Gestinyl 20/75 micrograms film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Gestinyl 20/75 micrograms coated tablets

Ethinylestradiol/Gestodene

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 the 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").
• The contraceptive pill does not protect you against sexually transmitted infections.
• This medicine may increase your risk of complications such as blood clots and breast cancer.
• Some women should not take the contraceptive pill due to current medical conditions or diseases. Please read this leaflet carefully to ensure that Gestinyl is suitable for you.
• To prevent pregnancy, it is important to take Gestinyl exactly as directed and to start each pack on time. Please make sure you understand what to do if you miss a tablet or if you think you may be pregnant.

Read the entire leaflet carefully before you start taking this medicine, as 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 should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Gestinyl is and what it is used for
2. What you need to know before taking Gestinyl
3. How to take Gestinyl
4. Possible side effects
5. How to store Gestinyl
6. Contents of the pack and other information

1. What Gestinyl is and what it is used for

• Gestinyl is a contraceptive pill used to prevent pregnancy.
• Each tablet contains a small amount of two different types of female hormones: ethinylestradiol and gestodene.
• Contraceptive pills such as Gestinyl, which contain two hormones, are known as combined pills.

2. What you need to know before you start taking Gestinyl

General considerations Before starting to take Gestinyl, 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”). Before you can start taking Gestinyl, your doctor will ask you some questions about your personal medical history and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your personal situation, may carry out some additional tests. This leaflet describes various situations in which you should stop taking this medicine, or in which its effectiveness may be reduced. In such situations, you should not have sexual intercourse, or you should use another type of non-hormonal contraceptive precaution, for example, a condom or another barrier method. Do not use rhythm or temperature methods. These methods may not be reliable, since Gestinyl alters the monthly changes in body temperature and cervical mucus. Gestinyl, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Do not take Gestinyl

You must not use Gestinyl if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable.

• if you 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 prolonged period (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 which 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 diseases 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 hyperhomocysteinaemia.

• if you have (or have ever had) a type of migraine called “migraine with aura”;

• if you have (or have had) inflammation of the pancreas (pancreatitis);

• if you have or have had a serious liver disease and your liver function is still not normal;

• if you have or have had a liver tumour;

• if you have (have had), or suspect you may have breast cancer or cancer of the genital organs;

• if you have vaginal bleeding of unknown origin;

• if you are allergic to ethinylestradiol, gestodene, or any of the other components of this medicine (listed in section 6). This may present as itching, rash, or swelling;

• 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 Gestinyl”).

Warnings and precautions

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”. Psychiatric disorders Some women using hormonal contraceptives such as Gestinyl have reported depression or a 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 further medical advice as soon as possible. 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 difficulties, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema.

Any of the conditions listed below may worsen when taking the pill. Or they may make it less suitable for you. You may still be able to take Gestinyl, but you will need to take special care and have more frequent check-ups.

Tell your doctor if you have any of the following conditions

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

In certain situations, you should take special care when using Gestinyl or any other combined hormonal contraceptive, and your doctor may need to carry out periodic examinations. If any of the following conditions apply to you, inform your doctor before starting to use Gestinyl:

• 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 Gestinyl after childbirth;
• if you have inflammation of the veins beneath the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if a close relative has (or has had) breast cancer or has been diagnosed with it;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you or your close relatives have ever had heart or circulation problems, such as hypertension;
• if you or your close relatives have ever had blood clotting disorders;
• if you have a hereditary condition called porphyria;
• if you are overweight (obesity);
• if you have migraines;
• if you have depression;
• if you have epilepsy (see section "Other medicines and Gestinyl");
• if you have had (or have had) a condition that first appeared during pregnancy or a previous use of sex hormones (e.g., hearing loss, porphyria (a blood disorder), gestational herpes (skin rash with blisters during pregnancy), Sydenham's chorea (a nervous disorder causing sudden involuntary movements));
• if you have (or have had) chloasma (brownish-yellow pigmented patches, known as "pregnancy mask", especially on the face). In such cases, avoid direct exposure to sunlight or ultraviolet rays.

Gestinyl and thrombosis

Blood clots

Using a combined hormonal contraceptive such as Gestinyl 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 the veins (called "venous thrombosis", "venous thromboembolism" or VTE);
• in the 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 Gestinyl is small.

How to recognize a blood clot

Seek urgent medical attention if you experience 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., turning pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without known cause or rapid breathing; Sudden cough without 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 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 fullness in the chest, arm, or beneath 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 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.

? See your doctor as soon as possible. Do not take any more Gestinyl until your doctor tells you it is safe to do so. In the meantime, use another method of contraception, such as a condom.

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 adverse effects are rare. They occur most 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 (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 that you take a combined hormonal contraceptive for the first time. 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 is still slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Gestinyl, 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 Gestinyl is small:

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will experience a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will experience a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing gestodene, such as Gestinyl, about 9–12 women will experience a blood clot in one year.
• Your risk of developing a blood clot will depend 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/patch/ring 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 Gestinyl	About 9-12 out of 10,000 women

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

The risk of having a blood clot with Gestinyl 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 a close relative has had a blood clot in the leg, lung, or another organ at a young age (i.e., before about 50 years). In this case, you might have an inherited blood clotting disorder;
• if you need surgery or if you are immobile for a long time due to injury or illness, or if your leg is in a cast. You may need to stop taking Gestinyl several weeks before surgery or while you are less mobile. If you need to stop taking Gestinyl, ask your doctor when you can start taking it again;
• as you get older (especially over 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 risk factors listed above.

It is important that you inform your doctor if you have any of the above conditions, even if you are unsure. Your doctor may decide to stop treatment with Gestinyl.

Inform your doctor if any of the above conditions change while you are using Gestinyl, for example, if a close relative experiences a thrombosis without a known cause or if you gain a lot of weight.

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 stroke.

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

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

• with age (especially over about 35 years);
• if you smoke. When using a combined hormonal contraceptive like Gestinyl, 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, 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 suffer from migraines, especially migraines with aura;
• if you have a heart condition (valve disorder, heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

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

If any of the above conditions change while you are using Gestinyl—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.

Gestinyl and cancer

It appears that taking the pill slightly increases the risk of cervical cancer, although this may be due to unprotected sexual intercourse rather than the pill itself. All women should have regular Pap smears.

If you have breast cancer, or have had it in the past, you should not take the pill.

The pill slightly increases the risk of breast cancer. This risk increases the longer the pill is taken, but returns to normal after about 10 years of stopping it. Since breast cancer is uncommon in women under 40 years of age, the additional cases of breast cancer among current and recent pill users are small. For example:

• Among 10,000 women who have never taken the pill, about 16 will develop breast cancer by age 35.
• Among 10,000 women who take the pill for 5 years in their early twenties, about 17–18 will develop breast cancer by age 35.
• Among 10,000 women who have never taken the pill, about 100 will develop breast cancer by age 45.
• Among 10,000 women who take the pill for 5 years in their early thirties, about 110 will develop breast cancer by age 45.

Your risk of developing breast cancer is higher

• if you have a close relative (mother, sister, or grandmother) who has had breast cancer;
• if you have significant overweight.

? See your doctor as soon as possible if you notice any changes in your breasts, such as dimpling of the skin, changes in the nipple, or any lump you can see or feel.

Taking the pill has also been associated with liver diseases, such as jaundice and benign (non-cancerous) liver tumors, although this is uncommon. Very rarely, the pill has also been linked to certain types of liver cancer in women who have taken it for a long time.

? See your doctor as soon as possible if you have severe stomach pain, or yellowing of the skin or eyes (jaundice). You may need to stop taking Gestinyl.

Bleeding between periods

Some women experience light bleeding or spotting while taking Gestinyl, especially during the first few months. Usually, this bleeding is not a cause for concern and will stop after one or two days. Continue taking Gestinyl as usual. The problem should resolve after the first few packs.

You may also experience unexpected bleeding if you do not take the tablets regularly, so try to take the tablets at the same time every day. In addition, unexpected bleeding can sometimes be caused by other medications.

? Make an appointment with your doctor if you have intermenstrual bleeding or spotting that

• lasts beyond the first few months;
• starts after you have been taking Gestinyl for some time;
• continues even after you have stopped taking Gestinyl.

What to do if you do not have bleeding during the rest period

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

If bleeding does not occur during two consecutive cycles, you may be pregnant. Contact your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Other medicines and Gestinyl

Always inform the doctor prescribing Gestinyl about any medications or herbal preparations you are taking. Also inform any other doctor or dentist who prescribes you another medication (or the pharmacist dispensing it) that you are taking Gestinyl. They will advise you whether you need to take additional contraceptive precautions (for example, condoms) and, if so, for how long.

• Some medicines may reduce the effectiveness of Gestinyl in preventing pregnancy or may cause unexpected bleeding.

This includes medicines used to treat epilepsy (e.g., hydantoin, topiramate, felbamate, lamotrigine, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine) and tuberculosis (e.g., rifampicin), immunomodulating agents (cyclosporine), HIV infections (ritonavir), or other infectious diseases (griseofulvin); and the herbal remedy St. John's wort.

• If you wish to use St. John's wort products while taking Gestinyl, you must consult your doctor first.
• Gestinyl may affect the effectiveness of other medicines, e.g., medicines containing the immunomodulator cyclosporine or the antiepileptic lamotrigine (this may lead to an increased frequency of epileptic seizures).
• Do not take Gestinyl if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as increases in liver function test results (elevated liver enzyme ALT) may occur.

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

Gestinyl can be restarted approximately 2 weeks after completion of this treatment. See section “Do not take Gestinyl”.

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

Laboratory tests

If you need to have a blood test, inform your doctor or the person performing the test that you are taking the pill, as oral contraceptives may alter the results of certain laboratory tests.

Pregnancy and breastfeeding

You must not take Gestinyl if you are pregnant. If pregnancy occurs while you are taking Gestinyl, stop taking it immediately and consult your doctor.

In general, the use of Gestinyl is not recommended during the breastfeeding period. If you are breastfeeding and wish to start taking Gestinyl, consult your doctor.

Consult your doctor or pharmacist before starting to take any medicine.

Driving and use of machines

There is no information suggesting that Gestinyl affects the ability to drive or use machines.

Gestinyl contains lactose and sucrose

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

3. How to take Gestinyl

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

Take one Gestinyl tablet every day, with a small amount of water if necessary. You may take the tablets with or without food, but you must take them at approximately the same time each day.

Each blister pack contains 21 tablets. Next to each tablet is printed the day of the week. For example, if you start on a Wednesday, take the tablet marked "WE". Follow the direction of the arrow on the blister pack until you have taken all the tablets.

Afterwards, do not take any tablets for 7 days. During these 7 tablet-free days (also called the "rest period" or "tablet-free week"), a bleed should occur. This bleed, known as "withdrawal bleeding," usually begins on the second or third day of the rest period.

On the eighth day after the last Gestinyl tablet (i.e., after the rest period), start the next blister pack, even if the bleeding has not stopped. This means you should start the next pack on the same day of the week, and withdrawal bleeding should occur during this time.

If you use Gestinyl in this way, you will also be protected against pregnancy during the 7 days when you do not take the tablets.

When to start the first blister pack

• If you have not used hormonal contraceptives in the previous month

Start taking Gestinyl on the first day of your cycle (i.e., the first day of your menstruation). If you start taking Gestinyl on the first day of your period, you will be immediately protected against pregnancy. You may also start taking Gestinyl between days 2–5 of the cycle, but in this case you must use additional contraceptive measures (e.g., a condom) during the first 7 days.

• Switching from another combined hormonal contraceptive (oral tablet, vaginal ring, or patch)

You may start taking Gestinyl the day after the rest period of your previous oral contraceptive (or after the last placebo tablet). When switching from a vaginal ring or patch, follow your doctor's advice.

• Switching from a progestogen-only contraceptive (progestogen-only pill, injection, implant, or progestogen-releasing intrauterine device (IUD))

You may switch at any time from the pill, from an injectable when your next injection is due. In the case of an implant or IUD, on the same day of its removal. In all cases, additional contraceptive measures (e.g., a condom) must be used during the first 7 days of taking the tablets.

• After an abortion

Follow your doctor's instructions.

• After childbirth

You may start taking Gestinyl between 21 and 28 days after childbirth. If you start after day 28, you must use a barrier method (e.g., a condom) during the first 7 days of using Gestinyl.

If you have had sexual intercourse after giving birth before starting to take Gestinyl (again), you must first ensure that you are not pregnant, or wait until your next menstruation.

Let your doctor advise you if you are unsure about when to start.

• If you are breastfeeding and wish to start taking Gestinyl (again) after having a baby

Gestinyl must not be used during breastfeeding. See the section "Pregnancy and breastfeeding".

If you take more Gestinyl than you should

No serious harmful effects have been reported from taking too many Gestinyl tablets.

If you take several tablets at once, you may experience symptoms of nausea or vomiting. Young girls may experience vaginal bleeding.

If you have taken more Gestinyl tablets than you should, or discover that your child has taken them, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Gestinyl

• If you are less than 12 hours late in taking a tablet, contraceptive protection is not reduced. Take the tablet as soon as you remember and take the following tablets at the usual time.
• If you are more than 12 hours late in taking a tablet, contraceptive protection may be reduced. The greater the number of tablets you have forgotten, the higher the risk that contraceptive protection will be reduced.

The risk of incomplete protection against pregnancy is greater if you forget a tablet at the beginning or end of the pack. Therefore, you must follow the rules below (see also the diagram below):

• More than one tablet forgotten in the pack

Consult your doctor.

• One tablet forgotten in week 1

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at the usual time and use additional precautions for the next 7 days, e.g., a condom. If you have had sexual intercourse in the week before forgetting the tablet or have forgotten to start a new pack after the rest period, you should consider that there is a risk of pregnancy. In this case, consult your doctor.

• One tablet forgotten in week 2

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at the usual time. Contraceptive protection is not reduced and additional precautions are not necessary.

• One tablet forgotten in week 3

You have two options:

1. Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Return to taking the tablets at the usual time. Instead of the rest period, go directly to the next pack.

You are likely to have your period (withdrawal bleeding) at the end of the second pack, but you may also experience spotting or intermenstrual bleeding during the second pack.

1. You may also stop taking tablets and go directly into the 7-day rest period (noting the day on which you forgot the tablet). If you wish to start a new pack on your usual starting day, make the rest period shorter than 7 days.

If you follow either of these two recommendations, you will remain protected against pregnancy.

• If you have forgotten any of the tablets in a pack and do not have a bleed during the first rest period, you may be pregnant. You must consult your doctor before starting the next pack.

What to do in case of vomiting or severe diarrhea

If you vomit within 3–4 hours after taking the tablet or have severe diarrhea, there is a risk that the active ingredients in the tablet may not be completely absorbed by your body. The situation is similar to missing a tablet. After vomiting or experiencing severe diarrhea, you should take another tablet from a reserve strip as soon as possible. If possible, take it within 12 hours of your usual time. If this is not possible or more than 12 hours have passed, follow the instructions in the section "If you forget to take Gestinyl".

Delayed menstrual period: what you should know

Although not recommended, it is possible to delay your menstrual period (withdrawal bleeding). This can be done by going directly to a new pack of Gestinyl instead of the rest period, after the first pack. You may experience spotting (drops or stains of blood) or intermenstrual bleeding during the use of the second pack. After the usual 7-day rest period, continue with the next pack.

You may consult your doctor before deciding to delay your menstrual period.

Changing the first day of your menstrual period: what you should know

If you take the tablets as instructed, your menstrual period/withdrawal bleeding will begin during the rest week. If you need to change this day, do so by shortening the rest period (but never lengthening it). For example, if your rest period starts on Friday and you wish to change the day to Tuesday (3 days earlier), you should start a new pack 3 days earlier than usual. If you make the rest period very short (e.g., 3 days or less), you may not experience withdrawal bleeding during that rest period. In this case, you may experience spotting (drops or stains of blood) or intermenstrual bleeding.

If you are unsure how to proceed, consult your doctor.

If you stop taking Gestinyl

You may stop taking Gestinyl whenever you wish. If you do not want to become pregnant, consult your doctor about other reliable contraceptive methods.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 Gestinyl, consult your doctor.

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 to take Gestinyl.

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 the section “Warnings and precautions”).

Serious adverse effects – seek immediate medical attention

Uncommon 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 (e.g., DVT)

• in a lung (e.g., PE)

• myocardial infarction

• stroke

• mini-stroke or temporary symptoms similar to stroke, known as transient ischaemic attack (TIA)

• blood clots in the liver, stomach/intestine, kidneys or eyes.

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

Signs of a blood clot (see section 2 “Blood clots”).

• Signs of a severe allergic reaction or worsening of hereditary angioedema :

• swelling of the hands, face, lips, mouth, tongue or throat. Swelling of the tongue or throat may cause difficulty swallowing and breathing.

• skin rash with red, itchy bumps (urticaria).

• Liver cancer

Signs of breast cancer include:

• dimpling of the skin
• changes in the nipple
• lumps that are visible or can be felt.

Signs of cervical cancer include:

• vaginal discharge with odor and/or blood
• unusual vaginal bleeding
• pelvic pain
• painful sexual intercourse.

Signs of serious liver problems include:

• severe pain in the upper part of the abdomen
• yellowing of the skin or eyes (jaundice)
• liver inflammation (hepatitis)
• itching all over the body.

? If you think you may have any of these symptoms, see a doctor immediately. You may need to stop taking Gestinyl.

Less serious adverse effects

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

• headaches
• nervousness

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

• nausea
• stomach pain
• weight gain
• depressive states or mood changes
• tender or sore breasts
• vaginitis, including candidiasis
• fluid retention
• migraine
• loss of interest in sex / increased interest in sex
• dizziness
• visual disturbances
• acne
• irregular bleeding
• amenorrhoea
• hypomenorrhoea

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

• nausea and stomach discomfort, including vomiting
• skin rash, which may cause itching
• hyperlipidaemia
• hypertension
• hirsutism (excessive hair growth)
• alopecia
• changes in serum lipid levels, including hypertriglyceridaemia

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

• intolerance to contact lenses
• vaginal discharge or discharge
• lupus erythematosus (autoimmune disease)
• glucose intolerance
• a hereditary form of deafness (otosclerosis)
• gallstones (cholelithiasis)
• yellowish discoloration of the skin (jaundice)
• tender red nodules (erythema nodosum)
• decreased serum folate levels

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

• hepatic adenomas (benign liver tumours)
• changes in glucose tolerance or effect on peripheral insulin resistance
• exacerbation of a hereditary disease called porphyria
• optic neuritis
• retinal vascular thrombosis
• pancreatitis
• erythema multiforme (scaly lesions)
• haemolytic uraemic syndrome (damage to the small blood vessels in the kidneys)

Other reported adverse effects

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

• Bleeding and spotting between periods may occur during the first few months, but this usually stops once your body has adjusted to Gestinyl. If bleeding continues, becomes heavy, or starts again, consult your doctor (see section 2 “Bleeding between periods”).

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

• Chloasma (yellowish-brown patches on the skin). This can occur even if you have been using Gestinyl for several months. Chloasma may be reduced by avoiding excessive sunlight and/or ultraviolet lamps.

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

• Onset or worsening of chorea (movement disorder)

• Conditions that may worsen during pregnancy or with previous use of the pill:

• yellowish discoloration of the skin (jaundice)

• persistent itching (pruritus)

• gallstones

• some rare diseases such as systemic lupus erythematosus

• blistering rash during pregnancy (herpes gestationis)

• a hereditary form of deafness (otosclerosis)

• a hereditary disease called porphyria

? Tell your doctor, pharmacist or family planning nurse if you are concerned about any adverse effect you think may be due to Gestinyl. Also inform them if any existing medical condition worsens while you are taking Gestinyl.

Reporting of adverse effects

If you experience any type of 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gestinyl

Do not store above 30°C.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gestinyl

• Each tablet contains 20 micrograms of ethinylestradiol and 75 micrograms of gestodene.
• The other components are:

Tablet core: magnesium stearate, povidone K-25, corn starch, lactose monohydrate.

Tablet coating: povidone K-90, macrogol 6000, talc, calcium carbonate, sucrose, glycolized montan wax.

Appearance of the product and contents of the pack

Gestinyl are white, round, biconvex film-coated tablets with no imprint on either side.

The tablets are supplied in blister packs, each blister containing 21 tablets. The blisters are packed in cardboard boxes. Each box contains 1, 3 or 6 blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Effik, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Manufacturer

Haupt Pharma Münster GmbH

Scheebrüggenkamp 15

48159 Münster

Germany

This medicinal product is authorized in the European Economic Area countries under the following names

Denmark	Gestinyl, film-coated tablets
Spain	Gestinyl 20/75 micrograms film-coated tablets
Finland	Gestinyl 20 microg/75 microg tablet, coated
Hungary	Gestomix 20 microgram / 75 microgram film-coated tablet
Italy	GEDODIOL 20 micrograms / 75 micrograms coated tablets
Poland	Kontracept
United Kingdom	Sunya 20/75 coated tablets

Date of the last review of this leaflet: June 2023

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