Package Leaflet: Information for the User

Drelle0.02 mg/3 mg Film-Coated Tablets

Ethinylestradiol/Drospirenone

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package 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. Do not pass it on to others. It may harm them, even if their symptoms seem the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this package leaflet, please tell your doctor, pharmacist or nurse. See section 4.

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 blood clots in veins and arteries, especially in the first year or when restarting use of a CHC after a break of 4 weeks or more.
• Be aware and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).

• Drelle is a contraceptive and is used to prevent pregnancy.
• • Each of the 24 pink tablets contains a small amount of two different female hormones, known as drospirenona 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 known as combined contraceptives.

Do not take Drelle

Do 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 leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs,
• If you know that you have a disorder that affects 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 spend a lot of time without standing up (see section “Blood Clots”),
• If you have ever had a heart attack or a stroke,
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA),
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:

• Severe diabetes with vascular 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) a liver disease and your liver function has not yet normalized,
• If your kidneys do not function well (renal failure),
• If you have (or have ever had) a liver tumor,
• If you have (or have ever had) or if you suspect that you have breast cancer or cancer of the reproductive organs,
• If you have vaginal bleeding, whose cause is unknown,
• If you are allergic to ethinylestradiol or drospirenone or to any of the other components of this medication (including in section 6). This may manifest as itching, rash, or inflammation.

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

Warnings and Precautions

Consult your doctor or pharmacist before starting Drelle.

Inform your doctor if you suffer from any of the following conditions

In some situations, you should be particularly careful while using Drelle or any other combined hormonal contraceptive, and your doctor may need to perform regular check-ups. If you develop any of the following situations, inform your doctor before taking Drelle. If the condition develops or worsens while you are using Drelle, also inform your doctor.

• If a close relative has had breast cancer,
• If you have liver disease or gallbladder disease,
• If you have diabetes,
• If you have depression,
• If you have inflammatory bowel disease (Crohn's disease or ulcerative colitis),
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure),
• If you have sickle cell anemia (a genetic disorder of red blood cells),
• 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 need surgery or spend a lot of time without standing up (see section 2 “Blood Clots”),
• If you are at higher risk of blood clots after childbirth. Ask your doctor when you can start taking Drelle after childbirth,
• If you have superficial thrombophlebitis (inflammation of the veins under the skin),
• If you have varicose veins,
• If you have epilepsy (see “Other medications and Drelle”),
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system),
• If you have any disease that appeared for the first time during pregnancy or during a previous use of sex hormones; (for example, hearing loss, a blood disorder called porphyria, skin rash with blisters during pregnancy (herpes gestationalis), a nervous disorder characterized by involuntary movements (Sydenham's chorea),
• If you have or have ever had brownish-yellow patches (melasma), also known as “pregnancy patches”, especially on the face. In this case, you shouldavoid direct exposureto the sun or ultraviolet rays,
• If you experience symptoms of angioedema such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria potentially with difficulty breathing,contact a doctor immediately. Hormone-containing products can cause or worsen symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Drelle increases the risk of suffering ablood clotcompared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• In arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or ATE).

The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or very rarely fatal effects.

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek immediate medical attentionif you notice any of the following signs or symptoms.

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 thromboembolism). However, these adverse effects are rare. They occur more frequently in the first year of use of 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 breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism.
• In very rare cases, a blood clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).

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

The risk of a blood clot in a vein is higher during the first year in which you take a combined hormonal contraceptive for the first time. The risk may be higher if you restart taking a combined hormonal contraceptive (the same medication or a different medication) after a break of 4 weeks or more.

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

When you stop taking Drelle, the risk of a blood clot in a vein returns to normal in a few weeks.

What is the risk of a blood clot in a vein?

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

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

• Of 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 a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone, or norgestimato, about 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing drospirenone like Drelle, between 9 and 12 women will develop a blood clot in a year.
• The risk of a blood clot in a vein will depend on your personal history (see “Factors that increase the risk of a blood clot” below).

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

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

• If you are overweight (body mass index (BMI) greater than 30 kg/m2),
• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before about 50 years). In this case, you may have a hereditary disorder of blood clotting,
• If you need surgery or spend a lot of time without standing up due to an injury or illness or if you have your leg immobilized. You may need to interrupt the use of Drelle for several weeks before the surgical procedure or while you have less mobility. If you need to interrupt the use of Drelle, ask your doctor when you can start using it again,
• With increasing age (especially above about 35 years),
• If you have given birth recently.

The risk of a blood clot in a vein increases the more conditions you have.

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

It is essential to inform your doctor if you suffer from any of the conditions above, even if you are unsure. Your doctor may decide that you need to interrupt the use of Drelle.

If any of the conditions above change while you are using Drelle, for example, a close relative experiences a blood clot 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 blood clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

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

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

• With age (above about 35 years,
• If you smoke.When using a combined hormonal contraceptive like Drelle, you are advised to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive,
• If you are overweight,
• If you have high blood pressure,
• If any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also be at higher risk of having a 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 have migraines, especially migraines with aura,
• If you have a heart problem (valve disorder, irregular heart rhythm called atrial fibrillation),
• If you have diabetes.

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

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

Drelle and cancer

In women who use combined contraceptives, a slightly higher incidence of breast cancer has been observed, but it is not known whether this is due to the treatment. For example, tumors may be more likely to be detected in women taking combined contraceptives because they are examined by their doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to undergo regular breast examinations and to consult your doctor if you notice any lump.

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

Mental health disorders:

Some women who use hormonal contraceptives like Drelle have reported depression or a depressed mood. Depression can be severe and sometimes may induce suicidal thoughts. If you experience mood changes and depressive symptoms, consult your doctor for additional medical advice as soon as possible.

Spotting between periods

During the first few months of taking Drelle, you may experience unexpected bleeding (bleeding outside of the days of use of the placebo pills). If this bleeding persists beyond a few months or starts after a few 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 pills correctly, have not had intense vomiting or diarrhea, and have not taken other medications, it is very unlikely that you are pregnant.

If your expected period does not come in two consecutive instances, you may be pregnant. Consult your doctor immediately. Start with the next pack only if you are sure you are not pregnant.

Other medications and Drelle

Some medications may have a certain influence on Drelle and make itless effective for preventing pregnancy,or may cause unexpected bleeding. Among them are:

• Medications used in the treatment of:

• Epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, felbamate, topiramate),
• Tuberculosis (e.g., rifampicin),
• Human immunodeficiency virus (HIV) 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.

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

• Medications containing ciclosporin,
• The antiepileptic lamotrigine (may lead to an increase in seizure frequency),
• Theophylline (used to treat respiratory problems),
• Tizanidine (used to treat muscle pain and/or cramps).

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

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

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

Consult your doctor or pharmacist before using any medication.

Taking Drelle with food and drinks

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

Laboratory tests

If you need a blood test, inform your doctor or the laboratory staff that you are taking a contraceptive, as contraceptives can affect the results of some tests.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Pregnancy

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

Consult your doctor or pharmacist before using any medication.

Breastfeeding

Generally, it is not recommended to take Drelle during breastfeeding. If you want to take the contraceptive while breastfeeding, consult your doctor.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

There is no information to suggest that the use of Drelle has any effect on your ability to drive or operate machinery.

Drelle contains lactose.

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult them before taking the medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

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

The Drelle tablets of different colors are ordered. A blister contains 28 tablets.

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

Do not confuse the tablets:take a pink tablet for the first 24 days and then a white tablet for the last 4 days. After that, you must start another blister immediately (24 pink tablets and then 4 white tablets). Therefore, there is no interval between two blisters.

Since the composition of the tablets is different, you have to start the blister with the tablet from the top left corner and take the tablets every day. Follow the direction of the arrows on the blister to take the tablets in the correct order.

Preparation of the blister

To help you follow the order of taking, each Drelle package contains 7 adhesive strips with the 7 days of the week. Choose the strip of the week that starts with the day you take the first tablet. For example, if you take your first tablet on a Wednesday, use the strip that starts with “WED”.

Stick the adhesive strip of the week on the top of the Drelle blister, where it is indicated “Stick the adhesive strip here!”, so that the first day is placed above the tablet marked with “1”. Now you will have a day marked above each tablet and you will be able to check visually if you have taken your tablet. The arrows indicate the order of taking the tablets.

Along the 4 days when you take the placebo tablets (the placebo days), you should have menstruation (the so-called withdrawal bleeding). Usually it starts on the 2nd or 3rd day after taking the last active pink tablet of Drelle. After taking the last white tablet, start the next blister, even if menstruation has not finished. This means that you must start the next blisteron the same day of the weekthat you started the previous one and that menstruation by withdrawal should take place during the same days every month.

Since the composition of the tablets is different, you have to start the blister with the tablet from the top left corner and take the tablets every day. Follow the direction of the arrows on the blister to take the tablets in the correct order.

If you take Drelle in this way, you will also be protected against pregnancy during the 4 days when you take the placebo tablet.

When can you start with the first blister?

• If you have not taken 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 menstruation, you will be protected immediately against pregnancy. You can also start between days 2-5 of your cycle, but you must use additional contraceptive methods (e.g., a condom) during the first 7 days.

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

You can start taking Drelle preferably on the day after taking the last active tablet (the last tablet that contains active ingredients) of your previous contraceptive, but no later than the day after the days without tablets (or after the last inactive tablet of your previous contraceptive). When changing from a vaginal combined contraceptive ring or patch, follow your doctor's recommendations.

• Change from a method based exclusively on progestagens (only progestagen pill, injection, implant, or progestagen-releasing IUD).

You can change from the only progestagen pill on any day (if it is an implant or an IUD, on the same day of its removal; if it is an injectable, on the day of the next injection), but in all cases, it is recommended that you use additional contraceptive methods (e.g., a condom) during the first 7 days of taking tablets.

• After an abortion.

Follow your doctor's recommendations.

• After having a child.

After having a child, you can start taking Drelle between 21 and 28 days. 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 having a child, you have already had sexual intercourse before starting to take Drelle (again), you must be sure that you are not pregnant or wait for your next menstrual period.

• If you are breastfeeding and want to start taking Drelle (again) after having a child.

Read the section “Breastfeeding”.

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

If you take more Drelle than you should

No serious cases of overdose of Drelle have been reported.

The symptoms that may appear if you take many tablets at once are nausea and vomiting. Adolescent girls may experience vaginal bleeding.

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

If you forgot to take Drelle

The last 4 tablets of the4th rowof the blister are placebo tablets. If you forgot to take one of these tablets, the contraceptive effect of Drelle will not be lost. You must discard the forgotten placebo tablet.

If you forgot to take an active pink tablet (tablets 1-24 of the blister), follow these steps:

• if you are delayedless than 24 hoursin taking some tablets, the protection against pregnancy will not be reduced. Take the tablet as soon as you remember and the subsequent tablets at the usual time,
• if you are delayedmore than 24 hoursin taking some tablets, the protection against pregnancy may be reduced. The greater the number of tablets you have forgotten, the greater the risk of becoming pregnant.

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

• Forgetting more than one tablet from the blister

Consult your doctor.

• Forgetting a tablet during days 1-7 (first row)

Take the forgotten tablet as soon as you remember, although this means that you will have to take two tablets at once. Continue taking the subsequent tablets at the usual time and useadditional precautions, for example, a condom, during the next 7 days. If you have had sexual intercourse in the week before forgetting the tablet, you must know that there is a risk of pregnancy. In that case, consult your doctor.

• Forgetting a tablet during days 8-14 (second row)

Take the forgotten tablet as soon as you remember, although this means that you will have to take two tablets at once. Continue taking the subsequent tablets at the usual time. The contraceptive protection will not be reduced and you do not need to take additional precautions.

• Forgetting a tablet between days 15 and 24 (third or fourth row)

You can choose between two options:

Probably, you will have menstruation at the end of the second blister, during the taking of the white placebo tablets, although you may experience spotting or bleeding during the taking of the second blister.

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

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

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

If you have vomiting in the 3-4 hours after taking a tablet or experience intense diarrhea, there is a risk that the active ingredients will not be fully absorbed by the body. This is similar to what happens when you forget a tablet. After vomiting or diarrhea, you must take a tablet from a spare package as soon as possible. If possible, take it before 24 hourshave passed since the usual time you take your contraceptive. If it is not possible or more than 24 hours have passed, follow the advice in the section “If you forgot to take Drelle”.

Delay of menstrual period: what should you know?

Although it is not recommended, it is possible to delay your menstrual period if you do not take the white placebo tablets from the 4th row and start taking the tablets from a new blister of Drelle until the end of this new blister. You may experience spotting (drops or spots of blood) or bleeding during the use of the second blister. Finish this second blister by taking the 4 white placebo tablets from the 4th row. Then start the next blister.

Before deciding to delay your menstrual period, ask your doctor.

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

If you take the tablets according to the instructions, your menstrual period will startduring the placebo days. If you have to change that day, you can do it by reducing thedays of placebothe days you take the white placebo tablets (but never extending – 4 days is the maximum!). For example, if you start the placebo days on a Friday and want to change it to a Tuesday (3 days earlier), you must start a new blister 3 days earlier than usual. It is possible that you will not have bleeding during these days. Then you may experience spotting or bleeding.

If you are not sure how to proceed, consult your doctor.

If you interrupt the treatment with Drelle

You can stop taking Drelle when you want. If you do not want to become pregnant, consult your doctor about other effective methods of birth control. If you want to become pregnant, it is recommended that you stop taking Drelle and wait until your menstrual period before trying to become pregnant. This way, you will be able to calculate your estimated date of delivery more easily.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

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

All women taking combined hormonal contraceptives are at a higher 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 of taking combined hormonal contraceptives, see section 2 “What you need to know before starting to take Drelle”.

Severe side effects

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

The following side effects are related to the use of Drelle:

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

• mood changes,
• headaches,
• nausea,
• breast pain, problems with periods such as irregular periods, absence of periods.

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

• depression, nervousness, drowsiness,
• dizziness, tingling and pins and needles,
• migraine, varicose veins, increased blood pressure,
• stomach pain, vomiting, indigestion, gas, intestinal inflammation, diarrhea,
• acne, itching, skin rash,
• discomfort and pain, such as back pain, limb pain, muscle cramps,
• vaginal yeast infection, pelvic pain, breast enlargement, benign lumps in the breasts, uterine/vaginal bleeding (which usually resolves during treatment), vaginal discharge, hot flashes, vaginal inflammation (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),
• anemia, increased platelet count in blood,
• allergic reaction,
• endocrine disorder,
• increased appetite, loss of appetite, abnormally high potassium levels in blood, abnormally low sodium levels in blood,
• absence of orgasm, insomnia,
• dizziness, tremors,
• eye disorders, such as eyelid inflammation, dry eyes
• unusually fast heart rate,
• inflammation of a vein, nasal bleeding, fainting,
• abdominal enlargement, intestinal disorder, feeling of flatulence, gastric hernia, fungal infection of the mouth, constipation, dry mouth,
• pain in the bile ducts or gallbladder, inflammation of the gallbladder,
• brownish-yellow patches on the skin, eczema, hair loss, acne-like skin inflammation, skin dryness, skin inflammation with swelling, excessive hair growth, skin disorders, skin marks, skin inflammation, skin inflammation due to photosensitivity, skin nodules,
• difficult or painful sex, vaginal inflammation (vulvovaginitis), post-coital bleeding, amenorrhea, breast quists, breast enlargement, abnormal cell growth in the surface mucosa of the cervix, cervical atrophy or loss of the uterine lining, ovarian cysts, uterine enlargement,
• unwellness,
• 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.
  • transient ischemic attack (TIA), which is a temporary stroke-like symptom.
  • blood clots in the liver, stomach/intestine, kidneys, or eye.

The risk of having 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 their symptoms).

• Unknownthe following side effects have also been reported, but their frequency cannot be estimated from the available data:
• • hypersensitivity,
  • erythema multiforme (skin rash with circular red patches or ulcers).

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: http;//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine

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

Expiration Date

Do not use this medication after the expiration date that appears on the packaging and blister after “CAD/EXP”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Drelle

-The active principles are etinilestradiol and drospirenona.

Cada comprimido de color rosa contienen:0,02mg of etinilestradiol and 3 mg of drospirenona.

The white tablets do not contain active principle.

-The other components are:

Active pink tablets:

Core: lactose monohydrate, pregelatinized cornstarch, povidone (E-1201), croscarmelosa sodium, polisorbate 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 package

Cada blíster of Drelle contains 24 active tablets coated with a pink film in the 1st, 2nd, 3rd, and 4th row of the blíster and 4 placebo tablets coated with a white film in the 4th row.

The Drelle tablets, both pink and white, are coated tablets, the core of the tablet is coated.

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible 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

Last review date of this leaflet:March 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.