Minulet

Package leaflet: Information for the user

MINULET 0.075 mg + 0.03 mg film-coated tablets

Gestodene/Ethinylestradiol
Please read all of this leaflet carefully before you start 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible methods of contraception when used correctly.
• They slightly increase the risk of blood clots forming in the 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").

Contents of this leaflet:

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

1. What Minulet is and what it is used for

Minulet contains the active substances ethinylestradiol and gestodene, which belong to a group of
medicines called combined hormonal contraceptives.
Minulet is a contraceptive pill used to prevent pregnancy by inhibiting ovulation.
Minulet is a combined pill, as each coated tablet contains a combination of two different female hormones, namely gestodene (a substance similar to progesterone) and ethinylestradiol (an oestrogen).

2. What you should know before taking Minulet

General information
Before starting Minulet, 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").

Do not take Minulet
Do not take Minulet 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 methods of birth control that may be more suitable for your case.

• if you are allergic to any of the active substances (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 blood vessel 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 scheduled for surgery or will be bedridden 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 ischemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following conditions, which could increase the risk of forming 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 hyperhomocysteinemia, which causes high levels of homocysteine in the blood
• if you have (or have ever had) a type of migraine called "migraine with aura";
• if you have any of the following conditions that could increase the risk of forming a blood clot in a blood vessel:
• conditions related to high blood pressure
• kidney problems
• if you have one or more conditions that could increase the risk of forming a blood clot in a vein or artery (see section "Warnings and precautions");
• if you have or have ever had serious liver disease, until liver function returns to normal;
• if you have or have ever had pancreatitis (inflammation of the pancreas) associated with a severe disorder of fat metabolism (hypertriglyceridemia);
• if you have or have ever had a liver tumor (benign or malignant);
• if you have a hormone-sensitive (estrogen- and progestin-sensitive) breast or uterine cancer that may grow faster due to these hormones, or if such a tumor is suspected;
• if you have ever experienced yellowish or yellow skin and mucous membrane discoloration (jaundice);
• if you have vaginal bleeding of unknown cause;
• if you are or think you may be pregnant;
• if you are being treated with ritonavir, a medicine used to treat HIV infection;
• if you have hepatitis C and are taking other medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see section "Other medicines and Minulet")

Warnings and precautions
Talk to your doctor or pharmacist before taking Minulet.
Stop taking Minulet and contact your doctor immediately if you notice any possible signs of a
blood clot, such as:
severe pain and/or swelling in one of the legs
sudden severe chest pain that may extend to the left arm
sudden shortness of breath
sudden cough without an obvious cause
any unusual, severe, or prolonged headache, or worsening of migraine
partial or complete blindness or double vision
difficulty or inability to speak
dizziness or fainting
weakness, unusual sensation, or numbness in any part of the body

Inform your doctor if any of the following conditions apply to you, as you may require close monitoring.
Your doctor may recommend a different, non-hormonal contraceptive method. Contact your doctor also if any of the following conditions appear or worsen while using Minulet:

• smoking;
• overweight;
• impaired glucose tolerance (a sugar). If you have diabetes or already have glucose intolerance, your doctor will monitor you closely during treatment with this medicine;
• heart valve problems or heart rhythm disorders;
• inflammation of veins under the skin (superficial phlebitis);
• if migraine (severe headache on one side of the head) occurs for the first time or worsens. Your doctor may advise you to stop treatment with this medicine;
• if you have varicose veins;
• if you notice changes in mood (psychological depression) or worsening of pre-existing depression. Minulet should be discontinued if severe depression occurs;
• high blood pressure. If your blood pressure increases, you must stop treatment with this medicine;
• if you have epilepsy;
• if you have breast lumps;
• if a close family member has had breast cancer;
• liver or gallbladder diseases;
• if you have hearing loss due to a condition known as otosclerosis;
• 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 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 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);
• certain medical conditions characterized by resistance to Activated Protein C, hyperhomocysteinemia, antithrombin-III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibody syndrome (anticardiolipin antibodies, lupus anticoagulant), which predispose to venous or arterial thrombosis;
• if you are scheduled for surgery or will be bedridden 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 Minulet;
• if you have inflammation of veins under the skin (superficial thrombophlebitis);
• if you have impaired glucose tolerance (a sugar). If you have diabetes or already have glucose intolerance; if you suffer from fluid retention in the body. Caution is required if you have other disorders that may worsen due to increased fluid in the body;
• if you have a skin condition causing itching, red spots, and blisters (herpes gestationis). You may have experienced this problem during a previous pregnancy;
• if yellowish and/or brown patches appear on the skin (chloasma). These patches are more likely to reappear during treatment with Minulet if you had them during a previous pregnancy. In this case, avoid direct exposure to sunlight or ultraviolet rays (e.g., in a tanning bed) while using this medicine;
• if you have gallstones (small stones that form in the gallbladder, a small organ involved in fat digestion);
• if you have porphyria (a disorder characterized by attacks affecting hemoglobin production);
• if you have a disease characterized by involuntary, irregular, and sudden movements (Sydenham's chorea);
• if you have low folate (vitamin B) levels in the blood;
• if you notice yellowish or yellow discoloration of the skin and mucous membranes (jaundice), with or without itching. These symptoms may be caused by impaired bile flow (a substance produced by the liver and involved in digestive processes) and may indicate liver problems. If you experience this condition, stop treatment with this medicine;
• if blood laboratory tests show that levels of certain substances normally produced by the liver are significantly higher than normal. In this case, treatment with Minulet should be temporarily stopped until these values return to normal;
• if you have vision problems such as double vision, bulging eyes, or retinal changes.

Psychiatric disorders
Some women using hormonal contraceptives, including Minulet, have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor as soon as possible for further medical advice.
If you have hereditary angioedema, medicines containing estrogens may trigger or worsen angioedema symptoms. Contact your doctor immediately 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.

With the use of hormonal oral contraceptives, your risk of developing:
BLOOD CLOTS increases
Using a combined hormonal contraceptive such as Minulet increases your risk of developing a blood clot compared to not using one. In rare cases, a blood clot can 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 TEA). Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, these effects can be fatal. It is important to remember that the overall risk of a harmful blood clot associated with Minulet is low.

HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor immediately if you notice any of the following signs or symptoms.
Do you have any of these signs? What might you be suffering from?

• swelling in one leg or along a vein in the leg, Deep vein thrombosis or foot, especially if accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking
• increased warmth in the affected leg
• change in skin color of the leg, such as paleness, redness, or bluish discoloration
• sudden and unexplained shortness of breath
• sudden cough without an obvious cause, possibly with coughing up blood
• sharp chest pain that may worsen when breathing deeply
• severe dizziness or lightheadedness
• rapid or irregular heartbeat

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 developing blood clots in 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 travels from the leg and lodges in 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 in which you
start taking a combined hormonal contraceptive for the first time. The risk may also be higher
if you restart taking a combined hormonal contraceptive (the same medication or a different one) 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 Minulet, 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 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 Minulet 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 over 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 over one year.
• Among 10,000 women who use a combined hormonal contraceptive containing gestodene, such as Minulet, about 9–12 will develop a blood clot over one year.
• The risk of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot in a vein”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Minulet 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 immobile for a prolonged period due to injury or illness, or if you have a plaster cast on your leg. You may need to stop taking Minulet several weeks before surgery or during periods of reduced mobility. If you need to stop taking Minulet, ask your doctor when you can start taking it again;
• with increasing age, especially over 35 years;
• other conditions associated with blood clot in a vein;
• if you have given birth less than 6 weeks ago.

The risk of developing a blood clot increases when you have more than one of these conditions.
Long-distance air travel (lasting > 4 hours) may temporarily increase the risk of blood clot formation, especially if you have any 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 your use of Minulet.
If any of the conditions listed above change while you are using Minulet—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 Minulet is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Minulet, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years old, 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 fats 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 conditions listed above change while you are taking Minulet—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.

Minulet and cancer
A slight increase in the risk of breast cancer has been observed in women using combined oral contraceptives compared to women of the same age who do not use them. This risk gradually decreases after stopping treatment and disappears approximately 10 years later.
Studies have reported an increased risk of cervical cancer (a part of the uterus) in women who use combined oral contraceptives over a relatively long period. It is currently unclear whether this is caused by the pill or due to sexual behavior and other factors (e.g., human papillomavirus infection, a virus that can cause uterine lesions).
In rare cases, benign or malignant liver tumors have been reported in women using combined oral contraceptives. These tumors may also cause internal bleeding that could be life-threatening. If you experience unusually severe pain in the upper abdomen or notice an enlarged liver, contact your doctor.

Irregular bleeding
During the first few months of taking Minulet, unexpected bleeding (i.e., bleeding outside the days when you are not taking tablets) may occur. Consult your doctor if irregular bleeding persists beyond 3 treatment cycles or if it recurs after a previous period of regular bleeding.
Sometimes, menstruation may not occur during the tablet-free days. It is unlikely that you are pregnant if you have taken this medicine correctly. However, if you realize you have not taken the medicine correctly, or if withdrawal bleeding does not occur for the second time, you must confirm that you are not pregnant before continuing to take Minulet.
After stopping oral contraceptives, absence of menstruation (amenorrhea) with possible lack of ovulation or irregular menstrual cycles (oligomenorrhea) may occur, especially if such conditions were already present before starting the pill.

Reduced or loss of effectiveness
The contraceptive effect of Minulet may be reduced if you forget to take a tablet, if you experience vomiting or diarrhea, or if you take certain other medicines.
Preparations containing Hypericum perforatum (St. John's wort) reduce the effectiveness of oral contraceptives. Therefore, if you need to take such preparations, your doctor will advise you to use an alternative contraceptive method to Minulet.
Preparations containing Hypericum perforatum induce enzymes responsible for drug metabolism, and this effect may persist for at least 2 weeks after stopping treatment; therefore, the contraceptive activity of Minulet may be reduced. Unintended pregnancies and resumption of menstruation have been reported.
See also the section “Other medicines and Minulet” and section 3 “What to do in case of vomiting and diarrhea”.

Medical examinations and check-ups
Before starting treatment with Minulet, your doctor will ask you questions about your medical history and that of your family. Your doctor will also perform a thorough examination to assess your general health and to rule out possible pregnancy. While taking this medicine, you will undergo regular medical check-ups to monitor your general health. You should have your first follow-up visit 3 months after starting Minulet.

Minulet does not protect you from infections such as HIV (AIDS) or other sexually transmitted diseases.

Children
The safety and efficacy of Minulet have only been established in women of reproductive age. Therefore, the use of this medicine is not indicated in girls before the onset of their first menstrual period.

Elderly
The safety and efficacy of Minulet have only been established in women of reproductive age. Therefore, the use of this medicine is not recommended in women after the onset of menopause.

Other medicines and Minulet
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Interactions between Minulet and other medicines may lead to irregular bleeding between periods and loss of contraceptive effectiveness, resulting in the risk of unintended pregnancy.

The following medicine must not be taken together with Minulet (see section “Do not take Minulet”):

• ritonavir (a medicine for HIV infection), because it reduces the effectiveness of Minulet.

The following medicines may reduce the effectiveness of Minulet, and therefore their concomitant use is not recommended:

• phenobarbital, phenytoin, primidone, carbamazepine, topiramate, oxcarbazepine, and felbamate (medicines for seizures and epilepsy);
• barbiturates (medicines used as sedatives and tranquilizers);
• rifabutin and rifampicin (antibiotics used to treat tuberculosis);
• griseofulvin (medicine for fungal infections);
• dexamethasone (medicine for inflammation) and phenylbutazone (medicine for inflammation and pain);
• modafinil (medicine for excessive sleepiness);
• some protease inhibitors and nevirapine (medicines used to treat HIV/AIDS);
• herbal preparations containing Hypericum perforatum (St. John's wort), a natural substance used for depression.

Always inform the doctor prescribing the pill about any medicines you are already taking, and also inform any other doctors or dentists who prescribe medicines for you that you are using MINULET, so they can determine whether and for how long you need to use additional contraceptive methods.

The following medicines may increase the effectiveness and/or side effects caused by Minulet:

• atorvastatin (medicine used to reduce fat levels in the blood);
• vitamin C;
• paracetamol (medicine used for pain and to reduce fever);
• indinavir (medicine used to treat HIV infection);
• fluconazole and voriconazole (medicines used for fungal infections);
• troleandomycin (an antibiotic). Concomitant administration of Minulet and troleandomycin may increase the risk of bile retention in the liver (intrahepatic cholestasis).

Minulet may interfere with the effectiveness and/or side effects of the following medicines:

• cyclosporine (medicine to prevent organ rejection after transplantation);
• theophylline (medicine for asthma);
• corticosteroids (medicines for inflammation and allergies);
• lamotrigine (medicine for epilepsy);
• levothyroxine (medicine for underactive thyroid);
• valproate (medicine for seizures);
• flunarizine (medicine used for migraine). Concomitant administration of Minulet and flunarizine increases the risk of milk discharge from the breasts in women who are not breastfeeding (galactorrhea).

If you are being treated with any of the medicines listed above, you must use a barrier contraceptive method (e.g., condom) together with Minulet, not only during concomitant use but also for an additional 7 days afterward. In the case of treatment with rifampicin, you must use a barrier contraceptive method for up to 28 days after stopping the concomitant treatment. If concomitant treatment continues beyond the end of a pack of Minulet tablets, you must immediately start the next pack of Minulet without observing the tablet-free interval.

If you are prescribed long-term treatment with any of the medicines listed above, your doctor will advise you to use another type of medicine or a barrier contraceptive method to avoid unintended pregnancies.

Interactions with laboratory tests
The use of Minulet may affect the results of certain laboratory tests, such as values measuring liver, thyroid, adrenal gland, and kidney function, as well as the levels of certain proteins in the blood, including proteins affecting lipid (fat) metabolism, carbohydrate (sugar) metabolism, blood clotting, and the blood clot dissolution mechanism (fibrinolysis). In addition, blood levels of folic acid may decrease.
However, these values are generally within the normal range.
Do not use Minulet if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, as this may cause elevated liver function blood test results (increased ALT liver enzymes).
Your doctor will prescribe another type of contraceptive before starting treatment with these medicines. Minulet may be restarted approximately 2 weeks after completion of this treatment.
See section "Do not use Minulet".

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take Minulet if you are pregnant.
If you discover you are pregnant while taking Minulet, stop taking this medicine and consult your doctor.
If you have recently given birth and wish to start or resume treatment with Minulet, your doctor will consider the increased risk of blood clot formation in blood vessels.

Breastfeeding
The use of Minulet during breastfeeding is not recommended because this medicine may alter breast milk and reduce its production. In addition, Minulet passes into breast milk, although no negative effects of this medicine on the infant's health are currently known.
If you wish to breastfeed, your doctor will recommend another suitable form of contraception.

Driving and operating machinery
The effects of Minulet on the ability to drive vehicles and operate machinery are unknown.

Minulet contains lactose and sucrose
Minulet contains lactose and sucrose, two types of sugars. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Minulet contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. How to take Minulet

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

The Minulet pack contains 21 tablets. You must take one tablet daily for 21 consecutive days, starting with the tablet marked with the number 1 (located next to the word "START") and continuing with the others in numerical order, as indicated by the arrows, until the pack is finished.

Puncture the blister on the day of the week you started taking the tablets (e.g., "Mon"). If you are taking the tablets correctly, this will be the same day of the week on which you will take tablet number 1, 8, and 15 in the following weeks, and on which you should start taking the first tablet of a new Minulet pack.

After taking all 21 tablets, you must stop taking them for 7 days.

Your menstrual period usually begins 2 or 3 days after taking the last tablet.

After the 7 tablet-free days, start taking tablets from the new Minulet pack the next day, i.e., on day 8, even if bleeding is still occurring.

Swallow the tablets whole, without chewing, preferably at the same time each day, ideally after the evening meal.

How to start taking Minulet

• If you have not used any hormonal contraceptive during the previous month: Start taking Minulet on the first day of your cycle, i.e., the first day of menstruation, taking the tablet marked with the number 1. If you start taking Minulet between day 2 and day 5 of your cycle, you must also use a barrier contraceptive method (e.g., condom) during the first 7 days of taking this medicine.
• If you were using another combined oral contraceptive (containing two active substances): You may take the first Minulet tablet the day after the last active tablet of the previous contraceptive, without any tablet-free interval:
  • the day after the last active tablet (the last tablet containing the active substances) of the previous contraceptive. If in doubt, ask your doctor.
  • You may also start later, but not later than the day after the usual tablet-free interval or the day after the last inactive tablet (the last tablet not containing active substances) of the previous contraceptive.
• If you were using another progestogen-only contraceptive method (the so-called mini-pill, an injectable method, an implant, or an intrauterine device):
  • If you were using the mini-pill: you may start taking Minulet at any time, beginning the day after you stopped taking the mini-pill.
  • If you were using an implant or an intrauterine device: start taking Minulet on the same day the implant or intrauterine device is removed.
  • If you were using an injectable contraceptive: start taking Minulet on the day the next injection would have been due.

In any case, you must use a barrier contraceptive method (e.g., condom) for the first 7 days of treatment with Minulet.

• After an abortion during the first 3 months of pregnancy: You may start taking Minulet immediately as prescribed by your doctor, and no additional barrier contraceptive methods (e.g., condom) are required.
• After childbirth or an abortion in the second trimester of pregnancy: You must not start Minulet earlier than 21–28 days after childbirth or abortion, as the risk of blood clots is higher. Your doctor will advise you to use a barrier contraceptive method (e.g., condom) during the first 7 days of taking this medicine. If you have had sexual intercourse before starting Minulet, make sure you are not pregnant, or wait for the onset of your first menstrual period.

If you take more Minulet than you should
If you accidentally ingest/overdose on Minulet, inform your doctor immediately or go to the nearest hospital.

If you take more tablets than required, you may experience stomach and intestinal problems (nausea and abdominal pain), breast tenderness, confusion, drowsiness/fatigue, and vaginal bleeding.

If you forget to take Minulet
If you forget to take one or more Minulet tablets, there is a risk of unintended pregnancy.

• If you realize you missed a tablet within 12 hours of your usual time, take the missed tablet immediately and continue taking the following tablets at your usual time.
• If you realize you missed a tablet more than 12 hours after your usual time, or if you missed two or more tablets, there is a risk of pregnancy. The risk of pregnancy is particularly high if you miss tablets at the beginning or end of the pack. In this case, follow the rules below:

If you missed 1 tablet during the first week of taking Minulet
Take the missed tablet immediately as soon as you remember, even if this means taking two tablets on the same day, and continue taking the following tablets at your usual time.
For the next 7 days, you must also use a barrier contraceptive method (e.g., condom). If you had sexual intercourse during the week before you missed the tablet, there is a possibility of pregnancy. Inform your doctor immediately.

If you missed 1 tablet during the second week of taking Minulet
Take the missed tablet immediately as soon as you remember, even if this means taking two tablets on the same day, and continue taking the following tablets at your usual time. Minulet remains effective, provided you have taken the tablets correctly during the 7 days before the missed tablet. Otherwise, or if you missed more than one tablet, you must use additional contraceptive protection for 7 days to prevent pregnancy.

If you missed 1 tablet during the third week of taking Minulet
You may choose one of the following two options without needing to use additional contraception (e.g., condom), provided you took the tablets correctly during the 7 days before the missed tablet. Otherwise, follow the first option and use additional precautions to avoid pregnancy for the next 7 days.

1. Take the missed tablet immediately as soon as you remember, even if this means taking two tablets on the same day, and continue taking the following tablets at your usual time. After finishing the first pack, immediately start taking tablets from the next pack without observing the usual tablet-free interval between packs. In this way, your menstrual period will not occur until after finishing the second pack. However, you may experience vaginal bleeding during tablet intake.

Or:

2. Do not take any further tablets from the current pack. After a 7-day interval, including the day the tablet was missed, resume taking Minulet by starting a new pack. If you missed tablets and do not have a menstrual period during the first regular tablet-free interval, there may be a pregnancy. Therefore, consult your doctor before continuing treatment with Minulet.

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What to do in case of vomiting and diarrhoea
If you vomit or have diarrhoea within 4 hours of taking the tablet, the situation is similar to that which
occurs when you forget to take a tablet. You must use tablets from a new blister pack, as described above
(see section “If you forget to take Minulet”).

What to do in case of unexpected bleeding
With all oral contraceptives, you may experience vaginal bleeding between periods during the first
months of use. Irregular bleeding usually disappears once your body has adapted to the pill (usually
after about 3 cycles of use). You should always consult your doctor, particularly if this bleeding persists,
becomes heavy, or recurs frequently.

What to do in case of absence of menstruation
If you have taken all tablets correctly, have not had vomiting, and have not taken other medicines, it is
very unlikely that you are pregnant. Continue using the product as usual.
If you miss your period for two consecutive cycles, pregnancy may have occurred. Consult your doctor
immediately. Do not start a new pack until your doctor has ruled out pregnancy.

If you stop treatment with Minulet
You may stop using Minulet at any time. If you do not wish to become pregnant, consult your doctor for
advice on other methods of birth control.
After stopping treatment with Minulet, you may not have periods for several months (amenorrhoea).
This is more common if you already had irregular cycles before starting treatment with this medicine.
This effect usually resolves spontaneously, but if it does not, you should inform your doctor.
If you stop treatment with Minulet because you wish to become pregnant, it is advisable to wait until
your periods return to normal before trying to conceive.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 Minulet, inform your doctor.
All women taking combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolism, VTE) or blood clots in arteries (arterial thromboembolism, ATE). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before taking Minulet”.

STOP taking Minulet IMMEDIATELY if you experience any of the following side effects because they are serious:

• swelling of the face, tongue and/or throat, causing difficulty in swallowing and breathing (angioedema)

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

• in a leg or foot (deep vein thrombosis, DVT)

• in a lung (pulmonary embolism, 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 on conditions that increase the risk of blood clots and symptoms of a blood clot)

• inflammation of a vein (phlebitis)

• high blood pressure (hypertension)

• coronary artery problems, the blood vessels supplying blood to the heart

• increased levels of fats (cholesterol, triglycerides) in the blood

• development of breast lumps (fibrocystic mastopathy), severe breast pain (mastodynia)

• severe and unusual headache or migraine, as these may be symptoms that precede a stroke

• dizziness

• changes in vision, as this may be a symptom preceding a stroke or loss of vision

• worsening of epileptic seizures

• benign or malignant liver tumours (e.g. focal nodular hyperplasia or hepatic adenoma)

• yellowish discoloration of the skin and mucous membranes (cholestatic jaundice)

• liver diseases (hepatitis, impaired liver function)

• appearance of yellowish and/or brown patches on the skin (chloasma)

• inflammation of the optic nerve (optic neuritis)

• cervical cancer

• breast cancer

The following side effects have been reported more commonly during use of Minulet. Please consult your doctor, who may recommend an alternative medicine to Minulet:

• nausea and feeling unwell
• mild headache, migraine
• weight gain or weight loss
• irritability
• nervousness
• heavy legs
• breast tenderness, pain on touch, increased sensitivity, swelling or discharge
• bleeding between periods, infrequent bleeding (oligomenorrhea), absence of bleeding (amenorrhea), and painful menstruation (dysmenorrhea)
• changes in vaginal discharge
• changes in sexual desire
• eye irritation while wearing contact lenses
• fluid retention in the body and/or swelling (oedema)
• vaginal infection, including vaginal candidiasis
• increased or decreased appetite
• depressed mood

The following side effects have been reported rarely:

• vomiting, abdominal pain, abdominal cramps
• bloating sensation
• skin disorders: patchy hair loss (alopecia), acne, excessive and abnormal hair growth, oily skin (seborrhoea), skin rash (exanthema), a type of skin reaction called “nodular erythema”, a type of skin reaction called “erythema multiforme”
• inflammation of the pancreas (pancreatitis)
• chronic inflammatory bowel diseases (Crohn’s disease and ulcerative colitis)
• severe abdominal pain, which may be a symptom of serious intestinal problems (ischaemic colitis)
• very severe allergic reactions, including very rare cases of urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms
• worsening of systemic lupus erythematosus (an autoimmune disease)
• decreased levels of folate (vitamin B) in the blood
• worsening of varicose veins
• gallstones (small stones forming in the gallbladder, a small organ involved in fat digestion)
• worsening of porphyria, a disease affecting haemoglobin production
• depression
• worsening of pre-existing gallbladder diseases
• blood clots in veins (venous thromboembolism, VTE) or blood clots in arteries (arterial thromboembolism, ATE)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Minulet

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.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Minulet contains
The active substances are gestodene and ethinylestradiol.
Each coated tablet contains 0.075 mg of gestodene and 0.03 mg of ethinylestradiol.
The other components are: lactose, sucrose (see section 2 “Minulet contains lactose and
sucrose”), maize starch, povidone 25,000, talc, calcium sodium edetate, magnesium stearate, povidone
K-90, macrogol 6000, calcium carbonate, ethylene glycol ester of montanic acid (E wax).
Description of the appearance of Minulet and contents of the pack
Minulet coated tablets are white, round, biconvex coated tablets.
Minulet is available in packs containing one PVC blister with 21 coated 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.
Marketing Authorisation Holder and Manufacturer
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina
Manufacturer
Pfizer Ireland Pharmaceuticals
Little Connell, Newbridge, County Kildare
Ireland