MINESSE 0.06 mg/0.015 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

MINESSE0.06mg/0.015 mg film-coated tablets

Gestodene/Ethinylestradiol

Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive after a break 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").

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed to you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

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

1. What MINESSE is and what it is used for

• MINESSE is an oral contraceptive pill used to prevent pregnancy.
• Each of the 24 pale yellow tablets contains a small amount of two different female hormones, called gestodene and ethinylestradiol.
• The 4 white tablets do not contain active ingredients and are called placebo tablets.
• Contraceptive pills that contain two hormones are called "combined" pills

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

Do not takeMINESSE

You should not use MINESSE 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 gestodene or ethinylestradiol or any of the other components of this medicine (listed in section 6).

• If you have (or have ever had) a blood clot in a blood vessel of the legs (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.
• If you know you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies.
• If you need an operation or if you spend a lot of time without getting up (see section "Blood clots").
• If you have ever had a heart attack or a stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary symptoms of 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 blood vessel damage
  • very high blood pressure
  • very high levels of fat in the blood (cholesterol or triglycerides)
  • a condition called hyperhomocysteinemia.
• If you have (or have ever had) a type of migraine called "migraine with aura".
• If you have (or have ever had) a benign tumor (called focal nodular hyperplasia or hepatic adenoma) or malignant liver tumor or if you have recently had liver disease. In such cases, your doctor will tell you to stop the pills until your liver is working normally.
• If you have vaginal bleeding of unknown cause.
• If you have breast cancer or cancer of the uterus or any cancer that is sensitive to female sex hormones or if you are suspected of having it.
• If you have Hepatitis C and are taking certain antiviral medications such as ombitasvir/paritaprevir/ritonavir/dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also section "Other medicines and MINESSE").

Warnings and precautions

Tell your doctor if you suffer from any of the following conditions.

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

• If any blood test has shown that you have high levels of sugar, high levels of cholesterol and fats, or high levels of prolactin (a hormone that stimulates milk production).
• If you are obese.
• If you have a benign breast tumor or if a close relative has ever had breast cancer.
• If you have a disease of the uterus (uterine dystrophy).
• If you suffer from epilepsy (see also 'Use of other medicines').
• If you suffer from migraines.
• If you have hearing loss due to a disorder called otosclerosis.
• If you suffer from asthma.
• 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 (an inherited disease of red blood cells).
• If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you need an operation or spend a lot of time without getting up (see section 2 "Blood clots").
• If you have just given birth, you are at a higher risk of blood clots. You should ask your doctor when you can start taking MINESSE after childbirth.
• If you have inflammation of the veins that are under the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you or a close relative (parents, grandparents, brothers, sisters, ...) have ever had a disease with a tendency to produce blood clots (in the leg, lung, or other organs, heart attacks, strokes).
• If during any pregnancy, or when using another contraceptive pill, you have suffered from a skin disease that causes itching, red spots, and blisters (pregnancy herpes).
• If you have had color spots on your face (chloasma) during pregnancy or when using another contraceptive pill. In this case, avoid direct sun exposure when using MINESSE.
• If you suffer from gallstones.
• If you suffer from any heart, liver, or kidney disease.
• If you suffer from depression.
• If you have high blood pressure.
• If you suffer from a disease known as chorea, characterized by involuntary, irregular, and sudden movements.
• If you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema.

Psychiatric disorders:

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

Do not hesitate to ask your doctor or pharmacist for advice if you have any doubts about the use of MINESSE.

BLOOD CLOTS

The use of a combined hormonal contraceptive like MINESSE increases your risk of blood clots compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In the veins (this is called "venous thrombosis", "venous thromboembolism" or VTE).
• In the arteries (this is called "arterial thrombosis", "arterial thromboembolism" or ATE).

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

It is important to remember that the overall risk of a harmful blood clot due to MINESSE is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if 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 the veins (venous thrombosis). However, these side effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a 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 in which you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medicine or a different one) after an interruption of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking MINESSE, your risk of a blood clot returns to normal within 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 MINESSE is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will have a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 will have a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive that contains gestodene like MINESSE, about 9-12 women will have 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

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

• If you are overweight (body mass index or BMI over 30 kg/m2).
• If any of your close relatives have had a blood clot in the leg, lung, or other organs at a young age (i.e., before the age of about 50). In this case, you may have a hereditary disorder of blood clotting.
• If you need to have surgery or if you spend a lot of time without getting up due to an injury or illness or if you have a leg in a cast. You may need to stop using MINESSE several weeks before surgery or while you have reduced mobility. If you need to stop using MINESSE, ask your doctor when you can start using it again.
• As you get older (especially above about 35 years).
• If you have given birth in the last few weeks.

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

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

It is important to inform your doctor if you suffer from any of the above conditions, even if you are not sure. Your doctor may decide that you should stop using MINESSE.

If any of the above conditions change while you are using MINESSE, for example, a close relative experiences a thrombosis without 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 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 important to note that the risk of a heart attack or stroke due to MINESSE is very small, but it can increase:

• With age (above about 35 years).
• If you smoke.When using a combined hormonal contraceptive like MINESSE, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

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

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

MINESSE and cancer

The detection of breast cancer is slightly higher in women who use combined pills, but it is not known if this is caused by the pill. It is possible that these women have simply been examined more thoroughly and more frequently, or that breast cancer has been detected earlier.

Studies indicate cases of cervical cancer in women who use combined pills for a relatively long time. Currently, it is not known if this is caused by the pill or if it is related to sexual behavior (e.g., frequent changes of partner) and other factors.

In rare cases, benign liver tumors, and in even fewer cases, malignant liver tumors, have been reported in users of the pill. Consult your doctor if you suffer from any of these conditions.

3. How to take MINESSE

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

Dosage

• Start taking MINESSE with the first tablet, located next to the word "START".
• Puncture the empty compartment in the center of the blister pack corresponding to the day of the week you took the first tablet. This will be the starting day for any new blister pack. It will also be the day of the week you should take the tablets with the colored edge (numbers 8, 15, and 22). This will help you verify that you are taking the tablets correctly.
• Each blister pack contains 28 tablets. Take one tablet at the same time every day, for 28 consecutive days, following the direction indicated by the arrows, without skipping any, as follows: take one active pale yellow tablet every day for the first 24 days, and then one white placebo tablet each day for the last 4 days.
• After taking the last tablet, continue taking MINESSE the next day, starting a new blister pack without leaving an interval between blister packs. Each blister pack should be started on the same day of the week. Since there is no pause in taking the medication, it is essential that you already have the next blister pack before finishing the previous one.
• Bleeding usually starts two or three days after taking the last active pale yellow tablet of the blister pack and may not have ended before starting the next blister pack.

Method and route of administration

Swallow each tablet with a large glass of water.

If you have not taken any hormonal contraceptive in the previous month

Take the first tablet on the first day of your menstruation.

If you are switching from another contraceptive pill

Finish the blister pack you have started (if your current pill blister pack also contains hormone-free tablets, do not take them). Start the MINESSE blister pack the next day, without leaving any day without taking a pill.

If you were using a progestin-only method (progestin-only pill, injectable, or implant)

• switching from a progestin-only pill: you can start MINESSE at any time during the menstrual cycle, the day after stopping the progestin-only pill
• switching from an implant: start MINESSE on the day of implant removal
• switching from an injectable contraceptive: start MINESSE on the day corresponding to the next injection

In any case, it is necessary to use a barrier contraceptive method (e.g., a condom) during the first 7 days of taking the pill.

If you are starting MINESSE after an abortion or miscarriage during the first trimester

You can usually start immediately, but follow your doctor's advice before doing so.

If you are starting MINESSE after giving birth or an abortion in the second trimester

Like any other contraceptive pill, MINESSE should not be started before 21 to 28 days after giving birth or an abortion, due to an increased risk of blood clots. If you start later, it is recommended to use a barrier contraceptive method during the first 7 days of taking the pill. If you have had sexual intercourse before starting MINESSE, make sure you are not pregnant or wait until your next menstruation.

Always ask your doctor for advice.

Duration of use

Your doctor will indicate how long you should use this pill.

If you take more MINESSE than you should

Overdose may cause gastrointestinal problems (e.g., nausea, vomiting, abdominal pain), mastalgia, dizziness, drowsiness/fatigue, and menstrual cycle disorders (bleeding). Ask your doctor for advice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take MINESSE

If you realize you forgot a pale yellow tablet within 12 hours of the time you normally take it, take the forgotten tablet immediately and continue normally, taking the next tablet at the usual time until you finish the blister pack.

If you realize you forgot a pale yellow tablet after 12 hours of the time you normally take it, there is a risk of becoming pregnant. In this case:

• take the last forgotten tablet immediately, even if it means taking 2 tablets on the same day
• continue taking the contraceptive until you finish the blister pack
• also use a barrier contraceptive method (condom, spermicides...) for the next 7 days

If you have forgotten one or more pale yellow tablets in a blister pack and do not get the bleeding that should occur when taking the white tablets, you may be pregnant.

If you have forgotten one or more white tablets, you are still protected as long as it has not been more than 4 days between the last active pale yellow tablet of the current blister pack and the first active pale yellow tablet of the next blister pack.

Ask your doctor for advice.

If you experience vomiting or severe diarrhea within 4 hours of taking a tablet, a situation similar to forgetting a tablet occurs. After vomiting or diarrhea, take another tablet from a reserve blister pack as soon as possible. If possible, take it within 12 hoursof the usual time you take your contraceptive. If this is not possible or more than 12 hours have passed, follow the advice in the section "If you forget to take MINESSE".

If these episodes of vomiting or severe diarrhea recur over several days, you should use a barrier contraceptive method (condom, spermicide...) until the start of the next blister pack. Ask your doctor for advice.

4. Possible side effects

Like all medications, MINESSE can cause side effects, although not all people experience them. If you experience any side effect, especially if it is severe and persistent, or have any change in health that you think may be due to MINESSE, 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 taking MINESSE".

If you experience any of the following serious side effects, seek medical attention immediately:

• A serious allergic reaction – frequency not known

Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat, skin rash, and hives.

• Angioedema – frequency not known

Symptoms include swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing (see also section "Warnings and precautions").

• Retinal vein thrombosis – frequency not known
• Symptoms occur more frequently in one eye.
• Painless blurred vision that can progress to vision loss.
• Sudden loss of vision.

• Hemolytic uremic syndrome (a condition that affects the blood and kidneys) – frequency not known

Symptoms include vomiting, diarrhea (which may be bloody), fever, feeling of weakness, and urinating less frequently than usual.

• Pancreatitis – rare (may affect up to 1 in 10,000 people)

Symptoms include severe upper abdominal pain that can radiate to the back.

• Erythema multiforme – frequency not known

Symptoms include a skin rash with pink-red spots, especially on the palms of the hands or soles of the feet, which can form blisters. Ulcers may also appear in the mouth, eyes, or genitals, as well as fever.

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

• headache, including migraine
• abdominal pain
• breast pain
• breast tenderness
• very light or absent menstruation

Common (may affect up to 1 in 10 people):

• vaginal infection, including candidiasis
• bleeding between menstruations
• mood changes, including depression and changes in sexual appetite
• nervousness or dizziness
• nausea, vomiting
• feeling of bloating
• acne
• painful menstruation
• changes in menstrual flow or cervical changes (ectropion)
• fluid retention in tissues or edema (acute fluid retention)
• weight gain or loss
• skin rash
• hair loss

Uncommon (may affect up to 1 in 100 people):

• increased appetite
• decreased appetite
• excessive body hair
• skin discoloration (chloasma)
• changes in laboratory test results: increased cholesterol, triglycerides, or blood pressure
• nipple discharge
• breast enlargement
• worsening of varicose veins

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

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

• In a leg or foot (i.e., DVT).
• In a lung (i.e., PE).
• Heart attack.
• Stroke.
• Transient ischemic attack (TIA) or temporary stroke-like symptoms.
• Blood clots in the liver, stomach/intestine, kidneys, or eye.

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).

• liver or biliary disorders (such as hepatitis or abnormal liver function)
• gallbladder disease, including gallstones and worsening of this condition

Frequency not known (cannot be estimated from available data):

• benign liver tumor (called focal nodular hyperplasia or hepatic adenoma) or malignant liver tumor
• worsening of an immune system disease (lupus), liver disease (porphyria), or a disease called chorea characterized by irregular, sudden, and involuntary movements
• obstruction of bile flow in the liver or worsening of this condition
• inflammatory or ischemic intestinal disease, symptoms include abdominal cramps and pain, diarrhea (which may be bloody), or weight loss
• intolerance to a sugar called glucose
• intolerance to contact lenses
• abdominal cramps
• jaundice (yellowing of the skin or eyes)
• red and painful lumps under the skin (erythema nodosum)
• inflammation of the optic nerve that can lead to partial or total loss of vision

If you think any of the side effects you are experiencing is serious, or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of MINESSE

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

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

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Packaging Content and Additional Information

Composition ofMINESSE

Pale yellow tablet:

The active ingredients are: 0.06 mg of gestodene and 0.015 mg of ethinylestradiol.

The other components are: lactose monohydrate, microcrystalline cellulose, magnesium stearate, potassium polacrylate, polyethylene glycol 1450, purified water, glycolized montan wax, Opadry Yellow [hydroxypropylmethylcellulose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172)].

White tablet:

It does not contain active ingredient (placebo).

The other components are: lactose monohydrate, microcrystalline cellulose, magnesium stearate, potassium polacrylate, polyethylene glycol 1500, purified water, glycolized montan wax, Opadry White [hydroxypropylmethylcellulose, hydroxypropylcellulose, titanium dioxide (E171), polyethylene glycol].

Appearance of the Product and Packaging Content

MINESSE is presented in the form of film-coated tablets.

Each package contains 1, 3 or 6 blisters, each with 28 tablets (24 active pale yellow tablets with "60" on one side and "15" on the other side of the tablet and 4 inactive white tablets). Each blister is packaged in an aluminum bag containing a sachet with silica gel desiccant. After opening each bag, which contains the blister, the desiccant sachet should be discarded.

Only some package sizes may be marketed.

Marketing Authorization Holder

Wyeth Farma, S.A.

Ctra. Burgos, Km.23

San Sebastián de los Reyes

28700-Madrid

Manufacturer

Pfizer Ireland Pharmaceuticals Unlimited Company,

Little Connell,

Newbridge,

Co. Kildare,

Ireland

Local Representative

Pfizer, S.L.

Avda. de Europa, 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Date of the Last Revision of this Leaflet: February 2023

Other Sources of Information

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