Elin

Leaflet accompanying the packaging: patient information

Elin, 250 micrograms + 35 micrograms, tablets

Norgestrel + Ethinyl Estradiol

Important information about combined hormonal contraceptives:

• They are among the most reliable reversible methods of contraception, provided they are used correctly.
• They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• Please remain vigilant and consult a doctor if you suspect you may have symptoms of a blood clot (see section 2. "Blood clots").

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Elin and what is it used for
• 2. Important information before taking Elin
• 3. How to take Elin
• 4. Possible side effects
• 5. How to store Elin
• 6. Contents of the packaging and other information

1. What is Elin and what is it used for

Elin is a combined, oral contraceptive tablet used to prevent pregnancy. Elin should only be used to prevent pregnancy.
This contraceptive contains two types of female sex hormones: estrogen and progestogen. Due to the content of two hormones, the medicine is referred to as a "combined, hormonal contraceptive".
The hormones contained in it prevent the release of an egg from the ovaries, which makes it impossible to become pregnant. Additionally, the medicine thickens the mucus in the cervix, making it difficult for sperm to enter.
The medicine is used in a 21-day cycle, which means that for 21 days you should take one tablet daily, and after 21 days you should take a 7-day break.

2. Important information before taking Elin

General notes

Before starting to use Elin, you should read the information about blood clots (thrombosis) provided in section 2. It is especially important to familiarize yourself with the symptoms of blood clots

• see section 2. "Blood clots".

Each patient, before starting to take the medicine or deciding to continue taking it, should familiarize themselves with the benefits and risks associated with its use.
Although Elin is suitable for most healthy women, not all patients can use it.
Patients who have any diseases or risk factors listed in this leaflet should inform their doctor.

When not to take Elin

You should not use Elin if you have any of the conditions listed below. If you have any of the conditions listed below, you should inform your doctor. The doctor will then inform you which other contraceptive methods would be more suitable for you.

• if you are allergic to norgestrel, ethinyl estradiol, or 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 in your leg (deep vein thrombosis), lung (pulmonary embolism), or other organ;
• if you know you have a disease that affects blood clotting, such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you have (or have ever had) a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a disease in which there is severe chest pain, which can be the first symptom of a heart attack) or a transient ischemic attack (TIA - transient symptoms of a stroke);
• if you are breastfeeding, and your baby is less than 6 weeks old;
• if you have been diagnosed with breast cancer, uterine cancer, cervical cancer, or vaginal cancer;
• if you have vaginal bleeding of unknown cause;
• if you need to have surgery or if you are going to be immobile for a long time - see section 2. "Blood clots";
• if you suffer from any of the following diseases that may increase the risk of forming blood clots in arteries:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fat in the blood (cholesterol or triglycerides),
• a disease called hyperhomocysteinemia;
• if you smoke 15 or more cigarettes per day and are at least 35 years old;
• if you have or have recently had a severe liver disease;
• if you have hepatitis C and are taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also "Elin and other medicines");
• if you have breast cancer or liver cancer;
• if you have or have had pancreatitis;
• if you have not started menstruating (adolescent girls);
• if you have (or have ever had) a certain type of migraine called migraine with aura.

Medical examinations

Before starting to use the medicine, the patient must undergo a medical examination. The doctor will take a medical history, including a family history, and measure blood pressure. Other examinations, such as a breast examination, will only be performed on patients who need them or who have specific concerns.

• Regular medical examinations with a doctor or nurse will usually take place when prescribing the next prescription for the medicine.
• The patient should regularly have a cervical smear test.
• In addition, every month the patient should examine their breasts and nipples, and if they notice or feel anything unusual, such as lumps or indentation in the skin, they should inform their doctor.
• Before having a blood test, the patient should inform their doctor that they are taking the medicine, as it may affect the results of some laboratory tests.
• In the event of planned surgery, the patient should inform their doctor, as they may need to stop taking the medicine about 4-6 weeks before the surgery. This is to reduce the risk of blood clots. The doctor will inform the patient when they can resume taking the medicine.

Warnings and precautions

Before starting to take Elin, you should discuss it with your doctor, pharmacist, or nurse.
When should you contact your doctor?
You should seek medical attention immediately

• if you notice any possible symptoms of a blood clot, which may indicate the formation of a blood clot in your leg (deep vein thrombosis), lung (pulmonary embolism), heart attack, or stroke - see section "Blood clots" below.

Description of symptoms of these serious side effects - see "How to recognize a blood clot".

If you have any of the following conditions or diseases, you should tell your doctor.

If any of the following conditions or diseases occur during the use of Elin, you should also inform your doctor.

• advanced age;
• severe obesity (weight over 90 kg);
• smoking;
• thrombosis in your medical history, including in your close family;
• high blood pressure or increased blood pressure;
• prolonged bed rest due to major surgery, injury, or illness;
• irregular heartbeat (atrial fibrillation), heart valve disease, heart failure, heart attack, or stroke in young people in your close family;
• blood disease (porphyria);
• hearing loss;
• diabetes;
• gallstones;
• liver disease, including jaundice;
• a nervous system disease characterized by involuntary movements of the body (Sydenham's chorea);
• Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• systemic lupus erythematosus (a disease that affects the natural defense system);
• hemolytic-uremic syndrome (a type of blood clotting disorder that causes kidney failure);
• sickle cell anemia (a hereditary disease of red blood cells);
• elevated levels of certain fats in the blood (hypertriglyceridemia) in you or your family. Hypertriglyceridemia is associated with an increased risk of pancreatitis;
• need for surgery or prolonged immobilization - see section 2. "Blood clots";
• recent childbirth - in this case, you are at increased risk of blood clots. You should ask your doctor how soon after childbirth you can start using Elin;
• superficial thrombophlebitis (inflammation of superficial veins);
• varicose veins of the legs;
• pregnancy prurigo (a skin rash during pregnancy);
• chloasma (brown or yellowish patches on the face, especially during pregnancy);
• depression;
• current or past breast cancer in your close family;
• epilepsy;
• hereditary angioedema. If you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or breathing, you should contact your doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema;
• migraine;
• suspected pregnancy.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Elin, increases the risk of blood clots compared to not using them. In rare cases, a blood clot can block blood vessels, causing serious health problems.
Blood clots can develop:

• in veins (this is called venous thrombosis or venous thromboembolic disease, or VTE);
• in arteries (this is called arterial thrombosis or arterial thromboembolic disease).

Recovery from blood clots is not always complete. In rare cases, the consequences can be long-term, and in very rare cases, the disorder can be fatal.

HOW TO RECOGNIZE A BLOOD CLOT

You should seek medical attention immediately if you notice any of the following symptoms.

BLOOD CLOTS IN VEINS

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thrombosis). However, this is a rare occurrence. Most often, it occurs in the first year of using a combined hormonal contraceptive.
• If a blood clot forms in the leg or foot, it can lead to deep vein thrombosis.
• If the clot starts to move and gets stuck in the lung, it can lead to pulmonary embolism.
• In very rare cases, a blood clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in veins the highest?

The risk of blood clots in veins is highest in the first year of using a combined hormonal contraceptive for the first time. The risk may also be higher when you resume using a combined hormonal contraceptive (the same or different) after a break of 4 weeks or more.
After the first year of use, the risk is lower, but it is always slightly higher than in women who do not use combined hormonal contraceptives.
After stopping Elin, the risk of blood clots returns to normal within a few weeks.

What is the risk of blood clots?

The risk depends on the natural risk of VTE in the individual woman and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the leg (deep vein thrombosis) or lung (pulmonary embolism) in women using Elin is small.

• Among 10,000 women who do not use any combined hormonal contraceptive and are not pregnant, blood clots may occur in about 2 women per year.
• Among 10,000 women using combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestrel, such as Elin, blood clots may occur in about 5-7 women per year.
• The risk of blood clots will depend on the patient's medical history (see below "Factors that increase the risk of blood clots").

Factors that increase the risk of blood clots in veins

The risk of blood clots in veins when using Elin is small, but certain circumstances can increase this risk. The risk is higher:

• if you are overweight (body mass index (BMI) over 30 kg/m);
• if any of your close relatives have had a blood clot in a vein at a young age (e.g., under 50 years). This may indicate that you have a hereditary blood clotting disorder;
• if you need to have surgery or if you are going to be immobile for a long time due to injury or illness, or if you have a leg in a cast. There may be a need to stop using Elin for a few weeks before planned surgery and during reduced mobility. If you need to stop using Elin, you should ask your doctor when you can resume using it.
• with age (especially over 35 years);
• if you have recently given birth.

The risk of blood clots is higher if you have more than one of these diseases.
Travel by air (lasting more than 4 hours) may temporarily increase the risk of blood clots, especially if you have any of the risk factors listed above.
If you have any of the situations described, you should tell your doctor, even if you are not sure. Your doctor may decide that you should stop using Elin.
If there are changes in the circumstances listed above during the use of Elin, such as if someone in your close family develops thrombosis for no known reason or if you gain significant weight.

BLOOD CLOTS IN ARTERIES

What can happen if a blood clot forms in an artery?

Similarly to veins, the formation of a blood clot in an artery can lead to serious health problems. Examples of these health problems include heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It should be remembered that the risk of heart attack or stroke when using Elin is very small, but it may increase:

• with age (over 35 years);
• if you smoke. Women using combined hormonal contraceptives, such as Elin, should quit smoking. If you cannot quit smoking and are over 35 years old, your doctor may recommend using 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 (under 50 years). In this case, you may also be at increased risk of heart attack or stroke;
• if you or any of your close relatives have had high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraines with aura;
• if you have heart problems (heart valve disease, a type of arrhythmia called atrial fibrillation);
• if you have diabetes.

If you have more than one of these diseases or if any of them are particularly severe, the risk of blood clots may be even higher.
If there are changes in the circumstances listed above during the use of Elin, such as if you start smoking, if someone in your close family develops thrombosis for no known reason, or if you gain significant weight.

Psychiatric disorders

Some women using hormonal contraceptives, including Elin, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts.
If mood changes and symptoms of depression occur, you should seek medical advice as soon as possible.

Elin and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This includes medicines available without a prescription, such as herbal remedies.
Certain types of medicines and herbal remedies may affect the level of Elin in your blood and make it less effective in preventing pregnancy or cause unexpected bleeding.
This includes:

• medicines used to treat HIV and hepatitis C infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz) or other infectious diseases (griseofulvin);
• medicines for epilepsy (such as topiramate, sodium valproate, carbamazepine, primidone, oxcarbazepine, and felbamate);
• medicines for high blood pressure in the lungs (bosentan);
• medicines for excessive daytime sleepiness (modafinil);
• medicines for relaxation and sleep disorders (sedatives, such as barbiturates);
• St. John's Wort - a herbal remedy used to treat depression.

Elin may also affect the action of other medicines, such as:

• cyclosporin (used to prevent transplant rejection, treat rheumatoid arthritis, and certain skin diseases);
• lamotrigine (used to treat epilepsy);
• prednisolone (a corticosteroid that reduces inflammation);
• theophylline (used to treat asthma, bronchitis, and chronic obstructive pulmonary disease).

If you are taking any of these medicines, you should consult your doctor before starting to use Elin, as they may need to adjust their dosage.
You should not use Elin if you have hepatitis C and are taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as they may cause abnormal liver function test results (increased ALT activity).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
Elin can be used again about 2 weeks after stopping these medicines (see "When not to take Elin").
Combined hormonal contraceptives and cancer

Breast cancer

Breast cancer is diagnosed more often in women who use combined hormonal contraceptives. On the other hand, it is possible that combined hormonal contraceptives are not the cause of the increased number of women with breast cancer. It is likely that women who use these contraceptives are more likely to undergo medical examinations, which means a higher likelihood of detecting cancer. The increased risk gradually decreases after stopping the use of combined hormonal contraceptives. After 10 years, the risk of breast cancer is the same as in women who have never used combined hormonal contraceptives.

Cervical cancer

Cervical cancer is also diagnosed more often in women who use combined hormonal contraceptives. However, this may be due to other factors, such as a larger number of sexual partners and sexually transmitted diseases.

Liver cancer

In rare cases, women using combined hormonal contraceptives have been found to have liver tumors that are not cancerous. Even more rarely, liver tumors that are cancerous have been found. They can cause internal bleeding with severe abdominal pain.

If you notice any of the above symptoms, you should seek medical attention immediately.

Elin with food, drink, and alcohol

Food and drink should not affect the way Elin works.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before using this medicine.
Elin is contraindicated in pregnancy. If you suspect you are pregnant while taking Elin, you should have a pregnancy test to confirm pregnancy before deciding to stop taking the medicine.
For breastfeeding women, the doctor or nurse may advise against taking the medicine and recommend a different contraceptive method. Breastfeeding does not prevent pregnancy.

Driving and using machines

There is no data on the effect of Elin on the ability to drive and use machines.

Sexually transmitted diseases

Elin does not protect against sexually transmitted diseases, such as chlamydia or HIV. The only protection is the use of condoms.

Elin contains lactose

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

Sodium content

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is "sodium-free".

3. How to take Elin

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

Elin should be taken every day for 21 days

Elin is available in a blister pack containing 21 tablets, each marked with the day of the week.
Take one tablet every day at the same time.
Start with the tablet marked with the current day of the week.
Follow the direction of the arrows on the blister pack. Take one tablet every day.
Swallow the tablet whole, if necessary with a little water. Do not chew the tablets.

Seven-day (7) break from taking tablets

After taking all 21 tablets from the blister pack, do not take any tablets for 7 days. If you take the last tablet from the pack on a Friday, take the first tablet from a new pack on the following Saturday.
Within a few days of taking the last tablet from the blister pack, you can expect bleeding similar to a period. The bleeding may continue until you start taking tablets from the next blister pack.
During the 7-day break from taking tablets, there is no need to use additional contraceptive methods, provided the tablets have been taken correctly and you start taking tablets from the next blister pack on time.

Starting a new blister pack

After 7 days without taking tablets, start taking tablets from a new blister pack, even if you are still bleeding. The tablets from the new blister pack should be started on time.
Provided the medicine is taken correctly, the start of the new blister pack will always fall on the same day of the week.

If you did not use hormonal contraception in the previous month

Start taking the medicine on the first day of your period (the first day of bleeding). If you start taking the medicine on the first day of your period, you will be protected against pregnancy immediately. You can also start taking the medicine between the 2nd and 5th day of your period, but you will need to use additional protection (e.g., a condom) for the first 7 days.

Switching from a combined hormonal contraceptive or a combined hormonal contraceptive vaginal ring or patch

It is best to start taking Elin on the day after taking the last active tablet (containing active substances) of your previous contraceptive, but no later than the day after the end of the break from taking your previous contraceptive (or the day after taking the last placebo tablet).
When switching from a contraceptive vaginal ring or patch, follow your doctor's instructions.

Switching from a progestogen-only method (minipill, injection, implant, or intrauterine system releasing progestogen)

You can switch from the minipill to Elin on any day (from an implant or intrauterine system on the day of its removal, from an injectable contraceptive on the day it is due to be administered), but you should use additional protection (e.g., a condom) for the first 7 days of taking Elin.

After a miscarriage

Follow your doctor's instructions.

After childbirth

You can start taking Elin between 21 and 28 days after giving birth. If you start taking Elin more than 28 days after giving birth, you should use a barrier method (e.g., a condom) for the first 7 days of taking the medicine.
If you have had sex after giving birth and before starting to take Elin, you should check if you are pregnant or wait for your next period.

For breastfeeding women who want to resume taking Elin after childbirth

See the section "Breastfeeding".
If you are unsure about when to start taking Elin, you should consult your doctor.

Missing a dose of Elin

If the delay in taking a tablet is less than 12 hours, the level of protection against pregnancy will remain unchanged. Take the tablet as soon as possible, and take the next tablets at the usual time.
If the delay in taking a tablet is more than 12 hours, the level of protection against pregnancy may be reduced. The more tablets you miss, the higher the risk of pregnancy.
The risk of reduced protection against pregnancy is highest if you miss a tablet at the beginning or end of the blister pack. Therefore, you should follow the instructions below (see the diagram).

Missing more than one tablet from the pack

You should consult your doctor.

Missing one tablet in week 1

Take the missed tablet as soon as possible, even if it means taking two tablets at the same time. Continue taking the tablets at the usual time and use additional protection (e.g., a condom) for the next 7 days. If you had sex in the week before missing the tablet, you may be pregnant. In this case, you should consult your doctor.

Missing one tablet in week 2

Take the missed tablet as soon as possible, even if it means taking two tablets at the same time. Continue taking the tablets at the usual time. The protection against pregnancy remains unchanged, and there is no need to use additional protection.

Missing one tablet in week 3

There are two options:

• 1. Take the missed tablet as soon as possible, even if it means taking two tablets at the same time. Continue taking the tablets at the usual time. Instead of the break from taking tablets, start the next pack. You will probably have bleeding at the end of the second pack, but you may also have some bleeding or spotting during the second pack.
• 2. You can also stop taking tablets from the pack and go straight to the 7-day break (make a note of the day you missed the tablet). If you want to start the new pack on the same day, the break should be less than 7 days. Following one of the above instructions will prevent pregnancy. If you miss any tablets from the pack and do not have bleeding during the break, you may be pregnant. In this case, you should consult your doctor before starting the next pack.

If you delay starting the next packor the break from taking tablets is more than 8 days, you will not be protected against pregnancy. If you have had sex in the last 7 days, you should consult your doctor, nurse, or pharmacist. You may need to consider using a contraceptive after sex. You should also use additional protection for 7 days.

Lost tablet

If you lose a tablet, take a tablet from a spare pack. Then continue taking the tablets from the current pack. You can keep the spare pack in case you lose more tablets.

What to do in case of vomiting or severe diarrhea

If vomiting or severe diarrhea occur within 3-4 hours of taking a tablet, the active substances in the tablet may not be fully absorbed by the body. The procedure is similar to that in case of a missed tablet. After vomiting or diarrhea, take another tablet from the spare pack as soon as possible. If possible, take the tablet within 12 hoursof the usual time of taking the tablets. If this is not possible or more than 12 hours have passed, follow the instructions in the section "Missing a dose of Elin".

No bleeding

Occasionally, bleeding may not occur. This may mean pregnancy, although this is unlikely if the tablets have been taken correctly. Start the next pack at the usual time. If you suspect pregnancy (e.g., due to missing tablets or taking other medicines) or if you do not have a second bleeding, you should have a pregnancy test.
If you are pregnant, stop taking the medicine and consult your doctor.

Taking more than the recommended dose of Elin

Although the risk of harm is low if you take more than one tablet, you may feel nauseous, vomit, or have bleeding from the genital tract.
If you experience any of these symptoms, you should consult your doctor.

If you want to delay your period

If you want to delay your period, you should finish the tablets in the current pack. Start the next pack the next day, without a break. Continue taking the tablets as usual.
While taking tablets from the second pack, you may have unexpected bleeding or spotting, but this is not a cause for concern. You should start the next pack after the usual 7-day break, even if you are still bleeding or spotting.

Decision to become pregnant

If you plan to become pregnant after stopping Elin, it is best to use a different contraceptive method until you have had a natural period, as this will help your doctor determine the due date.
However, there is no risk to you or your baby if you become pregnant immediately after stopping Elin.

5. How to store Elin

The medication should be stored out of sight and reach of children. Do not use this medication after the expiration date stated on the blister and carton after: EXP. The expiration date refers to the last day of the specified month. The inscription on the packaging after the abbreviation EXP means the expiration date, and after the abbreviation Lot/LOT means the batch number. Store in the original packaging to protect from light. Medications should not be disposed of in the sewage system. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package contents and other information

What Elin contains

• The active substances of the medication are norgestimate and ethinylestradiol. Each tablet contains 250 micrograms of norgestimate and 35 micrograms of ethinylestradiol.
• Other ingredients are:

anhydrous lactose, lactose monohydrate (see section 2. "Elin contains lactose"), povidone K-25, all-rac-α-tocopherol, microcrystalline cellulose, sodium croscarmellose (see section 2. "Sodium content"), starch 1500, magnesium stearate, indigo carmine, lake (E132).

What Elin looks like and what the packaging contains

Elin is a blue, round, uncoated tablet with a flat edge and a diameter of 6.4 mm, with the number "146" embossed on one side and smooth on the other. Each package contains 1, 3, 6, or 13 blisters of 21 tablets. Each carton contains blisters packaged separately in a laminated aluminum bag. Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder

Polpharma S.A. Pharmaceutical Works, ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Importer

Eurofins Analytical Services Hungary Kft, Kerulet, Anonymus Utca 6/IV, IV Kerulet, Budapest, 1045, Hungary, Polpharma S.A. Pharmaceutical Works, ul. Pelplińska 19, 83-200 Starogard Gdański, Date of last update of the leaflet:March 2023