Edelsine 0.250/0.035 mg tablets: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Edelsine 0.250 mg/0.035 mg tablets

Norgestimate/Ethinylestradiol

Important things you need 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 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”).

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, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only and must not be given to others, even if they have the same symptoms as you, because it could harm them.
If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Edelsine is and what it is used for

Edelsine is a low-dose combined oral contraceptive used to prevent pregnancy.

Each tablet contains two types of female hormones, norgestimate and ethinylestradiol.

Edelsine prevents the egg from being released from the ovary, thereby preventing pregnancy. In addition, Edelsine makes the fluid (mucus) in your cervix thicker, making it more difficult for sperm to enter the uterus. The contraceptive effect begins from the first tablet.

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

General considerations

Before starting to use this medicine, you should 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”).

When you must not use Edelsine

Do not use this medicine 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 more suitable.

If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs.
If you know you have a disorder affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
If you need surgery or will be immobile for a long time (see section “Blood clots”).
If you have ever had a heart attack or 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 transient ischaemic attack (TIA, temporary stroke-like symptoms).
If you have any of the following conditions that may increase your risk of developing a 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 are allergic to norgestimate, ethinylestradiol, or any of the other components of this medicine (listed in section 6).
If you have severe liver disease, while liver function values have not returned to normal.
If you have any type of liver tumour (malignant or benign).
If you know or suspect you have breast cancer or cancer of the genital organs.
If you have abnormal growth of the endometrial lining (endometrial hyperplasia).
If you have vaginal bleeding of unknown origin.
If you have had jaundice related to pregnancy or previous use of hormonal contraceptives.
If you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Edelsine”).

Do not use this medicine if you:

Are pregnant or think you might be pregnant.
Are postmenopausal.

When you must be especially careful with Edelsine

When should you consult your doctor?

Seek urgent medical attention

if you notice possible signs of a blood clot which may indicate that 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”.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Edelsine.

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

If any condition develops or worsens while you are using this medicine, you should also inform your doctor.

Seek immediate medical advice if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat, difficulty swallowing, or hives potentially accompanied by breathing difficulties. Medicines containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema.
If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
If you have systemic lupus erythematosus (SLE, a disease affecting your body's natural defense system).
If you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure).
If you have sickle cell anemia (a hereditary red blood cell disorder).
If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
If you require surgery or will be immobile for prolonged periods (see section 2 “Blood clots”).
If you have recently given birth, you are at higher risk of developing blood clots. Ask your doctor when you can start taking Edelsine after childbirth.
If you have inflammation of the veins beneath the skin (superficial thrombophlebitis).
If you have varicose veins.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Edelsine 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 long-lasting serious effects, and very rarely, they may be fatal.

It is important to remember that the overall risk of a harmful blood clot due to this medicine 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 might you be suffering from?
Swelling in one leg or foot, 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., pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without known cause or rapid breathing. Sudden cough without a clear cause, possibly bringing up blood. Sharp chest pain that may worsen when taking a deep breath. Severe dizziness or lightheadedness. Rapid or irregular heartbeat. Severe stomach pain. If you are unsure, consult your doctor, as some of these symptoms such as cough or shortness of breath may be mistaken for a milder condition such as a respiratory infection (e.g., a "common cold").	Pulmonary embolism
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 congestion in the chest, arm, or beneath the breastbone. Feeling of fullness, indigestion, or suffocation. Upper body discomfort radiating to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Severe 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 problems in one or both eyes. Sudden difficulty walking, dizziness, loss of balance or coordination. Sudden, severe, or prolonged headache without 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 effects are rare. They occur more frequently during the first year of using 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 travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
Very rarely, a clot may form in a vein of another organ such as the eye (retinal vein thrombosis).

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

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

When you stop taking this medicine, your risk of developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

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

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

Among 10,000 women who are not using any combined hormonal contraceptive and are not pregnant, about 2 may develop a blood clot within one year.
Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate such as Edelsine, between 5 and 7 women will develop a blood clot within one year.
Your risk of having a blood clot will vary depending 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 pill/patch/ring and who are not pregnant	About 2 out of 10,000 women.
Women using a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate.	About 5-7 out of 10,000 women.
Women who use Edelsine	About 5-7 out of 10,000 women.

Factors that increase your risk of a blood clot in a vein

The risk of developing a blood clot with this medicine is small, but certain conditions increase this risk. Your risk is higher:

If you are overweight (body mass index or BMI above 30 kg/m²).
If a close relative has had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years). In this case, you may have an inherited blood clotting disorder.
If you need surgery or will be immobile for long periods due to illness, injury, or if your leg is in a cast. You may need to stop taking this medicine several weeks before surgery or while you are less mobile. If you need to stop taking this medicine, ask your doctor when you can start again.
As you get older (especially over about 35 years of age).
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 risk factors listed above.

It is important to inform your doctor if you have any of the above conditions, even if you are unsure. Your doctor may decide that you need to stop taking this medicine.

If any of the above conditions change while you are using this medicine—for example, a close relative experiences a thrombosis without a known cause or you gain significant 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 this medicine is very small, but may increase:

With age (over about 35 years).
If you smoke. When using a combined hormonal contraceptive such as Edelsine, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
If you are overweight.
If you have high blood pressure.
If a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case, your risk of heart attack or stroke may also be higher.
If you or a close relative has high levels of fat in the blood (cholesterol or triglycerides).
If you suffer from migraines, especially migraines with aura.
If you have a heart condition (valve disorders, heart rhythm disorders such as 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 developing a blood clot may be further increased.

If any of the above conditions change while you are using this medicine—for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain significant weight—inform your doctor.

Additionally, consult your doctor, pharmacist, or nurse before starting this medicine, and inform them if you are in any of these situations, so your doctor can decide whether you can use oral contraceptives and determine how often you should have medical check-ups during treatment with this medicine. Inform your doctor if you have any of the following conditions, or if they develop or worsen while using this medicine:

If you have epilepsy.
If you have liver or gallbladder problems.
If you have or have had chloasma (yellow-brown patches on the skin, skin discoloration during pregnancy, especially on the face). If this occurs, you should avoid exposure to sunlight and UV radiation.

Inform your doctor if any of these conditions appear or worsen during treatment with this medicine.

Oral contraceptives and cancer

The risk of developing breast cancer generally increases with age. This risk is slightly increased with oral contraceptives. Compared to the lifetime risk of developing cancer, the increase associated with oral contraceptive use is small. The increased risk of breast cancer gradually decreases over the 10 years following discontinuation of oral contraceptives. Breast cancer diagnosis in women using oral contraceptives has not been delayed compared to women who do not use them.

Rarely, benign and even malignant liver tumors have been reported in women using oral contraceptives. These tumors can be life-threatening due to internal bleeding. Consult your doctor if you experience sudden or severe abdominal pain.

An increased incidence of cervical cancer has been observed with long-term use of oral contraceptives. This may not necessarily be related to oral contraceptive use and could be due to sexual behavior or other factors.

Psychiatric disorders

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

Breakthrough bleeding

During the first few months of taking this medicine, unexpected bleeding (bleeding outside the rest week) may occur. If this bleeding persists for more than a few months or starts after several months, your doctor should investigate the cause.

Absence of menstruation

If you have taken all tablets correctly, have not vomited or had severe diarrhea, and have not taken other medications, it is highly unlikely that you are pregnant. However, if you miss two consecutive periods, you should undergo a gynecological examination or a pregnancy test before continuing treatment with this medicine. Consult your doctor if you missed taking any tablets and do not get your period.

Blood levels of nutrients and folates may be lower in women taking oral contraceptives. This may be important in women who become pregnant shortly after stopping oral contraceptives.

The following conditions may appear or worsen during both pregnancy and use of oral contraceptives, but a direct link to oral contraceptive use has not been confirmed:

Jaundice and itching associated with bile flow obstruction (cholestasis)
Gallstones
Porphyria (increased secretion of blood pigments)
Systemic lupus erythematosus (SLE)—a connective tissue disease
Hemolytic uremic syndrome (HUS)—a blood disorder that damages the kidneys
Sydenham's chorea
Herpes gestationis (a rare skin condition occurring during pregnancy)
Otosclerosis (a type of hearing loss)
Severe depression or history of this condition.

Women using oral contraceptives should have regular medical check-ups. The frequency of these check-ups depends on the potential risks of contraceptives affecting a condition or disease.

Edelsine, like other oral contraceptives, does not protect against HIV (AIDS) or other sexually transmitted infections.

Other medicines and Edelsine

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. They can advise you whether you need to take additional contraceptive precautions.

Do not use Edelsine if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in blood tests measuring liver function (elevated liver enzyme ALT).

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

You may restart this medicine 2 weeks after completing this treatment (see section “When not to use Edelsine”).

Some medicines and herbal treatments may affect blood levels of this medicine, possibly reducing its effectiveness in preventing pregnancy or causing unexpected bleeding. These include medicines used to treat:

Epilepsy (such as: phenytoin, barbiturates, carbamazepine, felbamate, oxcarbazepine, phenytoin, primidone, and topiramate)
Tuberculosis and other infections (such as: griseofulvin and rifampicin)
HIV/AIDS and hepatitis C virus infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as: ritonavir, nevirapine, efavirenz, atazanavir, indinavir, and etravirine)
Pulmonary hypertension (bosentan)
St. John's wort (a herbal remedy used for depression)

This medicine may affect the action of other medicines such as:

Cyclosporine (an immunosuppressant used to prevent transplant rejection)
Lamotrigine used for epilepsy (this may increase the risk of seizures)

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before taking any medicine.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not take this medicine during pregnancy. If you become pregnant, stop treatment and contact your doctor. Inform your doctor if you have taken this medicine during pregnancy.

Breastfeeding

Using this medicine while breastfeeding may affect the child. Therefore, you should not take this medicine while breastfeeding unless your doctor advises you to do so. Breastfeeding mothers should monitor milk volume, as this medicine may reduce milk production.

Fertility

This medicine is used to prevent pregnancy.

Driving and using machines

No known effects.

Edelsine contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Edelsine

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

The contraceptive effect begins with the first tablet.

Each calendar blister pack contains 21 tablets.

First treatment cycle

Take the first tablet on the first day of your menstrual period. Continue taking 1 tablet daily (you must take the tablets in consecutive order to ensure that you have taken one tablet each day). It is advisable to take the tablets at the same time every day, for example at bedtime.

After taking all 21 tablets from one pack, you will have a 7-day break during which menstruation will occur. If menstruation does not occur, start a new 21-day treatment cycle after the 7-day break.

Second and subsequent cycles

Begin the next treatment cycle/calendar blister pack on the same day of the week as you started the previous cycle. If menstruation does not occur after the second cycle, consult your doctor.

Delaying menstruation

After finishing all tablets in one pack, start a new pack to delay menstruation for as many days as desired. Afterwards, take a 7-day break, then continue with a new 21-tablet pack, starting on a new day.

Intermenstrual bleeding

Continue the treatment even if intermenstrual bleeding or spotting occurs. This type of bleeding usually resolves after the first three treatment cycles. If bleeding persists, consult your doctor or healthcare professional.

What to do in case of vomiting or severe diarrhea

If you vomit within 3 hours after taking the tablet or experience severe diarrhea for more than 24 hours, contraceptive effectiveness may be reduced. Therefore, you should use an additional non-hormonal contraceptive method (e.g., condom) for 7 days after recovery. If diarrhea or vomiting persists, contact your doctor or healthcare professional.

If you take more Edelsine than you should

If you have taken more Edelsine than prescribed, or if, for example, a child accidentally ingests this medicine, consult your doctor so that they can assess the risks and advise you on what to do.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20.

If you forget to take Edelsine:

If less than 12 hours have passed since the time you were supposed to take the tablet, contraceptive protection is not reduced. Take the missed tablet as soon as you remember and continue taking the remaining tablets at your usual time.
If more than 12 hours have passed since the time you were supposed to take the tablet, contraceptive protection may be reduced. The more tablets you miss, the higher the risk of reduced contraceptive effect. The risk of pregnancy increases particularly if you miss a tablet at the beginning or end of the treatment cycle. In such cases, do the following:

If you miss more than 1 tablet in a cycle

Consult your doctor.

If you miss 1 tablet in week 1

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. Remember to use an additional contraceptive method (other than hormonal contraceptives, e.g., condom) for the next 7 days. If you had sexual intercourse in the previous 7 days, you may be pregnant; therefore, you should contact your doctor immediately.

If you miss 1 tablet in week 2

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the remaining tablets at your usual time. If you have taken the tablets correctly during the 7 days prior to the missed tablet, the contraceptive effect is not reduced and no additional contraceptive method is necessary.

If you miss 1 tablet in week 3

In this case, you must choose one of the following options:

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the remaining tablets at your usual time. Start the next pack immediately after finishing the current one—there should be no break between packs. It is unlikely that withdrawal bleeding will occur until after finishing the second pack, but you may experience spotting or breakthrough bleeding during the second pack.
Stop taking tablets from the current pack and start a new pack after a 7-day break (including the day on which you missed the tablet).

If you missed taking any tablets and do not have withdrawal bleeding during the following 7-day break, you may be pregnant. Consult your doctor before starting a new pack.

If you stop taking Edelsine

You may stop taking this medicine at any time. If you do not wish to become pregnant, ask your doctor for advice on other reliable methods of birth control. If you wish to become pregnant, stop taking this medicine.

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

4. Possible adverse effects

Like all medicines, this medicine 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 this medicine, consult your doctor.

Serious adverse effects

Contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing or hives, potentially with difficulty breathing (see also section “Warnings and precautions”).

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

The following adverse effects have been reported with Edelsine:

Very common adverse effects (may affect more than 1 in 10 people)

Headache
Nausea, vomiting and diarrhoea
Vaginal bleeding between periods
Painful periods
Abnormal withdrawal bleeding (early menstrual flow)

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

Urinary tract infection
Vaginal infection
Allergic reaction
Swelling due to fluid retention
Mood problems such as depression
Mood changes
Difficulty sleeping
Nervousness
Migraine
Dizziness
Stomach pain
Abdominal distension
Constipation
Gas
Acne
Skin rash
Muscle cramps
Pain in limbs
Back pain
Missing one or more periods
Vaginal discharge
Breast pain
Chest pain
Swelling
Feeling tired or weak
Weight gain

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

Abnormal cervical smear
Weight gain or weight loss
Increased or decreased appetite
Anxiety
Changes in sex drive
Fainting
Numbness or tingling of the skin
Vision problems
Dry eyes
Palpitations
High blood pressure or increased blood pressure
Hot flushes
Difficulty breathing
Hair loss
Excessive body hair
Itching with or without hives
Redness of the skin
Skin discoloration
Muscle pain
Breast discharge
Breast enlargement
Ovarian cysts
Vaginal dryness and dryness of the external vaginal skin
Weight loss
Breast cancer
Non-cancerous (benign) liver tumour
Non-cancerous (benign) breast lump
Abnormal changes in breast tissue
Abnormal blood fats (such as cholesterol)
Seizures or fits
Difficulty wearing contact lenses
Swelling of the face, tongue and throat causing difficulty swallowing or breathing, possibly accompanied by skin rash
Painful red lumps on arms and legs
Night sweats
Decreased milk production

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

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).

Fluid-filled lump in the breast
Appetite problems
Dizziness or sensation of spinning (vertigo)
Rapid heartbeat
Inflammation of the pancreas (pancreatitis)
Inflammation of the liver (hepatitis)
Excessive sweating
Increased sensitivity to light

Adverse effects with unknown frequency (frequency cannot be estimated from available data)

Blood clots in a vein – this may lead to blockage of blood vessels in the liver, causing liver enlargement, pain and swelling due to fluid accumulation around the abdomen (Budd-Chiari syndrome).
Worsening of symptoms of hereditary and acquired angioedema (swelling of the face, tongue and/or throat, difficulty swallowing or hives potentially with difficulty breathing).

The following adverse effects have been associated with the use of hormonal contraceptives in general: benign and malignant liver tumours, biliary obstruction, jaundice caused by biliary obstruction, gallstones, enlargement of uterine fibroids, increased cervical erosion, reversible infertility (ability to become pregnant) after stopping hormonal contraceptives, premenstrual syndrome, dandruff, hirsutism (excessive hair growth), herpes gestationis (a rare skin disease occurring during pregnancy), melasma (pigmentation spots which may become permanent), bruising (skin bleeding), changes in the cornea, movement disorder, increased sensitivity to sugars.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Edelsine

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Do not store above 25°C.

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

6. Contents of the pack and other information

Composition of Edelsine

The active substances are norgestimate and ethinylestradiol. Each tablet contains 0.250 mg of norgestimate and 0.035 mg of ethinylestradiol.
The other components (excipients) are: anhydrous lactose, magnesium stearate, pregelatinized corn starch, crospovidone, and aluminium lake containing indigo carmine (E132).

Appearance of the product and contents of the pack

Edelsine are blue, round tablets, with "C 250" engraved on both sides.

Each blister contains 21 tablets.

Packs may contain: 1 x 21 or 3 x 21 tablets.

Marketing Authorisation Holder

Laboratorios Effik S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Manufacturer

Delpharm Lille SAS

Parc d'Activités Roubaix-Est

22 Rue de Toufflers

CS 50070

59452 LYS-LEZ-LANNOY Cedex

France

Effik

Batiment Le Newton

11 Rue Jeanne Braconnier

92360 Meudon

France

Date of the most recent revision of this leaflet: September 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).