MINESSE Фильм-coated таблетки

Содержание инструкции

1. MINESSE
   1. Cos’è MINESSE e a cosa serve
   2. Cosa deve sapere prima di prendere MINESSE
   3. How to take MINESSE
   4. Possible side effects
   5. How to store MINESSE
   6. Package contents and other information

MINESSE

60 micrograms/15 micrograms, 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 blood clots forming in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks
• Pay attention and consult a doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”)

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What MINESSE is and what it is used for
• 2. What you need to know before you take MINESSE
• 3. How to take MINESSE
• 4. Possible side effects
• 5. How to store MINESSE
• 6. Contents of the pack and other information

1. Cos’è MINESSE e a cosa serve

• 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 substances and are called “placebo tablets”.
• Contraceptive pills that contain two hormones are called “combined pills”.

2. Cosa deve sapere prima di prendere MINESSE

General notes
Before starting to take MINESSE, your doctor will ask you some questions about your medical history
and family history. Your doctor will also measure your blood pressure and, depending on your situation,
may perform other tests.
Before starting to use MINESSE, you must read the information on blood clots in paragraph 2. It is
particularly important that you read the symptoms of a blood clot (see paragraph 2 “Blood clots”).
This leaflet describes several situations that require stopping MINESSE or in which
the reliability of MINESSE may be reduced. In such situations, you should abstain from sexual intercourse
or use non-hormonal contraceptive measures, such as condoms or other barrier methods.
Do not use the rhythm method or basal body temperature method. These methods can be unreliable because
MINESSE alters the monthly variations in body temperature and cervical mucus.

MINESSE, like all hormonal contraceptives, does not protect against HIV (AIDS) infection or other
sexually transmitted diseases.
Do not take MINESSE
Do not use MINESSE if you have any of the conditions listed below. If you have any of the conditions
listed below, consult your doctor. Your doctor will discuss other birth control methods with you
that may be more suitable for your case.

• if you are allergic to gestodene or ethinylestradiol or any of the other ingredients of this medicine (listed in paragraph 6);
• if you have (or have ever had) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lung (pulmonary embolism, PE) or in other organs;
• if you know you have a disorder that affects blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies;
• if you are going to have an operation or if you will be bedridden for a long period (see paragraph “Blood clots”);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or a transient ischemic attack (TIA - symptoms of a temporary stroke);
• if you have one of the following diseases, which may increase the risk of blood clots forming in the arteries:
• severe diabetes with damage to blood vessels
• very high blood pressure
• very high levels of fats (cholesterol or triglycerides) in the blood
• a condition known as 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 a malignant liver tumor or if you have recently had a liver disease. In these cases, your doctor will ask you to stop taking the tablets until your liver is functioning normally;
• if you have vaginal bleeding of unknown cause;
• if you have breast cancer or uterine cancer or hormone-sensitive cancers or if you are suspected of having one of these cancers;
• if you have Hepatitis C and are taking certain antiviral medicines such as ombitasvir/paritaprevir/ritonavir, dasabuvir and glecaprevir/pibrentasvir (see paragraph “Other medicines and MINESSE”).

Warnings and precautions
When should you see a doctor?
Contact a doctor urgently

• if you notice possible signs of a blood clot that may indicate you have a blood clot in your leg (deep vein thrombosis), a blood clot in your lung (pulmonary embolism), a heart attack or a stroke (see the following section "Blood clot (thrombosis)"). For a description of the symptoms of these serious side effects, see the section “How to recognize a blood clot”.

Tell your doctor if any of the following conditions apply to you.
If this condition appears or worsens while you are using MINESSE, you should tell your doctor.

• if blood tests have shown that you have high blood sugar levels, high cholesterol and fat levels, or high prolactin levels (a hormone that stimulates milk production);
• if you are obese;
• if you have a benign breast tumor or have a close relative who has had breast cancer;
• if you have a uterine disease (uterine dystrophy);
• if you suffer from epilepsy (see also “Taking other medicines”);
• if you suffer from migraines;
• if you have hearing loss due to a condition known as 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 the body’s 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 red blood cell disease);
• if you have high levels of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are going to have an operation or if you will be bedridden for a long period (see paragraph 2 “Blood clots”);
• if you have just given birth, your risk of developing blood clots is higher. Ask your doctor how long after giving birth you can start taking MINESSE;
• if you have inflammation of the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins.
• if you or a close relative (parents, grandparents, siblings…) have ever suffered from a disease with a tendency to develop blood clots (in the legs, lungs or elsewhere; heart attack; stroke);
• if during a pregnancy, or during the use of another contraceptive pill, you have had a skin condition that caused itching, red spots and blisters (herpes gestationis);
• if you have had spots on your face (chloasma) during pregnancy or during the use of another contraceptive pill. In this case, avoid direct exposure to sunlight while using MINESSE;
• if you suffer from gallstones;
• if you suffer from heart, liver or kidney disease;
• if you suffer from depression;
• if you suffer from high blood pressure;
• if you suffer from a condition known as “chorea”, characterized by involuntary, irregular and sudden movements.

Psychiatric disorders
Some women who use hormonal contraceptives, including MINESSE, have reported depression or depressed mood.
Depression can be severe and sometimes can lead to suicidal thoughts. If you experience
mood changes and depressive symptoms, consult your doctor as soon as possible for further medical advice.
If you suffer from hereditary angioedema, products containing estrogens may induce or worsen the symptoms
of angioedema. You should seek immediate medical attention if you experience symptoms of angioedema, such as swelling
of the face, tongue and/or throat and/or difficulty swallowing or hives accompanied by difficulty
breathing.
Do not hesitate to ask your doctor or pharmacist if you have any doubts about using MINESSE.

BLOOD CLOTS
The use of a combined hormonal contraceptive like MINESSE causes an increased risk of developing
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 develop

• in the veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in the arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE). Healing from blood clots is not always complete. Rarely, serious long-term effects can occur or, very rarely, these effects can be fatal.

It is important to remember that the overall risk of a harmful blood clot associated with MINESSE is
low.
HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor immediately 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 linked to an increased risk of blood clots in the veins (venous thrombosis). However, these side effects are rare. Most cases occur in the first year of using 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.
• Very rarely, the clot can form in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year you take
a combined hormonal contraceptive for the first time. The risk may also be higher if you
restart a combined hormonal contraceptive (the same medicine or a different medicine)
after a break of 4 or more weeks.
After the first year, the risk decreases but is still slightly higher than if you were not using
a combined hormonal contraceptive.
When you stop taking MINESSE, the risk of developing a blood clot returns to
normal levels within a few weeks.

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

• Out of 10,000 women who do not use any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone or norgestimate, about 5-7 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive containing gestodene, such as MINESSE, about 9-12 will develop a blood clot in a year.
• The risk of a blood clot forming depends on your medical history (see below “Factors that increase the risk of a blood clot forming”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with MINESSE is low but some conditions cause an
increase. Your risk is higher:

• if you are significantly overweight (body mass index or BMI greater than 30 kg/m²);
• if a close relative of yours has had a blood clot in the leg, lung or another organ at a young age (under about 50 years). In this case you may have an inherited blood clotting disorder;
• if you need to have surgery or if you need to be bedridden for a long period due to an injury or illness or if you have a leg in plaster. It may be necessary to stop taking MINESSE a few weeks before surgery or during the time when you are less mobile. If you need to stop taking MINESSE, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years);
• if you have given birth less than a few weeks ago.

The risk of developing a blood clot increases when you have more than one of these conditions.
Air travel (lasting >4 hours) can temporarily increase the risk of a blood clot
forming, especially if you have some of the other risk factors listed.
It is important that you tell your doctor if any of these conditions apply to you, even if
you are not sure. Your doctor may decide to stop you from taking MINESSE.
If any of the above conditions change while you are using MINESSE, for example if a close relative
develops a thrombosis for no known reason or if you gain a lot of weight, contact your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems, for example,
they can cause a heart attack or a stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of MINESSE is very
low but it can increase:

• with increasing age (over 35 years);
• if you smoke.When you use a combined hormonal contraceptive like MINESSE it is advisable that you stop smoking. If you cannot stop smoking and you 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 a close relative of yours has had a heart attack or stroke at a young age (under about 50 years). In this case you may also be at high risk of heart attack or stroke;
• if you, or a close relative, have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valve defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions or if one of them is particularly severe, the risk of developing
a blood clot may be even higher.
If any of the above conditions change while you are using MINESSE, for example if you start to
smoke, if a close relative develops a thrombosis for no known reason or if you gain a lot of weight,
contact your doctor.

MINESSE and cancer
Breast cancer has been observed slightly more frequently in women who use combined pills
but it is not known whether this is caused by the pill. It may be that these women were
simply visited more carefully and more often and that therefore breast cancer was
detected earlier.
In women who use combined pills for a relatively long period, studies have
reported cases of cervical cancer. Currently it is not known whether this is caused by the pill or are
attributable to sexual behaviour (e.g. more frequent changes of partner) and other factors.
In rare cases, benign and, even more rarely, malignant liver tumors have been reported in women who use the pill. If you suffer from unusually severe abdominal pain, contact your doctor.

Intermenstrual bleeding
During the first few months of taking MINESSE, unexpected bleeding may occur
(bleeding outside the days you take the placebo tablets). If this bleeding
persists for more than a few months, or starts after a few months, your doctor should investigate the cause.

What to do if your period does not appear during the placebo days
If you have taken all the yellow-pale active tablets correctly, you have not had vomiting or severe diarrhea and
you have not taken any other medicines, it is very unlikely that you are pregnant.
If your period does not appear for two consecutive times, you may be pregnant. Contact your doctor immediately.
Do not start the next blister until you are sure you are not pregnant.

If your period does not appear after stopping MINESSE
When you stop taking MINESSE it may take some time before your period returns. If
this condition persists for a prolonged time, consult your doctor.

Other medicines and MINESSE
Always tell your doctor what medicines or herbal products you are already taking, including
over-the-counter medicines. Also tell any other doctor or dentist who
prescribes you a medicine (or the pharmacist) that you are using MINESSE. They can tell you if you need to use
additional contraceptive precautions (e.g. a condom) and, if so, for how
long.
Some medicines may have an influence on the blood levels of Minesse, they may make Minesse less
effective in preventing pregnancyand may cause unexpected bleeding.
These include:

• Medicines used for the treatment of:
• HIV and Hepatitis C infections (called protease inhibitors and non-nucleoside reverse transcriptase inhibitors);
• epilepsy (e.g. phenobarbital, phenytoin, primidone, carbamazepine or topiramate);
• tuberculosis (rifabutin, rifampicin);
• fungal infections (griseofulvin, azole antifungals e.g.: itraconazole, voriconazole, fluconazole);
• bacterial infections (macrolide antibiotics e.g. clarithromycin, erythromycin);
• some heart conditions, high blood pressure (calcium channel blockers e.g.: verapamil, diltiazem);
• arthritis, osteoarthritis (etoricoxib);
• sleep disorders (modafinil);
• the St John's wort herbal remedy, which is used to treat some types of depression;
• grapefruit juice.

Troleandomycin may increase the risk of cholestasis (retention of bile in the liver) when
administered in combination with Combined Oral Contraceptives, (COCs).
Minesse may influence the effectof other medicines, e.g.:

• lamotrigine
• cyclosporine
• theophylline
• tizanidine

Ask your doctor or pharmacist for advice before taking any medicine
Do not use Minesse if you have Hepatitis C and are taking certain medicines for Hepatitis C such as those
containing ombitasvir / paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, as this may cause
an increase in blood test results of liver function (increased liver enzymes ALT).
Your doctor will prescribe you another type of contraceptive before starting treatment with these medicines.
Minesse can be resumed approximately two weeks after completion of this treatment. See the
section "Do not use Minesse".

Pregnancy
If you are pregnant, your doctor has no reason to prescribe you a contraceptive.
If you discover that you are pregnant while taking MINESSE, stop taking this pill and consult
your doctor. If you are planning a pregnancy, tell your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding
The use of MINESSE is not recommended if you are breast-feeding.
If you want to breast-feed, your doctor will advise you on a suitable form of contraception.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
The effect of MINESSE on the ability to drive and use machines has not been studied. It
is unlikely that MINESSE will affect your ability to drive and use machines. Dizziness has been reported among
the side effects. If you experience dizziness, do not drive and do not use machines until
the effect has completely resolved.

MINESSE contains lactose.
If you suffer from intolerance to certain sugars, consult your doctor before taking MINESSE.

3. How to take MINESSE

Take this medicine always exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.

Dosage

• Always start taking MINESSE with the tablet marked with the number 1 next to the word “START” (Beginning).
• Puncture the empty cell in the centre of the blister corresponding to the day of the week you took the first tablet. This will be the starting day of each new blister. It will also be the day of the week you take tablets number 8, 15 and 22 marked with a differently coloured border. This will help you check that you are taking the tablets correctly.
• Each blister contains 28 tablets. Take one tablet at the same time each day, for 28 consecutive days, following the direction indicated by the arrows, without ever making a mistake, as follows: take one pale yellow active tablet a day, for the first 24 days; then one white placebo tablet every day for the last 4 days.
• After taking the last tablet, continue to take MINESSE the next day starting another blister without any interval between one blister and the next. You must always start a new blister on the

same day of the week. Because there are no breaks in taking the tablets, it is important that you have already
obtained a new blister before finishing one.

• Menstruation usually starts two or three days after you have taken the last pale yellow tablet from the blister and may not have finished before starting the next blister.

Method and route of administration
Take each tablet with a large glass of water.

If you have not used a hormonal contraceptive in the previous month
Take the first tablet on the first day of your period.

If you were using another contraceptive pill
Finish the blister you are taking (if the pack of pills you are taking also contains the
hormone-free (inactive) tablets, do not take them). Then start the blister of MINESSE the next day,
without leaving any interval without taking a pill.

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

• Switching from a progestin-only pill: you can start MINESSE at any time during your menstrual cycle, the day after you stop taking the progestin-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 your next injection was due.

In any case, you should use a barrier method of contraception (e.g. a condom) for the first 7
days of taking the pill.

If you start MINESSE after an abortion occurring in the first trimester
You can start taking MINESSE immediately, but you must follow your doctor's advice before
starting.

If you start MINESSE after childbirth or after an abortion occurring during the second trimester
As with any other contraceptive pill, MINESSE should not be started before 21-28 days
after childbirth or abortion, as the risk of blood clots is higher. If you start later, we recommend
that you use a barrier method of contraception 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 for your next
period.
Always ask your doctor for advice.

Duration of use
Your doctor will tell you how long you should take this pill.

If you take more MINESSE than you should
An overdose can cause gastrointestinal problems (e.g. nausea, vomiting, abdominal pain),
breast tenderness, dizziness, drowsiness/fatigue and menstrual irregularities (bleeding).
Ask your doctor for advice.

If you forget to take MINESSE
If you forget to take the pill, there is a risk of becoming pregnant
If you realise you have not taken a pale yellow tablet within 12 hours of the time you normally
take the tablet,take the forgotten tablet immediately and continue normally, taking
the next tablet at the usual time until the end of the blister.

If you realise you have not taken a pale yellow tablet more than 12 hours after the time you take
it normally, there is a risk of becoming pregnant. In this case:

• take the forgotten tablet immediately, even if this means taking 2 tablets on the same day;
• continue to take the contraceptive until the end of the blister;
• also, use a barrier method of contraception (condom, spermicide) for the next 7 days;
• if this period of 7 days extends beyond the last pale yellow tablet, discard the remaining tablets and start the next blister.

If you have forgotten pale yellow tablets in a blister and you do not have your expected period, which
should start while you are taking the white tablets, you may be pregnant.
If you have forgotten one or more white tablets, you are still protected as long as no more than 4 days pass between
the last pale yellow tablet of the current blister and the first pale yellow tablet of the next blister.
Ask your doctor for advice.
In case of severe vomiting or diarrhoea within 4 hours of taking the pill, the situation is similar to that
which occurs when you forget a tablet. Following vomiting or diarrhoea, you should take another tablet from a reserve blister as soon as
possible. If possible, take it within 12 hoursof the usual time for taking the pill. If this is not possible, or 12 hours have already passed, you must follow the instructions
provided in “If you forget to take MINESSE”.
If these episodes of severe vomiting or diarrhoea recur for several days, you should use a barrier method
of contraception (condom, spermicide...) until the start of the next blister.
Ask your doctor for advice.

4. Possible side effects

Like all medicines, MINESSE can cause side effects, although not everybody gets them.
If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think could be due to MINESSE, tell your doctor.
A higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) is present in all women who take
combined hormonal contraceptives. For more detailed information on the different risks associated with
taking combined hormonal contraceptives, see section 2 “What you need to know before you
take MINESSE”.

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

• A severe allergic reaction - the frequency of this effect is unknownSymptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat, skin rash, hives.
• Retinal vein thrombosis - the frequency of this effect is unknown
• Symptoms that occur more frequently in one eye
• painless blurred vision that may progress to vision loss
• sudden loss of vision
• Hemolytic uremic syndrome (a condition affecting the blood and kidneys) - the frequency with which this effect occurs is unknownSymptoms include vomiting, diarrhea (possibly with blood), fever, feeling weak, decreased urine output.
• Pancreatitis - this condition occurs rarely(may affect 1 to 10 women out of 10,000) Symptoms include severe pain in the upper part of the abdomen, which may spread to the back.
• Erythema multiforme - the frequency with which this effect occurs is unknownSymptoms include a rash with pink to red pustules, especially on the palms of the hands or soles of the feet, which may fill with pus. Ulcers may also appear in the mouth, eyes or genitals, and fever.

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

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

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

• vaginal infection, including vaginal candidiasis
• breakthrough bleeding
• mood swings, including depression or altered libido
• nervousness or dizziness
• nausea, vomiting
• feeling of bloating
• acne
• painful periods
• change in menstrual flow
• changes in vaginal secretions or change to the cervix (ectropion)
• fluid retention in the tissues or edema (marked fluid retention)
• weight loss or gain
• skin rash
• hair loss

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

• increased appetite
• decreased appetite
• excessive hair growth
• skin patches (chloasma)
• changes in laboratory test results: increased levels of cholesterol, triglycerides 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 an artery, for example: in a leg or foot (DVT) or in the lung (PE) or heart attack or stroke or mini-stroke or temporary stroke-like symptoms, known as a transient ischemic attack (TIA) or blood clots in the liver, stomach/intestine, kidneys or eye.

The possibility of developing 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 the symptoms of a blood clot)

• liver or biliary diseases (such as hepatitis or abnormal liver function)
• gallbladder disease including the appearance of gallstones or worsening of this condition

Not known:frequency cannot be estimated based on available data

• benign liver tumor (called focal nodular hyperplasia or hepatic adenoma) or malignant liver tumor
• worsening of an autoimmune disease (lupus), a liver disease (porphyria) or a disease known as “chorea” characterized by irregular, sudden and involuntary movements
• obstruction of bile flow in the liver or worsening of this condition
• possible worsening of ischemic bowel disease or inflammatory bowel disease - symptoms include cramps and abdominal pain, diarrhea (possibly with blood), weight loss
• intolerance to a sugar called glucose
• intolerance to contact lenses
• abdominal cramps
• jaundice (yellowing of the skin or eyes)
• red and painful nodules under the skin (erythema nodosum)
• inflammation of the optic nerve that can lead to partial or total vision loss

If any of these side effects gets serious, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store MINESSE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister after “Exp.”. The
expiry date refers to the last day of that month.
No special storage conditions are required.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MINESSE contains
Pale yellow tablet
The active ingredients are: 60 micrograms of gestodene and 15 micrograms of ethinylestradiol.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, magnesium stearate, polacrilin
potassium, polyethylene glycol 1450, purified water, montanglic wax, Yellow Opadry [hydroxypropylmethyl
cellulose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172)].
White tablet
Does not contain active ingredients.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, magnesium stearate, polacrilin
potassium, polyethylene glycol 1500, purified water, montanglic wax, White Opadry
[hydroxypropylmethyl cellulose, hydroxypropylcellulose, titanium dioxide (E171), polyethylene glycol].

Description of the appearance of MINESSE and package contents
MINESSE is available in the form of film-coated tablets.
Each pack contains 1, 3 or 6 blisters, each containing 28 tablets (24 pale yellow active tablets with “60” imprinted on one side and “15” on the other side of the tablet and 4 white placebo
tablets).
Each blister is packaged in an aluminum pouch containing a desiccant bag of silica gel.
The silica gel desiccant bag can be discarded after opening the pouch containing the blister.
Not all pack sizes may be marketed.

Marketing authorization holder
Pfizer Italia S.r.l. - Via Isonzo, 71 – 04100 Latina

Manufacturer
Pfizer Ireland Pharmaceuticals
Little Connell
Newbridge
Co. Kildare
Ireland

Other sources of information
More detailed information on this medicine is available on the website of the national competent
authority.