DROSIANE DIARIO 0.03 mg/3 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Drosiane Daily 0.03 mg/3 mg film-coated tablets EFG

ethinylestradiol/drospirenone

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, do not pass it on to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and talk to your doctor if you think you might have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of the package leaflet:

1. What is Drosiane Daily and what is it used for
2. What you need to know before you start taking Drosiane Daily
3. How to take Drosiane Daily
4. Possible side effects
5. Storage of Drosiane Daily
6. Package contents and further information

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

Drosiane Daily is a contraceptive and is used to prevent pregnancy.

Each of the 21 yellow tablets contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.

The 7 white tablets do not contain active ingredients and are also called placebo tablets.

Contraceptives that contain two hormones are called combined contraceptives.

2. What you need to know before starting to take Drosiane Daily

Do not take Drosiane Daily

You should not take Drosiane Daily if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable:

• if you have (or have ever had) a blood clot in a blood vessel of the legs (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs,
• if you know 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 an operation or if you spend a lot of time without getting 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, temporary 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 blood vessel damage,
• very high blood pressure,
• very high levels of fat in the blood (cholesterol or triglycerides),
• a condition called hyperhomocysteinemia,

• if you have (or have ever had) a type of migraine called "migraine with aura",
• if you have (or have had in the past) a liver disease and your liver function has not yet normalized,
• if your kidneys do not work well (renal failure),
• if you have (or have had in the past) a tumor in the liver,
• if you have (or have had in the past), or if you suspect you have breast cancer or cancer of the genital 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 medicine (including those listed in section 6). This may be manifested 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 medicines and Drosiane Daily").

Additional information on special populations

Use in children

Drosiane Daily is not designed for use in women whose periods have not yet started.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Drosiane Daily.

Tell your doctor if you are affected by any of the following conditions

In some situations, it is necessary to be particularly careful during the use of Drosiane Daily or any other combined pill. Your doctor may examine you regularly. If the condition develops or worsens while you are using Drosiane Daily, you should also inform your doctor:

• if a close relative has or has had breast cancer,
• if you have a liver or gallbladder disease,
• if you have diabetes,
• if you have depression,
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease),
• if you have systemic lupus erythematosus (SLE - a disease that affects your natural defense system),
• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure),
• if you have sickle cell anemia (a hereditary disease 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 developing pancreatitis (inflammation of the pancreas),
• if you need an operation or spend a lot of time without getting up (see section 2 "Blood clots"),
• if you have just given birth, you are at a higher risk of developing blood clots. You should ask your doctor when you can start taking Drosiane Daily after childbirth,
• if you have inflammation of the veins that are under the skin (superficial thrombophlebitis),
• if you have varicose veins,
• if you have epilepsy (see "Other medicines and Drosiane Daily"),
• if you have any disease that appeared for the first time during pregnancy or during previous use of sex hormones; (for example, hearing loss, a blood disease called porphyria, blistering skin rash during pregnancy (herpes gestationalis), a nervous disease in which involuntary movements appear (Sydenham's chorea)),
• if you have or have ever had chloasma (a skin discoloration, especially on the face or neck known as "pregnancy spots"). If so, avoid direct sunlight or ultraviolet light,
• if you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

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

Blood clots can form:

• In the veins (this is called "venous thrombosis", "venous thromboembolism" or VTE).
• In the arteries (this is called "arterial thrombosis", "arterial thromboembolism" or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious long-term effects or, very rarely, they can be fatal.

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent 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 the veins (venous thrombosis). However, these side 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 can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in a vein of 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 also be higher if you start taking a combined hormonal contraceptive (the same medicine or a different one) after an interruption 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 Drosiane Daily, your risk of a blood clot returns to normal within 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 Drosiane Daily is small.

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains drospirenone, such as Drosiane Daily, between 9 and 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 in a vein" below).

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

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

• If you are overweight (body mass index or BMI over 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 the age of 50).
• If you need an operation or spend a lot of time without getting up due to an injury or illness or if you have a leg in a cast. You may need to stop using Drosiane Daily several weeks before surgery or while you have reduced mobility. If you need to stop using Drosiane Daily, ask your doctor when you can start using it again.
• As you get older (especially above 35 years).
• If you have recently given birth.

The risk of a blood clot increases with the number of conditions you have.

Long-distance 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 above conditions, even if you are not sure. Your doctor may decide that you should stop using Drosiane Daily.

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

BLOOD CLOTS IN AN ARTERY

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

Like a blood clot in a vein, a 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 Daily is very small, but it can increase:

• With age (above 35 years),
• if you smoke.When using a combined hormonal contraceptive like Drosiane Daily, you are advised to stop smoking. If you are unable to stop 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 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, heart rhythm disorder 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 may be increased further.

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

Drosiane Daily and cancer

Cervical cancer has been detected more frequently in women who take combined hormonal contraceptives. However, this may be due to other factors, including sexually transmitted diseases.

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

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

Psychiatric disorders

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

Irregular bleeding

During the first few months in which you are taking Drosiane Daily, you may have unexpected bleeding (breakthrough bleeding).

3. How to take Drosiane Diario

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

Each blister pack contains 21 active yellow pills and 7 white placebo pills.

The pills of Drosiane Diario of different colors are ordered. A blister pack contains 28 pills.

Take one pill of Drosiane Diario every day, with some water if necessary. You can take the pills with or without food, but you must take the pills every day at approximately the same time.

Do not confuse the pills:take a yellow pill for the first 21 days and then a white pill for the last 7 days. Then you must start another blister pack immediately (21 yellow pills and then 7 white pills). Therefore, there is no interval between two blister packs.

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

Preparing the blister pack

To help you follow the order of intake, each package of Drosiane Diario contains 7 self-adhesive strips with the 7 days of the week. Choose the strip of the week that starts with the day you take the first pill.

According to the day of the week you are going to start taking the pills, you should choose the corresponding adhesive strip, for example, if you start on Wednesday, take the one that indicates "WED" as the initial pill. Then, you have to stick the corresponding strip on the top left of the package, in the "Start" position. This way, there is a day of the week indicated above each pill, and you can visually check if you have taken a certain pill. The arrows show the order in which the pills should be taken.

During the 7 days when you take placebo pills (placebo days), menstruation usually begins (also called withdrawal bleeding). Usually, menstruation starts on the second or third day after taking the last active yellow pill of Drosiane Diario. Once you have taken the last white pill, you must start the next package, even if you have not finished bleeding. This means that you should start the next package on the same day of the week you started the previous one, and that menstruation should take place during the same days every month.

If you take Drosiane Diario as indicated, you will also be protected against pregnancy during the 7 days you are taking the placebo pills.

When can you start with the first blister pack?

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

Start taking Drosiane Diario on the first day of your cycle (i.e., the first day of your menstruation). If you start Drosiane Diario on the first day of your menstruation, you will be immediately protected 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.

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

You can start taking Drosiane Diario preferably the day after taking the last active pill (the last pill that contains active ingredients) of your previous contraceptive, but no later than the day after the pill-free days (or after the last inactive pill of your previous contraceptive). When changing from a combined vaginal ring or patch, follow your doctor's recommendations.

• Changing from a progestin-only method (progestin-only pill, injection, implant, or intrauterine device).

You can change from the progestin-only pill at any time (if it is an implant or intrauterine device, on the day of its removal; if it is an injectable, when the next injection is due), but in all cases, it is recommended that you use additional contraceptive measures (e.g., a condom) during the first 7 days of pill taking.

• After an abortion.

Follow your doctor's recommendations.

• After having a child.

After having a child, you can start taking Drosiane Diario between 21 and 28 days later. If you start later, you must use one of the so-called barrier methods (e.g., a condom) during the first 7 days of taking Drosiane Diario.

If, after having a child, you have already had sexual intercourse before starting to take Drosiane Diario again, you must be sure you are not pregnant or wait for your next menstrual period.

• If you are breastfeeding and want to start taking Drosiane Diario again after having a child.

Read the section "Breastfeeding".

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

If you take more Drosiane Diario than you should

No cases have been reported where an overdose of Drosiane Diario has caused serious harm.

The symptoms that may appear if you take many pills at the same time are nausea and vomiting. Adolescent girls may experience vaginal bleeding.

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

If you forget to take Drosiane Diario

The last pills of the 4th rowof the blister pack are placebo pills. If you forget one of these pills, the contraceptive effect of Drosiane Diario is not lost. You must discard the forgotten placebo pill.

If you forget an active yellow pill (pills from the 1st, 2nd, or 3rd row), you must follow these steps:

• if you delay less than 12 hoursin taking a pill, the protection against pregnancy does not decrease. Take the pill as soon as you remember and the following pills at the usual time,
• if you delay more than 12 hoursin taking a pill, the protection against pregnancy may be reduced. The more pills you have forgotten, the higher the risk that the protection against pregnancy decreases.

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

• Forgetfulness of more than one pill from the blister pack

Consult your doctor.

• Forgetfulness of a pill during week 1

Take the forgotten pill as soon as you remember, even if it means taking two pills at the same time. Continue taking the following pills at the usual time and use additional precautions, e.g., a condom, for the next 7 days. If you have had sexual intercourse in the week before forgetting the pill, you should know that there is a risk of pregnancy. In this case, consult your doctor.

• Forgetfulness of a pill during week 2

Take the forgotten pill as soon as you remember, even if it means taking two pills at the same time. Continue taking the following pills at the usual time. The contraceptive protection does not decrease, and you do not need to take additional precautions.

• Forgetfulness of a pill during week 3

You can choose between two options:

1. Take the forgotten pill as soon as you remember, even if it means taking two pills at the same time. Continue taking the following pills at the usual time. Instead of continuing with the white placebo pills, discard them and start taking the next blister pack (the day you take the first pill will be different).

Probably, you will have your period at the end of the second blister pack, during the intake of the white placebo pills, although you may experience spotting or bleeding during the intake of the second blister pack.

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

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

What to do in case of vomiting or severe diarrhea?

If you vomit within 3-4 hours after taking a pill or suffer from severe diarrhea, there is a risk that the active ingredients are not fully absorbed by the body. This is similar to what happens when you forget a pill. After vomiting or diarrhea, you must take a pill from a reserve package as soon as possible. If possible, take it before 12 hours have passed since the usual time you take your contraceptive. If it is not possible or more than 12 hours have passed, follow the advice in the section "If you forget to take Drosiane Diario".

Delayed 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 pills from the 4th row and start directly taking the pills from a new blister pack of Drosiane Diario until you finish this new blister pack. You may experience spotting (drops or spots of blood) or bleeding during the use of the second blister pack. Finish this second blister pack by taking the 7 white pills from the 4th row. Then, start the next blister pack.

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

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

If you take the pills as instructed, your menstrual period will start during the placebo week. If you need to change that day, you can do so by reducing the placebo days - the days you take the white pills - (but never extending them beyond 7 days, which is the maximum!). For example, if you start the placebo days on a Friday and want to change it to Tuesday (3 days earlier), you must start a new blister pack 3 days earlier than usual. You may not experience 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 treatment with Drosiane Diario

You can stop taking Drosiane Diario whenever you want. If you do not want to become pregnant, consult your doctor about other effective birth control methods. If you want to become pregnant, it is advisable to stop taking Drosiane Diario and wait until your menstrual period before trying to become pregnant. This way, you can more easily calculate the estimated date of delivery.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. If you suffer from any adverse effect, especially if it is severe and persistent, or have any change in health that you think may be due to Drosiane Diario, consult your doctor.

All women who take 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 taking Drosiane Diario".

Severe Adverse Effects

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

The following adverse effects are related to the use of Drosiane Diario:

Frequent:may affect up to 1 in 10 people

• menstrual changes, bleeding between periods, breast pain, breast tenderness, vaginal discharge, and vaginal fungal infection,
• headache, mood changes,
• migraine,
• nausea.

Uncommon:may affect up to 1 in 100 people

• breast enlargement, changes in libido (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,
• hearing problems,
• skin diseases: 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 target-shaped lesions or ulcers),
• breast secretion,
• 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 those of a stroke, called a transient ischemic attack (TIA),
  • 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 symptoms of a blood clot).

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

• worsening of symptoms of hereditary and acquired angioedema.

Reporting Adverse Effects:

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

5. Storage of Drosiane Diario

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

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

This medicine does not require special storage conditions.

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

6. Package Contents and Additional Information

Composition of Drosiane Diario

A blister pack of Drosiane Diariocontains 21 active yellow tablets in rows 1, 2, and 3, and 7 white placebo tablets in row 4.

Active Tablets:

• The active ingredients are ethinylestradiol 0.03 mg and drospirenone 3 mg.
• The other components are:

Tablet core: lactose monohydrate, cornstarch, pregelatinized cornstarch, crospovidone, povidone, polysorbate 80, magnesium stearate.

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

White Placebo Tablets

Tablet core: anhydrous lactose, povidone, magnesium stearate.

Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, talc.

Appearance and Package Contents

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

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

Drosiane Diario is available in packages of 1, 2, 3, 6, and 13 blisters, each containing 28 (21 active tablets and 7 placebo tablets).

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Laboratorios León Farma, S.A.

C/ La Vallina s/n

Polígono Industrial de Navatejera

24193 Villaquilambre, León

Spain

or

Lek Pharmaceutical d.d.

Verovskova 57

1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Otto von Guericke Alle 1

39179 Barleben

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Estonia: Marionelle 0.03 mg/3 mg õhukese polümeerikattega tabletid

Finland: Rubira 0.03 mg/3 mg kalvopäällysteiset tabletit

Norway: Rubira 3 mg/0.03 mg filmdrasjerte tabletter

Date of the Last Revision of this Prospectus:December 2022

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