Iasminelle

1. What is Yasminelle and what is it used for

• Yasminelle is a contraceptive pill and is used to prevent pregnancy.
• Each coated tablet contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol.
• Contraceptive pills containing two hormones are called "combined" pills.

2. Important information before using Yasminelle

General notes

Before starting to take Yasminelle, one should read the information about blood clots in section 2. It is especially important to read about the symptoms of blood clots (see section "BLOOD CLOTS").
Before starting to use Yasminelle, the doctor will ask a few questions about health and about the health of close relatives. The doctor will also measure blood pressure and, if necessary, perform other examinations.
This leaflet describes several situations in which one should stop using Yasminelle or in which the reliability of Yasminelle may be reduced. In such situations, one should either not have sexual intercourse or use additional non-hormonal contraceptive methods, e.g. condoms or other mechanical methods. One should not use the calendar method or the temperature measurement method. These methods may be unreliable because Yasminelle modifies the monthly changes in body temperature and cervical mucus.

Yasminelle, like other hormonal contraceptive products, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

When not to use Yasminelle

Do not use Yasminelle if the patient has any of the following conditions. If the patient has any of the following conditions, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.

Do not use Yasminelle:

• if the patient is allergic to ethinylestradiol or drospirenone or any of the other ingredients of this medicine (listed in section 6). May cause: itching, rash or swelling;
• if the patient currently has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if the patient knows that they have blood coagulation disorders - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient needs to undergo surgery or will not be walking for a long time (see section "BLOOD CLOTS");
• if the patient has had a heart attack or stroke;
• if the patient has (or has had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (transient stroke symptoms);
• if the patient has any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides),
• a disease called hyperhomocysteinemia;
• if the patient has (or has had in the past) a type of migraine called "migraine with aura";
• if the patient has (or has had in the past) liver disease, and liver function is still abnormal;
• if the patient has kidney problems (kidney failure);
• if the patient has (or has had in the past) liver cancer;
• if the patient has (or has had in the past) or suspects breast or genital cancer;
• if the patient has unexplained vaginal bleeding.

Do not use Yasminelle in patients with hepatitis C and taking medicinal products containing ombitasvir, paritaprevir, and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section "Yasminelle and other medicines").
Additional information for special populations
Children and adolescents
Yasminelle is not intended for use in girls who have not yet started their menstrual cycle.
Women of advanced age
Yasminelle is not intended for use after menopause.
Women with liver function disorders
Yasminelle should not be taken if the patient has liver disease. See also sections "When not to use Yasminelle" and "Warnings and precautions".
Women with kidney function disorders
Yasminelle should not be taken if the patient has kidney failure or acute kidney failure. See also sections "When not to use Yasminelle" and "Warnings and precautions".

Warnings and precautions

When to contact a doctor
One should immediately contact a doctor

• if the patient notices possible symptoms of blood clots, which may indicate that the patient has blood clots in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), heart attack, or stroke (see section below "BLOOD CLOTS").

In order to obtain a description of the symptoms of the serious side effects mentioned, see section "How to recognize the occurrence of blood clots".

One should tell the doctor if the patient has any of the following conditions.

In certain situations, one should be particularly careful when using Yasminelle or any other combined hormonal contraceptive and regular medical examination may also be necessary. If these symptoms occur or worsen while using Yasminelle, one should also tell the doctor.

• if breast cancer has occurred or is present in the family;
• if the patient has liver or gallbladder disease;
• if the patient has diabetes;
• if the patient has depression;
• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if the patient has sickle cell anemia (a hereditary disease of red blood cells);
• if the patient has been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or has a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of pancreatitis;
• if the patient needs to undergo surgery or will not be walking for a long time (see section "BLOOD CLOTS");
• if the patient is immediately after childbirth, then she is at increased risk of blood clots. One should consult a doctor to find out how soon they can start taking Yasminelle after childbirth;
• if the patient has superficial thrombophlebitis (blood clots in the veins under the skin);
• if the patient has varicose veins;
• if the patient has epilepsy (see section "Yasminelle and other medicines");
• if the patient has systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if the patient has a disease that first appeared during pregnancy or while taking sex hormones (e.g. hearing loss, porphyria (a blood disease), herpes during pregnancy (a skin rash with blisters during pregnancy), Sydenham's chorea (a nervous system disease in which sudden movements of the body occur));
• if the patient has or has ever had chloasma (skin discoloration, especially on the face and neck, so-called pregnancy spots). If so, one should avoid direct exposure to sunlight or ultraviolet radiation;
• if the patient experiences symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives that may cause difficulty breathing, one should immediately contact a doctor. Estrogen-containing medications may cause or worsen symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS

The use of combined hormonal contraceptive products such as Yasminelle is associated with an increased risk of blood clots, compared to not using these products. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur:

• in veins (hereinafter referred to as "venous thromboembolism" or "venous thromboembolic disease");
• in arteries (hereinafter referred to as "arterial thromboembolism" or "arterial thromboembolic disease").

Not always is there a complete recovery after a blood clot. In rare cases, the effects of a blood clot can be permanent or very rarely fatal.

It should be remembered that the total risk of harmful blood clots caused by Yasminelle is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS

One should immediately contact a doctor if any of the following symptoms are noticed.

Is the patient experiencing any of these symptoms? Why is the patient likely to suffer?

• swelling of the leg or swelling along a vein in the leg or foot, Deep vein thrombosis

BLOOD CLOTS IN VEINS

What can happen if blood clots form in a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they can occur. Most often, they occur in the first year of using combined hormonal contraceptives.

In rare cases, blood clots can form in the veins of the leg or foot, which can lead to the development of deep vein thrombosis.

• If a blood clot forms in the veins of the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot moves from the leg and settles in the lungs, it can cause pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein the highest

The risk of blood clots in a vein 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 medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to not using combined hormonal contraceptives.
If the patient stops using Yasminelle, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The total risk of blood clots in the legs or lungs associated with Yasminelle is small.

• Within a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• Within a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• Within a year, about 9-12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Yasminelle, will develop blood clots.

The risk of blood clots depends on the patient's individual medical history (see section "Factors that increase the risk of blood clots", below).

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with Yasminelle is small, but some factors can increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) over 30 kg/m);
• if someone in the patient's immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years of age). In this case, the patient may have hereditary blood coagulation disorders;
• if the patient needs to undergo surgery or will not be walking for a long time (see section "BLOOD CLOTS");
• with age (especially over 35 years);
• if the patient has given birth in the last few weeks.

The risk of blood clots increases with the number of risk factors present in the patient.
Traveling by air (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
One should tell the doctor if any of the above factors apply to them, even if they are not sure. The doctor may decide to stop using Yasminelle.
One should inform the doctor if any of the above conditions change while using Yasminelle, e.g. if the patient starts smoking, if someone in their immediate family is diagnosed with a blood clot without a known cause, or if the patient gains weight significantly.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in an artery

Similarly to blood clots in veins, blood clots in arteries can cause serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It should be emphasized that the risk of heart attack or stroke associated with Yasminelle is very small, but it may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive like Yasminelle, it is recommended to quit smoking. If the patient is unable to quit smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's immediate family has had a heart attack or stroke at a young age (under 50 years of age). In this case, the patient may also be at increased risk of having a heart attack or stroke;
• if the patient or someone in their immediate family has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, arrhythmia called 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 even higher.
One should inform the doctor if any of the above conditions change while using Yasminelle, e.g. if the patient starts smoking, if someone in their immediate family is diagnosed with a blood clot without a known cause, or if the patient gains weight significantly.

Yasminelle and cancer

In women using combined hormonal contraceptives, breast cancer is slightly more common, but it is not known if this is caused by the pills. For example, it may be that more tumors are detected in women using combined hormonal contraceptives because they are examined more often by their doctors. The frequency of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important to regularly examine one's breasts and contact a doctor if any lumps are felt.
In women using the pill, rare cases of benign liver tumors and even rarer cases of malignant liver tumors have been reported. If one experiences unusual, severe abdominal pain, they should contact their doctor.

Mental disorders

Some women using hormonal contraceptives, including Yasminelle, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, one should contact a doctor as soon as possible for further medical advice.

Intermenstrual bleeding

During the first few months of taking Yasminelle, one may experience unexpected bleeding (bleeding outside of the break week). If such bleeding lasts longer than a few months or starts after a few months, the doctor should investigate the cause.

What to do if bleeding does not occur during the break week

If all the tablets have been taken according to the schedule, no vomiting or severe diarrhea has occurred, and no other medicines have been taken, it is very unlikely that the patient is pregnant.
If the expected bleeding does not occur twice in a row, it may mean that the patient is pregnant. One should immediately contact their doctor. One should not start the next blister until they are sure they are not pregnant.

Yasminelle and other medicines

Always inform the doctor about any medicines or herbal products that are already being taken.
One should also tell any other doctor, including the dentist or pharmacist, who prescribes another medicine that they are using Yasminelle. They may say that additional contraceptive products (e.g. condoms) should be used and, if so, for how long.
Some medicines may:

• affect the level of Yasminelle in the blood;
• make Yasminelle less effective in preventing pregnancy;
• cause unexpected bleeding.

This applies to medicines:

• used to treat: epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine), tuberculosis (e.g. rifampicin), HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz), fungal infections (e.g. griseofulvin, ketoconazole), arthritis, degenerative joint disease (etoricoxib), pulmonary hypertension (bosentan),
• herbal products containing St. John's wort ( Hypericum perforatum).

Yasminelle may affect the action of othermedicines, e.g.:

• containing cyclosporin,
• antiepileptic - lamotrigine (may lead to increased frequency of seizures),
• theophylline (used for breathing problems),
• tizanidine (used to treat muscle pain and/or muscle spasms).

Do not use Yasminelle in patients with hepatitis C and taking medicinal products containing ombitasvir, paritaprevir, and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as they may cause elevated liver function test results (elevated levels of the liver enzyme ALT).
The doctor will recommend a different type of contraception before starting these medicines.
One can resume using Yasminelle about 2 weeks after completing the treatment. See section "When not to use Yasminelle".
Before using any medicine, one should consult their doctor or pharmacist.

Yasminelle with food and drink

Yasminelle can be taken with or without food, and if necessary, it can be washed down with a small amount of water.

Laboratory tests

If a blood test is necessary, one should tell the doctor or laboratory staff that they are taking Yasminelle, as oral contraceptives may affect the results of some tests.

Pregnancy

Pregnant women should not take Yasminelle. If the patient becomes pregnant while using Yasminelle, they should stop using it immediately and contact their doctor. If the patient wants to become pregnant, they can stop using Yasminelle at any time (see also section "Stopping the use of Yasminelle").
Before using any medicine, one should consult their doctor or pharmacist.

Breastfeeding

Yasminelle is not recommended for use during breastfeeding. If the patient wants to take Yasminelle while breastfeeding, they should contact their doctor.
Before using any medicine, one should consult their doctor or pharmacist.

Driving and using machines

There is no information suggesting that the use of Yasminelle affects the ability to drive or operate machinery.

Yasminelle contains lactose monohydrate

If the patient does not tolerate some sugars, they should contact their doctor before using Yasminelle.

3. How to use Yasminelle

One should take one Yasminelle tablet every day, if necessary with a small amount of water. The tablets can be taken with or without food, but they should be taken every day at about the same time.
The blister pack contains 21 coated tablets. Next to each tablet, the day of the week is printed on which it should be taken. If, for example, one starts on a Wednesday, they should take the tablet marked "Wednesday". See section "Translation of the days of the week on the packaging" at the end of the leaflet. One should move in the direction of the arrow on the blister pack until all 21 tablets have been taken.
Then, one should not take any tablets for 7 days. During this 7-day break (also called the break week), bleeding should start. This is called "withdrawal bleeding" and usually starts on the 2nd or 3rd day of the break week.
On the 8th day after taking the last Yasminelle tablet (i.e. after the 7-day break), one should start the next blister pack, regardless of whether the bleeding has stopped or not. This means that one should start each blister pack on the same day of the week and that withdrawal bleeding should occur on the same days of the week in a 28-day cycle.
If one uses Yasminelle in this way, they are also protected against pregnancy during the 7 days when they are not taking tablets.

When can the first blister be started

• If no hormonal contraceptive has been used in the previous month.One should start taking Yasminelle on the first day of the cycle (i.e. on the first day of menstruation). If one starts taking Yasminelle on the first day of menstruation, they are immediately protected against pregnancy. One can also start between days 2-5 of the cycle, but in this case, additional protective measures (e.g. condoms) should be used for the first 7 days.
• Changing from a combined hormonal contraceptive or a combined contraceptive vaginal ring or patch.One can start taking Yasminelle the next day after taking the last active tablet from the previous pack, but no later than the day after the end of the previous contraceptive's tablet-free period (or after the last inactive tablet). In the case of changing from a combined contraceptive vaginal ring or patch, one should follow the doctor's instructions.
• Changing from a progestogen-only method (mini-pill, injection, implant, or intrauterine system releasing progestogen).One can switch on any day from the mini-pill (from an implant or intrauterine system on the day of its removal, or from injections when the next injection is scheduled) but in all cases, additional protective measures (e.g. condoms) should be used for the first 7 days of tablet-taking.
• After a miscarriageOne should follow the doctor's instructions.
• After childbirthAfter childbirth, one can start taking Yasminelle from the 21st to the 28th day after delivery. If one starts later than 28 days, they should use a mechanical method (e.g. condoms) for the first 7 days of taking Yasminelle. If, after childbirth, one has had sexual intercourse before (re)starting Yasminelle, one should first make sure they are not pregnant or wait for the next menstrual period.

If the patient is unsure when to start, they should consult their doctor.

• If the patient is breastfeeding and wants to start taking Yasminelle (again) after childbirth.One should read the section "Breastfeeding".

Overdose of Yasminelle

There are no reports of serious harmful effects from taking too many Yasminelle tablets at once.
If several tablets are taken at the same time, symptoms may occur such as nausea, 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 too many Yasminelle tablets are taken or if a child has swallowed some, one should consult their doctor or pharmacist.

Missed dose of Yasminelle

• If it has been less than 12 hourssince the missed tablet, contraceptive protection is not reduced. The tablet should be taken as soon as possible, and the next tablets should be taken at the usual time.
• If it has been more than 12 hourssince the missed tablet, contraceptive protection may be reduced. The more tablets that are missed, the higher the risk of becoming pregnant.

The risk of reduced contraceptive protection is highest if tablets are missed at the beginning or end of the blister pack. Therefore, one should follow the rules below (see also the diagram below):

• More than one tablet has been missed in this blister packOne should contact a doctor.
• One tablet has been missed in week 1.One should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time and additional protectionshould be used, e.g. condoms, for the next 7 days. If one has had sexual intercourse in the week before missing the tablet, one should be aware that there is a risk of pregnancy. In this case, one should contact their doctor.
• One tablet has been missed in week 2.One should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time. Contraceptive protection is not reduced, and additional protection is not needed.
• One tablet has been missed in week 3.There are two options to choose from:
• 1. One should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time. One should not take a break from taking tablets, but go straight to the next blister pack.

Most likely, withdrawal bleeding will occur at the end of the second blister pack, but it may also occur as spotting or intermenstrual bleeding during the second blister pack.

• 2. One can also stop taking tablets from the blister pack and go straight to the 7-day tablet-free period (note the day on which the tablet was missed). If one wants to start the new blister pack on their usual start day, the tablet-free period can be shortened to less than 7 days.

If one follows one of these recommendations, contraceptive protection will be maintained.

• If the patient has missed taking any of the tablets from the blister pack and withdrawal bleeding does not occur during the first tablet-free period, it may mean that they are pregnant. One should contact their doctor before going on to the next blister pack.

What to do if vomiting or severe diarrhea occur

If vomiting occurs within 3-4 hours after taking a tablet or severe diarrhea occurs, there is a risk that the active substances from the tablet have not been fully absorbed into the body.
The situation is similar to that when a tablet is missed. After vomiting or diarrhea, one should take another tablet from the reserve blister pack as soon as possible. If possible, one should take it within 12 hoursafter the normal time of taking the tablet. If this is not possible, one should follow the advice given in the section "Missed dose of Yasminelle".

Delaying the onset of withdrawal bleeding: what to know

Even if it is not recommended, delaying the onset of withdrawal bleeding is possible by going straight to a new Yasminelle blister pack without taking a break, up to the end of the second blister pack. Spotting or intermenstrual bleeding may occur during the second blister pack. After the usual 7-day break, one should starttaking tablets from the next blister pack.
One can ask their doctor for advice before deciding to delay the onset of withdrawal bleeding.

4. Possible side effects

Like all medicines, Yasminelle can cause side effects, although not everybody gets them. If you experience any side effects, especially severe and persistent ones, or changes in your health that you think are related to the use of Yasminelle, you should consult your doctor.
All women taking combined hormonal contraceptives have an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). For more detailed information on the various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2 "Important information before taking Yasminelle".

Severe side effects

You should immediately contact your doctor if you experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, which may cause difficulty breathing (see also "Warnings and precautions").
The following side effects have been associated with the use of Yasminelle.
Common side effects(occurring in 1 to 10 out of every 100 people):

• mood swings
• headache
• abdominal pain (stomach)
• acne
• breast pain, breast enlargement, breast tenderness, painful or irregular periods
• weight gain.

Uncommon side effects(occurring in 1 to 10 out of every 1,000 people):

• candidiasis (fungal infection)
• herpes simplex
• allergic reactions
• increased appetite
• depression, nervousness, sleep disorders
• tingling and numbness, dizziness
• vision problems
• heart rhythm disorders or extremely rapid heart rate
• blood clots (thrombosis) in the lung (pulmonary embolism), high blood pressure, low blood pressure, migraine, varicose veins
• sore throat
• nausea, vomiting, gastritis and/or enteritis, diarrhea, constipation
• hair loss (alopecia), eczema (dermatitis), itching, rash, dry skin, seborrheic dermatitis
• neck pain, limb pain, muscle cramps
• urinary tract infection
• breast tumor (benign and malignant), milk secretion in non-pregnant women (galactorrhea), ovarian cysts, sudden flushing of the face, absence of periods, very heavy periods, discharge, vaginal dryness, lower abdominal pain (pelvis), abnormal Pap smear, decreased libido
• fluid retention, lack of energy, strong thirst, increased sweating
• weight loss.

Rare side effects(occurring in 1 to 10 out of every 10,000 people):

• asthma
• hearing impairment
• erythema nodosum (a skin condition characterized by red, painful nodules)
• erythema multiforme (a rash in the form of redness or ulcers)
• harmful blood clots in a vein or artery, 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 symptoms, known as transient ischemic attack blood clots in the liver, stomach/intestine, kidneys, or eye.

The likelihood of blood clots may be higher if you have any other risk factors (see section 2 for more information on risk factors for blood clots and symptoms of blood clots).

Reporting side effects

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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Yasminelle

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 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.

6. Contents of the pack and other information

What Yasminelle contains

• The active substances of Yasminelle are: ethinylestradiol (Ethinylestradiolum) (in the form of ethinylestradiol betadex chloride) and drospirenone (Drospirenonum). Each tablet contains 0.02 milligrams of ethinylestradiol and 3 milligrams of drospirenone.
• Other ingredients of Yasminelle are: lactose monohydrate, cornstarch, magnesium stearate. Coating: hypromellose, talc, titanium dioxide (E 171), iron oxide red (E 172), see section 2 "Yasminelle contains lactose monohydrate".

What Yasminelle looks like and contents of the pack

• Each Yasminelle blister pack contains 21 light pink film-coated tablets.
• Yasminelle tablets are film-coated; the core of the tablet is covered with a coating. The tablets are light pink, round with convex surfaces, one side with the letters "DS" embossed in a regular hexagon.
• Yasminelle is available in packs containing 1 or 3 blisters, each of 21 tablets.

For more detailed information, please contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Ireland, the country of export:

Bayer Limited
1st Floor, The Grange Offices
The Grange, Brewery Road, Stillorgan
Co. Dublin, A94 H2K7, Ireland

Manufacturer:

Bayer AG
Mullerstrasse 178, 13353 Berlin, Germany
Bayer Weimar GmbH und Co. KG.
Döbereinerstr. 20, 99427 Weimar, Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Ireland, the country of export, authorization number:PA1410/024/001
Parallel import authorization number:33/22

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

European Economic Area:

• Austria, Belgium, Cyprus, Czech Republic, Estonia, Finland, Greece, Spain, Netherlands, Ireland, Lithuania, Luxembourg, Latvia, Malta, Germany, Norway, Poland, Portugal, Slovenia, Sweden, Italy:

Yasminelle

• France: Jasminelle

Translation of the day of the week on the packaging:

Monday

• Monday
• Tuesday
• Wednesday
• Thursday
• Friday
• Saturday
• Sunday

Date of revision of the leaflet: 17.06.2024

[Information about the trademark]