Label: information for the user

Gestinyl20/75 micrograms coated tablets

Ethinylestradiol/Gestodeno

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 suffering a blood clot in the veins and arteries, especially in the first year or when restarting 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 label to ensure that Gestinyl is suitable for you.
• To prevent pregnancy, it is essential to take Gestinyl as indicated and start each package on time. Please make sure you understand what to do if you forget to take a tablet or if you think you are pregnant.

• 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 known as combined pills.

Do not take

Do 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 leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs;
• If you know that you have a disorder that affects blood clotting, for example: protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies;
• If you need surgery or if you spend a lot of time without standing 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 a strong pain in the chest and may be the first sign of a heart attack) or a transient ischemic attack (TIA, symptoms of a stroke);
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:

• Severe diabetes with vascular 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) pancreatitis (inflammation of the pancreas);
• If you have or have had a severe liver disease and your liver function is not yet normal;
• If you have or have had a liver tumor;
• If you have (have had), or suspect that you have breast cancer or genital organ cancer;
• If you have unexplained vaginal bleeding;
• If you are allergic to ethinylestradiol, gestodeno, or any of the other components of this medication (including in section 6). This may be recognized by itching, hives, 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 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 be able to continue taking Gestinyl but you will need to be extra careful and have more frequent check-ups.

Inform your doctor if you have any of the following conditions

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

In some situations, you should 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, 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 (LES, 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 a higher risk of pancreatitis (inflammation of the pancreas);
• If you need surgery or spend a lot of time without standing up (see section 2 “Blood Clots”).
• If you are at higher risk of blood clots after giving birth. Ask your doctor when you can start taking Gestinyl after childbirth;
• If you have superficial thrombophlebitis (inflammation of the veins under the skin);
• If you have varicose veins;
• If a close relative has (has had) breast cancer or has been diagnosed;
• If you have liver disease or gallbladder disease;
• If you have diabetes;
• If you or your close relatives have had any heart or circulation problems, such as high blood pressure;
• If you or your close relatives have had any blood clotting problems;
• If you have a hereditary disease called porphyria;
• If you are overweight (obesity);
• 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 a previous use of sex hormones (e.g., hearing loss, porphyria, herpes gestationalis, Sydenham's chorea);
• If you have (have had) melasma (brown or dark patches on the skin, 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 suffering 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 veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE);
• In arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or ATE).

The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.

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 attentionif you notice any of the following signs or symptoms.

?Seek medical attention as soon as possible. Do not take more Gestinyl until your doctor tells you it is safe to do so. In the meantime, use another form 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 a combined hormonal contraceptive like Gestinyl has been associated with an increased risk of blood clots in veins (venous thromboembolism). However, these adverse 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 may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism (PE).
• In rare cases, a blood clot may form in a vein in another organ, such as the eye (retinal vein thrombosis).

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

The risk of a blood clot in a vein is higher during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive again (the same medication or a different medication) after a break 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 a blood clot returns to normal in a few weeks.

What is the risk of a blood clot?

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

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

• Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone, or norgestimato, 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing gestodeno like Gestinyl, 9-12 will develop a blood clot in a year.
• The risk of 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 a blood clot in a vein

Your risk of a blood clot with Gestinyl is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (BMI greater than 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 surgery or spend a lot of time without standing up due to an injury or illness, or if you have a leg cast. You may need to stop taking Gestinyl for several weeks before the surgery or while you have limited mobility. If you need to stop taking Gestinyl, ask your doctor when you can start taking it again;
• With increasing age (especially over the age of 35);
• If you have given birth recently.

Your risk of a blood clot increases as you have more of these conditions.

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

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

Inform your doctor if any of the conditions listed above change while you are using Gestinyl, for example, if a close relative experiences a blood clot 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 blood clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

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

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

• With increasing age (over the age of 35);
• 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, 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). In this case, you may also be at higher risk of 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, arrhythmia called atrial fibrillation);
• If you have diabetes.

If you have one or more of these conditions or if any of them are particularly severe, your risk of a blood clot may be even higher.

If any of the conditions listed above change while you are using Gestinyl, for example, if you start smoking, a close relative experiences a blood clot without a known cause, or you gain a lot of weight, inform your doctor.

Gestinyl and cancer

It appears that taking the pill increases the risk ofuterine cervical cancer, although this may be due to having unprotected sex and not the pill itself. All women should undergo periodicsmears.

If you havebreast canceror have had it in the past, do not take the pill.

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

• Of 10,000 women whonevertook the pill, 16 will have breast cancer at 35 years old.
• Of 10,000 women whotook the pill for 5 years in their early twenties, 17-18 will have breast cancer at 35 years old.
• Of 10,000 women whonevertook the pill, 100 will have breast cancer at 45 years old.
• Of 10,000 women whotook the pill for 5 years in their early thirties, 110 will have breast cancer at 45 years old.

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 are significantly overweight.

?Seek medical attention 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 that you can see or feel.

The pill has also been associated with liver diseases, such as jaundice and non-cancerous liver tumors, but this is rare. In very rare cases, the pill has also been associated with some forms of liver cancer in women who have taken it for a long time.

?Seek medical attention as soon as possible if you have severe stomach pain or yellow skin or eyes (jaundice). You may need to stop taking Gestinyl.

Menstrual bleeding

Some women experience a small amount of bleeding or spotting while taking Gestinyl, especially during the first few months. Normally, this bleeding is not a cause for concern and will stop within 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 pills regularly, so try to take the pills at the same time every day. Additionally, unexpected bleeding can sometimes be caused by other medications.

?Make an appointment with your doctorif you have intermenstrual bleeding or spotting that:

• persists beyond the first few months;
• starts after you have been taking Gestinyl for a while;

- continues even after you stop taking Gestinyl.

What to do if no bleeding occurs during the pill-free period

If you have taken all the pills correctly, have not vomited, and have not had severe diarrhea, and have not taken other medications, it is 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 taking the next pack until you are sure you are not pregnant.

Other medications and Gestinyl

• Some medications may make Gestinyl less effective in preventing pregnancy, or may cause unexpected bleeding.

This includes medications used to treat epilepsy (e.g., phenytoin, topiramate, felbamate, lamotrigine, primidone, barbiturates, carbamazepine, oxcarbazepine) and tuberculosis (e.g., rifampicin), immunomodulators (ciclosporin), HIV (ritonavir) or other infectious diseases (griseofulvin); and the herbal preparation St. John's Wort.

• If you want to use St. John's Wort while taking Gestinyl, consult your doctor first.
• Gestinyl may affect the effectiveness of other medications, e.g., medications containing the immunomodulator ciclosporin, or the antiepileptic lamotrigine (this may cause an increase in seizure frequency).
• Do not take Gestinyl if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may cause increases in liver enzyme levels (ALT).

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

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

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

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 hormonal contraceptives can affect the results of some blood tests.

Pregnancy and breastfeeding

Do not take Gestinyl if you are pregnant. If you become pregnant while taking Gestinyl, stop taking it immediately and consult your doctor.

Generally, it is not recommended to use Gestinyl during breastfeeding. If you are breastfeeding and want to start taking Gestinyl, consult your doctor.

Consult your doctor or pharmacist before starting any medication.

Driving and operating machinery

No information is available to suggest that Gestinyl affects driving or operating machinery.

Gestinyl contains lactose and saccharose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the medication administration instructions indicated 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 can take the tablets with or without food, but you must take them approximately at the same time every day.

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

Do not take any tablets for 7 days after that. During those 7 days without tablets (also called "rest week" or "week without tablets"), a bleeding should occur. This bleeding, known as "withdrawal bleeding," usually starts on the second or third day of the rest week.

On the eighth day after the last Gestinyl tablet (i.e., after the rest week), start the next blister pack, even if the bleeding has not stopped. This means that you must start the next blister pack on the same day of the week and that 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 do not take the tablets.

When can you start with the first blister pack

• If you have not used hormonal contraceptives in the past 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 must take additional contraceptive measures (e.g., a condom) during 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 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 progestin-only contraceptive (progestin-only pill, injection, implant, or intrauterine device (IUD) releasing progestin)

You can switch at any time from the pill, from an injectable when it's due for the next injection. In the case of an implant or IUD, on the same day of its removal. In all cases, you must take additional contraceptive measures (e.g., a condom) during the first 7 days of taking the tablets.

• 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 after day 28, you must use a barrier method (e.g., a condom) during the first 7 days of using Gestinyl.

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

Let your doctor advise you if you are unsure 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 adverse effects have been reported for taking too many Gestinyl tablets.

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

If you have taken more Gestinyl tablets than you should, or if you discover that 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 takeGestinyl

• If you delayless than 12 hoursin taking a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and take the next tablets at the usual time.
• If you delaymore than 12 hoursin taking a tablet, the protection against pregnancy may be reduced. The greater the number of tablets you have forgotten, the greater the risk of reduced protection against pregnancy.

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

• More than one tablet forgotten in the blister 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 once. Continue taking the tablets at the usual time and takeadditional precautionsfor the next 7 days, for example, a condom. If you have had sex in the week before forgetting the tablet or have forgotten to start a new pack after the rest period, you must consider the risk of pregnancy. In that 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 once. Continue taking the tablets at the usual time. The protection against pregnancy is not reduced, and you do not need to take additional precautions.

• One tablet forgotten in week 3

You can choose between two options:

1.Take the forgotten tablet as soon as you remember, even if you have to take two tablets at once. Continue taking the tablets at the usual time. Instead of the rest period, go directly to the next pack.

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

2.You can also interrupt taking the tablets and go directly to the rest period of 7 days (marking the day you forgot the tablet). If you want to start a new pack on the established start day, make the rest period shorter than 7 days.

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

• If you have forgotten one or more tablets in a pack, and you do not have bleeding in 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 intense diarrhea

If you vomit within 3-4 hours after taking the tablet or have intense diarrhea, there is a risk that your body will not fully absorb the active ingredients of the tablet. The situation is similar to forgetting to take a tablet. After vomiting or diarrhea, you must take another tablet from a reserve strip as soon as possible. If possible, take itwithin 12 hoursafter the usual time. If this is not possible or more than 12 hours have passed, you must follow the instructions in the section "If you forgot to take Gestinyl."

Delayed menstrual period: what you should know

Although not recommended, it is possible to delay the menstrual period (withdrawal bleeding). This can be done by going directly to a new Gestinyl pack instead of the rest period 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 rest period of 7 days, continue with the next pack.

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

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

If you take the tablets following the instructions, your menstrual period/withdrawal bleeding will start during the rest period. If you need to change that day, do it by shortening the rest period (but never lengthening it!). For example, if your rest period starts on a Friday, and you want to change the day to Tuesday (3 days earlier), you must 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 that case, you may experience spotting (drops or spots of blood) or intermenstrual bleeding.

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

If you interrupt treatment withGestinyl

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.

Like other medicines, this medicine may cause side effects, although not everyone will experience them. If you experience any side effect, especially if it is severe and persistent, or if you notice any change in your health that you think may be related to Gestinyl, consult your doctor.

All women taking 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 starting to take Gestinyl.

Seek medical attention 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 side effects – seek medical attention immediately

Frequent side effects(may affect more than 1 in 10 people)

• Headaches
• Nervousness

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

• Nausea
• Abdominal pain
• Weight gain
• Depressive states or mood changes
• Breast tenderness or irritation
• Vaginitis, including candidiasis
• Fluid retention
• Migraine
• Loss of interest in sex or increased interest in sex
• Dizziness
• Visual disturbances
• Acne
• Irregular bleeding
• Amenorrhea
• Menorrhagia

Rare side effects(may affect up to 1 in 100 people)

• Nausea and stomach discomfort, including vomiting
• Rash, which may cause itching
• Hyperlipidemia
• Hypertension
• Hirsutism (excessive hair growth)
• Alopecia
• Changes in serum lipid levels, including hypertriglyceridemia

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

• Poor tolerance of contact lenses
• Vaginal discharge or flow
• Lupus erythematosus (autoimmune disease)
• Glucose intolerance
• A hereditary form of deafness (otosclerosis)
• Bile stones (cholelithiasis)
• Yellowing of the skin (jaundice)
• Red, sensitive nodules (erythema nodosum)
• Decreased serum folate levels

Very rare side 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
• Multiform erythema (scaly lesions)
• Uremic hemolytic syndrome (damage to small blood vessels in the kidneys)

Other reported side effects

Frequent side effects(may affect more than 1 in 10 people)

• It may sometimes causebleeding and spotting between periodsin the first few months, but this usually disappears once your body has adapted to Gestinyl. If the bleeding continues, becomes heavy or starts again, consult your doctor (see section 2 “Bleeding between periods”).

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

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

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

• Appearance or worsening ofchorea(movement disorder)

• Conditions that may worsen during pregnancy or previous use of the pill:
• Yellowing of the skin(jaundice)
• Persistent itching(pruritus)
• Bile stones
• Some rare diseases such assystemic lupus erythematosus
• Herpes gestationalwith blisters during pregnancy
• A hereditary form of deafness (otosclerosis)
• A hereditary disease calledporphyria

?Inform your doctor, pharmacist or family planning specialist if you are concerned about any side effect that you think may be related to Gestinyl. Also tell them if any existing disease worsens while you are taking Gestinyl.

Reporting side effects

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

Do not store above 86°F (30°C).

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

Do not use this medication after the expiration date that appears on the blister pack and on the case after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofGestinyl

• Each tablet contains20 micrograms of ethinylestradiol and 75 micrograms of gestodeno.
• 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, saccharose, glycolated montan wax.

Appearance of the product and contents of the package

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

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Effik Laboratories, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Responsible manufacturer

Haupt Pharma Münster GmbH

Scheebrüggenkamp 15

48159 Münster

Germany

This medicine is authorized by the member states of the European Economic Area with the following names

Last review date of this leaflet:June 2023

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