Drelle 0.02 mg/3 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Drelle 0.02 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

1. What Drelle is and what it is used for

• Drelle is a contraceptive used to prevent pregnancy.
  • Each of the 24 pink tablets contains a small amount of two different female hormones called drospirenone and ethinylestradiol.
  • The 4 white tablets do not contain active ingredients and are also referred to as placebo tablets.
  • Contraceptives that contain two hormones are called combined contraceptives.

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

General considerations Before starting to take Drelle, 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 Drelle, 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 health status, may carry out other tests. This leaflet describes several situations in which you should stop taking Drelle or in which the effectiveness of Drelle may be reduced. In such situations, you should either avoid sexual intercourse or use additional non-hormonal contraceptive precautions, such as condoms or other barrier methods. Do not use rhythm or temperature methods. These methods may not be reliable because Drelle alters the monthly changes in body temperature and cervical mucus. Drelle, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted disease.

Do not take Drelle

You must not take Drelle 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 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 diseases that may increase your risk of forming a 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 has not returned to normal,

• if your kidneys do not work properly (renal failure),

• if you have (or have ever had) a liver tumour,

• 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 manifest as itching, rash, or swelling.

Do not take Drelle if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Drelle”).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Drelle.

When should you consult your doctor? Seek urgent medical attention If you notice possible signs of a blood clot, which may mean you are experiencing a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section “Blood clots” 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.

In certain situations, you must take special care when using Drelle or any other combined hormonal contraceptive, and your doctor may need to perform periodic check-ups. If you develop any of the following conditions, you must inform your doctor before taking Drelle. If the condition develops or worsens while you are using Drelle, you must also inform your doctor.

• if a close relative has or has had breast cancer,
• if you have 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 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 a prolonged period (see section 2 “Blood clots”),
• if you have recently given birth, you are at increased risk of blood clots. You should ask your doctor when you can start taking Drelle after childbirth,
• if you have inflammation of the veins beneath the skin (superficial thrombophlebitis),
• if you have varicose veins,
• if you have epilepsy (see “Other medicines and Drelle”),
• if you have systemic lupus erythematosus (SLE, a disease affecting your body’s natural defense system),
• if you have ever had a condition that first occurred during pregnancy or during a previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering rash during pregnancy (herpes gestationis), a nervous disorder involving involuntary movements (Sydenham’s chorea)),
• if you have or have ever had brownish-yellow patches (chloasma), also known as “pregnancy mask,” especially on the face. In such cases, you must avoid direct exposure to sunlight or ultraviolet radiation,
• if you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives potentially accompanied by breathing difficulties, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

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

Blood clots can form:

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

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

It is important to remember that the overall risk of a harmful blood clot due to Drelle 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 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., if it becomes 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, sudden sharp 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 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 beneath the breastbone, sensation 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, sudden loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you must 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 events 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 higher 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 is always somewhat higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Drelle, the 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 overall risk of developing a blood clot in the leg or lung (DVT or PE) with Drelle is small.

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5 to 7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Drelle, 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 the 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 Drelle	About 9–12 out of 10,000 women

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

The risk of having a blood clot with Drelle 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). In this case, you might have an inherited blood clotting disorder,
• if you need surgery or will be immobile for a long time due to injury, illness, or having a plaster cast on your leg. You may need to stop taking Drelle several weeks before surgery or while you are less mobile. If you need to stop taking Drelle, ask your doctor when you can start taking it again,
• as you get older (especially over approximately 35 years of age),
• if you gave 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 unsure. Your doctor may decide that you need to stop taking Drelle.

If any of the above conditions change while you are using Drelle—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 may lead to a heart attack or stroke.

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

It is important to note that the risk of heart attack or stroke with Drelle is very small, but it may increase:

• with age (especially over approximately 35 years),
• if you smoke. When using a combined hormonal contraceptive like Drelle, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive,
• if you are overweight,
• if you have high blood pressure,
• if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke,
• if you or a close relative has high levels of fat in the blood (cholesterol or triglycerides),
• if you suffer from migraines, especially migraines with aura,
• if you have a heart condition (valve disorder, heart rhythm disorder called atrial fibrillation),
• if you have diabetes.

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

If any of the above conditions change while you are using Drelle—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.

Drelle and cancer

A slightly increased rate of breast cancer has been observed in women using combined contraceptives, but it is not known whether this is due to the treatment. For example, more tumors may be detected in women taking combined contraceptives 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.

Benign liver tumors have been reported rarely, and malignant liver tumors even more rarely, in users of hormonal contraceptives. See your doctor if you experience unusually severe abdominal pain.

Psychiatric disorders:

Some women using hormonal contraceptives such as Drelle 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 additional medical advice as soon as possible.

Bleeding between periods

During the first few months of taking Drelle, you may experience unexpected bleeding (bleeding outside the placebo tablet days). If this bleeding persists 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 pink active tablets correctly, have not had vomiting or 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. Consult your doctor immediately. Start the next pack only if you are certain you are not pregnant.

Other medicines and Drelle

Inform your doctor who prescribed Drelle at all times about any other medicines or herbal preparations you are taking. Also inform any other doctor or dentist who prescribes you another medicine (or your pharmacist) that you are taking Drelle. They may advise you whether you need to take additional contraceptive precautions (for example, condoms), and if so, for how long, or whether you should modify the use of any other medicine you require.

Some medicines may have a certain influence on Drelle and make it less effective in preventing pregnancy, or may cause unexpected bleeding. These include:

• Medicines used in the treatment of:

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

• tuberculosis (e.g.: rifampicin),

• HIV infection and hepatitis C (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),

• herbal preparations containing St. John's wort.

• Drelle may influence the effect of other medicines, e.g.:

• medicines containing cyclosporine,

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

• theophylline (used to treat respiratory problems),

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

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

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

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

Consult your doctor or pharmacist before using any medicine.

Taking Drelle with food and drinks

Drelle can be taken with or without food and with some water if necessary.

Laboratory tests

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

Pregnancy and breast-feeding

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

Pregnancy

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

Consult your doctor or pharmacist before using any medicine.

Breast-feeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

There is no information suggesting that the use of Drelle has any effect on the ability to drive or use machines.

Drelle contains lactose.

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

3. How to take Drelle

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

Each blister contains 24 pink active tablets and 4 white placebo tablets.

The Drelle tablets of different colors are arranged in order. One blister contains 28 tablets.

Take one Drelle tablet every day with some water if necessary. You may take the tablets with or without food, but you must take them every day at approximately the same time.

Do not confuse the tablets: take one pink tablet for the first 24 days, then one white tablet for the last 4 days. After that, start a new blister immediately (24 pink tablets followed by 4 white tablets). Therefore, there is no break between two blisters.

Since the composition of the tablets differs, you must start the blister with the tablet in the upper left corner and take the tablets every day in sequence. Follow the direction of the arrows on the blister to take the tablets in the correct order.

Blister preparation

To help you follow the correct order of intake, each Drelle pack contains 7 adhesive strips with the 7 days of the week. Choose the strip that starts with the day on which you take your first tablet. For example, if you take your first tablet on a Wednesday, use the strip starting with "WED".

Attach the weekly adhesive strip to the top of the Drelle blister, where it says “Place adhesive strip here!”, so that the first day is positioned above the tablet marked “1”. Now each tablet will have a day marked above it, allowing you to visually check whether you have taken your tablet. The arrows indicate the order for taking the tablets.

During the 4 days when you take the placebo tablets (the placebo days), you should experience menstruation (the so-called withdrawal bleeding). This usually begins on the 2nd or 3rd day after taking the last pink active tablet of Drelle. After taking the last white tablet, start the next blister immediately, even if menstruation has not finished. This means you must start the next blister on the same day of the week as you started the previous one, and the withdrawal bleeding should occur on the same days every month.

If you take Drelle in this way, you are also protected against pregnancy during the 4 days when you take the placebo tablets.

When can you start the first blister?

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

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

• Switching from another combined hormonal contraceptive, combined vaginal contraceptive ring, or patch.

You may preferably start taking Drelle the day after taking the last active tablet (the last tablet containing active ingredients) of your previous contraceptive, but no later than the day after the tablet-free interval (or after the last inactive tablet of your previous contraceptive). 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 progestogen-releasing IUD).

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

• After an abortion.

Follow your doctor’s recommendations.

• After giving birth.

After giving birth, you may start taking Drelle between 21 and 28 days postpartum. If you start later, you must use one of the so-called barrier methods (e.g., a condom) during the first 7 days of using Drelle.

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

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

Read the section “Breast-feeding”.

Consult your doctor if you have any doubts about when to start.

If you take more Drelle than you should

No cases of serious harm due to overdose of Drelle have been reported.

Symptoms that may occur if you take many tablets at once include nausea and vomiting. Adolescent women may experience vaginal bleeding.

If you have taken more Drelle tablets than you should, or discover that a child has taken them, contact your doctor or pharmacist immediately, go to the nearest hospital immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and amount taken.

If you forget to take Drelle

The last 4 tablets in the 4th row of the blister are placebo tablets. If you forget one of these tablets, the contraceptive effect of Drelle is not lost. Discard the forgotten placebo tablet.

If you forget a pink active tablet (tablets 1–24 of the blister), follow the steps below:

• if you are less than 24 hours late in taking a tablet, protection against pregnancy is not reduced. Take the tablet as soon as you remember, and continue taking the following tablets at your usual time,
• if you are more than 24 hours late in taking a tablet, protection against pregnancy may be reduced. The greater the number of tablets you have forgotten, the higher the risk of becoming pregnant.

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

• Missing more than one tablet from the blister

Consult your doctor.

• Missing one tablet during days 1–7 (first row)

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

• Missing one tablet during days 8–14 (second row)

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. Contraceptive protection is not reduced, and you do not need to take additional precautions.

• Missing one tablet between days 15 and 24 (third or fourth row)

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 following tablets at your usual time. Instead of continuing with the white placebo tablets, discard them and start taking the next blister (the day you take the first tablet will be different).

You will likely have your period at the end of the second blister, during the intake of the white placebo tablets, although you may experience spotting or bleeding during the second blister.

2. You may also stop taking the pink active tablets and go directly to the 4 white 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 regular starting day, take the placebo tablets for fewer than 4 days.

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

If you have forgotten to take any tablet from a blister and do not have your period during the placebo days, this may mean you are pregnant. In this case, you must see your doctor before continuing with the next blister.

What should you do in case of vomiting or severe diarrhea?

If you vomit within 3–4 hours after taking a tablet or suffer from severe diarrhea, there is a risk that the active ingredients are not fully absorbed by your body. This is similar to what happens when you forget a tablet. After vomiting or diarrhea, take a tablet from a reserve pack as soon as possible. If possible, take it within 24 hours of your usual time of taking the contraceptive. If this is not possible or more than 24 hours have passed, follow the advice in the section “If you forget to take Drelle”.

Delayed menstruation: what should you know?

Although not recommended, it is possible to delay your period by not taking the white placebo tablets in the 4th row and instead starting directly with the tablets from a new Drelle blister, continuing until the end of this new blister. You may experience spotting (drops or blood stains) or bleeding during the use of the second blister. Finish this second blister by taking the 4 white tablets in the 4th row. Then start the next blister.

Before deciding to delay your period, consult your doctor.

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

If you take the tablets as instructed, your period will begin during the placebo days. If you wish to change that day, you may do so by shortening the number of placebo days (i.e., the days when you take the white tablets) (but never extend them—4 days is the maximum). For example, if you usually start the placebo days on a Friday and wish to change it to Tuesday (3 days earlier), you should start a new blister 3 days earlier than usual. It is possible that no bleeding will occur during these days. You may then experience spotting or bleeding.

If you are unsure how to proceed, consult your doctor.

If you stop treatment with Drelle

You may stop taking Drelle 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 Drelle and wait until your 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 product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone will experience them. If you experience any adverse effect, especially if it is severe and persistent, or if you have any change in your health that you think could be due to Drelle, 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 take Drelle”.

Serious adverse effects

Contact your 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 potentially accompanied by difficulty breathing (see also section “Warnings and precautions”).

The following are adverse effects associated with the use of Drelle:

• Common (may affect up to 1 in 10 patients):

• mood changes,

• headache,

• nausea,

• breast tenderness, menstrual problems such as irregular periods, absence of periods.

• Uncommon (may affect up to 1 in 100 patients):

• depression, nervousness, drowsiness,

• dizziness, tingling and prickling sensations,

• migraine, varicose veins, increased blood pressure,

• stomach pain, vomiting, indigestion, flatulence, stomach inflammation, diarrhoea,

• acne, itching, skin rash,

• discomfort and pain, such as back pain, limb pain, muscle cramps,

• vaginal fungal infection, pelvic pain, breast enlargement, benign breast lumps, uterine/vaginal bleeding (which usually resolves during treatment), vaginal discharge, hot flushes, inflammation of the vagina (vaginitis), menstrual problems, painful periods, shorter periods, heavier periods, vaginal dryness, abnormal cervical smear, loss of interest in sex,

• lack of energy, increased sweating, fluid retention,

• weight gain.

• Rare (may affect up to 1 in 1,000 patients):

• candidiasis (a fungal infection),

• anaemia, increased number of platelets in blood,

• allergic reaction,

• hormonal disorder (endocrine),

• increased appetite, loss of appetite, abnormally high potassium concentration in blood, abnormally low sodium concentration in blood,

• absence of orgasm, insomnia,

• vertigo, tremors,

• eye disorders, such as eyelid inflammation, dry eyes,

• unusually rapid heart rate,

• vein inflammation, nosebleed, fainting,

• abdominal swelling, intestinal disorder, feeling of bloating, gastric hernia, oral fungal infection, constipation, dry mouth,

• pain in the bile ducts or gallbladder, inflammation of the gallbladder,

• yellowish-brown skin patches, eczema, hair loss, acne-like skin inflammation, dry skin, skin inflammation with swelling, excessive hair growth, skin disorders, stretch marks on the skin, skin inflammation, photosensitivity-related skin inflammation, skin nodules,

• painful or difficult sexual intercourse, inflammation of the vagina (vulvovaginitis), bleeding after intercourse, withdrawal bleeding, breast cysts, increased number of breast cells (hyperplasia), malignant breast lumps, abnormal growth of the mucosal surface of the cervix, shrinking or loss of the uterine lining, ovarian cysts, increased size of the uterus,

• malaise,

• weight loss,

• harmful blood clots in a vein or artery, for example:

  • in a leg or foot (i.e., DVT).
  • in a lung (i.e., PE).
  • heart attack.
  • stroke.
  • mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA).
  • blood clots in the liver, stomach/intestine, kidneys or eye.

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

• Not known: the following adverse effects have also been reported, but their frequency cannot be estimated from the available data:
  • hypersensitivity,
  • erythema multiforme (skin rash with target-like red patches or ulcers).

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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http;//www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Drelle

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

Expiry date

Do not use this medicine after the expiry date stated on the packaging and blister after "CAD/EXP". The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

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

6. Contents of the pack and other information

Composition of Drelle

• The active substances are ethinylestradiol and drospirenone.

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

The white tablets do not contain any active substance.

• The other components are:

Pink active tablets:

Core: lactose monohydrate, pregelatinized corn starch, povidone (E-1201), sodium croscarmellose, polysorbate 80, magnesium stearate (E-572).

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

White placebo tablets:

Core: anhydrous lactose, povidone (E1201), magnesium stearate (E572).

Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

Appearance of the product and contents of the pack

Each Drelle blister contains 24 film-coated pink active tablets in the 1st, 2nd, 3rd and 4th rows of the blister, and 4 film-coated white placebo tablets in the 4th row.

Drelle tablets, both pink and white, are film-coated tablets, with the tablet core coated.

Drelle is available in packs of 1, 3, 6 and 13 blisters, each containing 28 (24+4) tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Laboratorios León Farma, S.A.

C/ La Vallina s/n

Polígono Industrial de Navatejera

24193 Villaquilambre, León

Spain

or

Lek Pharmaceutical d.d.

Verovskova 57

1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

Date of the most recent review of this leaflet: March 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es.