DROSIANELLE 3 mg/0.02 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Drosianelle 3 mg/0.02 mg film-coated tablets EFG

drospirenone/ethinylestradiol

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. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects 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 see 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 Drosianelle and what is it used for
2. What you need to know before you start taking Drosianelle
3. How to take Drosianelle
4. Possible side effects
5. Storage of Drosianelle

1. Contents of the pack and other information

1. What is Drosianelle and what is it used for

Drosianelle is a contraceptive and is used to prevent pregnancy.

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

Contraceptives that contain two hormones are called combined contraceptives.

2. What you need to know before taking Drosianelle

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 blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs.
• If you know you have a disorder 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 long time immobile (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 stroke symptoms).
• 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 had in the past) 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 returned to normal.
  • 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 genitals.
  • If you have vaginal bleeding, whose cause is unknown.
  • If you are allergic to ethinylestradiol or drospirenone or any of the other components of this medicine. This may be manifested by itching, rash, or inflammation.
  • If you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Other medicines and Drosianelle").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Drosianelle.

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

In some situations, you will need to be extra careful while using Drosianelle or any other combined contraceptive, and it may be necessary for your doctor to examine you from time to time. If the condition develops or worsens while you are using Drosianelle, you should 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 Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease),
• 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 (an inherited 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 long time immobile (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 Drosianelle after childbirth,
• If you have inflammation of the veins just under the skin (superficial thrombophlebitis),
• If you have varicose veins,
• If you have epilepsy (see "Other medicines and Drosianelle"),
• If you have any disease that first appeared during pregnancy or during previous use of sex hormones; (e.g., loss of hearing, a blood disease called porphyria, blistering rash during pregnancy (herpes gestationis), a nervous disease in which involuntary movements appear (Sydenham's chorea)),
• If you have or have had chloasma (a discoloration of the skin, especially on the face or neck, known as "pregnancy patches"). In this case, avoid direct exposure to the sun or ultraviolet rays,
• 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 can cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Drosianelle increases your risk of developing 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 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 Drosianelle 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 Drosianelle, 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 Drosianelle 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 Drosianelle, 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" below).

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

The 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 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 about 50). In this case, you may have an inherited blood clotting disorder.
• If you need an operation or spend a long time immobile due to an injury or illness, or if you have your leg in a cast. You may need to stop using Drosianelle several weeks before surgery or while you are less mobile. If you need to stop using Drosianelle, ask your doctor when you can start using it again.
• As you get older (especially above about 35 years).
• If you have just given birth a few weeks ago.

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

Long-haul 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 Drosianelle.

If any of the above conditions change while you are using Drosianelle, for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain much 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 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 about 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, heart rhythm disturbance 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 Drosianelle, for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain much weight, inform your doctor.

Drosianelle 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 incidence 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 you should see 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. See your doctor if you experience unusually severe abdominal pain.

Psychiatric disorders

Some women who use hormonal contraceptives like Drosianelle 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 Drosianelle, you may have unexpected bleeding (bleeding outside of the pill-free days). If this bleeding persists for more than 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 vomited, and have not had severe diarrhea, and if you have not taken any other medicines, it is unlikely that you are pregnant. Continue to take Drosianelle as usual.

3. How to take Drosianelle

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 always at approximately the same time every day.

A pack (blister pack) contains 21 tablets. The day of the week on which 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 “WED” on the side. Follow the direction of the arrow on the pack until you have taken all 21 tablets.

Then, you should not take any tablets for 7 days. During these 7 days when you do not take tablets (called a tablet-free period), you should have your period. Usually, your period (which can also be called 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 the 7-day tablet-free period), start the next pack, even if you have not yet finished your period. This means that you should start the next pack on the same day of the week that you started the previous one, and your period should occur during the same days every month.

If you use 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 pack?

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

Start taking Drosianelle on the first day of your cycle (i.e., the first day of your period). If you start Drosianelle on the first day of your period, 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.

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

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

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

You can switch from the progestin-only pill at any time (if it is an implant or IUD, 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 tablet-taking.

• After an abortion.

Follow your doctor's recommendations.

• After having a child.

After having a child, you can start taking Drosianelle 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 using Drosianelle.

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

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

Read the section “Breastfeeding”.

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

If you take more Drosianelle than you should

No cases have been reported in which an overdose of Drosianelle has caused serious harm.

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 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 Drosianelle

• if you are less than 12 hourslate in taking a tablet, the protection against pregnancy will not decrease. Take the tablet as soon as you remember and the following tablets at the usual time,
• if you are more than 12 hourslate in taking a tablet, the protection against pregnancy may be reduced. The more tablets you have forgotten, the higher the risk that the protection against pregnancy decreases.

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

• Forgetfulness of more than one tablet from the blister pack

Consult your doctor.

• Forgetfulness of a tablet in week 1

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

• Forgetfulness of a tablet in week 2

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

• Forgetfulness of a tablet in week 3

You can choose between two options:

1. Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue taking the following tablets at the usual time. Instead of starting the tablet-free period, start the next pack.

You will probably have your period (withdrawal bleeding) at the end of the second pack, although you may experience spotting or bleeding during the second pack.

1. You can also stop taking tablets. You should start a 7-day tablet-free period (noting the day you forgot to take the tablet). If you want to start a new pack on your fixed start day, the tablet-free period must be less than 7 days.

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 do not have your period 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 pack.

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

If you vomit within 3 or 4 hours after taking a tablet or have severe 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 reserve pack as soon as possible. If possible, take it before 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 forget to take Drosianelle”.

Delayed period: what should you know?

Although it is not recommended, it is possible to delay your 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 (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 period, ask your doctor.

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

If you take the tablets according to the instructions, your period (withdrawal bleeding) will start during the tablet-free period. If you need to change this day, you can do so by shortening ( but never lengthening - 7 days is the maximum!) the tablet-free period. For example, if your tablet-free period starts on a Friday and you want to change it to a 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 have withdrawal bleeding during this period. Then you may experience spotting or bleeding.

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

If you stop treatment with Drosianelle

You can stop taking Drosianelle 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 recommended that you stop taking Drosianelle and wait until your period before trying to become pregnant. This way, you can more easily calculate the estimated due date.

If you have any other questions about the use of this medication, 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 experience any adverse effect, especially if it is severe and persistent, or have any change in health that you think may be due to Drosianelle, 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 Drosianelle".

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 potentially life-threatening urticaria with difficulty breathing (see also the "Warnings and Precautions" section).

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

Frequent:may affect up to 1 in 10 people

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

Infrequent:may affect up to 1 in 100 people

• candidiasis (fungal infections),
• cold sores (herpes simplex),
• allergic reactions,
• increased appetite,
• depression, nervousness, sleep disturbances,
• tingling sensation, dizziness (vertigo),
• vision problems,
• irregular or unusually rapid heartbeats,
• high blood pressure, low blood pressure, migraine, varicose veins,
• throat irritation,
• nausea, vomiting, stomach and/or intestinal inflammation, diarrhea, constipation,
• sudden swelling of the skin and/or mucous membranes (such as tongue or throat), and/or difficulty swallowing or urticaria along with difficulty breathing (angioedema), hair loss (alopecia), eczema, itching, rash, dry skin, alteration of the skin's sebum secretion (seborrheic dermatitis),
• neck pain, limb pain, muscle cramps,
• bladder infection,
• breast lumps (benign and cancerous), milk production while not pregnant (galactorrhea), ovarian cysts, hot flashes, absence of periods, very heavy periods, vaginal bleeding, vaginal dryness, pelvic pain in the lower abdomen, abnormal cervical smear (Pap smear), decreased interest in sex,
• 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 target-like redness 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 those of a stroke, called a transient ischemic attack (TIA).
  • Blood clots in the liver, stomach/intestine, kidneys, or eye.

The likelihood 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 adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. 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 Drosianelle

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

Do not use this medicine after the expiration date stated on the packaging or blister after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE Point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Drosianelle

• The active ingredients are drospirenone and ethinylestradiol. Each film-coated tablet contains 3 mg of drospirenone and 0.02 mg of ethinylestradiol.
• The other ingredients are: lactose monohydrate, pregelatinized corn starch, povidone, sodium croscarmellose, polysorbate 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 Package Contents

Film-coated tablets, round, pink.

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

Package sizes:

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

Not all 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

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 under the following names:

Czech Republic: Rhonya 3 mg/0.02 mg film-coated tablets

Denmark: Finminette film-coated tablets

Estonia: Madeleine 0.02 mg/3 mg, thin-film coated tablets

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

Hungary: Deciora 3 mg/0.02 mg film 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

Date of the Last Revision of this Leaflet: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