Package Leaflet: Information for the User

Drosbelalle Daily 3mg/0.02mg 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 aware 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, 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 is Drosbelalle Daily and for what it is used

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

3. How to take Drosbelalle Daily

4. Possible side effects

5. Storage of Drosbelalle Daily

6. Contents of the pack and additional information

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

Each pink tablet contains a small amount of two different female hormones, known as ethinyl estradiol 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 Drosbelalle Diario, 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 Drosbelalle 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 Drosbelalle Diario, or in which the effect of Drosbelalle 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 Drosbelalle Diario alters the monthly changes in body temperature and cervical mucus.

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

Do not use Drosbelalle Diario

You should not use Drosbelalle 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 Taking Drosbelalle Diario with other medicines).

When to be particularly careful with Drosbelalle 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 Drosbelalle Diario, you should also inform your doctor.

• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• If you have hemolytic uremic syndrome (HUS, a 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 have recently given birth, you are at greater risk of blood clots. Ask your doctor when you can start taking Drosbelalle 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 Drosbelalle 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 lasting or even fatal effects.

It is essential to remember that the overall risk of a serious blood clot due to Drosbelalle Diario is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent 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 may 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 Drosbelalle 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 Drosbelalle 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 like Drosbelalle Diario, 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 Drosbelalle 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 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). 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 Drosbelalle Diario for several weeks before the surgery or while you have less mobility. If you need to stop using Drosbelalle 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 have any of the conditions above, even if you are unsure. Your doctor may decide that you should stop using Drosbelalle Diario.

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

With age (over about 35 years).

• If you smoke. When using a combined hormonal contraceptive like Drosbelalle 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 any of your close relatives have 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 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, irregular 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 Drosbelalle 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.

Drosbelalle 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 and, even more rarely, malignant tumors have been reported in users of contraceptives. Consult your doctor if you experience sudden severe abdominal pain.

Mental health disorders:

Some women who use hormonal contraceptives like Drosbelalle 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 Drosbelalle Diario, unexpected bleeding (bleeding outside of the placebo period) may occur. If you experience such bleeding for more than a few months or if it starts after a few months, your doctor must investigate the cause.

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

If you have taken all the pink 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.

Taking Drosbelalle Diario with other medicines

Always inform your doctor who prescribed Drosbelalle Diario about any other 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 Drosbelalle 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 Drosbelalle 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)
  • infections caused by HIV and hepatitis C viruses (the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
  • medicines for the treatment of high blood pressure in the lungs (bosentan)
  • fungal infections (e.g. griseofulvin, ketoconazole)
  • arthritis (etoricoxib)

• St. John's Wort.

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

• medicines that contain ciclosporin
• the antiepileptic lamotrigine (this 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 Drosbelalle 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 tests in the blood (elevated ALT levels).

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

Drosbelalle Diario can be restarted approximately 2 weeks after the completion of this treatment. See the section “Do not use Drosbelalle Diario”.

Taking Drosbelalle 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 may affect the results of some tests.

Pregnancy, breastfeeding, and fertility

If you are pregnant, do not take Drosbelalle Diario. If you become pregnant during treatment with Drosbelalle Diario, stop treatment immediately and consult your doctor.If you wantto become pregnant, you can stop takingDrosbelalle Diario at any time (see also: “Stopping treatment with Drosbelalle Diario”).

Consult your doctor or pharmacist before using any medicine.

In general, it is not recommended to take Drosbelalle 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 Drosbelalle Diario has any effect on your ability to drive or operate machinery.

Important information about some of the components of Drosbelalle Diario

Drosbelalle 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 pink tablets and 7 white tablets containing placebo.

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

Take one tablet of Drosbelalle 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 pink tablet for the first 21 days, and then a white tablet for the last 7 days. Then, you should start taking a new pack (21 pink 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 Drosbelalle Diario includes seven adhesive strips that have the days of the week printed on them. You should 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 should 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 specific tablet. The arrows show the order in which the tablets should be taken.

During the 7 days in which you take placebo tablets (placebo week), menstruation (also called withdrawal bleeding) usually begins. Normally, menstruation begins the second or third day after taking the last active tablet, pink, of etinilestradiol/drospirenona. Once you have taken the last white tablet, you should 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 Drosbelalle Diario as indicated, you will also be protected against pregnancy during the 7 days in which 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 Drosbelalle Diario on the first day of the cycle (i.e., the first day of your menstruation). If you start Drosbelalle 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 should 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 Drosbelalle Diario the day after the break week of your previous contraceptive (or after taking the last inactive tablet). When changing from a vaginal combined contraceptive ring or patch, follow your doctor's recommendations.

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

You can change 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 having a child.

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

If, after having a child, you have already had sex before starting to take Drosbelalle Diario (again), you should first make sure you are not pregnant or wait for your next menstrual period.

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

Read the section "Breastfeeding".

Let your doctor advise you if you are not sure when to start.

If you take more Drosbelalle 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 women may experience vaginal bleeding.

If you have taken too many tablets of Drosbelalle Diario, or if you discover that a child has taken them, consult your doctor or pharmacist immediately or call the Toxicology Information Service 91 562 04 20 indicating the medication and the amount used.

If you forget to take Drosbelalle Diario.

The tablets in the fourth row of the pack are placebo tablets. If you forget to take one of these tablets, the effect of Drosbelalle 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 efficacy of Drosbelalle Diario tablets.

If you forget to take a tablet from the 1st, 2nd, or 3rd row, follow these recommendations:

• If you are late less than 12 hours in 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 late more than 12 hours in 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):

• Forget more than one tablet from the pack.

Consult your doctor.

• Forget a tablet in week 1.

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the subsequent tablets at the usual time and use additional 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.

• Forget a tablet in week 2.

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

• Forget 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 tablets, although you may experience spotting 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 that you are pregnant. In that case, you should consult your doctor before continuing with the next pack.

Like all medications,Drosbelalle Diariomay 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 Drosbelalle 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 useDrosbelalle Diario”.

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

• In a leg or foot (i.e., deep vein thrombosis).
• In a lung (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 risk of having a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

The following is a list ofside effects relatedto the useof Drosbelalle Diario.

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

• Mood swings
• Headaches
• 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 ofthe skin and/or mucous membranes(e.g.the tongueor throat),and/ordifficulty swallowingor 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 nipples (galactorrhea), ovarian cysts, hot flashes, absence of menstruation, heavy menstruation, 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
• Blockage of a blood vessel by a clot formed in some part of the body
• Erythema nodosum (characterized by painful nodules on the skin of a reddish color)
• Erythema multiforme (characterized by skin rash with the aim in the form of 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 experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly through theSpanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es*. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special storage conditions.

Do not take Drosbelalle Daily 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 Drosbelalle Diario

A blister pack of Drosbelalle Diario contains 21 active pink 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 0.02 mg of ethinylestradiol and 3 mg of drospirenone.

The other components are:

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

Coating: 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).

Placebo tablets:

Tablet core: anhydrous lactose, povidone, magnesium stearate.

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

Appearance of Drosbelalle Diario and content of the container

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

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

• Drosbelalle 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:

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

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.