Donabel 2 mg/0.03 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

dienogest/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 have symptoms of a blood clot (see section “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, ask your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may 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

What Donabel is and what it is used for
What you need to know before taking Donabel
How to take Donabel
Possible side effects
How to store Donabel
Contents of the pack and other information

1. What Donabel is and what it is used for

Donabel is a medicine

to prevent pregnancy (“contraceptive pill”).
for the treatment of women with moderate acne who require a contraceptive pill after failure of appropriate topical treatments or oral antibiotics.

It contains a small amount of female hormones, specifically a progestogen (dienogest) and an oestrogen (ethinylestradiol).

Contraceptive pills containing two hormones are known as “combined” pills or combined oral contraceptives.

Oral contraceptive pills (taken by mouth) are a highly effective method of birth control. When taken regularly (without missing tablets), the chance of becoming pregnant is very low.

2. What you need to know before starting Donabel

General considerations

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

Before you can start taking Donabel, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your individual situation, may perform additional tests.

This leaflet describes several situations in which you should stop taking this medicine, or in which its effectiveness may be reduced. In such cases, you should not have sexual intercourse without using additional non-hormonal contraceptive precautions, such as a condom or another barrier method. Do not use rhythm or temperature methods. These methods are unreliable because contraceptive pills alter the usual changes in body temperature and cervical mucus that occur during the menstrual cycle.

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

Your acne will usually improve after 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

Do 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 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), in your lungs (pulmonary embolism, PE), or in 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 are due to have surgery or if you will be immobile for long periods (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 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 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 hyperhomocysteinemia.
If you have (or have ever had) a type of migraine called “migraine with aura”.
If you have or have had a hormone-dependent tumour (e.g. breast cancer or genital organ cancer).
If you have or have had benign or malignant liver tumours.
If you have or have had liver disease, which may cause yellowing of the skin (jaundice) or itching all over the body, and may indicate abnormal liver function.
If you have vaginal bleeding of unknown origin.
If you are pregnant or suspect you may be pregnant.
If you are allergic to ethinylestradiol, dienogest, or any of the other ingredients of this medicine (listed in section 6).

Do not take Donabel

If you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Donabel”).

If any of the above situations apply to you, inform your doctor before starting Donabel. Your doctor will likely recommend another type of oral contraceptive or a 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 women (girls) who have not yet had their first menstrual period.

Elderly women

Donabel is not indicated for use after menopause.

Hepatic impairment

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

Renal impairment

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

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 clots” below).

For a description of the symptoms of these serious adverse effects, see “How to recognize a blood clot”.

If the combined pill is used by a woman who also has any of the conditions listed below, closer monitoring may be required.

Inform your doctor if you have any of the following conditions

If any of these conditions develop or worsen while taking Donabel, you should also inform your doctor.

if you smoke;
if you have diabetes mellitus;
if you are overweight;
if you have hypertension;
if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
if you have systemic lupus erythematosus (SLE, a disease affecting your natural defence system);
if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
if you have sickle cell anaemia (an inherited red blood cell disorder);
if you have high levels of fat in the blood (hypertriglyceridaemia) or a known family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas);
if you need surgery or will be immobile for long periods (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 Donabel after childbirth;
if you have inflammation of veins beneath the skin (superficial thrombophlebitis);
if you have varicose veins;
if you have a heart valve disorder or heart rhythm disorders;
if any of your close relatives have had a blood clot (thrombosis in the lower limbs, lungs – pulmonary embolism, or elsewhere), a heart attack, or a stroke at a young age;
if a close relative has or has ever had breast cancer;
if you suffer from migraine;
if you have epilepsy (see “Other medicines and Donabel”);
if you have liver or biliary disease;
if you have developed a condition for the first time during pregnancy or previous use of sex hormones (e.g. hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy called herpes gestationis, a nervous disorder called Sydenham’s chorea);
if you develop brownish patches on your face and body (chloasma), which may be minimized by avoiding sunlight and ultraviolet radiation;
if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat, difficulty swallowing, or hives potentially accompanied by breathing difficulties, contact your doctor immediately. Medicines containing oestrogens may cause or worsen symptoms of hereditary or acquired angioedema.

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

BLOOD CLOTS

Using a combined hormonal contraceptive such as Donabel 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 veins (called “venous thrombosis”, “venous thromboembolism” or VTE).
In arteries (called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, there may be serious long-term effects, and very rarely, they may be fatal.

It is important to remember that the overall risk of a harmful blood clot due to Donabel 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 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. if it becomes 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 dizziness or lightheadedness. Rapid or irregular heartbeat. Severe stomach 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)
Chest pain, discomfort, pressure, heaviness Feeling of tightness or fullness in the chest, arm, or beneath the breastbone. Feeling of fullness, indigestion, or suffocation. Upper body discomfort radiating to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Severe 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 effects 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 venous 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 higher 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 is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Donabel, 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 VTE (venous thromboembolism) and the type of combined hormonal contraceptive you are taking.

The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Donabel 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 5–7 will develop a blood clot in one year.
Among 10,000 women who use a combined hormonal contraceptive containing dienogest and ethinylestradiol, such as Donabel, about 8–11 will develop a blood clot in one year.

Your risk of developing a blood clot will depend on your personal medical 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 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 Donabel	About 8-11 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 Donabel 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 have 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 require 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 using Donabel several weeks before surgery or while you are less mobile. If you need to stop using Donabel, 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 (> 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed above.

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 using Donabel.

If any of the above conditions change while you are using Donabel—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?

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can lead to 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 Donabel is very small, but it may increase:

with age (especially over about 35 years).
if you smoke. When using a combined hormonal contraceptive such as Donabel, 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 any of your close relatives have 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 disorders, heart rhythm disorders such as 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 developing a blood clot may be further increased.

If any of the above conditions change while you are using Donabel—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.

Pill and cancer

A slightly increased frequency of breast cancer has been observed in women taking combined oral contraceptives, but it is not known whether this is caused by the treatment. For example, it may be due to more frequent detection of tumors in women taking combined oral contraceptives because they are examined more often by their doctor. The incidence of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is important to regularly examine your breasts and to contact your doctor if you notice any lumps.

Rarely, benign liver tumors and, even more rarely, 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 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 unclear to what extent this risk is increased due to sexual behavior or other factors such as human papillomavirus.

The tumors mentioned above can cause a potentially life-threatening condition or death.

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

Bleeding between periods

During the first few months of taking Donabel, you may experience unexpected bleeding or spotting between regular periods. You may also need to use feminine hygiene products and should continue taking the tablets as usual. Irregular bleeding usually stops once your body gets used to the pill (usually after 3 months of use).

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

What to do if you do not have bleeding during the rest period

If you have taken the tablets correctly, have not vomited or had severe 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 tablets correctly before the first withdrawal period or if you miss two consecutive withdrawal periods, you may be pregnant. Contact your doctor immediately. Start the next pack only if you are sure you are not pregnant. In the meantime, use non-hormonal contraception (see also “General considerations”).

Other medicines and Donabel

Always inform your doctor about any medicines or herbal remedies you are taking. Also inform any other doctor or dentist who prescribes you other medicines (or the pharmacist) that you are taking Donabel. They can advise you whether you need additional contraceptive precautions (e.g., condoms) and for how long, or whether you should change the use of another medicine you need.

Some medicines:

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

These include medicines used to treat:

epilepsy (e.g., barbiturates, phenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine, topiramate, and felbamate);
tuberculosis (e.g., rifampicin);
infections caused by HIV or hepatitis C virus (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
fungal infections (e.g., griseofulvin, azole antifungals such as itraconazole, voriconazole, fluconazole);
bacterial infections (macrolide antibiotics, e.g., clarithromycin, erythromycin);
certain heart conditions, high blood pressure (calcium channel blockers, e.g., verapamil, diltiazem);
joint diseases: arthritis, osteoarthritis (etoricoxib);
the herbal remedy St. John’s wort (Hypericum perforatum);
grapefruit juice.

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

lamotrigine
cyclosporine
melatonin
midazolam
theophylline
tizanidine.

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

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

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

Ask your doctor or pharmacist for advice before taking any medicine. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. They can advise you on additional protective measures while taking another medicine together with Donabel.

Laboratory tests

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy

If you are pregnant or think you might be pregnant, you should not take Donabel. If you become pregnant while taking Donabel, you must stop taking it immediately and contact your doctor. If you wish to become pregnant, you can stop taking Donabel at any time (see “If you stop treatment with Donabel”).

Breastfeeding

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

Driving and use of machines

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

Donabel contains soya lecithin

This medicine contains soya lecithin (soybean oil). Do not use this medicine if you are allergic to peanuts or soybeans.

Donabel contains glucose and lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Donabel contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free.”

3. How to take Donabel

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Each pack of Donabel contains 21, 3 x 21, 6 x 21 or 13 x 21 film-coated tablets. The days of the week on which you should take the tablets are indicated on the pack.

You should take the tablets every day at the same time, with some liquid if necessary. Take one tablet daily for 21 consecutive days. The next pack should be started after a 7-day tablet-free interval, during which withdrawal bleeding usually occurs, typically beginning 2–3 days after the last tablet and possibly continuing when starting the next pack.

Start your next pack of Donabel on the 8th day after taking the last tablet. You must start the next pack of Donabel even if bleeding continues. Each new pack should be started on the same day of the week as the previous one, making it easier to remember when to restart and ensuring your cycle occurs on the same days of the month.

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

Taking the first pack of Donabel

If you have not used any hormonal contraceptive in the past month

Start taking one tablet on the first day of your menstrual cycle (the first day of menstruation). You may also start between day 2 and day 5 of your period, but in this case you must 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, combined transdermal patch)

You may start taking Donabel the day after taking the last active tablet of your previous contraceptive (meaning there will be no tablet-free interval). If your previous pack also contained inactive tablets (placebo tablets), you may 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 may start later, but no later than the day after the end of the tablet-free interval 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 preferably start taking Donabel on the day you remove it, and no later than the day you would normally reapply it.

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

Switching from a progestogen-only contraceptive (tablet, injection, implant) or a progestogen-releasing intrauterine system (IUS)

You may stop taking progestogen-only tablets at any time and start taking Donabel the next day at the usual time. However, if you have sexual intercourse, use an additional contraceptive method (barrier method) during the first 7 days of use.

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

After giving birth

If you have recently given birth, your doctor may advise you to start taking Donabel after your first period. However, in some cases you may start taking the hormonal contraceptive earlier—please consult your doctor. You must not breastfeed while taking Donabel unless specifically instructed otherwise by your doctor.

If you are breastfeeding and wish to start taking Donabel, speak with your doctor.

After an abortion or miscarriage

Talk to your doctor about the possibility of taking Donabel.

If you take more Donabel than you should

There is no data available on overdose with Donabel. Overdose may cause nausea, vomiting, and vaginal bleeding in young women. Vaginal bleeding may even occur in young girls who have not yet had their first menstrual period if they have accidentally taken this medicine. If you have taken more Donabel than you should, contact your doctor.

If you suspect a child has 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 at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Donabel

If less than 12 hours have passed since you were supposed to take the tablet, contraceptive reliability is maintained. Take the missed tablet as soon as possible and then continue taking the following tablets at your usual time.
If you are more than 12 hours late in taking a tablet, protection against pregnancy may be reduced. The more consecutive tablets you miss, the higher the risk of pregnancy.

The risk of pregnancy is especially high if a tablet is missed at the beginning or end of the pack. Therefore, follow these rules:

If you miss more than one tablet

Contact your doctor.

Do not take more than 2 tablets in one day to make up for a missed tablet.

If you have missed several tablets and do not experience withdrawal bleeding during the first tablet-free interval, pregnancy should be considered. In this case, speak with your doctor before starting the next pack.

Follow these instructions if you forget to take a tablet:

If you miss a tablet in week 1

If you forget to start a new pack or miss a tablet during the first 7 days, there is a risk of pregnancy (if you had sexual intercourse in the 7 days before missing the tablet). Contact your doctor before starting a new pack.

If you have not had sexual intercourse before missing 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 your usual time. Use additional contraceptive precautions (barrier method—condom) for the next 7 days.

If you miss 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 your usual time. Contraceptive reliability is maintained, and you do not need to use additional contraceptive measures.

If you miss a tablet in week 3

If you follow either of the two procedures described below, additional contraceptive measures are not necessary:

Option 1: Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time). Thereafter, continue taking the tablets at your usual time. Then, start the next pack immediately after taking the last tablet of the current pack—i.e., without a tablet-free interval between packs. Withdrawal bleeding is unlikely to occur until the end of the second pack, but spotting or intermenstrual bleeding may occur during the days you are taking the tablets.

Option 2: You may also stop taking tablets from the current pack. In this case, maintain a tablet-free interval of up to 7 days, including the day you missed the tablet, and then continue with tablets from the next pack.

If you vomit or have severe diarrhoea

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

If you want to delay your period

You can delay your period by continuing to take Donabel without a tablet-free interval after finishing the previous pack. Intermenstrual bleeding can be delayed until the end of the second pack, or for a shorter period if needed. During the second pack, you may experience spotting or bleeding while taking the tablets. Regular intake of Donabel resumes after the usual 7-day tablet-free interval.

If you want to change the first day of your period

If you follow the instructions correctly, your period will start approximately on the same day every four weeks. If you need to change this day, you may shorten (but never extend) the next tablet-free interval by as many days as desired. 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 pack three days earlier than usual. However, if the tablet-free interval is too short (3 days or less), withdrawal bleeding may not occur, but spotting or bleeding may occur during the second pack.

What to do if you have bleeding between periods

In some cases, women taking combined oral contraceptives may experience light intermittent bleeding or spotting, especially during the first few months. As your body adapts to the effects of the tablets, irregular bleeding will disappear—usually by the third cycle. If bleeding continues, becomes heavier, or recurs, speak with your doctor.

What to do if withdrawal bleeding does not occur

If the tablets have been taken correctly according to instructions and there has been no vomiting or diarrhoea, pregnancy is very unlikely. You should continue taking Donabel as usual. If you miss two consecutive periods, you may be pregnant. Contact your doctor immediately. You may continue taking Donabel after a pregnancy test has been performed and your doctor confirms it is safe to do so.

If you stop taking Donabel

You may stop taking Donabel 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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. If you experience any adverse effect, especially if it is severe and persistent, or have any change in your health that you think could be due to Donabel, 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 Donabel”.

Serious adverse effects

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

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

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

Common adverse effects (may affect up to 1 in 10 people):

headache,
breast pain, including discomfort and breast tenderness.

Uncommon adverse effects (may affect up to 1 in 100 people):

inflammation of the vagina and external genitalia (vaginitis/vulvovaginitis),
fungal infections of the vagina and genitals,
increased appetite,
depressive mood,
dizziness,
migraine,
high or low blood pressure,
abdominal pain (including upper and lower abdominal pain, discomfort/bloating),
nausea, vomiting or diarrhoea,
acne,
alopecia (hair loss),
rash (including skin discoloration),
itching (in some cases affecting the whole body),
irregular menstrual bleeding, including heavy bleeding (menorrhagia), light bleeding (hypomenorrhoea), irregular bleeding and absence of bleeding,
intermenstrual bleeding (vaginal/uterine haemorrhage),
breast enlargement, including breast swelling,
breast edema,
dysmenorrhoea (menstrual pain),
vaginal discharge,
ovarian cysts,
pelvic pain,
fatigue, including weakness (asthenia) and malaise (tiredness, weakness and general discomfort),
changes in body weight (increase, decrease or fluctuations).

Rare adverse 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),
fungal and yeast infections,
cold sores,
flu (influenza),
bronchitis,
sinus infection (sinusitis),
upper respiratory tract infections,
viral infections,
uterine fibroids (benign tumours in the uterus),
breast lipomas (benign tumours in the fatty tissue of the breast),
anaemia,
hypersensitivity (allergic reactions),
masculinization (virilism),
loss of appetite (anorexia),
depression,
mental disorders,
insomnia,
sleep disorders,
aggression,
ischaemic stroke (reduced or interrupted blood supply to the brain),
cerebrovascular disorders,
change in muscle tone - dystonia (muscle disorders that may cause abnormal postures or movements),
dry or irritated eyes,
oscillopsia (an eye disorder in which objects appear to move) or other vision disorders,
sudden hearing loss,
tinnitus,
vertigo,
hearing impairment,
cardiovascular disorders (disorders affecting blood supply to the heart),
rapid heartbeat (tachycardia),
harmful blood clots in a vein or artery, for example:
in a leg or foot (i.e., deep vein thrombosis),
in a lung (i.e., pulmonary embolism),
heart attack,
stroke,
transient ischaemic attack (TIA) or stroke-like symptoms, known as transient ischaemic attack (TIA),
blood clots in the liver, stomach/intestine, kidneys or eye.
increased diastolic blood pressure (the lowest blood pressure value reached between two heartbeats),
orthostatic hypotension (dizziness or fainting upon standing up after sitting or lying down),
hot flushes,
varicose veins,
venous disorders, vein pain,
asthma,
deep breathing,
stomach inflammation,
intestinal inflammation,
indigestion (dyspepsia),
skin reactions,
skin problems including skin allergic reactions, neurodermatitis/atopic dermatitis, eczema, psoriasis,
excessive sweating,
chloasma (brownish-yellow patches, also known as pregnancy mask, especially on the face),
pigmentation disorders/increased pigmentation,
seborrhoea (oily skin),
dandruff,
hirsutism (male-pattern hair growth),
orange peel skin,
spider angioma (blood vessels appearing like spider webs, with a central red spot on the skin),
back pain,
bone and muscle discomfort,
muscle pain,
pain in arms and legs,
abnormal cell growth on the surface of the cervix (cervical dysplasia),
pain or cysts in uterine appendages (fallopian tubes and ovaries),
cysts in the breasts,
fibrocystic breast disease (benign growths in the breasts),
pain during intercourse (dyspareunia),
milk secretion from the breast gland (galactorrhoea),
menstrual disorders,
chest pain,
peripheral oedema (fluid retention in the body),
flu-like illness,
inflammation.

Adverse reactions reported with the use of oral contraceptives for which the exact frequency is unknown are: mood changes, increased or decreased sexual desire (libido), intolerance to contact lenses, urticaria, skin disorders such as erythema nodosum or erythema multiforme, milk secretion from the breast, fluid retention.

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

Description of selected adverse reactions

Adverse reactions with very low incidence or late-onset 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”).

Tumours

The frequency of breast cancer diagnosis among users of hormonal contraceptives is slightly increased. Because breast cancer is rare in women under 40 years of age, the risk of developing breast cancer is minimal compared to the overall risk. It is not known whether there is a causal relationship with the use of combined oral contraceptives.
Liver tumours (benign and malignant).

Other conditions

women with hypertriglyceridaemia (increased fat levels in the blood may lead to a higher risk of pancreatitis while taking combined oral contraceptives),
increased blood pressure,
onset or worsening of conditions whose association with combined oral contraceptives is not clear: jaundice and/or itching associated with cholestasis (interruption of bile outflow), gallstones, porphyria (metabolic disorder), systemic lupus erythematosus (chronic autoimmune disease), haemolytic-uraemic syndrome (a disease caused by blood clot formation), a nervous disorder called Sydenham's chorea, herpes gestationis (a blistering disease occurring during pregnancy), hearing loss due to otosclerosis,
liver impairment,
changes in glucose tolerance or peripheral insulin resistance,
Crohn's disease, ulcerative colitis,
chloasma (yellowish-brown patches on the skin).

Interactions

Unexpected bleeding and/or contraceptive failure may result from interactions between other medicines and oral contraceptives (e.g., St. John's wort, medicines used to treat epilepsy, tuberculosis, HIV infection and other infections). See also “Other medicines and Donabel”.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

More information about oral contraceptives

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

Menstrual bleeding may become lighter and shorter. This may reduce the risk of anaemia. Menstrual pain may be reduced or disappear completely.

In addition, users of pills containing 50 micrograms of ethinylestradiol (high-dose pill) have been reported to have a lower incidence of certain serious diseases. These include benign breast diseases, ovarian cysts, pelvic infections (inflammatory diseases of the small pelvic organs), ectopic pregnancy (fetus developing outside the uterus), and endometrial (uterine lining) and ovarian cancer. This may also apply to the use of low-dose pills, but so far it has only been confirmed for endometrial and ovarian cancer.

5. Storage of Donabel

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure, please 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 Donabel

The active substances are dienogest and ethinylestradiol. Each tablet contains 2 mg of dienogest and 0.03 mg of ethinylestradiol.
The other components are:

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

Coating: Opaglos 2 clear, containing: sodium carmellose, glucose, maltodextrin, sodium citrate dihydrate, soya lecithin.

Appearance of the product and contents of the pack

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Effik, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Manufacturer

Laboratorios León Farma, S.A.

C/ La Vallina s/n, Polígono Industrial Navatejera

24193 Villaquilambre, León

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

CZ: Calleto

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

PT: Denille 2 mg + 0.03 mg coated tablet

EE: Ammily 2 mg/0.03 mg

LT: Ammily 2 mg/0.03 mg plevele dengtos tabletes

LV: Ammily 2 mg/0.03 mg apvalkotas 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

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

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