Package Leaflet: Information for the User

Aidraelle3 mg/0.02 mgCoated Tablets EFG

Drospirenone/Ethinylestradiol

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. 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 blood clots in veins and arteries, especially in the first year or when restarting use of a CHC after a break 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”).

1.What is Aidraelle and what is it used for

2.What you need to know before you start taking Aidraelle

• Do not take Aidraelle
• Warnings and precautions
• Blood clots
• Aidraelle and cancer
• Spotting between periods
• What to do if you do not have a period during the week of rest
• Other medicines and Aidraelle
• Taking Aidraelle with food and drink
• Lab tests
• Pregnancy and breastfeeding
• Driving and using machines
• Important information about some of the components of Aidraelle

3.How to take Aidraelle

• When can you start with the first blister pack?
• If you take more Aidraelle than you should
• If you forget to take Aidraelle
• What to do in case of vomiting or severe diarrhea
• What to do if you do not have a period during the week of rest?
• Delayed menstrual period: what you should know?
• Change in the first day of your menstrual period: what you should know?
• If you interrupt the treatment with Aidraelle

4.Possible side effects

5Storage of Aidraelle

6.Contents of the pack and additional information

Aidraelleis a contraceptive and is used to prevent pregnancy.

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

Contraceptives that contain two hormones are known as combined contraceptives.

General Considerations

Before starting to takeaidraelle, you should read the information about blood clots in section2. It is particularly important that you read the symptoms of a blood clot (see section2 “Blood Clots”).

Before starting to takeaidraelle, your doctor will ask you some questions about your personal and family medical history. The 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 ofaidraelle, or in which the effect of aidraelle may be reduced.

In these situations, you should not have sexual intercourse or 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 becauseaidraelle alters the monthly changes in body temperature and cervical mucus.

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

Do not take aidraelle

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

• If you have (or have ever had) a blood clot in a vein in your leg (deep vein thrombosis, DVT), in your 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 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, symptoms of a stroke).
• If you have any of the following diseases that may increase your risk of forming a blood clot in your arteries:

• Severe diabetes with vascular damage.
• Very high blood pressure.
• Very high levels of fat in your blood (cholesterol or triglycerides).
• A condition called hyperhomocysteinemia.

• If you have (or have ever had) a type of migraine called “migraine with aura”.

• If you have or have had liver disease and your liver function has not normalized yet.
• 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.
• Ifyou are allergic to ethinylestradiol or drospirenona, or to any of the other components of this medication (including in section 6). This may manifest as itching, rash, or inflammation.

Do not takeaidraelleif you have hepatitis C and are taking medications that contain ombitasvir / paritaprevir / ritonavir and dasabuvir or glecaprevir / pibrentasvir (see also the section Other Medications andaidraelle).

Additional Information on Special Populations

Children and Adolescents

Aidraelleis not indicated for use in women who have not yet had their first menstrual period.

Older Women

Aidraelleis not indicated for use after menopause.

Women with Liver Disease

Do not takeaidraelleif you have liver disease. See sections “Do not take aidraelle” and “Warnings and Precautions”.

Women with Renal Disease

Do not take aidraelleif you are suffering from kidney dysfunction or acute renal failure. See sections “Do not take aidraelle” and “Warnings and Precautions”.

Warnings and Precautions

Consult your doctor or pharmacist before starting to takeaidraelle.

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, 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 in your leg or foot, it may cause deep vein thrombosis (DVT).

• If a blood clot breaks loose from your leg and lodges in your lung, it may cause a pulmonary embolism (PE).

• In 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 you take a combined hormonal contraceptive for the first time. The risk may be higher also if you restart taking a combined hormonal contraceptive (the same medication or a different medication) after a break of 4weeks 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 aidraelle, 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 aidraelle 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 10,000women 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 drospirenona, such asaidraelle, 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

Your risk of a blood clot with aidraelle 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 a vein, lung, or other organ at a young age (i.e., before about 50years). You may have a hereditary disorder of blood clotting.
• If you need surgery or if you 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 interrupt the use of aidraelle for several weeks before the operation or while you have less mobility. If you need to interrupt the use of aidraelle, ask your doctor when you can start using it again.
• With increasing age (especially above about 35years).
• If you have given birth recently.

Your risk of a blood clot 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 conditions listed above, even if you are unsure. Your doctor may decide that you need to interrupt the use of aidraelle.

If any of the conditions listed above change while you are using aidraelle, 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, such as 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 using aidraelle is very small, but it may increase:

• With age (above about 35 years).
• If you smoke.When using a combined hormonal contraceptive like aidraelle, you are advised to quit smoking. If you are unable to quit smoking and are over 35years, 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 your 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 any of the conditions listed above or if any of them are particularly severe, your risk of a blood clot may be increased even further.

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

Aidraelle and Cancer

Women who use combined hormonal contraceptives have a slightly higher risk of breast cancer, 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 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 undergo 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 combined hormonal contraceptives. Consult your doctor if you have any unusual abdominal pain.

Spotting between Menstrual Periods

During the first few months of takingaidraelle, you may experience unexpected bleeding (bleeding outside of the menstrual period). If you experience these bleeding for more than a few months or if they start after a few months, your doctor should investigate the cause.

What to do if you do not have your period during the menstrual period?

If you have taken all the 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 your expected period does not arrive for two consecutive times, 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 Medications andaidraelle

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicationor herbal preparations. Also, inform any other doctor or dentist who prescribes another medication (or your pharmacist) that you are takingaidraelle. They may advise you to take additional contraceptive precautions (e.g., condoms) and, if so, for how long, or if you need to modify the use of another medication that you need.

Some medications

-may affect the levels of aidraelle in your blood

-may make itless effective in preventing pregnancy

- may cause unexpected bleeding.

This may occur with:

• medications used in the treatment of:
• • epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
  • tuberculosis (e.g., rifampicin)
  • infections by the HIVand Hepatitis C viruses (the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such asritonavir,nevirapina, efavirenz)
  • fungal infections(e.g., griseofulvin,ketoconazole)
  • arthritis, osteoarthritis (etoricoxib)
  • high blood pressure in the blood vessels of the lungs (bosentan)

• herbal preparations of St. John's Wort.

Aidraelle 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 cramps).

Do not take aidraelle if you have Hepatitis C and are taking medications that contain ombitasvir / paritaprevir / ritonavir and dasabuvir or glecaprevir / pibrentasvir, as this may cause increases in liver enzyme test results (elevated ALT levels).

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

Aidraelle can be restarted approximately 2 weeks after the completion of this treatment. See the section “Do not take aidraelle”.

Consult your doctor or pharmacist before taking any medication.

Taking aidraelle with Food and Drinks

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 hormonal contraceptives may affect the results of some tests.

Pregnancy andLactation

Pregnancy

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

If you are pregnant, do not takeaidraelle. If you become pregnant while taking aidraelle, stop the treatment immediately and contact your doctor. If you want to become pregnant, you can stop taking aidraelle at any time (see “If you interrupt the treatment withaidraelle”).

Lactation

Generally, it is not recommended to take aidraelle during lactation. If you want to take the contraceptive while breastfeeding, you should consult your doctor.

Driving and Operating Machines

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

Aidraelle contains Lactose

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

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

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

Each blister contains 21 tablets. The day of the week when you should take the tablet is printed on each tablet. For example, if you start on a Wednesday, you should take a tablet with "MIE". Follow the direction of the arrow on the blister until you have taken the 21 tablets.

Do not take any tablets for 7 days after that. During these 7 days when no tablets are taken (called the tablet-free break period), menstruation should occur. Usually, menstruation, also known as withdrawal bleeding, begins on the second or third day of the break period.

On the eighth day after taking the last aidraelle tablet (i.e., after the 7-day tablet-free break period), start the next blister, even if menstruation has not finished. This means that you should start the next blister on the same day of the week as the previous one, and menstruation should occur on the same days every month.

By using aidraelle in this way, you will also be protected against pregnancy during the 7 days when no tablets are taken.

When can you start with the first blister?

• If you have not taken any hormonal contraceptives in the past month.

Start taking aidraelle on the first day of your cycle (i.e., the first day of your menstruation). If you start aidraelle on the first day of your menstruation, you will be protected immediately against pregnancy. You can also start on days 2-5 of your cycle, but you should 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 aidraelle preferably the day after taking the last active tablet (i.e., the last tablet containing active ingredients) of your previous contraceptive, or at the latest the day after the break period of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive). When switching from a vaginal combined contraceptive ring or patch, follow your doctor's recommendations.

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

You can switch from the progestin-only pill at any time. If it is an implant or an IUD, on the same day of its removal; if it is an injection, when the next injection is due. 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 giving birth.

After giving birth, you can start taking aidraelle 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 taking aidraelle.

If, after giving birth, you have had sex again before starting aidraelle (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 aidraelle again after giving birth.

See the "Pregnancy and Breastfeeding" section.

Ask your doctor if you are unsure when to start.

If you take more aidraelle than you should.

No serious cases of overdose have been reported in which the ingestion of an excessive amount of aidraelle has caused harm.

The symptoms that may appear if you take many tablets can be feeling unwell or having vomiting or vaginal bleeding. This bleeding can occur even in girls who have not yet had their first menstrual period, if they accidentally take this medication.

If you have taken too many aidraelle tablets, or if a child has taken them, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take aidraelle.

• If you are lateless than 12 hoursin taking a tablet, the protection against pregnancy does 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 a tablet, the protection against pregnancy may decrease. The more tablets you have forgotten, the greater the risk of becoming pregnant.

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

• Forgetting more than one tablet from the blister.

Consult your doctor.

• Forgetting 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 useadditional precautions, such as a condom, for 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, even if this means taking two tablets at once. Continue taking the tablets at the usual time. The protectionagainst pregnancydoes not decrease and you do not need to take additional precautions.

• Forgetting a tablet in week 3.

You can choose between two options:

1.Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the tablets at the usual time. Instead of starting the break period, start taking the next blister.

Probably, you will have menstruation at the end of the second blister, although you may experience light bleeding or spotting during the second blister.

2.You can also interrupt taking tablets and go directly to the break period (noting the day you forgot to take the tablet). If you want to start a newblister on your scheduled start day, the break period should lastless than 7 days.

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

• If you have forgotten to take a tablet and do not have menstruation during the break period, you may be pregnant. In that case, you should consult your doctor before continuing with the next blister.

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

If you have vomiting within 3-4 hours after taking a tablet or have intense diarrhea, there is a risk that the active ingredients of the contraceptive will not be fully absorbed by the body. The situation is almost equivalent to forgetting a tablet. After vomiting or diarrhea, you should take a tablet from a reserve blister as soon as possible. If possible, take it within12 hoursafter the usual time when you take your contraceptive. If this is not possible or more than 12 hours have passed, follow the advice in the "If you forgot to take aidraelle" section.

Delayed menstrual period: what should you know?

Although not recommended, it is possible to delay your menstrual period if you start taking a new aidraelle blister instead of starting the break period and finish it. You may experience light bleeding or spotting during the second blister. After the usual break period, continue with the next blister.

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

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 beginduring the break period. If you need to change that day, reduce the number of break days (but never increase – 7 at most!). For example, if your break period starts on Friday and you want to change it to Tuesday (3 days earlier), you should start a new blister 3 days earlier than usual. If you make the break period very short (e.g., 3 days or less), you may not experience bleeding during these days. Then you may experience light bleeding or spotting.

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

If you interrupt treatment with aidraelle.

You can stop taking aidraelle whenever you want. If you do not want to become pregnant, consult your doctor about other effective birth control methods.

If you want to become pregnant, stop taking aidraelle and wait until your menstrual period before trying to become pregnant. This way, you will be able to calculate your probable due date more easily.

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

Like all medications,this medicationmay 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 this medication, consult your doctor.

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 urticaria with possible difficulty breathing (see also the "Warnings and Precautions" section).

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 section2 "What you need to know before starting to take aidraelle".

The following list of side effects has been associated with the use ofaidraelle

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

• Mood changes
• Headache,
• Abdominal pain (stomach pain)
• Acne
• Breast pain, breast enlargement,Breast tenderness,Irregular or painful menstruation
• Weight gain.

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

• Candidiasis(a fungal infection)
• Herpeslabial(simple herpes)
• Allergic reactions
• Increased appetite
• Depression, nervousness, sleep disorders
• Tickling and pinching, dizziness
• Visual problems
• Irregular or unusually fast heart rate
• Blood clots (thrombosis)in the lungs (pulmonary embolism), high blood pressure,Low blood pressure,Migraine, varicose veins
• Sore throat
• Nausea, vomiting, inflammation of the stomach and/or intestines, diarrhea, constipation
• Sudden swelling of the skin and/or mucous membranes (e.g. tongue or throat), and/or difficulty swallowing or urticaria with difficulty breathing (angioedema), hair loss (alopecia), eczema, itching, skin rashes, dry skin, seborrheic dermatitis
• Neck pain, limb pain, muscle cramps
• Urinary tract infection
• Breast lumps (benign or cancerous), milk production without being pregnant(galactorrhea), ovarian cysts, hot flashes, amenorrhea, heavy menstruation, vaginal discharge, vaginal dryness, lower abdominal pain(pelvic), abnormal cervical smears(Papanicolau or Papanicolau staining), decreased interest in sex
• Fluid retention, lack of energy, excessive thirst, increased sweating
• Weight loss.

Rare side effects(may affect up to 1 in 1,000people):

• Asthma
• Auditory problems
• Erythema nodosum (characterized by painful red nodules on the skin)
• Erythema multiforme (skin rash with red spots or ulcers)

• Deleterious blood clots in a vein or artery, for example:
• • In a leg or foot (i.e., TVP).
  • In a lung (i.e., EP).
  • Heart attack.
  • Stroke.
  • Transient ischemic attack (TIA) or temporary symptoms similar to a stroke.
  • 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 section2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

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 prospectus. You can also report themdirectlythrough the Spanish System for the Pharmacovigilance of Medicinal Products for Human Usehttps://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.

Do not store at a temperature above 30°C.

Do not usethis medicationafter the expiration date that appears on the packaging after “CAD.:”.

Theexpiration dateisthelastdayof themonththatisindicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGREpoint 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 ofaidraelle

• The active principles are drospirenone and ethinylestradiol. Each film-coated tablet contains 3 milligrams of drospirenone and 0.02 milligrams of ethinylestradiol.
• The other components are:

Core of the tablet: lactose monohydrate, potassium polacrilex, povidone, magnesium stearate.

Coating: Opadry II pink that contains: macrogol, polyvinyl alcohol, titanium dioxide (E-171), talc, yellow iron oxide (E-172), red iron oxide (E-172).

Appearance of the product and contents of the package

Each blister pack of aidraellecontains 21 film-coated tablets.

Aidraelle is available in carton boxes of 1 and 3 blister packs,whichcontainablister pack of PVC/PVDC/Aluminum with 21 film-coated tablets.

Thetablets of aidraelle are cylindrical, biconvex, pink in color, and approximately 6mm in diameter.

There is a cardboard insert in each carton box to store the blister pack.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra)- Spain

Responsible manufacturer:

Cyndea Pharma, S.L.

Emiliano Revilla Sanz Industrial Estate

Avenida de Ágreda, 31

42110 Ólvega (Soria)

Spain

Last review date of this leaflet: July 2024

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

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/78877/P_78877.html

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