Minesse

Patient Information Leaflet

MINESSE

60 micrograms/15 micrograms, film-coated tablets
Gestodene/Ethinylestradiol
Important things to know about combined hormonal contraceptives (CHCs):

• They are among the most reliable reversible contraceptive methods when 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.
• Be alert and contact your doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Please read all of this leaflet carefully before you start taking this medicine, as 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 give it to others, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 taking MINESSE
3. How to take MINESSE
4. Possible side effects
5. How to store MINESSE
6. 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 light-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".
• Oral contraceptives that contain two hormones are known as "combined" pills.

2. What you should know before taking MINESSE

General notes
Before starting 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 additional examinations.
Before starting to use MINESSE, you must 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 that require discontinuation of MINESSE or in which the effectiveness of MINESSE may be reduced. In such cases, you should abstain from sexual intercourse or use non-hormonal contraceptive methods, such as condoms or other barrier methods.
Do not use rhythm or basal body temperature methods. These methods may 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 with you other birth control methods that may be more suitable for your case.

• if you are allergic to gestodene or ethinylestradiol or to any of the other ingredients of this medicine (listed in section 6);
• if you have (or have ever had) a blood clot in a vein of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are due to undergo surgery or will be confined to bed for a prolonged period (see section “Blood clots”);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain that may be an early sign of heart attack) or transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following conditions, which could increase the risk of developing clots in the arteries:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats (cholesterol or triglycerides) in the blood
  • a condition known as 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 tumour (called focal nodular hyperplasia or hepatic adenoma) or malignant tumour of the liver, or if you have recently had liver disease. In such cases, your doctor will ask you to stop taking the tablets until your liver functions normally;
• if you have vaginal bleeding of unknown cause;
• if you have breast cancer, 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, dasabuvir, or glecaprevir/pibrentasvir (see section “Other medicines and MINESSE”).

Warnings and precautions
When should you contact a doctor?
Seek urgent medical advice

• if you notice signs suggestive of a blood clot which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the 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, refer to the section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you.
If any of these conditions develop or worsen while you are using MINESSE, inform 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 tumour or a close relative who has had breast cancer;
• if you have a uterine disease (uterine dystrophy);
• if you have epilepsy (see also “Taking other medicines”);
• if you suffer from migraine;
• 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 affecting the body’s natural defence system);
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are due to undergo surgery or will be confined to bed for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking MINESSE;
• if you have inflammation of veins near the skin surface (superficial thrombophlebitis);
• if you have varicose veins;
• if you or a close relative (parents, grandparents, siblings…) have ever had a disease with a tendency to develop blood clots (in legs, lungs, or elsewhere; heart attack; stroke);
• if during pregnancy or while using another contraceptive pill you developed a skin condition causing itching, red spots, and blisters (herpes gestationis);
• if you have had facial spots (chloasma) during pregnancy or while using 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 using hormonal contraceptives, including MINESSE, have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or depressive symptoms occur, consult your doctor as soon as possible for further medical advice.
If you have hereditary angioedema, products containing oestrogens may induce or worsen angioedema symptoms. 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 breathing difficulties.
Do not hesitate to ask your doctor or pharmacist for advice if you have any doubts about using MINESSE.

BLOOD CLOTS
Using a combined hormonal contraceptive such as MINESSE increases the risk of developing a blood clot compared to not using one. In rare cases, a blood clot may block blood vessels and cause serious problems.
Blood clots can develop

• in veins (a condition called “venous thrombosis”, “venous thromboembolism”, or VTE)
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism”, or ATE). Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, such events may 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
Seek immediate 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 forming in the veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and travels to the lung, it can cause a pulmonary embolism.
• Very rarely, a clot may 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 of taking a combined hormonal contraceptive for the first time. The risk may also be higher when restarting a combined hormonal contraceptive (the same or a different product) after a break of 4 or more weeks.
After the first year, the risk decreases but remains 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 (venous thromboembolism) and the type of combined hormonal contraceptive you are using.
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 any 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, about 9–12 will develop a blood clot in one year.
• Your risk of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

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 certain conditions can increase it. Your risk is higher:

• if you are very overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in a leg, lung, or another organ at a young age (under approximately 50 years). In this case, you may have an inherited blood clotting disorder;
• if you are due to undergo surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in plaster. It may be necessary to stop taking MINESSE several weeks before surgery or during periods of reduced mobility. 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 within the last few weeks.

The risk of developing a blood clot increases when you have more than one of these conditions.
Air travel (lasting >4 hours) may temporarily increase the risk of blood clot formation, especially if you have some of the other risk factors listed above.
It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. 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 thrombosis without a known cause or if you gain significant 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 lead to a heart attack or 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 may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as MINESSE, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years of age, your doctor may recommend using 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 approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke;
• if you or a close relative have high levels of fat in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular 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 smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.

MINESSE and cancer
Breast cancer has been observed slightly more frequently in women using combined oral contraceptives, but it is not known whether this is caused by the pill. It may simply be that these women are examined more thoroughly and more frequently, leading to earlier detection of breast cancer.
In women who use combined oral contraceptives for a relatively long time, studies have reported an increased incidence of cervical cancer. It is currently unknown whether this is caused by the pill or is attributable to sexual behavior (e.g., more frequent changes of partner) and other factors.
In rare cases, benign liver tumors and, even more rarely, malignant liver tumors have been reported in women using the pill. If you experience 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 when you take the placebo tablets). If this bleeding persists for more than a few months or starts after several months, your doctor should investigate the cause.

What to do if menstruation does not occur during the placebo days
If you have taken all the active pale-yellow tablets correctly, have not vomited or had severe diarrhea, and have not taken other medications, it is very unlikely that you are pregnant.
If you miss two consecutive periods, you may be pregnant. Contact your doctor immediately. Do not start the next pack until you are certain you are not pregnant.

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

Other medicines and MINESSE
Always inform your doctor about any medicines or herbal products you are currently taking, including those purchased without a prescription. Also inform any other doctor or dentist who prescribes medication for you (or your pharmacist) that you are using MINESSE. They can advise you whether you need to use additional contraceptive precautions (e.g., condom) and, if so, for how long.
Some medicines may affect the blood levels of MINESSE, may make MINESSE less effective in preventing pregnancy, and may cause unexpected bleeding.
These include:

• Medicines used to treat:
• HIV and hepatitis C virus 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);
• certain heart conditions, high blood pressure (calcium channel blockers e.g.: verapamil, diltiazem);
• arthritis, osteoarthritis (etoricoxib);
• sleep disorders (modafinil);
• St. John’s wort, an herbal remedy used to treat certain types of depression;
• grapefruit juice.

Troleandomycin may increase the risk of intrahepatic cholestasis (bile retention in the liver) when administered concomitantly with Combined Oral Contraceptives (COCs).
MINESSE may affect the effect of other medicines, e.g.:

• lamotrigine
• ciclosporine
• theophylline
• tizanidine

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

Pregnancy
If you are pregnant, your doctor has no reason to prescribe you a contraceptive.
If you discover you are pregnant while taking MINESSE, stop taking the pill and consult your doctor. If you are planning a pregnancy, inform your doctor.
Consult your doctor or pharmacist before taking any medicine.

Breast-feeding
The use of MINESSE is not recommended during breast-feeding.
If you wish to breast-feed, your doctor will advise you on a suitable form of contraception.
Consult your doctor or pharmacist before taking any medicine.

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

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

3. How to take MINESSE

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Dosage

• Always start taking MINESSE with the tablet marked with the number 1 located next to the word “START”.

• Pierce the empty cell in the centre of the blister corresponding to the day of the week on which you took the first tablet. This will be the starting day for each new blister. It will also be the day of the week on which you take tablets number 8, 15 and 22, which are marked with a differently coloured border. This will help you ensure that you are taking the tablets correctly.

• Each blister contains 28 tablets. Take one tablet at the same time every day for 28 consecutive days, following the direction of the arrows, without missing any. Take one light yellow active tablet daily for the first 24 days, followed by one white placebo tablet daily for the last 4 days.

• After taking the last tablet of the blister, continue taking MINESSE the next day by starting a new blister immediately, without any break between blisters. You must always start a new blister on the same day of the week. Since there are no breaks, it is important that you obtain a new blister before finishing the current one.

• Your period usually starts two or three days after taking the last light yellow tablet of the blister, and may not have finished before you start the next blister.

Method and route of administration
Take each tablet with a full 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 oral contraceptive
Finish the current pack (if your current pill pack contains hormone-free (inactive) tablets, do not take them). Then start MINESSE the next day, without leaving any gap.

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 a contraceptive injection: Start MINESSE on the day the next injection would have been due.

In all cases, you must use a barrier contraceptive method (e.g. a condom) for the first 7 days of taking the pill.

If starting MINESSE after a first-trimester abortion
You may start taking MINESSE immediately, but you must follow your doctor’s advice before starting.

If starting MINESSE after childbirth or a second-trimester abortion
As with any other contraceptive pill, MINESSE must not be started earlier than 21–28 days after childbirth or abortion, because the risk of blood clots is higher during this period. If you start later, we recommend using 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 for your next period.

Always consult your doctor.

Duration of use
Your doctor will advise you on how long to take this pill.

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

If you forget to take MINESSE
If you forget to take the pill, you may become pregnant

• If you realize you have not taken a light yellow tablet within 12 hours of your usual time, take the missed tablet immediately and continue taking the next tablet at your usual time until the end of the blister.
• If you realize you have not taken a light 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 the contraceptive until the end of the blister;
  • In addition, use a barrier contraceptive method (condom, spermicide) for the next 7 days;
  • If this 7-day period extends beyond the last light yellow tablet of the current blister, discard the remaining tablets and start the next blister immediately.

If you have missed one or more light yellow tablets and do not have your expected period (which should start while taking the white tablets), 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 light yellow tablet of the current blister and the first light yellow tablet of the next blister.

Consult your doctor.

If you vomit or have severe diarrhoea within 4 hours of taking the tablet, this situation is similar to missing a tablet. After vomiting or severe diarrhoea, take another tablet as soon as possible from a spare blister. If possible, take it within 12 hours of your usual time of taking the tablet. If this is not possible, or if more than 12 hours have passed, follow the instructions under “If you forget to take MINESSE”.

If episodes of vomiting or severe diarrhoea persist for several days, use a barrier contraceptive method (condom, spermicide, etc.) until the start of the next blister.

Consult your doctor.

4. Possible side effects

Like all medicines, MINESSE may cause side effects, although not everyone experiences them. If you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health that you think may be due to MINESSE, inform 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 (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you should know before taking MINESSE”.

If you experience any of the following serious side effects, contact your doctor immediately:

• Severe allergic reaction – the frequency of this effect is unknown
  Symptoms 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 occurring in one eye
• Painless blurring of vision that may progress to vision loss
• Sudden vision loss
• Haemolytic uraemic syndrome (a condition affecting blood and kidneys) – the frequency of this effect is unknown
  Symptoms include vomiting, diarrhoea (possibly with blood), fever, feeling weak, reduced urine output.
• Pancreatitis – this condition occurs rarely (may affect 1 to 10 women in 10,000)
  Symptoms include severe upper abdominal pain, which may extend to the back.
• Erythema multiforme – the frequency of this effect is unknown
  Symptoms include pink to red rash with pustules, especially on the palms of the hands or soles of the feet, which may fill with pus. Mouth ulcers, eye or genital ulcers, and fever may also occur.

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

• Headache, including migraine
• Abdominal pain
• Breast pain
• Breast tenderness
• Very light or absent menstrual bleeding

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

• Vaginal infection, including vaginal candidiasis
• Intermenstrual bleeding
• Mood changes, including depression or altered libido
• Nervousness or dizziness
• Nausea, vomiting
• Feeling of bloating
• Acne
• Painful menstruation
• Changes in menstrual flow
• Changes in vaginal discharge or changes in the cervix (ectropion)
• Fluid retention in tissues or oedema (marked fluid retention)
• Weight loss or weight gain
• Skin rash
• Hair loss

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

• Increased appetite
• Decreased appetite
• Excessive hair growth
• Facial pigmentation (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 (DVT), in a lung (PE), heart attack, stroke, transient ischaemic attack (TIA), or temporary stroke-like symptoms, or 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 on conditions that increase the risk of blood clots and symptoms of a blood clot).

• Liver or biliary diseases (such as hepatitis or abnormal liver function)
• Gallbladder disease, including development of gallstones or worsening of this condition

Not known: frequency cannot be estimated from the available data

• Benign liver tumour (called focal nodular hyperplasia or hepatic adenoma) or malignant liver tumour
• Worsening of an autoimmune disease (lupus), a liver disease (porphyria), or a condition known as “chorea” characterised by irregular, sudden and involuntary movements
• Obstruction of bile flow in the liver or worsening of this condition
• Possible worsening of intestinal ischaemic disease or inflammatory bowel disease – symptoms include abdominal cramps and pain, diarrhoea (possibly with blood), weight loss
• Intolerance to a sugar called glucose
• Contact lens intolerance
• Abdominal cramps
• Jaundice (yellowing of the skin or eyes)
• Painful red nodules under the skin (erythema nodosum)
• Optic neuritis, which may lead to partial or total vision loss

If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects helps 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 stated on the carton and blister after "Exp.".
The expiry date refers to the last day of that month.
No special storage conditions are required.
Do not dispose of medicines via 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
Yellowish tablet
The active substances are: 60 micrograms of gestodene and 15 micrograms of ethinylestradiol.
Other components: monohydrate lactose, microcrystalline cellulose, magnesium stearate, polacrilin
potassium, polyethylene glycol 1450, purified water, montanglycol wax, Opadry Yellow [hydroxypropylmethyl
cellulose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172)].
White tablet
Does not contain active substances.
Other components: monohydrate lactose, microcrystalline cellulose, magnesium stearate, polacrilin
potassium, polyethylene glycol 1500, purified water, montanglycol wax, Opadry White
[hydroxypropylmethyl cellulose, hydroxypropylcellulose, titanium dioxide (E171), polyethylene glycol].
Description of the appearance of MINESSE and package contents
MINESSE is available as film-coated tablets.
Each pack contains 1, 3 or 6 blisters, each blister containing 28 tablets (24 active yellowish tablets with “60”
imprinted on one side and “15” on the other side of the tablet, and 4 white placebo tablets).
Each blister is packed in an aluminium pouch containing a silica gel desiccant sachet.
The silica gel desiccant sachet may 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 medicinal product is available on the website of the Member State's Authority.