Minisse 0.06 mg/0.015 mg film-coated tablets: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

MINESSE 0.06 mg/0.015 mg film-coated tablets

Gestodene/Ethinylestradiol

Important things you need 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 developing a blood clot in veins and arteries, especially during 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 be experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

What MINESSE is and what it is used for
What you need to know before taking MINESSE
How to take MINESSE
Possible side effects
How to store MINESSE
Contents of the pack and other 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 any active ingredients and are referred to as placebo tablets.
Contraceptive pills that contain two hormones are called "combined" pills.

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

General considerations

Before you start taking MINESSE, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out some additional tests.

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

This leaflet describes several situations in which you should stop using MINESSE, or in which the effectiveness of MINESSE may be reduced. In such situations, you should not have sexual intercourse or you must use additional non-hormonal contraceptive precautions, for example, use of a condom or another barrier method. Do not use the rhythm method or temperature method. These methods may not be reliable since MINESSE alters the monthly changes in body temperature and cervical mucus.

MINESSE, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted disease.

Do not take MINESSE

You must 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 which alternative method of contraception would be more suitable.

If you are allergic to gestodene or ethinylestradiol, or to 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 in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs.
If you know you have a disorder affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
If you require surgery or if you will be immobile for a long time (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 causing severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).
If you have any of the following conditions that may increase your risk of developing 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 hyperhomocysteinaemia.
If you have (or have ever had) a type of migraine called “migraine with aura”.
If you have (or have ever had) a benign (called focal nodular hyperplasia or hepatic adenoma) or malignant liver tumour, or if you have recently had liver disease. In such cases, your doctor will instruct you to stop taking the tablets until your liver is functioning normally.
If you have vaginal bleeding of unknown cause.
If you have breast or uterine cancer or any cancer sensitive to female sex hormones, or if such cancer is suspected.
If you have Hepatitis C and are taking certain antiviral medicines such as ombitasvir/paritaprevir/ritonavir with dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and MINESSE”).

Warnings and precautions

When should you consult your doctor?

Seek urgent medical assistance

If you notice possible signs of a blood clot which may mean you are experiencing a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section “Blood clot (thrombosis)” below).

For a description of the symptoms of these serious adverse effects, see “How to recognize a blood clot”.

Tell your doctor if you have any of the following conditions.

If any of these conditions develop or worsen while you are using MINESSE, you should also inform your doctor.

If blood tests have shown that you have high levels of sugar, high cholesterol and fat levels, or elevated levels of prolactin (a hormone that stimulates milk production).
If you are obese.
If you have a benign breast tumor or if any close relative has ever had breast cancer.
If you have a uterine disorder (uterine dystrophy).
If you suffer from epilepsy (see also 'Use of other medicines').
If you suffer from migraine.
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 affecting your body's natural defense system).
If you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure).
If you have sickle cell anemia (an inherited red blood cell disorder).
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 require surgery or will be immobile for long periods (see section 2 “Blood clots”).
If you have recently given birth, you are at increased risk of blood clots. Ask your doctor when you can start taking MINESSE after delivery.
If you have inflammation of veins beneath the skin (superficial thrombophlebitis).
If you have varicose veins.
If you or a close relative (parents, grandparents, siblings) have ever had a condition that tends to cause blood clots (in the leg, lung, or elsewhere, heart attacks, strokes).
If during a pregnancy or while using another contraceptive pill, you experienced a skin condition causing itching, red spots, and blisters (prurigo gestationis).
If you have developed facial pigmentation (chloasma) during pregnancy or while using another contraceptive pill. In this case, avoid direct sun exposure while using MINESSE.
If you suffer from gallstones.
If you have any heart, liver, or kidney disease.
If you suffer from depression.
If you have high blood pressure.
If you have a condition 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 hives with possible breathing difficulties, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema.

Psychiatric disorders:

Some women using hormonal contraceptives such as Minesse have reported depression or a depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor for further medical advice as soon as possible.

Do not hesitate to seek advice from your doctor or pharmacist if you have any questions about the use of MINESSE.

BLOOD CLOTS

Using a combined hormonal contraceptive such as MINESSE increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

In veins (called “venous thrombosis”, “venous thromboembolism” or VTE).
In arteries (called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, there may be serious long-term effects or, very rarely, they may 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 assistance if you notice any of the following signs or symptoms.

Are you experiencing any of these signs?	What might you be suffering from?
Swelling in one leg or foot, or along a vein in the leg or foot, especially when accompanied by: Pain or tenderness in the leg, which may only be noticeable when standing or walking. Increased warmth in the affected leg. Skin discoloration of the leg, e.g., turning pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without known cause or rapid breathing. Sudden cough without clear cause, possibly bringing up blood. Sharp chest pain that may worsen when breathing deeply. Severe dizziness or lightheadedness. Rapid or irregular heartbeat. Severe abdominal pain. If you are unsure, consult a doctor, as some of these symptoms such as cough or shortness of breath may be mistaken for a milder condition like a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: Sudden loss of vision, or Painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye).
Chest pain, discomfort, pressure, heaviness. Feeling of tightness or fullness in the chest, arm, or below the sternum. Feeling of fullness, indigestion, or suffocation. Upper body discomfort radiating to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Extreme weakness, anxiety, or shortness of breath. Rapid or irregular heartbeat.	Heart attack.
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. Sudden confusion, difficulty speaking or understanding speech. Sudden vision problems in one or both eyes. Sudden difficulty walking, dizziness, loss of balance or coordination. Sudden, severe, or prolonged headache without known cause. Loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
Swelling and slight bluish discoloration of a limb. Severe abdominal pain (acute abdomen).	Blood clots blocking other blood vessels.

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 events are rare. They occur more frequently during the first year of using a combined hormonal contraceptive.
If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism (PE).
Very rarely, a clot may form in a vein of another organ such as the eye (retinal vein thrombosis).

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

The risk of developing a blood clot in a vein is higher during the first year of first-time use of a combined hormonal contraceptive. The risk may also be increased if you restart 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 remains slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking MINESSE, your risk of developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

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

The overall risk of developing a blood clot in the leg or lung (DVT or PE) with MINESSE is low.

Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.
Among 10,000 women who use a combined hormonal contraceptive containing gestodene, such as MINESSE, between about 9 and 12 women will develop a blood clot in one year.
Your risk of developing a blood clot will depend on your personal medical history (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/ring and who are not pregnant	About 2 out of 10,000 women
Women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate	About 5–7 out of 10,000 women
Women who use MINESSE	About 9–12 out of 10,000 women

Factors that increase your risk of a blood clot in a vein

The risk of having a blood clot with MINESSE is small, but certain conditions increase this risk. Your risk is higher:

If you are overweight (body mass index or BMI above 30 kg/m²).
If any of your close relatives has had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years of age). In this case, you might have an inherited blood clotting disorder.
If you require surgery or will be immobile for a long time due to injury, illness, or if your leg is in a cast. You may need to stop taking MINESSE several weeks before surgery or while you are less mobile. If you need to stop taking MINESSE, ask your doctor when you can start again.
With increasing age (especially over about 35 years).
If you have given birth within the last few weeks.

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

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

It is important to inform your doctor if you have any of the above conditions, even if you are unsure. Your doctor may decide that you need to stop taking MINESSE.

If any of the above conditions change while you are using MINESSE—for example, a close relative experiences a thrombosis without a known cause, or you gain significant 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 lead to a heart attack or stroke.

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

It is important to note that the risk of heart attack or stroke while using MINESSE is very small, but it may increase:

With age (over 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 recommend that you use a different type of contraceptive.
If you are overweight.
If you have high blood pressure.
If a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have an increased risk of 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 suffer from migraines, especially migraines with aura.
If you have a heart condition (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, your risk of developing a blood clot may be further increased.

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

MINESSE and cancer

Breast cancer detection is slightly higher in women who use combined oral contraceptives, but it is not known whether the pill causes this. It is possible that these women have simply been examined more thoroughly and more frequently, meaning breast cancer is detected earlier.

Studies indicate an increased incidence of cervical cancer in women who use combined oral contraceptives for a relatively long time. It is currently unknown whether this is caused by the pill or related to sexual behavior (e.g., frequent partner changes) and other factors.

Rare cases of benign liver tumors, and even rarer cases of malignant liver tumors, have been reported in users of oral contraceptives. Consult your doctor if you experience unusually severe abdominal pain.

Bleeding between periods

During the first few months of taking MINESSE, you may experience unexpected bleeding (bleeding outside the placebo pill days). If this bleeding persists beyond a few months, or begins after several months, your doctor should investigate the cause.

What to do if you do not have your period during the placebo days

If you have taken all the light yellow active tablets correctly, have not vomited or had severe diarrhea, and have not taken any other medications, it is very unlikely that you are pregnant.

If you miss two consecutive expected periods, you may be pregnant. Contact your doctor immediately. Do not start the next pack until you are certain you are not pregnant.

If you do not have your period after stopping MINESSE

After stopping MINESSE, it may take some time before your period returns. If this continues for a prolonged period, consult your doctor.

Other medicines and MINESSE

Always inform your doctor about any medications or herbal remedies you are using, including any medication obtained without a prescription. Also inform any other doctor or dentist who prescribes a medication for you (or your pharmacist) that you are taking MINESSE. They will advise you whether you need to take additional contraceptive precautions (for example, a condom), and if so, for how long.

Some medicines can affect the blood levels of MINESSE, may make it less effective in preventing pregnancy, and may cause unexpected bleeding.

These include:

Medicines used to treat:
HIV and hepatitis C virus infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors)
Epilepsy (e.g. phenobarbital, phenytoin, primidone, carbamazepine, topiramate, felbamate)
Tuberculosis (e.g. rifabutin, rifampicin)
Fungal infections (griseofulvin, azole antifungals, e.g. itraconazole, voriconazole, fluconazole)
Bacterial infections (macrolide antibiotics, e.g. clarithromycin, erythromycin)
Certain heart conditions, high blood pressure (calcium channel blockers, e.g. verapamil, diltiazem)
Arthritis, osteoarthritis (etoricoxib)
Sleep disorders (modafinil)

The herbal remedy St. John’s wort, used to treat certain types of depression
Grapefruit juice

Troleandomycin may increase the risk of intrahepatic cholestasis (bile retention in the liver) when taken with combined oral contraceptives (COCs).

MINESSE may affect the action of other medicines, e.g.:

Lamotrigine
Cyclosporine
Theophylline
Tizanidine

Do not take MINESSE if you have hepatitis C and are taking certain medicines for hepatitis C such as those containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause increases in liver function test results (elevated liver enzyme ALT).

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

MINESSE can be restarted approximately 2 weeks after completion of this treatment. See section “Do not take MINESSE”.

Consult your doctor or pharmacist before using any medicine.

Pregnancy

If you are pregnant, there is no reason for your doctor to prescribe contraceptives.

If you discover you are pregnant while taking MINESSE, stop taking the pill and consult your doctor.

If you plan to become pregnant, consult your doctor.

Consult your doctor or pharmacist before using any medicine.

Breast-feeding

It is not recommended that you use MINESSE during breast-feeding.

If you wish to breast-feed, your doctor will recommend an appropriate method of contraception.

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

The influence of MINESSE on the ability to drive and use machines has not been studied. It is unlikely that MINESSE affects your ability to drive or use machines. Dizziness has been reported as an adverse effect. If you experience dizziness, do not drive or operate machinery until symptoms resolve.

MINESSE contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. HOW TO TAKE MINESSE

Follow exactly the instructions for administration of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

Begin taking MINESSE with tablet number 1, located next to the word "START".
Pierce the empty compartment in the center of the blister pack corresponding to the day of the week on which 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 on which you should take tablets number 8, 15, and 22, which have a colored edge. 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. Specifically: take one pale yellow active tablet each day for the first 24 days, followed by one white placebo tablet for each of the last 4 days.
After taking the last tablet, continue taking MINESSE the next day by starting a new blister pack without any break between packs. Each new blister pack should be started on the same day of the week. Since there is no interruption in taking the medication, it is important that you already have the next blister pack available before finishing the current one.
Bleeding usually begins two or three days after taking the last pale yellow tablet in the blister pack and may not have finished 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 menstrual period.

If you are switching from another oral contraceptive

Finish the current blister pack you are on (if your current contraceptive pack contains hormone-free tablets, do not take them). Start the MINESSE blister pack the next day, without leaving any gap in tablet intake.

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

Switching from a progestogen-only pill: You may start MINESSE at any time during your menstrual cycle, the day after stopping the progestogen-only pill.
Switching from an implant: Start MINESSE on the day the implant is removed.
Switching from an injectable contraceptive: Start MINESSE on the day the next injection would have been due.

In all cases, 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 a first-trimester abortion

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

If you are starting MINESSE after childbirth or second-trimester abortion

Like any other oral contraceptive, MINESSE should not be started earlier than 21 to 28 days after childbirth or second-trimester 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, ensure you are not pregnant or wait until your next menstrual period.

Always seek advice from your doctor.

Duration of use

Your doctor will advise you on 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), breast tenderness, dizziness, drowsiness/fatigue, and menstrual cycle disturbances (bleeding). Seek advice from your doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take MINESSE

If you forget to take a tablet, you risk becoming pregnant

If you realize you missed a pale yellow tablet within 12 hours of your usual time, take the missed tablet immediately and continue taking the following tablets at your usual time until the end of the pack.

If you realize you missed a pale yellow tablet more than 12 hours after your usual time, there is a risk of pregnancy. In this case:

take the missed tablet immediately, even if this means taking two tablets on the same day
continue taking your contraceptive tablets as usual until the end of the pack
additionally, use a barrier contraceptive method (condom, spermicides, etc.) for the next 7 days
if this 7-day period extends beyond the last pale yellow tablet, discard all remaining tablets and start the next pack immediately

If you have missed one or more pale yellow tablets in a pack and do not experience the expected bleeding during the white tablet intake period, you may be pregnant.

If you have missed one or more white tablets, you are still protected provided that no more than 4 days pass between the last pale yellow tablet of the current pack and the first pale yellow tablet of the next pack.

Consult your doctor for advice.

If you experience vomiting or acute diarrhea within 4 hours after taking a tablet, this situation is similar to missing a tablet. After vomiting or diarrhea, take another tablet from a备用 pack as soon as possible. Ideally, take it within 12 hours of your usual time for taking the contraceptive. If this is not possible or more than 12 hours have passed, follow the instructions in the section “If you forgot to take MINESSE”.

If episodes of vomiting or acute diarrhea recur over several days, you should use a barrier contraceptive method (condom, spermicide, etc.) until starting the next pack. Consult your doctor for advice.

4. Possible adverse effects

Like all medicines, MINESSE may cause adverse effects, although not everyone experiences them. If you experience any adverse effect, especially if it is severe and persistent, or if you have any change in your health that you think may be due to MINESSE, consult your doctor.

All women taking combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism, VTE) or blood clots in the arteries (arterial thromboembolism, TEA). For more detailed information about the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting to take MINESSE”.

If you experience any of the following serious adverse effects, seek immediate medical attention:

A serious allergic reaction – frequency unknown

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

Angioedema – frequency unknown

Symptoms include swelling of the face, tongue and/or throat and/or difficulty swallowing or hives possibly accompanied by difficulty breathing (see also section “Warnings and precautions”).

Retinal vein thrombosis – frequency unknown
Symptoms usually occur in one eye.
Painless blurred vision that may progress to vision loss.
Sudden loss of vision.
Haemolytic uraemic syndrome (a condition affecting the blood and kidneys) – frequency unknown

Symptoms include vomiting, diarrhoea (which may be bloody), fever, feeling weak and urinating less than usual.

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

Symptoms include severe upper abdominal pain that may extend to the back.

Erythema multiforme – frequency unknown

Symptoms include a skin rash with red-pink spots, especially on the palms of the hands or soles of the feet, which may form blisters. Mouth, eye or genital ulcers may also appear, 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 periods or absence of menstruation

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

vaginal infection including vaginal candidiasis
bleeding between periods
mood changes including depression and changes in sex drive
nervousness or dizziness
nausea, vomiting
sensation of bloating
acne
painful periods
changes in menstrual blood flow
changes in vaginal discharge or cervical changes (ectropion)
fluid retention in tissues or oedema (acute fluid retention)
weight gain or weight loss
skin rash
hair loss

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

increased appetite
decreased appetite
excessive body hair growth
facial pigmentation spots (chloasma)
changes in laboratory test results: increased cholesterol or triglyceride levels, or increased blood pressure
nipple discharge
increased breast size
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.
Mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA).
Blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information about 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 tumour (called focal nodular hyperplasia or hepatic adenoma) or malignant liver tumour
worsening of an immune system disease (lupus), a liver disease (porphyria), or a condition called chorea characterised by irregular, sudden, involuntary movements
obstruction of bile flow in the liver or worsening of this condition
inflammatory or ischaemic bowel disease; symptoms include abdominal cramps and pain, diarrhoea (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, painful lumps under the skin (erythema nodosum)
inflammation of the optic nerve that may lead to partial or total vision loss

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of MINESSE

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

Do not use this medicine after the expiry date stated on the packaging and blister after "CAD". The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of MINESSE

Pale yellow tablet:

The active substances are: 0.06 mg gestodene and 0.015 mg ethinylestradiol.

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

White tablet:

Contains no active substance (placebo).

The other components are: monohydrate lactose, microcrystalline cellulose, magnesium stearate, polacriline potassium, polyethylene glycol 1500, purified water, glycol monostearate, Opadry White [hypromellose, hydroxypropylcellulose, titanium dioxide (E171), polyethylene glycol].

Appearance of the product and contents of the pack

MINESSE is presented as film-coated tablets.

Each pack contains 1, 3 or 6 blisters, each with 28 tablets (24 pale yellow active tablets imprinted with “60” on one side and “15” on the other side of the tablet, and 4 inactive white tablets). Each blister is packed in an aluminium pouch containing a sachet of silica gel desiccant. After opening each pouch containing the blister, the desiccant sachet should be discarded.

Only certain pack sizes may be marketed.

Marketing Authorisation 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 most recent revision of this leaflet: February 2023

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/