Drosianelle 3 mg/0,02 mg comprimidos recubiertos con pelicula efg

Prospect: information for the patient

Drosianelle 3 mg/0.02 mg film-coated tablets EFG

drospirenone/ethinyl estradiol

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribedonlyto you, and you should not give it to other people even if they have the same symptomsas you,as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. 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 suffering a blood clot in the veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a pause of 4weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section2 “Blood clots”).

6. Contents of the package andadditional information

Drosianelle is a contraceptive and is used to prevent pregnancy.

Each of the tablets contains a small amount of two different female hormones, known as drospirenone and ethinyl estradiol.

Contraceptives that contain two hormones are known as combined contraceptives.

Do not take Drosianelle

You should not use Drosianelle 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 2 “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, symptoms of a stroke).
• 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. This may manifest as itching, rash, or inflammation.
  • If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other Medications and Drosianelle”).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Drosianelle.

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

In some situations, you will need to take special care while using Drosianelle or any other combined hormonal contraceptive, and you may need to have a periodic examination by your doctor. If the condition develops or worsens while you are using Drosianelle, you must also inform your doctor.

• if a close relative has or has had breast cancer,
• if you have any liver or gallbladder disease,
• if you have diabetes,
• if you have depression,
• if you have inflammatory bowel disease (Crohn's disease or ulcerative colitis),
• if you have systemic lupus erythematosus (SLE, a disease that affects your immune system),
• 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 a higher 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. You should ask your doctor when you can start taking Drosianelle after childbirth,
• if you have superficial thrombophlebitis,
• if you have varicose veins,
• if you have epilepsy (see “Other Medications and Drosianelle”),
• 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 in which involuntary movements occur (Sydenham's chorea)),
• if you have or have had melasma (a skin discoloration, especially on the face or neck, known as “pregnancy mask”). In that case, avoid direct exposure to 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 with possible difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

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

Blood clots can form:

• In veins (known as “deep vein thrombosis”, “venous thromboembolism” or VTE).
• In arteries (known as “arterial thrombosis”, “arterial thromboembolism” or TEA).

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

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek immediate medical assistanceif 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 may 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 of taking 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 one) 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 Drosianelle, your risk of a blood clot returns to normal in a few weeks.

What is the risk of a blood clot?

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 Drosianelle is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, 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, 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing drospirenone like Drosianelle, 9-12 will develop a blood clot in a year.
• The risk of a blood clot will depend on your personal history (see “Factors that increase your risk of a blood clot” below).

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

Your risk of a blood clot with Drosianelle 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 old). In this case, you may have an inherited blood clotting disorder.
• If you need surgery or spend a lot of time without standing up due to an injury or illness, or if you have a leg cast. You may need to interrupt the use of Drosianelle for several weeks before the surgery or while you have less mobility. If you need to interrupt the use of Drosianelle, ask your doctor when you can start using it again.
• With increasing age (especially above about 35 years).
• If you have recently given birth.

Your risk of a blood clot increases the more conditions you have.

Long flights (more than 4 hours) may temporarily increase your 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 have any of the conditions listed above, even if you are unsure. Your doctor may decide that you should interrupt the use of Drosianelle.

If any of the conditions listed above change while you are using Drosianelle, 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 your risk of a blood clot in an artery

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

• With age (above about 35 years).
• If you smoke.When using a combined hormonal contraceptive like Drosianelle, 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 close relative has had a heart attack or stroke at a young age (less than about 50 years old). In this case, you may also be at higher risk of a heart attack or stroke.
• If you or any close relative has 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, arrhythmia called atrial fibrillation).
• If you have diabetes.

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

If any of the conditions listed above change while you are using Drosianelle, 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.

Drosianelle and Cancer

Breast cancer has been detected more frequently in women taking combined hormonal contraceptives. However, this may be due to other causes, including sexually transmitted diseases.

In women using 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 unusual abdominal pain.

Mental Health Disorders

Some women who use hormonal contraceptives like Drosianelle 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, contact your doctor for additional medical advice as soon as possible.

Spotting between periods

During the first few months of taking Drosianelle, you may experience unexpected bleeding (bleeding outside of the days without 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 pill-free interval

If you have taken all the pills correctly, have not had severe vomiting or diarrhea, and have not taken other medications, it is highly unlikely that you are pregnant.

If your expected period does not arrive in two consecutive instances, you may be pregnant. Consult your doctor immediately. Do not start the next pack until you are certain that you are not pregnant.

Other Medications and Drosianelle

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take other medications.

Some medications may affect the blood levels ofDrosianelleand may make it less effective for preventing pregnancy, or may cause unexpected bleeding. These include:

• medications used in the treatment of:

• epilepsy (e.g.: primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, felbamate, topiramate),
• tuberculosis (e.g: rifampicin),
• infections with HIV and hepatitis C (the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz),
• infections with fungi (e.g., griseofulvin, ketoconazole),
• arthritis, osteoarthritis (etoricoxib),
• high blood pressure in the blood vessels of the lungs (bosentan).

• herbal medicinal preparations.
• Drosianelle may affect the effect of other medications, p. e.g.,

• medications containing ciclosporin,
• the antiepileptic lamotrigine (this may lead to a higher frequency of seizures),
• theophylline (used to treat respiratory problems),
• triazanidine (used to treat muscle pain and/or muscle cramps).

Do not take Drosianelle 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.

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

Taking Drosianelle with food and drinks

Drosianelle 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 hormonal contraceptives may 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 this medication. If you become pregnant during treatment with Drosianelle, stop treatment immediately and contact your doctor. If you want to become pregnant, you can stop taking Drosianelle at any time (see “If you interrupt treatment with Drosianelle”).

Breastfeeding

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

Driving and Operating Machines

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

Drosianelle contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult them before taking the medication.

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; it is essentially “sodium-free”.

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

Take one Drosianelle tablet every day with a glass of water if necessary. You can take the tablets with or without food, but approximately at the same time every day.

One pack (blister) contains 21 tablets. The day of the week when you should take the tablet is printed next to each tablet. For example, if you start on a Wednesday, you should take a tablet with "MIE" on the side. Follow the direction of the arrow on the pack until you have taken all 21 tablets.

Do not take any tablets for 7 days after that. During those 7 days when you should not take tablets (called a tablet-free period), your menstruation should occur. Usually, menstruation, also known as withdrawal bleeding, starts on the second or third day of the tablet-free period.

On the eighth day after taking the last Drosianelle tablet (i.e., after a 7-day tablet-free period), start the next pack, even if your menstruation has not finished. This means that you should start the next pack on the same day of the week as the previous one, and your menstruation should occur on the same days every month.

By using Drosianelle in this way, you will also be protected against pregnancy during the 7 days when you do not take any tablets.

When can you start with the first blister?

• If you have not taken any hormonal contraceptives in the past month.

Start taking Drosianelle on the first day of your cycle (i.e., the first day of your menstruation). If you start Drosianelle 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 should use additional contraceptive methods (e.g., a condom) during the first 7 days.

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

You can start taking Drosianelle preferably 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 days (or after the last inactive tablet of your previous contraceptive). When switching from a vaginal combined contraceptive ring or patch, follow your doctor's recommendations.

• Switching from a progestin-only method (pill only with progestin, injection, implant, or IUD).

You can switch from the progestin-only pill on any day (if it's an implant or IUD, on the day of its removal; if it's an injectable, on the day of the next injection), but in all cases, it's 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 giving birth.

After giving birth, you can start taking Drosianelle between 21 and 28 days. If you start later, you should use one of the barrier methods (e.g., a condom) during the first 7 days of using Drosianelle.

If, after giving birth, you have already had sex before starting to take Drosianelle (again), you should be sure you are not pregnant or wait for your next menstrual period.

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

Read the section "Breastfeeding".

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

If you take more Drosianelle than you should

No serious cases of overdose of Drosianelle 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 Drosianelle 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 Toxicology Information Service 91 562 04 20 indicating the medication and the amount used.

If you forget to take Drosianelle

• if you are lateless than 12 hoursin taking some tablets, the protection against pregnancy does not decrease. Take the tablet as soon as you remember and the subsequent tablets at the usual time,
• if you are latemore than 12 hoursin taking some tablets, the protection against pregnancy may decrease. The more tablets you have forgotten, the greater the risk of decreased protection against pregnancy.

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

• Forgetting more than one tablet from the pack

Consult your doctor.

• Forgetting a tablet in week 1

Take the forgotten tablet as soon as you remember, even if this means taking 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 sex in the week before forgetting the tablet, you should know that there is a risk of pregnancy. In that case, consult your doctor.

• Forgetting a tablet in week 2

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the subsequent tablets at the usual time. The contraceptive protection does not decrease, and you do not need to take additional precautions.

• Forgetting a tablet in week 3

You can choose between two options:

You may experience spotting (small drops or spots of blood) or bleeding during the use of the second pack. After the usual 7-day tablet-free period, continue with the next pack.

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

• If you have forgotten to take a tablet from a pack and you do not have menstruation during the tablet-free days, this may mean that you are pregnant. In this case, you should go to your doctor before continuing with the next pack.

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

If you have vomiting in the 3 or 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 the vomiting or diarrhea, you should take a tablet from a spare pack as soon as possible. If possible, take itbefore 12 hourshave passed since the usual time you take your contraceptive. If this is not possible or more than 12 hours have passed, follow the advice in the section "If you forgot to take Drosianelle".

Delayed menstrual period: what should you know?

Although it is not recommended, it is possible to delay your menstrual period (withdrawal bleeding) until the end of a new pack if you continue taking a second pack of Drosianelle instead of starting the tablet-free period. You may experience spotting (small drops or spots of blood) or bleeding during the use of the second pack. After the usual 7-day tablet-free period, continue with the next pack.

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

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

If you take the tablets according to the instructions, your menstrual period (withdrawal bleeding) will start during the tablet-free period. If you need to change that day, you can do so by shortening (but never extending 7 days is the maximum!) the tablet-free period. For example, if your tablet-free period starts on Friday and you want to change it to Tuesday (3 days earlier), you should start a new pack 3 days earlier than usual. If you make the tablet-free period very short (e.g., 3 days or less), you may not experience menstrual bleeding during this period. Then you may experience spotting or bleeding.

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

If you interrupt the treatment with Drosianelle

You can stop taking Drosianelle whenever you want. If you do not want to get pregnant, consult your doctor about other effective birth control methods. If you want to get pregnant, it is recommended that you stop taking Drosianelle and wait until your menstrual period before trying to get pregnant. This way, you can calculate your estimated due date more easily.

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

Like all medicines, this medicine may 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 Drosianelle, 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 section2 “What you need to know before starting to take Drosianelle”.

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 urticaria potentially with difficulty breathing (see also section “Warnings and precautions”).

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

Common:may affect up to 1 in 10 people

• mood changes,
• headaches,
• abdominal pain (stomach pain),
• acne,
• breast pain, breast enlargement, breast tenderness, painful or irregular periods,
• weight gain.

Uncommon:may affect up to 1 in 100 people

• yeast infections (fungal infections),
• herpes labialis (simple herpes),
• allergic reactions,
• increased appetite,
• depression, nervousness, sleep disturbances,
• tingling sensation, dizziness,
• vision problems,
• irregular or unusually fast heartbeats,
• high blood pressure, low blood pressure, migraines, varicose veins,
• throat irritation,
• nausea, vomiting, inflammation of the stomach and/or intestines, diarrhea, constipation,
• sudden swelling of the skin and/or mucous membranes (such as tongue or throat), and/or difficulty swallowing or urticaria with difficulty breathing (angioedema), hair loss (alopecia), eczema, itching, hives, dry skin, alteration of skin sebaceous secretion (seborrheic dermatitis),
• neck pain, limb pain, muscle cramps,
• urinary tract infection,
• breast lumps (benign and cancerous), milk production while not pregnant (galactorrhea), ovarian cysts, hot flashes, amenorrhea, heavy or irregular periods, vaginal bleeding, vaginal dryness, lower abdominal pelvic pain, abnormal cervical smear (Papanicolaou or Pap smear), decreased libido,
• fluid retention, lack of energy, excessive thirst, increased sweating,
• weight loss.

Rare:may affect up to 1 in 1,000 people

• asthma,
• hearing problems,
• erythema nodosum (a skin disease characterized by the formation of painful, red nodules),
• erythema multiforme (characterized by the appearance of a rash or skin eruption with red spots 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.
  • Mild or temporary symptoms similar to a stroke, known as a transient ischemic attack (TIA).
  • Blood clots in the liver, stomach/intestine, kidneys, or eye.

The chances of having a blood clot may be higher if you have any other condition that increases this risk (see section2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

Unknown:the following side effects have also been reported, but their frequency cannot be estimated from the available data:

• worsening of symptoms of hereditary and acquired angioedema.

Reporting of 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: https://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.

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

This medication does not require special conditions for conservation.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Drosianelle

• The active principles are drospirenone and ethinylestradiol. Each film-coated tablet contains 3 mg of drospirenone and 0.02 mg of ethinylestradiol.
• The other components are: lactose monohydrate, cornstarch pregelatinized, povidone, sodium croscarmellose, polisorbate 80, magnesium stearate in the core; partially hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, talc, yellow iron oxide (E-172), red iron oxide (E-172), black iron oxide (E-172) in the coating.

Appearance of the product and contents of the package

Film-coated, round, pink tablets.

The tablets are packaged in Alu/PVC/PVDC blisters inside cardboard boxes.

Package sizes:

Blisters: 1x21, 2x21, 3x21, 6x21, and 13x21 film-coated tablets.

Only some package sizes may be commercially available.

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

Ljubljana 1546

Slovenia

or

Salutas Pharma GmbH

Otto von Guericke Alle 1

Barleben D-39179

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Republic of Czechia:Rhonya 3 mg/0.02 mg coated tablets

Denmark:Finminette film-coated tablets

Estonia:Madeleine 0.02 mg/3 mg, tablets with a thin polymeric coating

Finland:Tasminetta 0.02 mg/3 mg film-coated tablets

Hungary:Deciora 3 mg/0.02 mg film-coated tablet

Ireland:Freedonel 0.02 mg/3 mg Film-Coated Tablets

Norway:Finminette 3 mg/0.02 mg film-coated tablets

Portugal:Drosianelle Drospirenone + Ethinylestradiol 3 mg + 0.02 mg Film-Coated Tablet

Last review date of this leaflet:December 2022

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