Triminulet

Patient Information Leaflet: Information for the User

TRIMINULET coated tablets

0.050 mg + 0.03 mg
0.070 mg + 0.04 mg
0.100 mg + 0.03 mg
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 other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

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

• They are one of the most reliable reversible contraceptive methods when used correctly.
• They slightly increase the risk of developing blood clots 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”).

Contents of this leaflet:

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

1. What Triminulet is and what it is used for

Triminulet contains the active substances ethinylestradiol and gestodene, which belong to a group of
medicines called combined hormonal contraceptives.
Triminulet is a contraceptive pill used to prevent pregnancy by inhibiting ovulation.
The Triminulet pack contains 3 types of tablets of different colours: beige, dark brown, and white. Triminulet is a combined pill, as each tablet contains, depending on the colour, different amounts of two female hormones: gestodene (a substance similar to progesterone) and ethinylestradiol (an oestrogen).

2. What you should know before taking Triminulet

General information
Before starting Triminulet, 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 Triminulet
Do not take Triminulet 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 might be more suitable
for your case.

• if you are allergic to either 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 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 long 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 which 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 may 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, 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 may 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 may 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 fat metabolism disorder (hypertriglyceridaemia);
• if you have or have ever had a benign or malignant liver tumour;
• if you have or have ever had a hormone-sensitive breast or uterine cancer (sensitive to female hormones such as estrogens and progestogens) that may grow faster due to these hormones, or if such a tumour is suspected;
• if you have ever experienced yellowish or yellow skin and mucous membranes (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 Triminulet”)

Warnings and precautions
Talk to your doctor or pharmacist before taking Triminulet.
Stop taking Triminulet 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 your legs
sudden severe chest pain that may spread 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 your doctor may monitor you
closely. Your doctor may recommend a different, non-hormonal contraceptive method. Contact your doctor also if any of the following
conditions develop or worsen while you are using Triminulet.

• smoking;

• being overweight;

• impaired glucose tolerance (a sugar). If you have diabetes or already have impaired glucose tolerance, your doctor will monitor you closely during treatment with this medicine;

• heart valve problems or heart rhythm disorders;

• inflammation of veins near the skin surface (superficial phlebitis);

• migraine (severe headache on one side of the head) occurring for the first time or worsening. Your doctor may advise you to stop taking this medicine;

• varicose veins;

• mood changes (psychological depression) or worsening of pre-existing depression. Triminulet should be discontinued if severe depression occurs;

• high blood pressure. If your blood pressure rises, 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 disease;

• hearing loss due to a condition known as otosclerosis;

• Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);

• systemic lupus erythematosus (SLE, a disease affecting the body's natural defense system);

• haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);

• sickle cell anaemia (an inherited red blood cell disorder);

• 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);

• certain medical conditions characterized by resistance to Activated Protein C, hyperhomocysteinaemia, 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 due to undergo surgery or will be confined to bed for a long 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 Triminulet;

• inflammation of veins near the skin surface (superficial thrombophlebitis);

• impaired glucose tolerance (a sugar). If you have diabetes or already have impaired glucose tolerance;

• fluid retention in the body. Caution is needed if you have other disorders that may worsen due to increased fluid in the body;

• a skin condition causing itching, red spots and blisters ( herpes gestationis ). You may have experienced this during a previous pregnancy;

• yellowish and/or brown patches on the skin (chloasma). These patches are more likely to reappear during treatment with Triminulet if you had them
  during a previous pregnancy. In this case, avoid direct exposure to sunlight or ultraviolet rays (e.g. in a solarium) while using this medicine;

• gallstones (small stones developing in the gallbladder, a small organ involved in fat digestion);

• porphyria (a disorder that occurs in attacks and affects haemoglobin production);

• a disease characterized by involuntary, irregular and sudden movements (Sydenham's chorea);

• low folate (vitamin B) levels in the blood;

• 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 digestion) and may indicate liver problems. If you experience this condition, stop treatment with this medicine;

• if blood laboratory tests show abnormally high levels of substances normally produced by the liver. In this case, treatment with Triminulet should be temporarily stopped until these values return to normal;

• vision problems such as double vision, bulging eyes, or retinal changes.

Psychiatric disorders
Some women using hormonal contraceptives, including Triminulet, have reported depression or low 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 oestrogens 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.
Use of hormonal oral contraceptives increases your risk of:
BLOOD CLOTS
Using a combined hormonal contraceptive such as Triminulet 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 ATE). Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, these may be fatal. It is important to remember that the overall risk of a harmful blood clot associated with Triminulet 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 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 colour of the leg, such as paleness, redness or blueness

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 may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and travels to the lung, it may 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 if you restart taking a combined hormonal contraceptive (the same medicine 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 Triminulet, 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 venous thromboembolism (VTE) and on the type of combined hormonal contraceptive you are taking.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Triminulet 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 within 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 within one year.
• Among 10,000 women who use a combined hormonal contraceptive containing gestodene, such as Triminulet, about 9–12 will develop a blood clot within one year.
• The likelihood 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 Triminulet 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 the 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 need to undergo surgery or must remain bedridden for a prolonged period due to injury or illness, or if you have a leg in a cast. You may need to stop taking Triminulet several weeks before surgery or during periods of reduced mobility. If you need to stop taking Triminulet, ask your doctor when you can start taking it again;
• with increasing age, especially over 35 years;
• other conditions associated with blood clots 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.
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 have you stop taking Triminulet.
If any of the conditions listed above change while you are using Triminulet, 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 Triminulet is very low but may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Triminulet, it is advisable to stop smoking. If you cannot 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 Triminulet, 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.

Triminulet 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 after about 10 years.
Studies have reported an increased risk of cervical cancer (a part of the uterus) in women who use combined oral contraceptives for a relatively long time. It is currently unknown 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 can also cause internal bleeding that could be life-threatening. If you experience unusually severe pain in the upper abdomen or notice liver enlargement, contact your doctor.

Irregular bleeding
During the first months of taking Triminulet, unexpected bleeding (i.e., bleeding outside the days when you are not taking tablets) may occur. Consult your doctor if such irregular bleeding persists beyond 3 treatment cycles or reappears after a previous period of regularity.
Sometimes, menstruation may not occur during the days when you are not taking the tablet. 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 Triminulet.
After stopping the oral contraceptive, 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 Triminulet may be reduced if you forget to take a tablet, if you vomit or have 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 Triminulet.
Hypericum perforatum preparations induce enzymes responsible for drug metabolism, and this effect may persist for at least 2 weeks after stopping treatment; therefore, the contraceptive activity of Triminulet may be reduced. Unintended pregnancies and return of menstrual bleeding have been reported.
See also the section “Other medicines and Triminulet” and section 3 “What to do in case of vomiting and diarrhea.”

Medical examinations and check-ups
Before starting treatment with Triminulet, your doctor will ask you questions about your medical history and that of your family. The doctor will also perform a thorough examination to assess your general health and to exclude 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 Triminulet.

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

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

Elderly
The safety and efficacy of Triminulet 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 Triminulet
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Interactions between Triminulet and other medicines may lead to irregular bleeding between periods and a loss of contraceptive effectiveness, resulting in the risk of unintended pregnancies.

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

• ritonavir (a medicine used to treat HIV infection), because it reduces the effectiveness of Triminulet.

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

• phenobarbital, phenytoin, primidone, carbamazepine, topiramate, oxcarbazepine, and felbamate (medicines used to treat seizures and epilepsy);
• barbiturates (medicines used as sedatives and tranquilizers);
• rifabutin and rifampicin (antibiotics used to treat tuberculosis);
• griseofulvin (a medicine used to treat fungal infections);
• modafinil (a medicine used to treat 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 all other doctors or dentists who prescribe medicines for you that you are using TRIMINULET, 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 Triminulet:

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

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

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

If you are being treated with any of the medicines listed above, you should use a barrier contraceptive method (e.g., condom) together with Triminulet, not only during concomitant treatment but also for an additional 7 days afterward. In the case of treatment with rifampicin, you should use a barrier contraceptive method for up to 28 days after stopping concomitant treatment.
If concomitant treatment must continue after you have finished all the tablets in one pack of Triminulet, you should immediately start taking the next pack of Triminulet without observing the tablet-free interval.
If you are prescribed prolonged 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 Triminulet 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 Triminulet if you have hepatitis C and are taking other 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.
Triminulet may be resumed approximately 2 weeks after completing this treatment. See section "Do not use Triminulet."

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

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

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

Driving and use of machines
No effects of Triminulet on the ability to drive or operate machinery are known.

Triminulet contains lactose and sucrose
Triminulet 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.

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

3. How to take Triminulet

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

The calendar pack of Triminulet contains 3 types of tablets of different colours:

• six beige tablets numbered from 1 to 6
• five dark brown tablets numbered from 7 to 11
• ten white tablets numbered from 12 to 21

You must take one tablet daily for 21 consecutive days, starting with the tablet marked number 1 (located next to the word “START”) and continuing with the other tablets in numerical order, as indicated by the arrows, until the end of the pack (tablet 21).
Pierce the blister on the day of the week on which 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 the new pack of Triminulet.

After taking all 21 tablets, you must stop taking the tablets for 7 days.
Your period will usually start 2 or 3 days after taking the last tablet.
Start taking the tablets from the new pack of Triminulet the day after the end of the tablet-free interval, 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 your evening meal.

How to start taking Triminulet

If you have not taken any hormonal contraceptive in the previous month:
Start taking Triminulet on the first day of your cycle, i.e. the first day of your period, taking the tablet marked number 1.
If you start taking Triminulet between day 2 and day 5 of your cycle, you must 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 hormones as active ingredients):
You may take the first tablet of Triminulet the day after the last tablet of the previous contraceptive, without any tablet-free interval:

• the day after the last active tablet (the last tablet containing active ingredients) of the previous contraceptive. If in doubt, consult 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 ingredients) 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 Triminulet 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 Triminulet on the same day the implant or intrauterine device is removed.
• If you were using an injectable contraceptive: start taking Triminulet on the day the next injection of the injectable contraceptive was due.

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

After an abortion during the first 3 months of pregnancy:
You may start taking Triminulet immediately, as prescribed by your doctor, and no additional barrier contraceptive methods (e.g. condom) are necessary.

After childbirth or an abortion in the second trimester of pregnancy:
Do not start Triminulet 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 Triminulet, make sure you are not pregnant or wait for the onset of your first period.

If you take more Triminulet than you should
In case of accidental ingestion/overdose of Triminulet, contact your doctor immediately or go to the nearest hospital.
If you take more tablets than you should, you may experience stomach and intestinal problems (nausea and abdominal pain), breast tenderness, confusion, drowsiness/fatigue, and vaginal bleeding.

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

• If you realize you missed a tablet within 12 hours of the 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 2 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 such cases, follow the rules below:

If you missed 1 tablet during the first week of taking Triminulet:
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 Triminulet:
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.
Triminulet 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 an additional contraceptive method for 7 days to avoid pregnancy.

If you missed 1 tablet during the third week of taking Triminulet:
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 tablet-free interval between packs. In this way, your period will not occur until the end of 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 on which the tablet was missed, resume taking Triminulet 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 possibility of pregnancy. For this reason, consult your doctor before continuing treatment with Triminulet.

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What to do in case of vomiting and diarrhoea
If you vomit or have diarrhoea within 3–4 hours after taking the tablet, the situation is similar to
forgetting a tablet. You must use tablets from a new pack, as described above (see section “If you forget to take Triminulet”).

What to do in case of unexpected bleeding
With all oral contraceptives, you may experience vaginal bleeding between periods during the first few months of use. Irregular bleeding usually disappears once your body has adjusted to the pill (typically after about 3 cycles of use). You should always consult your doctor, but especially 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 vomited, 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 twice in succession, 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 Triminulet
You may stop using Triminulet at any time. If you do not wish to become pregnant, consult your doctor for advice on alternative methods of birth control.
After stopping Triminulet, you may not have a period 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 Triminulet because you wish to become pregnant, it is advisable to wait until your periods return to a regular pattern 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 could be due to Triminulet, tell your doctor.

An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) exists in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2, “What you should know before taking Triminulet”.

STOP taking Triminulet immediately if you experience any of the following side effects, as 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 (DVT)
• in a lung (PE)
• heart attack
• stroke
• mini-stroke or temporary symptoms similar to those of a stroke, 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)
• problems with the coronary arteries, the blood vessels supplying blood to the heart
• increased levels of fats (cholesterol, triglycerides) in the blood
• development of lumps in the breast (fibrocystic mastopathy), severe breast pain (mastodynia)
• severe and unusual headache and migraine, as these may be symptoms that can 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)
• yellow/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)
• malignant tumour of the cervix
• breast cancer

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

• nausea and feeling unwell
• 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 (oligomenorrhoea), absence of bleeding (amenorrhoea), and painful menstrual periods (dysmenorrhoea)
• changes in vaginal discharge
• changes in sexual desire
• eye irritation following the use of 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)
• 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 developing 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

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 Triminulet

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 no longer required. This will help protect the environment.

6. Package contents and other information

What Triminulet contains
The active substances are gestodene and ethinylestradiol.
Each beige tablet contains 0.050 mg of gestodene and 0.03 mg of ethinylestradiol.
Each dark brown tablet contains 0.070 mg of gestodene and 0.04 mg of ethinylestradiol.
Each white tablet contains 0.100 mg of gestodene and 0.03 mg of ethinylestradiol.
The other components are: lactose, sucrose (see section 2 “Triminulet contains lactose and sucrose”), maize starch, povidone 25,000, talc, calcium sodium edetate, magnesium stearate, povidone K-90, macrogol 6000, calcium carbonate, titanium dioxide (E171), glycerine, wax E, yellow iron oxide (E172), chocolate brown iron oxide (E172).

Description of the appearance of Triminulet and pack contents
Triminulet is available in calendar packs, each containing a PVC blister of 21 coated tablets.
Each blister contains 6 beige tablets numbered from 1 to 6, five dark brown tablets numbered from 7 to 11, and ten white tablets numbered from 12 to 21.
Each blister is packaged 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
Italy

Manufacturer
Pfizer Ireland Pharmaceuticals
Little Connell
Newbridge, Co. Kildare
Ireland