Yasminelle

Package leaflet: Information for the user

Yasminelle 0.02 mg / 3 mg film-coated tablets

ethinylestradiol/drospirenone
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may be harmful to them.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible methods of contraception, if used correctly.
• They slightly increase the risk of blood clots forming in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
• Be alert and contact your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of this leaflet

1. What Yasminelle is and what it is used for
2. What you need to know before you use Yasminelle
   When not to use Yasminelle
   Warnings and precautions
   Blood clots
   Yasminelle and cancer
   Psychiatric disorders
   Intermenstrual bleeding
   What to do if you do not have a withdrawal bleed during the tablet-free week
   Other medicines and Yasminelle
   Yasminelle with food and drink
   Laboratory tests
   Pregnancy
   Breast-feeding
   Driving and using machines
   Yasminelle contains lactose
3. How to take Yasminelle
   When to start the first pack
   If you take more Yasminelle than you should
   If you forget to take Yasminelle
   What to do if you vomit or have severe diarrhoea
   How to delay your period: what you need to know
   How to change the day your period starts: what you need to know
   If you stop taking Yasminelle
4. Possible side effects
5. How to store Yasminelle
6. Contents of the pack and other information

1. What Yasminelle is and what it is used for

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

2. What you should know before using Yasminelle

General information
Before starting to use Yasminelle, you must read the information about blood clots in section 2. It is
particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).
Before taking Yasminelle, your doctor will ask you some questions about your personal health history and that
of your family members. Your doctor will also measure your blood pressure and, depending on your individual
situation, may carry out further examinations.
This leaflet describes various situations in which you should stop using Yasminelle or in which the safety of
Yasminelle may be reduced. In such situations, you must abstain from sexual intercourse or use additional
non-hormonal contraceptive methods, such as a condom or another barrier method. Do not use the rhythm
method or basal body temperature method. These methods may be unreliable because Yasminelle alters the
monthly variations in body temperature and cervical mucus.
Yasminelle, like all hormonal contraceptives, does not protect against HIV (AIDS) infection or other
sexually transmitted diseases.
When not to use Yasminelle
Do not use Yasminelle if you have any of the conditions listed below. If you have any of the conditions listed
below, consult your doctor. Your doctor will discuss with you other methods of birth control that might be
more suitable for your case.
Do not use Yasminelle:

• if you have (or have ever had) a blood clot in a blood vessel of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are due to undergo surgery or will be bedridden for a prolonged period (see section “Blood clots”); if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain which may be an early sign of heart attack) or transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following conditions, which could increase the risk of developing clots in the arteries:
  o severe diabetes with blood vessel damage
  o very high blood pressure
  o very high levels of fats (cholesterol or triglycerides) in the blood
  o a condition known as hyperhomocysteinaemia
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you have (or have ever had) a liver disease and liver function is still abnormal;
• if your kidneys do not work properly (renal failure);
• if you have (or have ever had) a liver tumour;
• if you have (or have ever had) or if it is suspected that you have cancer of the breast or genital organs;
• if you have unexplained vaginal bleeding;
• if you are allergic to ethinylestradiol or drospirenone or any of the excipients of this medicine (listed in section 6). This condition may cause itching, skin rashes, or swelling.
• Do not use Yasminelle if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Yasminelle”).

Additional information on special populations
Children and adolescents
Yasminelle is not indicated in women whose menstrual cycle has not yet started.
Elderly patients
Yasminelle is not indicated after menopause.
Patients with liver impairment
Do not take Yasminelle if you suffer from liver disease. See also sections “Do not take Yasminelle” and “Warnings and precautions”.
Patients with renal impairment
Do not take Yasminelle if you suffer from renal failure or acute renal failure. See also sections “Do not take Yasminelle” and “Warnings and precautions”.
Warnings and precautions
When should you contact a doctor?
Contact a doctor urgently

• if you notice signs of a possible blood clot which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see the following section “Blood clots”). For a description of the symptoms of these serious side effects, refer to the section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you.
In some situations, you must be particularly careful when using Yasminelle or any other combined oral
contraceptive, and your doctor may need to examine you regularly. If any of these conditions appear or
worsen while you are using Yasminelle, you must inform your doctor.

• if a close relative has or has had breast cancer;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you suffer from depression;
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE, a disease affecting the body’s natural defence system);
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are due to undergo surgery or will be bedridden for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Yasminelle;
• if you have inflammation of veins near the skin surface (superficial thrombophlebitis);
• if you have varicose veins;
• if you suffer from epilepsy (see “Other medicines and Yasminelle”);
• if you have a disease that first occurred during pregnancy or during previous use of sex steroids (e.g., hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (herpes gestationis), a nerve disorder causing sudden jerky movements of the body (Sydenham’s chorea));
• if you have or have ever had chloasma (skin discoloration, especially on the face or neck, known as “pregnancy mask”). In this case, 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 hives with possible breathing difficulties, contact your doctor immediately. Products containing oestrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Yasminelle increases the risk of developing a blood clot
compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE). Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, such effects may be fatal. It is important to remember that the overall risk of a harmful blood clot associated with Yasminelle is low.

HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor immediately if you notice any of the following signs or symptoms.
Do you have one of these signs? You may probably be suffering from:

• swelling in one leg or along a vein in the leg or foot, especially if accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking
• increased warmth in the affected leg

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of developing blood clots in veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same or a different product) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not using a combined hormonal contraceptive.
When you stop taking Yasminelle, the risk of developing a blood clot returns to normal levels within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your individual baseline risk of venous thromboembolism (VTE) and the type of combined hormonal contraceptive you are taking.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Yasminelle is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Yasminelle, about 9–12 will develop a blood clot in one year.
• Your risk of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Yasminelle is low, but certain conditions can increase this risk. Your risk is higher:

• if you are very overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in a leg, lung, or another organ at a young age (under approximately 50 years). In this case, you may have an inherited blood clotting disorder;
• if you are scheduled for surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in a cast. You may need to stop taking Yasminelle several weeks before surgery or during periods of reduced mobility. If you need to stop taking Yasminelle, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years of age);
• if you have given birth less than a few weeks ago. The risk of developing a blood clot increases if you have more than one of these conditions. Air travel (lasting >4 hours) may temporarily increase the risk of blood clots, especially if you have other listed risk factors. It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide that you should stop taking Yasminelle. If any of the above conditions change while you are using Yasminelle—for example, if a close relative develops thrombosis without a known cause or if you gain significant weight—contact your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems—for example, they can lead to a heart attack or stroke.
Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of Yasminelle is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Yasminelle, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke;
• if you or a close relative have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes. If you have more than one of these conditions or if one of them is particularly severe, the risk of developing a blood clot may be even higher. If any of the above conditions change while you are using Yasminelle—for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.

Yasminelle and cancer
Breast cancer is observed slightly more frequently in women who use combined oral contraceptives, but it is not known whether this is due to the treatment. For example, it is possible that more cancers are diagnosed in women using the pill because they undergo more frequent medical check-ups. The occurrence of breast cancer gradually decreases after stopping the combined pill. It is important that you regularly examine your breasts and contact your doctor if you feel any lump.
Benign liver tumors have been observed rarely in women using oral contraceptives, and malignant liver tumors even more rarely. Contact your doctor if you experience unusually severe abdominal pain.
Psychiatric disorders
Some women using hormonal contraceptives, including Yasminelle, have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or depressive symptoms, consult your doctor as soon as possible for further medical advice.
Intermenstrual bleeding
During the first months of taking Yasminelle, unexpected bleeding (bleeding outside the pill-free week) may occur. If such bleeding persists for more than a few months or starts after several months, your doctor should investigate the cause.
What to do if menstruation does not occur during the pill-free week
If you have taken all tablets correctly, have not experienced vomiting or severe diarrhea, and have not taken other medications, it is highly unlikely that you are pregnant.
If you miss two consecutive periods, you may be pregnant. Contact your doctor immediately. Do not start the next pack until you are certain you are not pregnant.
Other medicines and Yasminelle
Always inform your doctor if you are taking any medicines or herbal products. Inform any other doctor or dentist who prescribes you a new medicine (or pharmacist) that you are taking Yasminelle. They will advise you whether you need to use additional contraceptive measures (e.g., condoms), and if so, for how long, or whether the use of another medicine you may need should be adjusted.
Some medicines:

• affect the levels of Yasminelle in the blood;
• may make it less effective in preventing pregnancy;
• may cause unexpected bleeding. These include:
  ■ medicines used to treat:
  o epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
  o tuberculosis (e.g., rifampicin)
  o HIV and hepatitis C virus infections (ritonavir, nevirapine, efavirenz—known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors)
  o fungal infections (griseofulvin, ketoconazole)
  o arthritis, osteoarthritis (etoricoxib)
  o high blood pressure in the pulmonary arteries (bosentan)
  o St. John’s wort (Hypericum perforatum), a herbal remedy.

Yasminelle may also affect the action of other medicines, for example:
o medicines containing cyclosporine;
o the antiepileptic lamotrigine (this may lead to an increased frequency of epileptic seizures);
o theophylline (used to treat respiratory problems);
o tizanidine (used to treat muscle pain and/or muscle spasms).

Do not use Yasminelle if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir,
as these products may cause increases in liver function blood test results (elevated liver enzyme ALT). Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines. Yasminelle may be resumed approximately 2 weeks after completing this treatment. See section “Do not use Yasminelle”.
Ask your doctor or pharmacist for advice before taking any medicine.
Yasminelle with food and drink
Yasminelle can be taken with or without food, if necessary with a little water.
Laboratory tests
If you need to have a blood test, inform your doctor or laboratory staff that you are taking the pill, as hormonal contraceptives may affect the results of certain tests.
Pregnancy
If you are pregnant, you must not use Yasminelle. If you become pregnant while taking Yasminelle, stop immediately and contact your doctor. If you wish to become pregnant, you can stop taking Yasminelle at any time (see also “If you stop taking Yasminelle”).
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
The use of Yasminelle is generally not recommended during breast-feeding. If you wish to take the pill while breast-feeding, consult your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There is no evidence to suggest that Yasminelle affects the ability to drive or use machinery.
Yasminelle contains lactose
If you have an intolerance to certain sugars, contact your doctor before taking Yasminelle.

3. How to take Yasminelle

Take one Yasminelle tablet every day, if necessary with a little water. You may take the tablets with or without food, but you must take them at approximately the same time each day.
The blister pack contains 21 film-coated tablets. Next to each tablet, the day of the week on which it should be taken is printed. For example, if you start on Wednesday, take the tablet next to the label WED. Follow the direction of the arrows on the blister pack until all 21 tablets have been taken.
Then, do not take any tablets for 7 days. During these 7 days (the so-called "tablet-free interval"), your menstrual period should occur. This is known as "withdrawal bleeding" and usually begins on the second or third day of the tablet-free interval.
Start the next blister pack on the eighth day after taking the last Yasminelle tablet (i.e. after the 7-day break), regardless of whether your menstrual bleeding has stopped or not. This means that each new Yasminelle blister pack should be started on the same day of the week, and your periods will also begin on the same day each month.
When taking Yasminelle as described above, you are protected against pregnancy during the 7 days when you do not take the tablets.

When can you start the first blister pack?

• If you have not used a hormonal contraceptive in the previous month Start taking Yasminelle on the first day of your cycle (i.e. the first day of your menstrual period). If you start on the first day of your period, contraceptive protection is immediate. You may also start taking Yasminelle between day 2 and day 5 of your cycle; however, in this case, you must use additional contraceptive measures (e.g. a condom) for the first 7 days.
• Switching from a combined hormonal contraceptive, a combined contraceptive vaginal ring, or a contraceptive patch Start taking Yasminelle preferably the day after the last active tablet (the last tablet containing active ingredients) of your previous pill, or at the latest the day after the end of the tablet-free interval (or after the last inactive tablet of your previous pill). When switching from a combined contraceptive vaginal ring or a contraceptive patch, follow your doctor’s advice.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or progestogen-releasing intrauterine system (IUS)) You may switch on any day from the progestogen-only pill (from an implant or IUS on the day of its removal, from an injectable when the next injection would normally be due); however, in all these cases, use additional contraceptive measures (e.g. a condom) for the first 7 days of taking the tablets.
• After an abortion Follow your doctor’s advice.
• After childbirth You may start taking Yasminelle between day 21 and day 28 after childbirth. If you start later than day 28, use a so-called barrier method (e.g. a condom) during the first 7 days of taking Yasminelle. If you have had sexual intercourse after childbirth before starting (or restarting) Yasminelle, make sure you are not pregnant, or wait for your menstrual period.
• If you are breastfeeding and wish to start (or restart) taking Yasminelle Read section “Breast-feeding”.

Ask your doctor for advice if you are unsure about when to start.

If you take more Yasminelle than you should
There are no reports of serious harmful effects following an overdose of Yasminelle tablets.
If you take several tablets at once, you may experience nausea, vomiting, or vaginal bleeding.
Even girls who have not yet had their first period but have accidentally taken this medicine may experience such bleeding.
If you have taken too many Yasminelle tablets, or if you find that a child has taken any of the tablets, contact your doctor or pharmacist immediately.

If you forget to take Yasminelle

• If the delay in taking a tablet is less than 12 hours, contraceptive protection is not reduced. Take the missed tablet as soon as you remember, and then continue taking the tablets at your usual time.
• If the delay in taking a tablet is more than 12 hours, contraceptive protection may be reduced. The greater the number of missed tablets, the higher the risk of becoming pregnant.

The risk of incomplete contraceptive protection is greatest if you miss a tablet at the beginning or end of the pack. Therefore, follow the instructions below (see also the diagram provided below):

• More than one tablet missed in this pack Consult your doctor.

• One tablet missed in the first week
  Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time and use additional contraceptive measures (e.g. a condom) for the next 7 days. If you had sexual intercourse in the week before the missed tablet, you may be pregnant. In this case, consult your doctor.

• One tablet missed in the second week
  Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. Contraceptive protection remains effective, and no additional precautions are necessary.

• One tablet missed in the third week
  You have two options:

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Skip the tablet-free interval and start the next blister pack immediately.

You will most likely not have a menstrual period until the end of the second pack, but you may experience light bleeding or spotting during the second pack.

2. You may also stop taking tablets from the current pack and go directly to the 7-day break (including the day of the missed tablet in the count). If you wish to start the next pack on your usual day, observe an interval shorter than 7 days.

If you follow either of these two recommendations, you will remain protected against pregnancy.

• If you have missed any tablets from the pack and do not have your period during the first tablet-free interval, you may be pregnant. Consult your doctor before starting a new blister pack.

What to do in case of vomiting or severe diarrhoea
If you vomit within 3–4 hours after taking a tablet or have severe diarrhoea, the active ingredients of the pill may not be completely absorbed by your body. This situation is similar to missing a tablet. After vomiting or severe diarrhoea, take another tablet from a spare pack as soon as possible. If possible, take it within 12 hours of your usual tablet-taking time. If this is not possible, or if more than 12 hours have passed, follow the instructions in the section “If you forget to take Yasminelle”.

How to delay your period: what you need to know
Although not recommended, you may delay your period by starting a new Yasminelle blister pack immediately, without observing the 7-day interval. During the use of this second pack, you may experience light bleeding or spotting. Continue with the next blister pack after the usual 7-day break.
You may consult your doctor before deciding to delay your period.

How to change the day your period starts: what you need to know
If you take the tablets as instructed, your period will start during the tablet-free week. If you wish to change the day your period starts, shorten the normal break between two packs (but never extend it – 7 days is the maximum!). For example, if your break normally starts on Friday and you wish to move it to Tuesday (3 days earlier), start the next pack 3 days earlier. If you make the break between two cycles very short (e.g. 3 days or less), you may not have any bleeding during this interval. Afterwards, you may experience light bleeding or spotting.
If you are unsure what to do, consult your doctor.

If you stop taking Yasminelle
You may stop taking Yasminelle at any time. If you still wish to avoid pregnancy, consult your doctor for advice on other reliable methods of birth control. If you wish to become pregnant, stop taking Yasminelle and wait for your menstrual period before trying to conceive. This will make it easier to estimate your expected date of delivery.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health that you think may be due to Yasminelle, tell your doctor.
All women taking combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before taking Yasminelle”.

Serious side effects
Contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible difficulty breathing (see also section “Warnings and precautions”).

The following side effects have been reported with the use of Yasminelle.

Common side effects (may occur in 1 to 10 women in 100):

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

Uncommon side effects (may occur in 1 to 10 women in 1,000):

• Candidiasis (fungal infection)
• cold sores (herpes simplex)
• allergic reactions
• increased appetite
• depression, nervousness, sleep disorders
• tingling sensations, dizziness
• vision problems
• irregular or abnormally rapid heartbeat
• blood clot (thrombosis) in the lungs (pulmonary embolism), high blood pressure, low blood pressure, migraine, varicose veins
• sore throat
• nausea, vomiting, inflammation of the stomach and/or intestine, diarrhoea, constipation
• hair loss (alopecia), eczema, itching, skin rashes, dry skin, oily skin (seborrhoeic dermatitis)
• neck pain, limb pain, muscle cramps
• bladder infection
• breast lump (benign and cancer), milk production outside of pregnancy (galactorrhoea), ovarian cysts, hot flushes, absence of menstruation, very heavy menstrual bleeding, vaginal discharge, vaginal dryness, lower abdominal (pelvic) pain, abnormal vaginal smear (PAP test), decreased interest in sex
• fluid retention, lack of energy, excessive thirst, increased sweating
• weight loss.

Rare side effects (may occur in 1 to 10 women in 10,000):

• asthma
• hearing impairment
• erythema nodosum (characterised by red, painful skin nodules)
• erythema multiforme (skin eruption with target-like lesions or ulcers)
• harmful blood clots in a vein or an artery, for example:
  ➢ in a leg or foot (DVT)
  ➢ in a lung (PE)
  ➢ heart attack
  ➢ stroke
  ➢ mini-stroke or temporary symptoms similar to stroke, known as transient ischaemic attack (TIA)
  ➢ blood clots in the liver, stomach/intestine, kidneys or eye.
  The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Yasminelle

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the pack after “Do not use after” or
“EXP.”
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Yasminelle contains

• The active substances are ethinylestradiol (as beta-cyclodextrin clathrate) and drospirenone. Each tablet contains 0.020 milligrams of ethinylestradiol (as beta-cyclodextrin clathrate) and 3 milligrams of drospirenone.
• The excipients are monohydrate lactose, maize starch, magnesium stearate (E470b), hypromellose (E464), talc (E553b), titanium dioxide (E171), iron oxide red (E172). See section 2 “Yasminelle contains lactose”.

Description of the appearance of Yasminelle and package contents

• Each Yasminelle blister contains 21 light pink film-coated tablets.
• Yasminelle tablets are film-coated; the tablet core is coated. The tablets are light pink in colour, round, with convex faces, and on one of them the letters “DS” are marked within a regular hexagon.
• Yasminelle is available in packs containing 1, 3, 6 and 13 blisters, each blister containing 21 film-coated tablets.

It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
Bayer S.p.A. - Viale Certosa, 130 - 20156, Milan, Italy
Manufacturer responsible for batch release
Bayer AG – 13342 Berlin, Germany
and
Bayer Weimar GmbH und Co. KG, Döbereinerstr. 20, 99427 Weimar, Germany
This medicinal product is authorized in the Member States of the European Economic Area under the following names:

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