Prospect: information for the patient

Drosianelle Diario 0.02 mg/3 mg film-coated tablets EFG

etinilestradiol/drospirenona

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, pharmacist or nurse.
• This medicine has been prescribed only for you, and you must not give it to other people, even if they present the same symptoms as 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 the use of a combined hormonal contraceptive after a pause of 4 weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).

Drosianelle Diario is a contraceptive and is used to prevent pregnancy.

Each of the 21 pink tablets contains a small amount of two different female hormones, known as drospirenone and ethinyl estradiol.

The 7 white tablets do not contain active ingredients and are also referred to as placebo tablets.

Contraceptives that contain two hormones are known as combined contraceptives.

When Not to Take Drosianelle Diario

You should not take Drosianelle Diario if you have any of the following 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.

Do Not Take Drosianelle Diario

• 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 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 stroke,
• if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA),
• if you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:
• severe diabetes with vascular damage,
• very high blood pressure,
• very high levels of fat in the blood (cholesterol or triglycerides),
• a condition called hyperhomocysteinemia,
• if you have (or have ever had) a type of migraine called “migraine with aura”
• if you have (or have ever had) a liver disease and your liver function has not yet normalized,
• if your kidneys do not function well (renal failure),
• if you have (or have ever had) a liver tumor,
• if you have (or have ever had), or if you suspect that you have breast cancer or cancer of the reproductive organs,
• if you have vaginal bleeding, whose cause is unknown,
• if you are allergic to ethinylestradiol or drospirenone or to any of the other components of this medication (including in section 6). This may manifest 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 Drosianelle Diario”).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Drosianelle Diario.

Inform Your Doctor if You Are Affected by Any of the Following Conditions

In some situations, you need to be especially careful during the use of Drosianelle Diario or any other combined pill. Your doctor may examine you regularly. If the condition develops or worsens while you are using Drosianelle Diario, 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 inflammatory bowel disease (Crohn's disease or ulcerative colitis),
• 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 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 recently gave birth, you are at a higher risk of blood clots. Ask your doctor when you can start taking Drosianelle Diario again after the birth,
• if you have superficial thrombophlebitis (inflammation of the veins under the skin),
• if you have varicose veins,
• if you have epilepsy (see “Other Medications and Drosianelle Diario"),
• if you have any disease that appeared for the first time during pregnancy or during a previous use of sex hormones (for example, hearing loss, a blood disorder called porphyria, skin rash with blisters during pregnancy (herpes gestationalis), a nervous disorder characterized by involuntary movements (Sydenham's chorea)),
• if you have or have ever had melasma (a skin discoloration, especially on the face or neck, known as “pregnancy mask”). If so, avoid direct sunlight or ultraviolet light,
• 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 the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

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

Blood clots can form:

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek Urgent 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 a combined hormonal contraceptive like Drosianelle Diario has been associated with an increased risk of blood clots in veins (venous thromboembolism, VTE). 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 of 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 (PE).
• 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 of taking a combined hormonal contraceptive for the first time. The risk may be higher if you restart 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 Diario, 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 Diario 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 taking a combined hormonal contraceptive containing levonorgestrel, noretisterone, or norgestimato, 5-7 will develop a blood clot in a year.
• Of every 10,000 women taking a combined hormonal contraceptive containing drospirenone like Drosianelle Diario, 9-12 may develop a blood clot in a year.
• The risk of a blood clot will depend on your personal history (see “Factors That May Increase Your Risk of a Blood Clot in a Vein”).

Factors That Increase Your Risk of a Blood Clot in a Vein

Factors That May Increase Your Risk of a Blood Clot in a Vein

The risk of a blood clot in a vein is higher:

• if you are overweight (body mass index, BMI, greater than 30 kg/m2),
• if any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before about 50 years). In this case, you may have 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 your leg immobilized. You may need to stop taking Drosianelle Diario for several weeks before surgery or while you have limited mobility. If you need to stop taking Drosianelle Diario, consult your doctor when you can start taking it again,
• with increasing age (especially above about 35 years),
• if you recently gave birth.

The risk of a blood clot in a vein 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 above conditions, even if you are unsure. Your doctor may decide to stop taking Drosianelle Diario.

If any of the above conditions change while you are using Drosianelle Diario, for example, a close relative experiences a blood clot without a known cause, or if 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, such as a heart attack or 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 Diario is very small but may increase:

• with age (above about 35 years),
• if you smoke. When using a combined hormonal contraceptive like Drosianelle Diario, you are advised to quit smoking. If you cannot 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). 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 even higher.

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

Drosianelle Diario 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 combined hormonal contraceptives like Drosianelle Diario have reported depression or a depressed mood. Depression can be severe and sometimes 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 Diario, you may experience unexpected bleeding (bleeding outside of the days of placebo pill use). 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 Placebo Days

If you have taken all the active pink 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 you are not pregnant.

Other Medications and Drosianelle Diario

Some medications may affect the blood levels of Drosianelle Diario, losing its contraceptive effect, or may cause unexpected bleeding. This may occur with medications used to treat:

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

• Drosianelle Diario may affect the effect of other medications, for example,

• medications containing ciclosporin,
• the antiepileptic lamotrigine (may lead to an increase in seizure frequency),
• theophylline (used to treat respiratory problems),
• tizanidine (used to treat muscle pain and/or muscle cramps).

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

Taking Drosianelle Diario with Food and Drinks

Drosianelle Diario can be taken with or without food and with a little water if needed.

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, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, or if you think you might be pregnant, or if you plan to become pregnant, 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 Diario, stop treatment immediately and contact your doctor. If you want to become pregnant, you can stop taking Drosianelle Diario at any time (see “If You Want to Stop Taking Drosianelle Diario”).

Breastfeeding

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

Drosianelle Diario Contains Lactose and Sodium

If your doctor has told you that you have a certain sugar intolerance, consult them before taking this 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.

Each blister contains 21 active pink tablets and 7 white placebo tablets.

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

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

Do not confuse the tablets:take a pink tablet for the first 21 days and then a white tablet for the last 7 days. After that, you must start another blister immediately (21 pink tablets and then 7 white tablets). Therefore, there is no interval between two blisters.

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

Preparation of the blister

To help you follow the order of taking, each package of Drosianelle Diario contains 7 adhesive strips with the 7 days of the week. Choose the strip of the week that starts with the day you take the first tablet.

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

During the 7 days when you take placebo tablets (placebo days), menstruation (also called withdrawal bleeding) usually starts. Normally, menstruation starts the second or third day after taking the last active tablet, the pink one, of Drosianelle Diario. Once you have taken the last white tablet, 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 that you started the previous one, and menstruation should occur on the same days every month.

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

When can you start with the first blister?

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

Start taking Drosianelle Diario on the first day of your cycle (i.e., the first day of your menstruation). If you start Drosianelle Diario on the first day of your menstruation, you will be protected immediately against pregnancy. You can also start between days 2-5 of your cycle, but you must use additional contraceptive methods (e.g., a condom) during the first 7 days.

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

You can start taking Drosianelle Diario 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 days without tablets (or after the last inactive tablet of your previous contraceptive). When changing from a vaginal combined contraceptive ring or patch, follow your doctor's recommendations.

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

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

• After an abortion.

Follow your doctor's recommendations.

• After having a child.

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

If, after having a child, you have already had sex before starting to take Drosianelle 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 Drosianelle Diario (again) after having a child.

Read the section "Breastfeeding".

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

If you take more Drosianelle Diario than you should

No serious cases of overdose of Drosianelle Diario 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 Diario tablets than you should, or if you discover that a child has taken them, consult your doctor or pharmacist immediately or call the Toxicological Information Service 91 562 04 20 indicating the medication and the amount used.

If you forgot to take Drosianelle Diario

The last tablets of the4th rowof the blister are placebo tablets. If you forgot one of these tablets, the contraceptive effect of Drosianelle Diario is not lost. You must discard the forgotten placebo tablet.

If you forgot an active pink tablet (tablets of the1st, 2nd, or 3rd row), you must follow these steps:

• If you delayless than 12 hoursin taking some tablets, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and the subsequent tablets at the usual time,
• If you delaymore than 12 hoursin taking some tablets, the protection against pregnancy may be reduced. The more tablets you have forgotten, the greater the risk of reduced protection against pregnancy.

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):

• Forgot more than one tablet from the blister

Consult your doctor.

• Forgot a tablet during week 1

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

• Forgot a tablet during week 2

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

• Forgot a tablet during week 3

You can choose between two options:

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

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

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

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

If you have vomiting in the 3-4 hours after taking a tablet or experience intense diarrhea, there is a risk that the active ingredients will not be fully absorbed by the body. This is similar to what happens when you forget a tablet. After vomiting or diarrhea, you must take a tablet from a reserve package as soon as possible. If possible, take it before 12 hourshave 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 forgot to take Drosianelle 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 tablets of the 4th row and start taking the tablets of a new package of Drosianelle Diario until the end of this new package. You may experience spotting (drops or blood spots) or bleeding during the use of the second package. Finish this second package by taking the 7 white placebo tablets of the 4th row. Then start 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 will start duringthe placebo week. If you have to change that day, you can do it by reducing the placebo days - the days when you take the white tablets- (but never extending – 7 days is the maximum). For example, if you start the placebo days on Friday and want to change it to Tuesday (3 days earlier), you must start a new package 3 days earlier than usual. It is possible that you will not have bleeding during these days. Then you may experience spotting or bleeding.

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

If you interrupt the treatment with Drosianelle Diario

You can stop taking Drosianelle Diario when 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 Diario 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 can cause side effects, although not everyone will experience them. If you experience any side effect, especially if it is severe and persistent, or if you have any health changes that you think may be due to Drosianelle Diario, consult your doctor.

All women taking combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 "What you need to know before starting Drosianelle Diario”.

Severe side effects

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

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

Common(may affect up to 1 in 10 patients)

• mood changes,
• headaches,
• abdominal pain (stomach pain),
• acne
• breast pain, problems with periods such as irregular periods, absence of periods, breast tenderness,
• weight gain.

Uncommon(may affect up to 1 in 100 patients)

• yeast infection (candidiasis),
• herpes labialis (simple herpes),
• allergic reactions,
• increased appetite,
• depression, nervousness, sleep disturbances,
• tingling sensation, dizziness,
• vision problems,
• irregular or unusually fast heartbeats,
• blood clot (thrombosis) in a blood vessel in the legs or lungs (pulmonary embolism), high blood pressure, low blood pressure, migraine, varicose veins,
• throat pain,
• nausea, vomiting, inflammation of the stomach and/or intestines, diarrhea, constipation,
• sudden swelling of the skin or mucous membranes (tongue or throat) and/or difficulty swallowing along with difficulty breathing (angioedema), hair loss (alopecia), eczema, hives, itching, dry skin, oily skin (seborrheic dermatitis),
• neck pain, pain in the limbs and muscle cramps,
• urinary tract infection,
• breast lumps (benign or cancerous), milk secretion from the breasts without being pregnant (galactorrhea), ovarian cysts, hot flashes, absence of periods, heavy periods, vaginal bleeding, vaginal dryness, lower abdominal pain (pelvic), abnormal Pap smear, loss of interest in sex,
• fluid retention, lack of energy, excessive thirst, increased sweating,
• weight loss.

Rare(may affect up to 1 in 1,000 patients)

• asthma,
• hearing loss,
• blockage of a blood vessel by a clot formed elsewhere in the body,
• erythema nodosum (characterized by painful red nodules on the skin),
• erythema multiforme, (characterized by a skin rash with red spots in the shape of a target or ulcers),
• dangerous blood clots in a vein or artery, such as:
• • in a leg or foot (i.e., DVT). ,
  • in the lung (i.e., PE),
  • myocardial infarction,
  • stroke,
  • a mild or transient stroke symptom, known as a transient ischemic attack (TIA),
  • blood clots in the liver, stomach/intestine, kidneys, or eye.

The risk of suffering a blood clot may be higher if you have any of these conditions that increase the 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 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine

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

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

This medication does not require special storage conditions

Medicines should not be thrown down the drain 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 Diario

A blister ofDrosianelle Diariocontains 21 active pink tablets in rows 1, 2, and 3, and 7 white placebo tablets in row 4.

Active Tablets:

Tablet core: lactose monohydrate, pregelatinized cornstarch, povidone, sodium croscarmellose, polisorbate 80, magnesium stearate.

Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

Placebo Tablets:

Tablet core: anhydrous lactose, povidone, magnesium stearate.

Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

Appearance of the Product and Contents of the Package

The active tablets are coated pink film-coated round tablets.

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

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

Only some package sizes may be marketed.

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/ Serrano 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

1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Otto von Guericke Alle 1

39179 Barleben

Germany

This Medicinal Product is Authorized in the Member States of the European Economic Area with the Following Names:

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

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

Last Review Date of this Leaflet:December 2022

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