Danielle 2 mg/0.03 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Danielle 2 mg/0,03 mg film-coated tablets EFG

Dienogest and Ethinylestradiol

Important things you need to 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 developing a blood clot in veins and arteries, especially during the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and consult your doctor if you think you may be experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Danielle is and what it is used for
2. What you need to know before taking Danielle
3. How to take Danielle
4. Possible side effects
5. How to store Danielle
6. Contents of the pack and other information

1. What Danielle is and what it is used for

Danielle 2mg/0.03 mg film-coated tablets, also called Danielle, is an oral contraceptive containing a combination of two hormones.

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

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

General considerations

Before starting to use Danielle, 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”).

This leaflet describes several situations in which you should stop taking Danielle or in which its contraceptive effect may be reduced. In such situations, you should not have sexual intercourse or should use a non-hormonal contraceptive method (for example, a condom) or another barrier method.

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

Oral contraceptives and cancer risk

Studies have shown that breast cancer occurs more frequently in women who take oral contraceptives than in those who do not, but there is no evidence that this is caused by taking them. Women who take oral contraceptives are examined more frequently, which is why breast cancer is detected at an earlier stage.

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

Rarely, benign liver tumours have been detected in users of oral contraceptives, and malignant liver tumours are even rarer. These tumours may 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 certain that this is due to oral contraceptives, because the incidence of cervical cancer is influenced by many other factors, such as sexual behaviour (e.g. frequent change of partner).

Ovarian cancer

Ovarian cancer occurs less frequently than breast cancer. Hormone replacement therapy (HRT) with oestrogens alone or with a combination of oestrogen-progestogen has been associated with a slightly increased risk of ovarian cancer.

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

When not to use Danielle

Do 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 which other form of contraception would be more suitable.

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or other organs.

• If you know you have a disorder affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.

• If you need surgery or will be immobile for a long time (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 and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).

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

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

• 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 ingredients of Danielle.

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

• If you have an active liver tumour (benign or malignant) or a family history of such tumours.

• If you have known or suspected tumours of the genital organs or breasts.

• If you have vaginal bleeding of unknown origin.

• If you have pancreatitis or have had pancreatitis associated with severe hypertriglyceridaemia.

• If you have severe renal insufficiency or acute renal failure.

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

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

• If you have diabetes mellitus with vascular complications.
• If you have severe hypertension.
• If you have severe lipid metabolism disorders (dyslipidaemia).
• If you have or have previously had biochemical factors that may indicate a predisposition to blood clotting disorders, including activated protein C resistance (APC), deficiency of antithrombin III, protein C or protein S, elevated levels of an amino acid called homocysteine in the blood (hyperhomocysteinaemia), or rare protein-type antibodies such as antiphospholipid antibodies.

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

If any of the conditions listed above apply to you, inform your doctor before starting to take Danielle. Your doctor may recommend another type of oral contraceptive or a non-hormonal method of contraception.

Warnings and precautions.

When should you consult your doctor? Seek urgent medical attention If you notice possible signs of a blood clot which may mean you are experiencing a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section “Blood clot (thrombosis)” below). For a description of the symptoms of these serious side effects, see “How to recognize a blood clot”.

Inform your doctor if you have any of the following conditions:

If any of these conditions develop or worsen while you are using Danielle, you must also inform your doctor.

• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE, a disease affecting your body's natural defense system).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure).
• If you have sickle cell anemia (an inherited red blood cell disorder).
• 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 require surgery or will be immobile for a prolonged period (see section 2 “Blood clots”).
• If you have recently given birth, you are at increased risk of blood clots. You should ask your doctor when you can start taking Danielle after childbirth.
• If you have inflammation of the veins beneath the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you have diabetes mellitus.
• If you have obesity (body mass index greater than 30 kg/m²).
• If you have not yet reached your final adult height.
• If you have hypertension.
• If you have heart valve disease or cardiac rhythm disorders.
• If any of your close relatives have had thrombosis, heart attack, or stroke.
• If you suffer from migraine.
• If you have seizures (“Sydenham's chorea”).
• If you or a close relative have high cholesterol or triglyceride levels (fats in the blood).
• If you have liver disease or biliary complications.
• If you have jaundice and/or generalized itching.
• If you have a rare metabolic disorder involving hemoglobin (porphyria).
• If you have hereditary angioedema.
• If you have endogenous depression.
• If during late pregnancy you developed blister-like skin rashes (gestational pemphigoid or herpes gestationis).
• If you have hearing loss due to otosclerosis (in the middle ear).
• If you have, or have previously had, brownish-yellow patches on the skin, especially on the face (chloasma); if this occurs, you should avoid direct sunlight or ultraviolet light.
• If you smoke. Smoking increases the risk of serious side effects with oral contraceptive use, such as heart attack and stroke. This risk increases with the amount you smoke and with age.

If you take the pill, stop smoking, especially if you are over 35 years old. If you do not stop smoking, you should use other contraceptive methods, particularly if other risk factors are present.

When should you visit your doctor?

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

Contact your doctor as soon as possible if you experience any of the following:

• If you experience any change in your health (see in particular the symptoms described in this leaflet), or disorders mentioned in the leaflet affecting your close family members.
• If you can feel a lump in your breast.
• If you need to take other medications.
• Before any planned major surgery or period of immobilization (consult your doctor at least 4 weeks in advance).
• If you experience unusual, heavy, or irregular vaginal bleeding.
• If you have missed one or more pills during the first week of treatment or if you had sexual intercourse within the last 7 days.
• If you did not have withdrawal bleeding two times in a row, or if you suspect you are pregnant (treatment with combined oral contraceptives may be restarted only if your doctor considers it safe).

PSYCHIATRIC DISORDERS

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

BLOOD CLOTS

Using a combined hormonal contraceptive such as Danielle increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In the veins (called “venous thrombosis”, “venous thromboembolism” or VTE).
• In the arteries (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, they may be fatal.

It is important to remember that the overall risk of a harmful blood clot due to Danielle is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if you notice any of the following signs or symptoms.

Are you experiencing any of these signs?	What might you be suffering from?
Swelling in one leg or foot, or along a vein in the leg or foot, especially when accompanied by: Pain or tenderness in the leg, which may only be noticeable when standing or walking. Increased warmth in the affected leg. Change in skin color of the leg, e.g., turning pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without known cause or rapid breathing. Sudden cough without clear cause, possibly bringing up blood. Sharp pain that may worsen upon deep breathing. Severe chest pain or dizziness. Rapid or irregular heartbeat. Severe abdominal pain. If you are unsure, consult a doctor, as some of these symptoms such as cough or shortness of breath may be mistaken for a milder condition like a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: Sudden loss of vision, or Painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye).
Pain, discomfort, pressure, or heaviness in the chest. Feeling of tightness or fullness in the chest, arm, or below the sternum. Sensation of fullness, indigestion, or suffocation. Upper body discomfort radiating to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Extreme weakness, anxiety, or shortness of breath. Rapid or irregular heartbeat.	Heart attack.
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. Sudden confusion, difficulty speaking or understanding speech. Sudden vision problems in one or both eyes. Sudden difficulty walking, dizziness, loss of balance or coordination. Sudden, severe, or prolonged headache without known cause. Loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
Swelling and slight bluish discoloration of a limb. Severe abdominal pain (acute abdomen).	Blood clots blocking other blood vessels.

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 thrombosis). However, these adverse events are rare. They occur more frequently 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 a vein of another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein higher?

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

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

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

What is the risk of developing a blood clot?

The risk depends on your natural risk of venous thromboembolism (VTE) and on 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 Danielle is small.

• Among 10,000 women who do not use a 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 to 7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing dienogest and ethinylestradiol, such as Danielle, about 8 to 11 women will develop a blood clot in one year.
• Your risk of developing a blood clot will depend on your personal history (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal contraceptive pill/patch/ring and who are not pregnant	About 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5-7 out of 10,000 women
Women who use Danielle	About 8-77 out of 10,000 women

Factors that increase your risk of a blood clot in a vein

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

• If you are overweight (body mass index or BMI above 30 kg/m²).
• If any of your close relatives has had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years of age). In this case, you might have an inherited blood clotting disorder.
• If you need surgery or will be immobile for a long time due to injury or illness, or if your leg is in a cast. You may need to stop taking Danielle several weeks before surgery or while you are less mobile. 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 of age).
• If you have given birth within the last few weeks.

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

Air travel (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

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

If any of the above conditions change while you are using Danielle—for example, a close relative experiences a thrombosis without a known cause, or you gain a significant amount of weight—inform your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

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

Factors that increase your risk of a blood clot in an artery

It is important to note that the risk of heart attack or stroke while using Danielle is very small, but it may increase:

• With age (over about 35 years).
• If you smoke. When using a combined hormonal contraceptive like Danielle, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use 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 about 50 years). In this case, you may also have an increased risk of 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 suffer from migraines, especially migraines with aura.
• If you have a heart condition (valve disorder, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

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

If any of the above conditions change while you are using Danielle—for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain a significant amount of weight—inform your doctor.

Taking Danielle with other medicines

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

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

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

Combined oral contraceptives may also affect the effectiveness of certain medicines, for example, medicines containing cyclosporine or lamotrigine.

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

Tell your doctor, and even your dentist, if you are prescribed other medicines that you are taking Danielle. They can advise you whether you need to use any additional non-hormonal contraceptive method and for how long.

Women receiving short-term treatments (lasting up to one week) with the products listed above should use additional contraceptive precautions, such as a barrier method (e.g., condoms), during the period of taking the medicine and for at least 7 more days.

If you take rifampicin, you must use additional contraceptive precautions (e.g., barrier method). These additional precautions should be taken during the time of concomitant medication and continued for 28 days after stopping treatment. If you finish a pack while taking this medicine, you should start the next pack without the usual break.

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

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

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

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

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

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

Using Danielle during breastfeeding may lead to a reduction in the volume of milk produced and changes in its composition. Small amounts of active substances and/or excipients may be excreted in breast milk, which could possibly affect newborns; therefore, you should not take Danielle while breastfeeding.

Driving and using machines

Danielle does not affect the ability to drive or use machines.

Important information about some ingredients of Danielle

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

3. How to take Danielle

Follow exactly the instructions for taking Danielle provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

Each pack of Danielle contains 21, 3x21 or 6x21 film-coated tablets. The days of the week on which the tablets should be taken are indicated on the pack.

You should try to take the tablets at the same time each day, with a drink if necessary. Take one tablet daily, following the direction of the arrows, until the pack is finished. There are 7 days when you should not take any tablets. During this "tablet-free" period, you should have a bleed, usually 2–3 days after taking the last tablet.

You must start taking the next pack of Danielle on the 8th day after taking the last tablet. You should start the next pack of Danielle even if bleeding continues. Each new pack should be started on the same day of the week as you started the previous pack; this makes it easier to remember when to start again, and your cycle will always occur on the same day of the week.

If you follow these instructions, the contraceptive will protect you from unwanted pregnancy from the first day of treatment.

Taking your first pack of Danielle

If you have not used hormonal contraception in the past month:

Take one tablet starting on the first day of your menstrual cycle (the first day of menstruation is counted as day 1), taking the pill marked with the correct day of the week on the blister pack.

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

The first tablet of Danielle should be taken following the usual tablet-free interval or on the first day immediately after the last tablet of your previous contraceptive (without having a "tablet-free" period).

If your previous product contained placebo tablets (without hormones), start Danielle following the usual placebo interval or after the last active tablet (containing hormones). If you are unsure which tablets are active, ask your doctor or pharmacist.

If you were using a vaginal ring or transdermal patch, you should start taking Danielle on the day you remove the vaginal ring or transdermal patch, but no later than the day your next application would have been due.

If switching from a progestogen-only oral contraceptive:

Women taking only progestogen may switch to Danielle at any time and may take it the following day (within the normal schedule). They should use an additional contraceptive method, such as a barrier method (condom), for the next 7 days.

If you have used injectable contraceptives, an implant, or an IUD (intrauterine device) releasing progestogen:

Women using implants or IUDs may start on the day the implant or IUD is removed. If you received injectable contraceptives, you may start taking Danielle on the day your next injection would have been 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 recently given birth, your doctor may advise you to start taking Danielle after your first period. However, in some cases, hormonal contraception may be started earlier—please consult your doctor. You should not breastfeed while taking Danielle unless specifically instructed by your doctor.

After a miscarriage or abortion: 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 overdose with Danielle. Based on information from other combined oral contraceptives, the toxicity of overdose is very low in both adults and children. Overdose may cause nausea, vomiting, and vaginal bleeding in young women. If you have taken more Danielle than you should, please contact your doctor.

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

If you forget to take Danielle

Do not take a double dose to make up for missed doses.

If you take the tablet less than 12 hours after the scheduled time, no precautions are needed; take the missed tablet as soon as possible and continue taking the next tablet at the usual time. The contraceptive protection of Danielle should not be affected.

If you forget to take a tablet for more than 12 hours, contraceptive protection may be reduced. The risk of unwanted pregnancy is high if you missed a tablet at the beginning or end of the pack. In this case, the following rules apply.

If you forgot to take one tablet in the first week:

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

If you forgot to take one tablet in the second week:

Take the last missed tablet, even if this means taking two tablets in one day, and then continue taking tablets at the usual time. If you have taken the tablets regularly in the past 7 days, no additional contraceptive precautions are needed.

If you forgot to take one tablet in the third week:

Follow one of the following options; no additional contraceptive precautions are needed, provided you have taken the tablets regularly in the past 7 days.

You have two options:

1. Take the last missed tablet, even if this means taking two tablets in one day, and then continue taking tablets at the usual time. Start the next pack immediately after finishing the current one—i.e., do not have a break between packs. Bleeding is unlikely until the end of the second pack, and you may experience spotting or bleeding during tablet intake.
2. The second option is to stop the current pack, allow a maximum 7-day tablet-free interval (including the days when tablets were missed), and then start a new pack. If you wish to start the new pack on the same day of the week as usual, the tablet-free interval may be shorter than 7 days.

If you forgot to take more than one tablet:

Consult your doctor. Remember that in this case, the contraceptive method may not be effective. If you missed several tablets in the current pack and there is no bleeding during the first tablet-free interval, pregnancy is likely. You are advised to contact your doctor before starting a new pack of Danielle.

Gastrointestinal disturbances

If vomiting or diarrhoea occurs within 3–4 hours after taking a tablet, the tablet may not have been properly absorbed from the gastrointestinal tract. This situation is similar to missing a tablet. In this case, take a tablet as soon as possible within 12 hours of the usual time. If more than 12 hours have passed, follow the instructions in the section "If you forget to take Danielle".

Delaying menstrual bleeding

You can delay menstrual bleeding by continuing to take Danielle without a break after finishing the previous pack. Menstrual bleeding can be delayed until the end of the second pack, or if necessary, for a shorter period. During the second pack, some spotting or bleeding may occur. After finishing the second pack of tablets, a 7-day break should be taken, after which you may resume taking Danielle.

If you wish to start your menstrual cycle on a different day

If you follow the instructions for taking the tablets, your cycle will occur approximately on the same day every four weeks. If you wish to have your menstrual cycle start on a different day of the week, shorten the tablet-free interval as needed. Never extend the tablet-free interval. For example, if you normally have your period on Friday but would like it on Tuesday (i.e., three days earlier), you should start the next pack three days earlier. However, if the tablet-free interval is too short (3 days or less), there may be no bleeding or spotting, but bleeding may occur during the second pack.

What 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 usually stops—typically by the third cycle. If bleeding continues, becomes heavier, or recurs, speak with your doctor.

What to do if you do not have a bleed?

If the tablets have been taken correctly according to instructions and there has been no vomiting or diarrhoea, pregnancy is very unlikely. Continue taking Danielle as usual. If you miss your period more than twice, you may be pregnant.

Contact your doctor immediately. You may continue taking Danielle after a pregnancy test has been performed and your doctor confirms it is safe to do so.

If you stop taking Danielle

You may stop taking Danielle at any time. If you do not wish to become pregnant, ask your doctor about other reliable contraceptive methods.

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

4. Possible adverse effects

Like all medicines, Danielle may produce adverse effects, although not everyone experiences them. If you experience any adverse effect, especially if it is severe and persistent, or have any change in health that you think may be due to Danielle, consult your doctor.

All women who take 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 starting to use Danielle".

The following classification is used to specify the frequency of side effects: Very common: may affect more than 1 in 10 women Common: may affect up to 1 in 10 women Uncommon: may affect up to 1 in 100 women Rare: may affect up to 1 in 1,000 women Very rare: may affect up to 1 in 10,000 women, including isolated cases and those with unknown frequency

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

Serious adverse effects

For serious side effects in women taking combined oral contraceptives, see the section "Take special care before taking Danielle". If necessary, seek immediate medical help.

Other possible adverse effects

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

Organ System		Frequency of Adverse Reactions
	Common		Uncommon		Rare
Disorders of the nervous system	Headache		Migraine, leg cramps
Psychiatric disorders			Depressed mood, nervousness	Anorexia, decreased libido, aggressive reactions, apathy
Ocular disorders			Ophthalmological disorders	Visual disturbances, conjunctivitis, intolerance to contact lenses
Ear and labyrinth disorders				Hearing loss
Cardiac disorders				Increased heart rate and cardiac problems
Vascular disorders			Vein disorders High or low blood pressure	Harmful blood clots in a vein or artery, e.g.: In a leg or foot (i.e., DVT) In a lung (i.e., PE) Heart attack Stroke Mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA) Blood clots in the liver, stomach/intestine, kidneys, or eye
Blood and lymphatic system disorders				Anemia
Respiratory, thoracic and mediastinal disorders				Sinusitis, asthma, upper respiratory tract infections
Gastrointestinal disorders	Abdominal pain		Nausea, vomiting	Diarrhea
Skin and subcutaneous tissue disorders			Acne/acne-like dermatitis, rash, eczema, skin irritation, chloasma, hair loss	Erythema multiforme, pruritus
Endocrine disorders				Hirsutism, virilization
Renal and urinary disorders			Urinary tract infections
Reproductive system and breast disorders	Breast tenderness or pain	Breast tenderness or pain, irregular bleeding, absence of bleeding, dysmenorrhea, ovarian cyst development, dyspareunia, vaginitis/vulvovaginitis, changes in vaginal discharge	Hypomenorrhea, mastitis, fibrocystic breast changes, breast discharge, leiomyoma, endometritis, salpingitis
Infections and infestations		Vaginal candidiasis or other fungal infections
General disorders and administration site conditions		Hot flushes, fatigue/weakness, feeling unwell, back pain, changes in body weight, increased appetite, edema	Allergic reactions, flu-like symptoms

Your chances of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information about conditions that increase the risk of blood clots and symptoms of a blood clot).

The following adverse reactions have been observed in women taking combined oral contraceptives (see section 2, "Take special care before taking Danielle"):

• thrombosis;
• hypertension;
• hepatic tumours;
• yellow-brown patches on the face and body (chloasma);
• development or worsening of disorders whose pathogenesis is not clearly understood, but which have been associated with the use of combined oral contraceptives:
• inflammatory bowel disease (Crohn's disease or ulcerative colitis);
• haemoglobin metabolism disorder (porphyria);
• certain disorders of the immune system (systemic lupus erythematosus);
• rash in the later stages of pregnancy (herpes gestationis or gestational pemphigoid);
• seizures, Sydenham's chorea;
• blood coagulation disorder in combination with kidney disease (haemolytic uraemic syndrome);
• hereditary angioedema;
• jaundice.

Oral contraceptives and breast cancer

The risk of breast cancer is slightly increased in women taking combined oral contraceptives. However, since the risk of developing breast cancer below the age of 40 is small, the overall risk remains low.

Sex hormones influence the mammary glands. Hormonal changes (e.g., due to the use of hormonal contraceptives) may create an environment in which hormonal sensitivity of the mammary glands to other factors promoting cancer development is increased, thereby increasing the likelihood of cancer development. Some studies indicate that the risk of developing breast cancer in middle-aged women is associated with early and prolonged use of combined oral contraceptives.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed 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 listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Danielle

Keep out of the reach and sight of children.

Do not use Danielle after the expiry date ("EXP") printed on the carton and blister. The expiry date refers to the last day of the month indicated.

Do not use Danielle if you notice any visible signs of deterioration.

Do not store above 30°C.

Medicines must not be disposed of via wastewater drains or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Danielle

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

Core: monohydrate lactose, magnesium stearate, corn starch, povidone, and talc (E-553b).

Coating: Opaglos 2clear, containing: sodium carmellose, monohydrate glucose, maltodextrin, sodium citrate (E-331), lecithin (soy) (E-322).

Nature of the product and pack contents

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

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Laboratorios León Farma S.A.

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

24193, León, Spain

Date of the most recent review of this leaflet: March 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es//