Prospecto: information for the patient

Drosiane 3 mg/0.03 mg film-coated tablets EFG

drospirenone/ethinyl estradiol

Read this prospect carefully before starting to take this medicine, 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 medicine has been prescribedonlyto you, and you must not give it to other people even iftheyhave 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 pack and additional information

Drosiane 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 Drosiane

You should not use Drosiane 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, 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:

• Diabetes with severe 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 normalized yet,
• If your kidneys do not function well (renal insufficiency),
• If you have (or have ever had) a tumor in the liver,
• 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 with 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 Drosiane”).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Drosiane.

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

In some situations, you should take special care while using Drosiane or any other combined hormonal contraceptive, and you may need to have regular check-ups with your doctor. If the condition develops or worsens while you are using Drosiane, you should also inform your doctor.

• If a close relative 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 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 “Blood Clots”),
• If you are at increased risk of blood clots after childbirth. You should ask your doctor when you can start taking Drosiane again after childbirth,
• If you have superficial thrombophlebitis (inflammation of veins under the skin),
• If you have varicose veins,
• If you have epilepsy (see “Other Medications and Drosiane”),
• 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 this 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. Hormonal products can cause or worsen symptoms of hereditary and acquired angioedema.

Blood Clots

The use of a combined hormonal contraceptive like Drosiane 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 ATE).

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 harmful blood clot due to Drosiane is small.

How to Recognize a Blood Clot

Seek immediate medical attention if 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 start 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 4weeks 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 Drosiane, 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 global risk of a blood clot in the leg or lung (DVT or PE) with Drosiane 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 10,000women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone, or norgestimato, about 5-7will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing drospirenone like Drosiane, about 9-12 women 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 Drosiane is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index (BMI) greater than 30kg/m2).
• If a close relative has had a blood clot in the leg, lung, or other organ at a young age (i.e., before about 50years). In this case, you may have a hereditary 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 your leg immobilized. You may need to interrupt the use of Drosiane for several weeks before the surgery or while you have less mobility. If you need to interrupt the use of Drosiane, ask your doctor when you can start taking it again.
• With increasing age (especially above about 35years).
• If you have recently given birth.

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

Long flights (more than 4hours) 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 suffer from any of the conditions above, even if you are unsure. Your doctor may decide that you should interrupt the use of Drosiane.

If any of the conditions above change while you are using Drosiane, 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 Drosiane is very small, but it may increase:

• With age (above 35years).
• If you smoke.When using a combined hormonal contraceptive like Drosiane, you are advised to quit smoking. If you are unable to quit smoking and are over 35years, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If a close relative has had a heart attack or stroke at a young age (less than about 50years). In this case, you may also be at increased risk of a heart attack or stroke.
• If you or a 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 above change while you are using Drosiane, 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.

Drosiane and Cancer

Cervical 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 detected more frequently in women taking combined contraceptives because they are examined by their doctor more often. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives.

It is essential to have 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 Drosiane 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

During the first few months of taking Drosiane, you may experience unexpected bleeding (bleeding outside of the days without pills). If these 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 Drosiane

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

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

• Medications used to treat:

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

• Herbal medicinal preparations.
• Drosiane 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),
• Tizanidine (used to treat muscle pain and/or muscle cramps).

Do not take Drosiane 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.

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

Taking Drosiane with Food and Drinks

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

Breastfeeding

Generally, it is not recommended to take Drosiane 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 Drosiane has any effect on your ability to drive or operate machines.

Drosiane contains lactose

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

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

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

One package (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 package 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, begins on the second or third day of the tablet-free period.

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

If you use Drosiane 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 Drosiane on the first day of your cycle (i.e., the first day of your menstruation). If you start taking Drosiane 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 Drosiane 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 same 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 Drosiane between 21 and 28 days. If you start later, you should use one of the so-called barrier methods (e.g., a condom) during the first 7 days of taking Drosiane.

If, after giving birth, you have already had sex before starting to take Drosiane (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 Drosiane again after giving birth.

Read the "Breastfeeding" section.

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

If you take more Drosiane than you should

No serious cases of overdose of Drosiane 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 Drosiane 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 Drosiane

• 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 following 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 that the protection against pregnancy will decrease.

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 package

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 following 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 following 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:

Probably, you will experience menstrual bleeding (withdrawal bleeding) at the end of the second package, although you may experience spotting or bleeding during the use of the second package.

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

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

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 have 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 should take a tablet from a spare package 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 instructions in the section "If you forgot to take Drosiane".

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 package if you continue taking a second package of Drosiane instead of starting the tablet-free period. You may experience spotting (small drops of blood) or bleeding during the use of the second package. After the usual 7-day tablet-free period, continue with the next package.

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 begin 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 begins on Friday and you want to change it to Tuesday (3 days earlier), you should start a new package 3 days earlier than usual.

If you shorten the tablet-free period too much (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 about what to do, consult your doctor.

If you interrupt treatment with Drosiane

You can stop taking Drosiane 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 Drosiane 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 questions 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 change that you think may be due to Drosiane, 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 Drosiane”.

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

Severe side 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 potentially difficulty breathing (see also section “Warnings and precautions”).

Common:may affect up to 1 in 10 people

• menstrual disorders, bleeding between periods, breast pain, breast tenderness,
• headaches, changes in mood,
• migraines,
• nausea,
• thick, white vaginal discharge and vaginal yeast infection.

Uncommon:may affect up to 1 in 100 people

• breast enlargement, changes in sex drive,
• high blood pressure, low blood pressure,
• vomiting, diarrhea
• acne, itching, skin rash, hair loss (alopecia),
• vaginal infection,
• fluid retention and changes in body weight.

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

• allergic reactions (hypersensitivity), asthma,
• breast secretion,
• hearing problems,
• erythema nodosum (a skin disease characterized by the formation of painful, red nodules) or 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 stroke 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 Medicines 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 conservation conditions.

Medications should not be disposed of through drains or trash. Dispose of 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 packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Drosiane

• The active principles are drospirenone and ethinylestradiol. Each coated tablet contains 3 mg of drospirenone and 0.03 mg of ethinylestradiol.
• The other components are: lactose monohydrate, cornstarch, pregelatinized cornstarch, crospovidone, povidone, polisorbate 80, magnesium stearate in the core; partially hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, talc, yellow iron oxide (E-172) in the coating.

Appearance of the product and contents of the package

Coated tablets, round, yellow in color.

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

Package sizes: 1x21, 2x21, 3x21, 6x21, and 13x21 coated tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

c/ Serano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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

Republic of Czechia:Rhonya 3 mg/0.03 mg coated tablets

Denmark:Finminette film-coated tablets

Estonia:Marionelle 0.03 mg/ 3 mg tablets with a thin polymeric coating

Finland:Tasminetta 0.03 mg/3 mg coated tablets

Hungary:Deciora 3 mg/0.03 mg film-coated tablets

Ireland:Freedo 0.03 mg/3 mg Film-Coated Tablets

Norway:Finminette 3 mg/0.03 mg film-coated tablets

Portugal:Drosianne Drospirenone + Ethinylestradiol 3 mg + 0.03 mg Coated Tablet

Last review date of this leaflet:December 2022

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