Melodene-15 0.06 mg/0.015 mg film-coated tablets: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Melodene-15 0.06 mg / 0.015 mg film-coated tablets

gestodene / ethinylestradiol

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 you should not give it to others, 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 these effects 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 developing a blood clot in veins and arteries, especially during the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
Be alert and consult your doctor if you think you may be experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Leaflet contents

What Melodene-15 is and what it is used for
What you need to know before taking Melodene-15
How to take Melodene-15
Possible side effects
How to store Melodene-15
Contents of the pack and other information

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

Melodene-15 is a combined oral 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 contain no active substances and are referred to as placebo tablets.
Contraceptive pills containing two hormones are called "combined" pills.

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

General considerations

Before starting to take Melodene-15, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).

Before you start taking Melodene-15, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure, and depending on your individual situation, may carry out some additional tests.

This leaflet describes several situations in which you should stop using Melodene-15, or in which the effectiveness of Melodene-15 may decrease. In such situations, you should either avoid sexual intercourse or use additional non-hormonal contraceptive precautions, for example, condoms or another barrier method. Do not use the rhythm method or the temperature method. These methods may not be reliable because Melodene-15 alters the monthly changes in body temperature and cervical mucus.

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

Do not use Melodene-15

You must 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 which alternative form of contraception would be most suitable.

If you are allergic to the active substances (gestodene or ethinylestradiol) or to any of the other ingredients of this medicine (listed in section 6).
If you have (or have ever had) a blood clot in a blood vessel of the legs (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE), or in other organs.
If you know you have a disorder affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
If you require surgery or will be immobile for a long period (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 conditions that may increase your risk of developing 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 (called focal nodular hyperplasia or hepatic adenoma) or malignant liver tumour, or if you have recently had liver disease. In such cases, your doctor will instruct you to stop taking the tablets until your liver is functioning normally.
If you have vaginal bleeding of unknown cause.
If you have breast or uterine cancer, or any cancer sensitive to female sex hormones, or if such cancer is suspected.

Do not use Melodene-15 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 Melodene-15”).

Warnings and precautions

When should you consult your doctor?

Seek urgent medical attention

If you notice possible signs of a blood clot which may mean you are experiencing a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section “Blood clots” below).

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

In some situations, you should take special care when using Melodene-15 or any other combined hormonal contraceptive, and your doctor may need to examine you periodically.

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

If any of these conditions develop or worsen while you are using Melodene-15, you must also inform your doctor.

If blood tests have shown that you have high blood sugar levels, high cholesterol levels, or elevated levels of prolactin (a hormone that stimulates milk production).
If you are obese.
If you have had a benign breast tumor or if a close relative has ever had breast cancer.
If you have a uterine disorder (uterine dystrophy).
If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
If you have systemic lupus erythematosus (SLE, a disease affecting your body's natural defense system).
If you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure).
If you have sickle cell anemia (an inherited red blood cell disorder).
If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
If you require surgery or will be immobile for long periods (see section 2 “Blood clots”).
If you have recently given birth, you are at increased risk of blood clots. Ask your doctor when you can start taking Melodene-15 after childbirth.
If you have inflammation of veins beneath the skin (superficial thrombophlebitis).
If you have varicose veins.
If you or a close relative (parents, grandparents, siblings) have ever had a condition that predisposes to blood clots (in the leg, lung, or elsewhere), heart attack, or stroke.
If you have epilepsy (see also “Other medicines and Melodene-15”).
If you suffer from migraines.
If you have hearing loss due to a disorder called otosclerosis.
If you have asthma.
If during a pregnancy or while using another contraceptive pill, you experienced a skin condition causing itching, red patches, and blisters (herpes gestationis).
If you have had facial skin discoloration (chloasma) during pregnancy or while using another contraceptive pill. In this case, avoid direct sun exposure while using Melodene-15.
If you have gallstones.
If you have any heart, liver, or kidney disease.
If you have depression.
If you have high blood pressure.
If you have a condition 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 hives with possible breathing difficulty, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

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

BLOOD CLOTS

Using a combined hormonal contraceptive such as Melodene-15 increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

In veins (called “venous thrombosis”, “venous thromboembolism” or VTE).
In arteries (called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. 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 Melodene-15 is small.

HOW TO RECOGNIZE A BLOOD CLOT

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

Are you experiencing any of these signs?	What could you possibly be suffering from?
Swelling in one leg or along a vein in the leg or foot, especially when accompanied by: Pain or tenderness in the leg, which may only be noticeable when standing or walking. Increased warmth in the affected leg. Change in skin color of the leg, e.g., turning pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without a known cause or rapid breathing. Sudden cough without a clear cause, possibly bringing up blood. Sharp chest pain that may worsen upon deep breathing. Severe dizziness or lightheadedness. Rapid or irregular heartbeat. 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 like a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: Sudden loss of vision. Or Painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye).
Chest pain, discomfort, pressure, or heaviness. Feeling of tightness or fullness in the chest, arm, or below the sternum. Feeling of fullness, indigestion, or suffocation. Upper body discomfort radiating to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Extreme weakness, anxiety, or shortness of breath. Rapid or irregular heartbeat.	Heart attack.
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. Sudden confusion, difficulty speaking or understanding speech. Sudden vision difficulty in one or both eyes. Sudden difficulty walking, dizziness, loss of balance, or coordination. Sudden, severe, or prolonged headache without a known cause. Loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
Swelling and slight bluish discoloration of a limb. Severe 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 (PE).
Very rarely, a clot may form in a vein of another organ, such as the eye (retinal vein thrombosis).

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

The risk of developing a blood clot in a vein is higher during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be increased 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 remains slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Melodene-15, your risk of developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

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

The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Melodene-15 is low.

Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in 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 in one year.
Among 10,000 women who use a combined hormonal contraceptive containing gestodene, such as Melodene-15, between 9 and 12 women will develop a blood clot in one year.
Your individual risk of developing a blood clot depends on your personal medical history (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal contraceptive pill and who are not pregnant	About 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5–7 out of 10,000 women
Women who use Melodene-15	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 Melodene-15 is small, but certain conditions increase the risk. Your risk is higher:

If you are overweight (body mass index or BMI above 30 kg/m²).
If any of your close relatives have had a blood clot in the leg, lung, or another organ at a young age (i.e., before the age of about 50). In this case, you may have an inherited blood-clotting disorder.
If you need surgery or if you are immobile for a long time due to illness, injury, or having a leg in a cast. You may need to stop taking Melodene-15 several weeks before surgery or while you are less mobile. If you need to stop taking Melodene-15, ask your doctor when you can start taking it again.
With increasing age (especially above about 35 years).
If you have given birth within the last few weeks.

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 listed risk factors.

It is important to inform your doctor if you have any of the above conditions, even if you are uncertain. Your doctor may decide that you need to stop taking 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 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 lead to a heart attack or stroke.

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

It is important to note that the risk of heart attack or stroke while using Melodene-15 is very small, but it may increase:

With age (above about 35 years).
If you smoke. When using a combined hormonal contraceptive such as Melodene-15, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend that you 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 have high levels of fat in the blood (cholesterol or triglycerides).
If you have migraines, especially migraines with aura.
If you have a heart condition (valve disorders, 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, your risk of developing a blood clot may be further increased.

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 significant amount of weight—inform your doctor.

Melodene-15 and cancer

Breast cancer detection is slightly higher in women who use combined oral contraceptives, but it is not known whether the pill causes it. It may be that these women have simply been examined more thoroughly and more frequently, meaning breast cancer is detected earlier.

Studies indicate an increased occurrence of cervical cancer in women who use combined oral contraceptives for a relatively long time. It is currently unknown whether this is caused by the pill or whether it is related to sexual behavior (e.g., frequent change of partners) and other factors.

In rare cases, benign liver tumors have been reported in users of the pill, and even more rarely, malignant liver tumors. Consult your doctor if you experience unusually severe abdominal pain.

Psychiatric disorders

Some women who use hormonal contraceptives such as Melodene-15 have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or symptoms of depression, contact your doctor for medical advice as soon as possible.

Bleeding between periods

During the first few months of taking Melodene-15, you may experience unexpected bleeding (bleeding during the placebo days). If this bleeding persists beyond a few months or starts after several months, your doctor should investigate the cause.

What to do if you do not have your period during the placebo days

If you have taken all the active pale yellow tablets correctly, have not had vomiting or severe diarrhea, and have not taken any other medications, it is very unlikely that you are pregnant.

If you miss two consecutive expected periods, you may be pregnant. Contact your doctor immediately. Do not start the next pack until you are certain you are not pregnant.

Other medicines and Melodene-15

Always inform your doctor about any medications or herbal remedies you are taking, including any medication obtained without a prescription. Also inform any other doctor or dentist who prescribes you a medication (or the pharmacist) that you are taking Melodene-15. They will advise you whether you need to take additional contraceptive precautions (for example, a condom) and, if so, for how long.

Some medicines:

may affect the blood levels of Melodene-15
may cause Melodene-15 to be less effective in preventing pregnancy
may cause unexpected bleeding

These include:

medicines used to treat:
HIV and Hepatitis C virus infections (called protease inhibitors and non-nucleoside reverse transcriptase inhibitors)
epilepsy (e.g. phenobarbital, phenytoin, primidone, carbamazepine, topiramate or felbamate)
tuberculosis (e.g. rifabutin, rifampicin)
fungal infections (griseofulvin, azole antifungals, e.g. itraconazole, voriconazole, fluconazole)
bacterial infections (macrolide antibiotics, e.g. clarithromycin, erythromycin)
certain heart conditions, high blood pressure (calcium channel blockers, e.g. verapamil, diltiazem)
arthritis, osteoarthritis (etoricoxib)
sleep disorders (modafinil)
the herbal remedy St. John's wort, used to treat certain types of depression
grapefruit juice

Troleandomycin may increase the risk of intrahepatic cholestasis (bile retention in the liver) when administered with combined oral contraceptives (COCs).

Melodene-15 may affect the effect of other medicines, e.g.:

lamotrigine
ciclosporin
theophylline
tizanidine

Do not take Melodene-15 if you have Hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause increases in liver function test results (elevation of liver enzyme ALT). Your doctor will prescribe another type of contraceptive before starting treatment with these medicines. Melodene-15 may be restarted approximately 2 weeks after completion of this treatment. See section “Do not use Melodene-15”.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy

If you are pregnant, there is no reason for your doctor to prescribe contraceptives.

If you discover you are pregnant while taking Melodene-15, stop taking the pill and consult your doctor.

If you plan to become pregnant, consult your doctor.

Consult your doctor or pharmacist before using any medicine.

Breast-feeding

It is not recommended that you use Melodene-15 while breast-feeding.

If you wish to breast-feed, your doctor will recommend an appropriate form of contraception.

Consult your doctor or pharmacist before using any medicine.

Melodene-15 contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Melodene-15

Dosage

Start taking Melodene-15 with tablet number one, located next to the word "START".
To help you follow the correct order of intake, 7 self-adhesive strips with the 7 days of the week are provided. Choose the weekly strip starting with the day on which you take your first tablet. For example, if you take your first tablet on a Wednesday, use the adhesive strip starting with "WED". Attach the weekly strip to the top of the Melodene-15 blister pack, where it says "Place the adhesive strip here!".
Each blister pack contains 28 tablets. Take one tablet at the same time every day for 28 consecutive days, following the direction indicated by the arrows, without missing any. Specifically: take one yellowish active tablet each day for the first 24 days, followed by one white placebo tablet each day for the last 4 days.
After taking the last tablet, continue taking Melodene-15 the next day by starting a new blister pack, without leaving any break between packs. Each blister pack should be started on the same day of the week. Since there is no break in taking the medication, it is important that you already have the next blister pack available before finishing the current one.
Bleeding usually begins two or three days after taking the last yellowish tablet of the pack and may not have finished before starting the next 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 menstrual period.

If you are switching from another contraceptive pill

Finish the current blister pack (if your current pill pack 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 progestogen-only method (progestogen-only pill, injectable method, or implant)

When switching from a progestogen-only pill, you may start Melodene-15 at any time during your menstrual cycle, the day after stopping the progestogen-only pill.
When switching from an implant: start Melodene-15 on the day of implant removal.
When switching from a contraceptive injection: start Melodene-15 on the day when the next injection would have been due.

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

If you are starting Melodene-15 after an early pregnancy termination (first trimester)

You can usually start immediately, but follow your doctor's advice before doing so.

If you are starting Melodene-15 after childbirth or after a second-trimester pregnancy termination

Like any other contraceptive pill, Melodene-15 should not be started earlier than 21 to 28 days after childbirth or after a second-trimester pregnancy termination, due to an increased risk of blood clots. If you start later, it is recommended 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, ensure that you are not pregnant or wait until your next menstrual period.

Always consult your doctor.

Duration of use

Your doctor will advise you on 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 tenderness, dizziness, drowsiness/fatigue, and menstrual cycle disturbances (vaginal bleeding). This bleeding may even occur in girls who have not yet had their first menstrual period, if they have accidentally taken this medication.

Seek advice from your doctor. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Melodene-15

If you forget to take a tablet, you may become pregnant

If you realize you missed a pale yellow tablet within 12 hours of your usual intake time, take the missed tablet immediately and continue taking the following tablets at your usual time until the end of the blister pack.

If you realize you missed a pale yellow tablet more than 12 hours after your usual intake time, there is a risk of becoming pregnant. In this case:

take the last missed tablet immediately, even if this means taking two tablets on the same day
continue taking your contraceptive tablets as usual until the end of the blister pack
additionally, use a barrier contraceptive method (condom, spermicides, etc.) for the next 7 days
if this 7-day period extends beyond the last pale yellow tablet, discard all remaining tablets and start the next blister pack immediately.

If you have missed one or more pale yellow tablets in a pack and do not experience the expected withdrawal bleeding during the white tablet phase, you may be pregnant.

If you have missed one or more white tablets, you are still protected provided that no more than 4 days pass between the last pale yellow tablet of the current pack and the first pale yellow tablet of the next pack. Consult your doctor for advice.

If you experience vomiting or acute diarrhea within 4 hours after taking a tablet, this creates a situation similar to missing a tablet. After vomiting or diarrhea, take another tablet from a reserve blister pack as soon as possible. If possible, take it within 12 hours of your usual intake time. If this is not possible or more than 12 hours have passed, follow the advice in the section “If you forgot to take Melodene-15”.

If episodes of vomiting or acute diarrhea recur over several days, you should use a barrier contraceptive method (condom, spermicide, etc.) until the start of the next blister pack. Consult your doctor for advice.

4. Possible adverse effects

Like all medicines, Melodene-15 may cause adverse effects, although not everyone experiences 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 Melodene-15, consult your doctor.

All women who take combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolism (VTE)) or blood clots in 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 take Melodene-15”.

Serious adverse 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 hives with possible difficulty breathing (see also section “Warnings and precautions”).

The most frequently reported adverse effects (more than 10%) among women using Melodene-15 are absence or reduced frequency of menstruation during use or after discontinuation, intermenstrual bleeding, or headache including migraine.

Frequent adverse effects (may affect up to 1 in 10 people):

vaginal infection including vaginal candidiasis
mood changes including depression and changes in sex drive
nervousness or dizziness
nausea, vomiting, or abdominal pain
acne
breast pain, tenderness, swelling, or discharge
painful menstruation or changes in menstrual blood flow
changes in vaginal discharge or cervical changes (ectropion)
fluid retention in tissues or edema (acute fluid retention)
weight gain or weight loss

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

changes in appetite
cramps or gas
rash, excessive body hair, hair loss, or skin discoloration on the face (chloasma)
changes in laboratory test results: increased cholesterol or triglyceride levels, or increased blood pressure

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

allergic reactions (such as very rare cases of hives or serious breathing or circulation disorders)
glucose intolerance
intolerance to contact lenses
jaundice
a type of skin reaction called nodular erythema
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.
- Mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA).
- Blood clots in the liver, stomach/intestine, kidneys, or eye.

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

Very rare adverse effects (may affect up to 1 in 10,000 people):

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Melodene-15

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

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Pack contents and other information

Composition of Melodene-15

Pale yellow tablet:

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

White tablet:

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

Appearance of the medicine and contents of the pack

Melodene-15 is available as film-coated tablets.

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

Only certain pack sizes may be marketed.

Marketing Authorisation 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 latest revision of this leaflet: 10/2022

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