Prospect: information for the user

Danielle 2 mg/0.03 mg film-coated tablets EFG

Dienogest and Ethinylestradiol

Important things you should know about combined hormonal contraceptives (CHCs):

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

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may have to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

1. What Danielle is and for what it is used

2. What you need to know before starting to take Danielle

3. How to take Danielle

4. Possible adverse effects

5. Storage of Danielle

6. Contents of the package and additional information

Danielle 2mg/0.03 mg film-coated tablets, also known as Danielle, is an oral contraceptive that contains a combination of two hormones.

Danielle is a low-hormone contraceptive that contains two types of female sex hormones in small amounts, called ethinylestradiol (has effects similar to estrogens) and dienogest (has effects similar to the natural luteinizing hormone, progesterone). Danielle tablets are identical. Administration of Danielle improves symptoms such as acne development that can occur in women with increased hormonal male effect, called "androgenic effect".

General Considerations

Before starting to use Danielle, read the information about blood clots in section 2. It is particularly important that you read the symptoms of a blood clot (see section 2 “Blood Clots”).

This leaflet describes several situations in which you should interrupt the use of Danielle or in which its contraceptive effect may be reduced. In these situations, you should not have sex or use a non-hormonal contraceptive method (e.g. a condom) or another barrier method.

Danielle, like other combined oral contraceptives, does not protect against HIV (AIDS) or any other sexually transmitted disease.

Oral Contraceptives and Cancer Risk

In studies, it has been observed that breast cancer appears more frequently in women taking oral contraceptives than in those who do not use them, but there is no evidence that the cause is the use of these contraceptives. Women taking oral contraceptives are examined more frequently, so breast cancer is detected at an earlier stage.

10 years after stopping oral contraceptives, this small difference disappears.

Rarely, benign liver tumors are detected in users of oral contraceptives, and even more rarely, malignant liver tumors occur. These tumors can cause internal bleeding (abdominal). Contact your doctor immediately if you have upper abdominal pain.

Some studies have shown that there are more cases of cervical cancer among women who use oral contraceptives for a long time. However, it is not entirely clear whether this is due to these contraceptives, as the incidence of cervical cancer is affected by many other factors, for example, by sexual habits (e.g. frequent change of partner).

Cervical Cancer

Cervical cancer occurs less frequently than breast cancer. The use of hormone replacement therapy (HRT) with estrogen alone or with a combination of estrogen-progestogen has been associated with a slightly increased risk of cervical cancer.

The risk of cervical cancer varies with age. For example, in women aged 50-54 who do not follow HRT, about 2 cases of cervical cancer per 2,000 women have been observed over a 5-year period. In women receiving HRT for 5 years, about 3 cases per 2,000 patients have been observed (i.e. about 1 additional case).

When Not to Use Danielle

You should not use Danielle if you have any of the conditions listed below.

Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable.

• If you have (or have ever had) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE), or in other organs.
• If you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need surgery or if you spend a lot of time without standing up (see section “Blood Clots”).
• If you have ever had a heart attack or a stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, symptoms of a stroke).

• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:

• Severe diabetes with vascular damage.
• Very high blood pressure.
• Very high levels of fat in the blood (cholesterol or triglycerides).
• A condition called hyperhomocysteinemia.

• If you have (or have ever had) a type of migraine called “migraine with aura”.

• If you are allergic to ethinylestradiol, dienogest, or any of the other components of Danielle;

• If you have a severe active liver disease, family history, or jaundice, or itching all over the body, as these may be the first signs of liver disease;

• In case of active liver tumor (benign or malignant) or family history of it.

• If you know or suspect you have tumors of the genital organs or breasts.

• If you have unexplained vaginal bleeding.

• If you have pancreatitis or have had it associated with severe hypertriglyceridemia.

• In case of severe renal insufficiency or acute renal insufficiency.

• If you have hepatitis C and are taking medications containing ombitasvir / paritaprevir / ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section “Taking Danielle with other medications”).

The risk of thromboembolism increases if the following conditions are present:

• If you have diabetes mellitus with vascular damage.
• If you have severe hypertension.
• If you have severe lipid metabolism disorders (dyslipidemia).
• If you have or have had previously biochemical factors that may indicate a predisposition to blood clotting disorders, including resistance to activated protein C (APC), lack of antithrombin III or protein C or protein S, if the level of an amino acid called homocysteine exceeds the normal level in the blood (hyperhomocysteinemia), or if there are rare antibodies of the type protein, such as antiphospholipid antibodies.

If you experience any of the disorders mentioned above while taking Danielle, stop taking the medication immediately and consult your doctor. In the meantime, you should use non-hormonal contraceptives.

If you are affected by any of the conditions mentioned above, inform your doctor before starting to take Danielle. Your doctor may recommend another type of oral contraceptive or another non-hormonal contraceptive method.

Adverse Reactions and Precautions

Inform Your Doctor If You Suffer From Any of the Following Conditions:

If the condition develops or worsens while you are using Danielle, you should also inform your doctor.

• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (LES, a disease that affects your natural defense system).
• If you have hemolytic uremic syndrome (SUH, a blood clotting disorder that causes kidney insufficiency).
• If you have sickle cell anemia (a hereditary disease of red blood cells).
• If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you need surgery or spend a lot of time without standing up (see section 2 “Blood Clots”).
• If you recently gave birth, you are at higher risk of blood clots. Ask your doctor when you can start taking Danielle after delivery.
• If you have superficial vein inflammation under the skin (thrombophlebitis).
• If you have varicose veins.
• If you have diabetes mellitus;
• If you are obese (BMI is greater than 30 kg/m2);
• If you have not reached your final adult height;
• If you have hypertension;
• If you have a heart valve disease or cardiac rhythm disorders;
• If any of your close relatives have had thrombosis, heart attack, or stroke;
• If you have migraines;
• If you have seizures (“Sydenham's chorea”);
• If you or a close relative have high levels of cholesterol or triglycerides (fat in the blood);
• If you have liver disease or biliary complications;
• If you have jaundice and/or itching all over the body;
• If you have a rare metabolic disorder-hemoglobinopathy (porphyria);
• If you have hereditary angioedema;
• If you have endogenous depression;
• If you had gestational herpes or pemphigoid during the last stages of your pregnancy;
• If you have otosclerosis (in the middle ear);
• If you have, or have had, brown-yellow patches on the skin, especially on the face (melasma), if this occurs, avoid direct sunlight or ultraviolet light;
• If you smoke. Smoking cigarettes increases the risk of serious side effects with the use of oral contraceptives, such as heart attack and stroke. This risk increases even more with age.

If you take the pill, stop smoking, especially if you are over 35 years old. If you cannot stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive.

When to Visit Your Doctor

Your doctor will schedule regular check-ups while you are taking the pill. Depending on your situation and health status, your doctor will decide how often these check-ups are needed and what type of tests will be performed.

Get in touch with your doctor as soon as possible if you experience any of the following:

• If you experience any change in your health status (see, in particular, the symptoms described in this leaflet), or if you have any of the disorders mentioned in the leaflet about your close relatives;
• If you can feel a lump in your breast;
• If you have to take other medications;
• Before a planned major surgery or immobilization (ask your doctor at least 4 weeks in advance);
• If you experience unusual, heavy, or irregular vaginal bleeding;
• If you have forgotten to take one or more pills during the first week of treatment or if you have had sex in the last 7 days;
• If you did not have withdrawal bleeding twice in a row or if you suspect you are pregnant (oral contraceptive treatment can be restarted if your doctor considers it safe).

PSYCHIATRIC DISORDERS

Some women who use hormonal contraceptives like Danielle have reported depression or a depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Danielle increases your risk of blood clots compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• In arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or TEA).

The recovery from blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.

It is essential to remember that the overall risk of a blood clot causing harm due to Danielle is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek Emergency Medical Assistanceif you notice any of the following signs or symptoms.

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 blood clots in veins (venous thromboembolism). However, these adverse effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a leg vein or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in a vein of another organ, such as the eye (retinal vein thrombosis).

When Is the Risk of a Blood Clot in a Vein Higher?

The risk of a blood clot in a vein is higher during the first year of taking a combined hormonal contraceptive for the first time. The risk may be higher if you restart taking a combined hormonal contraceptive (the same medication or a different one) after a break of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Danielle, your risk of a blood clot returns to normal in a few weeks.

What Is the Risk of a Blood Clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of a blood clot in the leg or lung (DVT or PE) with Danielle is small.

- Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.

- Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel or noretisterone or norgestimato, about 5-7 will develop a blood clot in a year.

- Of every 10,000 women who use a combined hormonal contraceptive containing dienogest and ethinylestradiol like Danielle, about 8-11 women will develop a blood clot in a year.

- The risk of a blood clot will depend on your personal history (see “Factors That Increase Your Risk of a Blood Clot” below)

Factors That Increase Your Risk of a Blood Clot in a Vein

The risk of a blood clot with Danielle is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (BMI greater than 30 kg/m2).

• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e. before about 50 years old). You may have a hereditary disorder of blood clotting.

• If you need surgery or spend a lot of time without standing up due to an injury or illness or if you have a leg cast. You may need to stop taking Danielle for several weeks before the surgery or while you have limited mobility. If you need to stop taking Danielle, ask your doctor when you can start taking it again.

• As you get older (especially over about 35 years old).

• If you have given birth recently.

The risk of a blood clot increases with the more conditions you have.

Long flights (over 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you have any of the conditions mentioned above, even if you are unsure. Your doctor may decide that you should stop taking Danielle.

If any of the conditions mentioned above change while you are using Danielle, for example, a close relative experiences a blood clot without a known cause or you gain a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

What Can Happen If a Blood Clot Forms in an Artery?

Like a blood clot in a vein, a blood clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

Factors That Increase Your Risk of a Blood Clot in an Artery

It is essential to note that the risk of a heart attack or stroke due to Danielle is very small, but it may increase:

• With age (over about 35 years old).
• If you smoke.When using a combined hormonal contraceptive like Danielle, you are advised to stop smoking. If you cannot 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 any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years old). You may also be at higher risk of a heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, cardiac rhythm disorder called atrial fibrillation).
• If you have diabetes.

If you have one or more of these conditions or if any of them are particularly severe, your risk of a blood clot may be increased even more.

If any of the conditions mentioned above change while you are using Danielle, for example, you start smoking, a close relative experiences a blood clot without a cause, or you gain a lot of weight, inform your doctor.

Taking Danielle with Other Medications

Inform your doctor or pharmacist if you are taking or have recently taken other medications, even those purchased without a prescription.

Some medications may affect the effectiveness of combined oral contraceptives. One of the first signs of this may be bleeding. Such medications include, for example:

• Medications used to treat epilepsy (e.g. phenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine, topiramate, and felbamate);
• Medications used to treat tuberculosis (e.g. rifampicin);
• Antibiotics used to treat certain infections (e.g. ampicillin, tetracycline, griseofulvin);
• Ritonavir, rifabutin, efavirenz, nevirapine, nelvinafir;
• St. John's Wort (Hypericum perforatum).

The combination of oral contraceptives may also affect the effectiveness of some medications, for example, medications containing ciclosporin or lamotrigine.

The progestogen may influence the effect of certain medications for lowering blood pressure and anti-inflammatory non-steroidal drugs.

Inform Your Doctor If You Are Prescribed Other Medications, Even Your Dentistthat you are taking Danielle. They may inform you if you need to use any other non-hormonal contraceptive method and for how long.

Women who receive short-term treatments (with a maximum duration of one week) of the above products should take additional contraceptive precautions, such as using a barrier method (condom) during the medication period and for at least 7 days afterward.

If you are taking rifampicin, you should use additional contraceptive precautions (e.g. barrier method). These additional precautions should be taken during the time of concomitant medication and continue for 28 days after the treatment is completed. If you finish a package while taking this medication, the next package should be started without the usual break.

Ask your doctor if you are taking medications that induce your liver enzyme system for a long time (please also read the leaflet of other products to ensure this). In some cases, you may need to choose a non-hormonal contraceptive method.

Do not use Danielle if you have hepatitis C and are taking medications containing ombitasvir / paritaprevir / ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (as they may cause an increase in liver function in blood test results (elevated ALT enzyme).

Your doctor will prescribe another type of contraceptive before starting treatment with these medications.

Danielle can be taken again approximately 2 weeks after this treatment. See section “When Not to Use Danielle”.

Pregnancy, Lactation, and Fertility

Consult your doctor or pharmacist before using any medication.

If you are pregnant or think you may be, do not take Danielle. If you become pregnant while taking Danielle, stop taking it immediately.

The use of Danielle during lactation may lead to a reduction in milk volume and changes in its composition. Through milk, small amounts of the active substances and/or excipients may be excreted, which may affect newborns, so do not take Danielle if you are breastfeeding.

Driving and Operating Machines

Danielle does not affect driving and operating machines.

Important Information About Some Components of Danielle

This medication contains lactose, glucose, and lecithin (soya). If your doctor has told you that you have an intolerance to certain sugars, peanuts, or soya, consult with them before taking Danielle.

Follow exactly the administration instructions provided by Danielle as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Each package of Danielle contains 21, 3x21 or 6x21 coated tablets. The package indicates the days of the week when you should take the tablets.

You should try to take the tablets at the same time every day, with some liquid if necessary. Take one tablet every day, following the direction of the arrows, until you have finished the package. There are 7 days when you should not take any tablets. During this "no tablet" period, you should have a bleeding, usually 2-3 days after taking the last tablet.

You should start taking the next package of Danielle on the 8th day after you took the last tablet. You should start taking the next package of Danielle even if you are still bleeding. Each new package will start on the same day of the week as the previous one, making it easier to remember when to start again, and your cycle will always be on the same day of the month.

If you follow the instructions, Danielle will protect you from an unplanned pregnancy from the first day of treatment.

First package of Danielle

If you have not been treated with hormonal contraception in the last month:

You will take a tablet from the first day of the menstrual cycle (the first day of menstruation will be counted as day 1), taking the tablet marked with the correct day of the week from the blister.

If you switch to Danielle from a combined contraceptive (combined oral contraceptive, vaginal ring, transdermal patch):

The first tablet of Danielle should be taken following the usual gap or on the first day immediately after the last tablet of your previous contraceptive (without a "no tablet" period).

If your previous product had placebo tablets (without hormones), Danielle should be initiated following the usual interval of the placebo tablet or after the last active tablet (which contains hormones). If you are not sure which tablets are active, ask your doctor or pharmacist.

If you used a vaginal ring or transdermal patch, you should start taking Danielle on the day you remove the ring or patch, but no later than when the next application is due.

If you switch from a progestin-only contraceptive:

Women who take only progestin can switch to Danielle at any time and can take it the next day (in the usual time). You should use an additional contraceptive method, such as a barrier method (condom), for the next 7 days.

If you had used injectable contraceptives or an implant or IUD (Intrauterine Device) that releases progestins:

Women who use implants or IUDs can start taking Danielle on the day the implant or IUD is removed. If you received injectable contraceptives, you can start taking Danielle when the next injection is due. You should use an additional contraceptive method, such as a barrier method (condom), for the next 7 days.

After giving birth:

If you have just given birth, your doctor may advise you to start taking Danielle after your first period. However, in some cases, you may start hormonal contraception earlier, please consult your doctor. Do not breastfeed your baby if you take Danielle, unless your doctor has ordered it.

After an abortion or miscarriage: Follow your doctor's instructions.

Ask your doctor or pharmacist if you think Danielle is too strong or too weak for you.

If you take more Danielle than you should

There is no available data on Danielle overdose. Based on information from other combined oral contraceptives, the toxicity of an overdose is very low in both adults and children. An overdose may cause nausea, vomiting, and, in young women, vaginal bleeding. If you have taken more Danielle than you should, please contact your doctor.

If you suspect a child has taken several tablets, consult your doctor immediately.

If you forget to take Danielle

Do not take a double dose to compensate for the missed doses.

If you take the tabletbefore 12 hoursof the time it is due, no precautions are necessary; you should take the medication as soon as possible and the next tablet should be taken at the usual time. The contraceptive protection of Danielle should not be affected.

If you forgot to take a tablet formore than 12 hours, the contraceptive protection will be lower. The risk of an unplanned pregnancy is very high if you forgot to take the tablet at the beginning or end of the package. In this case, the following rules should be applied.

If you forgot to takeonetablet in thefirst week:

You should take the last missed tablet, even if this means taking two tablets in one day and then taking the tablets at the usual time. You should take additional contraceptive precautions (e.g., condom) for the next 7 days. However, if sexual intercourse has occurred in the last 7 days, pregnancy cannot be ruled out. In this case, inform your doctor immediately.

If you forgot to takeonetablet in thesecond week:

You should take the last missed tablet, even if this means taking two tablets in one day and then taking the tablets at the usual time. If you have taken the tablet regularly in the last 7 days, there is no need to take additional contraceptive precautions.

If you forgot to takeonetablet in thethird week:

You should follow the protocols below and should not take additional contraceptive precautions, as you have taken the tablets regularly in the last 7 days.

You have two options:

1.You should take the last missed tablet, even if this means taking two tablets in one day and then taking the tablets at the usual time. The next package should be started as soon as the current one is finished, i.e., no break should be left between the packages. It is unlikely that you will have bleeding until the end of the second package and you may stain or bleed even on the days of taking the tablet.

2.The second option is not to continue with the package that is already in use, save a maximum of 7 days of rest period (including the days when the tablet was not taken), and then start a new package. If you want to start the new package on the same day of the week as usual, the rest period can be less than 7 days.

If you forgot to takemore than one tablet:

Ask your doctor. Do not forget that in this case, the contraceptive method is not effective. If you did not take several tablets from the current package and there is no bleeding in the first rest period, there is a high probability of pregnancy. You are advised to contact your doctor before starting a new package of Danielle.

Alteration Gastro-intestinal

If there are vomiting or diarrhea within 3-4 hours after taking the tablet, it may occur that the tablet is not absorbed correctly from the gastrointestinal tract. The situation is similar to if you had forgotten to take a tablet. In this case, a tablet should be taken as soon as possible, within 12 hours of the usual time. If more than 12 hours have passed, you should follow the instructions in the section "If you forgot to take Danielle".

Delaying menstrual bleeding

You can delay the time of bleeding, if after finishing the previous package, you continue taking Danielle without a rest period. Menstrual bleeding can be delayed until the end of the second package, or if necessary, for a shorter period. During the taking of the second package, some spotting or bleeding may occur. After finishing the second package of tablets, you should leave a 7-day rest period, then you can take Danielle again.

Starting menstrual cycle on a different day

If you follow the instructions for taking the tablets, your cycle will be approximately the same day every four weeks. If you want to start your menstrual cycle on a different day of the week, the rest period should be reduced as necessary. Never extend the rest period. Suppose you normally have your cycle on Friday, but you would like to have it on Tuesday (i.e., three days earlier). You should start taking tablets from the next package three days earlier. However, if the rest period is too short (3 days or less), there will be no bleeding or spotting, but bleeding may occur during the taking of the second package.

What happens if you have bleeding between periods?

In some cases, women taking combined oral contraceptives may experience bleeding or spotting, especially during the first few months. You may need to use sanitary pads or tampons, but you should continue taking the pills. When your body adapts to the effects of the tablets, irregular bleeding will disappear; usually, this occurs in the third cycle. If bleeding continues, is more intense, or returns, talk to your doctor.

What to do if no bleeding occurs

If the tablets have been taken correctly, according to the instructions, and there have been no vomiting or diarrhea, pregnancy is very unlikely. You should take Danielle as usual. If you do not have your period in more than two occasions, you may be pregnant.

Contact your doctor immediately. You can continue taking Danielle after you have done the pregnancy test and your doctor has confirmed that you can do so.

Stopping treatment with Danielle

You can stop taking Danielle at any time you want. If you do not want to be pregnant, ask your doctor about other reliable contraceptive methods.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medicines, Danielle may cause side effects, although not everyone will experience them.If you experience any side effect, especially if it is severe and persistent, or if you have any health change that you think may be related to Danielle, consult your doctor.

All women taking combined hormonal contraceptives are at a higher 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 of taking combined hormonal contraceptives, see section 2 “What you need to know before starting to use Danielle.”

Certain factors may increase this risk even further (see section 2).

Severe side effects

For severe side effects in women taking combined oral contraceptives, see the section "Be careful before taking Danielle." If necessary, seek immediate medical help.

Other possible side effects

The following table lists adverse reactions with Danielle in decreasing order of frequency. These are the frequencies of possibly related side effects observed during clinical trials. None of the adverse reactions that occurred were "very common".

The chances of having 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).

The following adverse reactions have been observed in women taking oral contraceptives (see section 2. "Be careful before taking Danielle"):

• Thrombosis;
• Hypertension;
• Hepatic tumors;
• Yellow-brown skin discoloration (melasma);
• The development or worsening of disorders whose pathogenesis is not clear, but have been related to the use of combined oral contraceptives:
• Inflammatory bowel disease (Crohn's disease or ulcerative colitis);
• Hemoglobin metabolism disorder (porphyria);
• Some immunological disorders (systemic lupus erythematosus);
• Herpes gestational or pemphigoid gestational in the last stages of pregnancy;
• Seizures, Sydenham's chorea;
• Blood coagulation disorder combined with renal disease (hemolytic-uremic syndrome);
• Hereditary angioedema;
• Icterus.

Oral contraceptives and breast cancer

The risk of breast cancer is slightly higher in women taking combined oral contraceptives. However, since the risk of breast cancer below the age of 40 is small, the risk of breast cancer is small compared to the overall risk.

Hormonal changes (e.g., due to the use of hormonal contraceptives) can create an environment in which the sensitivity of breast tissue to other factors that favor the development of cancer is greater, and therefore, the probability of developing cancer is increased. Some studies recognize that the risk of developing breast cancer in middle-aged women is related to the early and prolonged use of combined oral contraceptives.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not mentioned in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep out of reach and sight of children.

Do not use Danielle after the expiration date (“CAD”) printed on the box and blister pack. The expiration date is the last day of the month indicated

Do not use Danielle if you observe visible signs of deterioration.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Danielle Composition

• The active principles are: 2 mg dienogest and 0.03 mg of ethinylestradiol.
• The other components are:

The core: lactose monohydrate, magnesium stearate, cornstarch, povidone, and talc (E-553b).

The coating: Opaglos 2clear, which contains: sodium carmelose, glucose monohydrate, maltodextrin, sodium citrate (E-331), and soy lecithin (E-322).

Product appearance and packaging contents

Danielle is a film-coated white, round, and biconvex tablet.

Danielle is available in packaging containing 21, 3x21, and 6x21 film-coated tablets.

Not all packaging sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa -Barcelona

Spain

Responsible Manufacturer

Laboratorios León Farma S.A.

C/La Vallina s/n, Polígono Industrial Navatejera, Villaquilambre

24193, León, Spain

Last review date of this leaflet: March 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)webpagehttp://www.aemps.gob.es//