Package Insert: Information for the User

Gynovin 0.075 mg / 0.03 mg Coated Tablets

gestodeno / etinilestradiol

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”).

1.What is Gynovin and what it is used for

2.What you need to knowbefore starting totake Gynovin

3.How to take Gynovin

4.Possible adverse effects

5.Storage of Gynovin

6. Contents of the package and additional information

Gynovin is a combined oral contraceptive pill. It inhibits ovulation and produces changes in cervical mucus (produced by the cervix). It is used to prevent pregnancy and to achieve states of ovarian rest (reduction or interruption of ovarian activity).

General Considerations

Before starting to use Gynovin, read the information about blood clots in section 2. It is particularly important that you read the symptoms of a blood clot (see section 2 “Blood Clots”).

Do not use Gynovin

Do not use Gynovin 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 are allergic to the active ingredients or to any of the other components of this medication (listed in section 6)
• If you have (or have ever had) a blood clot in a vein in your leg (deep vein thrombosis, DVT), in your 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 severe chest pain 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 your arteries:

• Diabetes with severe vascular damage.
• Very high blood pressure.
• Very high levels of fat in your 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 thrombogenic valvulopathies (diseases of the heart valves that may cause blood clots).

• If you have arrhythmias that may cause blood clots (thrombogenic arrhythmias).

• If you have severe liver disease, unless your liver function tests have normalized.
• If you have (or have ever had) liver tumors (benign or malignant).
• If you have (or suspect you may have) malignant diseases of the reproductive organs or breasts.
• If you have unexplained vaginal bleeding.
• If you are pregnant or suspect you may be pregnant.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Gynovin.

If any of the risk situations mentioned below are present, your doctor must assess the benefits of using Gynovin against the possible risks, and discuss them with you before you decide to start using it.

Inform your doctor if you suffer from any of the following conditions

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

• 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 your 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 surgery or spend a lot of time without standing up (see section “Blood Clots”).
• If you have recently given birth, you are at higher risk of blood clots. Ask your doctor when you can start taking Gynovin after childbirth.
• If you have superficial thrombophlebitis (inflammation of the veins under the skin).
• If you have varicose veins.

• If you have heart diseases (those that cause certain types of arrhythmias).
• If you have high blood pressure, particularly if it worsens or does not improve with anti-hypertensive medications.
• If you have severe migraines.
• If you have diabetes.
• If you have depression or a history of depression, as it may worsen or recur when using hormonal contraceptives.
• If you have certain types of jaundice (yellow discoloration of mucous membranes, eyes, and/or skin) or liver function disorders.
• If you have itching, especially if it occurred during a previous pregnancy.
• If you have permanent brown spots on your face, especially if you had them during a previous pregnancy. If so, avoid sunlight and ultraviolet radiation (e.g., tanning beds).
• If you experience angioedema symptoms such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogen can cause or worsen symptoms of hereditary and acquired angioedema.

Contact your doctor if you suspect you may be pregnant.

Do not use Gynovin if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section “Other medications and Gynovin”).

BLOOD CLOTS

The use of a combined hormonal contraceptive like Gynovin 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 Gynovin is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attentionif you notice any of the following signs or symptoms.

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 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 your leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from your leg and lodges in your lung, it may cause a pulmonary embolism (PE).
• In very rare cases, a blood clot can form in a vein in another organ, such as your eye (retinal vein thrombosis).

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

The risk of a blood clot in a vein is higher during the first year you take a combined hormonal contraceptive for the first time. The risk may be higher if you restart taking 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 always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Gynovin, 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 your leg or lung (DVT or PE) with Gynovin is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 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, about 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing gestodene like Gynovin, about 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 is small, but some conditions increase it. Your risk is higher:

• If you are overweight (body mass index (BMI) of 30 kg/m2 or higher).
• If one of your close relatives has had a blood clot in their leg, lung, or another organ at a young age (i.e., before about 50 years old). 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 your leg immobilized. You may need to stop taking Gynovin for several weeks before surgery or while you have limited mobility. If you need to stop taking Gynovin, ask your doctor when you can start taking it again.
• As you get older (especially over about 35 years old).
• If you have given birth recently.

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

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 above, even if you are unsure. Your doctor may decide to stop you from taking Gynovin.

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

BLOOD CLOTS IN AN ARTERY

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

Like a blood clot in a vein, a 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 Gynovin is very small, but it may increase:

• With age (over about 35 years old).
• If you smoke.When using a combined hormonal contraceptive like Gynovin, you are advised to quit smoking. If you cannot 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 one of your close relatives has had a heart attack or stroke at a young age (less than about 50 years old). You may also be at higher risk of a heart attack or stroke.
• If you or one of your close relatives has high levels of fat in your 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 above change while you are using Gynovin, for example, you start smoking, a close relative experiences a blood clot without a known cause, or you gain a lot of weight, inform your doctor.

• Tumors

Cases of breast tumors have been observed at a slightly higher frequency in women using oral contraceptives, but it is unclear whether this is due to the treatment. For example, tumors may be more likely to be detected in women using oral contraceptives because they visit their doctor more frequently. This increased frequency decreases gradually after stopping treatment. After ten years, the chances of having breast tumors will be the same as for women who have never used oral contraceptives.

In some studies, an increased risk of cervical cancer has been reported in users who have been taking oral contraceptives for long periods, but there is still controversy about the extent to which this finding can be attributed to other factors, such as sexual behavior and sexually transmitted diseases.

Rare cases of benign liver tumors and, even more rarely, malignant liver tumors have been reported in users of oral contraceptives. This can cause internal bleeding, which may lead to severe abdominal pain. If this occurs, you should contact your doctor immediately.

There has been an observed increase in the relative risk of cervical cancer and cervical intraepithelial neoplasia (serious diseases of the cervix). Given the biological influence of oral contraceptives on these lesions, it is recommended that, when prescribing oral contraceptives, cervical cytology should be performed periodically.

Malignant tumors can pose a threat to life or have a fatal outcome.

• Mental health disorders

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

If a severe depression case occurs, the medication should be discontinued, and an alternative contraceptive method should be used. Women with a history of depression should be closely monitored.

• Other conditions

In women with hypertriglyceridemia (high triglycerides in the blood) or a family history of the same, there may be an increased risk of pancreatitis (inflammation of the pancreas) during the use of oral contraceptives.

Women who have been treated for hyperlipidemias (high levels of fats in the blood, such as triglycerides and/or cholesterol) should be monitored if they decide to take oral contraceptives.

During the use of oral contraceptives, many users experience small increases in blood pressure, although rare cases with clinical relevance are uncommon. If high blood pressure develops while using oral contraceptives, you should consult your doctor.

In women with endometrial hyperplasia (thickening of the inner lining of the uterus), your doctor should carefully assess the risk-benefit ratio before prescribing oral contraceptives and closely monitor you during treatment, performing cervical cytology periodically.

The following conditions may appear or worsen with pregnancy and with the use of oral contraceptives: jaundice (yellow discoloration of mucous membranes, eyes, and/or skin) and/or pruritus (itching) related to cholestasis (bile flow obstruction), gallstone formation, porphyria (a metabolic disorder of hemoglobin), systemic lupus erythematosus (inflammatory skin disease), hemolytic uremic syndrome (blood disorder causing kidney failure), Sydenham's chorea (involuntary movements), herpes gestationis (skin and mucous membrane lesions that occur during pregnancy), and otosclerosis (a type of ear disorder).

Acute or chronic liver function disorders require the suspension of oral contraceptives until liver function tests return to normal. The reappearance of cholestatic jaundice (yellow discoloration of mucous membranes, eyes, and/or skin related to bile flow obstruction), which first appeared during a pregnancy, or during previous use of sex hormones, requires the suspension of oral contraceptives.

Oral contraceptives may alter peripheral resistance to insulin and glucose tolerance. There is no evidence that this requires a change in treatment for diabetic patients taking low-dose oral contraceptives (with <0.05 mg of ethinylestradiol). However, diabetic patients should be closely monitored while taking oral contraceptives.

Oral contraceptives have been associated with inflammatory bowel disease (Crohn's disease and ulcerative colitis).

Occasionally, melasma (brown skin patches) may occur, especially in women with a history of melasma during pregnancy. If you are prone to melasma, avoid exposure to the sun or ultraviolet radiation while taking oral contraceptives.

It should be noted that oral contraceptives do not protect against HIV (AIDS) infection or other sexually transmitted diseases.

Medical examination and consultation

Before starting or restarting treatment with Gynovin, your doctor must perform a complete medical history and physical examination to rule out contraindications and observe precautions, and these should be repeated at least once a year during the use of combined oral contraceptives.

Reduced efficacy

The efficacy of oral contraceptives may decrease if you forget to take a pill (see section “If you forgot to take Gynovin”), if you experience gastrointestinal disorders such as vomiting or severe diarrhea (see section “Recommendations in case of gastrointestinal disorders”), or if you take other medications simultaneously (see section “Taking Gynovin with other medications”).

Irregularities in menstrual control

During the use of any oral contraceptive, irregular bleeding or spotting may occur, especially during the first few months of use. If these irregularities persist or occur after previously regular cycles, possible non-hormonal causes should be considered, and you should consult your doctor to rule out malignant processes, infections, or pregnancy.

Some women may not experience withdrawal bleeding during the pill-free week. If you have taken the oral contraceptive as instructed in the section “How to take Gynovin,” it is unlikely that you are pregnant. However, if you have not taken the oral contraceptive as instructed before your first missed period or if a second missed period occurs, you should rule out pregnancy before continuing to take the oral contraceptive.

If you are unsure about any of the above points, consult your doctor before taking Gynovin.

Other medications and Gynovin

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Certain medications may interact, in which case you may need to change the dose or discontinue one of the medications. It is especially important to inform your doctor if you are using any of the following medications.

The medications listed below may prevent combined hormonal contraceptives from working properly, and if this occurs, you may become pregnant:

• Treatment of hepatitis C and HIV (inhibitors of protease, e.g., ritonavir and nelfinavir, and non-nucleoside reverse transcriptase inhibitors, e.g., nevirapina) and other infections (griseofulvina)
• Treatment of tuberculosis (rifampicin, rifabutina)
• Treatment of fungal infections (griseofulvina, azole antifungals, e.g., itraconazol, voriconazol, fluconazol)
• Treatment of bacterial infections (macrolide antibiotics, e.g., claritromicina, eritromicina)
• Treatment of certain heart diseases and high blood pressure (calcium channel blockers, e.g., verapamilo, diltiazem)
• Treatment of arthritis and osteoarthritis (etoricoxib)
• Some antiepileptics (topiramato, barbiturates (fenobarbital), phenytoin, carbamazepine, primidona, oxcarbazepine, felbamato, ethosuximida).
• Antacids, including lansoprazol.
• Some mood elevators (modafinilo).
• Orange juice

You should not take preparations based on medicinal plants with St. John's Wort (Hypericum perforatum) simultaneously with Gynovin, as its efficacy may be reduced, with a risk of unplanned pregnancy and intermenstrual bleeding. The reduction in anticonceptive effect lasts until two weeks after stopping the herbal preparation.

It is recommended that you use another reliable contraceptive method if you take any of the medications listed above. The effect of some of these medications may last up to 28 days after stopping treatment.

Gynovin may reduce the effect of anticoagulants, analgesics (such as paracetamol and salicylates), fibrates (medications to reduce triglycerides and/or cholesterol levels), lamotrigine (anticonvulsant), oral antidiabetics, and insulin, and increase the effect of other medications such as beta-blockers (metoprolol), theophylline (for asthma treatment), corticosteroids (such as prednisolone), cyclosporine (increasing the risk of liver toxicity), flunarizine (increasing the risk of lactation), midazolam, melatonin, and tizanidine.

You should never take another medication on your own initiative without your doctor's recommendation, as some combinations should be avoided.

Do not take Gynovin if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver function test results (elevated ALT enzyme levels).

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

Gynovin can be restarted approximately two weeks after completing this treatment. See the section “Do not use Gynovin”.

You should consult the prescribing information for the medications you are taking concurrently to identify possible interactions.

Laboratory tests

The use of oral contraceptives may affect the results of certain laboratory tests.

Inform your doctor if you are scheduled to undergo any laboratory tests, as you are using oral contraceptives.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or suspect you may be pregnant, consult your doctor or pharmacist before using this medication.

Gynovin is not indicated during pregnancy. If you become pregnant, you should stop taking Gynovin immediately and consult your doctor.

During the use of oral contraceptives, small amounts of the contraceptive may be eliminated through breast milk, but there is no evidence that this affects the baby's health. However, oral contraceptives are generally not recommended until the end of breastfeeding.

If you want to use Gynovin after childbirth or abortion in the second trimester, see the section “How to take Gynovin”.

Driving and operating machinery

No effects on driving or operating machinery have been observed.

Gynovin contains lactose, sucrose, and sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free.”

This medication contains lactose and sucrose. If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

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

Remember to take your medication, as forgetting coated tablets may reduce the effectiveness of the preparation.

Combined oral contraceptives, when taken correctly, have an error rate of approximately 1% per year. The error rate may increase if tablets are forgotten or taken incorrectly.

The first tablet is removed from one of the marked boxes with the corresponding day of the week (e.g., "LU" for Monday). Tablets should be taken every day approximately at the same time, with a little liquid if necessary, and in the order indicated in the blister pack. One tablet will be taken daily for 21 consecutive days. A new blister pack will be started after a 7-day interval without taking tablets, during which a withdrawal bleeding (period) usually occurs. The withdrawal bleeding, similar to a period, will appear two or three days after taking the last tablet, and it may not have ended before starting the next blister pack.

How to start taking Gynovin

• If no hormonal contraceptive has been taken previously (in the past month)

Tablets will be started on day 1 of the woman's natural cycle (i.e., the first day of menstrual bleeding). It can also be started on days 2 to 5 of the cycle, but in that case, it is recommended to use an additional barrier method, such as a condom, during the first 7 days of tablet taking.

• To replace a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch)

You should start taking Gynovin preferably the day after taking the last hormone-containing tablet of the COC you were previously taking, or at the latest, on the day after the usual interval without taking tablets or hormone-free tablets of your previous COC. This means that, at the latest, Gynovin treatment should be initiated on the same day that a new blister pack (blister) of the previous COC should be started. In the case of a vaginal ring or transdermal patch, start taking Gynovin preferably on the day of removal of the last ring or patch from a cycle, or at the latest, when the next application should have been made.

• To replace a method based exclusively on progestogens (progestogen-only pill, injection, implant), or a progestogen-releasing intrauterine system (IUS)

You can replace the progestogen-only pill with Gynovin on any day (if it is an implant or an IUS, on the day of its removal; if it is an injectable, on the day of the next injection), but in all cases, it is recommended to use an additional barrier method, such as a condom, during the first 7 days of tablet taking.

• After a first-trimester abortion

You can start taking Gynovin immediately. When you do so, you do not need to take additional contraceptive measures.

• After childbirth or a second-trimester abortion

It is recommended that you start taking Gynovin 21-28 days after childbirth or a second-trimester abortion. If you do so later, you should use an additional barrier method during the first 7 days. However, if sexual intercourse has already taken place, you should rule out the possibility of pregnancy before starting the COC, or you should wait for your first menstrual period.

If you take more Gynovin than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service (Tel: 91 562 04 20), indicating the medication and the amount ingested. It is recommended to bring the packaging and leaflet to the healthcare professional.

No serious adverse reactions have been reported due to overdose. The symptoms that may appear in this case are: nausea, vomiting, or vaginal bleeding. This bleeding may occur even in girls who have not yet had their first menstrual period, if they have accidentally taken this medication. There is no antidote, and treatment should be symptomatic.

If you forgot to take Gynovin

Contraceptive protection does not decrease if the taking of a tablet is delayedless than 12 hours. In this case, you should take the tablet as soon as you remember it and continue taking the next tablets at the usual time (although this may mean taking two tablets on the same day). In this case, you do not need to take any additional contraceptive measures.

If you delay takingmore than 12 hours, contraceptive protection may be reduced. The guidelines to follow in case of forgetting are governed by two basic rules:

1. Never suspend tablet taking for more than 7 days.
2. You must take the tablets uninterruptedly for 7 days to achieve an adequate suppression of the hypothalamic-pituitary-ovarian axis.

Consequently, and following the above indications, in daily practice, the following can be advised:

• Week 1

You should take the last forgotten tablet as soon as you remember it, even if this means taking two tablets at the same time. From then on, you will continue taking the tablets at your usual time. In addition, during the next 7 days, you should use an additional barrier method, such as a condom. If you have had sexual intercourse in the 7 days prior, you should consider the possibility of pregnancy. The more tablets you have forgotten and the closer you are to the 7-day interval, the greater the risk of pregnancy.

• Week 2

You should take the last forgotten tablet as soon as you remember it, even if this means taking two tablets at the same time. From then on, you will continue taking the tablets at your usual time. If you have taken the tablets correctly in the 7 days prior to the forgotten tablet, you will not need to take any additional contraceptive measures. However, if you have forgotten to take more than 1 tablet, it is recommended that you take additional precautions for 7 days.

• Week 3

The risk of reduced effectiveness is imminent due to the proximity of the 7-day interval. However, by adjusting the tablet-taking schedule, you can still prevent the reduction of contraceptive protection. Therefore, if you follow one of the two options below, you will not need to take any additional contraceptive measures, provided that you have taken all the tablets correctly in the 7 days prior to the first forgotten tablet. If not, you should follow the first of the two options below and take additional contraceptive precautions for 7 days.

1. You should take the last forgotten tablet as soon as you remember it, even if this means taking two tablets at the same time. From then on, you will continue taking the tablets at your usual time. You should start the next blister pack as soon as the current one runs out, without leaving a gap between them. It is unlikely that you will have a withdrawal bleeding (period) until you finish the second blister pack, but you may experience spotting or bleeding during the taking of the next blister pack.
2. You can also stop taking the tablets from the current blister pack. Then you should complete an interval of up to 7 days without taking tablets, including the days when you forgot to take the tablets, and then start again with the next blister pack.

If, in the case of forgetting to take tablets, you do not present withdrawal bleeding (period) in the first interval without tablets, you should consider the possibility of pregnancy.

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

Recommendations in case of gastrointestinal disorders

In case of severe gastrointestinal disorders, absorption may not be complete, and you should take additional contraceptive measures.

If you experience vomiting in the 3-4 hours following tablet taking, you should follow the guidelines for forgetting to take tablets, as described in the section "If you forgot to take Gynovin". If you do not want to change your usual tablet-taking schedule, you should take the extra tablets needed from another blister pack.

How to delay withdrawal bleeding (period)

To delay a period, you should continue with the next Gynovin blister pack without leaving the usual 7-day interval. You can maintain this duration as long as you want until the second blister pack is finished. During that time, you may experience bleeding or spotting. Then, you should leave the usual 7-day interval without tablets and resume regular Gynovin taking.

To change the period to another day of the week to which you are accustomed according to your current cycle, you can advise shortening the 7-day interval as many days as you want. The shorter the interval, the greater the risk of not having withdrawal bleeding (period) and of experiencing intermenstrual bleeding or spotting during the taking of the next blister pack (as occurs when a period is delayed).

Special populations

Pediatric population

Gynovin is only indicated after menarche (appearance of the first period).

Geriatric population

It is not applicable. Gynovin is contraindicated after menopause.

Patients with liver dysfunction

Gynovin is contraindicated in women with severe liver dysfunction.

Patients with renal dysfunction

Gynovin has not been specifically studied in patients with renal dysfunction. There are no available data to suggest a change in treatment in this population of patients.

Like all medicines, Gynovin can 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 have any health changes that you think may be related to Gynovin, 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 section2 “What you need to know before starting Gynovin”.

Severe side effects

Contact your 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 (also see section “Warnings and precautions”).

Side effects are listed in order of decreasing severity within each frequency range.

Very common: May affect more than 1 in 10 people

Common: May affect up to 1 in 10 people

Uncommon: May affect up to 1 in 100 people

Rare: May affect up to 1 in 1,000 people

Very rare: May affect up to 1 in 10,000 people

1. Infections and infestations

Common: Vaginitis (vaginal inflammation), including candidiasis (vaginal yeast infection).

1. Immune system disorders

Rare: Allergic reactions such as very rare cases of urticaria (itching) and severe reactions accompanied by difficulty breathing, dizziness, and even loss of consciousness.

Very rare: Worsening of systemic lupus erythematosus (autoimmune inflammatory and chronic disorder).

1. Metabolism and nutrition disorders

Uncommon: Changes in appetite (increase or decrease).

Rare: Glucose intolerance.

Very rare: Worsening of porphyria (hemoglobin metabolism disorder).

1. Mental disorders

Common: Mood changes, including depression; changes in libido (sex drive).

1. Nervous system disorders

Very common: Headaches, including migraines.

Common: Nervousness, dizziness.

Very rare: Worsening of chorea (movement disorder).

1. Eye disorders

Rare: Contact lens intolerance.

Very rare: Optic neuritis, retinal vascular thrombosis (eye anomalies and visual disorders).

1. Vascular disorders

Uncommon: Increased blood pressure.

Rare: Harmful blood clots in a vein or artery, for example:

The risk of having a blood clot may be higher if you have any other condition that increases this risk (see section2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

Very rare: Worsening of varicose veins.

1. Gastrointestinal disorders

Common: Nausea, vomiting, abdominal pain.

Uncommon: Cramps, bloating.

Very rare: Pancreatitis (pancreas inflammation), hepatic adenomas (frequent non-cancerous liver tumors), hepatocellular carcinoma (liver cancer).

1. Hepatobiliary disorders

Rare: Cholestatic jaundice (yellow discoloration of mucous membranes, eyes, and/or skin related to bile flow obstruction).

Very rare: Cholecystopathy (gallbladder disorders), including gallstones.

1. Skin and subcutaneous tissue disorders

Common: Acne.

Uncommon: Skin rash, hypersensitivity reactions (abnormal skin sensitivity), melasma (skin discoloration) that may persist, hirsutism (excessive hair growth), alopecia (hair loss).

Rare: Erythema nodosum (a type of skin inflammation with the appearance of nodules on the legs).

Very rare: Erythema multiforme (a type of skin inflammation).

1. Renal and urinary disorders

Very rare: Hemolytic-uremic syndrome (blood disorder).

1. Reproductive and mammary system disorders

Very common: Bleeding, spotting.

Common: Breast pain, breast tenderness, breast enlargement, breast secretion, dysmenorrhea (painful menstruation), changes in menstrual flow, changes in vaginal secretion, and cervical ectropion (alteration of the cervical mucosa), amenorrhea (absence of menstruation).

1. General disorders and administration site conditions

Common: Fluid retention, edema (swelling), weight changes (gain or loss).

1. Laboratory investigations

Uncommon: Changes in lipid levels (fats) in the blood, including hypertriglyceridemia.

Rare: Decreased levels of folates (derivatives of folic acid) in the blood.

Description of selected adverse reactions

The following list includes rare or delayed adverse reactions that are considered related to the group of combined oral contraceptives (see sections “Do not use Gynovin” and “Warnings and precautions”).

Tumors

• The frequency of breast cancer diagnosis among users of COCs is slightly increased. Since breast cancer is rare in women under 40, this increase is low compared to the overall risk of breast cancer. The causal relationship with COC use is unknown.
• Hepatic tumors (benign and malignant)

Other alterations

• Women with hypertriglyceridemia (increased blood fats, resulting in an increased risk of pancreatitis when using COCs)
• Hypertension
• Appearance or worsening of alterations whose association with COC use is not conclusive: jaundice and/or pruritus related to cholestasis (bile flow obstruction); formation of gallstones; a metabolic disorder called porphyria; systemic lupus erythematosus (a chronic autoimmune disease); hemolytic-uremic syndrome (a blood disorder); a neurological disorder called Sydenham's chorea; gestational herpes (a type of skin alteration that occurs during pregnancy); hearing loss related to otosclerosis
• Liver function disorders
• Changes in glucose tolerance or effect on peripheral insulin resistance
• Crohn's disease, ulcerative colitis
• Melasma (skin discoloration)

Interactions

Interactions between oral contraceptives and other medications (e.g., St. John's Wort, epilepsy medications, tuberculosis, HIV, and other infections) may lead to unexpected bleeding and/or contraceptive failure (see section “Taking Gynovin with other medications”).

Reporting of adverse reactions

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

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

Do not store at a temperature above 25°C. Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medicines 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 the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Gynovin

• The active principles are: gestodeno and ethinylestradiol. Each coated tablet of Gynovin contains0.075 mg of gestodeno and 0.03 mg of ethinylestradiol.
• The other components are: lactose monohydrate, cornstarch, povidone K 25, calcium and sodium edetate, magnesium stearate (E470b), saccharose, povidone K 90, macrogol 6000, calcium carbonate (E170), talc (E553b) and glycolated montan wax.

Appearance of the product and contents of the packaging

Gynovin is presented in packaging of 1 or 3 blisters (the packaging where the coated tablets are found). Each blister contains 21 round white coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 - 5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing

Bayer Weimar GmbH & Co. KG, Weimar

Döbereinerstr. 20

99427 Weimar

Germany

Last review date of this leaflet:10/2022

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.