots associated with taking Lesine is small, but some factors can increase this risk. The risk is higher:
The risk of blood clots increases with the number of risk factors present in you.
Taking a long-haul flight (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor.
It is essential to tell your doctor if any of these risk factors apply to you, even if you are not sure. Your doctor may decide to stop Lesine.
You should inform your doctor if any of the above conditions change while taking Lesine, e.g., if someone in your close family is diagnosed with a blood clot without a known cause or if you gain weight significantly.
Similar to blood clots in veins, blood clots in arteries can cause serious consequences, such as a heart attack or stroke.
It is essential to note that the risk of a heart attack or stroke associated with taking Lesine is very small, but it may increase:
If you have more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.
You should inform your doctor if any of the above conditions change while taking Lesine, e.g., if you start smoking, if someone in your close family is diagnosed with a blood clot without a known cause, or if you gain weight significantly.
Women taking combined contraceptives have a slightly higher risk of breast cancer, but it is not known if this is caused by the contraceptive. For example, it may be that more tumors are detected in women taking combined contraceptives because these women are examined by doctors more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives.
It is essential to examine your breasts regularly and contact your doctor if you feel any lump.
Women taking combined contraceptives have also been reported to have, in rare cases, benign liver tumors, and in even rarer cases, malignant liver tumors. If you experience unusual, severe abdominal pain, you should contact your doctor.
During the first few months of taking Lesine, you may experience unexpected bleeding (bleeding outside of the withdrawal week). If such bleeding lasts longer than a few months or starts after a few months, your doctor should investigate the cause.
If you have taken all the tablets according to the schedule, have not vomited, or had severe diarrhea, and have not taken any other medicines, it is very unlikely that you are pregnant.
If the expected withdrawal bleeding does not occur for the second time in a row, it may mean that you are pregnant. You should contact your doctor immediately. Do not start the next blister pack until you are sure you are not pregnant.
Some women taking hormonal contraceptives, including Lesine, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If you experience mood changes and symptoms of depression, you should contact your doctor as soon as possible for further medical advice.
You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should also tell any other doctor or dentist prescribing another medicine (or pharmacist) that you are taking Lesine. They may tell you whether you should use additional contraceptive methods (such as condoms) and for how long or whether you should modify the use of other medicines.
Some medicines may affect the level of Lesine in your blood and may make it less effective in preventing pregnancyor may cause unexpected bleeding. These include:
Lesine may affect the action of other medicines, such as:
medicines containing cyclosporin,
antiepileptic medicines containing lamotrigine (may lead to an increased frequency of epileptic seizures),
theophylline (used for breathing problems),
tizanidine (used to treat muscle pain and/or muscle spasms).
Before taking any medicine, consult your doctor or pharmacist.
You should not take Lesine if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may cause an increase in liver function test results in the blood (increase in liver enzyme ALT).
Your doctor will prescribe a different type of contraception before starting treatment with these medicines.
Lesine can be taken again about 2 weeks after the end of this treatment. See section "When not to take Lesine".
Lesine can be taken with or without food, if necessary with a small amount of water.
If a blood test is necessary, you should tell your doctor or laboratory staff that you are taking a contraceptive, as oral contraceptives may affect the results of some tests.
Pregnancy
Pregnant women should not take Lesine. If you become pregnant while taking Lesine, you should stop taking it immediately and contact your doctor.
If you want to become pregnant, you can stop taking Lesine at any time (see also "Stopping Lesine").
Before taking any medicine, consult your doctor or pharmacist.
Breastfeeding
Lesine is not usually recommended for women who are breastfeeding. If you want to use a contraceptive while breastfeeding, you should contact your doctor.
Before taking any medicine, consult your doctor or pharmacist.
There is no information to suggest that taking Lesine affects your ability to drive or use machines.
This medicine contains less than 1 mmol sodium (23 mg) per dose, which means it is essentially "sodium-free".
If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.
This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist.
You should take one Lesine tablet every day, if necessary with a small amount of water.
You can take the tablets with or without food, but you should take them at the same time every day.
The blister pack contains 21 tablets. The day of the week is printed next to each tablet. If, for example, you start taking the tablets on a Wednesday, you should take the tablet with "Wed" printed next to it (see "Translation of day symbols on the packaging" at the end of the leaflet).
You should move in the direction of the arrow on the blister pack until all 21 tablets have been taken.
Then, you should not take any tablets for 7 days. During these 7 days (also called the withdrawal week), you should experience bleeding. This is called "withdrawal bleeding", which usually starts on the 2nd or 3rd day of the withdrawal week.
On the 8th day after taking the last Lesine tablet (i.e., after the 7-day withdrawal week), you should start the next blister pack, regardless of whether the bleeding has stopped or not. This means you should start each new blister pack on the same day of the week, and the withdrawal bleeding should occur on the same days every month.
If you take Lesine in this way, you are protected from pregnancy during the 7 days when you are not taking tablets.
If you have had sexual intercourse after giving birth, before (re)starting Lesine, you should first make sure you are not pregnant or wait for your next menstrual period.
You should read the section on "Breastfeeding".
If you are unsure when to start taking Lesine, you should consult your doctor.
There are no reports of serious, harmful effects from taking too many Lesine tablets at once.
If you take several tablets at the same time, you may experience nausea and vomiting or vaginal bleeding. This type of bleeding may occur even in girls who have not yet started their menstrual cycle but have taken the medicine by mistake.
If you take too many Lesine tablets or if a child accidentally swallows some, you should consult a doctor or pharmacist.
The risk of reduced protection from pregnancy is highest if you miss tablets at the beginning or end of the blister pack. Therefore, you should follow the rules below (see also the diagram below):
You should contact your doctor.
You should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. You should then take the next tablets at the usual time and use additional protection, such as condoms, for the next 7 days. If you had sexual intercourse in the week before missing the tablet, there is a risk of pregnancy. In this case, you should contact your doctor.
You should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. You should then take the next tablets at the usual time.
Your protection from pregnancy is not reduced, and you do not need to use additional protection.
There are two options to choose from:
It is likely that you will experience menstrual bleeding at the end of the second blister pack, but you may also experience spotting or breakthrough bleeding while taking tablets from the second blister pack.
If you follow one of these two instructions, your protection from pregnancy will be maintained.
Missed more than 1 tablet from one blister pack
Consult a doctor
Yes
Did you have sexual intercourse in the week before missing the tablet?
In week 1.
No
In week 2.
If you vomit within 3-4 hours of taking a tablet or experience severe diarrhea, there is a risk that the active substances in the tablet have not been fully absorbed into your body.
The situation is similar to missing a tablet. After vomiting or diarrhea, you should take another tablet from a spare blister pack as soon as possible. If possible, you should take it within 12 hoursof the normal time of taking the tablet. If this is not possible or more than 12 hours have passed, you should follow the instructions in the section "What to do if you forget to take Lesine".
Although it is not recommended, you can delay your period by going directly to a new Lesine blister pack, skipping the tablet-free week, until the end of the pack.
You may experience spotting or breakthrough bleeding while taking tablets from the second blister pack. After the usual 7-day tablet-free period, you should starttaking tablets from the next blister pack.
You can ask your doctor for advice before deciding to delay your period.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If side effects occur, especially severe and persistent ones or changes in health that the patient considers related to the use of Lesine, you should consult a doctor.
In all women taking combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, you should refer to point 2 "Important information before taking Lesine".
The following side effects have been associated with the use of Lesine.
Common side effects (may occur in up to 1 in 10 people):
Uncommon side effects (may occur in up to 1 in 100 people):
Rare side effects (may occur in up to 1 in 1000 people):
The likelihood of blood clots may be higher if the patient has any other risk factors (see point 2 for more information on risk factors for blood clots and symptoms of blood clots).
If you experience any side effects, including any not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 side effects will help gather more information on the safety of the medicine.
The medicine should be stored out of sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
The active substances of Lesine are ethinylestradiol and drospirenone.
Each film-coated tablet contains 0.03 mg of ethinylestradiol and 3 mg of drospirenone.
The other ingredients are:
Tablet core: lactose monohydrate, corn starch, pregelatinized starch, cornstarch, crospovidone, povidone K 30, polysorbate 80, magnesium stearate.
Tablet coating Opadry II Yellow: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172).
Yellow, round film-coated tablets.
Lesine is available in boxes of 1 or 3 blisters, each containing 21 tablets. The packaging includes a cardboard wallet in which the blister should be placed.
For more detailed information, you should contact the marketing authorization holder or parallel importer.
Theramex Ireland Limited
3 Floor, Kilmore House,
Park Lane, Spencer Dock,
Dublin 1
D01YE64
Ireland
Laboratorios León Farma, S.A., Pol. Ind. Navatejera, C/La Vallina s/n, 24008-Villaquilambre, León,
Spain
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Prodlekpol Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Netherlands marketing authorization number, country of export:RVG 107290
Parallel import authorization number:698/15
maa– Monday
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[Information about the trademark]
Member State | Medicinal product name |
Norway: | Dretine 0,03 mg/3 mg tablets, film-coated |
Austria: | Dretine 0,03 mg/3 mg 21 film-coated tablets |
Czech Republic: | Softine 0,03 mg/3 mg film-coated tablets |
Spain: | Dretine 0.03 mg/3 mg film-coated tablets |
Hungary: | Corenelle 0.03 mg/3 mg film-coated tablets |
Ireland: | Dretine 0.03 mg/3 mg film-coated tablets |
Poland: | Lesine |
Slovakia: | Softine 0,03mg/3mg film-coated tablets |
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