Label: Information for the User

Harmonet 0.075 mg/0.02 mg Coated Tablets

gestodeno and etinilestradiol

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

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

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 aware and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood Clots”).

Harmonet is a combined oral contraceptive medication.

Harmonet is prescribed for the following indications: combined oral contraception, menstrual cycle disorders, and ovarian rest.

In addition, the use of hormonal contraceptives may have beneficial effects on conditions such as dysmenorrhea (menstrual pain) and to reduce the incidence of certain alterations of the breasts and reproductive organs.

General Considerations

Before starting to use Harmonet, you should 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”).

When Not to Use Harmonet

You should not use Harmonet 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.

Do Not Take Harmonet

• If you are allergic to gestodeno, ethinylestradiol, or any of the other components of this medication (listed in section 6).
• If you have (or have had at any time) a blood clot in a 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 had at any time) 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 coronary heart disease or heart valve disease (valvulopathies with a possibility of forming blood clots).
• If you have arrhythmias (heart rhythm disorders) with a possibility of forming blood clots.
• 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 and/or uncontrolled blood pressure.
  • Very high levels of fat in the blood (cholesterol or triglycerides).
  • A condition called hyperhomocysteinemia.
• If you have (or have had at any time) a type of migraine called “migraine with aura”.
• If you are pregnant or think you may be pregnant.
• If you have severe liver function disorders. If you have or suspect liver tumors.
• If you have (or have had at any time) or suspect malignancies of the genital organs or breasts.
• If you have unexplained vaginal bleeding.
• If you have pancreatitis (inflammation of the pancreas) due to a severe increase in triglycerides.
• 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 Harmonet”).

Warnings and Precautions

When to Have Special Care with Harmonet

Before taking Harmonet, you will need to visit your doctor for a physical examination. It is essential that you communicate with your doctor if you have or have had any of the risk situations listed below. If so, your doctor must assess the benefits of using Harmonet 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 using Harmonet, 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 insufficiency).
• 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 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 recently gave birth, you are at higher risk of blood clots. Ask your doctor when you can start taking Harmonet after childbirth.
• If you have superficial thrombophlebitis (inflammation of the veins under the skin).
• If you have varicose veins.
• If you have any heart disease (chest pain, certain types of heart rhythm disorders, heart diseases).
• If you have high blood pressure, particularly if it worsens or does not improve with anti-hypertensive medications.
• If you have intense and repetitive migraines.
• If you have diabetes.
• If you have depression or a history of depression, as it may worsen or return when using hormonal contraceptives.
• If you have certain types of jaundice (yellowing of the 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 estrogens can cause or worsen symptoms of hereditary and acquired angioedema.
• If you have angioedema (inflammation similar to urticaria, but occurring under the skin instead of on the surface), particularly in women with hereditary angioedema (a problem with the immune system that is inherited from parents to children).

Psychiatric Disorders:

Some women who use hormonal contraceptives like Harmonet 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.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Harmonet 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, very rarely, fatal effects.

It is essential to remember that the global risk of a harmful blood clot due to Harmonet is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek Urgent Medical Assistanceif 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 thrombosis). 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 of 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.
• In very rare cases, a blood clot can form in a vein of 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 using a combined hormonal contraceptive for the first time. The risk may be higher if you start taking a combined hormonal contraceptive again (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 using a combined hormonal contraceptive.

When you stop taking Harmonet, 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 global risk of a blood clot in the leg or lung (DVT or PE) with Harmonet is small.

Factors That Increase Your Risk of a Blood Clot in a Vein

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

• If you are overweight (body mass index (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 about 50 years old). In this case, you may have an inherited 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 using Harmonet for several weeks before the surgery or while you have less mobility. If you need to stop using Harmonet, ask your doctor when you can start using it again.
• As you get older (especially over 35 years old).
• If you have recently given birth.

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 above conditions, even if you are unsure. Your doctor may decide to stop using Harmonet.

If any of the above conditions change while you are using Harmonet, 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 Harmonet is very small, but it may increase:

• With age (over 35 years old).
• If You Smoke.When using a combined hormonal contraceptive like Harmonet, 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 about 50 years old). 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 heart problems (valvular disorders, arrhythmias 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 increased even further.

If any of the above conditions change while you are using Harmonet, 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 with a slightly higher frequency in women using oral contraceptives, but it is unknown whether this is due to the treatment. For example, it may be that more tumors are 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.

Similarly, cervical tumors (cervix) occur more frequently in women using oral contraceptives. However, the appearance of this tumor is associated with an increase in sexual activity and sexually transmitted diseases, so it is unclear whether the oral contraceptive plays a direct role in this risk.

Rarely, cases of liver tumors have been reported in women using oral contraceptives. In these cases, internal bleeding may occur, causing severe abdominal pain. If this happens, you should contact your doctor immediately.

Other Conditions

Blood Pressure:

If you have high blood pressure or have a condition related to high blood pressure (including certain kidney diseases), it is recommended that you use other methods of contraception. If you decide to use hormonal contraceptives, you should monitor your blood pressure, but if it increases and cannot be controlled with medications, you should stop using this medication (see section “When Not to Use Harmonet”).

Bile Duct Obstruction:

Women who have had bile duct obstruction (obstruction of bile flow) during treatment with hormonal contraceptives in the past or during pregnancy are more prone to develop it again if they use hormonal contraceptives. These women should be monitored, and if bile duct obstruction occurs, they should stop using hormonal contraceptives (see section “When Not to Use Harmonet”).

Liver Damage:

Cases of severe liver damage have been reported with the use of hormonal contraceptives. If your doctor determines that you develop severe liver damage while taking hormonal contraceptives, they will stop your treatment with hormonal contraceptives and recommend the use of non-hormonal contraceptives (see section “When Not to Use Harmonet”).

Migraines:

Women with migraines (particularly those associated with symptoms such as weakness or numbness of a part of the body, or visual disturbances (aura)) who take hormonal contraceptives may be at increased risk of cerebral infarction (see section “When Not to Use Harmonet”).

Angioedema:

The use of hormonal contraceptives can worsen symptoms of angioedema (inflammation similar to urticaria, but occurring under the skin instead of on the surface), particularly in women with hereditary angioedema (a problem with the immune system that is inherited from parents to children).

Genital Bleeding:

You may not have your “period” during the week of rest. If you have taken the oral contraceptive correctly, it is very unlikely that you are pregnant. However, if you have two missed periods, you should consult your doctor as a pregnancy should be ruled out. If you have not taken the oral contraceptive as instructed in section “3. How to Take Harmonet” and have a missed period, you should stop treatment and use a non-hormonal contraceptive method until a pregnancy has been ruled out (see section “When Not to Use Harmonet”).

This medication may cause vaginal bleeding or spotting between periods. If this happens, continue treatment and if the bleeding continues after three cycles, consult your doctor immediately. Errors in using the pill can also cause spotting and light bleeding.

Effects on Carbohydrates and Lipids:

In users of hormonal contraceptives, cases of glucose intolerance have been reported. Women with glucose intolerance or diabetes mellitus should be closely monitored (see section “When Not to Use Harmonet”).

A small proportion of women taking hormonal contraceptives may experience changes in their lipid profile (analysis of fat content in blood). They should consider non-hormonal contraceptive methods if they have uncontrolled lipid disorders. In a small proportion of women taking hormonal contraceptives, persistent hypertriglyceridemia (increased triglycerides in blood) may occur. A significant increase in plasma triglycerides can lead to pancreatitis and other complications.

Women who have been treated for hyperlipidemia (increased cholesterol and/or triglycerides) should be monitored if they decide to take hormonal contraceptives (see section “When Not to Use Harmonet”).

Eye Disorders:

Cases of retinal vascular thrombosis have been reported with the use of hormonal contraceptives, which can lead to partial or complete loss of vision. If you experience visual changes, proptosis (bulging eyes), diplopia (double vision), papilledema (inflammation of the eye), or retinal vascular thrombosis, stop treatment with hormonal contraceptives and evaluate the cause immediately.

Depression:

If a severe depression occurs, treatment should be stopped and a non-hormonal contraceptive method used.

Women with a history of depression should be monitored.

Sexually Transmitted Diseases:

The oral contraceptive does not protect against HIV (AIDS) or any other sexually transmitted disease (e.g., chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis). You should use a condom to protect yourself against these diseases.

Other Medications and Harmonet

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

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

These instructions may also apply to medications you have taken/used before or may take/use later.

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

• Some treatments for viral infections and HIV (ritonavir, indinavir).
• Some antibiotics (rifampicin, rifabutin, griseofulvin, and troleandomycin).
• Some antiepileptics (topiramate, barbiturates (phenobarbital), phenytoin, carbamazepine, primidone, oxcarbazepine).
• Some anti-inflammatory medications (phenylbutazone, dexamethasone).
• Antacids.
• Laxatives.
• Some mood-enhancing medications (modafinil).
• Medications that reduce triglyceride and/or cholesterol levels (atorvastatin).
• Antifungals (fluconazole).
• Vitamin C.
• Analgesics (paracetamol).

The medicinal herb St. John's Wort (Hypericum perforatum)also reduces the effect of hormonal contraceptives, and cases of pregnancy have been reported in women taking the oral contraceptive and St. John's Wort at the same time. The decrease in contraceptive effect lasts for up to two weeks after stopping St. John's Wort.

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

Harmonet may reduce the effect of other medications, such as:

• Oral anticoagulants (acenocoumarol).
• Analgesics (such as paracetamol and salicylates).
• Oral antidiabetic medications and insulin.
• Lamotrigine (for treating epilepsy and certain psychiatric disorders).

Similarly, Harmonet may increase the effect of other medications, such as:

• Beta-blockers like metoprolol (for treating high blood pressure).
• Theophylline (for treating asthma).
• Corticosteroids (such as prednisolone).
• Ciclosporin (immunosuppressant), increasing the risk of liver toxicity.
• Flunarizine (for treating migraines), increasing the risk of lactation.

You should not take Harmonet 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 an increase in liver enzyme levels (ALT).

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

Harmonet can be used again approximately 2 weeks after completing this treatment. See section “Do Not Take Harmonet”.

Laboratory Tests:

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

Inform your doctor if you are scheduled for any laboratory tests, as hormonal contraceptives may affect the results.

Pregnancy, Breastfeeding, and Fertility

Consult your doctor or pharmacist before using any medication.

You should not use this medication if you are pregnant or think you may be pregnant (see section 3 “How to Take Harmonet” for information on using Harmonet after pregnancy).

If you become pregnant, you should stop taking this medication immediately and consult your doctor (see section “When Not to Use Harmonet”).

You should not use this medication until the end of the breastfeeding period.

Use in Girls and Adolescents

The efficacy and safety of hormonal contraceptives have been established in women of childbearing age.

It is not recommended for use before the first menstruation (menarche).

Older Women

It is not recommended for use in postmenopausal women.

Driving and Operating Machinery

No effects on driving or operating machinery have been observed.

Harmonet Contains Lactose and Sucrose

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

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

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

This medication is for oral administration.

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

Before starting treatment with Harmonet, your doctor must perform a detailed medical history and a thorough medical examination, including blood pressure, and rule out the existence of pregnancy. They must also perform an examination of the breasts, liver, limbs, and pelvic organs (urinary bladder, vagina, uterus, and final part of the large intestine). Your doctor may also need to perform a cervical cytology (a painless scraping of the cervix to take cells for analysis). Your doctor will repeat this examination at 3 months after starting treatment, and then annually.

See section 2 “What you need to know before starting to take Harmonet”.

Instructions for correct medication administration

You must take the tablets orally, in the order indicated on the blister pack, approximately at the same time, every day, with some liquid if necessary. You must take one tablet daily for 21 consecutive days and then be without taking tablets for 7 days. Each subsequent pack will start after the 7-day period without taking tablets, during which a bleeding usually occurs. This bleeding, similar to menstruation, usually begins between days 2 to 3 after taking the last tablet, and may not have ended before starting the next pack.

Your doctor will indicate the duration of your treatment with this medication.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

Start of the first Harmonet pack

• When no hormonal contraceptive has been used the previous month

The treatment starts on the first day of the menstrual cycle (i.e., the first day of bleeding).

For example, if bleeding occurs on a Monday, you should start taking the first tablet on the same day, with the tablet marked “Lu”, and follow the arrow indicator for the subsequent tablets.

You can also start on days 2-7 of the menstrual cycle, in which case it is recommended to use a non-hormonal contraceptive method for birth control (e.g., condoms or spermicides) during the first 7 days of taking tablets.

• When taking another contraceptive and changing to Harmonet

You can start taking Harmonet the day after taking the last active tablet of your current pack of pills (this means there is no break in tablets). If your current pack of pills also contains inactive tablets, you can start taking Harmonet the day after taking the last active tablet. Never delay beyond the next day after finishing the usual break without tablets or the break in inactive tablets of your previous contraceptive.

• When changing from a method that only contains a progestogen (mini-pill, implant, intrauterine device (IUD), or injection)

You can stop taking the progestogen pill (mini-pill) on any day and start taking Harmonet the next day at the same time.

Start using this medication when it is your next injection or the day they remove your implant or intrauterine device (IUD).

In all these situations, make sure to also use an additional barrier method when having sex (e.g., condoms, spermicides) during the first 7 days of taking tablets.

• After a first-trimester abortion

You can start taking the tablets immediately. If you do so, you do not need to take any additional measures.

• Postpartum

If you are breastfeeding, you should not take this medication (See “Pregnancy, breastfeeding, and fertility”).

The use of tablets begins 28 days after delivery in women who are not breastfeeding or have had a second-trimester abortion. If you start later, you must use an additional barrier method during the first 7 days of taking tablets. However, if you have already had sex, you must rule out the possibility of pregnancy before taking the contraceptive or wait for your next menstrual period.

Subsequent cycles

After the 7-day break, continue with a new pack of Harmonet, starting on the same day of the week as the first pack.

What to do if bleeding appears during the 21 days of taking covered tablets

The appearance of bleeding during the 3 weeks of taking covered tablets is not a reason to interrupt treatment. A light bleeding usually resolves on its own. If the bleeding reaches a similar intensity to normal menstruation and lasts for more than 3 cycles, you should consult your doctor.

Absence of bleeding

If bleeding does not appear during the break, it is advisable to consult your doctor immediately to rule out the possibility of pregnancy if the covered tablets have not been taken regularly or if you have had vomiting or diarrhea during the cycle.

If you forgot to take Harmonet

The contraceptive protection may be reduced if you forget to take the tablets. In particular, if you forget in the first week of treatment and had sex in the previous week, there may be a possibility of becoming pregnant.

• If you have delayedless than 12 hoursin taking some tablets, the efficacy of the pill is maintained. Take it as soon as you remember and take the next tablets at your usual time.
• If you have delayedmore than 12 hoursin taking some tablets, the efficacy of the contraceptive may be reduced.
• • Take the last forgotten tablet as soon as you remember, even if this means taking two tablets in one day. Continue taking the next tablets at your usual time, but use an additional barrier method (e.g., condoms or spermicides) during the next 7 days.
  • If you take the last tablet before the 7 days required for using an additional barrier method have ended, start another pack immediately without leaving a break between them. You will not have your period until the end of the new pack, although you may experience spotting or bleeding during the days you take the tablets.
  • If you do not have your period at the end of the new pack, contact your doctor, who must check that you are not pregnant before starting the next pack.

Advice in case of vomiting and/or diarrhea

If you experience vomiting or diarrhea within 4 hours of taking the tablet, you should follow the advice for forgetting to take the tablets. If you do not want to change your usual tablet-taking schedule, you must take the additional tablets needed from another pack.

How to delay a period

To delay a period, you must start a new pack immediately after finishing the current pack, without any break. Periods may be delayed as long as you want, but not beyond the end of the second pack. During this time, you may experience bleeding or spotting. Subsequently, regular tablet-taking is resumed after the usual 7-day break without tablets.

If you take more Harmonet than you should

You may experience nausea, vomiting, drowsiness, breast tenderness, dizziness, and vaginal bleeding; treatment will consist of suspending the administration of this medication. Contact your doctor or pharmacist as soon as possible.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service. Phone 915 620 420, indicating the medication and the amount used.

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

Like all medicines, this medicine 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 change that you think may be related to Harmonet, 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 Harmonet”.

Contact a doctor immediately if you experience any of the following angioedema symptoms: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing (also see “Warnings and precautions”).

The use of hormonal contraceptives has also been associated with an increased risk of:

• Cervical intraepithelial neoplasia (abnormal cells on the surface of the uterus) and cervical cancer (cancer of the cervix).
• Diagnosis of breast cancer (see “Be especially careful with Harmonet”).
• Benign liver tumors (e.g. nodular focal hyperplasia, hepatic adenomas).

Side effects are listed below, classified by frequency according to the following criterion:

Very common: may affect more than 1 in 10 patients.

Common: may affect up to 1 in 10 patients.

Uncommon: may affect up to 1 in 100 patients.

Rare: may affect up to 1 in 1,000 patients.

Very rare: may affect up to 1 in 10,000 patients.

Frequency not known: cannot be estimated from available data.

Infections and infestations

Common:Vaginitis (vaginal inflammation), including candidiasis

(vaginal yeast infection).

Malignant or unspecified neoplasms

Very rare:Liver carcinomas (malignant liver tumors).

Immune system disorders

Rare:Allergic reactions such as urticaria (hives), angioedema

(swelling of the face, lips, mouth, and in rare cases

accompanied by difficulty breathing, dizziness, and even loss

of consciousness).

Very rare:Worsening of systemic lupus erythematosus (autoimmune disease).

Metabolic and nutritional disorders

Uncommon:Changes in appetite (increase or decrease).

Rare:Glucose intolerance.

Very rare:Worsening of porphyria (familial metabolic disorder).

Mental disorders

Common:Changes in mood, including depression; changes in libido

(sex drive).

Nervous system disorders

Very common:Headache, including migraines (migraines).

Common:Nervousness, vertigo.

Very rare:Worsening of chorea (involuntary movements).

Eye disorders

Rare:Lens intolerance.

Very rare:Eye anomalies and visual disorders.

Vascular disorders

Uncommon:Increased blood pressure.

Rare:Formation of 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 section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

Very rare:Worsening of varicose veins.

Gastrointestinal disorders

Common:Nausea, vomiting, abdominal pain.

Uncommon:Colic, feeling of bloating.

Very rare:Pancreatitis (inflammation of the pancreas); ischemic colitis

(certain types of colon inflammation).

Frequency not known:Inflammatory bowel disease (Crohn's disease, ulcerative colitis).

Hepatobiliary disorders (liver and bile ducts)

Rare:Cholestatic jaundice (yellowing of the white of the eye and skin due to bile stasis).

Very rare:Biliary tract disorders (including gallstones).

Frequency not known:Liver damage (e.g. hepatitis, abnormal liver function).

Skin and subcutaneous tissue disorders

Common:Acne.

Uncommon:Rash (skin eruption), melasma (skin spots) that may

persist, hirsutism (excessive hair growth), alopecia (hair loss).

Rare:Nodular erythema (a type of skin inflammation with the appearance

of nodules on the legs).

Very rare:Multi-form erythema (a type of skin inflammation).

Renal and urinary disorders

Very rare:Haemolytic uraemic syndrome (renal disease with

blood alterations).

Reproductive and breast disorders

Very common:Vaginal bleeding or spotting.

Common:Abdominal pain, breast tenderness, nipple discharge, dysmenorrhea

(painful menstruation), changes in menstrual flow, changes in

vaginal discharge, cervical ectopy (alteration of the cervical mucosa),

amenorrhea (absence of menstruation).

General disorders

Common:Fluid retention, edema (swelling).

Other

Common:Changes in weight (increase or decrease).

Uncommon:Increased blood pressure, changes in lipid levels in the blood, including

hypertriglyceridemia (high levels of fatty acids in the blood).

Rare:Decreased folate levels in the blood.

Do not be alarmed by these side effects, as it is very likely that none of them will occur.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 Medicinal Products for Human Use: https://www.notificaram.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep the blister pack in the outer packaging to protect it from light.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Do not dispose of medications through the drains or trash. Dispose of empty packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of empty packaging and unused medications. By doing so, you will help protect the environment.

Composition of Harmonet

The active principles of Harmonet are: 0.075 mg of gestodeno and 0.02 mg of ethinylestradiol.

The other components (excipients) are: sucrose, lactose, cornstarch, povidone K-25, magnesium stearate, povidone K-90, macrogol 6,000, calcium carbonate, talc, and glycolated beeswax.

Appearance of the product and contents of the packaging

It is presented in calendar packaging that contains 1 or 3 blisters with 21 coated tablets per blister.

The blisters are packaged in an aluminum bag that contains a packet with a desiccant (silica gel).

After opening the aluminum bag, the desiccant can be removed.

Holder of the marketing authorization

Wyeth Farma, S.A.

Ctra. Burgos, Km 23. Algete, Km 1.

San Sebastián de los Reyes – Madrid

Spain

Responsible for Manufacturing

Pfizer Ireland Pharmaceuticals

Little Connell

Newbridge

County Kildare

Ireland

Local Representative

Pfizer, S.L.

Avda. de Europa, 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid) Spain

Last review date of this leaflet: November 2022

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