Logest(Minigeste)
Gestodene + Ethinylestradiol
Logest and Minigeste are different trade names for the same drug.
Logest is a combined oral contraceptive used to prevent pregnancy.
Each tablet contains a small amount of two different hormones. These are: gestodene (progestogen) and
ethinylestradiol (estrogen). Due to the small hormone content, Logest is classified as a low-dose drug.
Oral contraception is a very effective method of preventing pregnancy. During correct use of oral hormonal contraceptives, the likelihood of becoming pregnant is very low.
Before starting to take Logest, 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").
Logest should not be used if the patient has any of the conditions listed below. If the patient has any of the conditions listed below, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.
Logest should not be used if the patient has any of the conditions listed below. If the patient has any of the conditions listed below, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.
When not to use Logest:
Logest should not be used if the patient has hepatitis C and is taking antiviral drugs containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section "Logest and other drugs").
Before starting to take Logest, the patient should discuss it with their doctor or pharmacist.
When to contact a doctor?
The patient should see a doctor immediately
The patient should tell their doctor if they have any of the following conditions.In certain situations, the patient should exercise extra caution when using Logest or any other combined oral contraceptive. Regular medical check-ups may also be necessary. If any of the following conditions occur, the patient should inform their doctor before starting to take Logest. If these symptoms appear or worsen while taking Logest, the patient should also tell their doctor.
if they have varicose veins,
The use of combined hormonal contraceptives, such as Logest, is associated with an increased risk of blood clots compared to not using 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 long-lasting or, very rarely, fatal.
The patient should see a 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
| Pulmonary embolism |
Objawy występują najczęściej w jednym oku:
| Retinal vein thrombosis (blood clot in the eye) |
| Heart attack |
| Stroke |
| Blood clots blocking other blood vessels |
The risk of forming blood clots in veins is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of combined hormonal contraceptives (the same or a different drug) after a break of 4 weeks or more.
After the first year, the risk decreases, although it is always higher compared to not using combined hormonal contraceptives.
If the patient stops using Logest, the risk of blood clots returns to normal within a few weeks.
The risk of blood clots associated with Logest is small, but certain factors can increase this risk. The risk is higher:
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 heart attack or stroke associated with Logest 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 Logest, e.g., if they start smoking, someone in their immediate family is diagnosed with thrombosis without a known cause, or if they gain significant weight.
In the event of symptoms suggesting thrombosis, the patient should stop taking the tablets and consult their doctor immediately (see also "When to contact a doctor").
Women who take oral contraceptives have a slightly higher incidence of breast cancer than women of the same age who do not take them. It is not known whether this difference is caused solely by the use of hormonal contraceptives. The reason may also be that women who use hormonal contraceptives are more likely to be examined and have breast cancer detected earlier. The described difference in breast cancer incidence decreases gradually and disappears within 10 years of stopping oral contraceptives.
Rare cases of benign or, even more rarely, malignant liver tumors have been reported in women taking combined oral contraceptives. If severe abdominal pain occurs, the patient should inform their doctor as soon as possible.
There are reports of a higher incidence of cervical cancer in women who have used oral contraceptives for a long time. However, this association may not be related to the use of the tablets but to sexual behavior or other factors.
Some women who take hormonal contraceptives, including Logest, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, the patient should contact their doctor as soon as possible for further medical advice.
The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
Certain medications may affect the level of Logest in the blood and may reduce its effectiveness. These include medications used to treat: epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate), tuberculosis (e.g., rifampicin), HIV/HCV infection (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors), fungal infections (griseofulvin, azole antifungals, e.g., itraconazole, voriconazole, fluconazole), bacterial infections (macrolide antibiotics, e.g., clarithromycin, erythromycin), heart disease, high blood pressure (calcium channel blockers, e.g., verapamil, diltiazem), inflammation and degenerative joint disease (etoricoxib), other infectious diseases (e.g., griseofulvin), as well as products containing St. John's wort (Hypericum perforatum), used mainly to treat depressive moods, and grapefruit juice.
Oral contraceptives may affect the metabolism of other medications, whose levels in the blood and tissues may increase (e.g., cyclosporine) or decrease (e.g., lamotrigine). Logest may also affect melatonin, midazolam, theophylline, and tizanidine.
Logest should not be used if the patient has hepatitis C and is taking antiviral drugs containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as they may cause abnormal liver function test results in the blood (increased liver enzyme activity). The doctor will recommend a different type of contraception before starting these medications. Logest can be resumed about 2 weeks after the end of treatment. See section "When not to use Logest".
Note: The patient should read the information in the leaflets of other medications they are taking to recognize possible interactions.
Logest can be taken with or without food, and the tablet can be swallowed with a small amount of liquid if necessary. Logest should not be taken with grapefruit juice.
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 using this medication.
Pregnancy
Women who are pregnant should not take Logest. If the patient becomes pregnant while taking Logest, they should stop taking it immediately and consult their doctor. If the patient wants to become pregnant, they can stop taking Logest at any time (see section "Stopping Logest").
Breastfeeding
It is generally not recommended to use Logest while breastfeeding. If the patient wants to take oral contraceptives while breastfeeding, they should consult their doctor.
No effects of Logest on the ability to drive or use machines have been observed.
If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking Logest.
The patient should contact their doctor immediately if:
The situations and symptoms listed above are described in more detail in other parts of this leaflet.
This medication should always be used as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
The leaflet describes many situations in which the patient should stop taking Logest or in which the effectiveness of the drug may be reduced. It also lists circumstances in which the patient should not have sexual intercourse or should use additional contraceptive methods, such as condoms or other mechanical methods. The calendar method and temperature measurement method cannot be used because Logest affects temperature changes and cervical mucus properties characteristic of the menstrual cycle.
The blister pack contains 21 sugar-coated tablets. On the packaging, each tablet is marked with a symbol of the day of the week on which it should be taken (see: "Translation of day of the week symbols on the immediate packaging" at the end of the leaflet). The tablets should be taken in the order indicated on the packaging, every day, at approximately the same time, with a small amount of liquid if necessary. For 21 consecutive days, the patient should take 1 tablet per day.
Each subsequent pack should be started after a 7-day break, during which no tablets are taken, and when withdrawal bleeding usually occurs. Bleeding usually starts within 2-3 days of taking the last tablet and may still occur after starting the next pack. This means that the patient should always start each subsequent pack on the same day of the week, and bleeding will occur at approximately the same time every month.
If the patient has not taken oral contraceptives in the last month
The patient should start taking the tablets on the 1st day of their natural menstrual cycle (i.e., on the 1st day of menstrual bleeding). The patient can also start taking the tablets between the 2nd and 5th day of the menstrual cycle; in this case, during the first cycle, it is recommended to use an additional mechanical contraceptive method for the first 7 days of taking the tablets.
If the patient has previously taken another combined oral contraceptive
The patient should start taking Logest on the 1st day after taking the last active tablet of the previous combined oral contraceptive, but no later than the 1st day after the usual break in taking active tablets or placebo in the previous combined oral contraceptive.
If the patient has previously taken a progestogen-only tablet (minipill)
The patient can stop taking the minipill on any day and start taking Logest at the same time. If the patient has sexual intercourse during the first 7 days of taking Logest, they should use an additional mechanical contraceptive method.
If the patient has previously used injectable, implant, or intrauterine contraceptive
The patient should consult their doctor if they have any doubts about the use of Logest.
The patient may experience nausea, vomiting, or vaginal bleeding. This type of bleeding may occur even in girls who have not yet started menstruating but have taken the drug by mistake.
There are no reports of severe side effects after taking multiple Logest tablets at once. If the patient has taken a higher dose of Logest than recommended or someone else has taken it, they should inform their doctor.
The patient can stop taking Logest at any time. The doctor will recommend other contraceptive methods. If the patient stops taking Logest because they want to become pregnant, they should wait until they have a natural menstrual period. This will help determine the expected date of delivery. If the patient has any doubts about using this medication, they should consult their doctor or pharmacist.
If it has been less than 12 hourssince the patient missed a tablet, the contraceptive effectiveness of Logest is maintained. The patient should take the missed tablet as soon as possible and take the next one at the usual time.
If it has been more than 12 hourssince the patient missed a tablet, the effectiveness of Logest may be reduced. The more consecutive tablets the patient misses, the higher the risk of reduced contraceptive effectiveness. The risk of becoming pregnant is particularly high if the patient misses tablets at the beginning or end of the pack. In this case, the patient should follow the rules below (see also the scheme below).
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 take the next one at the usual time. For the next 7 days, the patient should use an additional mechanical contraceptive method.
The patient should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and take the next one at the usual time. The contraceptive effectiveness of Logest is maintained, and there is no need to use additional contraceptive methods. However, if the patient has made other mistakes in taking the tablets or has missed more than 1 tablet, they should use an additional mechanical contraceptive method for 7 days.
The patient can choose one of the following options without the need for additional contraceptive methods, provided that they have taken the tablets correctly for the previous 7 days. If not, they should follow the first of the two options below and use an additional mechanical contraceptive method for 7 days.
If the patient misses a tablet and does not have withdrawal bleeding during the first break after taking the tablets, it is possible that they are pregnant. Before starting the next pack of Logest, the patient should consult their doctor.
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 you consider related to the use of the Logest drug, you should consult a doctor.
All women using combined hormonal contraceptives have an increased risk of blood clots in veins (venous thromboembolism) or blood clots in arteries (arterial thromboembolism). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, refer to section 2 "Important information before using the Logest drug".
Severe side effects related to the intake of the Logest drug and their symptoms are described in the following sections of the leaflet: "Blood clots" / "Logest drug and cancer". You should read these sections to obtain additional information and, if necessary, immediately consult a doctor.
You should immediately contact a doctor if any of the following symptoms of angioedema occur: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives that may cause difficulty breathing (see also the "Warnings and precautions" section).
Below are symptoms reported by patients taking the Logest drug, although they may not have been caused by the drug.
Frequent (more than 1 in 100 people):
Uncommon (more than 1 in 1000 people and less than 1 in 100 people):
Rare (less than 1 in 1000 people):
The likelihood of blood clots may be higher if you have any other risk factors (refer to section 2 for further information on risk factors for blood clots and symptoms of blood clots).
Below are very rare side effects or side effects whose symptoms occur with a delay and are related to the use of combined oral contraception (refer to the "Contraindications" and "Warnings and precautions" sections):
Cancers
Other clinical conditions
Impaired liver function.
Combined oral contraceptives may affect insulin resistance and glucose tolerance.
Crohn's disease and ulcerative colitis.
Chloasma.
If you have hereditary angioedema, exogenous estrogens may cause the occurrence or worsening of its symptoms.
In some people, during the use of the Logest drug, other side effects may occur.
If you experience any side effects, including any side effects 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.
By reporting side effects, you can help gather more information on the safety of the drug.
The drug should be stored out of sight and reach of children.
Do not store above 25°C. Protect from light.
Do not use this medicine after the expiry date stated on the package and blister. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
The active substances are gestodene (0.075 mg) and ethinylestradiol (0.020 mg).
Other ingredients of the drug are:
Core:lactose monohydrate, cornstarch, povidone 25,000, magnesium stearate.
Coating:sucrose, povidone 700,000, macrogol 6,000, calcium carbonate, talc, montan wax.
White, round, film-coated tablet.
The Logest drug film-coated tablets are packaged in PVC/Aluminum blisters in a cardboard box.
Package size:
1x21 film-coated tablets
3x21 film-coated tablets
To obtain more detailed information, please contact the marketing authorization holder or the parallel importer.
Bayer Portugal, Lda.
Avenida Vitor Figueiredo nº4- 4th floor
2790-255 Carnaxide
Portugal
Bayer A.G.
Muellerstrasse, 178
13353 Berlin
Germany
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing authorization number in Portugal, the country of export:
2494086
2494185
Parallel import authorization number: 86/24
Translation of day-of-the-week symbols on the immediate packaging:
SEG-Monday
TER-Tuesday
QUA-Wednesday
QUI-Thursday
SEX-Friday
SÁB-Saturday
DOM-Sunday
[Information about the trademark]
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