Desogestrel + Ethinylestradiol
Marvelon and Marvelon 21 are different trade names for the same medicine.
Marvelon is a combined oral contraceptive. Each tablet contains a small dose of two different female hormones. These are desogestrel (progestagen) and ethinylestradiol (estrogen). Due to the small hormone content, Marvelon is called a low-dose contraceptive pill. Marvelon belongs to the group of monophasic, combined oral contraceptives, as all the tablets in the pack contain the same amount of hormones.
Marvelon is used to prevent pregnancy.
Oral contraception is a very effective method of birth control. The possibility of becoming pregnant while taking the contraceptive pills (provided that the patient does not forget to take the pills) is very small.
Before starting to take Marvelon, the patient should read the information about blood clots in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots").
This leaflet describes most situations where the patient should stop taking the pill or where the effectiveness of the pill may be reduced. In these situations, the patient should refrain from sexual intercourse or use additional, non-hormonal contraceptive methods, such as a condom or another mechanical method. The patient should not use the calendar method or the temperature measurement method. These methods may be ineffective because the contraceptive pill causes changes in temperature and cervical mucus that occur during the menstrual cycle.
Marvelon is prescribed by a doctor for each patient individually. The patient should not give Marvelon to others.
Marvelon should not be used to delay the start of menstrual bleeding.
In exceptional cases, where there is a need to delay the start of menstrual bleeding, the patient should consult a doctor.
Marvelon should not be taken if the patient has any of the conditions listed below. If the patient has any of these conditions, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.
If any of the above conditions occur for the first time while taking Marvelon, the patient should stop taking the medicine and consult a doctor, and use a non-hormonal contraceptive method during this time (see also section 2 "General notes").
Before starting to take Marvelon, the patient should discuss this with their doctor or pharmacist.
When should the patient contact their doctor?
The patient should see their doctor immediately
If these symptoms occur or worsen while taking Marvelon, the patient should also tell their doctor.
If any of the above factors occur for the first time while taking the tablets, the patient should contact their doctor immediately.
Taking combined hormonal contraceptives, such as Marvelon, 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 recovers fully from a blood clot. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.
The patient should see their doctor immediately if they notice any of the following symptoms.
Is the patient experiencing any of these symptoms?
Why is the patient likely to be suffering from
increased temperature in the affected leg;
| Pulmonary embolism |
Symptoms usually occur in one eye:
| Retinal vein thrombosis (blood clot in the eye) |
| Heart attack |
| Stroke |
| Blood clots blocking other blood vessels |
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 the patient stops taking Marvelon, the risk of blood clots returns to normal within a few weeks.
The risk of blood clots associated with taking Marvelon 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 the patient.
Taking a long-haul flight (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell the doctor if any of the above factors apply to the patient, even if they are not sure. The doctor may decide to stop the patient from taking Marvelon.
The patient should inform their doctor if any of the above conditions change while taking Marvelon, e.g., if they start smoking, if someone in their immediate family is diagnosed with a blood clot without a known cause, or if they gain significant weight.
Similarly to blood clots in veins, blood clots in arteries can cause serious complications, such as a heart attack or stroke.
It is essential to note that the risk of heart attack or stroke associated with taking Marvelon is very small, but it may increase:
If the patient has more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.
The patient should inform their doctor if any of the above conditions change while taking Marvelon, e.g., if they start smoking, if someone in their immediate family is diagnosed with a blood clot without a known cause, or if they gain significant weight.
Women taking contraceptive pills have a slightly higher risk of breast cancer than women of the same age who do not take the pill. This small increase in the risk of breast cancer disappears gradually within 10 years of stopping the pill. It is not known whether this difference is caused by the pill. It may be that women taking the pill are more likely to have their breasts examined and breast cancer is detected earlier.
In very rare cases, women taking the pill have been found to have benign liver tumors, and even more rarely, malignant liver tumors. These tumors can cause bleeding into the abdominal cavity. If the patient experiences severe abdominal pain, they should see their doctor immediately.
Chronic infection with the human papillomavirus (HPV) is the most significant risk factor for cervical cancer. It is thought that cervical cancer may occur slightly more often in women who have taken the pill for an extended period. This may not be caused by the pill. It is likely to be related to sexual behavior or other factors.
Some women taking hormonal contraceptives, including Marvelon, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, the patient should see their doctor as soon as possible for further medical advice.
The patient should always tell their doctor about any medicines or herbal products they are currently taking. The patient should also inform their doctor or dentist prescribing other medicines (or pharmacist) that they are taking Marvelon. They may inform the patient about the need to use additional contraceptive methods (e.g., condoms) and for how long, as well as whether it is necessary to modify the use of other medicines.
Certain medicines
This applies to medicines used to treat:
If the patient is taking medicines or herbal products that may reduce the effectiveness of Marvelon, they should use a mechanical contraceptive method as well. Due to the fact that the effect of another medicine on Marvelon may persist for up to 28 days after stopping the medicine, it is necessary to use additional mechanical contraception during this time.
Marvelon may affect the actionof other medicines, such as
If the patient has a hepatitis C virus infection and is taking medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir, pibrentasvir, they should not take Marvelon, as this may cause an increase in liver function test results in the blood (increase in liver enzyme ALT).
Before starting these medicines, the doctor will prescribe a different type of contraceptive.
Taking Marvelon can be resumed about 2 weeks after finishing this treatment. See section "When not to take Marvelon".
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Marvelon is contraindicated in pregnancy.
If the patient becomes pregnant while taking Marvelon, they should see their doctor immediately.
Marvelon should not be used during breastfeeding.
If the patient wishes to take Marvelon during breastfeeding, they should consult their doctor.
Taking Marvelon does not affect the ability to drive or use machines.
If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
There are no available clinical data on the efficacy and safety of Marvelon in children and adolescents under 18 years of age.
Regular check-ups
Women taking contraceptive pills should be informed by their doctor about the need for regular medical check-ups. These check-ups are usually performed once a year.
The patient should see their doctor immediately in the following cases:
This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
The pack of Marvelon contains 21 tablets. Each tablet has a symbol of the day of the week on which it should be taken. The tablets should be taken at the same time every day, if necessary with a glass of water. The patient should continue taking the tablets for 21 days, following the direction of the arrows. Then, they should wait for 7 days during which they do not take any tablets. Menstrual bleeding (withdrawal bleeding) should occur during these 7 tablet-free days. It usually starts 2-3 days after taking the last tablet of Marvelon. The patient should take the first tablet of the next pack on the 8th day, even if they are still bleeding. This means that the patient will always start a new pack on the same day of the week, and their period will occur at about the same time every month.
There are no available clinical data on the efficacy and safety of Marvelon in children and adolescents under 18 years of age.
The patient should start taking the first tablet of Marvelon on the first day of their menstrual cycle (i.e., the first day of their period). There is no need to use additional contraceptive methods.
The patient can also start taking the tablets between the 2nd and 5th day of their cycle, but in this case, they should use an additional contraceptive method (e.g., a condom) for the first 7 days of taking the tablets in the first cycle.
The patient can start taking Marvelon the day after taking the last active tablet of their previous contraceptive. If their previous contraceptive had placebo tablets, they can start taking Marvelon the day after taking the last active tablet (if in doubt, they should ask their doctor or pharmacist). The patient can also start taking Marvelon later, but no later than the day after the tablet-free period of their previous contraceptive (or the day after taking the last placebo tablet of their previous contraceptive).
In the case of a vaginal ring or patch, the patient should start taking Marvelon on the day they would normally remove the ring or patch, or on the day they would normally apply a new ring or patch.
The patient can stop taking the mini-pill and start taking Marvelon the next day, at the same time. The patient should also use an additional contraceptive method (e.g., a condom) for the first 7 days of taking the tablets in the first cycle, if they have sexual intercourse.
The patient should start taking Marvelon on the day they would normally have their next injection, or on the day the implant or intrauterine system is removed. The patient should also use an additional contraceptive method (e.g., a condom) for the first 7 days of taking the tablets, if they have sexual intercourse.
The doctor may advise the patient to wait until their first period before starting to take Marvelon. The doctor may also advise the patient to start taking the tablets earlier. If the patient is breastfeeding, they should discuss taking hormonal contraception with their doctor.
According to the doctor's advice.
No serious harmful effects have been reported after taking an overdose of Marvelon. If more than one tablet is taken at the same time, the patient may experience nausea, vomiting, or vaginal bleeding. If a child has taken Marvelon, the patient should consult their doctor.
The patient should consult their doctor.
The patient should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and continue taking the rest of the tablets as usual. For the next 7 days, the patient should use an additional contraceptive method (e.g., a condom). There is a risk of pregnancy if the patient has had sexual intercourse in the week before missing the tablet. The patient should consult their doctor.
The patient should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and continue taking the rest of the tablets as usual. The effectiveness of the pill is maintained, and there is no need to use additional contraceptive methods. If the above conditions are not met, or if the patient has missed more than one tablet, they should use an additional contraceptive method for the next 7 days.
You can stop taking Marvelon at any time. If you do not plan to become pregnant, you should ask your doctor for another contraceptive method.
In case of planning a pregnancy, it is usually recommended to wait until the first natural menstruation after stopping the tablets, which will make it easier to determine the expected date of delivery.
In case of any further doubts about the use of this drug, you should consult a doctor or pharmacist.
Like any medicine, Marvelon can cause side effects, although they do not occur in everyone. If side effects occur, especially severe and persistent ones, or changes in health that you consider related to the use of Marvelon, 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 thrombosis). To obtain detailed information about the various risk factors associated with the use of combined hormonal contraceptives, you should refer to point 2 "Important information before taking Marvelon".
You should immediately consult a doctor if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives potentially with dyspnea (see also point 2 "Important information before taking Marvelon").
Frequently(occurring more often than in 1 woman in 100, but less often than in 1 in 10 women):
Less frequently(occurring more often than in 1 woman in 1000, but less often than in 1 in 100 women):
Rarely(occurring more often than in 1 woman in 10,000, but less often than in 1 in 1000 women):
If you experience any side effects, including those not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products,
Aleje Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.
The medicine should be stored out of sight and reach of children.
Do not use the medicine after the expiration date stated on the package. The expiration date indicates the last day of the given month.
Store at a temperature below 25°C, in the original package.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of unused medicines. This will help protect the environment.
Do not use this medicine if you notice changes in the color of the tablets, crumbling of the tablets, or other visible signs of tablet degradation.
The active substances of the medicine are desogestrel in a dose of 0.15 mg and ethinylestradiol in a dose of 0.03 mg.
The other ingredients are: colloidal anhydrous silica, lactose monohydrate, potato starch, povidone, stearic acid, all-rac-α-tocopherol.
The tablets are round, biconvex, 6 mm in diameter, marked with code 5 below TR on one side and Organon* on the other.
21 tablets – 1 blister pack of 21 tablets.
63 tablets – 3 blister packs of 21 tablets.
PVC/Al blisters, each packaged separately in a cardboard box, with a paper sleeve.
A cardboard sleeve is attached to the package, in which you should place the blister pack after removing it from the protective foil.
Organon Biosciences S.R.L.
Strada Av. Popișteanu, Nr. 54A, Expo Business Park, Clădirea 2
Birou 306 și Birou 307, Etaj 3, Sectorul 1, Bucharest, Romania
N.V. Organon
Kloosterstraat 6, 5349 AB Oss
Netherlands
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Romania, the country of export: 1508/2009/01
1508/2009/02
Lu
[Information about the trademark]
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