Dienogest/ethinylestradiol Goibela 2 mg/0.03 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

dienogest/ethinylestradiol goibela 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 be experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Read all of this 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; do not pass it on to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What dienogest/ethinylestradiol goibela is and what it is used for

dienogest/ethinylestradiol goibela contains small amounts of female hormones known as progestogen (dienogest) and an oestrogen (ethinylestradiol).

Oral contraceptive pills containing two hormones are called "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 likelihood of becoming pregnant is very low.

Clinical trials have shown that in women in whom a pronounced effect of male hormones (called "androgens") causes acne, dienogest/ethinylestradiol goibela improves these symptoms.

dienogest/ethinylestradiol goibela is used:

• to prevent pregnancy;
• for the treatment of women with moderate acne who are willing to use an oral contraceptive pill after failure of appropriate topical treatments or oral antibiotics.

2. What you need to know before starting to take dienogest/ethinylestradiol goibela

General considerations Before starting to use dienogest/ethinylestradiol goibela, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”). Before you start taking dienogest/ethinylestradiol goibela, your doctor will ask you some questions about your personal medical history and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out other tests. This patient leaflet describes several situations in which you should stop using dienogest/ethinylestradiol goibela, or in which the effectiveness of dienogest/ethinylestradiol goibela may be reduced. In such situations, you should not have sexual intercourse or should use additional non-hormonal contraceptive precautions, for example, use a condom or another barrier method. Do not use rhythm or temperature methods. These methods are unreliable because dienogest/ethinylestradiol goibela alters the usual changes in body temperature and cervical mucus that occur during the menstrual cycle. dienogest/ethinylestradiol goibela, like other combined hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted infections.

Acne normally improves 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 it, and periodically thereafter.

Do not take dienogest/ethinylestradiol goibela

You must not use dienogest/ethinylestradiol goibela 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 are allergic to ethinylestradiol, dienogest, or any of the other ingredients of this medicine (listed in section 6).

• 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 require 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 forming 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 have (or have ever had) inflammation of the pancreas (pancreatitis) together with very high levels of fat (lipids) in the blood (hypertriglyceridaemia).

• If you have or have had benign or malignant liver tumours.

• If you smoke (see “The pill and vascular disorders”).

• If you have or have had a 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, have had, or are suspected of having hormone-sensitive cancer (e.g. breast or endometrial cancer).

• If you have vaginal bleeding of unknown origin.

• If you do not have menstruation (period) and the cause has not been determined.

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

If any of the above conditions occurs for the first time while you are taking the pill, you must stop taking the product immediately and consult your doctor. In the meantime, you should use a different, non-hormonal method of contraception. See also section "General considerations".

Additional information on special user groups

Children and adolescents

dienogest/ethinylestradiol goibela is not intended for women (girls) who have not yet started menstruating.

Use in elderly women

dienogest/ethinylestradiol goibela is not for postmenopausal women.

Hepatic impairment

Do not take dienogest/ethinylestradiol goibela if you have liver disease. (See also "Do not take dienogest/ethinylestradiol goibela" and "Warnings and precautions").

Renal impairment

Consult your doctor. Available data do not indicate the need to change the use of dienogest/ethinylestradiol goibela.

Warnings and precautions

When you should exercise special caution with dienogest/ethinylestradiol goibela

Consult your doctor or pharmacist before starting to take dienogest/ethinylestradiol goibela.

When should you consult your doctor? Seek urgent medical attention If you notice possible signs of a blood clot, which may indicate 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 (thrombosis)” below). For a description of the symptoms of these serious adverse effects, see “How to recognize a blood clot”.

In some situations, you may need to take special care when taking dienogest/ethinylestradiol goibela or other "combined pills", and you may need to visit your doctor regularly.

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

If any of these conditions develop or worsen while you are using dienogest/ethinylestradiol goibela, you must 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 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 long periods (see section 2 “Blood clots”);
• if you have recently given birth, you are at increased risk of blood clots. Ask your doctor when you can start taking dienogest/ethinylestradiol goibela 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 abnormalities;
• if any of your close relatives has had a blood clot (thrombosis in the leg, in the lung – pulmonary embolism, or elsewhere), heart attack, or stroke at a young age;
• if you suffer from migraine;
• if you have depression; some women using hormonal contraceptives such as dienogest/ethinylestradiol goibela 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 further medical advice as soon as possible;
• if you have epilepsy (see “Other medicines and dienogest/ethinylestradiol goibela”);
• if a close family member has or has had breast cancer;
• if you have liver or biliary disease;
• if you have or have had a condition that first occurred during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy known as herpes gestationis, a nervous disorder called Sydenham's chorea);
• if you have brownish-yellow patches on the skin, especially on the face (chloasma); if this occurs, you should avoid direct sunlight or ultraviolet light;
• if you have hereditary or acquired angioedema: products containing estrogens may cause or worsen angioedema symptoms. Contact your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with potential breathing difficulties.

If any of these conditions occur for the first time, recur, or worsen while taking the pill, consult your doctor.

BLOOD CLOTS

Using a combined hormonal contraceptive such as dienogest/ethinylestradiol goibela 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. In rare cases, there may be serious long-term effects or, very rarely, they may be fatal.

It is important to remember that the overall risk of a harmful blood clot due to dienogest/ethinylestradiol goibela 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., if it becomes pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without a known cause or rapid breathing. Sudden cough without a clear cause, possibly producing blood. Sharp chest pain that may worsen upon deep breathing. Severe dizziness or lightheadedness. 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).
Chest pain, discomfort, pressure, or heaviness. Feeling of tightness or fullness in the chest, arm, or below the breastbone. Sensation of fullness, indigestion, or suffocation. Upper body discomfort spreading 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 a 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 the 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 in 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 (PE).
• 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 of first-time use of a combined hormonal contraceptive. 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 remains somewhat higher than if you were not taking a combined hormonal contraceptive.

When you stop taking dienogest/ethinylestradiol goibela, 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 dienogest/ethinylestradiol goibela is low.

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot within 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 within one year.
• Among 10,000 women using a combined hormonal contraceptive containing dienogest and ethinylestradiol, such as dienogest/ethinylestradiol goibela, between 8 and 11 women will develop a blood clot within one year.
• Your individual 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 dienogest/ethinylestradiol goibela	Approximately 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 dienogest/ethinylestradiol goibela 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 require surgery or remain immobile for long periods due to injury or illness, or if your leg is in a cast. You may need to stop using dienogest/ethinylestradiol goibela several weeks before surgery or while you are less mobile. If you need to stop using dienogest/ethinylestradiol goibela, 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 less than a few weeks ago.

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

Air travel (over 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 conditions listed above, even if you are uncertain. Your doctor may decide that you need to stop using dienogest/ethinylestradiol goibela.

If any of the above conditions change while you are using dienogest/ethinylestradiol goibela—for example, if a close relative experiences a thrombosis without a known cause or if you gain significant 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 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 dienogest/ethinylestradiol goibela is very small, but it may increase:

• with age (over about 35 years);
• if you smoke. When using a combined hormonal contraceptive such as dienogest/ethinylestradiol goibela, 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 be at higher risk of heart attack or stroke;
• if you or a close relative has 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 dienogest/ethinylestradiol goibela—for example, if you start smoking, a close relative experiences a thrombosis without a known cause, or you gain significant weight—inform your doctor.

The 'pill' and cancer

Breast cancer has been observed more frequently in women using contraceptive pills, but it is not known whether this is caused by the treatment. It may be that more tumors are detected in women taking contraceptive pills because they are examined by their doctor more often. The occurrence of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is important that you regularly examine your breasts and contact your doctor if you notice any lump.

Rare cases of benign liver tumors and even rarer cases of malignant liver tumors have been reported in users of the contraceptive pill. In isolated cases, these tumors may cause 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.

Other conditions

• High blood pressure

An increase in blood pressure has been documented in women taking the 'pill'. This occurs more commonly in older users and with longer duration of use. The frequency of cases with high blood pressure increases with the progestogen content. Use another contraceptive method if you have had diseases caused by high blood pressure, or if you suffer from certain kidney diseases (in such cases consult your doctor; see also the sections "Do not take dienogest/ethinylestradiol goibela", "Stop taking dienogest/ethinylestradiol goibela immediately", and "Your doctor will perform periodic check-ups").

• Pigmentation spots

Yellowish-brown spots (chloasma) may occasionally appear on the skin, especially in women who have had them during pregnancy. For this reason, women with this tendency should avoid exposure to sunlight or ultraviolet light (e.g., tanning beds) while taking the 'pill'.

• Hereditary angioedema (swelling)

If you suffer from hereditary angioedema, medications containing oestrogen may cause or worsen angioedema symptoms. Consult your doctor immediately if you notice any symptoms of angioedema, such as swelling of the face, tongue, and/or skin rashes and/or difficulty swallowing, or skin eruptions, along with breathing difficulties.

• Irregular bleeding (bleeding between periods)

During the first months of using the 'pill', irregular bleeding (spotting or bleeding) may occur. Contact your doctor if irregular bleeding continues for more than 3 months, or if bleeding reappears after the end of a regular cycle.

It is possible that menstruation does not occur during the pill-free period. If you have taken dienogest/ethinylestradiol goibela correctly, pregnancy is unlikely. However, if you have not taken the 'pill' correctly before the first missed period, or if you miss two periods in a row, you may be pregnant. Pregnancy must be definitively ruled out before continuing to take dienogest/ethinylestradiol goibela.

After stopping the 'pill', it may take some time before your cycle returns to normal.

Reduced effectiveness

The effectiveness of the 'pill' may be reduced if you forget to take it, if you vomit, if you have intestinal disorders, severe diarrhoea, or if you are taking other medications simultaneously.

If you take dienogest/ethinylestradiol goibela together with medications containing St. John's wort, you should use an additional barrier contraceptive method (e.g., condoms) (see section "Use of dienogest/ethinylestradiol goibela with other medicines").

Doctor visits/check-ups

Before using dienogest/ethinylestradiol goibela, your doctor will ask about your medical history and that of your close relatives. A basic general and gynaecological medical check-up will be performed, including a breast examination and cervical cytology (Pap smear). Pregnancy must be absolutely ruled out. These check-ups should be repeated regularly while you are taking the 'pill'. Inform your doctor if you smoke or are taking other medications.

dienogest/ethinylestradiol goibela does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Other medicines and dienogest/ethinylestradiol goibela

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicines or herbal remedies. Also inform any other doctor or dentist who prescribes you another medicine (or the pharmacist) that you are using dienogest/ethinylestradiol goibela. They will advise you whether you need to use additional contraceptive measures (e.g., condoms), and if so, for how long, or whether you need to adjust the use of the other medicine.

Some medicines can influence the levels of dienogest/ethinylestradiol in the blood and may make it less effective in preventing pregnancy, or may cause unexpected bleeding.

• The following medicines used to treat the conditions listed below are included:

• epilepsy (e.g. phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate and felbamate);

• tuberculosis (e.g. rifampicin);

• HIV and hepatitis C infections (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 diseases, high blood pressure (calcium channel blockers, e.g. verapamil, diltiazem);

• arthritis, osteoarthritis (etoricoxib).

• medicines that increase intestinal motility (e.g. metoclopramide);

• herbal preparations such as St. John’s wort (Hypericum perforatum);

• grapefruit juice.

dienogest/ethinylestradiol goibela may influence the effectiveness of other medicines, for example:

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

Do not take dienogest/ethinylestradiol goibela if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause increases in liver function test results (elevation of the liver enzyme ALT).

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

dienogest/ethinylestradiol goibela can be restarted approximately 2 weeks after completion of this treatment. See section “Do not take dienogest/ethinylestradiol goibela”.

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 medicines. They may advise you on additional protective measures while taking another medicine together with dienogest/ethinylestradiol goibela.

Diabetes

In diabetic women, the need for hypoglycaemic agents (e.g. insulin) may change.

Laboratory tests

If you are having a blood test, inform your doctor or laboratory staff that you are taking an oral contraceptive, as this medicine may affect the results of some tests, including liver function, adrenal cortex, kidney and thyroid function values, as well as levels of certain blood proteins such as those affecting lipid (fat) metabolism, carbohydrate metabolism, blood coagulation and fibrinolysis. However, these changes usually remain within normal ranges.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not take dienogest/ethinylestradiol goibela during pregnancy. If you become pregnant while taking dienogest/ethinylestradiol goibela, you must stop taking it immediately and contact your doctor. If you wish to become pregnant, you may stop taking dienogest/ethinylestradiol goibela at any time (see “If you stop taking dienogest/ethinylestradiol goibela”).

Breastfeeding

The use of dienogest/ethinylestradiol goibela is generally not recommended during breastfeeding. If you wish to take the pill while breastfeeding, you must inform your doctor.

Driving and use of machines

No studies have been conducted on the effect on the ability to drive and use machines.

dienogest/ethinylestradiol goibela contains lactose

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

3. How to take dienogest/ethinylestradiol goibela

Follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Unless your doctor tells you otherwise, the usual dose is one dienogest/ethinylestradiol goibela coated tablet per day.

Each dienogest/ethinylestradiol goibela blister pack contains 21 film-coated tablets. Next to each tablet, the day of the week on which it should be taken is printed. Take the tablet at the same time each day, with some liquid if necessary. Follow the direction of the arrows each day until you have taken all 21 tablets. Do not take any tablet during the following 7 days. Withdrawal bleeding (menstruation) should occur during these 7 days. This usually begins 2 or 3 days after taking the last dienogest/ethinylestradiol goibela tablet.

Start a new blister pack on the 8th day, whether or not the bleeding has stopped. This means you should start each blister pack on the same day of the week, and withdrawal bleeding should occur on the same days each month.

With correct use of combined oral contraceptives, failure occurs in about 1% of women per year. If you miss a tablet or take it incorrectly, the frequency of failure may increase.

When to start taking dienogest/ethinylestradiol goibela

If you have not taken any contraceptive tablet during the previous month:

Start dienogest/ethinylestradiol goibela on the first day of your menstrual cycle (the first day of menstruation is counted as Day 1), taking the tablet corresponding to the day of the week you are on. Continue in the correct order for the following days. In this way, dienogest/ethinylestradiol goibela is effective from the very first day, and no additional contraceptive method is needed.

If you start taking dienogest/ethinylestradiol goibela between Day 2 and Day 5, use an additional barrier contraceptive method during the first 7 days of taking the 'pill'.

If switching from another combined hormonal contraceptive (combined oral contraceptive, vaginal ring, or patch):

You may start taking dienogest/ethinylestradiol goibela 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 dienogest/ethinylestradiol goibela the day after taking the last active tablet (if you are unsure whether the tablets contain active ingredients, ask your doctor or pharmacist). You may start later, but no later than the day after the tablet-free interval of your previous pill ends (or after taking the last placebo tablet of your previous pill). In the case of a patch or vaginal ring, you should preferably start taking dienogest/ethinylestradiol goibela on the day you remove it, but no later than the day you would have re-applied it.

If switching from a progestogen-only method (progestogen-only 'mini-pill', injection, implant, or intrauterine system (IUS) containing progestogen):

You may stop taking the mini-pills at any time and start taking dienogest/ethinylestradiol goibela the next day at the usual time. However, if you have sexual intercourse, you must use an additional contraceptive method (barrier method) during the first 7 days of taking dienogest/ethinylestradiol goibela. When switching from an injectable, implant, or IUS, start taking dienogest/ethinylestradiol goibela on the day you would normally have received the next injection or on the day the implant or IUS is removed. However, if you have sexual intercourse, you must use an additional contraceptive method (barrier method) during the first 7 days of taking the tablets.

After giving birth

If you have recently given birth, your doctor may advise you to start taking dienogest/ethinylestradiol goibela after your first period. However, in some cases, hormonal contraception may be started earlier—please consult your doctor.

If you have had sexual intercourse after giving birth and before starting dienogest/ethinylestradiol goibela, you must first ensure that you are not pregnant or wait until your next period occurs.

If you are breastfeeding and wish to start taking dienogest/ethinylestradiol goibela, consult your doctor.

After a miscarriage or abortion

Consult your doctor regarding the possibility of taking dienogest/ethinylestradiol goibela.

If you take more dienogest/ethinylestradiol goibela than you should

If you take more tablets than prescribed, consult your doctor or pharmacist. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

Possible signs of overdose include, for example, nausea, vomiting (usually occurring 12 to 24 hours after ingestion and possibly lasting several days), breast tenderness, dizziness, stomach pain, drowsiness/fatigue; adult women and adolescents may experience vaginal bleeding. Consult a doctor if relatively large quantities have been taken or if you discover that a child has taken the pill.

If you forget to take dienogest/ethinylestradiol goibela

If less than 12 hours have passed since you were supposed to take the tablet, the contraceptive effect of the pill remains. Take the forgotten tablet as soon as possible and continue taking the following tablets at the usual time.

If more than 12 hours have passed since you were supposed to take the tablet, protection against pregnancy is reduced. The more consecutive tablets you miss, the higher the risk of becoming pregnant.

The risk of pregnancy is especially high if you miss a tablet at the beginning or end of the pack. Therefore, follow the rules given below (see also the following diagram).

More than one tablet forgotten

Contact your doctor.

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

If you have missed several tablets and there is no bleeding during the first tablet-free interval, pregnancy may have occurred. In this case, contact your doctor before starting a new pack.

Follow the instructions below if you have forgotten to take a tablet:

If you forgot 1 tablet in Week 1:

If you forget to start a new pack or forget to take a tablet within the first 7 days, there is a risk you may be pregnant (if you had sexual intercourse within the 7 days before forgetting the tablet). Contact your doctor before starting the new pack. See also the following diagram.

If you have not had sexual intercourse before forgetting the tablet, take the forgotten 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. Use additional contraceptive precautions (use a barrier method, such as a condom) for the next 7 days.

If you forgot 1 tablet in Week 2:

Take the forgotten 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 effectiveness of the pill is maintained, and no additional contraceptive measures are needed.

If you forgot 1 tablet in Week 3:

If you follow one of the following options, no additional contraceptive measures are needed:

• Option 1: Take the forgotten tablet as soon as you remember (even if this means taking two tablets at the same time). Then continue taking the following tablets at your usual time. Start the next pack immediately after taking the last tablet of your current pack; that is, do not leave a tablet-free interval between packs. Bleeding is unlikely until the end of the second pack, but you may experience spotting or bleeding even during tablet-taking days.

Or,

• Option 2: You may stop taking tablets from the current blister pack. In this case, allow a maximum of 7 days of tablet-free interval, including the day you forgot to take the tablet, and then continue with tablets from a new blister pack.

If you forgot more than 1 tablet in the current blister pack:

If you have forgotten more than one tablet in the current blister pack, you are no longer protected against pregnancy.

The likelihood of becoming pregnant increases the more tablets you miss and the closer the missed tablets are to the tablet-free interval. Until your next normal menstruation, use an additional barrier contraceptive method (e.g., condoms). If no bleeding occurs after finishing the current blister pack, you may be pregnant. In this case, consult your doctor before starting a new blister pack.

If you vomit or have diarrhea

If you have gastrointestinal problems such as vomiting or diarrhea, the active ingredients in dienogest/ethinylestradiol goibela may not be completely absorbed into your body. If you vomit within 3 or 4 hours after taking the tablet, the effect is the same as if you had forgotten to take the tablet. Follow the instructions for missed tablets. If you wish to maintain your normal schedule, take a replacement tablet from another blister pack. If gastrointestinal symptoms persist for several days or are recurrent, use a barrier contraceptive method (e.g., condom) and inform your doctor.

If you want to delay your menstruation (your period)

If you wish to delay your period, continue immediately with the next blister pack of dienogest/ethinylestradiol goibela after taking the last tablet of the current pack. You may take all the tablets from this new pack as desired, up to the end of the second pack. To induce bleeding, stop taking the tablets. While using the second pack, you may experience bleeding or spotting. Regular intake of dienogest/ethinylestradiol goibela resumes after the 7-day tablet-free interval.

If you want to change the day your period starts

If you take the tablets as directed, your period will occur approximately on the same day every 4 weeks. If you wish to change the day, you may shorten (but never extend) the next tablet-free interval between packs. For example, if your period usually starts on Friday and you want it to start on Tuesday (3 days earlier), start the next pack 3 days earlier than usual. If you have a very short tablet-free interval (e.g., 3 days or less), you may not have a period during the break and may experience bleeding or spotting during the next pack.

If you stop taking dienogest/ethinylestradiol goibela

You may stop taking dienogest/ethinylestradiol goibela at any time. If you wish to avoid pregnancy, ask your doctor about other reliable contraceptive methods.

If you stop taking dienogest/ethinylestradiol goibela because you wish to become pregnant, it is generally recommended that you wait until you have had a natural period before trying to conceive. This will allow you to calculate the expected date of delivery more easily.

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 or persistent, or if you notice any change in your health that you think may be due to dienogest/ethinylestradiol goibela, 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 about the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting to take dienogest/ethinylestradiol goibela”.

Serious adverse effects

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

If any of the adverse effects are severe, or if you notice any adverse effects not listed in this leaflet, consult your doctor.

Other possible adverse effects

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

• headaches,
• breast tenderness, including discomfort and sensitivity in the breasts.

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

• genital inflammation (vaginitis/vulvovaginitis), fungal vaginal infections (candidiasis, vulvovaginal infections),
• increased appetite,
• depressive mood,
• dizziness,
• migraine,
• high or low blood pressure, rarely increase in diastolic blood pressure (lower blood pressure value),
• abdominal pain (including upper/lower abdominal pain, discomfort/bloating),
• nausea, vomiting or diarrhoea,
• acne,
• hair loss (alopecia),
• skin rash (including localized rashes),
• pruritus (sometimes generalized),
• irregular menstrual bleeding, including heavy bleeding (menorrhagia), light bleeding (hypomenorrhea), irregular bleeding (oligomenorrhea), and absence of bleeding (amenorrhea),
• spotting (vaginal bleeding and metrorrhagia),
• painful menstruation (dysmenorrhea), pelvic pain,
• breast enlargement, including breast swelling, breast edema,
• vaginal discharge,
• ovarian cysts,
• fatigue, including weakness and general malaise,
• changes in body weight (increase, decrease or fluctuations).

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

• inflammation of the fallopian tubes or ovaries,

• urinary tract infection,

• bladder infection (cystitis),

• breast infection (mastitis),

• cervical inflammation (cervicitis),

• fungal 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),

• development of male characteristics (virilism),

• loss of appetite (anorexia),

• depression,

• mental disorders,

• insomnia,

• sleep disorders,

• aggression,

• ischaemic stroke (reduced or interrupted blood flow to the brain),

• cerebrovascular disorders (disorders of blood flow to the brain),

• change in muscle tone – dystonia (muscle disorders that may cause abnormal postures or movements),

• dry or irritated eyes,

• oscillopsia (visual disorder where objects appear to move) or other vision disorders,

• sudden hearing loss,

• tinnitus,

• vertigo,

• hearing impairment,

• cardiovascular disorders (disorders of blood flow 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

• mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA)

• blood clots in the liver, stomach/intestine, kidneys or eye

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

• 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 and rapid breathing (hyperventilation),
• gastritis,
• intestinal inflammation,
• indigestion (dyspepsia),
• skin reactions,
• skin problems, skin allergic reactions, neurodermatitis/atopic dermatitis, eczema, psoriasis,
• excessive sweating,
• chloasma (yellowish-brown patches, known as “pregnancy mask,” especially on the face),
• pigmentary disorders/increased pigmentation,
• oily skin (seborrhoea),
• dandruff,
• male-pattern hair growth (hirsutism),
• cellulite,
• spider-like blood vessels with a central red spot on the skin (cutaneous naevus),
• back pain,
• discomfort in bones and muscles,
• muscle pain,
• pain in arms and legs,
• abnormal cell growth on the surface of the cervix (cervical dysplasia),
• pain or cysts in the uterine appendages (fallopian tubes and ovaries),
• breast cysts,
• fibrocystic breast disease (benign growths in the breast),
• pain during intercourse (dyspareunia),
• milk secretion from the breast gland (galactorrhoea),
• menstrual disorders,
• inflammation of tissue outside the breasts (accessory breasts),
• chest pain,
• peripheral oedema (fluid retention in the body),
• flu-like illness,
• inflammation,
• fever,
• irritability,
• increased levels of triglycerides and cholesterol in the blood (hypertriglyceridaemia, hypercholesterolaemia).

Frequency not known (cannot be estimated from available data):

• mood changes,
• increase or decrease in sexual desire (libido),
• intolerance to contact lenses,
• hives (urticaria),
• skin disorders such as painful red nodules (erythema nodosum) or rash with target-shaped redness or sores (erythema multiforme),
• breast secretion,
• fluid retention.

If you suffer from hereditary angioedema, oestrogen-containing medicines may cause or worsen angioedema symptoms (see section “Warnings and precautions”).

Description of selected adverse reactions

Adverse reactions with very low incidence or late-onset symptoms related to combined oral contraceptives are listed below (also see “Do not take dienogest/ethinylestradiol goibela” and “What you need to know before starting to take dienogest/ethinylestradiol goibela”).

Tumours

• The frequency of breast cancer diagnosis among users of the “pill” increases slightly. 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).
• Cervical cancer.

Other conditions

• Women with hypertriglyceridaemia (increased fat levels in the blood may increase the risk of pancreatitis during use of combined oral contraceptives).
• Increased blood pressure.
• Onset or worsening of conditions in which the association with combined oral contraceptives is not clear: jaundice and/or itching associated with cholestasis (blockage of bile flow), 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, gestational herpes (a blistering disease occurring during pregnancy), hearing loss caused by otosclerosis.
• In women with congenital angioedema (sudden swelling of eyes, mouth, throat, etc.), externally administered oestrogens may cause or worsen angioedema symptoms.
• Liver impairment.
• Changes in glucose tolerance or peripheral insulin resistance.
• Crohn’s disease, ulcerative colitis.
• Chloasma (yellowish-brown skin patches).

Interactions

Unexpected bleeding and/or contraceptive failure may be due to 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 dienogest/ethinylestradiol goibela”.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, 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.

5. Storage of dienogest/ethinylestradiol goibela

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

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

Do not store above 30°C.

Keep the blister pack inside the outer packaging to protect it from light.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, 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 dienogest/ethinylestradiol goibela

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

Core: lactose monohydrate, magnesium stearate, maize starch, povidone K-30.

Coating: Aquarius coating system, containing: hypromellose 2910, macrogol 400 (PEG), titanium dioxide.

Appearance of the product and contents of the pack

dienogest/ethinylestradiol goibela is a white, round, biconvex film-coated tablet.

dienogest/ethinylestradiol goibela is available in packs containing 21, 3x21 and 6x21 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios León Farma SA

La Vallina s/n, Pol. Ind. Navatejera,

24193, Villaquilambre, León, Spain

Date of the most recent review of this leaflet: December 2021

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/78572/P_78572.html

QR code to: https://cima.aemps.es/cima/dochtml/p/78572/P_78572.html