Dretine 0.03 mg/3 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Dretine 0.03 mg/3 mg film-coated tablets EFG

Ethinylestradiol/drospirenone

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Important things you should 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 a blood clot 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”).

Leaflet contents:

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

1. What Dretine is and what it is used for

Dretine is a contraceptive pill and is used to prevent pregnancy.

Each coated tablet contains a small amount of two different female hormones called drospirenone and ethinylestradiol.

Contraceptive pills containing two hormones are known as "combined" pills.

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

General considerations Before starting to use Dretine, you should 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”). Before you can start taking Dretine, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out other tests. This leaflet describes several situations in which you should stop using Dretine, or in which the reliability of Dretine may be reduced. In such situations, you should not have sexual intercourse or you should use additional non-hormonal contraceptive precautions, such as using a condom or another barrier method. Do not use rhythm or temperature methods. These methods may not be reliable because Dretine alters the monthly changes in body temperature and cervical mucus. Dretine, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted disease.

When not to use Dretine

Do not use Dretine 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 other form of contraception would be more suitable.

• 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 will be immobile for a long time (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 and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms)
• if you have any of the following conditions that may increase your risk of developing a blood clot in the arteries:
• Severe diabetes with blood vessel damage
• Very high 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 have (or have ever had) liver disease and your liver function is not yet normal
• if your kidneys do not function properly (renal insufficiency)
• if you have (or have ever had) a liver tumour
• if you have (or have ever had), or suspect you have breast cancer or cancer of the reproductive organs
• if you have vaginal bleeding of unknown cause
• if you are allergic to ethinylestradiol or drospirenone, or to any of the other ingredients of this medicine (listed in section 6). This may cause itching, rash, or swelling
• if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Taking Dretine with other medicines”)

Additional information on special populations

Children and adolescents

Dretine is not indicated for use in women whose menstrual periods have not yet started.

Elderly patients

Dretine is not indicated for use after menopause.

Women with hepatic impairment

Do not take Dretine if you have liver disease. See also the sections "Do not take Dretine" and "Warnings and precautions".

Women with renal impairment

Do not take Dretine if you have impaired kidney function or acute renal failure. See also the sections "When not to use Dretine" and "Warnings and precautions".

Warnings and precautions

Consult your doctor or pharmacist before taking Dretine.

When you should exercise special caution with Dretine

When should you consult your doctor? Seek urgent medical assistance If you notice possible signs of a blood clot which may indicate that you are suffering from 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 adverse effects, see “How to recognize a blood clot”

Inform your doctor if you have any of the following conditions

Talk to your doctor before taking Dretine. In certain situations, you should take special care when using Dretine or any other combined contraceptive, and your doctor may need to examine you periodically. If any of these conditions develop or worsen while you are using Dretine, you must also inform your doctor.

• if any close relative has or has ever had breast cancer
• if you have any liver or gallbladder disease
• if you have diabetes
• if you have depression
• 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 haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure)
• if you have sickle cell anaemia (an inherited red blood cell disorder)
• if you have high levels of fat in the blood (hypertriglyceridaemia) or a known family history of this condition. Hypertriglyceridaemia 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 blood clots. Ask your doctor when you can start taking Dretine after childbirth.
• if you have inflammation of veins beneath the skin (superficial thrombophlebitis)
• if you have varicose veins
• if you have epilepsy (see “Dretine and use of other medicines”)
• if you have any condition that first occurred during pregnancy or during previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (herpes gestationis), a nervous disorder involving involuntary movements (Sydenham's chorea))
• if you have or have ever had chloasma (skin discoloration, especially on the face or neck, also known as “pregnancy mask”). In such cases, avoid direct exposure to sunlight or ultraviolet light.

If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives, possibly with breathing difficulties, contact your doctor immediately. Medicines containing oestrogens may induce or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Using a combined hormonal contraceptive like Dretine 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 veins (called “venous thrombosis”, “venous thromboembolism” or VTE)
• in arteries (called “arterial thrombosis”, “arterial thromboembolism” or ATE)

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

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical help 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: pain or tenderness in the leg, which may only be noticeable when standing or walking increased warmth in the affected leg change in skin color of the leg, e.g. turning 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 Chest pain that may worsen when taking a deep breath Severe dizziness or lightheadedness Fast 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 like 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 vision loss	Retinal vein thrombosis (blood clot in the eye)
Pain, discomfort, pressure, heaviness in the chest Feeling of tightness or fullness in the chest, arm, or below the breastbone Sensation of fullness, indigestion, or suffocation Upper body discomfort spreading to the back, jaw, throat, arm, or stomach Sweating, nausea, vomiting, or dizziness Extreme weakness, anxiety, or shortness of breath Fast or irregular heartbeat	Heart attack
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body Sudden confusion, difficulty speaking or understanding Sudden vision problems 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 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 in 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 you take a combined hormonal contraceptive for the first time. The risk may also be increased if you restart taking a combined hormonal contraceptive (the same or a different medicine) 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 Dretine, 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 venous thromboembolism (VTE) and on the type of combined hormonal contraceptive you are taking.

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

• Among every 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 every 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 every 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Dretine, 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 medical history (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill / patch / vaginal ring and who are not pregnant	About 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5 – 7 out of 10,000 women
Women who use Dretine	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 Dretine 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 any of your close relatives has had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years of age). In this case, you might have an inherited blood clotting disorder.
• if you need surgery or if you remain immobile for long periods due to injury or illness, or if your leg is in a cast. You may need to stop taking Dretine several weeks before surgery or while you are less mobile. If you need to stop taking Dretine, ask your doctor when you can start taking it 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 unsure. Your doctor may decide that you need to stop taking Dretine.

If any of the above conditions change while you are using Dretine—for example, a close relative experiences a thrombosis without a known cause or 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 may 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 heart attack or stroke while using Dretine is very small, but it may increase:

• with age (over 35 years)
• if you smoke. When using a combined hormonal contraceptive like Dretine, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• if you are overweight
• if you have high blood pressure
• if any of your close relatives 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 any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides)
• if you suffer from migraines, especially migraine 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 is particularly severe, your risk of developing a blood clot may be further increased.

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

Dretine and cancer

A slightly higher incidence of breast cancer has been observed in women using combined oral contraceptives, but it is not known whether this is due to the treatment. For example, more tumors may be detected in women taking combined pills because they are examined by a doctor more frequently. The incidence of breast tumors gradually decreases after stopping combined hormonal contraceptives.

It is important to have regular breast examinations and you should see your doctor if you notice any lump.

In rare cases, benign liver tumors have been reported in users of oral contraceptives, and even more rarely, malignant liver tumors. See your doctor if you experience unusual severe abdominal pain.

Bleeding between periods

During the first few months of taking Dretine, you may experience unexpected bleeding (bleeding outside the days when taking placebo tablets). If such bleeding continues beyond a few months or begins after several months, your doctor should investigate the cause.

What to do if you do not have your period during the placebo days

If you have taken all the active pale pink tablets correctly, have not vomited or had severe diarrhea, and have not taken other medications, it is very unlikely that you are pregnant.

If you miss two consecutive expected periods, you may be pregnant. See your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Psychiatric disorders

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

Taking Dretine with other medicines

Always inform your doctor about any medications or herbal preparations you are taking. Also inform any other doctor or dentist who prescribes another medication for you (or your pharmacist) that you are using Dretine. They may advise you whether you need to take additional contraceptive precautions (for example, condoms) and, if so, for how long, or whether you need to adjust the use of another medication.

Some medicines can affect the levels of Dretine in the blood and may make it less effective in preventing pregnancy or may cause unexpected bleeding. This may occur with:

• Medicines used to treat

• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)

• tuberculosis (e.g. rifampicin)

• HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)

• fungal infections (griseofulvin, ketoconazole)

• arthritis, osteoarthritis (etoricoxib)

• high blood pressure in the blood vessels of the lungs (bosentan)

• the herbal remedy St. John’s wort.

• Dretine may influence the effect of other medicines, for example:

• medicines containing cyclosporine

• the antiepileptic lamotrigine (may lead to an increased frequency of seizures)

• theophylline (used to treat breathing problems)

• tizanidine (used to treat muscle pain or cramps).

Do not use Dretine if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause increases in blood parameters measuring liver function (increase in liver enzyme ALT).

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

Dretine may be restarted approximately 2 weeks after completing this treatment. See section “When not to use Dretine”.

Consult your doctor or pharmacist before taking any medicine.

Taking Dretine with food and drinks

Dretine can be taken with or without food, and with some water if needed.

Laboratory tests

If you require a blood test, inform your doctor or laboratory staff that you are taking the pill, as hormonal contraceptives may influence the results of certain tests.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, do not take Dretine. If you become pregnant during treatment with Dretine, stop treatment immediately and contact your doctor. If you wish to become pregnant, you may stop taking Dretine at any time (see “If you want to stop taking Dretine”).

Consult your doctor or pharmacist before taking any medicine.

Breastfeeding

In general, Dretine is not recommended during breastfeeding. If you wish to take the contraceptive while breastfeeding, you should consult your doctor.

Consult your doctor or pharmacist before taking any medicine.

Driving and use of machines

There is no information suggesting that the use of Dretine has any effect on the ability to drive or operate machinery.

Dretine contains lactose.

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Dretine

Follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Take one Dretine tablet daily with a glass of water if necessary. You may take the tablets with or without food, but always at approximately the same time each day.

The strip contains 21 coated tablets. The day of the week on which you should take the tablet is printed next to each tablet. For example, if you start on a Wednesday, you should take a tablet marked “WED” next to it. Follow the direction of the arrow on the pack until you have taken all 21 tablets.

Afterwards, you must not take any tablets for 7 days. During these 7 days without tablets (also called the break or rest week), your menstrual period should occur. Usually, menstruation, which may also be referred to as withdrawal bleeding, begins on the second or third day of the rest week.

On the 8th day after taking the last Dretine tablet (i.e., after the 7-day rest week), you must start the next strip, even if your menstrual bleeding has not yet finished. This means that you should start each new strip on the same day of the week, and your period should occur during the same days every month.

If you use Dretine in this way, you will also remain protected against pregnancy during the 7 days when you are not taking any tablets.

When to start the first strip

• If you have not used any hormonal contraceptives in the previous month

Start taking Dretine on the first day of your cycle (i.e., the first day of your period). If you start Dretine on the first day of your period, you are immediately protected against pregnancy. You may also start on days 2–5 of the cycle, but in this case you must use additional contraceptive methods (e.g., a condom) during the first 7 days.

• Switching from a combined hormonal contraceptive, combined vaginal contraceptive ring, or patch

You may preferably start taking Dretine the day after the last active tablet (the last tablet containing the active ingredient) of your previous pill, but no later than the day after the usual tablet-free interval of your previous pill (or after the last inactive tablet of your previous pill). When switching from a combined vaginal contraceptive ring or patch, follow your doctor's recommendations.

• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system (IUS) containing progestogen)

You may switch from a progestogen-only pill on any day (if using an implant or IUS, on the same day of removal; if using an injectable, at the time the next injection would be due), but in all cases you must use additional contraceptive measures (e.g., a condom) during the first 7 days of taking Dretine tablets.

• After an abortion

Follow your doctor’s recommendations.

• After giving birth

You may start taking Dretine between 21 and 28 days after giving birth. If you start later, use one of the so-called barrier methods (e.g., a condom) during the first seven days of using Dretine.

If, after giving birth, you have already had sexual intercourse before starting to take Dretine (again), you must be sure that you are not pregnant or wait until your next menstrual period.

• If you are breastfeeding and wish to start taking Dretine (again) after giving birth

Read the section “Breast-feeding”.

Ask your doctor if you are unsure about when to start.

If you take more Dretine than you should

There have been no reports of serious harm caused by an overdose of ethinylestradiol/drospirenone.

If you take many tablets at once, you may experience symptoms such as nausea or vomiting or vaginal bleeding. Even girls who have not yet started menstruating but who have accidentally taken this medicine may experience this type of bleeding.

If you have taken too many Dretine tablets, or if you find that a child has taken them, consult your doctor or pharmacist immediately or call the Toxicology Information Service at phone number 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you forget to take Dretine

• If you are less than 12 hours late in taking a tablet, protection against pregnancy is not reduced. Take the tablet as soon as you remember, then take the following tablets at the usual time.
• If you are more than 12 hours late in taking a tablet, protection against pregnancy may be reduced. The more tablets you forget, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is highest if you forget a tablet at the beginning or end of the strip. Therefore, you should take the following measures (see also the diagram below):

• More than one tablet forgotten in a strip

Consult your doctor.

• One tablet forgotten in week 1

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the following tablets at the usual time and use extra precautions for the next 7 days, for example, a condom. If you had sexual intercourse in the week before forgetting the tablet, you should be aware that there is a risk of pregnancy. In this case, consult your doctor.

• One tablet forgotten in week 2

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the following tablets at the usual time. Protection against pregnancy is not reduced, and you do not need to take extra precautions.

• One tablet forgotten in week 3

You have two options:

1. Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at the usual time. Instead of taking the usual 7-day tablet-free break, start the next strip immediately.

You will likely have a period at the end of the second strip, but you may experience light bleeding or spotting similar to menstruation during the second strip.

1. You may also stop the current strip and go directly to a 7-day tablet-free interval (note the day on which you forgot to take your tablet). If you wish to start a new blister pack on your usual starting day, reduce the tablet-free interval to fewer than 7 days.

If you follow either of these two recommendations, you will remain protected against pregnancy.

• If you have forgotten to take any tablets from the strip and do not have bleeding during the first tablet-free interval, you may be pregnant. See your doctor before starting the next strip.

What to do in case of vomiting or severe diarrhoea

If you vomit within 3–4 hours after taking a tablet or suffer from severe diarrhoea, there is a risk that the active ingredients of the pill are not fully absorbed by your body. This is similar to what happens when you forget a tablet. After vomiting or diarrhoea, take another tablet from a reserve strip as soon as possible. If possible, take it within 12 hours of your usual time for taking the contraceptive. If this is not possible or more than 12 hours have passed, follow the advice given under “If you forget to take Dretine”.

Delayed menstrual period: what you should know

Although not recommended, it is possible to delay your menstrual period by starting a new strip of Dretine immediately, without beginning the tablet-free break, and continuing until the end. You may experience light bleeding or spotting similar to menstruation while using the next strip. After the usual 7-day tablet-free interval, continue with the next strip.

You must consult your doctor before deciding to delay your menstrual period.

Changing the first day of your menstrual period: what you should know

If you take the tablets as instructed, your menstrual period will begin during the tablet-free week. If you wish to change this day, reduce the number of tablet-free days (but never increase them – 7 is the maximum). For example, if your tablet-free interval starts on a Friday and you wish to change it to Tuesday (3 days earlier), start the new strip 3 days earlier than usual. If you make the tablet-free interval very short (e.g., 3 days or less), you may not have any bleeding during these days. In this case, you may experience light bleeding or spotting.

If you are unsure what to do, consult your doctor.

If you want to stop taking Dretine

You may stop taking Dretine at any time. If you do not wish to become pregnant, consult your doctor about other effective methods of birth control. If you wish to become pregnant, stop taking Dretine and wait for your period before trying to conceive. This will make it easier to calculate your estimated due date.

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 gets them. If you experience any adverse effect, especially if it is severe and persistent, or if you have any health change you think may be due to Dretine, consult your doctor.

All women who take combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting to use Dretine”.

Serious adverse effects

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 following list of adverse effects has been associated with the use of Drospirenone/Ethinylestradiol:

Frequent adverse effects (may affect up to 1 in 10 women):

• menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness
• headache, depressed mood
• migraine
• nausea
• thick, whitish vaginal discharge and fungal vaginal infection

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

• changes in sex drive
• high blood pressure, low blood pressure
• vomiting, diarrhoea
• acne, skin rash, severe itching, hair loss (alopecia)
• increase in breast size
• vaginal infection
• fluid retention and changes in body weight

Rare adverse effects (may affect up to 1 in 1,000 people):

• allergic reactions (hypersensitivity), asthma
• breast discharge
• hearing problems
• skin conditions such as erythema nodosum (characterized by painful reddish skin nodules) or erythema multiforme (characterized by target-shaped skin rashes or ulcers)
• 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/intestines, 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 about conditions that increase the risk of blood clots and symptoms of a blood clot).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines Website: www.notificaRAM.es

5. Storage of Dretine

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister pack and container after the phrases “Do not use after:” or “EXP:”. The expiry date refers to the last day of the stated month.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dretine

The active substances are ethinylestradiol and drospirenone.

Each tablet contains 0.03 mg of ethinylestradiol and 3 mg of drospirenone.

The other components are:

Tablet core: monohydrate lactose, corn starch, pregelatinized corn starch, crospovidone, povidone, polysorbate 80, magnesium stearate.

Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, talc, yellow iron oxide (E-172).

Appearance of Dretine and pack contents

Film-coated tablets, round, yellow in colour.

Dretine is available in packs of 1, 2, 3, 6 and 13 blisters, each containing 21 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Theramex Ireland Limited
3rd Floor, Kilmore House,
Park Lane, Spencer Dock,
Dublin 1
D01 YE64
Ireland

Manufacturer

Laboratorios León Farma, S.A.
C/ La Vallina, s/n, Polígono Industrial Navatejera;
Villaquilambre 24193 (León)
Spain

Or

Merckle GmbH
Ludwig-Merckle-Strasse, 3
Blaubeuren
Germany

Local Representative

Theramex Healthcare Spain, S.L.
Calle Martínez Villergas 52, Edificio C, planta 2ª izquierda.
28027 Madrid
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Member State	Medicinal product name
Norway:	Dretine 0.03 mg/3 mg tablets, film-coated
Austria:	Dretine 0.03 mg/3 mg 21 Film-coated tablets
Czech Republic:	Softine 0.03 mg/3 mg coated tablets
Spain:	Dretine 0.03 mg/3 mg film-coated tablets
Hungary:	Corenelle 0.03 mg/3 mg film-coated tablet
Ireland:	Dretine 0.03 mg/3 mg Film-coated Tablets
Poland:	Lesine
Slovakia:	Softine 0.03 mg/3 mg film-coated tablets

Date of the last review of this leaflet: October 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/