Package Insert: Information for the User

Donabel 2 mg/0.03 mg Film-Coated Tablets EFG

dienogest/etinilestradiol

Important Information 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 “Blood Clots”).

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others, 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 package insert. See section 4.

Donabel is a medication

• for preventing pregnancy (“birth control pill”).
• for the treatment of women with moderate acne who accept receiving a birth control pill after the failure of suitable local treatments or oral antibiotics.

It contains a small amount of female hormones, specifically progesterone (dienogest) and an estrogen (etinilestradiol).

Birth control pills that contain two hormones are called combined pills or combined oral contraceptives.

Oral contraceptives (administered orally) are a very effective method of family planning. If taken regularly (without missing pills), the likelihood of becoming pregnant is very low.

Your acne will usually improve within three to six months of treatment and may continue to improve even after six months. You should discuss with your doctor the need to continue treatment three to six months after starting and periodically thereafter.

Do not take Donabel

You should not take Donabel 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 have or have had hormone-dependent tumors (for example, breast cancer or genital organ cancer).
• If you have or have had benign or malignant liver tumors.
• If you have or have had liver disease, which may cause yellowing of the skin (jaundice) or itching all over the body, and indicate an abnormality in liver function.
• If you have unexplained vaginal bleeding.
• If you are pregnant or suspect that you may be pregnant.
• If you are allergic to ethinylestradiol, dienogest or any of the other components of this medication (including in section 6).

Do not take Donabel

• If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also the section “Other Medications and Donabel”).

If you have any of the above situations, inform your doctor before starting to take Donabel. Your doctor may recommend another type of oral contraceptive or another non-hormonal contraceptive method. See also the section “General Considerations”.

Additional Information on Special Populations

Children and Adolescents

Donabel is not indicated for use in girls who have not yet had their first menstrual period.

Older Women

Donabel is not indicated for use after menopause.

Liver Disease

Do not take Donabel if you have liver disease. See also “Do not take Donabel” and “Warnings and Precautions”.

Renal Insufficiency

Consult your doctor. Available data do not indicate that it is necessary to change the use of Donabel.

Warnings and Precautions

If the combined pill is used by a woman who is also experiencing any of the conditions listed below, it may be necessary to monitor her more closely.

Inform your doctor if you suffer from any of the following conditions

If the condition develops or worsens while taking Donabel, you should also inform your doctor.

• if you smoke;
• if you have diabetes mellitus;
• if you are overweight;
• if you have high blood pressure;
• if you have inflammatory bowel disease (Crohn's disease or ulcerative colitis);
• if you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system);
• if you have hemolytic uremic syndrome (HUS, a disorder of blood clotting that causes kidney failure);
• 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 greater risk of blood clots. Ask your doctor when you can start taking Donabel after delivery;
• if you have superficial vein inflammation under the skin (thrombophlebitis);
• if you have varicose veins;
• if you have a heart valve disease or arrhythmia;
• if any of your close relatives have had a blood clot (deep vein thrombosis, pulmonary embolism or in any other location), a heart attack or a stroke at a young age;
• if a close relative has had breast cancer;
• if you have migraines;
• if you have epilepsy, (see “Other Medications and Donabel);
• if you have liver or gallbladder disease;
• if you have a disease that first appeared during pregnancy or previous use of sex hormones (for example, hearing loss, a blood disorder called porphyria, skin rash with blisters during pregnancy called herpes gestational, a nervous system disorder called Sydenham's chorea);
• if you have melasma, which can be reduced by avoiding the sun and ultraviolet radiation;
• if you experience symptoms of angioedema, such as facial, tongue and/or throat inflammation, difficulty swallowing or potentially life-threatening urticaria, contact your doctor immediately. Medications containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema.

If any of the above conditions worsen or first appear, inform your doctor as soon as possible.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Donabel increases your risk of suffering a blood clot 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 of blood clots is not always complete. In rare cases, there may be long-lasting or potentially life-threatening effects, or very rarely, they may be fatal.

It is essential to remember that the overall risk of a serious blood clot due to Donabel is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek immediate medical attentionif 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 vein in the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism (PE).
• In very rare cases, a blood clot can form in a vein in 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 in which you take 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 Donabel, 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 Donabel is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone or norgestimato, 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 Donabel, 8-11 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

Your risk of a blood clot is small, but some conditions increase it. Your risk is higher:

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

Long flights (> 4 hours) may temporarily increase your 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 above conditions, even if you are unsure. Your doctor may decide that you should stop taking Donabel.

If any of the above conditions change while you are using Donabel, 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 Donabel is very small, but it may increase:

• with age (above about 35 years).
• if you smoke. When using a combined hormonal contraceptive like Donabel, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend 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 (i.e., before about 50 years). You may also be at higher risk of a heart attack or stroke.
• if you 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, arrhythmia 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 further.

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

Birth Control Pills and Cancer

Breast cancer has been observed at a slightly higher frequency in women taking oral contraceptives, but it is not known whether this is caused by the treatment. For example, it may be due to the fact that women taking oral contraceptives are examined more frequently by their doctor. The appearance of breast tumors gradually decreases after stopping oral contraceptives. It is essential that you regularly examine your breasts and contact your doctor if you notice any lump.

In rare cases, benign liver tumors and, less frequently, malignant liver tumors have been reported in users of hormonal contraceptives. These tumors can cause potentially life-threatening internal bleeding. Consult your doctor immediately if you experience severe abdominal pain.

The most important risk factor for cervical cancer is persistent infection with the human papillomavirus (HPV).

Some studies suggest that long-term use of hormonal contraceptives is a risk factor for developing cervical cancer in women. However, it is not clear to what extent this risk is increased by sexual behavior or other factors such as HPV.

The tumors mentioned above can cause potentially life-threatening or fatal conditions.

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

Spotting

During the first few months of taking Donabel, you may experience unexpected bleeding or spotting between regular periods. You may also need sanitary products and take the pills as usual. Irregular bleeding usually disappears as your body adjusts to the pill (usually after 3 months of use).

Contact your doctor if this bleeding persists for more than a few months or if it starts after a few months.

What to do if no bleeding occurs during the break

If you have taken the pills correctly, have not had severe vomiting or diarrhea, and have not taken any other medication, it is very unlikely that you are pregnant. Continue taking Donabel as usual.

If you did not take the pills correctly before the first menstrual period or if you do not have a menstrual period for two consecutive times, you may be pregnant. Contact your doctor immediately. Start the next pack only if you are sure you are not pregnant. Meanwhile, use non-hormonal contraceptives (see also “General Considerations”).

Other Medications and Donabel

Always inform your doctor of the medications or herbal supplements you are using. Also inform any other doctor or dentist who prescribes other medications (or the pharmacist) that you are taking Donabel. They may tell you if you need to take additional contraceptive precautions (for example, condoms) and for how long, or if you need to change the use of another medication you need.

Some medications:

• can affect the levels of Donabel in the blood.
• may make it less effective in preventing pregnancy.
• may cause unexpected bleeding.

These include medications used to treat:

• epilepsy (for example, barbiturates, phenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine, topiramate, and felbamate);
• tuberculosis (for example, rifampicin);
• infections caused by the HIV or hepatitis C virus (called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz);
• fungus infections (for example, griseofulvin, azole antifungals such as itraconazole, voriconazole, fluconazole);
• bacterial infections (macrolide antibiotics, for example, clarithromycin, erythromycin);
• heart disease, high blood pressure (calcium channel blockers, for example, verapamil, diltiazem);
• joint diseases: arthritis, osteoarthritis (etoricoxib);
• St. John's Wort (Hypericum perforatum);
• orange juice.

Donabel may also interfere with the action of other medications, for example:

• lamotrigine
• ciclosporin
• melatonin
• midazolam
• theophylline
• tizanidine.

Do not take Donabel if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as these medications can cause increases in liver function parameters in the blood (elevated liver enzyme ALT).

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

Donabel can be restarted approximately 2 weeks after the end of this treatment. See the section “Do not take Donabel”.

Consult your doctor or pharmacist before taking any medication. Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. They may advise you on additional protective measures while taking another medication with Donabel.

Laboratory Tests

If you need a blood test, inform your doctor or the laboratory staff that you are taking the pill, as hormonal contraceptives can affect the results of some tests.

Pregnancy, Lactation, and Fertility

If you are pregnant or breastfeeding, or if you plan to become pregnant, consult your doctor or pharmacist before taking this medication.

Pregnancy

If you are pregnant or suspect that you may be pregnant, do not take Donabel. If you become pregnant while taking Donabel, stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Donabel at any time (see “Stopping Treatment with Donabel”).

Lactation

Generally, the use of Donabel is not recommended during breastfeeding. You should consult your doctor if you want to take the pill while breastfeeding.

Driving and Operating Machinery

Donabel does not affect driving and operating machinery.

Donabel contains soy lecithin

This medication contains soy lecithin (soy oil). Do not use this medication if you are allergic to peanuts or soy.

Donabel contains glucose and lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Donabel contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Each package of Donabel contains 21, 3 x 21, 6 x 21 or 13 x 21 coated tablets. The package indicates the days of the week on which you should take the tablets.

You should take the tablets every day at the same time, if necessary with some liquid. You should take one tablet daily for 21 consecutive days. The intake of tablets from the next package begins after an interval of 7 days without tablets, during which a bleeding usually occurs, which usually starts 2-3 days after taking the last tablet and may not have ended before starting the next package.

Start taking your next package of Donabel on the 8th day after taking the last tablet. You should start taking the next package of Donabel even if bleeding continues. 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 days of the month.

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

First package of Donabel intake

If no hormonal contraceptive has been applied in the last month

Start taking a tablet on the first day of the menstrual cycle (the first day of menstruation). It can also be taken from the 2nd to the 5th day of menstruation, but in this case, you should use an additional barrier contraceptive method during the first seven days of tablet intake.

Switching to Donabel from another combined contraceptive (combined oral contraceptive (COC), vaginal ring, transdermal combined patch)

You can start taking Donabel the day after taking the last tablet of your previous contraceptive (which means there will be no interval without tablets). If your previous package also contained inactive tablets (placebo tablets), you can start taking Donabel the day after taking the last active tablet (if you are unsure whether the tablets are active, consult your doctor or pharmacist). You can start taking it later, but no later than the day after completing the break of your previous contraceptive (or after taking the last placebo tablet of your previous contraceptive). In the case of a patch or vaginal ring, you should start taking Donabel preferably on the day you remove it and no later than the day you reapply it.

If you follow these instructions, you will not need to use any other contraceptive method.

Switching from a progestin-only contraceptive (pill, injection, implant) or a progestin-only intrauterine system (IUS)

You can stop taking the progestin-only tablets at any time and start taking Donabel the day after the usual time. However, if you have sex, use an additional barrier contraceptive method (barrier method) during the first 7 days of use.

In the case of an injection, an implant, or an IUS, start taking Donabel on the day you would normally receive the next injection or the day the implant or IUS is removed. However, if you have sex, use an additional barrier contraceptive method (barrier method) during the first 7 days of tablet intake.

After giving birth

If you have just given birth, your doctor may advise you to start taking Donabel after your first period. However, in some cases, you can start taking the hormonal contraceptive before, please consult your doctor. Do not breastfeed if you take Donabel, unless your doctor has ordered you to.

If you are breastfeeding and want to start taking Donabel, talk to your doctor.

After an abortion or spontaneous abortion

Talk to your doctor about the possibility of taking Donabel.

If you take more Donabel than you should

No data are available on Donabel overdose. Overdose may cause nausea, vomiting, and, in young women, vaginal bleeding. This vaginal bleeding may occur even in girls who have not yet had their first menstrual period if they accidentally take this medication. If you have taken more Donabel than you should, contact your doctor.

If you observe that a child has probably taken several tablets, contact your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Donabel

• If less than 12 hours have passed since you should have taken the tablet, the contraceptive's reliability is maintained. Take the missed tablet as soon as possible and continue taking the next tablets at the usual time.
• If you delay taking a tablet by more than 12 hours, the protection against pregnancy may be reduced. The more consecutive tablets you leave out, the higher the risk of becoming pregnant.

The risk of becoming pregnant is especially high if you miss a tablet at the beginning or end of the package. Therefore, you should follow the following rules:

• If you forget to take more than one tablet

Contact your doctor.

Do not take more than 2 tablets in a day to replace a missed tablet.

If you have forgotten to take several tablets and there is no withdrawal bleeding in the first break, you should consider the possibility of pregnancy. In this case, you should talk to your doctor before starting the next package.

Follow these instructions if you have forgotten to take a tablet:

If you have forgotten a tablet in week 1

If you forget to start taking a new package or if you forget to take a tablet during the first 7 days, there is a risk of pregnancy (if you have had sex in the 7 days before forgetting a tablet). Contact your doctor before starting a new package.

If you have not had sex before omitting the tablet, take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablet at the usual time. Take additional barrier contraceptive methods (condom) during the next 7 days.

If you have forgotten a tablet in week 2

Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablet at the usual time. The contraceptive's reliability is maintained, and you do not need to use additional contraceptive methods.

If you have forgotten a tablet in week 3

If you follow one of the two procedures explained below, you do not need to use additional contraceptive methods:

• Option 1: Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time). From then on, you should continue taking the tablets at the usual time. Then, you should start the next package immediately after taking the last tablet of the current package, i.e., without a break between packages. It is unlikely that withdrawal bleeding will occur until the end of the second package, but some spotting or intermenstrual bleeding may occur during the days you are taking the tablets.

or

• Option 2: You can also stop taking the tablets from the current package. In that case, you should maintain a break of up to 7 days without tablets, including the day you forgot the tablet, and then continue taking the tablets from the next package.

If you vomit or have intense diarrhea

If vomiting or intense diarrhea occurs within 3-4 hours after taking the tablet, it is possible that the tablet will not be absorbed correctly in the gastrointestinal tract. The situation is similar to that which occurs if you forget to take a tablet. In this case, you should take a tablet as soon as possible, if possible before 12 hours. If more than 12 hours have passed, you should follow the instructions in the section "If you forget to take Donabel."

If you want to delay your period

You can delay the onset of menstruation if, after completing the previous package, you continue taking Donabel without a break. Menstrual bleeding may be delayed until the end of the second package, or if necessary, for a shorter period. During the intake of the second package, you may experience some spotting or bleeding while taking the tablets. Regular intake of Donabel resumes after the usual 7-day break.

If you want to change the first day of your period

If you follow the instructions for taking the tablets, your period will start approximately on the same day every four weeks. If you need to change this day, you can shorten (but never lengthen) the next break by as many days as you want. For example, if your period usually starts on Friday, and you want it to start on Tuesday (i.e., three days earlier), you should start the next package three days earlier than usual. However, if the break is too short (3 days or less), there will be no withdrawal bleeding, but you may experience spotting or intermenstrual bleeding during the days you are taking the tablets.

What to do if you have bleeding between periods

In some cases, women taking combined oral contraceptives may experience a small, intermittent bleeding or spotting, especially during the first few months. When your body adapts to the effects of the tablets, irregular bleeding will disappear; usually, this happens in the third cycle. If bleeding continues, is more intense, or recurs, talk to your doctor.

What to do if there is no withdrawal bleeding

If the tablets have been taken correctly, according to the instructions, and there have been no vomiting or diarrhea, it is very unlikely that you will become pregnant. You should continue taking Donabel as usual. If you do not have your period twice in a row, you may be pregnant. Contact your doctor immediately. You can continue taking Donabel after the pregnancy test has been performed and your doctor confirms that you can do so.

If you interrupt treatment with Donabel

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

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

Like all medicines, this medicine can 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 changes that you think may be related to Donabel, 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 take Donabel”.

Severe side effects

For severe side effects in women taking combined oral contraceptives, see the section “Warnings and precautions”. If necessary, seek immediate medical help.

Immediately contact your doctor if you experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat and/or difficulty swallowing or potentially difficulty breathing (also see the section “Warnings and precautions”).

The following is a list of side effects that have been associated with the use of Donabel:

Frequent side effects(may affect up to 1 in 10 people):

• headache,
• breast pain, including discomfort and breast tenderness.

Less frequent side effects(may affect up to 1 in 100 people):

• vaginal and external genital inflammation (vaginitis/vulvovaginitis),
• yeast and fungal infections of the vagina and genitals,
• increased appetite,
• depressed mood,
• dizziness,
• migraine,
• high or low blood pressure,
• abdominal pain (including upper and lower abdominal pain, discomfort, and swelling),
• nausea, vomiting, or diarrhea,
• acne,
• hair loss (alopecia),
• pruritus (including skin rash),
• itching (in some cases, all over the body),
• irregular menstrual bleeding, including heavy bleeding (menorrhagia), light bleeding (hypomenorrhea), irregular bleeding, and amenorrhea,
• intermenstrual bleeding (vaginal/uterine hemorrhage),
• breast enlargement, including breast swelling,
• breast edema,
• menstrual cramps (dysmenorrhea),
• vaginal discharge,
• ovarian cysts,
• pelvic pain,
• fatigue, including weakness (asthenia) and general malaise (fatigue, weakness, and general discomfort),
• weight changes (gain, loss, or fluctuations).

Rare side effects(may affect up to 1 in 1,000 people):

• inflammation of the ovaries or Fallopian tubes,
• urinary tract inflammation,
• bladder inflammation (cystitis),
• breast inflammation (mastitis),
• yeast and fungal infections,
• herpes labialis,
• influenza,
• bronchitis,
• sinusitis (infection of the nasal sinuses),
• upper respiratory tract infections,
• viral infections,
• uterine fibroids (benign tumors in the uterus),
• mammillary lipomas (benign tumors in the fatty tissue of the breast),
• anemia,
• hypersensitivity (allergic reactions),
• virilization (masculinization),
• loss of appetite (anorexia),
• depression,
• mental disorders,
• insomnia,
• sleep disorders,
• aggressiveness,
• ischemic stroke (decreased or interrupted blood supply to the brain),
• cerebrovascular disorders,
• muscle dystonia (muscular disorders that can cause abnormal postures or movements),
• dry or irritated eyes,
• oscillopsia (ocular disorder in which objects appear to move) or other visual disorders,
• sudden loss of hearing,
• tinnitus,
• dizziness,
• hearing impairment,
• cardiovascular disorders (disorders of blood supply to the heart),
• rapid heart rate (tachycardia),
• harmful blood clots in a vein or artery, for example:

• in a leg or foot (deep vein thrombosis),
• in a lung (pulmonary embolism),
• heart attack,
• stroke,
• mild or transient stroke-like symptoms, known as transient ischemic attack (TIA),
• blood clots in the liver, stomach/intestine, kidneys, or eye.

• increased diastolic blood pressure (the lower value of blood pressure between two heartbeats),
• orthostatic hypotension (dizziness or fainting when standing up after sitting or lying down),
• hot flashes,
• varicose veins,
• venous disorders, pain in the veins,
• asthma,
• deep breathing,
• inflammation of the stomach,
• inflammation of the intestine,
• indigestion (dyspepsia),
• skin reactions,
• skin problems, including allergic skin reactions, neurodermatitis/atopic dermatitis, eczema, psoriasis,
• excessive sweating,
• melasma (brown-yellow skin patches, also known as pregnancy mask, especially on the face),
• pigmentation disorders/increased pigmentation,
• seborrhea (oily skin),
• dandruff,
• hirsutism (male-like hair growth),
• orange skin,
• spider veins (blood vessels with a web-like appearance, with a red central spot on the skin),
• back pain,
• muscle and bone pain,
• muscle pain,
• pain in the arms and legs,
• abnormal cell growth on the surface of the cervix (cervical dysplasia),
• pelvic pain or cysts in the ovaries or Fallopian tubes,
• breast cysts,
• benign breast growths (fibroadenoma),
• painful intercourse (dyspareunia),
• milk secretion (galactorrhea),
• menstrual disorders,
• chest pain,
• peripheral edema (fluid retention in the body),
• illness similar to the flu,
• inflammation.

The adverse reactions that have been reported with the use of oral contraceptives and for which the exact frequency is not known are: mood changes, increased or decreased libido, intolerance to contact lenses, urticaria, skin disorders such as erythema nodosum or multiforme, breast secretion, fluid retention.

The risk 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).

Selected adverse reaction descriptions

The adverse reactions with very low incidence or late onset of symptoms related to the group of combined oral contraceptives are listed below (also see “Do not take Donabel” and “What you need to know before starting to take Donabel”).

Cancer

• The frequency of breast cancer diagnosis among users ofcombined oral contraceptives is slightly increased. Since breast cancer rarely occurs in women under 40, the risk of developing breast cancer is minimal compared to the general risk. It is not known if there is a causal relationship with the use of combined oral contraceptives.
• Liver tumors(benign and malignant).

Other conditions

• women withhypertriglyceridemia(the increase inthe amountof fat in the blood mayincrease the risk of pancreatitis during theuse of combined oral contraceptives),
• increased blood pressure,
• appearance or worsening of conditionswhoseassociation with combined oral contraceptives is not clear: jaundice and/orpruritus associated with cholestasis (interruption of bile flow), gallstones, porphyria (metabolic disorder), systemic lupus erythematosus (chronic autoimmune disease), hemolytic-uremic syndrome (a disease caused by the formation of blood clots), a nervous disorder called Sydenham's chorea, gestational herpes (a blistering disease that occurs during pregnancy), hearing loss caused by otosclerosis,
• liver deterioration,
• changes in glucose tolerance or peripheral insulin resistance,
• inflammatory bowel disease (Crohn's disease, ulcerative colitis),
• melasma (brown-yellow skin patches).

Interactions

Unexpected bleeding and/or failure of the contraceptive may be due to interactions of other medications with oral contraceptives (e.g., St. John's Wort, medications for epilepsy, tuberculosis, HIV infection, and other infections). See also “Other medications and Donabel”.

Reporting adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

More information on oral contraceptives

Combined oral contraceptives may also produce health benefits unrelated to contraception.

Menstrual bleeding may be lighter and shorter. This may reduce the risk of anemia. Menstrual pain may be less or disappear completely.

Additionally, it has been reported that users of pills containing 50 micrograms of ethinylestradiol (high-dose pill) have a lower incidence of certain serious diseases. Among them are benign breast diseases, ovarian cysts, pelvic infections (inflammatory diseases of the small organs of the pelvis), ectopic pregnancy (the fetus develops outside the uterus), and endometrial and ovarian cancer. This may also apply to the use of a low-dose pill, but it has only been confirmed for endometrial and ovarian cancer.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Donabel

• The active principles are dienogest and etinilestradiol. Each tablet contains 2 mg of dienogest and 0.03 mg of etinilestradiol.
• The other components are:

Tablet core: lactose monohydrate, magnesium stearate, cornstarch, povidone 30, talc.

Coating: Opaglos 2 clear, which contains: sodium carmellose, glucose, maltodextrin, sodium citrate dihydrate, soy lecithin.

Appearance of the product and contents of the packaging

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

Donabel is available in packaging containing 21, 3 x 21, 6 x 21, and 13 x 21 film-coated tablets.

Only some packaging sizes may be marketed.

Marketing Authorization Holder

Effik Laboratories, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Responsible for manufacturing

León Farma Laboratories, S.A.

C/ La Vallina s/n, Industrial Estate Navatejera

24193 Villaquilambre, León

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

CZ: Calleto

ES: Donabel 2 mg/0.03 mg film-coated tablets EFG

PT: Denille 2 mg + 0.03 mg film-coated tablet

EE: Ammily 2 mg/0.03 mg

LT: Ammily 2 mg/0.03 mg coated tablets

LV: Ammily 2 mg/0.03 mg coated tablets

IT: Effiprev 2 mg/0.03 mg

FR: Dienopil 2 mg/0.03 mg

LU: Louise 2 mg/0.03 mg

BE: Louise 2 mg/0.03 mg

Last review date of this leaflet:January 2023

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