GESTINYL 20/75 micrograms FILM-COATED TABLETS

Introduction

Leaflet: information for the user

Gestinyl20/75 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 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 pause 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").
• The contraceptive pill will not protect you against sexually transmitted diseases.
• This medication 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 complications or diseases. Please read this leaflet to ensure that Gestinyl is suitable for you.
• To prevent pregnancy, it is essential to take Gestinyl as indicated and start each pack on time. Please make sure you understand what to do if you forget to take a tablet or if you think you are pregnant.

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• 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 or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Gestinyl and what is it used for
2. What you need to know before starting to take Gestinyl
3. How to take Gestinyl
4. Possible side effects
5. Storage of Gestinyl
6. Package contents and additional information

1. What is Gestinyl and what is it used for

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

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

Do not takeGestinyl

You should 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 that affects blood clotting, such as: 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 can 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 have (or have had) inflammation of the pancreas (pancreatitis);
• if you have or have had a severe liver disease and your liver function is still not normal;
• if you have or have had a liver tumor;
• if you have (have had), or suspect you 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 medication (including those listed in section 6). This can be recognized by itching, rash, or swelling;
• 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 Gestinyl").

Warnings and precautions

Some 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 be extra careful and have more frequent check-ups.

Tell your doctor if you have any of the following conditions

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

In some situations, you will need to be extra careful while using Gestinyl or any other combined hormonal contraceptive, and your doctor may need to perform regular check-ups. If any of the following conditions affect you, you should 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 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 just given birth, you are at a higher risk of blood clots. You should ask your doctor when you can start taking Gestinyl after childbirth;
• if you have inflammation of the veins that are under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if a close relative has (has had) breast cancer or has been diagnosed;
• if you have a liver or gallbladder disease;
• if you have diabetes;
• if you or your close relatives have ever had heart or circulation problems, such as high blood pressure;
• if you or your close relatives have ever had blood clotting problems;
• if you have a hereditary disease called porphyria;
• if you are overweight (obese);
• if you have migraines;
• if you have depression;
• if you have epilepsy (see section "Other medications and Gestinyl");
• if you have a disease that appeared for the first time during pregnancy or during previous use of sex hormones (e.g., hearing loss, porphyria (a blood disease), gestational herpes (skin rash with blisters during pregnancy), Sydenham's chorea (a nervous disease in which sudden body movements are produced));
• if you have (have had) chloasma (brown-gold pigmentation spots, called "pregnancy spots", especially on the face). In this case, avoid direct exposure to sunlight or ultraviolet rays;

Gestinyl and thrombosis

blood clots

The use of a combined hormonal contraceptive like Gestinyl increases your risk of having a blood clot 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 (which is called "venous thrombosis", "venous thromboembolism" or VTE);
• in the arteries (which is called "arterial thrombosis", "arterial thromboembolism" or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious long-term effects or, very rarely, they can be fatal.

It is essential 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 notice any of the following signs or symptoms.

Go to the doctor as soon as possible. Do not take any more Gestinyluntil your doctor tells you to do so. In the meantime, use another contraceptive method, 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 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 the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the 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 having a blood clot in a vein higher?

The risk of having 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 Gestinyl, your risk of having a blood clot returns to normal within a few weeks.

What is the risk of having 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 having a blood clot in the leg or lung (DVT or PE) with Gestinyl is small:

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 will have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains gestodene, such as Gestinyl, about 9-12 women will have a blood clot in a year.
• The risk of having a blood clot will depend on your personal history (see "Factors that increase your risk of a blood clot" below).

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 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 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 a leg in a cast. You may need to stop using Gestinyl several weeks before the operation or while you have reduced mobility. If you need to stop using Gestinyl, ask your doctor when you can start using it again;
• as you get older (especially over 35 years);
• if you have recently given birth.

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

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

It is essential that you inform your doctor if you have any of the conditions mentioned above, even if you are not sure. Your doctor may decide to stop your treatment with Gestinyl.

Tell your doctor if any of the conditions mentioned above 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 a stroke.

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

It is essential to note that the risk of a heart attack or stroke due to Gestinyl is very small, but it can increase:

• with age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive like Gestinyl, you are advised to quit smoking. If you are unable to quit 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 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 disorder 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 having a blood clot may be increased further.

If any of the conditions mentioned above change while you are using Gestinyl, for example, if 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 having unprotected sex and not the pill. All women should have regular Pap smears.

If you have breast canceror 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 you take the pill.

3. How to take Gestinyl

Follow the administration instructions of the medication indicated by your doctor or pharmacist exactly. In case of doubt, consult your doctor or pharmacist again.

Take one Gestinyl pill every day, with a small amount of water if necessary. You can take the pills with or without food, but you should take them approximately at the same time every day.

Each blister pack contains 21 pills. Next to each pill is the day of the week printed. If, for example, you start on a Wednesday, take a pill with "WED" next to it. Follow the direction of the arrow on the blister pack until you have taken all the pills.

Then, do not take any pills for 7 days. During these 7 days without pills (also called the "break" or "pill-free week"), bleeding should occur. This bleeding, known as "withdrawal bleeding," usually starts on the second or third day of the break.

On the eighth day after the last Gestinyl pill (i.e., after the break), 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 the 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 are not taking pills.

When can you start with 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 menstruation, you will be immediately protected against pregnancy. You can also start taking Gestinyl between days 2-5 of your cycle, but in this case, you should take additional contraceptive measures (such as a condom) for the first 7 days.

• Switching from another combined hormonal contraceptive, pill, vaginal ring, or patch

You can start taking Gestinyl the day after the break from your previous oral contraceptive (or after the last placebo pill). When switching from a vaginal ring or patch, follow your doctor's advice.

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

You can switch at any time from the pill, from an injectable when the next injection is due. In the case of an implant or IUD, on the day of its removal. In all cases, you should take additional contraceptive measures (such as a condom) for the first 7 days of taking the pills.

• After an abortion

Follow your doctor's instructions.

• After childbirth

You can start taking Gestinyl between 21 and 28 days after childbirth. If you start later than day 28, you should use a barrier method (such as a condom) for the first 7 days of using Gestinyl.

If you have had sex after giving birth before starting to take Gestinyl again, you should first make sure you are not pregnant, or wait until your next menstruation.

Let your doctor advise you if you are not sure when to start.

• If you are breastfeeding and want to start taking Gestinyl again after having a child

Gestinyl should not be used during breastfeeding. Read the section "Pregnancy and breastfeeding".

If you take more Gestinyl than you should

No serious harmful effects have been reported when taking too many Gestinyl pills.

If you take several pills at once, you may experience nausea or vomiting. Young girls may have vaginal bleeding.

If you have taken more Gestinyl pills than you should, or if your child has taken them, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Gestinyl

• If you are less than 12 hourslate in taking a pill, your protection against pregnancy will not be reduced. Take the pill as soon as you remember and take the next pills at the usual time.
• If you are more than 12 hourslate in taking a pill, your protection against pregnancy may be reduced. The more pills you have missed, the higher the risk that your protection against pregnancy will be reduced.

The risk of reduced protection against pregnancy is higher if you miss a pill at the beginning or end of the pack. Therefore, you should follow these rules (also consult the diagram below):

• More than one missed pill in the pack

Consult your doctor.

• One missed pill in week 1

Take the missed pill as soon as you remember, even if it means taking two pills at the same time. Continue taking the pills at the usual time and take additional precautionsfor the next 7 days, such as a condom. If you have had sex in the week before missing the pill or have missed starting a new pack after the break, you should consider the risk of pregnancy. In this case, consult your doctor.

• One missed pill in week 2

Take the missed pill as soon as you remember, even if it means taking two pills at the same time. Continue taking the pills at the usual time. Your protection against pregnancy will not be reduced, and you do not need to take additional precautions.

• One missed pill in week 3

You can choose between two options:

1. Take the missed pill as soon as you remember, even if it means taking two pills at the same time. Continue taking the pills at the usual time. Instead of the break, go directly to the next pack.

It is likely that you will have your period (withdrawal bleeding) at the end of the second pack, but you may also have spotting or intermenstrual bleeding during the second pack.

1. You can also stop taking the pills and go directly to the 7-day break (noting the day you missed the pill). If you want to start a new pack on the scheduled start day, make the break shorter than 7 days.

If you follow either of these recommendations, you will still be protected against pregnancy.

• If you have missed any of the pills in a pack and do not have bleeding during the first break, you may be pregnant. You should 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 a pill or have severe diarrhea, there is a risk that your body will not fully absorb the active ingredients of the pill. The situation is similar to if you miss a pill. After vomiting or having diarrhea, you should take another pill from a spare pack as soon as possible. If possible, take it within 12 hoursof the usual time. If this is not possible or more than 12 hours have passed, you should follow the instructions in the "If you forget to take Gestinyl" section.

Delayed menstrual period: what you should know

Although it is 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 break, after the first pack. You may experience spotting (drops or spots of blood) or intermenstrual bleeding during the use of the second pack. After the usual 7-day break, continue with the next pack.

You can 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 pills according to the instructions, your menstrual period/withdrawal bleeding will start during the break. If you need to change this day, do so by shortening the break (but never lengthening it!). For example, if your break starts on a Friday and you want to change the day to Tuesday (3 days earlier), you should start a new pack 3 days earlier than usual. If you make the break very short (e.g., 3 days or less), you may not experience withdrawal bleeding during that break. In this case, you may experience spotting (drops or spots of blood) or intermenstrual bleeding.

If you are not sure how to proceed, consult your doctor.

If you stop taking Gestinyl

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

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

4. Possible Adverse Effects

Like other medications, this medication may produce adverse effects, although not all people suffer from them. If you experience any adverse effect, especially if it is severe and persistent, or have any change in your health status that you believe may be due to Gestinyl, consult your doctor.

All women who take combined hormonal contraceptives are at a higher 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 of taking combined hormonal contraceptives, see section 2. What you need to know before taking 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 urticaria with possible difficulty breathing (see also the section "Warnings and Precautions").

Severe Adverse Effects – Seek Medical Attention Immediately

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 those of a stroke, known as a transient ischemic attack (TIA)
• blood clots in the liver, stomach/intestine, kidneys, or eyes.

The likelihood of experiencing a blood clot may be higher if you have any other disease that increases this risk (see section 2 for more information on diseases 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:

• swellingof the hands, face, lips, mouth, tongue, or throat. Inflammation of the tongue or throat can cause difficulty swallowing and breathing.
• skin rash with red bumps (urticaria) and itching.

• Liver cancer

Signs of Breast Cancer Include:

• dimplingof the skin
• changes in the nipple
• lumpsthat are visible or palpable.

Signs of Cervical Cancer Include:

• vaginal dischargewith odor and/or blood
• unusual vaginal bleeding
• pelvic pain
• painful intercourse.

Signs of Severe Liver Problems Include:

• severe painin the upper abdomen
• yellowing of the skin and eyes(jaundice)
• liver inflammation(hepatitis)
• itchingall 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 Severe 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
• breast tenderness or irritation
• vaginitis, including candidiasis
• fluid retention
• migraine
• decreased or increased interest in sex
• dizziness
• visual disturbances
• acne
• irregular bleeding
• amenorrhea
• hypomenorrhea

Uncommon Adverse Effects(may affect up to 1 in 100 people)

• nausea and stomach upset, including vomiting
• skin rash, which can cause itching
• hyperlipidemia
• hypertension
• hirsutism (excessive hair growth)
• alopecia
• changes in serum lipid levels, including hypertriglyceridemia

Rare Adverse Effects(may affect up to 1 in 1,000 people)

• intolerance to contact lenses
• vaginal discharge or flow
• systemic lupus erythematosus (an autoimmune disease)
• glucose intolerance
• a hereditary form of deafness (otosclerosis)
• gallstones (cholelithiasis)
• yellowing of the skin (jaundice)
• red, sensitive nodules (erythema nodosum)
• decreased serum folate levels

Very Rare Adverse Effects(may affect up to 1 in 10,000 people)

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

Other Reported Adverse Effects

Very Common Adverse Effects(may affect more than 1 in 10 people)

• Sometimes, bleeding and spotting between menstrual periodsmay occur during the first few months, but this usually disappears once your body has adapted 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(brown-yellow patches on the skin). This can occur even if you have been using Gestinyl for several months. Chloasma can be reduced by avoiding excessive sunlight and/or ultraviolet lamps.

Very Rare Adverse Effects(may affect up to 1 in 10,000 people)

• Appearance or worsening of chorea(movement disorder)

• Disorders that may worsen during pregnancy or previous use of the pill:
• yellowing of the skin(jaundice)
• persistent itching(pruritus)
• gallstones
• some rare diseases such as systemic lupus erythematosus
• blistering rashduring pregnancy (gestational herpes)
• a hereditary form of deafness (otosclerosis)
• a hereditary disease called porphyria

? Tell your doctor, pharmacist, or nursespecializing in family planning if you are concerned about any adverse effect that you think may be due to Gestinyl. Also, tell them if any existing disease worsens while taking Gestinyl.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Gestinyl

Do not store above 30°C.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the blister pack and carton after "EXP". The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofGestinyl

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

Core of the tablet: magnesium stearate, povidone K-25, cornstarch, lactose monohydrate.

Coating of the tablet: povidone K-90, macrogol 6000, talc, calcium carbonate, sucrose, glycerin montanate.

Appearance of the Product and Package Contents

Gestinyl are white, round, biconvex, and unmarked coated tablets.

The tablets are supplied in blisters, each blister contains 21 tablets. The blisters are supplied in cartons. Each carton contains 1, 3, or 6 blisters.

Only some package 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 medication is authorized by the member states of the European Economic Area under the following names

Date of the last revision of this prospectus:June 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).