Dretine Diario 0.03 mg/3 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Dretine diario 0.03 mg/3 mg film-coated tablets EFG

Ethinylestradiol/drospirenone

Important things you need to 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. Do not give it to others, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Dretine Daily is and what it is used for

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

Each of the 21 yellow 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 referred to as placebo tablets.

Contraceptive pills that contain two hormones are known as "combined" pills.

2. What you need to know before starting Dretine daily

General considerations Before starting to use Dretine 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 Dretine 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 circumstances, may carry out other tests. This leaflet describes several situations in which you should stop using Dretine daily, or in which the reliability of Dretine daily may be reduced. 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 Dretine daily alters the monthly changes in body temperature and cervical mucus. Dretine daily, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted disease.

When not to use Dretine daily

Do not use Dretine 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 what 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 need surgery or if you 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 diseases 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 hyperhomocysteinaemia
• 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 hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Dretine daily”)
• 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 genital organs
• if you have vaginal bleeding of unknown cause
• if you are allergic to ethinylestradiol or drospirenone, or to any of the other components of this medicine (listed in section 6). This may cause itching, rash, or swelling
• if you have hepatitis C and are taking medicines containing ombitasvir / paritaprevir / ritonavir and dasabuvir (see also section “Taking Dretine daily with other medicines”)

Additional information on special populations

Children and adolescents

Dretine daily is not indicated for use in women who have not yet started menstruating.

Elderly patients

Dretine daily is not indicated for use after menopause.

Women with hepatic impairment

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

Women with renal impairment

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

Warnings and precautions

When to exercise special caution with Dretine daily

Consult your doctor or pharmacist before taking Dretine daily.

When should you consult your doctor? Seek urgent medical assistance if you notice possible signs of a blood clot that 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 side effects, see “How to recognize a blood clot”

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

Tell your doctor if you have any of the following conditions

If any of these conditions develop or worsen while you are using Dretine daily, you should 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 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 higher risk of developing blood clots. You should ask your doctor when you can start taking Dretine 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 “Dretine daily 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 characterized by 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 accompanied by difficulty breathing, consult your doctor immediately. Medicines containing estrogens may induce or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

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

Blood clots may 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 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 bringing up 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 beneath 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 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 abdominal 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 Dretine 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 Dretine 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 Dretine 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 / 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 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 Dretine 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 illness or injury, or if your leg is in a cast. You may need to stop taking Dretine daily several weeks before surgery or while you are less mobile. If you need to stop taking Dretine daily, 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 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 conditions listed above, even if you are unsure. Your doctor may decide that you need to stop taking Dretine daily.

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

BLOOD CLOTS IN AN ARTERY

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

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 with Dretine daily is very small, but it may increase:

• with age (over 35 years)
• if you smoke. When using a combined hormonal contraceptive such as Dretine daily, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend that you 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 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 heart problems (valve disorders, heart rhythm disorders such as atrial fibrillation)
• if you have diabetes

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

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

Dretine daily and cancer

Breast cancer has been observed slightly more frequently in women who use combined oral contraceptives, but it is not known whether this is due to the treatment. For example, more tumours may be 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 lumps.

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

Bleeding between periods

During the first few months of taking Dretine daily, you may experience unexpected bleeding (bleeding outside the placebo tablet days). If this bleeding continues beyond a few months or starts 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 yellow tablets correctly, have not vomited or had severe diarrhoea, and have not taken any other medicines, 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 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 medical advice as soon as possible.

Other medicines and Dretine daily

Always inform your doctor about any medications or herbal preparations you are taking. Also inform any other doctor or dentist who prescribes you a medication (or your pharmacist) that you are using Dretine 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 adjust the use of another medication.

Some medicines can affect the daily blood levels of Dretine 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 daily 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 respiratory problems)

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

Do not use Dretine 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.

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

Consult your doctor or pharmacist before using any medicine.

Dretine daily with food and drink

Dretine daily 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 breast-feeding

Pregnancy

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

Consult your doctor or pharmacist before taking any medicine.

Breast-feeding

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

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

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

Important information about some of the ingredients of Dretine daily

Dretine daily contains lactose.

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

3. How to take Dretine daily

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

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

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

Take one Dretine daily tablet every day, 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 yellow tablet for the first 21 days, followed by one white tablet for the next 7 days. Then start a new strip (21 yellow 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 sequence, 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 Dretine daily comes with seven adhesive labels showing 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, select the corresponding weekly adhesive label. For example, if you start on Wednesday, apply the label marked “WED” as the starting tablet. Then attach the corresponding label to the top left of the pack, in the “Start” position. This way, each tablet has a day of the week indicated above it, allowing you to 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 typically starts on the second or third day after taking the last yellow active tablet of Dretine daily. After taking the last white tablet, you must start the next strip, regardless of whether the bleeding has stopped or not. This means 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 take Dretine 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 Dretine daily on the first day of your cycle (i.e., the first day of your period). If you start Dretine daily on the first day of your period, you are protected against pregnancy immediately. 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 ring, or patch

You may start taking Dretine daily preferably 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 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 of the next scheduled injection), but in all cases, use additional contraceptive measures (e.g., a condom) during the first 7 days of taking Dretine daily.

• After an abortion

Follow your doctor’s recommendations.

• After giving birth

You may start taking Dretine daily between 21 and 28 days after giving birth. If you start later, use a barrier method (e.g., a condom) during the first 7 days of using Dretine daily.

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

• If you are breastfeeding and want to start taking Dretine daily (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 daily than you should

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

If you take many tablets at once, you may experience symptoms such as nausea, 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 Dretine daily tablets, or find 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 Dretine daily

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

If you forget to take an active yellow tablet from rows 1st, 2nd, or 3rd, follow these instructions:

• If you are less than 12 hours late in taking a tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as you remember, and then take 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 miss, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is highest if you miss a yellow 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 missed in a strip

Consult your doctor.

• One tablet missed in week 1

Take the missed 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 (e.g., a condom) for the next 7 days. If you had sexual intercourse in the week before missing the tablet, be aware that there is a risk of pregnancy. In this case, consult your doctor.

• One tablet missed in week 2

Take the missed 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 no additional precautions are needed.

• One tablet missed in week 3

You have two options:

1. Take the missed 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 the usual 7-day 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 light bleeding or menstruation-like bleeding during the second strip.

2. Alternatively, you may stop taking the yellow active tablets and go directly to a 7-day period of placebo tablets (before taking the placebo tablets, note the day on which you missed your tablet). If you wish to start a new blister on your usual starting day, take the placebo tablets for less than 7 days.

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

• If you have missed any tablets in the strip and do not have bleeding during the first tablet-free period, 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 a yellow active 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 missing a tablet. After vomiting or diarrhea, take another yellow active tablet from a reserve strip as soon as possible. If possible, take it within 12 hours of your usual time of 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 Dretine daily”.

Delayed menstrual period: what you should know

Although not recommended, it is possible to delay your menstrual period by not taking the white placebo tablets in the 4th row and instead starting a new strip of Dretine daily immediately and completing it. You may experience light bleeding or menstruation-like bleeding while using the next strip. Finish 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 wish to change this day, reduce the number of placebo days (but never increase them – 7 is the maximum!). For example, if you normally start the placebo tablets on a Friday and want to change it 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 fewer), 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 Dretine daily

You may stop taking Dretine 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, stop taking Dretine daily and wait until your next 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 product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Dretine diario 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 Dretine diario, 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 diario”.

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 people):

• menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness
• headache, depressed mood
• migraine
• nausea
• thick, white 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, intense itching, hair loss (alopecia)
• breast enlargement
• 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 medical 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 type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects 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 Dretine daily

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Expiry date

Do not take Dretine daily after the expiry date stated on the blister and packaging following the phrase “Do not use after:” or “CAD:”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Instead, return any unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dretine diario

One strip of Dretine diario contains 21 yellow 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 0.03 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 hydrolysed polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, talc, and yellow 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 Dretine diario and contents of the pack

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

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

Dretine 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 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

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 Name	Medicinal Product Name
Norway:	Dretine 28 0.03 mg/3 mg tablets, film-coated
Spain:	Dretine diario 0.03 mg/3 mg film-coated tablets EFG
Poland:	Varel, 3 mg + 0.03 mg coated tablets
Romania:	Varena 0.03 mg/3 mg film-coated tablets

Date of the latest review of this leaflet: September 2024

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