AIDRAELLE 3 mg/0.02 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

aidraelle3 mg/0.02 mgfilm-coated tablets EFG

drospirenone/ethinylestradiol

Read this package leaflet carefully before you start taking this medicine, as it contains important information for you.Keep this package leaflet, you may need to read it again.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, consult your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and consult your doctor if you think you might have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of the package leaflet:

1. What is 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
   • Bleeding between menstrual periods
   • What should you do if you do not have your period during the week of rest?
   • Other medicines and aidraelle
   • Taking aidraelle with food and drink
   • Laboratory tests
   • Pregnancy and breastfeeding
   • Driving and using machines
   • Important information about some of the ingredients of aidraelle

1. How to take aidraelle
   • When can you start with the first blister?
   • If you take more aidraelle than you should
   • If you forget to take aidraelle
   • What should you do in case of vomiting or severe diarrhea?
   • What should you do if you do not have your period during the week of rest?
   • Delayed menstrual period: what should you know?
   • Change of the first day of your menstrual period: what should you know?
   • If you stop taking aidraelle

1. Possible side effects

5. Storage of aidraelle

1. Contents of the pack and further information

1. What is aidraelle and what is it used for

Aidraelle is a contraceptive and is used to prevent pregnancy.

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

Contraceptives that contain two hormones are called combined contraceptives.

2. What you need to know before taking aidraelle

General considerations

Before starting to take aidraelle, you should read the information about blood clots in section 2. It is especially important that you read the symptoms of a blood clot (see section 2 "Blood clots").

Before starting to take aidraelle, 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 state of health, may perform other tests.

This prospectus describes several situations in which you should interrupt the use of aidraelle, or in which the effect of aidraelle may decrease.

In such situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions, such as using a condom or another barrier method.

Do not use the rhythm method or the temperature method. These methods may not be reliable since aidraelle alters the monthly changes in body temperature and cervical mucus.

Aidraelle, like other hormonal contraceptives, does not protect against HIV infection (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 blood vessel of the legs (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.
• If you know you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies.
• If you need an operation or if you spend a long time without getting 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, temporary stroke symptoms).
• If you have any of the following diseases that may increase your risk of forming a clot in the arteries:

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

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

• If you have or have had liver disease in the past and your liver function has not yet returned to normal.
• If your kidneys do not work well (renal failure).
• If you have (or have had in the past) a liver tumor.
• If you have (or have had in the past) or if you suspect you have breast cancer or cancer of the sex organs.
• If you have vaginal bleeding, whose cause is unknown.
• If you are allergic to ethinylestradiol or drospirenone, or to any of the other components of this medicine (including those listed in section 6). This may be manifested by itching, rash, or inflammation.

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

Additional information on special populations

Children and adolescents

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

Older women

Aidraelle is not indicated for use after menopause.

Women with liver failure

Do not take aidraelle if you suffer from liver disease. See sections "Do not take aidraelle" and "Warnings and precautions".

Women with kidney failure

Do not take aidraelle if you are suffering from kidney malfunction or acute kidney failure. See sections "Do not take aidraelle" and "Warnings and precautions".

Warnings and precautions

Consult your doctor or pharmacist before starting to take aidraelle.

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

In some situations, you will need to be particularly careful while using aidraelle or any other combined contraceptive, and it may be necessary for your doctor to perform regular checks on you. If any of the following disorders affect you, you must inform your doctor before starting to take aidraelle.

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

• If a close relative has or has ever had breast cancer.
• If you have any liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• If you have sickle cell anemia (a hereditary disease of red blood cells).
• If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you need an operation or spend a long time without getting up (see section 2 "Blood clots").
• If you have just given birth, you are at a higher risk of blood clots. You should ask your doctor when you can start taking aidraelle after childbirth.
• If you have inflammation of the veins that are under the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you have epilepsy (see "Other medicines and aidraelle").
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• If you have a disease that may have appeared for the first time during pregnancy or during previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria, blistering skin rash during pregnancy (gestational herpes), a nervous disease in which involuntary movements appear (Sydenham's chorea)).
• If you have or have ever had chloasma (brownish discoloration, also known as "pregnancy spots", especially on the face and neck). In this case, you should avoid direct exposure to the sun or ultraviolet rays.
• If you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria, with possible difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen the symptoms of hereditary and acquired angioedema.

Psychiatric disorders:

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

BLOOD CLOTS

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

Blood clots can form:

• In the veins (which is called "venous thrombosis", "venous thromboembolism" or VTE).
• In the arteries (which is called "arterial thrombosis", "arterial thromboembolism" or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious long-term effects or, very rarely, they can be fatal.

It is essential to remember that the overall risk of a harmful blood clot due to aidraelle is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN

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

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in the veins (venous thrombosis). However, these side effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.

• If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).

• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.

• In very rare cases, a clot can form in a vein of another organ, such as the eye (retinal vein thrombosis).

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

The risk of a blood clot in a vein is higher during the first year in which you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medicine or a different one) after an interruption of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking aidraelle, your risk of a blood clot returns to normal within a few weeks.

What is the risk of a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of a blood clot in the leg or lung (DVT or PE) with aidraelle is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will have a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 will have a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive that contains drospirenone, such as aidraelle, between 9 and 12 women will have 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 aidraelle is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index or BMI over 30 kg/m2).
• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before the age of about 50). In this case, you may have a hereditary blood clotting disorder.
• If you need an operation or spend a long time without getting up due to an injury or illness or if you have a leg in a cast. You may need to stop using aidraelle several weeks before surgery or while you have reduced mobility. If you need to stop using aidraelle, ask your doctor when you can start using it again.
• As you get older (especially above about 35 years).
• If you have given birth in the past few weeks.

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

Long-distance air travel (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you suffer from any of the above conditions, even if you are not sure. Your doctor may decide that you should stop using aidraelle.

If any of the above conditions change while you are using aidraelle, for example, you start smoking, a close relative experiences a thrombosis 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 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 aidraelle is very small, but it can increase:

• With age (above about 35 years).
• If you smoke.When using a combined hormonal contraceptive like aidraelle, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or any of your close relatives have a high level of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

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

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

Aidraelle and cancer

Women who use combined contraceptives have a slightly higher incidence 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 contraceptives because they are examined by a doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to have regular breast exams, and you should see your doctor if you notice any lump.

3. How to take aidraelle

Follow the administration instructions for this medication exactly as indicated by your doctor. If in 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 take them at approximately the same time every day.

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

Then, do not take any tablets for 7 days. During these 7 days without tablets (called the tablet-free period), you should have your period. Usually, the period, also known as withdrawal bleeding, starts on the second or third day of the tablet-free week.

On the eighth day after taking the last aidraelle tablet (i.e., after the 7-day tablet-free period), start the next blister pack, even if you have not finished bleeding. This means you should start the next blister pack on the same day of the week you started the previous one, and your period should occur during the same days every month.

If you use aidraelle in this way, you will also be protected against pregnancy during the 7 days when you are not taking tablets.

When can you start with the first blister pack?

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

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

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

You can start taking aidraelle preferably the day after taking the last active tablet (the last tablet containing active ingredients) of your previous contraceptive, or at the latest on the day after the withdrawal week of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive). When switching from a vaginal ring or patch, follow your doctor's recommendations.

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

You can switch from the progestin-only pill at any time. If it is an implant or intrauterine device, on the 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 measures (e.g., a condom) during the first 7 days of tablet-taking.

• After an abortion.

Follow your doctor's recommendations.

• After having a child.

After having a child, you can start taking aidraelle between 21 and 28 days later. If you start later, you must use a barrier method (e.g., a condom) during the first 7 days of aidraelle use.

If, after having a child, you have had sexual intercourse before starting aidraelle again, you must first ensure you are not pregnant or wait for your next period.

• If you are breastfeeding and want to start takingaidraelleagain after having a child.

Refer to the section "Pregnancy and Breastfeeding".

Ask your doctor if you are unsure when to start.

If you take moreaidraellethan you should

No cases have been reported where an overdose of aidraelle has caused serious harm.

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

• If you are less than 12 hourslate in taking a tablet, your protection against pregnancy will not decrease. Take the tablet as soon as you remember and take the following tablets at the usual time.

• If you are more than 12 hourslate in taking a tablet, your protection against pregnancy may be reduced. The more tablets you have forgotten, the higher the risk of becoming pregnant.

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

• Forgetfulness of more than one tablet in the blister pack

Consult your doctor.

• Forgetfulness of a tablet in week 1

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

• Forgetfulness of a tablet in week 2

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

• Forgetfulness of a tablet in week 3

You can choose between two options:

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

You will likely have your period at the end of the second blister pack, although you may experience light bleeding or spotting during the second blister pack.

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

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

• If you have forgotten to take a tablet and do not have a period during the withdrawal week, you may be pregnant. In this case, consult your doctor before continuing with the next blister pack.

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

If you vomit within 3-4 hours after taking a tablet or suffer from severe 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, take a tablet from a reserve blister pack as soon as possible. If possible, take it within 12 hoursafter 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 aidraelle".

Delayed menstrual period: what should you know?

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

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

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

If you take the tablets according to the instructions, your menstrual period will start during the withdrawal week. If you need to change this day, reduce the number of withdrawal days (but never increase them - 7 days maximum!). For example, if your withdrawal week starts on a Friday and you want to change it to a Tuesday (3 days earlier), you should start a new blister pack 3 days earlier than usual. If you make the withdrawal week very short (e.g., 3 days or less), you may not have bleeding during these days. Then, you may experience light bleeding or spotting.

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

If you stop takingaidraelle

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 period before trying to become pregnant. This way, you will be able to calculate the expected date of delivery more easily.

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

4. Possible Adverse Effects

Like all medicines, this medicine may cause adverse effects, although not all people suffer from them. If you experience any adverse effect, especially if it is severe and persistent, or if you have any change in health that you think may be due to aidraelle, consult your doctor.

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

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

The following list of adverse effects has been associated with the use of aidraelle

Frequent Adverse Effects(may affect up to 1 in 10 people):

• mood changes
• headache,
• abdominal pain (stomach pain)
• acne
• breast pain, breast enlargement, breast tension, painful or irregular menstrual periods
• weight gain.

Uncommon Adverse Effects(may affect up to 1 in 100 people):

• Candidiasis (a fungal infection)
• herpes labialis (cold sore)
• allergic reactions
• increased appetite
• depression, nervousness, sleep disorders
• tingling and numbness, dizziness
• vision problems
• irregular or unusually rapid heart rate
• blood clots (thrombosis) in the lungs (pulmonary embolism), increased blood pressure, decreased blood pressure, migraine, varicose veins
• throat pain
• nausea, vomiting, stomach and/or intestinal inflammation, 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
• bladder infection
• breast lumps (benign or cancerous), milk production without being pregnant (galactorrhea), ovarian cysts, hot flashes, absence of menstruation, heavy menstrual bleeding, vaginal discharge, vaginal dryness, pelvic pain, abnormal cervical smears (Pap smear or Pap staining), decreased libido
• fluid retention, lack of energy, excessive thirst, increased sweating
• weight loss.

Rare Adverse Effects(may affect up to 1 in 1,000 people):

• asthma
• hearing problems
• erythema nodosum (characterized by painful red nodules on the skin)
• erythema multiforme (skin rash with red target-like lesions or ulcers)

• Harmful blood clots in a vein or artery, for example:
• • In a leg or foot (i.e., DVT).
  • In a lung (i.e., PE).
  • Heart attack.
  • Stroke.
  • Mild or temporary stroke-like symptoms, known as a 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).

Reporting Adverse Effects

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

5. Storage of aidraelle

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after "EXP.".

The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofaidraelle

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

Tablet core: lactose monohydrate, potassium polacrylate, povidone, magnesium stearate.

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

Appearance of the Product and Package Contents

Each aidraelle blister pack contains 21 film-coated tablets.

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

The aidraelle tablets are cylindrical, biconvex, pink in color, and have a diameter of approximately 6mm.

Each cardboard box contains a cardboard sleeve to store the blister pack.

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra)- Spain

Manufacturer:

Cyndea Pharma, S.L.

Pol. Ind. Emiliano Revilla Sanz

Avenida de Ágreda, 31

42110 Ólvega (Soria)

Spain

Date of the Last Revision of this Leaflet: July 2024

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

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

QR code to: https://cima.aemps.es/cima/dochtml/p/78877/P_78877.html