Melteva 0.02 mg/0.075 mg film-coated tablets: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Melteva 0.02 mg/0.075 mg coated tablets

Ethinylestradiol/Gestodene

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

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only and must not be given to other people,

even if they have the same symptoms as you, because it could harm them.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are

effects not listed in this leaflet. See section 4.

Important things you should know about combined hormonal contraceptives (CHCs):

? They are one of the most reliable reversible contraceptive methods if used correctly.

? They slightly increase the risk of developing a blood clot in the veins and arteries,

particularly 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”).

Contents of the leaflet

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

1. What Melteva is and what it is used for

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

This medicine comes in blisters (the packaging containing the coated tablets) of 21 coated tablets.

2. What you need to know before starting Melteva

General considerations

Before starting to take Melteva, 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”).

Do not take Melteva:

Do not use Melteva if you have any of the conditions listed below. Inform your doctor if you have any of these conditions. Your doctor will discuss with you which alternative method of contraception would be more suitable.

??If you are allergic to the active substances or to any of the other components 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 if you are going to be immobile for a long time (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 diseases that may increase your risk of forming a clot in the arteries:

o Severe diabetes with blood vessel damage.

o Very high blood pressure.

o Very high levels of fat in the blood (cholesterol or triglycerides).

o A condition called hyperhomocysteinaemia.

??If you have (or have ever had) a type of migraine called “migraine with aura”.

??If you have thrombogenic valvulopathies (heart valve disorders that may lead to clot formation).

??If you have heart rhythm disorders with risk of clot formation (thrombogenic arrhythmias).

??If you have or have had severe liver disease, as long as liver function test results have not returned to normal.

??If you have or have had liver tumours (benign or malignant).

??If you have or are suspected of having malignant conditions of the genital organs or breasts.

??If you have vaginal bleeding of unknown cause.

??If you are pregnant or suspect you might be pregnant.

??Do not use Melteva if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Melteva”)

When you should be especially careful with Melteva

When should you consult your doctor?

Seek urgent medical attention

o 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 clot (thrombosis)” below).

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

If any of the risk situations mentioned below are present, your doctor should evaluate the benefits of using this medicine, Melteva, against the possible risks and discuss them with you before you decide to start taking it.

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

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

If you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease).
If you have systemic lupus erythematosus (SLE, a disease affecting your body’s natural defense system).
If you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure).
If you have sickle cell anemia (a hereditary 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 prolonged periods (see section 2 “Blood clots”).
If you have recently given birth, you are at higher risk of developing blood clots. You should ask your doctor when you may start taking Melteva after childbirth.
If you have inflammation of the veins beneath the skin (superficial thrombophlebitis).
If you have varicose veins.
If you have heart diseases (such as those caused by certain types of cardiac rhythm disorders).
If you have high blood pressure, particularly if it worsens or does not improve while taking antihypertensive medications.
If you suffer from severe and recurrent migraines.
If you have diabetes.
If you have depression or a history of depression, as it may worsen or reappear while using hormonal contraceptives.
If you have certain types of jaundice (yellowing of mucous membranes, eyes, and/or skin) or liver function disorders.
If you experience itching, especially if it occurred during a previous pregnancy.
If you have permanent brown patches on the skin of your face, particularly if they occurred during a previous pregnancy. In such cases, avoid sunlight and ultraviolet radiation (e.g., sunbeds).
If you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing, or hives potentially accompanied by difficulty breathing, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

Also contact your doctor if you think you might be pregnant.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Melteva 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:

o In the veins (called “venous thrombosis,” “venous thromboembolism,” or VTE).

o In the arteries (called “arterial thrombosis,” “arterial thromboembolism,” or TEA).

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

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

HOW TO RECOGNIZE A BLOOD CLOT

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

Are you experiencing any of these signs?	What might you be suffering from?
o Swelling in one leg or foot or along a vein in the leg or foot, especially when accompanied by: o Pain or tenderness in the leg, which may only be noticeable when standing or walking. o Increased warmth in the affected leg o Change in skin color of the leg, e.g., if it becomes pale, red, or blue.	Deep vein thrombosis
o Sudden shortness of breath without known cause or rapid breathing o Sudden cough without clear cause, possibly bringing up blood o Sharp chest pain that may worsen when breathing deeply o Severe dizziness or lightheadedness o Rapid or irregular heartbeat o 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 such as a respiratory infection (e.g., a "common cold")	Pulmonary embolism
o Symptoms occurring more frequently in one eye: o Sudden loss of vision, or o Painless blurred vision, which may progress to vision loss	Retinal vein thrombosis (blood clot in an eye)
o Pain, discomfort, pressure, heaviness in the chest o Feeling of tightness or congestion in the chest, arm, or beneath the sternum o Feeling of fullness, indigestion, or suffocation o Upper body discomfort radiating to the back, jaw, throat, arm, or stomach o Sweating, nausea, vomiting, or dizziness o Extreme weakness, anxiety, or shortness of breath o Rapid or irregular heartbeat	Heart attack
o Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. o Sudden confusion, difficulty speaking or understanding. o Sudden vision difficulty in one or both eyes o Sudden difficulty walking, dizziness, loss of balance or coordination. o Sudden, severe, or prolonged headache without known cause. o 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
o Swelling and slight bluish discoloration of a limb o Severe stomach pain (acute abdomen)	Blood clots blocking other blood vessels

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in veins (venous thrombosis). However, these adverse events are rare. They occur more frequently during the first year of using a combined hormonal contraceptive.
If a blood clot forms in a vein 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.
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 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 Melteva, 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 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 Melteva 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 within one year.
Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5 to 7 will develop a blood clot within one year.
Among 10,000 women who use a combined hormonal contraceptive containing gestodene, such as Melteva, between 9 and 12 women will develop a blood clot within one year.
Your risk of developing a blood clot will depend on your personal history (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal tablet/patch/ring and who are not pregnant	About 2 out of 10,000 women
Women who use a combined oral contraceptive tablet containing levonorgestrel, norethisterone or norgestimate	About 5 – 7 out of 10,000 women
Women who use Melteva	About 9 – 12 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 Melteva is small, but certain conditions increase this 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 may have an inherited blood clotting disorder.
If you need surgery or if you are immobile for long periods due to injury or illness
or if your leg is in a cast. You may need to stop taking Melteva
several weeks before surgery or while your mobility is reduced. If you need to stop taking Melteva,
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 (more than 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 unsure. Your doctor may decide that you need to stop taking Melteva.

If any of the above conditions change while you are using Melteva—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 cause a heart attack or stroke.

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

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

With age (over about 35 years)
If you smoke. When using a combined hormonal contraceptive such as Melteva,
you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old,
your doctor may advise you to use a different type of contraceptive.
If you are overweight.
If you have high blood pressure.
If a close relative has had a heart attack or stroke at a young age
(under about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
If you or 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 Melteva—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.

??Tumors:

A slightly increased frequency of breast tumors has been observed in women using contraceptive pills, but it is unknown whether this is due to the treatment. For example, more tumors may be detected in women who use contraceptive pills because they visit their doctor more frequently. This increased frequency gradually decreases after stopping treatment. After ten years, the chances of having breast tumors will be the same as in women who have never used contraceptive pills.

Ovarian cancer occurs less frequently than breast cancer. The use of hormone replacement therapy (HRT) with estrogens alone or with a combination of estrogens and progestogens has been associated with a slightly increased risk of ovarian cancer.

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

In some studies, an increased risk of cervical cancer has been reported in women who have used combined oral contraceptives (COCs) for long periods, but controversy remains about how much this finding may be attributed to other factors such as sexual behavior and sexually transmitted infections.

Benign liver tumors have been rarely reported, and malignant liver tumors even more rarely, in users of COCs. This may cause internal bleeding leading to severe abdominal pain. If this occurs, you should contact your doctor immediately. A slight increase in the relative risk of cervical cancer and cervical intraepithelial neoplasia has been observed. Given the biological influence of COCs on these lesions, it is recommended that cervical cytology be performed periodically when prescribing a COC.

??Other conditions:

In women with hypertriglyceridemia (elevated triglycerides in the blood) or with a family history of the same, there may be an increased risk of pancreatitis (inflammation of the pancreas) during the use of COCs.

Women who have been treated for hyperlipidemia (elevated blood fats such as triglycerides and/or cholesterol) should be monitored if they decide to take oral contraceptives.

During the use of COCs, many users have shown small increases in blood pressure, although clinically significant cases are rare. If persistent high blood pressure develops during COC use, you should consult your doctor.

In women with endometrial hyperplasia (thickening of the inner lining of the uterus), the doctor should carefully evaluate the risk-benefit ratio before prescribing COCs and monitor the patient closely during treatment, performing periodic cervical cytology.

The following conditions may appear or worsen during pregnancy and with the use of COCs: jaundice (yellowing of the whites of the eyes and skin) and/or pruritus (itching) related to cholestasis (reduced or stopped bile flow), gallstone formation, porphyria (inherited metabolic disorder), systemic lupus erythematosus (inflammatory skin disease), hemolytic uremic syndrome (kidney disease with blood abnormalities), Sydenham's chorea (involuntary movements), herpes gestationis (skin and mucous membrane lesions appearing during pregnancy), and hearing loss due to otosclerosis (a type of ear disorder). Acute or chronic disorders of liver function require discontinuation of COC use until liver function markers return to normal. Recurrence of cholestatic jaundice, which first appeared during pregnancy or previous use of sex hormones, requires discontinuation of the COC.

COCS may alter peripheral insulin resistance and glucose intolerance. There is no evidence that the treatment regimen needs to be changed in diabetic women using low-dose COCs (with < 0.05 mg ethinylestradiol). However, diabetic women should be carefully monitored while taking COCs.

The use of COCs has been associated with Crohn's disease and ulcerative colitis (inflammatory bowel diseases).

Occasionally, melasma (brown skin patches) may occur, especially in women with a history of melasma during pregnancy. If you are prone to melasma, you should avoid exposure to sunlight or ultraviolet rays while taking COCs.

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

Women should be advised that oral contraceptives do not protect against HIV infection (AIDS) or other sexually transmitted infections.

Psychiatric disorders

Some women using hormonal contraceptives such as Melteva 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.

Examination and medical consultation

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

Reduced effectiveness

The effectiveness of COCs may decrease if you forget to take a tablet (see “What to do if you forget to take a tablet”), if you experience gastrointestinal disorders such as vomiting or severe diarrhea (see “Advice in case of gastrointestinal disorders”), or if you take other medications simultaneously (see “Use of other medicines”).

Cycle control irregularities

While using any COC, spotting or vaginal bleeding between periods may occur, especially during the first few months of use. If these bleeding irregularities persist or occur after previously regular cycles, non-hormonal causes should be considered, and you should see your doctor so appropriate diagnostic measures can be taken to rule out malignancies, infections, or pregnancy.

In some women, withdrawal bleeding (period) may not occur during the rest week. If you have taken the COC as directed in the section “How to take Melteva,” it is unlikely that you are pregnant.

However, if you have not taken the COC as directed before the first missed period, or if a second period is missed, pregnancy should be ruled out before continuing to take the COC.

If you have any doubts about any of the points above, consult your doctor before taking Melteva.

Other medicines and Melteva

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines. Certain medicines may interact. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines. It is especially important that you inform your doctor if you are using any of the following medicines:

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

??Some treatments for viral infections and HIV (ritonavir, nelfinavir,
nevirapine).

??Some antibiotics (penicillins and derivatives, rifampicin, rifabutin, griseofulvin,
erythromycin, tetracyclines).

??Some antiepileptics (topiramate, barbiturates (phenobarbital), phenytoin,
carbamazepine, primidone, felbamate, ethosuximide).

??Antacids and lansoprazole.

??Some mood-enhancing substances (modafinil).

You should not take herbal preparations containing St. John's wort (Hypericum perforatum) simultaneously with Melteva, as its effectiveness may be reduced, increasing the risk of unintended pregnancy and intermenstrual bleeding. The reduced contraceptive effect lasts up to two weeks after stopping St. John's wort.

It is advisable to use another reliable contraceptive method if you are taking any of the medicines listed above. The effect of some of these medicines may last up to 28 days after stopping treatment.

Melteva may reduce the effect of oral anticoagulants, analgesics (such as paracetamol and salicylates), fibrates (medicines to reduce triglyceride and/or cholesterol levels), oral antidiabetics, and insulin, and may increase the effect of other drugs such as β-blockers (metoprolol), theophylline (for asthma treatment), corticosteroids (such as prednisolone), cyclosporine (increasing the risk of liver toxicity), flunarizine (increasing the risk of lactation).

Do not take Melteva if you have Hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as increases in liver function test results (elevated liver enzyme ALT) may occur.

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

Melteva can be restarted approximately 2 weeks after completion of this treatment. See the section “Do not use Melteva.”

You should never take another medicine on your own initiative without your doctor's recommendation, as some combinations should be avoided.

You should consult the prescribing information of any medicines you are taking concurrently to identify possible interactions.

Laboratory tests

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

If you are scheduled for any laboratory test, inform your doctor that you are using oral contraceptives.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Melteva is not indicated during pregnancy. If pregnancy occurs, you must stop taking it immediately and consult your doctor.

Small amounts of oral contraceptives may be excreted in breast milk during COC use, but there is no evidence that this adversely affects the child's health. However, COCs are generally not recommended until breastfeeding has ended.

Driving and use of machines

No effects on the ability to drive or use machines have been observed.

Melteva contains lactose, sucrose, and sodium

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

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

3. How to take Melteva

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

Remember to take your medicine, as missing coated tablets may reduce the effectiveness of the preparation.

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

The first tablet should be taken from one of the boxes marked with the corresponding day of the week (e.g., "MO" for Monday). Tablets must be taken every day at approximately the same time, with some liquid if necessary, and in the order indicated on the blister pack. One tablet should be taken daily for 21 consecutive days. A new pack should be started after a 7-day tablet-free interval, during which withdrawal bleeding usually occurs. Withdrawal bleeding, similar to menstruation, typically appears two or three days after taking the last tablet, and may not have finished before starting the next pack.

How to start taking Melteva

??If you have not previously taken any hormonal contraceptive (in the previous month):

Tablets should be started on day 1 of the woman's natural cycle (i.e., the first day of menstrual bleeding). Alternatively, they may be started on days 2 to 5 of the cycle; however, in this case, it is recommended to additionally use a barrier method during the first 7 days of tablet intake.

??To replace another combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch):

You should preferably start taking Melteva the day after taking the last active tablet of your previous COC, or at the latest, the day after completing the usual tablet-free interval or placebo tablet period of your previous COC. This means that treatment with Melteva should be started no later than the day a new pack (blister) of the previous COC would have been started. If you have been using a vaginal ring or transdermal patch, you should preferably start taking Melteva the day after removing the last ring or patch of a cycle pack, or at the latest on the day the next application would have been due.

??To replace a progestogen-only method (progestogen-only pill, injection, implant) or a progestogen-releasing intrauterine system (IUS):

You may switch from the mini-pill to Melteva on any day (if using an implant or IUD, on the same day of removal; if using an injectable, on the day the next injection would be due); however, in all cases, it is recommended to additionally use a barrier method during the first 7 days of tablet intake.

??After a first-trimester abortion:

You may start taking Melteva immediately. In this case, no additional contraceptive measures are necessary.

??After childbirth or a second-trimester abortion:

It is recommended to start taking Melteva 21–28 days after childbirth or a second-trimester abortion. If you start later, you must additionally use a barrier method for the first 7 days. However, if sexual intercourse has already occurred, pregnancy must be ruled out before starting the COC, or you must wait until your first menstrual period.

If you forget to take Melteva

What to do if you miss a tablet

Contraceptive protection is not reduced if a tablet is taken less than 12 hours late. In this case, take the missed tablet as soon as you remember and continue taking the following tablets at your usual time (even if this means taking two tablets on the same day). In this case, no additional contraceptive measures are necessary.

If you are more than 12 hours late in taking a tablet, contraceptive protection may be reduced. The following two basic rules apply in case of a missed tablet:

You must not stop taking tablets for more than 7 days.
It is necessary to take tablets continuously for 7 days to achieve adequate suppression of the hypothalamic-pituitary-ovarian axis.

Accordingly, and following the above guidelines, the following advice may be given in daily practice:

??Week 1:

Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. After that, continue taking the tablets at your usual time. Additionally, use a barrier method (such as a condom) for the next 7 days. If you had sexual intercourse in the previous 7 days, consider the possibility of pregnancy. The more tablets you miss and the closer you are to the usual tablet-free interval, the higher the risk of pregnancy.

??Week 2:

Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. After that, continue taking the tablets at your usual time. If you took all tablets correctly in the 7 days before the missed tablet, you do not need to take additional contraceptive precautions. However, if you missed more than one tablet, it is advisable to use additional precautions for 7 days.

??Week 3:

The risk of reduced effectiveness is imminent due to the proximity of the rest week. However, by adjusting the tablet-taking schedule, a decrease in contraceptive protection can still be prevented. Therefore, if you follow one of the following options, you do not need to take additional contraceptive precautions, provided that you took all tablets correctly in the 7 days before the first missed tablet. If this is not the case, follow the first of the two options below and use additional contraceptive precautions for the next 7 days.

Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. After that, continue taking the tablets at your usual time. Start the next blister pack immediately after finishing the current one, without any break between packs. Withdrawal bleeding (period) is unlikely until you finish the second pack, but you may experience spotting or breakthrough bleeding during tablet intake.
Alternatively, you may stop taking tablets from the current blister pack. Then complete a tablet-free interval of up to 7 days (including the days when you missed tablets) and then start a new blister pack.

If you do not have withdrawal bleeding (period) during the first tablet-free interval after missing tablets, consider the possibility of pregnancy.

In case of doubt, consult your doctor or pharmacist.

Advice in case of gastrointestinal disturbances

In case of severe gastrointestinal disturbances, absorption may be incomplete, and additional contraceptive measures should be taken.

If you vomit within 3–4 hours after taking a tablet, follow the advice for missed tablets as described in the section "What to do if you miss a tablet." If you do not wish to change your normal tablet-taking schedule, take the necessary extra tablet(s) from another pack.

How to delay withdrawal bleeding (period)

To delay a period, continue with the next pack without taking the usual 7-day break. You may extend this for as long as desired until the second pack is finished. During this time, you may experience bleeding or spotting. Then take the usual 7-day tablet-free interval and resume regular intake of Melteva.

To shift your period to a different day of the week than your current cycle, you may shorten the tablet-free interval by as many days as desired. The shorter the interval, the higher the risk of not having withdrawal bleeding (period) and of experiencing breakthrough bleeding or spotting during the next pack (as occurs when delaying a period).

If you take more Melteva than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 915 620 420, indicating the medicine and amount ingested.

No serious adverse reactions due to overdose have been reported. Symptoms that may occur include: nausea, vomiting, and, in adolescents, slight vaginal bleeding. There is no antidote, and treatment should be symptomatic.

If you stop taking Melteva

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

Special populations

Paediatric population

Melteva is only indicated after menarche (onset of first menstruation).

Elderly population

Not applicable. Melteva is contraindicated after menopause.

Patients with hepatic impairment

Melteva is contraindicated in women with severe hepatic dysfunction.

Patients with renal impairment

Melteva has not been specifically studied in patients with renal impairment. No data are available to suggest a change in treatment in this patient population.

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 if you have any change in your health that you think may be due to Melteva, consult your doctor.

Contact a 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 with possible difficulty breathing (see also section 2 “Warnings and precautions”).

All women taking combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting to use Melteva”.

The use of oral contraceptives has been associated with:

Increased risk of cervical intraepithelial neoplasia and cervical cancer.
Increased risk of diagnosis of breast cancer (see “Take special care with Melteva”).

The frequency of adverse effects is classified as follows:

Very common (affects at least 1 in 10 people).
Common (affects at least 1 in 100 people).
Uncommon (affects at least 1 in 1,000 people).
Rare (affects at least 1 in 10,000 people).
Very rare (affects less than 1 in 10,000 people).
Not known (cannot be estimated from available data).

Infections and infestations

Common: Vaginitis (inflammation of the vagina), including candidiasis (fungal infection in the vagina).

Immune system disorders

Rare: Allergy-type reactions such as urticaria (itching).
Very rare: Worsening of systemic lupus erythematosus.
Not known: Angioedema (swelling of the face, lips, mouth, and in very rare cases, severe reactions accompanied by difficulty breathing, dizziness, and even loss of consciousness).

Metabolism and nutrition disorders

Uncommon: Changes in appetite (increase or decrease).
Rare: Glucose intolerance.
Very rare: Worsening of porphyria (a disorder of haemoglobin metabolism).

Psychiatric disorders

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

Nervous system disorders

Very common: Headaches, including migraines.
Common: Nervousness, dizziness.
Very rare: Worsening of chorea.

Eye disorders

Rare: Intolerance to contact lenses.
Very rare: Optic neuritis, retinal vascular thrombosis (eye abnormalities and visual disturbances).

Vascular disorders

Uncommon: Increased blood pressure.
Rare: Harmful blood clots in a vein or artery, for example:

In a leg or foot (i.e., DVT).
In a lung (i.e., PE).
Heart attack.
Stroke.
Transient ischaemic attack (TIA), a mild stroke or temporary stroke-like symptoms.
Blood clots in the liver, stomach/intestines, 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).

Very rare: Worsening of varicose veins.

Gastrointestinal disorders

Common: Nausea, vomiting, abdominal pain.
Uncommon: Colic, bloating.
Very rare: Pancreatitis, hepatic adenomas (common benign liver tumours), hepatocellular carcinoma (malignant liver tumour).

Hepatobiliary disorders

Rare: Cholestatic jaundice (yellowing of mucous membranes, eyes and/or skin related to interruption or reduction of bile flow).
Very rare: Cholecystopathy (gallbladder disorders), including gallstones.

Skin and subcutaneous tissue disorders

Common: Acne.
Uncommon: Rash, photosensitivity reactions (abnormal increase in skin sensitivity), chloasma (skin pigmentation) which may persist, hirsutism (excessive hair growth), alopecia (hair loss).
Rare: Erythema nodosum (a type of skin inflammation with nodules appearing on the legs).
Very rare: Erythema multiforme (a type of skin inflammation).

Renal and urinary disorders

Very rare: Haemolytic uraemic syndrome (a disease causing blood abnormalities).

Reproductive and breast disorders

Very common: Bleeding, spotting.
Common: Breast pain, breast tenderness, breast enlargement, breast discharge, dysmenorrhoea (painful menstruation), changes in menstrual flow, changes in vaginal discharge and cervical ectropion (alteration of the cervical mucosa), amenorrhoea (absence of menstruation).

General disorders and administration site conditions

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

Investigations

Uncommon: Changes in blood lipid levels (fats), including hypertriglyceridaemia.
Rare: Decreased serum folate levels (folic acid derivatives).

Description of selected adverse reactions

Listed below are very rare or delayed-onset adverse reactions considered related to combined oral contraceptives (see sections “Do not use Melteva” and “Warnings and precautions”).

Tumours

The frequency of breast cancer diagnosis among users of COCs is slightly increased. Since breast cancer is rare in women under 40 years of age, this increase is low in relation to the overall risk of breast cancer. Causality related to the use of COCs is unknown.
Liver tumours (benign and malignant).

Other disorders

Women with hypertriglyceridaemia (increased blood fats resulting in increased risk of pancreatitis when COCs are used).
Hypertension.
Onset or worsening of disorders whose association with COC use is not conclusive: jaundice and/or pruritus related to cholestasis (blocked bile flow); gallstone formation; a metabolic disorder called porphyria; systemic lupus erythematosus (a chronic autoimmune disease); haemolytic uraemic syndrome (a disease causing blood clots); a neurological disorder called Sydenham's chorea; herpes gestationis (a type of skin disorder occurring during pregnancy); hearing loss related to otosclerosis.
Alterations in liver function.
Changes in glucose tolerance or effects on peripheral insulin resistance.
Crohn’s disease, ulcerative colitis.
Chloasma (skin pigmentation).

Interactions

Interactions between oral contraceptives and other medicines (e.g. St. John’s wort, medications for epilepsy, tuberculosis, HIV and other infections) may lead to unexpected bleeding and/or contraceptive failure (see section “Taking Melteva with other medicines”).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Melteva

Keep out of the sight and reach of children.

Store below 30°C. Keep in the original packaging.

Do not use Melteva after the expiry date stated on the container.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Melteva

The active substances are: ethinylestradiol, 0.02 mg and gestodene, 0.075 mg.
The other components are: lactose, corn starch, povidone, calcium disodium edetate,
magnesium stearate, sucrose, povid游戏副本