Meliane 0,075 mg / 0,02 mg comprimidos recubiertos

Package Insert: Information for the User

Meliane 0.075 mg / 0.02 mg Coated Tablets

gestodeno / etinilestradiol

Important Information You Should Know About Combined Hormonal Contraceptives (CHCs):

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

1.What is Meliane and for what it is used

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

3.How to take Meliane

4.Possible adverse effects

5.Storage of Meliane

6. Contents of the package and additional information

Meliane is a combined oral contraceptive pill. It inhibits ovulation and produces changes in cervical mucus secretion (produced by the cervix). It is used to prevent pregnancy. It is also used in menstrual cycle disorders.

General Considerations

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

Do Not Use Meliane

Do not use Meliane if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable.

• If you are allergic to the active ingredients or to any of the other components of this medication (listed in section 6).
• If you have (or have had at any time) a blood clot in a vein in your leg (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE) or in other organs.
• If you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies.
• If you need surgery or if you spend a lot of time without standing up (see section “Blood Clots”).
• If you have ever had a heart attack or a stroke.
• If you have (or have had at any time) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary symptoms of a stroke).

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

• Diabetes with severe vascular damage.
• Very high blood pressure.
• Very high levels of fat in your blood (cholesterol or triglycerides).
• A condition called hyperhomocysteinemia.

• If you have (or have had at any time) a type of migraine called “migraine with aura”.
• If you have thrombogenic valvulopathies (diseases of the heart valves that may cause blood clots).

• If you have arrhythmias that may cause blood clots (thrombogenic arrhythmias).

• If you have or have had severe liver disease, unless liver function test values have normalized.
• If you have or have had liver tumors (benign or malignant).
• If you have or suspect you have malignant diseases of the reproductive organs or breasts.
• If you have unexplained vaginal bleeding.
• If you are pregnant or suspect you may be pregnant.

Do not use Meliane if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also the section “Other Medications and Meliane”).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Meliane.

If any of the risk situations mentioned below are present, your doctor must assess the benefits of using Meliane against the possible risks, and discuss them with you before you decide to start using it.

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

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

• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• If you have hemolytic-uremic syndrome (HUS, a disorder of blood clotting that causes kidney failure).
• If you have sickle cell anemia (a hereditary disease of red blood cells).
• If you have high levels of fat in your blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you need surgery or spend a lot of time without standing up (see section 2 “Blood Clots”).
• If you recently gave birth, you are at higher risk of blood clots. Ask your doctor when you can start taking Meliane again after childbirth.
• If you have superficial thrombophlebitis (inflammation of the veins under the skin).
• If you have varicose veins.
• If you have heart diseases (those that cause certain types of arrhythmias).
• If you have high blood pressure, especially if it worsens or does not improve with anti-hypertensive medications.
• If you have severe or frequent migraines.
• If you have diabetes.
• If you have depression or a history of depression, as it may worsen or recur when using hormonal contraceptives.
• If you have certain types of jaundice (yellow discoloration of mucous membranes, eyes, and/or skin) or liver function disorders.
• If you have itching, especially if it occurred during a previous pregnancy.
• If you have permanent brown spots on your face, especially if you had them during a previous pregnancy. If so, avoid sunlight and ultraviolet radiation (e.g., tanning beds).
• If you experience angioedema symptoms such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema.

Contact your doctor if you suspect you may be pregnant.

BLOOD CLOTS

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

Clots can form:

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

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

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

HOW TO RECOGNIZE A BLOOD CLOT

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

BLOOD CLOTS IN A VEIN

What Can Happen If a Blood Clot Forms in a Vein?

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

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

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

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

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

What Is the Risk of a Blood Clot?

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

The global risk of a blood clot in your leg or lung (DVT or PE) with Meliane is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone, or norgestimato, 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing gestodene like Meliane, 9-12 will develop a blood clot in a year.

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

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

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

• If you are overweight (body mass index (BMI) greater than 30 kg/m2).
• If any of your close relatives have had a blood clot in their leg, lung, or other organ at a young age (i.e., before about 50 years old). You may have an inherited disorder of blood clotting.
• If you need surgery or spend a lot of time without standing up due to an injury or illness, or if you have your leg immobilized. You may need to stop taking Meliane for several weeks before surgery or while you have limited mobility. If you need to stop taking Meliane, ask your doctor when you can start using it again.
• As you get older (especially over about 35 years old).
• If you have given birth recently.

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

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

It is essential to inform your doctor if you have any of the conditions above, even if you are unsure. Your doctor may decide to stop you from using Meliane.

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

BLOOD CLOTS IN AN ARTERY

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

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

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

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

• With age (over about 35 years old).
• If you smoke.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years old). You may also be at higher risk of a heart attack or stroke.
• If you or any of your close relatives have high levels of fat in your blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, arrhythmia called atrial fibrillation).
• If you have diabetes.

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

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

• Tumors

Cases of breast tumors have been observed with a slightly higher frequency in women using oral contraceptives, but it is unclear whether this is due to the treatment. For example, tumors may be more likely to be detected in women using oral contraceptives because they visit their doctor more frequently. This increased frequency decreases gradually after stopping treatment. After ten years, the chances of having breast tumors will be the same as for women who have never used oral contraceptives.

In some studies, an increased risk of cervical cancer has been reported in users who have been taking oral contraceptives for long periods, but there is still controversy about the degree to which this finding can be attributed to other factors, such as sexual behavior and sexually transmitted diseases.

Rare cases of benign liver tumors and, even more rarely, malignant liver tumors have been reported in users of oral contraceptives. This can cause internal bleeding, leading to severe abdominal pain. If this occurs, you should contact your doctor immediately.

There has been an observed increase in the relative risk of cervical cancer and cervical intraepithelial neoplasia (serious diseases of the cervix). Given the biological influence of oral contraceptives on these lesions, it is recommended that, when prescribing oral contraceptives, cervical cytology should be performed periodically.

Malignant tumors can pose a threat to life or have a fatal outcome.

• Mental Health Disorders

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

If a severe depression case occurs, the medication should be discontinued, and an alternative contraceptive method should be used. Women with a history of depression should be closely monitored.

• Other Conditions

In women with hypertriglyceridemia (high levels of triglycerides in the blood) or a known family history of this condition, there may be an increased risk of pancreatitis (inflammation of the pancreas) during the use of oral contraceptives.

Women with hyperlipidemia (high levels of fats in the blood, such as triglycerides and/or cholesterol) should be monitored if they decide to take oral contraceptives.

During the use of oral contraceptives, many users experience small increases in blood pressure, but rare cases with clinical relevance have been reported. If high blood pressure develops while using oral contraceptives, you should consult your doctor.

In women with endometrial hyperplasia (thickening of the inner uterine wall), the doctor should carefully assess the risk-benefit ratio before prescribing oral contraceptives and closely monitor the patient during treatment, performing cervical cytology periodically.

The following conditions may appear or worsen with pregnancy and with the use of oral contraceptives: jaundice (yellow discoloration of mucous membranes, eyes, and/or skin) and/or pruritus (itching) related to cholestasis (bile flow obstruction), gallstone formation, porphyria (a disorder of hemoglobin metabolism), systemic lupus erythematosus (inflammatory skin disease), hemolytic-uremic syndrome (blood disorder), Sydenham's chorea (involuntary movements), herpes gestationis (skin and mucous membrane lesions that occur during pregnancy), and otosclerosis (a type of ear disorder).

Acute or chronic liver function disorders require the suspension of oral contraceptive use until liver function test values return to normal. The reappearance of cholestatic jaundice (yellow discoloration of mucous membranes, eyes, and/or skin related to bile flow obstruction), which first appeared during a pregnancy, or during previous use of sex hormones, requires the suspension of oral contraceptives.

Oral contraceptives may alter peripheral resistance to insulin and glucose tolerance. There is no evidence that this requires a change in treatment for diabetic patients taking low-dose oral contraceptives (with <0.05 mg of ethinyl estradiol). However, diabetic patients should be closely monitored while taking oral contraceptives.

Oral contraceptives have been associated with inflammatory bowel disease (Crohn's disease and ulcerative colitis).

Occasionally, Meliane may cause melasma (brown spots on the skin), especially in women with a history of melasma during pregnancy. If you are prone to melasma, avoid exposure to the sun or ultraviolet radiation (e.g., tanning beds).

It should be noted that oral contraceptives do not protect against HIV (AIDS) infection or other sexually transmitted diseases.

Medical Examination and Consultation

Before starting or restarting treatment with Meliane, your doctor should perform a complete medical history and physical examination to rule out contraindications and precautions, and these should be repeated at least once a year during the use of combined oral contraceptives.

Reduced Efficacy

The efficacy of oral contraceptives may decrease if you forget to take a pill (see the section “If You Forget to Take Meliane”), if you experience gastrointestinal disorders such as vomiting or severe diarrhea (see the section “Recommendations in Case of Gastrointestinal Disorders”), or if you take other medications simultaneously (see the section “Taking Meliane with Other Medications”).

Irregularities in Cycle Control

During the use of any oral contraceptive, irregular bleeding or spotting may occur, especially during the first few months of use. If these irregularities persist or occur after previously regular cycles, possible non-hormonal causes should be considered, and you should consult your doctor to rule out malignant processes, infections, or pregnancy.

In some women, menstruation may not occur during the pill-free week. If you have taken the pill correctly as described in the section “How to Take Meliane,” it is unlikely that you are pregnant. However, if you have not taken the pill correctly before your first missed period or if a second missed period occurs, you should rule out pregnancy before continuing to take the pill.

If you are unsure about any of the above points, consult your doctor before taking Meliane.

Other Medications and Meliane

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Certain medications may interact, in which case you may need to change the dose or discontinue treatment with one of the medications. It is especially important to inform your doctor if you are using any of the following medications:

Medications listed below may prevent combined hormonal contraceptives from working properly, and if this occurs, you may become pregnant:

• Treatment of hepatitis C and HIV (inhibitors of protease, e.g., ritonavir and nelfinavir, and non-nucleoside reverse transcriptase inhibitors, e.g., nevirapina) and other infections (griseofulvin).
• Treatment of tuberculosis (rifampicin, rifabutina).
• Treatment of fungal infections (griseofulvin, azole antifungals, e.g., itraconazole, voriconazole, fluconazole).
• Treatment of bacterial infections (macrolide antibiotics, e.g., clarithromycin, erythromycin).
• Treatment of certain heart diseases and high blood pressure (calcium channel blockers, e.g., verapamil, diltiazem).
• Treatment of arthritis and osteoarthritis (etoricoxib).
• Some antiepileptic medications (topiramate, barbiturates (phenobarbital), phenytoin, carbamazepine, primidone, oxcarbazepine, felbamate, ethosuximide).
• Antacids, including lansoprazole.
• Some mood elevators (modafinil).
• Orange juice.

You should not take Meliane if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section “Other Medications and Meliane”).

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

Meliane can be restarted approximately 2 weeks after the completion of this treatment. See the section “Do Not Use Meliane”.

You should consult the prescribing information for the medications you are taking concurrently to identify possible interactions.

Laboratory Tests

The use of oral contraceptives may affect the results of certain laboratory tests.

Inform your doctor if you are scheduled to undergo any laboratory tests, as they may be affected by the use of oral contraceptives.

Pregnancy and Lactation

If you are pregnant or breastfeeding, or suspect you may be pregnant, consult your doctor or pharmacist before using this medication.

Meliane is not indicated during pregnancy. If you become pregnant, you should discontinue Meliane immediately and consult your doctor.

During the use of oral contraceptives, small amounts of the contraceptive may be eliminated through breast milk, but there is no evidence that this affects the baby's health. However, oral contraceptives are generally not recommended until the end of lactation.

If you want to use Meliane after childbirth or abortion in the second trimester, see the section “How to Take Meliane”.

Driving and Operating Machinery

No adverse effects on driving or operating machinery have been observed.

Meliane Contains Lactose and Sucrose

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

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor again.

Remember to take your medication, as forgetting coated tablets can reduce the effectiveness of the preparation.

Combined oral contraceptives, when taken correctly, have an error rate of approximately 1% per year. The error rate may increase if tablets are forgotten or taken incorrectly.

The first tablet is removed from one of the marked boxes with the corresponding day of the week (e.g. "LUN" for Monday). Tablets should be taken every day approximately at the same time, with a little liquid if necessary, and in the order indicated in the blister pack. One tablet will be taken daily for 21 consecutive days. A new blister pack will be started after a 7-day interval without taking tablets, during which a withdrawal bleeding (period) usually occurs. The withdrawal bleeding, similar to a period, will appear two or three days after taking the last tablet, and it may not have finished before starting the next blister pack.

How to start taking Meliane

• If no hormonal contraceptive has been taken previously (in the past month)

Tablets will be started on day 1 of the woman's natural cycle (i.e. the first day of menstrual bleeding). It can also be started on days 2 to 5 of the cycle, but in that case, it is recommended to use an additional barrier method, such as a condom, during the first 7 days of tablet taking.

• To replace a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch)

You should start taking Meliane preferably the day after taking the last hormone-containing tablet of the COC you were previously taking, or at the latest, the day after the usual interval without taking tablets or hormone-free tablets of your previous COC. This means that, at the latest, Meliane treatment should be initiated on the same day that a new blister pack (blister) of the previous COC should be started. If a vaginal ring or transdermal patch is used, you should start taking Meliane preferably the day the last ring or patch is removed from a cycle, or at the latest, when the next application should be made.

• To replace a method based exclusively on progestogens (progestogen-only pills, injection, implant), or a progestogen-releasing intrauterine system (IUS)

You can replace progestogen-only pills with Meliane on any day (if it is an implant or IUS, on the day of its removal; if it is an injectable, on the day of the next injection), but in all cases, it is recommended to use an additional barrier method, such as a condom, during the first 7 days of tablet taking.

• After a first-trimester abortion

You can start taking Meliane immediately. When you do so, you do not need to take any additional contraceptive measures.

• After childbirth or a second-trimester abortion

It is recommended that you start taking Meliane 21-28 days after childbirth or a second-trimester abortion. If you do so later, you should use an additional barrier method during the first 7 days. However, if sexual intercourse has already taken place, you should rule out the possibility of pregnancy before starting the COC, or you should wait until your first menstrual period.

If you take more Meliane than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service (Tel: 91 562 04 20), indicating the medication and the amount ingested. It is recommended to bring the packaging and leaflet to the healthcare professional.

No serious adverse reactions have been reported due to overdose. The symptoms that may appear in this case are: nausea, vomiting, or vaginal bleeding. This bleeding may occur even in girls who have not yet had their first menstrual period, if they have accidentally taken this medication. There is no antidote and treatment should be symptomatic.

If you forgot to take Meliane

Contraceptive protection does not decrease if the taking of a tablet is delayedless than 12 hours. In this case, you should take the tablet as soon as you remember it and continue taking the next tablets at the usual time (although this may mean taking two tablets on the same day). In this case, you do not need to take any additional contraceptive measures.

If you delay takingmore than 12 hours, contraceptive protection may be reduced. The guidelines to follow in case of forgetting are governed by two basic rules:

1. Never suspend tablet taking for more than 7 days.
2. You must take tablets uninterruptedly for 7 days to achieve adequate suppression of the hypothalamic-pituitary-ovarian axis.

Consequently, and following the above indications, in daily practice, the following can be advised:

• Week 1

You should take the last forgotten tablet as soon as you remember it, even if this means taking two tablets at once. From then on, you will continue taking the tablets at your usual time. In addition, during the next 7 days, you should use an additional barrier method, such as a condom. If you have had sexual intercourse in the previous 7 days, you should consider the possibility of pregnancy. The more tablets you have forgotten and the closer you are to the 7-day interval, the greater the risk of pregnancy.

• Week 2

You should take the last forgotten tablet as soon as you remember it, even if this means taking two tablets at once. From then on, you will continue taking the tablets at your usual time. If you have taken the tablets correctly in the 7 days before the forgotten tablet, you will not need to take any additional contraceptive measures. However, if you have forgotten to take more than 1 tablet, it is recommended that you take additional precautions for 7 days.

• Week 3

The risk of reduced effectiveness is imminent due to the proximity of the 7-day interval. However, by adjusting the tablet-taking program, you can still prevent contraceptive protection from being reduced. Therefore, if you follow one of the two options below, you will not need to take any additional contraceptive measures, provided that in the 7 days before the first forgotten tablet, you have taken all the tablets correctly. If not, you should follow the first of the two options indicated below and you should take additional contraceptive precautions for 7 days.

1. You should take the last forgotten tablet as soon as you remember it, even if this means taking two tablets at once. From then on, you will continue taking the tablets at your usual time. You should start the next blister pack as soon as the current one runs out, without leaving a gap between them. It is unlikely that you will have withdrawal bleeding (period) until you finish the second blister pack, but you may experience spotting or bleeding during tablet taking.
2. You can also stop taking the tablets from the current blister pack. Then you should complete an interval of up to 7 days without taking tablets, including the days when you forgot to take the tablets, and then you will start again with the next blister pack.

If, in case of forgetting to take tablets, you do not present withdrawal bleeding (period) in the first interval without tablets, you should consider the possibility of pregnancy.

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

Recommendations in case of gastrointestinal disorders

In case of severe gastrointestinal disorders, absorption may not be complete, and you should take additional contraceptive measures.

If you experience vomiting in the 3-4 hours following tablet taking, you should follow the guidelines for forgetting to take tablets, as described in the section "If you forgot to take Meliane". If you do not want to change your usual tablet-taking schedule, you should take the extra tablets needed from another blister pack.

How to delay withdrawal bleeding (period)

To delay a period, you should continue with the next Meliane blister pack without leaving the usual 7-day interval. You can maintain this duration as long as you want until the second blister pack is finished. During that time, you may experience bleeding or spotting. Then, you should leave the usual 7-day interval without tablets and resume regular Meliane tablet taking.

To change the period to a different day of the week to which you are accustomed according to your current cycle, you can be advised to shorten the interval as many days as you want. The shorter the interval, the greater the risk of not having withdrawal bleeding (period) and of experiencing intermenstrual bleeding or spotting during the next blister pack (as occurs when a period is delayed).

Special populations

Pediatric population

Meliane is only indicated after menarche (appearance of the first period).

Geriatric population

No. Meliane is contraindicated after menopause.

Patients with liver dysfunction

Meliane is contraindicated in women with severe liver dysfunction.

Patients with renal dysfunction

Meliane has not been specifically studied in patients with renal dysfunction. There are no available data to suggest a change in treatment in this patient population.

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

All women taking combined hormonal contraceptives are at a higher risk of presenting blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section2 “What you need to know before starting to take Meliane”.

Severe side 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 urticaria with possible difficulty breathing (see also section “Warnings and precautions”).

Side effects are listed in order of decreasing severity within each frequency interval.

Very common: May affect more than 1 in 10 people

Common: May affect up to 1 in 10 people

Uncommon: May affect up to 1 in 100 people

Rare: May affect up to 1 in 1,000 people

Very rare: May affect up to 1 in 10,000 people

1. Infections and infestations

Common: Vaginitis (vaginal inflammation), including candidiasis (vaginal fungal infection).

1. Immune system disorders

Rare: Allergic reactions such as urticaria (itching) and severe reactions accompanied by difficulty breathing, dizziness, and even loss of consciousness.

Very rare: Worsening of systemic lupus erythematosus (autoimmune inflammatory and chronic disorder).

1. Metabolism and nutrition disorders

Uncommon: Changes in appetite (increase or decrease).

Rare: Glucose intolerance.

Very rare: Worsening of porphyria (metabolic disorder of hemoglobin).

1. Mental and behavioral disorders

Common: Mood changes, including depression; changes in libido (sexual desire).

1. Nervous system disorders

Very common: Headaches, including migraines.

Common: Nervousness, dizziness.

Very rare: Worsening of chorea (movement disorder).

1. Eye disorders

Rare: Contact lens intolerance.

Very rare: Optic neuritis, retinal vascular thrombosis (eye anomalies and visual disorders).

1. Vascular disorders

Uncommon: Increased blood pressure.

Rare: Harmful blood clots in a vein or artery, for example:

The risk of having a blood clot may be higher if you have any other condition that increases this risk (see section2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

Very rare: Worsening of varicose veins.

1. Gastrointestinal disorders

Common: Nausea, vomiting, abdominal pain.

Uncommon: Cramps, bloating.

Very rare: Pancreatitis (inflammation of the pancreas), hepatic adenomas (frequent non-cancerous liver tumors), hepatocellular carcinoma (malignant liver tumor).

1. Hepatobiliary disorders

Rare: Cholestatic jaundice (yellow discoloration of mucous membranes, eyes, and/or skin related to bile flow obstruction).

Very rare: Cholecystopathy (bile duct disorders), including gallstones.

1. Skin and subcutaneous tissue disorders

Common: Acne.

Uncommon: Skin rash, hypersensitivity reactions (abnormal skin sensitivity), melasma (skin discoloration) that may persist, hirsutism (excessive hair growth), alopecia (hair loss).

Rare: Erythema nodosum (a type of skin inflammation with the appearance of nodules on the legs).

Very rare: Erythema multiforme (a type of skin inflammation).

1. Renal and urinary disorders

Very rare: Hemolytic-uremic syndrome (disease that produces alterations in the blood).

1. Reproductive and breast disorders

Very common: Bleeding, spotting.

Common: Breast pain, breast tension, breast enlargement, breast secretion, dysmenorrhea (painful menstruation), changes in menstrual flow, changes in vaginal secretion, and cervical ectropion (alteration of the mucosa of the cervix), amenorrhea (absence of menstruation).

1. General disorders and administration site conditions

Common: Fluid retention, edema (swelling), weight changes (gain or loss).

1. Laboratory investigations

Uncommon: Changes in lipid levels (fats) in the blood, including hypertriglyceridemia.

Rare: Decreased levels of folates (derivatives of folic acid) in the blood.

Selected adverse reaction descriptions

The following are rare or delayed adverse reactions that are considered related to the group of combined oral contraceptives (see sections “Do not use Meliane” and “Warnings and precautions”).

Tumors

• The frequency of breast cancer diagnosis among users of COCs is slightly increased. Since breast cancer is rare in women under 40, this increase is low compared to the overall risk of breast cancer. The causal relationship with the use of COCs is unknown.
• Benign and malignant liver tumors.

Other alterations

• Women with hypertriglyceridemia (increase in fats in the blood, resulting in an increased risk of pancreatitis when using COCs).
• Hypertension.
• Appearance or worsening of alterations whose association with the use of COCs is not conclusive: jaundice and/or pruritus related to cholestasis (bile flow obstruction); formation of gallstones; a metabolic disorder called porphyria; systemic lupus erythematosus (chronic autoimmune disease); hemolytic-uremic syndrome (disease with the appearance of blood clots); a neurological disorder called Sydenham's chorea; gestational herpes (a type of skin alteration that occurs during pregnancy); hearing loss related to otosclerosis.
• Liver function disorders.
• Changes in glucose tolerance or effect on peripheral insulin resistance.
• Crohn's disease, ulcerative colitis.
• Melasma (skin discoloration).

Interactions

Interactions between oral contraceptives and other medications (e.g. St. John's Wort, epilepsy medications, tuberculosis, HIV, and other infections) may lead to unexpected bleeding and/or failure of contraception (see section “Taking Meliane with other medications”).

Reporting of adverse reactions

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

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

Do not store at a temperature above 25°C. Store in the original packaging to protect it from light.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Meliane

• The active principles are: gestodeno and etinilestradiol. Each coated tablet of Meliane contains0.075 mg of gestodeno and 0.02 mg of etinilestradiol.
• The other components are: lactose monohydrate, cornstarch, povidone K 25, magnesium stearate (E470b), saccharose, povidone K 90, macrogol 6000, calcium carbonate (E170), talc (E553b) and glycerolated beeswax.

Appearance of the product and contents of the packaging

Meliane is presented in a blister (the packaging where the coated tablets are located) of 21 round coated tablets of white color.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 - 5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing

Bayer AG

Müllerstrasse 178

13353 Berlin

Germany

Last review date of this leaflet:10/2022

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