Minulet 0.075 mg/0.03 mg film-coated tablets: detailed information

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Minulet 0.075 mg/0.03 mg film-coated tablets

Gestodene and Ethinylestradiol

Read the entire leaflet carefully before you start taking this medicine, because

it contains important information for you.

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

Important information you should know about combined hormonal contraceptives (CHCs):

They are one of the most reliable reversible contraceptive methods if used correctly.
They slightly increase the risk of developing 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 weeks or more.
Be alert and consult your doctor if you think you may be experiencing symptoms of a blood clot (see section 2, "Blood clots").

Contents of the leaflet:

What Minulet is and what it is used for
What you need to know before taking Minulet
How to take Minulet
Possible side effects
How to store Minulet
Contents of the pack and other information

1. What Minulet is and what it is used for

Minulet is an oral contraceptive medication.

Minulet is prescribed for the following indications: hormonal oral contraception, menstrual cycle disorders, and ovarian suppression.

Additionally, the use of hormonal contraceptives may have beneficial effects on conditions such as dysmenorrhea (menstrual pain) and in reducing the incidence of certain breast and reproductive organ disorders.

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

General considerations

Before starting to use 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”).

When you must not use Minulet

Do not use Minulet if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you which alternative method of contraception would be more suitable.

If you are allergic (hypersensitive) to gestodene, ethinylestradiol, or any of the other ingredients of Minulet.
If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs.
If you know you have a disorder affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
If you require surgery or if you are going to be immobile for a long time (see section “Blood clots”).
If you have ever had a heart attack or a stroke.
If you have (or have ever had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).
If you have coronary heart disease or heart valve disorders (valvulopathies with risk of clot formation).
If you have heart rhythm disorders (arrhythmias) with risk of clot formation.
If you have any of the following conditions that may increase your risk of developing a clot in the arteries:
- Severe diabetes with blood vessel damage.
- Very high and/or uncontrolled blood pressure.
- Very high levels of fat in the blood (cholesterol or triglycerides).
- A condition called hyperhomocysteinemia.
If you have (or have ever had) a type of migraine called “migraine with aura”.
If you are pregnant or think you might be pregnant.
If you have severe liver function disorders.
If you have or are suspected of having a liver tumour.
If you have (or have ever had) or there is suspicion of malignant conditions of the genital organs or of the breasts.
If you have vaginal bleeding of unknown cause.
If you have pancreatitis (inflammation of the pancreas) due to severe increase in triglycerides.
If you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Use of other medicines”).

When you must be especially careful with Minulet

When should you consult your doctor?

Seek urgent medical attention

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

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

Before taking Minulet, you will need to visit your doctor for a physical examination. It is important that you inform your doctor if you currently have or have previously had any of the risk conditions listed below. If this is the case, your doctor must assess the benefits of using Minulet against the possible risks and discuss them with you before you decide to start using it.

Inform your doctor if you have any of the following conditions:

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

If you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease).
If you have systemic lupus erythematosus (SLE, a disease affecting your body’s natural defense system).
If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
If you have sickle cell anemia (an inherited red blood cell disorder).
If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
If you require surgery or will be immobile for long periods (see section 2 “Blood clots”).
If you have recently given birth, you are at increased risk of developing blood clots. You should ask your doctor when you can start taking Minulet after delivery.
If you have inflammation of the veins beneath the skin (superficial thrombophlebitis).
If you have varicose veins.
If you have any heart disease (chest pain, certain types of heart rhythm disorders, heart conditions).
If you have high blood pressure, especially if it worsens or does not improve while taking antihypertensive medications.
If you have severe and recurrent migraines.
If you have diabetes.
If you have depression or a history of depression, as it may worsen or reappear while using hormonal contraceptives.
If you have certain types of jaundice (yellowing of the eyes and/or skin) or liver function disorders.
If you have itching, especially if it occurred during a previous pregnancy.
If you have permanent brown patches on the skin of your face, particularly if you had them during a previous pregnancy. In such cases, avoid sunlight and ultraviolet radiation (e.g., sunbeds).
If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives possibly accompanied by difficulty breathing, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema.
If you have angioedema (swelling similar to hives but occurring beneath the skin rather than on the surface), particularly in women with hereditary angioedema (an immune system disorder passed from parents to children).

Psychiatric disorders:

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

BLOOD CLOTS

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

Blood clots can form:

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

Recovery from blood clots is not always complete. Rarely, there may be serious long-term effects, and very rarely, they may be fatal.

It is important to remember that the overall risk of a harmful blood clot due to Minulet is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if you notice any of the following signs or symptoms.

Are you experiencing any of these signs?

What might you be

suffering from?

? Swelling in one leg or foot, or along a vein in the leg or foot,

especially when accompanied by:

o Pain or tenderness in the leg, which may only be noticeable

when standing or walking.

o Increased warmth in the affected leg.

o Change in skin color of the leg, e.g., pale, red, or blue.

Deep vein thrombosis

? Sudden shortness of breath without known cause or rapid

breathing.

? Sudden cough without clear cause, possibly bringing up

blood.

? Sharp chest pain that may worsen when breathing deeply.

? Severe dizziness or lightheadedness.

? Rapid or irregular heartbeat.

? Severe stomach pain.

If you are unsure, consult a doctor, as some of these

symptoms, such as cough or shortness of breath, may be mistaken

for a milder condition such as a respiratory infection

(e.g., a "common cold").

Pulmonary embolism

Symptoms occurring more frequently in one eye:

? Sudden loss of vision. Or

? Painless blurred vision, which may progress to

loss of vision.

Retinal vein thrombosis

(blood clot in the eye)

? Pain, discomfort, pressure, or heaviness in the chest.

? Feeling of tightness or fullness in the chest, arm, or

below the breastbone.

? Feeling of fullness, indigestion, or suffocation.

? Upper body discomfort radiating to the back, jaw, throat,

arm, or stomach.

? Sweating, nausea, vomiting, or dizziness.

? Extreme weakness, anxiety, or shortness of breath.

? Rapid or irregular heartbeat.

Heart attack

? Sudden weakness or numbness in the face, arm, or

leg, especially on one side of the body.

? Sudden confusion, difficulty speaking or understanding.

? Sudden vision difficulty in one or both eyes.

? Sudden difficulty walking, dizziness, loss of balance or

coordination.

? Sudden, severe, or prolonged headache without known

cause.

? Loss of consciousness or fainting, with or without

seizures.

Sometimes stroke symptoms may be brief, with almost

immediate and complete recovery, but you should still seek

urgent medical attention as you may be at risk of another

stroke.

Stroke

? Swelling and slight bluish discoloration of a limb.

? Severe stomach pain (acute abdomen).

Blood clots blocking other

blood vessels

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in the veins (venous thrombosis). However, these adverse effects are rare. They occur most frequently 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 travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
Very rarely, a clot may form in a vein of another organ such as the eye (retinal vein thrombosis).

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

The risk of developing a blood clot in a vein is higher during the first year in which you take 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 weeks or more.

After the first year, the risk decreases, but it remains somewhat higher than if you were not taking a combined hormonal contraceptive.

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

What is the risk of developing a blood clot?

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

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

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

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

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

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

If you are 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 (i.e., before approximately 50 years). In this case, you might have an inherited blood clotting disorder.
If you require surgery or if you remain immobile for long periods due to injury, illness, or if your leg is in a cast. You may need to stop using Minulet several weeks before surgery or while you are less mobile. If you need to stop using Minulet, ask your doctor when you can start again.
As you get older (especially over about 35 years of age).
If you have given birth within the last few weeks.

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

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

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

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

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Just like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can lead to a heart attack or stroke.

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

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

With age (over 35 years).
If you smoke. When using a combined hormonal contraceptive such as Minulet, you are advised 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 about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
If you or a close relative has high levels of fat in the blood (cholesterol or triglycerides).
If you suffer from migraines, especially migraines with aura.
If you have a heart condition (valve disorder, heart rhythm disorder called atrial fibrillation).
If you have diabetes.

If you have one or more of these conditions, or if any of them are particularly severe, your risk of developing a blood clot may be further increased.

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

Tumors

Slightly more cases of breast cancer have been observed in women using oral contraceptives, but it is unknown whether this is due to the treatment. For example, more tumors may be detected in women who use oral contraceptives because they visit their doctor more frequently. This increased incidence gradually decreases after stopping treatment. After ten years, the likelihood of developing breast cancer will be the same as in women who have never used oral contraceptives.

Similarly, cervical (cervix) cancer occurs more frequently in women who use oral contraceptives. However, the development of this tumor is associated with increased sexual activity and sexually transmitted infections, so it is unclear whether the oral contraceptive plays a direct role in this risk.

Rare cases of liver tumors have been reported in women using oral contraceptives. In these cases, internal bleeding may occur, causing severe abdominal pain. If this happens, you should contact your doctor immediately. Some studies suggest that the use of hormonal contraceptives may be associated with an increased risk of cervical intraepithelial neoplasia or invasive cervical cancer in certain groups of women.

Other conditions

Blood pressure:

If you have hypertension (high blood pressure) or suffer from a disease related to hypertension (including certain kidney diseases), it is preferable to use other contraceptive methods. If you decide to use hormonal contraceptives, your blood pressure should be monitored. However, if it increases and cannot be controlled with medication, you must stop treatment with this medicine (see section “When not to use Minulet”).

Cholestasis:

Women who have previously experienced cholestasis (obstruction of bile flow) during treatment with hormonal contraceptives or during pregnancy are more likely to develop it again if they use hormonal contraceptives. These women should be monitored, and if cholestasis occurs, treatment with hormonal contraceptives should be discontinued.

Liver damage:

Cases of severe liver injury have been reported with the use of hormonal contraceptives. If your doctor determines that you develop severe liver damage while taking hormonal contraceptives, treatment will be stopped and you will be advised to use non-hormonal contraceptives (see section “When not to use Minulet”).

Migraine:

Women with migraines (particularly those associated with symptoms such as loss of strength or sensation in part of the body, or visual disturbances (aura)) who take hormonal contraceptives may have an increased risk of cerebral infarction (see section “When not to use Minulet”).

Angioedema:

The use of hormonal contraceptives may worsen symptoms of angioedema (a swelling similar to hives but occurring beneath the skin rather than on the surface), particularly in women with hereditary angioedema (an immune system disorder passed from parents to children).

Genital bleeding:

You may not have your “period” during the rest week. If the contraceptive pill has been taken correctly, it is very unlikely that you are pregnant. However, if you miss two periods, you should consult your doctor to rule out pregnancy. If you have not taken the contraceptive pill according to the instructions in section 3 “How to take Minulet” and miss a period, you should stop treatment and use a non-hormonal contraceptive method until pregnancy has been ruled out (see section “When not to use Minulet”).

This medicine may cause vaginal bleeding or spotting between periods. If this occurs, continue treatment, but if the bleeding continues beyond the first three cycles, consult your doctor immediately. Mistakes in taking the pill may also cause spotting and light bleeding.

When you stop using this medicine, you may experience irregular or light bleeding, or no bleeding at all, especially during the first 3 months and particularly if your periods were already irregular before starting hormonal treatment.

Effects on carbohydrates and lipids:

Cases of glucose intolerance have been reported in users of hormonal contraceptives. Women with glucose intolerance or diabetes mellitus should be carefully monitored (see section “When not to use Minulet”).

A small proportion of women taking hormonal contraceptives may experience changes in their lipid profile (blood fat analysis). Non-hormonal contraceptive methods should be considered in women with uncontrolled lipid disorders. A small proportion of women taking hormonal contraceptives may develop persistent hypertriglyceridemia (increased triglycerides in the blood). A significant increase in plasma triglycerides may lead to pancreatitis and other complications.

Women previously treated for hyperlipidemia (elevated cholesterol and/or triglycerides) should be monitored if they decide to use hormonal contraceptives (see section “When not to use Minulet”).

Eye disorders:

Cases of retinal vascular thrombosis have been reported with the use of hormonal contraceptives, which may lead to partial or complete vision loss. If signs or symptoms such as visual changes, onset of proptosis (bulging eyes), diplopia (double vision), papilledema (optic disc swelling), or retinal vascular lesions occur, treatment with hormonal contraceptives should be discontinued and the cause evaluated immediately.

Depression:

If a severe episode of depression occurs, treatment should be stopped and an alternative contraceptive method used.

Women with a history of depression should be monitored.

Sexually transmitted infections:

The contraceptive pill does not protect against HIV (AIDS) or any other sexually transmitted infection (e.g., chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, or syphilis). Condoms must be used to protect against these infections.

Use of Minulet with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, including those obtained without a prescription.

You should never take another medicine on your own initiative without your doctor’s recommendation, as some combinations should be avoided.

Note that these instructions may also apply to medicines you have taken or used previously or may take or use in the future.

The following medicines may prevent combined hormonal contraceptives from working properly, and if this occurs, you could become pregnant:

Some treatments for viral infections and HIV (ritonavir, indinavir).
Some antibiotics (rifampicin, rifabutin, griseofulvin, and troleandomycin).
Some antiepileptics (topiramate, barbiturates (phenobarbital), phenytoin, carbamazepine, primidone, oxcarbazepine).
Some anti-inflammatory drugs (phenylbutazone, dexamethasone).
Antacids.
Laxatives.
Some mood-enhancing substances (modafinil).
Medicines that reduce triglyceride and/or cholesterol levels (atorvastatin).
Antifungals (fluconazole).
Vitamin C.
Analgesics (paracetamol).

The herbal remedy St. John’s wort (Hypericum perforatum) also reduces the effectiveness of hormonal contraceptives, and cases of pregnancy have been reported in women taking both the contraceptive pill and St. John’s wort preparations. The reduced contraceptive effect lasts up to two weeks after stopping St. John’s wort.

It is advisable to use another reliable contraceptive method if you are taking any of the medicines listed above. The effect of some of these medicines may last up to 28 days after stopping treatment.

Minulet may reduce the effect of other medicines, such as:

Oral anticoagulants (acenocoumarol).
Analgesics (such as paracetamol and salicylates).
Oral antidiabetics and insulin.
Lamotrigine (used to treat epilepsy and some psychiatric disorders).

Likewise, Minulet may increase the effect of other drugs such as:

Beta-blockers like metoprolol (used to treat high blood pressure).
Theophylline (used to treat asthma).
Corticosteroids (such as prednisolone).
Cyclosporine (an immunosuppressant), increasing the risk of liver toxicity.
Flunarizine (used to treat migraine), increasing the risk of lactation.

Do not take MINULET if you have Hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as increases in liver function test results (elevated liver enzyme ALT) may occur.

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

MINULET can be restarted approximately 2 weeks after completing this treatment. See section “Do not take MINULET.”

Laboratory tests

The use of hormonal contraceptives may affect the results of certain laboratory tests.

If you are scheduled for any laboratory test, inform your doctor that you are using hormonal contraceptives.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

Do not use this medicine if you are pregnant or think you might be pregnant (for information on using Minulet after pregnancy, see section 3 “How to take Minulet”).

If you become pregnant, you must stop taking this medicine immediately and consult your doctor (see section “When not to use Minulet”).

This medicine should not be used until the end of the breastfeeding period.

Use in children

The efficacy and safety of hormonal contraceptives have been established in women of reproductive age.

Its use is not indicated before the first menarche (menstruation).

Elderly

Not indicated in postmenopausal women.

Driving and use of machines

No effects on the ability to drive or operate machinery have been observed.

Minulet contains lactose, sucrose, and sodium

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

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; thus, it is essentially “sodium-free.”

3. How to take Minulet

Follow exactly the instructions for taking Minulet provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

This medicine is for oral administration.

Remember to take your medicine regularly, as forgetting to take Minulet may reduce its effectiveness.

Before starting treatment with Minulet, your doctor should perform a detailed medical history and thorough physical examination, including blood pressure measurement, and must rule out pregnancy. Your doctor should also perform an examination of the breasts, liver, limbs, and pelvic organs (bladder, vagina, uterus, and lower part of the large intestine). Your doctor may also need to perform a cervical cytology test (a gentle, painless scraping of the cervix to collect cells for analysis). Your doctor will repeat this examination 3 months after starting treatment and then annually.

See section 2 “What you need to know before starting to take Minulet”.

Instructions for correct administration of the medicine

You must take the tablets orally, in the order indicated on the blister pack, approximately at the same time every day, with some liquid if needed. Take one tablet daily for 21 consecutive days, followed by a 7-day tablet-free interval. Each new pack should be started after this 7-day break, during which withdrawal bleeding usually occurs. This bleeding, similar to a menstrual period, typically begins 2 to 3 days after taking the last tablet and may not have finished before the next pack is started.

Your doctor will advise you on the duration of your treatment with this medicine.

If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

Starting the first pack of Minulet

When no hormonal contraceptive has been used the previous month

Treatment should start on the first day of the menstrual cycle (i.e., the first day of bleeding). For example, if bleeding starts on a Monday, you should begin taking this medicine on the same day, starting with the coated tablet marked “Lu”, and follow the directional arrow for subsequent doses.

It is also permitted to start on days 2–7 of the menstrual cycle. In this case, it is recommended to use a non-hormonal contraceptive method as backup (e.g., condoms or spermicide) for the first 7 days of tablet intake.

When switching from another contraceptive to Minulet

You may start taking Minulet the day after taking the last active tablet of your current pill pack (meaning there is no tablet-free break). If your current pill pack also contains inactive tablets, you may start Minulet the day after taking the last active tablet. You must not delay starting Minulet beyond the day following the end of the usual tablet-free interval or the interval of inactive tablets in your previous contraceptive.

When switching from a method containing only a progestogen (mini-pill, implant, intrauterine device (IUD), or injection)

You may stop taking the progestogen-only pill (mini-pill) on any day and start taking Minulet the next day at the same time.

Begin using this medicine on the day you are due for your next injection or on the day your implant or intrauterine device (IUD) is removed.

In all these situations, make sure to also use an additional barrier method during sexual intercourse (e.g., condoms or spermicides) for the first 7 days of taking the tablets.

After a first-trimester abortion

You may start taking the tablets immediately. If you do so, no additional contraceptive measures are needed.

Postpartum

If you are breastfeeding, you must not take this medicine (see “Pregnancy, breastfeeding and fertility”).

Tablet use should begin 28 days after delivery in women who are not breastfeeding, or after a second-trimester abortion. If you start later, you must use an additional barrier method for the first 7 days of tablet intake. However, if you have already had sexual intercourse, pregnancy must be ruled out before starting the contraceptive, or you must wait until your next menstrual period.

Subsequent cycles

After the 7-day break, continue with a new pack of Minulet, starting on the same day of the week as the first pack was started.

What to do if bleeding occurs during the 21 days of taking coated tablets

Bleeding during the 3 weeks of taking coated tablets is not a reason to stop treatment. Light bleeding usually resolves on its own. If bleeding becomes as heavy as a normal menstrual period and persists for more than 3 cycles, you should consult your doctor.

Absence of bleeding

If vaginal bleeding does not occur during the tablet-free interval, you should consult your doctor immediately to rule out pregnancy, especially if the coated tablets were not taken regularly or if vomiting or diarrhea occurred during the cycle.

If you forget to take Minulet

Contraceptive protection may be reduced if you miss tablets. In particular, if the missed dose occurs in the first week of treatment and you had sexual intercourse in the previous week, there may be a risk of pregnancy.

If you are less than 12 hours late taking a tablet, contraceptive efficacy is maintained. Take the tablet as soon as you remember and take the following tablets at your usual time.
If you are more than 12 hours late taking a tablet, contraceptive efficacy may be reduced.
- Always take the last missed tablet as soon as you remember, even if this means taking two tablets in one day. Continue taking the following tablets at your usual time, but use an additional barrier method (such as condoms or spermicides) for the next 7 days.
- If you finish the pack before completing the 7 days requiring additional contraceptive protection, start a new pack immediately without a break. You will not have a menstrual period until the end of the new pack, although you may experience spotting or bleeding during tablet intake.
- If you do not have a period at the end of the new pack, contact your doctor. Your doctor must confirm that you are not pregnant before starting the next pack.

Advice in case of vomiting and/or diarrhea

If vomiting or diarrhea occurs within 4 hours after taking a tablet, follow the advice for missed tablets. If you do not wish to change your regular tablet-taking schedule, take the necessary additional tablets from another pack.

How to delay a period

To delay a period, start a new pack immediately after finishing the current pack, without any break. Periods can be delayed for as long as desired, but not beyond the end of the second pack. During this time, you may experience bleeding or spotting. After this, resume regular tablet intake following the usual 7-day tablet-free interval.

If you take more Minulet than you should

You may experience nausea, vomiting, drowsiness, breast tenderness, dizziness, and vaginal bleeding. Treatment consists of stopping the administration of this medicine. Contact your doctor or pharmacist as soon as possible.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Telephone 915 620 420, indicating the medicine and the amount taken.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

All women who take 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 starting Minulet”.

Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat, and/or difficulty swallowing, or hives with possible difficulty breathing (see also section “Warnings and precautions”).

The use of hormonal contraceptives has also been associated with an increased risk of:

Cervical intraepithelial neoplasia (abnormal cells on the surface of the cervix) and cervical cancer (cancer of the cervix).
Diagnosis of breast cancer (see “Take special care with Minulet”).
Benign liver tumours (e.g. focal nodular hyperplasia, hepatic adenomas).

The adverse effects listed below are classified according to their frequency based on the following criteria:

Very common: may affect more than 1 in 10 people.

Common: may affect up to 1 in 10 people.

Uncommon: may affect up to 1 in 100 people.

Rare: may affect up to 1 in 1,000 people.

Very rare: may affect up to 1 in 10,000 people.

Frequency not known: cannot be estimated from available data.

Infections and infestations

Common: Vaginitis (inflammation of the vagina), including candidiasis (fungal infection in the vagina).

Benign/malignant neoplasms or unspecified

Very rare: Liver carcinomas (malignant liver tumours).

Immune system disorders

Rare: Allergic-type reactions such as urticaria (itching), angioedema (swelling of face, lips, mouth and, in very rare cases, accompanied by difficulty breathing, dizziness and even loss of consciousness).

Very rare: Worsening of systemic lupus erythematosus (an autoimmune disease).

Metabolic and nutritional disorders

Uncommon: Changes in appetite (increase or decrease).

Rare: Glucose intolerance.

Very rare: Worsening of porphyria (a hereditary metabolic disorder).

Psychiatric disorders

Common: Mood changes, including depression, changes in libido (sex drive).

Nervous system disorders

Very common: Headache, including migraine.

Common: Nervousness, dizziness.

Very rare: Worsening of chorea (involuntary movements).

Eye disorders

Rare: Intolerance to contact lenses.

Very rare: Eye abnormalities and visual disturbances.

Vascular disorders

Uncommon: Increase in blood pressure.

Rare: Formation of harmful blood clots in a vein or artery, for example:

In a leg or foot (i.e., DVT).
In a lung (i.e., PE).
Heart attack.
Stroke.
Mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA).
Blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

Very rare: Worsening of varicose veins.

Gastrointestinal disorders

Common: Nausea, vomiting, abdominal pain.

Uncommon: Colic, bloated feeling.

Very rare: Pancreatitis (inflammation of the pancreas), ischaemic colitis (certain types of inflammation of the colon).

Frequency not known: Inflammatory bowel disease (Crohn’s disease, ulcerative colitis).

Hepatobiliary disorders (liver and gallbladder)

Rare: Cholestatic jaundice (yellowing of the whites of the eyes and skin due to bile retention).

Very rare: Cholecystopathy (gallbladder disorders), including gallstones.

Frequency not known: Liver injury (e.g. hepatitis, abnormal liver function).

Skin and subcutaneous tissue disorders

Common: Acne.

Uncommon: Rash, chloasma (skin pigmentation) which may persist, hirsutism (excessive hair growth), alopecia (hair loss).

Rare: Erythema nodosum (a type of skin inflammation causing nodules on the legs).

Very rare: Erythema multiforme (a type of skin inflammation).

Renal and urinary disorders

Very rare: Haemolytic uraemic syndrome (a kidney disease with blood abnormalities).

Reproductive system and breast disorders

Very common: Unexpected vaginal bleeding or spotting.

Common: Breast pain or tenderness, breast swelling, galactorrhoea (milk secretion), dysmenorrhoea (painful menstruation), changes in menstrual flow, changes in vaginal discharge and cervical ectopy (alteration of the cervical mucosa), amenorrhoea (absence of menstruation).

General disorders

Common: Fluid retention, oedema (swelling).

Other

Common: Changes in body weight (increase or decrease).

Uncommon: Increase in blood pressure, changes in blood lipid levels, including hypertriglyceridaemia (high levels of fatty acids in blood).

Rare: Decrease in blood folate levels.

Do not be alarmed by these adverse effects, as it is very likely that none of them will occur.

Reporting of adverse effects:

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

5. Storage of Minulet

This medicine does not require any special storage conditions.

Keep out of the sight and reach of children.

Do not use Minulet after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Minulet

The active substances in Minulet are: 0.075 mg of gestodene and 0.03 mg of ethinylestradiol.

The other components (excipients) are: lactose, corn starch, povidone K-25, magnesium stearate, calcium disodium edetate, sucrose, macrogol 6000, calcium carbonate, talc, povidone K90 and emulsifying wax.

Appearance of the product and contents of the pack

It is presented in calendar packs containing 1 or 3 blisters of 21 coated tablets per blister. The blister(s) are packed in an aluminium bag containing a sachet with desiccant (silica gel). After opening the aluminium bag, the desiccant may be removed.

Marketing Authorization Holder

Wyeth Farma, S.A.

Ctra. Burgos, Km 23. Desvío Algete, Km 1.

San Sebastián de los Reyes – Madrid

Spain

Manufacturer

Pfizer Ireland Pharmaceuticals Unlimited Company

Little Connell

Newbridge

Co. Kildare

W12 HX57

Ireland

Local representative

Pfizer, S.L.

Avda. de Europa, 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Date of the most recent review of this leaflet: November 2022

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