Package Leaflet: Information for the User

Drosbela Diario 3mg/0.03mg Film-Coated Tablets

Drospirenone/Ethinylestradiol

Important Information You Should Know About Combined Hormonal Contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of suffering a blood clot in the veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a pause of 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”).

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

• Keep this leaflet, as you may need to read it again.
  If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isDrosbela Diarioand for what it is used

2. What you need to know before starting to takeDrosbela Diario

3. How to takeDrosbela Diario

4. Possible side effects

5. Storage ofDrosbela Diario

6. Contents of the pack and additional informationl

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

Each pink tablet contains a small amount of two different female hormones, known as ethinylestradiol and drospirenone.

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

Contraceptives that contain two hormones are called "combined" tablets

General Considerations

Before starting to use Drosbela Diario, you should read the information about blood clots in section 2. It is particularly important that you read the symptoms of a blood clot (see section 2 “Blood Clots”).

Before starting to take Drosbela Diario, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your health status, perform other tests.

This leaflet describes several situations in which you should interrupt the use of Drosbela Diario, or in which the effect of Drosbela Diario may be reduced.

In these situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions, such as the use of a condom or other barrier method.

Do not use the rhythm or basal body temperature method. These methods may not be reliable because Drosbela Diario alters the monthly changes in body temperature and cervical mucus.

Drosbela Diario, like other hormonal contraceptives, does not protect against HIV (AIDS) or any other sexually transmitted disease.

Do not use Drosbela Diario

You should not use Drosbela Diario 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 had in the past) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.
• If you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies.
• If you need surgery or if you spend a lot of time without standing up (see section “Blood Clots”).
• If you have ever had a heart attack or a stroke.
• If you have (or have had in the past) 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 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 had at any time) a type of migraine called “migraine with aura”.

• If you have hepatitis C and are taking medications that contain ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also the section “Use of Drosbela Diario with other medicines”).

When to be particularly careful with Drosbela Diario

When to consult your doctor?

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

If the condition develops or worsens while you are using Drosbela Diario, you should also inform your doctor.

• 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 disorder of blood clotting 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 Drosbela Diario after delivery.
• If you have superficial thrombophlebitis (inflammation of the veins under the skin).
• If you have varicose veins.
• If you experience symptoms of angioedema such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

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

Blood clots can form:

• In veins (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 harmful blood clot due to Drosbela Diario is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek immediate medical attentionif you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in veins (venous thromboembolism). However, these adverse effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism.
• In very rare cases, a blood clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).

When is the risk of a blood clot in a vein higher?

The risk of a blood clot in a vein is higher during the first year in which a combined hormonal contraceptive is taken for the first time. The risk may be higher if you restart taking a combined hormonal contraceptive (the same medication or a different medication) 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 Drosbela 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 global risk of a blood clot in the leg or lung (DVT or PE) with Drosbela Diario is small.

Of every 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.

• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone, or norgestimato, about 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing drospirenone as [brand name], 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 Drosbela Diario is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index (BMI) greater than 30 kg/m2).
• If one of your close relatives has had a blood clot in the leg, lung, or other organ at a young age (i.e. before about 50 years). You may have an inherited disorder of blood clotting.
• If you need surgery or spend a lot of time without standing up due to an injury or illness or if you have a leg cast. You may need to stop using Drosbela Diario for several weeks before the operation or while you have less mobility. If you need to stop using Drosbela Diario, ask your doctor when you can start using it again.
• As you get older (especially over about 35 years).
• If you have given birth recently.

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

Long flights (over 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 conditions above, even if you are unsure. Your doctor may decide that you need to stop using Drosbela Diario.

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

BLOOD CLOTS IN AN ARTERY

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

Like a blood clot in a vein, a blood clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

Factors that increase your risk of a blood clot in an artery

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

With age (over about 35 years).

• If you smoke. When using a combined hormonal contraceptive like Drosbela Diario, you are advised to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If one of your close relatives has had a heart attack or stroke at a young age (less than about 50 years). You may also be at higher risk of a heart attack or stroke.
• If you or one of your close relatives has high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart condition (valve disorder, abnormal heart rhythm called atrial fibrillation).
• If you have diabetes.

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

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

Drosbela Diario and cancer

Women who use combined hormonal contraceptives have a slightly higher rate of breast cancer, 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 hormonal 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 have regular breast examinations, and you should consult your doctor if you notice any lump.

In rare cases, benign tumors in the liver have been reported in users of contraceptives, and even more rarely, malignant tumors. Consult your doctor if you experience sudden severe abdominal pain.

Mental health disorders:

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

Spotting between menstrual periods

During the first few months of using Drosbela Diario, you may experience unexpected bleeding (bleeding outside of the placebo period). If you experience these bleedings for more than a few months, or if they start after a few months, your doctor needs to investigate the cause.

What to do if you do not have a period during the placebo phase?

If you have taken all the yellow pills correctly, have not vomited, and have not had severe diarrhea, and have not taken any other medication, it is very unlikely that you are pregnant.

If you do not have two consecutive menstrual periods, you may be pregnant. In this case, consult your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Other medicines and Drosbela Diario

Always inform your doctor who prescribed Drosbela Diario about any medicines or herbal preparations you are taking. Also, inform any other doctor or dentist who prescribes another medicine (or your pharmacist) that you are taking Drosbela Diario. They may advise you to take additional contraceptive precautions (e.g. condoms) and, if so, for how long.

Some medicines mayinfluence the blood levels of Drosbela Diario andmay make it less effective in preventing pregnancy, or may cause unexpected bleeding. This applies to:

• medicines used in the treatment of
• • epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
  • tuberculosis (e.g. rifampicin)
  • viruses such as HIV and Hepatitis C (the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
  • other infections (griseofulvin/ketoconazole)
  • arthritis, osteoarthritis (etoricoxib)
  • Medicines for the treatment of high blood pressure in the lungs (bosentan)

• St. John's Wort.

Drosbela Diario may influence the effect of other medicines, e.g.:

• medicines that contain ciclosporin (medicine used to combat infections). The antiepileptic lamotrigine (which may lead to an increase in the frequency of seizures).
• theophylline (used to treat respiratory problems)
• tizanidine (used to treat muscle pain and/or cramps)

Do not take Drosbela Diario if you have Hepatitis C and are taking medications that contain ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver function parameters in the blood (elevated ALT levels).

Your doctor will prescribe another type of contraceptive before starting treatment with these medications.

Drosbela Diario can be restarted approximately 2 weeks after completing this treatment. See the section “Do not use Drosbela Diario”.

Taking Drosbela Diario with food, drinks, and alcohol

You can take the pills with or without food, with a glass of water if necessary.

Laboratory tests

If you need a blood test, inform your doctor or the laboratory staff that you are taking a contraceptive, as contraceptives can affect the results of some tests.

Pregnancy, breastfeeding, and fertility

If you are pregnant, you should not take Drosbela Diario. If you become pregnant while taking Drosbela Diario, stop taking it immediately and consult your doctor.If you wantto become pregnant, you can stop taking Drosbela Diario at any time (see also: “Stopping treatment with Drosbela Diario”).

Consult your doctor or pharmacist before using any medicine.

In general, it is not recommended to take Drosbela Diario during breastfeeding. If you want to take the contraceptive while breastfeeding, you should consult your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

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

Important information about some of the components of Drosbela Diario

Drosbela Diario contains lactose.

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

Each blister contains 21 active yellow tablets and 7 white tablets containing placebo.

The two different types of colored tablets of Drosbela Diario are placed in order. A pack contains 28 tablets.

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

Do not confuse the tablets: take a yellow tablet for the first 21 days, and then a white tablet for the last 7 days. Then, you must start taking a new pack (21 yellow tablets and 7 white tablets). Therefore, there is no period of rest without tablets between packs.

Due to the different composition of the tablets, you must start with the first tablet located in the top left corner and then take a tablet every day. To maintain the order, follow the direction of the arrows on the pack.

Preparation of the pack

To control the daily intake of the contraceptive, each pack (blister) of Drosbela Diario includes seven adhesive strips that have the days of the week printed on them. You must know the day of the week on which you will take the first tablet.

According to the day of the week on which 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 must stick the corresponding strip on the top left of the pack, 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 week), menstruation (also called withdrawal bleeding) usually starts. Normally, menstruation starts the second or third day after taking the last active tablet, yellow, of etinilestradiol/drospirenona. Once you have taken the last white tablet, you must start a new pack, even if you have not finished bleeding. This means that you should start the new pack on the same day of the week on which you started the previous one, and menstruation should occur on the same days every month.

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

When can you start with the first pack?

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

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

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

You can start taking Drosbela Diario the day after the break week of your previous contraceptive (or after taking the last inactive tablet). When switching from a vaginal combined contraceptive ring or patch, follow your doctor's recommendations.

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

You can switch from the progestin-only pill on any day (if it is an implant or 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 to use additional contraceptive methods (e.g., a condom) during the first 7 days of taking tablets.

• After an abortion.

Follow your doctor's recommendations.

• After giving birth.

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

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

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

Read the section "Breastfeeding".

Let your doctor advise you if you are unsure when to start.

If you take more Drosbela Diario than you should

No serious cases of overdose of etinilestradiol/drospirenona 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 too many Drosbela Diario tablets, or if 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 forget to take Drosbela Diario

The tablets in thefourthrow of the pack are placebo tablets. If you forget to take one of these tablets, the effect of Drosbela Diario will not be affected. You should discard the forgotten placebo tablet to avoid prolonging the placebo week, which could have a negative effect on the effectiveness of Drosbela Diario tablets.

If you forget to take a tablet from the1st, 2nd, or 3rdrow, follow these recommendations:

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

The risk of incomplete protection against pregnancy is maximum if you forget to take the tablet at the beginning of the pack (1st row) or at the end of week 3 (3rd row of the pack). Therefore, you should take the following measures (see also the diagram below):

• Forgetting more than one tablet from the pack

Consult your doctor.

• Forgetting a tablet in week 1

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

• Forgetting a tablet in week 2

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

• Forgetting a tablet in week 3

You can choose between two options:

Probably, you will experience bleeding (withdrawal bleeding) at the end of the second pack, during the taking of the second pack's tablets. You may experience spotting (small drops of blood) or bleeding during the taking of the second pack.

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

• If you have forgotten to take a tablet and you do not have your period during the placebo week, this may mean you are pregnant. In that case, you should consult your doctor before continuing with the next pack.

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

If you have vomiting in the 3-4 hours following the taking of an active yellow tablet or experience intense diarrhea, there is a risk that the active principles 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 itbefore 12 hourshave passed since the usual time you take your contraceptive. If this is not possible or more than 12 hours have passed, follow the advice in the section "If you forget to take Drosbela Diario".

Delay of menstrual period: what should you know?

Although it is not recommended, it is possible to delay your menstrual period (withdrawal bleeding) until the end of a new pack if you do not take the white placebo tablets from the fourth row and start taking a second pack of Drosbela Diario. You may experience spotting (small drops of blood) or bleeding during the use of the second pack. After the usual placebo week in which you take the 7 white tablets, start the next pack.

You should consult your doctor before deciding to delay your menstrual period.

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

If you take the tablets as indicated, your menstrual period (withdrawal bleeding) will start during theplacebo week. If you have to change that day, you can do so by shortening (but never lengthening! – 7 is the maximum) the placebo week. For example, if your placebo week starts on Friday and you want to change it to Tuesday (3 days earlier), you should start a new pack 3 days earlier than usual. If you make the placebo week very short (e.g., 3 days or less), you may not experience menstruation (withdrawal bleeding) during this period. Then you may experience spotting (small drops of blood) or bleeding.

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

If you interrupt the treatment with Drosbela Diario

You can stop taking Drosbela Diario when you want. If you do not want to become pregnant, consult your doctor about other effective birth control methods.If youwant to become pregnant, stop takingDrosbela Diario and waita periodbefore trying to becomepregnant.You will beable to calculate yourprobable due datemore easily.

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

Like all medicines, Drosbela Diario may cause side effects, although not everyone will experience them.If you experience any side effect, especially if it is severe and persistent, or if you have any health changes that you think may be related to Drosbela 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 to use Drosbela Diario”.

Severe blood clots in a vein or artery, for example:

• In a leg or foot (i.e., deep vein thrombosis).
• In the lungs (i.e., pulmonary embolism).
• Heart attack.
• Stroke.
• Mild stroke or temporary symptoms similar to a stroke, known as transient ischemic attack (TIA).
• Blood clots in the liver, stomach/intestine, kidneys, or eye.

The chances of having a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

The following is a list of side effects related to the use of Drosbela Diario.

Frequent side effects(may affect up to 1 in 10 women):

• Mood swings
• Headache
• Abdominal pain (stomach pain)
• Acne
• Breast pain, breast enlargement, painful or irregular periods, weight gain.

Infrequent side effects(may affect up to 1 in 100 women):

• Candidiasis (vaginal infection)
• Herpes simplex (on the lips)
• Allergic reactions
• Increased appetite
• Depression, nervousness, sleep disorders, loss of interest in sex
• Tickling and pins and needles, dizziness
• Visual problems
• Irregular or unusually fast heart rhythm
• Blood clots (thrombosis) in a blood vessel in the legs or lungs (pulmonary embolism), high blood pressure, migraine, varicose veins
• Sore throat
• Nausea, vomiting, inflammation of the stomach and/or intestine, diarrhea, constipation
• Sudden swelling of the skin and/or mucous membranes (e.g., the tongue or throat), and/or difficulty swallowing or urticaria with possible difficulty breathing (angioedema),hair loss (alopecia), itching, skin rash, dry skin, seborrheic dermatitis
• Neck pain, pain in the limbs, muscle cramps
• Urinary tract infection
• Breast lumps (benign and cancerous), milk production in the breasts (galactorrhea), ovarian cysts, hot flushes, absence of periods, heavy periods, vaginal discharge, vaginal dryness, abdominal pain (pelvic), abnormal cervical smears
• Fluid retention, lack of energy, excessive thirst, increased sweating
• Weight loss.

Rare side effects(may affect between 1 in 1,000 women):

• Asthma
• Auditory problems
• Obstruction of a blood vessel by a clot formed in some part of the body
• Erythema nodosum (characterized by painful red nodules on the skin)
• Erythema multiforme (characterized by skin rash with redness or blisters)

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

Reporting side effects

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

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

This medication does not require special storage conditions.

Do not take Drosbela Diario after the expiration date that appears on the packaging after the phrase “Do not use after:” or “CAD:”

Do not dispose of medications through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Drosbela Diario

A blister pack of Drosbela Diario contains 21 active yellow tablets in rows 1, 2, and 3 of the blister pack and 7 white placebo tablets in row 4.

Active tablets:

The active principles are 0.03 mg of ethinylestradiol and 3 mg of drospirenone.

The other components are:

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

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

Placebo tablets:

Tablet core: anhydrous lactose, povidone, magnesium stearate.

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

Appearance of Drosbela Diario and content of the container

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

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

• Drosbela Diario is available in boxes of 1, 2, 3, 6, and 13 containers (blister packs), each containing 28 tablets (21 active tablets plus 7 placebo tablets)

Only some container sizes may be marketed.

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

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Exeltis Healthcare S.L.

Avda. de Miralcampo 7.

Polígono Industrial Miralcampo.

19200 Azuqueca de Henares. (Guadalajara).

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera;

La Vallina s/n;

24193-Villaquilambre, León

Spain

Last review date of this leaflet: September 2022

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