This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use EDELSINE 0.250/0.035 mg TABLETS

Introduction

Package Leaflet: Information for the User

Edelsine 0.250 mg/0.035 mg tablets

Norgestimate/Ethinyl Estradiol

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 the use of a combined hormonal contraceptive after a break of 4 weeks or more.
Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 "Blood Clots").

Read the entire package leaflet carefully before starting to take this medication, because it contains important information for you.

Keep this package leaflet, as you may need to read it again.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medication has been prescribed to you only and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Package Leaflet Contents

What Edelsine is and what it is used for
What you need to know before starting to take Edelsine
How to take Edelsine
Possible side effects
Storage of Edelsine
Package contents and additional information

1. What Edelsine is and what it is used for

Edelsine is a low-dose combination oral contraceptive that serves to prevent pregnancy.

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

Edelsine prevents the egg from being released from the ovary, so you cannot become pregnant. Additionally, Edelsine makes the fluid (mucus) in your cervix thicker, making it harder for sperm to enter the uterus. The contraceptive effect begins from the first tablet.

2. What you need to know before taking Edelsine

General considerations

Before starting to use this medication, 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").

When not to use Edelsine

You should not use this medication if you have any of the conditions listed below.

Tell 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 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 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 may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary stroke symptoms).
If you have any of the following diseases that may increase your risk of forming 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, ethinyl estradiol, or any of the other components of this medication (including those 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 tumor (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 mucosa (endometrial hyperplasia).
If you have vaginal bleeding of unknown origin.
If you have jaundice associated with pregnancy or previous use of hormonal contraceptives.
If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section "Other medications and Edelsine").

Do not use this medication if you:

Are pregnant or think you may be pregnant.
Are in menopause.

When to be careful with Edelsine

When should you consult your doctor?

Seek urgent medical attention

If you notice possible signs of a blood clot that may mean you are suffering from a blood clot in your leg (i.e., deep vein thrombosis), a blood clot in your lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section "Blood clots" below).

To get a description of the symptoms of these serious side effects, see "How to recognize a blood clot".

Warnings and precautions

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

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

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

Consult your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, difficulty swallowing, or urticaria potentially with difficulty breathing. Medications that contain estrogens can cause or worsen the 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 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 recently given birth, you are at a higher risk of blood clots. You should ask your doctor when you can start taking Edelsine after childbirth.
If you have inflammation of the veins that are under the skin (superficial thrombophlebitis).
If you have varicose veins.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Edelsine increases your risk of blood clots 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 this medication 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 of a 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 temperature of the affected leg. Change in skin color of the leg, e.g., if it becomes pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without a known cause or rapid breathing. Sudden cough without a clear cause, which may bring up blood. Sudden severe chest pain that may increase with deep breathing. Severe dizziness or fainting. 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, can be confused with a milder condition like a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms that occur more frequently in one eye: Sudden loss of vision, or Blurred vision without pain, which can progress to loss of vision.	Retinal vein thrombosis (blood clot in the eye).
Pain, discomfort, pressure, or heaviness in the chest. Feeling of tightness or congestion in the chest, arm, or under the breastbone. Feeling of fullness, indigestion, or choking. Discomfort in the upper body that radiates to the back, jaw, throat, arm, and stomach. Sweating, nausea, vomiting, or fainting. 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 difficulty understanding. Sudden difficulty seeing in one eye or both eyes. Sudden difficulty walking, dizziness, loss of balance, or loss of coordination. Sudden severe headache without a known cause. Loss of consciousness or fainting, with or without seizures. Sometimes the symptoms of a stroke can be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of having another stroke.	Stroke
Swelling and slight bluish discoloration of a limb. Severe stomach pain (acute abdomen).	Blood clots that block 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 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 your leg or foot, it can cause deep vein thrombosis (DVT).
If a blood clot moves from your leg and lodges in your lung, it can cause a pulmonary embolism.
In very rare cases, a clot can form in a vein in 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 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 medication 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 this medication, 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 this medication is small.

Out of 10,000 women who do not take any combined hormonal contraceptive and are not pregnant, about 2 may have a blood clot in a year.
Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethindrone, or norgestimate, like Edelsine, between 5 and 7 women will have a blood clot in a year.
The 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 a blood clot in a year
Women who do not usea combined hormonal pill/patch/ring and who are not pregnant	About 2 out of 10,000 women.
Women who use a combined hormonal pill that contains levonorgestrel, norethindrone, 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 having a blood clot with this medication 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 organ at a young age (i.e., before the age of about 50). In this case, you may have a hereditary blood clotting disorder.
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 your leg in a cast. You may need to stop using this medication several weeks before surgery or while you have reduced mobility. If you need to stop using this medication, ask your doctor when you can start using it again.
As you get older (especially above about 35 years).
If you have recently given birth.

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

Long-haul flights (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you suffer from any of the above conditions, even if you are not sure. Your doctor may decide to stop you from using this medication.

If any of the above conditions change while you are using this medication, 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 this medication is very small, but it can increase:

With age (above about 35 years).
If you smoke. When using a combined hormonal contraceptive like 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 any of your close relatives have had a heart attack or stroke at a young age (less than about 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 high levels of fat in the blood (cholesterol or triglycerides).
If you have migraines, especially migraines with aura.
If you have a heart problem (valve disorder, heart rhythm disturbance called atrial fibrillation).
If you have diabetes.

If you have one or more 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 this medication, 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.

In addition, consult your doctor, pharmacist, or nurse before starting to take this medication, and inform them if you are in any of these situations, so your doctor can decide if you can use oral contraceptives and establish the frequency of medical examinations during treatment with this medication. Inform your doctor if you suffer from any of the following conditions or if they develop or worsen while you are using this medication:

If you have epilepsy.
If you have liver or gallbladder problems.
If you have or have had chloasma (yellow-brown spots on the skin, skin spots during pregnancy, especially on the face). If this happens, you should avoid sun exposure and UV radiation.

Inform your doctor if any of these situations appear or worsen during treatment with this medication.

Oral contraceptives and cancer

The risk of breast cancer generally increases with age. This risk is also increased with oral contraceptives. Compared to getting breast cancer at some point in life, the increase in risk associated with oral contraceptives is small. The increase in risk of breast cancer decreases gradually over the 10 years following the end of oral contraceptive use. Breast cancer diagnosed in women who use oral contraceptives has not advanced as much as in women who do not use them.

Benign and even malignant liver tumors have been rarely found in women who use oral contraceptives. These tumors can be life-threatening due to internal bleeding. Consult your doctor if you experience sudden or severe abdominal pain.

More cases of cervical cancer have been found in women who use oral contraceptives for a long time. This may not necessarily be related to the use of oral contraceptives and may be due to sexual behavior or other factors.

Psychiatric disorders

Some women who use hormonal contraceptives like Edelsine have reported depression or a depressed mood. Depression can be severe and sometimes can induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

Bleeding between periods

During the first few months you are taking this medication, you may experience unexpected bleeding (bleeding outside of the week of rest). If this bleeding continues for more than a few months or starts after some months, your doctor should investigate what is wrong.

Absence of period

If you have taken all the pills correctly, have not vomited, and have not had severe diarrhea, and have not taken other medications, it is highly unlikely that you are pregnant. However, if this persists for two consecutive months, you should have a gynecological examination or a pregnancy test before continuing treatment with this medication. Consult your doctor if you forgot to take any pills and do not get your period.

Blood levels of nutrients and folate may be lower in women who take oral contraceptives. This may be important in women who become pregnant soon after stopping oral contraceptive treatment.

The following conditions may appear or worsen during pregnancy as well as during the use of oral contraceptives

2. Qué necesita saber antes de empezar a tomar Edelsine

Antes de empezar a tomar Edelsine, su médico querrá saber si padece alguna de las siguientes enfermedades, o si las ha padecido en el pasado. La presencia de algunas de estas enfermedades puede significar que Edelsine no sea el medicamento más adecuado para usted, o que necesite una vigilancia médica más estrecha. En algunos casos, también puede ser necesario que su médico le realice análisis de sangre regulares.

Si tiene alguna de las siguientes enfermedades, o si las ha padecido en el pasado, es especialmente importante que informe a su médico:

Presión arterial alta.
Enfermedades del corazón o del sistema circulatorio, como por ejemplo, angina de pecho, ataque al corazón, coágulos sanguíneos, acidente vascular cerebral (accidente cerebrovascular) o cualquier enfermedad que afecte la circulación sanguínea.
Enfermedades del hígado o de la vesícula biliar, como por ejemplo, ictericia (decoloración amarillenta de la piel y los ojos) o cirrosis.
Enfermedades de la sangre que puedan afectar la coagulación, como por ejemplo, la deficiencia de proteína C o la deficiencia de proteína S.
Enfermedades del sistema nervioso, como por ejemplo, la migraña o la epilepsia.
Enfermedades de los pulmones, como por ejemplo, la enfermedad pulmonar obstructiva crónica (EPOC).
Enfermedades del estómago o del intestino, como por ejemplo, la enfermedad de Crohn o la colitis ulcerosa.
Enfermedades de los riñones, como por ejemplo, la enfermedad renal crónica.
Enfermedades del sistema inmunológico, como por ejemplo, el lupus eritematoso sistémico (LES) o la artritis reumatoide.
Enfermedades de la piel, como por ejemplo, el herpes gestacional o la psoriasis.
Enfermedades de los huesos, como por ejemplo, la osteoporosis.
Enfermedades de la glándula tiroides, como por ejemplo, el hipotiroidismo o el hipertiroidismo.
Enfermedades de la glándula suprarrenal, como por ejemplo, la enfermedad de Addison.
Enfermedades del sistema endocrino, como por ejemplo, el síndrome de Cushing o la enfermedad de Graves.