Label: information for the patient

Lenzetto 1.53 mg/dose, transdermal spray solution

estradiol

Read this label carefully before starting to use this medication, as it contains important information for you.

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

1. What is Lenzetto and how is it used

2. What you need to know before starting to use Lenzetto

3. How to use Lenzetto

4. Possible adverse effects

5. Storage of Lenzetto

6. Contents of the package and additional information

Lenzetto is a Hormone Replacement Therapy (HRT). It contains the female hormone estrogen. Lenzetto is used in postmenopausal women when at least 6 months have passed since their last natural menstrual period.

Lenzetto may also be used in women who have had surgery to remove their ovaries, as this causes instant menopause.

Lenzetto is a spray solution that contains small amounts of a medication called estradiol. When sprayed on the skin as directed, it passes through the skin into the bloodstream.

Lenzetto is used for:

Relief of symptoms that occur after menopause

During menopause, the amount of estrogen produced by the woman's body decreases. This can cause symptoms such as hot flashes in the face, neck, and chest ("hot flashes"). Lenzetto relieves these symptoms after menopause. Lenzetto will only be prescribed if your symptoms seriously interfere with your daily life.

Lenzetto is indicated for treating symptoms of estrogen deficiency after menopause, when menstruation no longer occurs after menopause. Symptoms of estrogen deficiency include hot flashes (sudden waves of heat and sweating throughout the body), difficulty sleeping, irritability, and vaginal dryness.

The experience in treating women over 65 years old is limited.

Lenzetto is not a contraceptive.

Medical History and Regular Reviews:

The use of THS involves risks that need to be considered when deciding whether to start using it, or to continue using it.

The experience in treating women with premature menopause (due to ovarian failure or surgery) is limited. If you have premature menopause, the risks of using THS may be different. Please consult your doctor.

Before starting (or resuming) THS, your doctor will ask you about your personal and family medical history. Your doctor may decide to perform a physical examination. This may include a breast examination and/or an internal examination, if necessary.

Once started on treatment withLenzetto, you should visit your doctor for regular check-ups (at least once a year). In these check-ups, discuss with your doctor the benefits and risks of continuing withLenzetto.

Undergo regular breast exams as recommended by your doctor.

Do not use Lenzetto

If any of the following situations apply to you. If you are unsure about any of the points below,consult your doctorbefore usingLenzetto.

Do not use Lenzetto

• if you have or have hadbreast cancer, or if you suspect you have it;
• if you havecancer sensitive to estrogen, such as endometrial cancer, or if you suspect you have it;
• if you have anyunexplained vaginal bleeding;
• if you have anexcessive thickening of the endometrium(endometrial hyperplasia) that is not being treated;
• if you have or have had ablood clot in a vein(thrombosis), such as in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism);
• if you have ablood clotting disorder (such as protein C deficiency, protein S deficiency, or antithrombin deficiency);
• if you have or have had a disease caused by blood clots in the arteries, such as aheart attack, stroke, orangina;
• if you have, or have had at any time, aliver diseaseand your liver function tests have not normalized;
• if you have a rare blood disorder called "porphyria" that is inherited;
• if you areallergicto estradiol or to any of the other components of Lenzetto (including those in section 6).

If any of the above conditions appear for the first time during the use of this medication, stop treatment immediately and consult your doctor immediately.

Warnings and Precautions

Consult your doctor or pharmacist before starting to useLenzetto.

Inform your doctor if you have ever had any of the following problems, before starting treatment, as they may recur or worsen during treatment withLenzetto. In that case, you should visit your doctor more frequently for check-ups:

• fibroids in your uterus;
• growth of the endometrium outside the uterus (endometriosis) or a history of excessive growth of the endometrium (endometrial hyperplasia);
• an increased risk of developing blood clots (see “Blood clot in a vein (thrombosis)”);
• an increased risk of developing estrogen-dependent cancer (such as having a mother, sister, or grandmother who has had breast cancer);
• high blood pressure;
• a liver disorder, such as a benign tumor in the liver;
• diabetes;
• gallstones;
• migraine or severe headache;
• a systemic autoimmune disease that affects multiple organs of the body (Systemic Lupus Erythematosus, SLE);
• epilepsy;
• asthma;
• a disorder that affects the eardrum and ear (otosclerosis);
• a very high level of fat in your blood (triglycerides);
• fluid retention due to heart or kidney problems;
• hereditary and acquired angioedema.

Stop treatment withLenzettoand see a doctor immediately

If you observe any of the following symptoms while using THS:

• any of the situations mentioned in the section “Do not use Lenzetto”;
• yellowing of your skin or the white of your eyes (jaundice). These may be signs of liver disease;
• swelling of the face, tongue, or throat and difficulty swallowing or urticaria accompanied by difficulty breathing, which suggests angioedema;
• a significant increase in your blood pressure (symptoms may include headache, fatigue, dizziness);
• migraine-type headaches that occur for the first time;
• if you become pregnant;
• if you notice signs of a blood clot, such as:
• painful and swollen legs
• sudden chest pain
• difficulty breathing.

For more information, see “Blood clot in a vein (thrombosis)”.

Note: Lenzetto is not a contraceptive. If you have had a menstrual period in the past 12 months or are under 50 years old, you may still need additional contraceptive measures to prevent pregnancy. Ask your doctor.

THS and Cancer

Endometrial Hyperplasia and Endometrial Cancer

THS with only estrogen will increase the risk of endometrial hyperplasia and endometrial cancer.

Taking a progestogen in addition to estrogen for at least 12 days of each 28-day cycle will protect you from this additional risk. Therefore, your doctor will prescribe a progestogen separately if you still have a uterus. If you have had a hysterectomy, consult your doctor to see if you can use this medication safely without progestogen.

In women with a uterus and not treated with THS, on average, 5 out of 1,000 will be diagnosed with endometrial cancer between the ages of 50 and 65.

In women aged 50-65 with a uterus and on THS with only estrogens, between 10 and 60 women out of 1,000 will be diagnosed with endometrial cancer (i.e., between 5 and 55 additional cases), depending on the dose and duration of treatment.

Lenzetto contains a higher dose of estrogen than other THS products with only estrogen. The risk of endometrial cancer when using Lenzetto with a progestogen is unknown.

Unexpected Bleeding

You will have a monthly bleeding (called withdrawal bleeding) while using Lenzetto if combined with a sequential progestogen dose. However, if you have unexpected bleeding or small losses (spotting) in addition to your monthly bleeding, which:

• continues after the first 6 months;
• starts after using Lenzetto for more than 6 months;
• continues after stopping Lenzetto;

see your doctor as soon as possible.

Breast Cancer

It has been demonstrated that hormone replacement therapy (HRT) with estrogen-progestogen or estrogen-only HRT increases the risk of breast cancer. The additional risk depends on the duration of HRT use. The additional risk becomes apparent within 3 years of use. After stopping HRT, the additional risk will decrease over time, and may persist for 10 years or more if HRT has been used for more than 5 years.

Comparison

In women aged 50-54 who do not use HRT, on average, 13-17 out of 1,000 will be diagnosed with breast cancer over a 5-year period.

In women aged 50 who start using estrogen-only HRT for 5 years, there will be 16-17 cases per 1,000 users (i.e., 0-3 additional cases).

In women aged 50 who start using estrogen-progestogen HRT for 5 years, there will be 21 cases per 1,000 users (i.e., 4-8 additional cases).

In women aged 50-59 who do not use HRT, on average, 27 out of 1,000 will be diagnosed with breast cancer over a 10-year period.

In women aged 50 who start using estrogen-only HRT for 10 years, there will be 34 cases per 1,000 users (i.e., 7 additional cases).

In women aged 50 who start using estrogen-progestogen HRT for 10 years, there will be 48 cases per 1,000 users (i.e., 21 additional cases).

Examine your breasts regularly. See your doctor if you notice any changes, such as:

• indentations in the skin
• changes in the nipple
• any lump that you can see or feel.

Additionally, you are advised to join screening programs when offered. For mammography, it is essential to inform the nurse/healthcare professional performing the radiography that you are using HRT, as this medication may increase the density of your breasts, which may affect the mammography results. When breast density increases, it is possible that mammography may not detect all lumps.

Ovarian Cancer

Ovarian cancer is rare, much less common than breast cancer. The use of HRT with estrogens alone or with a combination of estrogens-progestogens has been associated with a slightly higher risk of ovarian cancer.

The risk of ovarian cancer varies with age. For example, in women aged 50-54 who do not use HRT, approximately 2 cases of ovarian cancer per 2,000 women are observed over a 5-year period. In women on HRT for 5 years, approximately 3 cases per 2,000 patients are observed (i.e., approximately 1 additional case).

Effect of HRT on the Heart and Circulation

Blood Clots in a Vein (Thrombosis)

The risk ofblood clots in veinsis approximately 1.3 to 3 times higher in HRT users than in non-users, especially during the first year of treatment.

Blood clots can be serious, and if one breaks loose and travels to the lungs, it can cause chest pain, difficulty breathing, fainting, or even death.

You are more likely to develop a blood clot in your veins as you age and if you have any of the following situations. Inform your doctor if you have any of the following situations:

• you cannot walk for a long time due to major surgery, injury, or illness (see also section 3, “If you need surgery”).
• you have severe obesity (BMI>30 kg/m2).
• you have a blood clotting disorder that requires long-term treatment with a medication used to prevent blood clots.
• if any of your close relatives have ever had a blood clot in a leg, lung, or other organ.
• you have Systemic Lupus Erythematosus (SLE).
• you have cancer.

To know the signs of blood clots, see “Stop treatment withLenzettoand see a doctor immediately”.

Considering women aged 50 who do not use HRT, on average, 4-7 out of 1,000 will have a blood clot in a vein over a 5-year period.

In women aged 50 who have been using estrogen-progestogen HRT for 5 years, there will be 9-12 cases per 1,000 users (i.e., 5 additional cases).

In women aged 50 who have had a hysterectomy and have been using estrogen-only HRT for 5 years, there will be 5-8 cases per 1,000 users (i.e., 1 additional case).

Heart Disease (Myocardial Infarction)

There is no evidence that HRT prevents myocardial infarction.

Women over 60 who use estrogen-progestogen HRT are slightly more likely to develop heart disease than those who do not use HRT.

In women who have had a hysterectomy and are using estrogen-only HRT, there is no increased risk of developing heart disease.

Stroke

The risk of stroke is approximately 1.5 times higher in women treated with HRT than in those who are not treated. The number of additional stroke cases due to HRT use will increase with age.

Comparison:In women aged 50 who do not use HRT, on average, 8 out of 1,000 will have a stroke over a 5-year period. In women aged 50 who use HRT, there will be 11 cases per 1,000 users in 5 years (i.e., 3 additional cases).

Other Conditions

HRT does not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65. Consult your doctor.

Children

The estradiol aerosol can be accidentally transferred from the skin where it has been sprayed to other people. Do not allow other people, especially children, to come into contact with the area of your skin where the estradiol was sprayed, and cover the area if necessary, after the spray has dried. If a child comes into contact with the area of your skin where estradiol was sprayed, wash the child's skin with water and soap as soon as possible. Due to the transfer of estradiol, young children may show signs of unexpected puberty (such as breast development). In most cases, symptoms will disappear when children stop being exposed to the estradiol aerosol.

Consult your doctor if you notice any signs or symptoms (breast development or other changes) in a child who may have been accidentally exposed to the estradiol spray.

Other Medications and Lenzetto

Inform your doctor if you are using, have used recently, or may need to use any other medication.

Some medications may interfere with the effect ofLenzetto. This can cause irregular bleeding. This occurs with the following medications:

• Medications forepilepsy(such as phenobarbital, phenytoin, and carbamazepine)
• Medications fortuberculosis(such as rifampicin, rifabutin)
• Medications forHIV infection(such as nevirapine, efavirenz, ritonavir, and nelfinavir)
• Medicines(traditional) based on plants that containSt. John's Wort(Hypericum perforatum)

HRT may affect how other medications work:

• a medication for epilepsy (lamotrigine), which may increase the frequency of seizures;

• medications for hepatitis C virus (HCV) (e.g., a combination regimen for HCV, ombitasvir/paritaprevir/ritonavir with or without dasabuvir or glecaprevir/pibrentasvir) may cause elevated liver function test results (increased ALT levels) in women using HCV therapy with ethinylestradiol. Lenzetto contains estradiol instead of ethinylestradiol. It is unknown whether an increase in ALT levels can occur when using Lenzetto with this HCV combination regimen.

Inform your doctor or pharmacist if you are using or have used recently other medications, including over-the-counter medications, herbal medications, or other natural products.

Laboratory Tests

If you need a blood test, inform your doctor or laboratory personnel that you are using Lenzetto, as this medication may affect the results of some tests.

Pregnancy and Breastfeeding

Lenzetto is for use only in postmenopausal women. If you become pregnant, stop treatment with Lenzetto and contact your doctor.

Do not use Lenzetto while breastfeeding.

Driving and Operating Machinery

Lenzetto has no known effects on your ability to drive or operate machinery.

Lenzetto contains alcohol

This medication contains 65.47 mg of alcohol (ethanol) in each dose equivalent to72.74% v/v. It may cause a burning sensation on damaged skin.

Alcohol-based products are flammable. Keep away from fire. Avoid open flames, lit cigarettes, or the use of heat-producing appliances (e.g., hair dryers) while applying the spray to your skin until the medication spray has dried.

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

Your doctor will prescribe the lowest dose to treat your symptoms for as long as necessary.

During treatment, your doctor may adjust the dose according to your individual needs. Talk to your doctor if you consider the dose too strong or insufficient.

If you have not undergone a hysterectomy (surgical removal of the uterus), your doctor will give you some pills containing another hormone called progesterone to counteract the effects of estrogen on the uterine lining. Your doctor will explain how to take these pills. At the end of the treatment period with progesterones, a bleeding due to deprivation (see section "Unexpected bleeding") may occur.

If you need surgery

If you are going to undergo surgery, inform the surgeon that you are using Lenzetto. You may need to stop using Lenzetto about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, Blood clots in a vein). Ask your doctor when you can start using Lenzetto again.

Where to apply Lenzetto

The aerosol must be applied to dry and healthy skin on the inside of the forearm. If not possible, it must be applied to the inside of the thigh.

Do not apply Lenzetto to the breasts or any area close to the breasts.

How to apply Lenzetto

Before using a new applicator for the first time, the pump must be primed by spraying three times with the cap on:The container must be held in a vertical position as shown in Figure 1. With the cap on, press the button down three times with your thumb or index finger.

The medication is now ready for use.

DO NOT prepare the applicator before each dose; prepare it only once before starting to use a new container. If you forgot one or more doses, prepare the applicator according to the instructions in the section "If you forgot to use Lenzetto".

Make sure the skin where you want to spray the medication is healthy, clean, and dry.

How to apply your daily dose.

To apply your daily dose, remove the plastic cap, hold the container in a vertical position, and press the flat plastic cone against the skin (Figure 2).

You may need to move your arm or move the cone along your arm so that the cone is flat on the skin and there are no gaps between the cone and the skin.

Press the button down once. It must be pressed firmly and held before releasing.

If you need another spray, move the cone along your arm so that it is next to the area you have already sprayed. Press the button down once.

If you need a third spray, move the cone along your arm again and press the button down once.

If the second or third spray does not fit in the same inside of the forearm, you can also spray on the inside of your other forearm. If you have trouble putting the cone on the inside of the forearm as shown in Figure 3, or if it is difficult for you to use it on your forearms, you can also spray on the inner surface of the thigh.

When you have finished using Lenzetto, always put the cap on the container (Figure 4).

If the medication is used as instructed, regardless of the different forms or patterns of administration on the skin, each spray will release the same amount of active ingredient.

Leave the spray to dry for at least 2 minutes before dressing and at least 60 minutes before bathing or washing. If the Lenzetto spray comes into contact with another area of the skin, such as the hands, wash that area of the skin with water and soap immediately.

Lenzetto cannot be used on injured or damaged skin.

Do not massage or rub Lenzetto on the skin.

Do not let others touch the area of the skin where the spray has been applied until it has dried and cover it with clothing 2 minutes after application, if necessary.If another person (especially a child) accidentally touches the area of your skin where you have sprayed Lenzetto, tell that person to wash the area of their skin with water and soap immediately.

How long to use Lenzetto

Your doctor will probably recommend the lowest dose initially (one spray per day) and you should talk to your doctor about how the medication is working for you. If necessary, your doctor may increase the dose to two sprays per day. The maximum daily dose is three sprays.

How often to use Lenzetto

You must apply the total number of sprays (dose) prescribed by your doctor at the same time every day.

How long to use Lenzetto

Talk to your doctor every 3-6 months about how long you should use Lenzetto. You should only use Lenzetto for as long as you need it to relieve hot flashes associated with menopause.

Other useful information

Sunscreen can alter the absorption of estrogen from Lenzetto.

Avoid using sunscreen on the area of the skin where you plan to spray. However, if you need to use sunscreen, you must apply it at least one hour before using Lenzetto.

Lenzetto should be used with caution in extreme temperatures, such as in a sauna or in the sun.

There is limited data suggesting that the speed and degree of absorption of Lenzetto may be reduced in women with obesity. Consult your doctor. During treatment, your doctor may adjust the dose according to your individual needs.

If you use more Lenzetto than you should

If you use more Lenzetto than you should, or if children have accidentally used the medication, contact your doctor or the hospital for an opinion on the risk and advice on the measures to be taken.

If you use more Lenzetto than you should, you may feel unwell, vomit, and experience bleeding due to deprivation (unusual vaginal bleeding).

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

If you forgot to use Lenzetto

If you forgot to use Lenzetto at your usual time, apply the medication as soon as you remember and, on the next day, use it as you normally would. If it is almost time for your next dose, wait and apply the next dose as you normally would. If you forget one or more doses, you will need a first spray with the protective cap on. Do not use a double dose to compensate for the missed doses.

Forgetting a dose may increase the likelihood of intermenstrual bleeding and spotting.

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

If you interrupt treatment with Lenzetto

Your doctor will explain how to stop treatment with this medication when your treatment is finished.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

The following diseases have been reported more frequently in women usingTHSin comparison with women who do not useTHS:

• breast cancer;
• abnormal growth or breast cancer of the inner lining of the uterus (endometrial hyperplasia or cancer);
• ovarian cancer;
• blood clots in the veins of the legs or lungs (venous thromboembolism);
• heart disease:
• stroke;
• gallbladder disease;
• high blood pressure;
• liver problems;
• high blood sugar levels;
• probable memory loss if THS is initiated after the age of 65.

For more information on these side effects, see section 2.

Some side effects may be severe

The following symptoms require immediate medical attention:

• sudden chest pain;
• chest pain that spreads to the arm or neck;
• difficulty breathing;
• painful and swollen legs;
• yellowing of the eyes and skin (jaundice);
• unexpected vaginal bleeding (intermenstrual bleeding) or spotting after using Lenzetto for a while or after stopping treatment;
• changes in the breasts including dimpling of the skin, changes in the nipple, lumps that can be seen or felt;
• menstrual cramps;
• dizziness and fainting;
• changes in speech;
• changes in vision;
• migraine-type headaches without a known cause.

If any of the side effects you experience worsen or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

The following side effects have been reported with Lenzetto:

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

Headache, abdominal pain, nausea, rash, pruritus (itching), irregular uterine bleeding or vaginal bleeding including spotting, breast tenderness, breast pain, weight gain or loss.

Less frequent side effects(may affect up to 1 in 100 people)

Reactions of hypersensitivity, depressive mood, insomnia (difficulty sleeping), dizziness, vertigo (sensation of dizziness or spinning), visual disturbances, palpitations (feeling the heartbeat), diarrhea, dyspepsia (indigestion), increased blood pressure, erythema nodosum (characterized by painful and red skin nodules), urticaria (generalized or localized skin rash), skin irritation, edema (swelling due to fluid retention), muscle pain, breast discoloration, nipple discharge, uterine or cervical polyps, endometrial hyperplasia, ovarian cyst, genital inflammation (vaginitis), increased liver enzymes and cholesterol in the blood, armpit pain.

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

Anxiety, increased or decreased libido, migraine, intolerance to contact lenses, abdominal distension, vomiting, increased body hair, acne, muscle cramps, menstrual cramps, premenstrual syndrome, breast enlargement, fatigue.

The following side effects have been reported with Lenzetto during post-marketing surveillance: hair loss (alopecia), melasma (brownish-yellow skin patches, especially on the face), skin discoloration.

The following side effects have been reported with other THS::

Severe allergic reaction causing facial or throat swelling (angioedema), anaphylactic/anaphylactoid reactions (severe allergic reaction causing difficulty breathing or dizziness), glucose intolerance, depression, mood disturbances, irritability, exacerbation of chorea (Saint Vitus' dance), exacerbation of epilepsy, dementia, exacerbation of asthma, gallbladder disease, yellowing of the skin (jaundice), pancreatitis, benign neoplasia of the uterine smooth muscle, various skin disorders: skin discoloration, especially on the face or neck, known as "pregnancy mask" (melasma); red and painful skin nodules (erythema nodosum); rash with redness in the shape of a target or blisters (erythema multiforme), hemorrhagic rash, hair loss, joint pain, nipple discharge, breast lumps, enlargement of benign neoplasia of the uterine smooth muscle, changes in cervical mucus and lining, vaginal inflammation, vaginal fungal infections (candidiasis), abnormally low calcium levels in the blood.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for 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.

Do not use this medication after the expiration date that appears on the box and on the label after CAD. The expiration date is the last day of the month indicated.

Use within 56 days after the first use.

Do not refrigerate or freeze this medication.

Do not store at a temperature above 25 °C.

This product contains ethanol, which is flammable. Store away from heaters, open flames, and other ignition sources.

Medications should not be disposed of through drains or in the trash. Deposit containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition ofLenzetto

• The active principle is estradiol (as estradiol hemihydrate).Each spray contains 1.53 mg of estradiol(equivalent to 1.58 mg of estradiol hemihydrate).
• The other components are octisalate and 96% ethanol.

Appearance of the product and contents of the packaging

Lenzetto is a transdermal aerosol containing a solution of estradiol and octisalate in ethanol. Equipped with a dosing pump.

Lenzetto is presented in a plastic cap container. Inside, there is a glass container containing 6.5 ml of solution and designed to supply 56 sprays of 90 microliters after priming the dosing pump. Mark each spray made on the box chart.

Each spray contains 1.53 mg of estradiol.

Use only the number of sprays indicated on the label of each Lenzetto container, even if the container is not completely empty.

Packaging sizes:

1 container of 6.5 ml (56 sprays).

3 containers 3 x 6.5 ml (3 x 56 sprays).

Only some packaging sizes may be marketed.

Marketing authorization holder

Gedeon Richter Plc.

Gyömroi út 19-21.

1103 Budapest

Hungary

Responsible for manufacturing

Gedeon Richter România S.A.

Cuza Voda Street 99-105

Târgu-Mures

Romania - 540306

or

Gedeon Richter Plc.

Gyömroi út 19-21.

1103 Budapest

Hungary

For further information about this medicine, please contact the local representative of the marketing authorization holder:

Gedeon Richter Ibérica S.A.

Sabino Arana nº 28, 4º 2ª

08028 Barcelona, Spain

Last review date of this leaflet:January 2024

For detailed and updated information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/