Dretinelle Diario 0.02 mg/3 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Dretinelle daily 0.02 mg/3 mg film-coated tablets EFG

Ethinylestradiol/drospirenone

Important things 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 a blood clot in veins and arteries,
especially during the first year 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”).

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, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1 What Dretinelle Daily is and what it is used for

2 What you need to know before taking Dretinelle Daily

3 How to take Dretinelle Daily

4 Possible side effects

5 How to store Dretinelle Daily

6 Contents of the pack and other information

1. What Dretinelle daily is and what it is used for

Dretinelle daily is a contraceptive pill and is used to prevent pregnancy.

Each of the 21 pink film-coated tablets contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.

The 7 white film-coated tablets do not contain any active ingredients and are called placebo tablets.

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

2. What you need to know before starting to take Dretinelle daily

General considerations Before starting to use Dretinelle daily, 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 Dretinelle daily, 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 personal situation, may carry out other tests. This leaflet describes several situations in which you should stop using Dretinelle daily, or in which the effectiveness of Dretinelle daily may decrease. In such situations, you should not have sexual intercourse or 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 Dretinelle daily alters the monthly changes in body temperature and cervical mucus. Dretinelle daily, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted disease.

When not to use Dretinelle daily

Do not take Dretinelle daily

You should not use Dretinelle daily 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 of the legs (deep vein thrombosis, DVT), in the 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 transient ischaemic attack (TIA, temporary stroke-like symptoms)
• if you have any of the following conditions that may increase your risk of forming 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 tumor.
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Dretinelle daily”).
• if you have (or have ever had), or suspect you may have breast cancer or cancer of the genital 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.

Additional information on special populations

Children and adolescents

Dretinelle daily is not indicated for use in women whose periods have not yet started.

Elderly patients

Dretinelle daily is not indicated for use after menopause.

Women with hepatic impairment

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

Women with renal impairment

Do not take Dretinelle daily if you have impaired kidney function or acute renal failure. See also sections "Do not take Dretinelle daily" and "Warnings and precautions".

Warnings and precautions

When you should exercise special caution with Dretinelle daily

Consult your doctor or pharmacist before taking Dretinelle daily.

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

In some situations, you need to take special care when using Dretinelle daily or any other combined contraceptive, and your doctor may need to examine you periodically.

Inform your doctor if you have any of the following conditions

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

• if a close relative has or has 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 hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure)
• if you have sickle cell anemia (an inherited red blood cell disorder)
• if you have high levels of 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 blood clots. Ask your doctor when you can start taking Dretinelle daily after childbirth.
• if you have inflammation of the veins beneath the skin (superficial thrombophlebitis)
• if you have varicose veins
• if you have epilepsy (see “Dretinelle daily and use of other medicines”)
• if you have an immune system disease called SLE (systemic lupus erythematosus)
• 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 rash during pregnancy (herpes gestationis), a nervous system disorder involving involuntary movements (Sydenham’s chorea))
• if you have or have ever had chloasma (skin discoloration, especially on the face or neck, 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 difficulty breathing, consult your doctor immediately. Medicinal products containing estrogens may induce or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Dretinelle daily increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot may 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 TEA)

Recovery from blood clots is not always complete. In rare cases, long-lasting serious effects may occur, and very rarely, they may be fatal.

It is important to remember that the overall risk of a harmful blood clot due to Dretinelle daily 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: 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 producing blood Chest pain that may worsen on deep breathing 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 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 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 of the face, arm, or leg, especially on one side of the body Sudden confusion, difficulty speaking or understanding speech 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 more 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 of first-time use of a combined hormonal contraceptive. The risk may also be increased if you restart taking a combined hormonal contraceptive (the same medication 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 Dretinelle daily, 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 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 Dretinelle daily 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 Dretinelle daily, between 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 / 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 Dretinelle daily	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 Dretinelle daily 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 have 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 are immobile for long periods due to injury or illness, or if your leg is in a cast. You may need to stop taking Dretinelle daily several weeks before surgery or while you are less mobile. If you need to stop taking Dretinelle daily, ask your doctor when you can start again.
• with increasing age (especially over about 35 years)
• if you have given birth less than a few weeks ago

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 taking Dretinelle daily.

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

• with age (over 35 years)
• if you smoke. When using a combined hormonal contraceptive such as Dretinelle daily, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years of age, your doctor may advise you to use 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 migraine with aura
• if you have heart disease (valve disorders, 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 Dretinelle daily—for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain a significant amount of weight—inform your doctor.

Dretinelle daily and cancer

Breast cancer has been observed slightly more frequently in women using combined oral contraceptives, but it is not known whether this is due to the treatment. For example, it may be that more tumours are detected in women taking combined pills because they are examined by a doctor more often. The incidence of breast tumours 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.

Benign liver tumours have been reported rarely, and malignant liver tumours even more rarely, in users of oral contraceptives. Consult your doctor if you experience unusual severe abdominal pain.

Bleeding between periods

During the first few months of taking Dretinelle daily, you may experience unexpected bleeding (bleeding outside the placebo tablet days). If this bleeding persists 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 pink tablets correctly, have not had vomiting or severe diarrhoea, and have not taken other medications, it is very unlikely that you are pregnant.

If your expected period does not occur for two consecutive cycles, you may be pregnant. See your doctor immediately. Do not start the next pack until you are certain you are not pregnant.

Psychiatric disorders

Some women using hormonal contraceptives such as Dretinelle daily 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 further medical advice as soon as possible.

Other medicines and Dretinelle daily

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 Dretinelle daily. 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 change the use of another medication.

Some medicines can affect the levels of Dretinelle daily 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 (e.g. griseofulvin, ketoconazole)

• arthritis, osteoarthritis (etoricoxib)

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

• the herbal remedy St. John’s wort.

• Dretinelle may affect the action of other medicines, for example:

• Medicines containing cyclosporine

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

• theophylline (used to treat breathing problems)

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

Do not use Dretinelle daily 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.

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

Consult your doctor or pharmacist before taking any medicine.

Dretinelle daily with food and drink

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

Laboratory tests

If you need 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 Breast-feeding

Pregnancy

If you are pregnant, do not take Dretinelle daily. If you become pregnant while taking Dretinelle daily, stop treatment immediately and contact your doctor. If you wish to become pregnant, you may stop taking Dretinelle daily at any time (see “If you want to stop taking Dretinelle daily”). Consult your doctor or pharmacist before taking any medicine.

Breast-feeding

In general, Dretinelle daily is not recommended during breast-feeding. If you wish to take the contraceptive while breast-feeding, you should consult your doctor.

If you are pregnant or breast-feeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

There is no information to suggest that taking Dretinelle daily affects the ability to drive or operate machinery.

Important information about some of the ingredients of Dretinelle daily

Dretinelle daily contains lactose.

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

Dretinelle daily contains sodium.

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

3. How to take Dretinelle daily

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

Each pack contains 21 pink active tablets and 7 white placebo tablets.

The two different colored tablets of Dretinelle daily are arranged in order. One strip contains 28 tablets.

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

Do not confuse the tablets: take one pink tablet for the first 21 days, followed by one white tablet for the next 7 days. Then start a new strip (21 pink and 7 white tablets). Therefore, there is no break between two strips.

Due to the different composition of the tablets, you must start with the first tablet located in the top left corner and then take one tablet each day. For correct order, follow the direction of the arrows on the strip.

Preparing the strip

To help you remember to take your daily contraceptive, each strip (blister) of Dretinelle daily comes with seven adhesive stickers printed with the days of the week. You should know the day of the week on which you will take the first tablet.

Depending on the day of the week you plan to start taking the tablets, choose the corresponding weekly adhesive sticker. For example, if you start on Wednesday, place the sticker marked “WED” as your starting tablet. Then attach the appropriate sticker to the top left corner of the pack, in the “Start” position. This way, a day of the week is indicated above each tablet, and you can visually check whether you have taken a particular tablet. The arrows show the order in which the tablets should be taken.

During the 7 days when you take the white placebo tablets (the placebo days), bleeding usually begins (also called withdrawal bleeding). This usually starts on the second or third day after taking the last active pink tablet of Dretinelle daily. Once you have taken the last white tablet, you must start the next strip, whether or not the bleeding has stopped. This means you should start each new strip on exactly the same day of the week, and your period should occur during the same days every month.

If you take Dretinelle daily in this way, you are also protected against pregnancy during the 7 days when you are taking the placebo tablets.

When to start the first strip

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

Start taking Dretinelle daily on the first day of your cycle (i.e., the first day of your period). If you start Dretinelle daily 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) for the first 7 days.

? Switching from a combined hormonal contraceptive, combined vaginal contraceptive ring, or patch.

You may preferably start taking Dretinelle daily 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) releasing progestogen)

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

? After an abortion.

Follow your doctor’s recommendations.

? After giving birth.

After giving birth, you may start taking Dretinelle daily between 21 and 28 days later. If you start later than day 28, use one of the so-called barrier methods (e.g., a condom) for the first seven days of using Dretinelle daily.

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

? If you are breastfeeding and wish to start taking Dretinelle daily (again) after giving birth.

Read the section “Breast-feeding”.

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

If you take more Dretinelle daily than you should

No serious harm has been reported from overdosing on ethinylestradiol/drospirenone.

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

If you have taken too many Dretinelle daily tablets, or if you discover that a child has taken them, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Dretinelle daily

The tablets in the 4th row of the strip are the placebo tablets. If you forget to take one of these tablets, the effect of Dretinelle daily is not affected. Discard the forgotten placebo tablet.

If you forget to take a pink active tablet from rows 1st, 2nd, or 3rd, follow the instructions below:

? 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, and then continue taking the following tablets at your 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 greatest if you forget a pink tablet at the beginning or end of the strip. Therefore, 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 your usual time and use additional precautions for the next 7 days, e.g., a condom. If you had sexual intercourse in the week before forgetting the tablet, 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 your usual time. Protection against pregnancy is not reduced, and you do not need to take additional 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 your usual time. Instead of having a tablet-free interval, start the next strip immediately.

You will likely have a period at the end of the second strip, but you may experience slight bleeding or menstruation-like bleeding during the second strip.

2. You may also stop taking the active pink tablets and go directly to a 7-day period of placebo tablets (before taking the placebo tablets, note the day on which you forgot to take your tablet). If you wish to start a new blister on your usual starting day, take the placebo tablets for 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 diarrhea

If you vomit within 3–4 hours after taking an active pink tablet or have severe diarrhea, 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 miss a tablet. After vomiting or diarrhea, take another active pink 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 in “If you forget to take Dretinelle daily”.

Delayed menstrual period: what you should know

Although not recommended, it is possible to delay your menstrual period by skipping the white placebo tablets in the 4th row and going directly to a new strip of Dretinelle daily and completing it. You may experience slight bleeding or menstruation-like bleeding while using the next strip. End this second strip by taking the 7 white tablets in the 4th row. Then start your 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 placebo week. If you need to change this day, reduce the number of placebo days (but never increase them – 7 is the maximum!). For example, if you normally start taking the placebo tablets on Friday and wish to change to Tuesday (3 days earlier), start a new strip 3 days earlier than usual. If you make the placebo period very short (e.g., 3 days or less), you may not have any bleeding during these days. You may then experience light or menstruation-like bleeding.

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

If you stop taking Dretinelle daily

You may stop taking Dretinelle daily 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, it is advisable to stop taking Dretinelle daily and wait until your next menstrual period before trying to conceive. This will make it easier to calculate your estimated date of delivery.

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

4. Possible adverse effects

Like all medicines, Dretinelle daily may cause adverse effects, although not everyone experiences them. If you experience any adverse effect, especially if it is severe and persistent, or if you have any change in your health that you think may be due to Dretinelle daily, 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 Dretinelle daily”.

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 adverse effects have been associated with the use of Drospirenone/Ethinylestradiol:

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

• mood changes
• headache
• abdominal pain (stomach ache)
• acne
• breast pain, breast enlargement, breast tenderness, painful or irregular menstruation
• weight gain

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

• Candida (fungal infection)
• cold sores (herpes simplex)
• allergic reactions
• increased appetite
• depression, nervousness, sleep disorders
• tingling sensation, dizziness (vertigo)
• vision problems
• irregular heartbeat or unusually rapid heart rate
• blood clot (thrombosis) in the lungs (pulmonary embolism), high blood pressure, low blood pressure, migraine, varicose veins
• sore throat
• nausea, vomiting, inflammation of the stomach and/or intestine, diarrhea, constipation
• sudden swelling of the skin and/or mucous membranes (e.g., tongue or throat), and/or difficulty swallowing or hives accompanied by difficulty breathing (angioedema), hair loss (alopecia), itching, eczema, dry skin, skin disorder with increased oiliness (seborrheic dermatitis)
• neck pain, limb pain, muscle cramps
• bladder infection
• breast lumps (benign and cancer), milk production while not pregnant (galactorrhea), ovarian cysts, hot flushes, absence of periods, very heavy periods, vaginal discharge, vaginal dryness, lower abdominal pain (pelvic pain), abnormal cervical smear (Papanicolaou or vaginal cytology), decreased interest in sex
• fluid retention, lack of energy, excessive thirst, increased sweating
• weight loss

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

• asthma
• hearing loss
• blockage of a blood vessel due to a clot formed elsewhere in the body
• erythema nodosum (characterized by painful red nodules)
• erythema multiforme (characterized by target-shaped skin rash with redness or sores)
• 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 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dretinelle daily

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

This medicine does not require any special storage conditions.

Expiry date

Do not take Dretinelle daily after the expiry date which is stated on the blister and on the outer packaging, following the phrase “Do not use after:” or “EXP:”. The expiry date refers to the last day of the month indicated.

Medicines must 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 unsure, please ask your pharmacist how to properly 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 Dretinelle diario

One strip of Dretinelle diario contains 21 pink active tablets in rows 1, 2 and 3 of the strip and 7 white placebo tablets in row 4.

Active tablets:

The active substances are ethinylestradiol and drospirenone.

Each tablet contains 0.02 mg of ethinylestradiol and 3 mg of drospirenone.

The other components are:

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

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

Placebo tablets:

Tablet core: lactose, povidone, magnesium stearate.

Coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, talc.

Appearance of Dretinelle diario and contents of the pack

The active tablets are pink, round, film-coated tablets.

The placebo tablets are white, round, film-coated tablets.

• Dretinelle diario is available in packs of 1, 2, 3, 6 and 13 blisters, each containing 28 tablets (21 active tablets plus 7 placebo tablets).

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

Local Representative

Theramex Healthcare Spain, S.L.

Calle Martínez Villergas 52, Edificio C, planta 2ª izquierda.

28027 Madrid

Spain

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

Member State Name	Medicinal Product Name
Norway:	Dretinelle 0.02 mg/3 mg film-coated tablets
Spain:	Dretinelle daily 0.02 mg/3 mg film-coated tablets EFG
Poland:	Varenelle
Romania:	Varena 0.02 mg/3 mg film-coated tablets

Date of the most recent review of this leaflet: September 2024

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