MELODENE-15 0.06 mg / 0.015 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Melodene-15 0.06 mg/0.015 mgfilm-coated tablets

gestodene / ethinylestradiol

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, consult your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of having a blood clot in the veins and arteries, especially in 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 might have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of the package leaflet

1. What is Melodene-15 and what is it used for
2. What you need to know before you start taking Melodene-15
3. How to take Melodene-15
4. Possible side effects
5. Storage of Melodene-15
6. Package contents and further information

1. What is Melodene-15 and what is it used for

Melodene-15 is a hormonal contraceptive pill used to prevent pregnancy.

• Each of the 24 pale yellow tablets contains a small amount of two different female hormones, called gestodene and ethinylestradiol.
• The 4 white tablets do not contain active ingredients and are called placebo tablets.
• Contraceptive pills that contain two hormones are called "combined" pills.

2. What you need to know before starting to take Melodene-15

General considerations

Before starting to use Melodene-15, 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").

Before starting to take Melodene-15, your doctor will ask you some questions about your personal and family medical history. The doctor will also measure your blood pressure, and depending on your personal situation, may carry out some other tests.

This prospectus describes several situations in which you should interrupt the use of Melodene-15, or in which the reliability of Melodene-15 may decrease. In such situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions, for example, use of a condom or another barrier method. Do not use the rhythm method or the temperature method. These methods may not be reliable since Melodene-15 alters the monthly changes in body temperature and cervical mucus.

Melodene-15, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Do not use Melodene-15

You should not use Melodene-15 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 (gestodene or ethinylestradiol) or to any of the other components of this medicine (included in section 6).

• If you have (or have ever had) a blood clot in a blood vessel of the legs (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.
• If you know 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 an operation or if you spend a lot of time without getting 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 can 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 the arteries:

• Severe diabetes with blood vessel damage.
• Very high blood pressure.
• Very high levels of fat in the blood (cholesterol or triglycerides).
• A condition called hyperhomocysteinemia.

• If you have (or have ever had) a type of migraine called "migraine with aura".
• If you have (or have ever had) heart or blood vessel disease, especially:

• a heart rhythm disorder or a heart valve disorder
• disorders of certain heart blood vessels (coronary arteries)

• If you have (or have ever had) a benign tumor (called focal nodular hyperplasia or hepatic adenoma) or malignant liver tumor, or if you have recently suffered from liver disease. In such cases, your doctor will order you to stop the pills until your liver is functioning normally.
• If you have vaginal bleeding of unknown cause.
• If you have breast or uterine cancer, or any cancer that is sensitive to female sex hormones, or if it is suspected that you may have it.

Do not use Melodene-15 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 medicines and Melodene-15").

Warnings and precautions

In some situations, you must be particularly careful while using Melodene-15 or any other combined hormonal contraceptive, and it may be necessary for your doctor to examine you periodically.

Tell your doctor if you suffer from any of the following conditions.

If the condition develops or worsens while you are using Melodene-15, you should also inform your doctor.

• If any blood test has shown that you have high levels of sugar, high cholesterol or high levels of prolactin (a hormone that stimulates milk production).
• If you are obese.
• If you have a benign breast tumor or if a close relative has ever had breast cancer.
• If you have a uterine disease (uterine dystrophy).
• 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 a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you need an operation or spend a lot of time without getting up (see section 2 "Blood clots").
• If you have just given birth, you are at a higher risk of suffering from blood clots. You should ask your doctor when you can start taking Melodene-15 after childbirth.
• If you have inflammation of the veins that are under the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you or a close relative (parents, grandparents, brothers, sisters ...) have ever suffered from a disease with a tendency to produce blood clots (in the leg, lung or other organs, heart attacks, strokes).
• If you suffer from epilepsy (see also 'Other medicines and Melodene-15).
• If you suffer from migraines.
• If you suffer from hearing loss due to a disorder called otosclerosis.
• If you suffer from asthma.
• If during any pregnancy, or when using another contraceptive pill, you have suffered from a skin disease that produces itching, red spots and blisters (herpes gestationis).
• If you have had discoloration spots on your face (chloasma) during pregnancy or when using another contraceptive pill. In this case, avoid direct exposure to the sun when using Melodene-15.
• If you suffer from gallstones.
• If you suffer from any heart, liver or kidney disease.
• If you suffer from depression.
• If you have high blood pressure.
• If you suffer from a disease known as chorea, characterized by involuntary, irregular and sudden movements.
• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen the symptoms of hereditary and acquired angioedema.

Consult your doctor or pharmacist before starting to take Melodene-15.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Melodene-15 increases your risk of suffering from 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 (this is called "venous thrombosis", "venous thromboembolism" or VTE).
• In the arteries (this is called "arterial thrombosis", "arterial thromboembolism" or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious lasting effects or, very rarely, they can be fatal.

It is essential to remember that the overall risk of a harmful blood clot due to Melodene-15 is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if 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 side 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 the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very 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 in which you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medicine or a different one) after an interruption 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 Melodene-15, your risk of a blood clot returns to normal within 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 overall risk of a blood clot in the leg or lung (DVT or PE) with Melodene-15 is small.

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone or norgestimate, about 5-7 will have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains gestodene like Melodene-15, between about 9 and 12 women will have 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 a blood clot with Melodene-15 is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index or BMI over 30 kg/m2).
• If any of your close relatives have had a blood clot in the leg, lung or other organs at a young age (i.e., before the age of 50). In this case, you may have a hereditary disorder of blood clotting.
• If you need an operation or if you spend a lot of time without getting up due to an injury or illness or if you have a leg in a cast. You may need to stop using Melodene-15 several weeks before the operation or while you have less mobility. If you need to stop using Melodene-15, ask your doctor when you can start using it again.
• As you get older (especially over 35 years).
• If you have given birth in the last few weeks.

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

Long-distance flights (more than 4 hours) can 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 suffer from any of the above conditions, even if you are not sure. Your doctor may decide that you should stop using Melodene-15.

If any of the above conditions change while you are using Melodene-15, for example, a close relative experiences a thrombosis 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 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 Melodene-15 is very small, but it can increase:

• With age (over 35 years).
• If you smoke.When using a combined hormonal contraceptive like Melodene-15, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (less than 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or any of your close relatives have a high level of fat in the blood (cholesterol or triglycerides).
• If you suffer from migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

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

If any of the above conditions change while you are using Melodene-15, for example, you start smoking, a close relative experiences a thrombosis without a known cause or you gain a lot of weight, inform your doctor.

Melodene-15 and cancer

The detection of breast cancer is slightly higher in women who use combined pills, but it is not known if this is caused by the pill. It is possible that these women are simply being examined more closely and more frequently, or that breast cancer is being detected earlier.

Studies indicate cases of cervical cancer in women who use combined pills for a relatively long time. Currently, it is not known if this is caused by the pill or if it is related to sexual behavior (e.g., frequent changes of partner) and other factors.

In rare cases, benign liver tumors, and in even fewer cases, malignant liver tumors, have been reported in users of the pill. Consult your doctor if you suffer from unusual severe abdominal pain.

3. How to take Melodene-15

Dosage

• Start taking Melodene-15 with the first tablet, located next to the word "START".
• To help you follow the order of intake, 7 self-adhesive strips with the 7 days of the week are provided. Choose the strip that starts with the day you take the first tablet. For example, if you take your first tablet on a Wednesday, use the strip that starts with "WED". Stick the strip on top of the Melodene-15 blister pack where it says "Place the strip here!".
• Each blister pack contains 28 tablets. Take one pill at the same time every day, for 28 consecutive days, following the direction indicated by the arrows, without missing one, as follows: take one active pale yellow tablet each day for the first 24 days, and then one white placebo tablet each of the last 4 days.
• After taking the last tablet, continue taking Melodene-15 the next day, starting a new blister pack, without leaving an interval between the blister packs. Each of the blister packs should be started on the same day of the week. Since there is no pause in taking the medication, it is essential that you already have the next blister pack before finishing the previous one.
• Bleeding usually starts two or three days after taking the last active pale yellow tablet of the blister pack and may not have ended before starting the next blister pack.

Method and route of administration

Swallow each tablet with a large glass of water.

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

Take the first tablet on the first day of your menstruation.

If you are changing from another contraceptive pill

Finish the blister pack you have started (if your current pill pack also contains hormone-free tablets, do not take them). Start the Melodene-15 blister pack the next day, without leaving any day without taking a pill.

If you were using a progestin-only method (progestin-only pill, injectable, or implant)

• changing from a progestin-only pill, you can start Melodene-15 at any time during the menstrual cycle, the day after stopping the progestin-only pill
• changing from an implant: start Melodene-15 on the day of implant removal
• changing from an injectable contraceptive: start Melodene-15 on the day corresponding to the next injection

In any case, it is necessary to use a barrier-type contraceptive method (e.g., a condom) during the first 7 days of taking the pill.

If you are starting Melodene-15 after pregnancy termination in the first trimester

Normally, you can start immediately, but follow your doctor's advice before doing so.

If you are starting Melodene-15 after giving birth or pregnancy termination in the second trimester

Like any other contraceptive pill, Melodene-15 should not be started before 21 to 28 days after giving birth or pregnancy termination, due to an increased risk of blood clots. If you start later, it is advised to use a barrier contraceptive method during the first 7 days of taking the pill. If you have had sexual intercourse before starting Melodene-15, make sure you are not pregnant or wait until the next menstruation.

Always ask your doctor for advice.

Duration of use

Your doctor will indicate how long you should use this pill.

If you take more Melodene-15 than you should

Overdose may cause gastrointestinal problems (e.g., nausea, vomiting, abdominal pain), breast tension, dizziness, drowsiness/fatigue, and menstrual cycle disorders (vaginal bleeding). This bleeding may occur even in girls who have not yet had their first period, if they have accidentally taken this medication.

Ask your doctor for advice. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Melodene-15

If you realize you forgot a pale yellow tablet within 12 hours of the time you normally take it, take the forgotten tablet immediately and continue normally, taking the next one at the usual time until you finish the blister pack.

If you realize you forgot a pale yellow tablet after 12 hours of the time you normally take it, there is a risk of becoming pregnant. In this case:

• take the last forgotten tablet immediately, even if it means taking 2 tablets on the same day
• continue taking the contraceptive until you finish the blister pack
• also, use a barrier contraceptive method (condom, spermicides, etc.) for the next 7 days

If you have forgotten one or more pale yellow tablets in a blister pack and do not get the bleeding that should occur when taking the white tablets, you may be pregnant.

If you have forgotten one or more white tablets, you are still protected as long as it has not been more than 4 days between the last active pale yellow tablet of the current blister pack and the first active pale yellow tablet of the next blister pack. Ask your doctor for advice.

If you suffer from vomiting or severe diarrhea within 4 hours of taking the pill, a situation similar to forgetting a tablet occurs. After vomiting or diarrhea, you should take another tablet from a reserve blister pack as soon as possible. If possible, take it within 12 hoursafter the usual time you take your contraceptive. If this is not possible or more than 12 hours have passed, follow the advice in the section "If you forget to take Melodene-15".

If these episodes of vomiting or severe diarrhea are repeated for several days, you should use a barrier contraceptive method (condom, spermicide, etc.) until the start of the next blister pack. Ask your doctor for advice.

4. Possible side effects

Like all medications, Melodene-15 can cause side effects, although not everyone will experience them. If you suffer from any side effect, especially if it is severe and persistent, or have any change in health that you think may be due to Melodene-15, consult your doctor.

All women who take 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 taking Melodene-15".

Severe side effects

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 urticaria with possible difficulty breathing (see also the section "Warnings and precautions").

The most frequently reported side effects (more than 10%) among women using Melodene-15 are the absence or lower frequency of menstruations during use or after stopping, intermenstrual bleeding, or headache, including migraine.

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

• vaginal infection, including vaginal candidiasis
• mood changes, including depression and changes in sexual appetite
• nervousness or dizziness
• nausea, vomiting, or abdominal pain
• acne
• breast pain, tension, swelling, or discharge
• painful menstruations or changes in menstrual flow
• changes in vaginal discharge or cervical changes (ectropion)
• water retention in tissues or edema (acute fluid retention)
• weight gain or loss

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

• changes in appetite
• colic or gas
• rash, excessive body hair, hair loss, or skin discoloration (chloasma)
• changes in laboratory test results: increased cholesterol, triglycerides, or blood pressure levels

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

• allergic reactions (such as very rare cases of urticaria or severe respiratory or circulatory disorders)
• glucose intolerance
• intolerance to contact lenses
• jaundice
• a type of skin reaction called erythema nodosum
• 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.
  • Mild stroke or temporary symptoms similar to those of a stroke, called a transient ischemic attack (TIA).
  • Blood clots in the liver, stomach/intestine, kidneys, or eye.

The possibility 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 side effects (may affect up to 1 in 10,000 people):

• benign liver tumor (called focal nodular hyperplasia or hepatic adenoma) or malignant liver tumor
• worsening of an immune system disease (lupus), liver disease (porphyria), or a disease called chorea characterized by irregular, sudden, and involuntary movements
• certain types of eye disorders, such as optic nerve inflammation that can cause partial or total loss of vision, or blood clots in the retina
• pancreatic disorders
• increased risk of gallstones or bile flow obstruction
• liver or biliary disorders (such as hepatitis or abnormal liver function)
• blood or urinary disorders (hemolytic uremic syndrome)
• a certain type of skin reaction called erythema multiforme

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Reporting side effects

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

5. Storage of Melodene-15

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the box and on the blister pack after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Melodene-15 composition

Pale yellow tablet:

• The active ingredients are: 0.06 mg of gestodene and 0.015 mg of ethinylestradiol.
• The other components are: lactose monohydrate, microcrystalline cellulose, magnesium stearate, potassium polacrilin, OPADRY yellow YS-1-6386-G [hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172)], macrogol 1450, E wax (montan glycol wax).

White tablet:

• There is no active ingredient.
• The other components are: lactose monohydrate, microcrystalline cellulose, magnesium stearate, potassium polacrilin, OPADRY white Y-5-18024-A [hypromellose, hydroxypropylcellulose, titanium dioxide (E 171), macrogol 400], macrogol 1500, E wax (montan glycol wax).

Product appearance and package contents

Melodene-15 is presented in the form of film-coated tablets.

Each box contains 1, 3, or 6 blister packs, each with 28 tablets (24 active pale yellow tablets and 4 inactive white tablets).

Only some pack sizes may be marketed.

Marketing authorization holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 - 5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

Bayer WEIMAR GmbH und Co. KG

Doebereinerstrasse 20

99427 Weimar

Germany

Date of the last revision of this leaflet:10/2022

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.