Package Leaflet: Information for the user

Melteva 0.02 mg/0.075 mg coated tablets

Ethinylestradiol/Gestodeno

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

- Keep this leaflet, as you may need to read it again.

- If you have any doubts, consult your doctor or pharmacist.

- This medicine has been prescribed for you only and should not be given to others,

even if they have the same symptoms, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are 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 suffering a blood clot in the veins and arteries,

especially in the first year or when restarting use of a 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 Melteva is and what it is used for

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

3. How to take Melteva

4. Possible side effects

5. Storage of Melteva

6. Contents of the pack and additional information

Melteva is a combined oral contraceptive pill. It prevents ovulation and causes changes in cervical mucus secretion. It is used to prevent pregnancy and to achieve ovulatory rest states.

This medication is presented in blister packs (the packaging where the coated tablets are found) of 21 coated tablets.

General Considerations

Before starting to use Melteva, you should 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 take Melteva:

Do not use Melteva 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 included in section 6.

If you have (or have ever had) a blood clot in a vein of the legs (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.

If you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies.

If you need surgery or if you spend a lot of time without standing up (see section “Blood Clots”).

If you have ever had a heart attack or a stroke.

If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, symptoms of a stroke).

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

Diabetes with severe vascular damage.

Very high blood pressure.

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

A condition called hyperhomocysteinemia.

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

If you have thrombogenic valvulopathies (heart valve diseases that may cause blood clots).

If you have arrhythmias that may cause blood clots (cardiac 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 genital organs or breasts.

If you have unexplained vaginal bleeding.

If you are pregnant or suspect you may be pregnant.

If you have hepatitis C and are taking medications that contain ombitasvir / paritaprevir / ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also the section “Use of other medications”).

When to have special care with Melteva

If any of the risk situations mentioned below are present, your doctor should assess the benefits of using this medication Melteva 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 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 that affects your natural defense system).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• If you have sickle cell anemia (a hereditary disease of red blood cells).
• If you have high levels of fat in the blood (hypertriglyceridemia) or known family history of this condition. Hypertriglyceridemia has been associated with a higher risk of developing 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 developing blood clots. Ask your doctor when you can start taking Melteva 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 cardiac arrhythmias).
• If you have high blood pressure, particularly if it worsens or does not improve with anti-hypertensive medications.
• If you have severe and 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 (yellowing of the whites of the eyes and 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. sunbed).
• If you experience angioedema symptoms such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria potentially with 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 Melteva increases your risk of developing a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

in the veins (known as “deep vein thrombosis”, “venous thromboembolism” or TEV).

in the arteries (known as “arterial thrombosis”, “arterial thromboembolism” or TEA).

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 Melteva 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 the veins (venous thrombosis). 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 of the leg or foot, it may cause deep vein thrombosis (DVT).

– If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism.

– In rare cases, a blood clot can form in a vein of another organ, such as the eye (retinal vein thrombosis).

When is the risk of a blood clot in a vein higher?

The risk of a blood clot in a vein is higher during the first year of 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 Melteva, 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 TEV and the type of combined hormonal contraceptive you are taking.

The overall risk of a blood clot in the leg or lung (DVT or PE) with Melteva is small.

– Of every 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 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, about 5-7 will develop a blood clot in a year.

– Of every 10,000 women who use a combined hormonal contraceptive containing gestodene like Melteva, about 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

The risk of having a blood clot with Melteva 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 the leg, lung, or other organ at a young age (i.e., before about 50 years old). You may have a hereditary 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 a leg cast. You may need to stop taking Melteva for several weeks before the surgery or while you have less mobility. If you need to stop taking Melteva, ask your doctor when you can start taking it again.

– With age (especially above about 35 years).

– If you have recently given birth.

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

Long flights (over 4 hours) may temporarily increase the 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 mentioned above, even if you are unsure. Your doctor may decide to stop taking Melteva.

If any of the conditions mentioned above change while you are using Melteva, 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?

A blood clot in an artery can cause serious problems, such as 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 Melteva is very small, but it may increase:

– With age (above about 35 years)

– 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 having a heart attack or stroke.

– If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).

– If you have migraines, especially migraines with aura.

– If you have a heart problem (valve disorder, arrhythmia called atrial fibrillation).

– If you have diabetes.

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

If any of the conditions mentioned above change while you are using Melteva, 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 unknown whether this is due to treatment. For example, it may be that breast tumors are 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.

Cancer of the ovaries occurs less frequently than breast cancer. The use of THS with estrogens alone or with a combination of estrogens-progestogens has been associated with a slightly higher risk of ovarian cancer.

The risk of ovarian cancer varies with age. For example, in women aged 50-54 who do not use THS, about 2 cases of ovarian cancer have been observed per 2,000 women over a 5-year period. In women using THS for 5 years, about 3 cases have been observed per 2,000 patients (i.e., about 1 additional case).

In some studies, an increased risk of cervical cancer has been reported in users who have been taking AOC 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 ones have been reported in users of AOC. This can 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 AOC on these lesions, it is recommended that, when prescribing AOC, cervical cytologies be performed periodically.

Otras afecciones:

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

Women who have been treated for hyperlipidemias (high levels of fat in the blood such as triglycerides and/or cholesterol) should be monitored if they decide to take oral contraceptives.

During the use of AOC, many users experience small increases in blood pressure, although rare cases with clinical relevance are uncommon. If high blood pressure develops during the use of AOC, you should consult your doctor.

In women with endometrial hyperplasia (thickening of the inner lining of the uterus), your doctor should carefully assess the risk-benefit ratio before prescribing AOC, and closely monitor you during treatment, performing cervical cytologies periodically.

The following conditions may appear or worsen with pregnancy and with the use of AOC: jaundice (yellowing of the whites of the eyes and skin) and/or pruritus (itching) related to cholestasis (bile flow obstruction), gallstone formation, porphyria (a hereditary 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 that occur during pregnancy), and otosclerosis (a type of ear disorder). Acute or chronic liver function disorders require the suspension of AOC use until liver function test values return to normal. The reappearance of a cholestatic jaundice that first appeared during a pregnancy, or during previous use of sex hormones, requires the suspension of AOC use.

AOC may alter peripheral resistance to insulin and glucose intolerance. There is no evidence that this requires a change in treatment in diabetic women taking low-dose AOC (with <0.05 mg of ethinylestradiol). However, diabetic women should be closely monitored while taking AOC.

There has been an association between the use of AOC and Crohn's disease and ulcerative colitis (inflammatory bowel diseases).

Occasionally, AOC may cause melasma (brown spots on the skin), especially in women with a history of melasma during pregnancy. If you are prone to melasma, you should avoid exposure to the sun or ultraviolet radiation while taking AOC.

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

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

Exploración and consultation

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

Reduction of efficacy

The efficacy of AOC may decrease if you forget to take a pill (see “What to do if you forget to take a pill”), if you experience gastrointestinal disorders such as vomiting or intense diarrhea (see “Advice in case of gastrointestinal disorders”), or if you take other medications simultaneously (see “Use of other medications”).

Irregularities in menstrual control

During the use of any AOC, 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 take appropriate diagnostic measures 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 AOC as instructed in the section “How to take Melteva,” it is unlikely that you are pregnant.

However, if you did not take the AOC as instructed before the first missed period, or if a second missed period occurs, you should rule out pregnancy before continuing to take the AOC.

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

Other medications and Melteva

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 these cases, it may be necessary 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:

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

??Some antibiotics (penicillins and derivatives, rifampicin, rifabutina, griseofulvina, eritromicina, tetraciclinas).

??Some antiepileptics (topiramato, barbiturics (fenobarbital), phenytoin, carbamazepine, pirimidona, felbamato, ethosuximida).

??Anti-acids and lansoprazol.

??Some mood elevators (modafinil).

You should not take preparations based on medicinal plants with St. John's Wort (Hypericum perforatum) simultaneously with Melteva, as its efficacy may be reduced, with a risk of unplanned pregnancy and intermenstrual bleeding. The reduction in anticonceptive effect lasts until two weeks after stopping the St. John's Wort preparation.

It is recommended that you use another reliable contraceptive method if you take any of the medications listed above. The effect of some of these medications may last for up to 28 days after stopping treatment.

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

You should not take Melteva if you have hepatitis C and are taking medications that contain ombitasvir / paritaprevir / ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as it may cause increased liver enzyme levels (elevated ALT).

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

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

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

You should consult the prescribing information for the medications you are taking concurrently to identify potential 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 you are using oral contraceptives.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

Melteva is not indicated during pregnancy. If you become pregnant, you should stop taking it immediately and consult your doctor.

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

Driving and operating machinery

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

Melteva contains lactose, sucrose, and sodium

This medication 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.

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

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

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

The first tablet is removed from one of the marked compartments with the corresponding day of the week (e.g. "LU" for Monday). The tablets must 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 usually occurs. The withdrawal bleeding, similar to menstruation, 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 Melteva

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

The 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 during the first 7 days of taking tablets.

??To replace another combined hormonal contraceptive (CHC):

It should start taking Melteva the day after the end of the break week (in case of taking contraceptives for 21 days) or the day after the end of the taking of the placebo tablets (without active ingredient) of your previous combined oral contraceptive (COC) (in case of contraceptives for 28 days).

??To replace a method based exclusively on progestogens (mini-pill, injection,

implant) or a progesterone-releasing intrauterine system (IUS):

You can replace the mini-pill with Melteva on any day (if it is an implant or an IUS, on the same day of its removal; if it is an injectable, on the day corresponding to the next injection), but in all cases, it is recommended to use an additional barrier method during the first 7 days of taking the tablet.

??After a first-trimester abortion:

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

??After childbirth or a second-trimester abortion:

It is recommended that you start taking Melteva 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.

What to do if you forget to take Melteva

Conduct to follow if you forget to take a tablet

The 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 taking more than 12 hours, the contraceptive protection may be reduced. The conduct to follow in case of forgetting is governed by two basic rules:

1. Never suspend the taking of tablets for more than 7 days.

2. You must take the tablets uninterruptedly for 7 days to

achieve an adequate suppression of the hypothalamic-pituitary-ovarian axis.

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

??Week 1:

You should take the last forgotten tablet as soon as you remember it, although this may mean taking two tablets at once. From then on, you will continue to take the tablets at your usual time. In addition, during the next 7 days, you should use a barrier method, such as a condom. If you have had sexual intercourse in the previous 7 days, you should consider the possibility of becoming pregnant. The more tablets you have forgotten and the closer you are to the usual interval without taking tablets, the greater the risk of pregnancy.

??Week 2:

You should take the last forgotten tablet as soon as you remember it, although this may mean taking two tablets at once. From then on, you will continue to take the tablets at your usual time. If you have taken the tablets correctly in the 7 days before the day of 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 reduction in effectiveness is imminent due to the proximity of the break week. However, by adjusting the tablet-taking program, you can still prevent the contraceptive protection from being reduced. Therefore, if you follow one of the options below,

you will not need to take any additional contraceptive measures, as long as you have taken all the tablets correctly in the 7 days before the first forgotten tablet. If not, you should follow the first of the two options indicated below and take additional contraceptive precautions for the next 7 days.

1. You should take the last forgotten tablet as soon as you remember it, although this may mean taking two tablets at once. From then on, you will continue to take 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 a withdrawal bleeding (period) until you finish the second blister pack, but you may experience spotting or bleeding during the taking of the next tablets.

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 start again with the next blister pack.

If, after forgetting to take tablets, you do not have a withdrawal bleeding (period) in the first interval without tablets, you should consider the possibility of becoming pregnant.

However, in case of doubt, consult your doctor.

Advice in case of gastrointestinal disturbances

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

If you experience vomiting in the 3-4 hours following the taking of the tablet, you should follow the advice on forgetting to take a tablet, as described in the section "Conduct to follow if you forget to take a tablet". 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 a withdrawal bleeding

To delay a period, you should continue with the next blister pack without leaving the usual break week. You can maintain this extension as long as you want until you finish the second blister pack. During this period, you may experience bleeding or spotting. Then, you should leave the usual break week of 7 days without tablets and resume taking Melteva regularly.

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

What to do if you take more Melteva than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, tel.: 915 620 420, indicating the medication and the amount ingested.

No severe adverse reactions have been reported due to overdose. The symptoms that may appear in this case are: nausea, vomiting, and, in adolescents, light vaginal bleeding. There is no antidote, and treatment should be symptomatic.

What to do if you interrupt treatment with Melteva

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

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

Seek medical attention immediately if you experience any of the following angioedema symptoms: facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria with possible difficulty breathing (see also section 2 “Warnings and precautions”).

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

The use of oral contraceptives has been associated with:

- Increased risk of intraepithelial neoplasia and cervical cancer.

- Increased risk of breast cancer diagnosis (see “Be especially careful with Melteva”).

The frequency of side effects is classified as:

Very common (at least 1 in 10 patients).

Common (at least 1 in 100 patients).

Uncommon (at least 1 in 1,000 patients).

Rare (at least 1 in 10,000 patients).

Very Rare (Less than 1 in 10,000 patients).

Not known (Cannot be estimated from available data)

Infections and infestations

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

Immune system disorders

Rare:Allergic reactions such as urticaria (itching),

Very rare:Worsening of systemic lupus erythematosus.

Not known:Angioedema (facial swelling, lips, mouth, and very rare cases of 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.

Mental 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:Lens intolerance.

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

Vascular disorders

Uncommon:Increased blood pressure.

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

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

Very rare:Worsening of varicose veins.

Gastrointestinal disorders

Common:Nausea, vomiting, abdominal pain.

Uncommon:Colic, swelling.

Very rare:Pancreatitis, hepatic adenomas, hepatocellular carcinoma.

Hepatobiliary disorders

Rare:Cholestatic jaundice.

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

Skin and subcutaneous tissue disorders

Common:Acne.

Uncommon:Urticaria, photosensitivity reactions, melasma (skin spots) 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).

Renal and urinary disorders

Very rare:Hemolytic-uremic syndrome.

Reproductive and mammary system disorders

Very common:Bleeding, spotting.

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

General disorders and administration site conditions

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

Investigations

Uncommon:Changes in blood lipid levels, including hypertriglyceridemia.

Rare:Decreased serum folate levels.

Reporting of side effects

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

Keep out of sight and reach of children.

Do not store at a temperature above 86°F (30°C). Store in the original packaging.

Do not use Melteva after the expiration date shown on the container.

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

Composition of Melteva

- The active principles are: etinilestradiol, 0.02 mg and gestodeno, 0.075 mg.

- The other components are: lactose, cornstarch, povidone, calcium and sodium edetate, magnesium stearate, saccharose, povidone, poliglycol, calcium carbonate, talc, and glicolated montana wax.

- The other components are: lactose, cornstarch, povidone, calcium and sodium edetate, magnesium stearate, saccharose, povidone, poliglycol, calcium carbonate, talc, and glicolated montana wax.

Appearance of the product and content of the packaging

Melteva is presented in aluminum blisters of 21 tablets and 3x21 tablets.

The tablets are white, round, biconvex, and shiny.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Teva Pharma S.L.U.

c/ Anabel Segura 11, Edificio Albatros B, 1st floor

Alcobendas 28108 Madrid (Spain)

Responsible for manufacturing:

Haupt Pharma Münster GmbH.

Schleebrüggenkamp 15

48159 Münster

Germany

Last review date of this leaflet: November 2022

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