ETHINYLESTRADIOL/DROSPIRENONE CINFALAB 0.02mg/3mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ethinylestradiol/Drospirenone Cinfalab 0.02 mg/3 mg film-coated tabletsEFG

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

• 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, talk to 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 see 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 Ethinylestradiol/Drospirenone Cinfalab and what it is used for
2. What you need to know before you start taking Ethinylestradiol/Drospirenone Cinfalab
3. How to take Ethinylestradiol/Drospirenone Cinfalab
4. Possible side effects
5. Storage of Ethinylestradiol/Drospirenone Cinfalab
6. Package contents and further information

1. What is Ethinylestradiol/Drospirenone Cinfalab and what it is used for

Ethinylestradiol/Drospirenone Cinfalab is a contraceptive and is used to prevent pregnancy.

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

Contraceptives that contain two hormones are called combined contraceptives.

2. What you need to know before taking etinilestradiol/drospirenona cinfalab

General considerations

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

Before starting to take etinilestradiol/drospirenona, 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 carry out some other tests.

In this prospectus, several situations are described in which you should interrupt the use of etinilestradiol/drospirenona, or in which the effect of etinilestradiol/drospirenona may decrease. In such situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions, for example, use of a condom or another barrier method. Do not use the rhythm method or the temperature method. These methods may not be reliable since etinilestradiol/drospirenona alters the monthly changes in body temperature and cervical mucus.

Ethinylestradiol/drospirenona, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

When not to take etinilestradiol/drospirenona

You should not take etinilestradiol/drospirenona 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.

Do not take etinilestradiol/drospirenona cinfalab

• 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 lot of 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 in the past) a liver disease and your liver function has not yet normalized.
• If your kidneys do not work well (renal insufficiency).
• If you have (or have had in the past) a tumor in the liver.
• 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 (included in section 6). This can cause itching, rash or inflammation.

Do not take etinilestradiol/drospirenona if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also the section "Other medicines and etinilestradiol/drospirenona cinfalab").

Additional information on special populations

Children and adolescents

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

Older women

Ethinylestradiol/drospirenona is not indicated for use after menopause.

Women with liver insufficiency

Do not take etinilestradiol/drospirenona if you suffer from liver disease. See sections "Do not take etinilestradiol/drospirenona cinfalab" and "Warnings and precautions".

Women with renal insufficiency

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take etinilestradiol/drospirenona cinfalab.

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

In some situations, you will need to be particularly careful while taking etinilestradiol/drospirenona or any other combined contraceptive, and it may be necessary for your doctor to examine you periodically. If the condition develops or worsens while you are taking etinilestradiol/drospirenona, you should also inform your doctor.

• If a close relative has or has had breast cancer in the past.
• 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 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 lot of 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 etinilestradiol/drospirenona 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 etinilestradiol/drospirenona cinfalab")
• 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 had chloasma (a skin discoloration, especially on the face and neck, known as "pregnancy spots"). 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.

BLOOD CLOTS

The use of a combined hormonal contraceptive like etinilestradiol/drospirenona 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 (this is called "venous thrombosis", "venous thromboembolism" or VTE).
• In the arteries (this is called "arterial thrombosis", "arterial thromboembolism" or ATE).

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

It is important to remember that the overall risk of a harmful blood clot due to etinilestradiol/drospirenona 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 of 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 etinilestradiol/drospirenona, 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 etinilestradiol/drospirenona is small.

• Out of 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.
• Out of 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.
• Out of 10,000 women who use a combined hormonal contraceptive that contains drospirenone like etinilestradiol/drospirenona, 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 having a blood clot with etinilestradiol/drospirenona 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).
• If you need an operation or spend a lot of time without getting up due to an injury or illness or if you have a leg in a cast. You may need to stop taking etinilestradiol/drospirenona several weeks before surgery or while you have reduced mobility. If you need to stop taking etinilestradiol/drospirenona, 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 last few weeks.

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

Long-haul flights (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 important 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 taking etinilestradiol/drospirenona.

If any of the above conditions change while you are using etinilestradiol/drospirenona, for example, a close relative experiences a thrombosis without 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 important to note that the risk of a heart attack or stroke due to etinilestradiol/drospirenona is very small, but it can increase:

• With age (above about 35 years).
• If you smoke.When using a combined hormonal contraceptive like etinilestradiol/drospirenona, 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 more than one of these conditions or if any of them are particularly severe, the risk of a blood clot may be even higher.

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

Ethinylestradiol/drospirenona and cancer

It has been observed that breast cancer is slightly more common in women who use combined contraceptives, but it is not known if this is due to the treatment. For example, it may be due to the fact that women who use combined contraceptives are examined by their doctors more often, so breast cancer is detected earlier.

3. How to take ethinylestradiol/drospirenone cinfalab

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

Take one ethinylestradiol/drospirenone tablet every day, with some water if necessary. You can take the tablets with or without food, but always approximately at the same time every day.

The pack (blister) contains 21 tablets. Next to each tablet is printed the day of the week on which you should take the tablet. If, for example, you start on a Wednesday, take a tablet with “WED” next to it. Follow the direction of the arrow on the pack until you have taken all 21 tablets.

Then, you should not take any tablets for 7 days. During these 7 days when you are not taking tablets (called the withdrawal week), you should have your period. The period, which may also be called withdrawal bleeding, usually starts on the 2nd or 3rd day of the withdrawal week.

On the 8th day after taking the last ethinylestradiol/drospirenone tablet (i.e., after the 7-day withdrawal period), you should start with the next pack, even if you have not yet finished your period. This means that you should start each pack on the same day of the week, and your period should take place during the same days every month.

If you use ethinylestradiol/drospirenone in this way, you are also protected against pregnancy during the 7 days when you are not taking any tablets.

When can you start with the first pack?

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

Start taking ethinylestradiol/drospirenone on the first day of your cycle (i.e., the first day of your period). If you start ethinylestradiol/drospirenone on the first day of your period, you are 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 a combined hormonal contraceptive, vaginal ring, or patch.

You can start taking ethinylestradiol/drospirenone preferably the day after taking the last active tablet (the last tablet that contains active ingredients) of your previous contraceptive, but no later than the day after the 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 progestogen-only method (progestogen-only pill, injection, implant, or intrauterine device).

You can switch from the progestogen-only pill at any time (if it is an implant or intrauterine device, on the day of its removal; if it is an injectable, when the next injection is due), but in all cases, 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.

You can start taking ethinylestradiol/drospirenone between 21 and 28 days after having a child. If you start later than day 28, use a barrier method (e.g., a condom) during the first 7 days of taking ethinylestradiol/drospirenone. If, after having a child, you have had sexual intercourse before starting to take ethinylestradiol/drospirenone again, you should be sure that you are not pregnant or wait for your next menstrual period.

• If you are breastfeeding and want to start taking ethinylestradiol/drospirenone again after having a child.

Read the section “Breastfeeding”.

Ask your doctor if you are not sure when to start.

If you take more ethinylestradiol/drospirenone cinfalab than you should

No cases have been reported where an overdose of ethinylestradiol/drospirenone has caused serious harm.

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

If you have taken too many ethinylestradiol/drospirenone tablets, or discover that 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 ethinylestradiol/drospirenone cinfalab

• If you are less than 12 hourslate in taking a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and the following tablets at the usual time.
• If you are more than 12 hourslate in taking a tablet, the protection against pregnancy may be reduced. The more tablets you have missed, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is highest if you miss a tablet at the beginning or end of the pack. Therefore, you should follow the following recommendations (see the diagram below):

• Missing more than one tablet in the pack

Consult your doctor.

• Missing a tablet in week 1

Take the missed 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 and use additional precautions, for example, condoms, for the next 7 days. If you have had sexual intercourse in the week before missing the tablet, you may be pregnant. In this case, consult your doctor.

• Missing a tablet in week 2

Take the missed 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. The protection against pregnancy is not reduced, and you do not need to take additional precautions.

• Missing a tablet in week 3

You can choose between two options:

1. Take the missed 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 pack.

You will probably have your period at the end of the second pack, although you may experience light or period-like bleeding during the second pack.

1. You can also stop taking tablets and go straight to the withdrawal week (noting the day you missed the tablet). If you want to start a new pack on the day you usually start, your withdrawal week should last less than 7 days.

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

• If you have missed a tablet and do not have a period during the first withdrawal week, you may be pregnant. Contact your doctor before starting the next pack.

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

If you vomit within 3-4 hours after taking a tablet or have 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 missing a tablet. After vomiting or diarrhea, take a tablet from a reserve pack as soon as possible. If possible, take it within 12 hours after 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 ethinylestradiol/drospirenone cinfalab”.

Delayed menstrual period: what should you know?

Although it is not recommended, you can delay your menstrual period if you start a new pack of ethinylestradiol/drospirenone instead of continuing with the withdrawal week and finish it. You may experience light or period-like bleeding during the use of the second pack. After the usual withdrawal week, start the next pack.

You should ask your doctor for advice 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 the day, reduce the number of withdrawal days (but never increase them – 7 at most!). For example, if your withdrawal days usually start on Fridays and you want to change to Tuesdays (3 days earlier), start a new 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 or period-like bleeding.

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

If you stop treatment with ethinylestradiol/drospirenone cinfalab

You can stop taking ethinylestradiol/drospirenone at any time. If you do not want to become pregnant, consult your doctor about other effective methods of birth control. If you want to become pregnant, stop taking ethinylestradiol/drospirenone and wait until your menstrual period before trying to become pregnant. This way, you will be able to calculate the estimated 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 can cause adverse effects, although not all people suffer from them.

If you experience any adverse effect, especially if it is severe and persistent, or have any change in health that you think may be due to ethinylestradiol/drospirenone, 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 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 ethinylestradiol/drospirenone cinfalab".

The following list of adverse effects has been associated with the use of ethinylestradiol/drospirenone.

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

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

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

• Candida (a fungal infection)
• cold sore (herpes simplex)
• 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
• sore throat
• 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 along with breathing difficulties (angioedema), hair loss (alopecia), eczema, itching, skin rash, 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 menstruation, vaginal discharge, vaginal dryness, pain in the lower abdominal region (pelvic), 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 women):

• asthma
• hearing problems
• erythema nodosum (characterized by painful nodules on the skin, reddish in color)
• erythema multiforme (skin rash with target-like redness 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 likelihood 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 Medicines Agency's website: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ethinylestradiol/Drospirenone Cinfalab

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration 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 pharmacy's SIGRE collection point. 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 of Ethinylestradiol/Drospirenone Cinfalab

• The active ingredients are ethinylestradiol and drospirenone. Each tablet contains 0.02 mg of ethinylestradiol and 3 mg of drospirenone.
• The other ingredients are:

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

Tablet coating:polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, talc, yellow iron oxide (E-172), red iron oxide (E-172), black iron oxide (E-172).

Appearance of the Product and Package Contents

Film-coated tablets, round and pink in color.

They are presented in PVC/PVDC/ALU blisters.

Each package contains 21 or 21x3 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera; La Vallina s/n;

24008-Villaquilambre, León 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/)