Prospect: information for the user

Climen coated tablets

Valerato de estradiol / acetato de ciproterona

1.What is Climen and for what it is used

2.What you need to know before starting to take Climen

3.How to take Climen

1. Possible adverse effects
2. Storage of Climen
3. Contents of the package and additional information

Climen is indicated for:

• Hormonal replacement therapy (HRT) for:

• Treatment of menopausal symptoms (a time period in which reproductive function and menstruation cease in a woman), natural or surgically induced, e.g. hot flashes, nocturnal sweating, urogenital disorders (atrophic vulvovaginitis), depressive mood.

• Prevention of osteoporosis (bone mass loss) if you have a high risk of future fractures and cannot use other medications for this purpose. Consult with your doctor about all available treatment options.

Climen should not be used to prevent heart disease or to improve intellectual capacity.

Climen is not a contraceptive, nor does it restore fertility.

Follow carefully all the instructions given by your doctor.

Read the following information before using Climen.

Medical history and regular check-ups

The use of THS involves risks that must be taken into account when deciding whether to start or continue treatment.

The experience in treating women with premature menopause (due to ovarian insufficiency or surgical intervention) is limited. If you have premature menopause, the risks of using THS may be different. 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 Climen treatment, you must visit your doctor for regular check-ups (at least once a year). In these controls, discuss with your doctor the benefits and risks of continuing with Climen.

You should have regular breast examinations, as recommended by your doctor.

Do not take Climen

if any of the following conditions affect you. If you are unsure about any of the following points, consult your doctor before taking Climen. Do not take Climen:

• If you have or have hadbreast canceror if you suspect you may have it.
• If you havepremalignant lesionsknown or suspected to be influenced by sex hormones or hormone-dependent tumors.
• If you have acancer that depends on the action of estrogens, such as endometrial cancer, or if you suspect you may have it.
• If you have meningioma or have been diagnosed with meningioma (a generally benign tumor of the tissue layer located between the brain and the skull) at any time.
• If you are pregnant or suspect you may be pregnant or if you are breastfeeding.

• If you haveabnormal vaginal bleeding.

• If you haveexcessive thickening of the inner wall of the uterus(endometrial hyperplasia)and are not being treated.

• If you have or have hada blood clot in a vein(thrombosis), e.g. in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism).
• If you have a high risk of developing thrombosis arterial or venous (blood clot).

• If you have anyalteration that affects blood coagulation(such as protein C deficiency, protein S deficiency or antithrombin deficiency).

• If you have or have had recently a disease caused by blood clots in the arteries, such asheart attack, stroke or angina pectoris.

• If you have or have hadliver disease, and your liver function tests have not returned to normal.
• If you have a rare blood disorder called “porphyria” that is inherited.

• If you areallergic to estradiol valerate, ciproterone acetateor to any of the other components of this medication (including those listed in section 6).

If any of these diseases occur for the first time while taking Climen, discontinue treatment and consult your doctor immediately.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Climen.

Visit your doctor regularly and at least once a year. Discuss with your doctor in each visit about the need to adjust or continue treatment. Your doctor will check if you have a high risk of developing thrombosis due to a combination of risk factors or a very high risk factor. If the risk is too high, your doctor will not prescribe THS.

For the treatment of climacteric symptoms, THS should only be initiated when symptoms affect the quality of life of the woman. In all cases, a careful evaluation of the risks and benefits should be performed at least annually, and THS should only be continued while the benefits outweigh the risks. The administration of the lowest dose and the shortest duration of treatment should always be considered.

A higher risk of a benign brain tumor (meningioma) has been reported with high doses (25 mg and above) of ciproterone acetate. If you are diagnosed with meningioma, your doctor will discontinue treatment with all medications containing ciproterone, including Climen, as a precaution (see section “Do not take Climen”).

Be especially careful with Climen:

Before starting treatment, inform your doctor if you have ever had any of the following problems, as they may recur or worsen during Climen treatment. If so, you should visit your doctor more frequently for check-ups:

• Any type of gynecological disorders, such as irregular, frequent, or persistent uterine bleeding, fibroids (a type of uterine tumor), endometriosis (the appearance of tissue from a part of the uterus called endometrium outside its usual location) or a history of endometrial hyperplasia (excessive thickening of the inner wall of the uterus).
• Increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)”).
• Increased risk of developing a cancer that depends on the action of estrogens (e.g., having a mother, sister, or grandmother who has had breast cancer).
• Changes or alterations in the breasts.

• High levels of certain fats (triglycerides) in the blood or a family history of this alteration due to the risk of developing pancreatitis (inflammation of the pancreas).

• High blood pressure.

• Liver disorders, such as a benign liver tumor.

• Diabetes.

• Galstones in the gallbladder.

• Migraines or severe headaches.

• A disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE).

• Epilepsy.

• Multiple sclerosis (a disease of the nervous system).

• Asthma.

• A disease that affects the eardrum and ear (otosclerosis).

• Fluid retention due to heart or kidney problems
• Minor chorea (a disease of the nervous system).
• Hereditary and acquired angioedema.

Stop taking Climen and see your doctor immediately

If you notice any of the following disorders while taking THS:

• Any of the disorders mentioned in the section “Do not take Climen”,
• Yellowing of the skin or the white of the eyes (jaundice).This may be a sign 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 blood pressure (symptoms may be headache, fatigue, dizziness),
• Migraine-like headaches that appear for the first time,
• If you become pregnant,
• If you notice signs of a blood clot, such as
• • Swollen and painful legs
  • Sudden chest pain
  • Difficulty breathing

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

Note: Climen is not a contraceptive.If you have had less than 12 months since your last menstrual period or if you are under 50 years old, you may still need to use an additional contraceptive method to prevent pregnancy. Ask your doctor.

Be especially careful not to exceed the recommended doses.

During treatment with THS, some serious diseases may appear more frequently, such as blood clots (thrombosis) and certain types of tumors.

THS and cancer

Endometrial hyperplasia and endometrial cancer

THS with estrogen alone increases the risk of endometrial hyperplasia and endometrial cancer.

The progestin in Climen protects against this increased risk.

In women with an intact uterus who are not using THS, a mean of 5 out of every 1,000 women, aged 50-65 years, will be diagnosed with endometrial cancer in a 5-year period.

In women with an intact uterus who use THS with estrogen alone, a mean of 10 to 60 out of every 1,000 women, aged 50-65 years, will be diagnosed with endometrial cancer (i.e., between 5 and 55 additional cases), depending on the dose and duration of treatment.

Unexpected bleeding

You will have menstrual bleeding once a month (also called bleeding of deprivation) while taking Climen. However, if you have irregular bleeding or spotting in addition to your menstrual period, which:

• Continues for longer than the first 6 months;
• Starts after taking Climen for more than 6 months;
• Continues after stopping treatment with Climen;

Consult your doctor as soon as possible.

Breast cancer

The available data show that the use of hormone replacement therapy (HRT) with estrogen-progestin combinations or with estrogen alone increases the risk of breast cancer.The additional risk depends on the duration of HRT use.The additional risk becomes apparent after 3 years of use. After stopping HRT, the additional risk will decrease over time, but the risk may persist for 10 years or more if HRT has been used for more than 5 years.

Your doctor will advise you on how to detect abnormalities in your breasts and will perform regular check-ups throughout treatment.

Comparison

In women aged 50-54 years who are not using HRT, a mean of 13 to 17 out of every 1,000 women will be diagnosed with breast cancer in a 5-year period.

In women aged 50 years who initiate HRT with estrogen alone for 5 years, there will be 16 to 17 cases per 1,000 users (i.e., between 0 and 3 additional cases).

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

In women aged 50-59 years who are not using HRT, a mean of 27 cases of breast cancer per 1,000 women will be diagnosed in a 10-year period.

In women aged 50 years who initiate HRT with estrogen alone for more than 10 years, there will be 34 cases per 1,000 users (i.e., 7 additional cases).

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

Check your breasts regularly. Consult your doctor if you detect any changes such as:

• Moles on the skin
• Changes in the nipple
• Any lump that you can see or feel

Additionally, it is recommended that you join breast cancer screening programs when offered. For breast cancer screening, it is essential to inform the nurse/healthcare professional who performs the radiography that you are a HRT user, as these medications can increase breast density, which can affect the results of the mammography. When breast density is increased, the mammography may not detect all lumps.

Ovarian cancer

Ovarian cancer occurs less frequently than breast cancer. The use of HRT with estrogen alone or with estrogen-progestin combinations 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 years who are not using HRT, approximately 2 cases of ovarian cancer per 2,000 women will be observed in a 5-year period. In women in treatment with HRT for 5 years, approximately 3 cases per 2,000 patients (i.e., approximately 1 additional case) will be observed.

Effects 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 compared to non-users, especially during the first year of use. The risk of thrombosis also increases with age.

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

You are more likely to have a blood clot in a vein with age and if any of the following conditions affect you. Inform your doctor if any of these situations affect you:

• You cannot walk for a prolonged period due to a major surgery, injury, or illness (see also section 3, If you need to undergo a surgical procedure)
• 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
• One of your close relatives has had a blood clot in a vein, lung, or any other organ
• You have systemic lupus erythematosus (SLE)
• You have cancer.

For the symptoms of a blood clot, see “Stop taking Climen and see your doctor immediately”.

Comparison

In women aged 50-54 years who are not using HRT, a mean of 4 to 7 out of every 1,000 will have a blood clot in a vein in a 5-year period.

In women aged 50-54 years who have been taking HRT with estrogen-progestin for more than 5 years, there will be 9 to 12 cases per 1,000 users (i.e., 5 additional cases).

Arterial thromboembolism

In large clinical trials with estrogen conjugates and medroxyprogesterone acetate (MPA) combinations, a possible increase in cardiovascular pathology was observed in the first year of use and an increase in the risk of stroke. It is unknown whether these findings can be extended to other HRT products that contain different estrogens and progestins, such as Climen.

Coronary heart disease (heart attack)

HRT does not prevent heart attacks.You should not use HRT to prevent cardiovascular diseases.

Women over 60 years old who are HRT users are slightly more likely to develop cardiovascular disease than those who do not use HRT.

Stroke

The risk of stroke is approximately 1.5 times higher in HRT users compared to non-users. The number of additional stroke cases due to HRT increases with age.

Comparison

In women aged 50-54 years who are not using HRT, a mean of 8 out of every 1,000 will have a stroke in a 5-year period. For women aged 50-54 years who are taking HRT, there will be 11 cases per 1,000 users in a 5-year period (i.e., 3 additional cases).

Dementia

There is limited evidence from clinical studies that HRT may increase the risk of significant cognitive impairment, such as memory loss (dementia), if treatment is initiated at 65 years or older.The risk may decrease if treatment is initiated in early menopause, as observed in other studies. It is unknown whether these findings can be extended to other HRT products.

Other diseases

If you are diabetic, you should be closely monitored while taking HRT, as it may affect carbohydrate metabolism (peripheral resistance to insulin and glucose tolerance).

If you suspect you have a prolactinoma (a non-cancerous tumor that causes an increase in prolactin secretion), it should be ruled out before starting treatment. If you have a prolactinoma, close medical supervision (including regular measurement of prolactin levels) is necessary.

If you develop a melasma (skin discoloration in patches with irregular borders and a dark brown color, which appears mainly on the face) during HRT treatment, especially if you have a history of melasma during pregnancy, you should avoid exposure to the sun or ultraviolet rays while on treatment.

Inform your doctor if you experience any alteration in kidney or heart function. Estrogens can cause fluid retention, and patients with kidney function alterations should be closely monitored.

You should evaluate with your doctor the possible alternative treatments available for your specific situation and how long treatment should be prolonged. This should be reviewed periodically throughout treatment.

If you have a uterine fibroid (a type of uterine tumor), it may increase in size due to the influence of estrogens. In that case, treatment should be suspended.

If you experience the reactivation of endometriosis, it is recommended that you suspend treatment.

Climen is not a contraceptive and should not be used as such; it also does not restore fertility.

To prevent pregnancy, additional contraceptive methods will be used when necessary, using non-hormonal methods (except for the rhythm and temperature methods). If there are indications of a possible pregnancy, treatment with Climen should be interrupted until it has been confirmed (see section “Pregnancy, lactation, and fertility”).

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. Ask your doctor.

In women with hereditary angioedema (swelling or edema of an allergic type that usually appears on the face), exogenous estrogens such as those in Climen may induce or worsen symptoms.

Additional information for special populations

Children and adolescents

Climen is not indicated for use in children and adolescents.

Geriatric population

There are no data to suggest a need for dose adjustment in elderly patients.

Patients with liver disease

Climen has not been specifically studied in patients with liver disease. Climen is contraindicated in women with severe liver disease (see section “Do not take Climen”).

Patients with renal disease

Climen has not been specifically studied in patients with renal disease.

Use of Climen with other medications

Inform your doctor or pharmacist if you are taking,have takenrecentlyor may need to take any other medication,including those purchased without a prescription,herbal remedies, or other natural products.

Certain medications may interact with the effect of Climen. This may cause irregular bleeding. In these cases, it may be necessary to change the dose or discontinue treatment with one of the medications. This applies to the following medications:

• Antiepileptic medications (e.g., barbiturates, phenytoin, primidone, carbamazepine) and possibly, oxcarbazepine, topiramate, and felbamate)
• Medications for tuberculosis treatment (e.g., rifampicin and rifabutin)
• Medications for HIV and hepatitis C infection (the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors) (e.g., nevirapine, efavirenz, ritonavir, nelfinavir)
• Herbal remedies containingSt. John's Wort(Hypericum perforatum). The effect of these herbal remedies remains for up to two weeks after stopping them.
• Medications for fungal infections (e.g., griseofulvin, fluconazole, itraconazole, ketoconazole, and voriconazole)
• Medications for bacterial infections (e.g., clarithromycin and erythromycin)
• Medications for certain heart diseases, high blood pressure (e.g., verapamil and diltiazem)
• Orange juice

HRT may affect the functioning of other medications:

• A medication for epilepsy (lamotrigine), as it 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 AHC with ethinyl estradiol. Climen contains estradiol instead of ethinyl estradiol. It is unknown whether an increase in ALT levels can occur when Climen is used with this HCV combination regimen.

There are substances (e.g., paracetamol) that may increase the circulating levels of estradiol in the blood and, therefore, may increase its effect.

In individual cases, the requirements for oral antidiabetic medications or insulin may vary due to the effects on glucose tolerance.

The simultaneous administration of Climen and cyclosporine may increase the circulating levels of cyclosporine, creatinine, and transaminases, through a mechanism of decreased hepatic elimination of cyclosporine.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Your doctor will advise you accordingly.

Laboratory tests

If you need a blood test, inform your doctoror the laboratory personnelthat you are taking Climen, as it may alter the results of certain tests or laboratory analyses.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or have plans to become pregnant, consult your doctor or pharmacist before using this medication.

Climen is only indicated for use in postmenopausal women.Do not use Climen if you are pregnant or plan to become pregnant..If pregnancy occurs during treatment with Climen, treatment should be discontinued immediately.

Do not use Climen if you are breastfeeding. Small amounts of sex hormones may be excreted in human milk.

Driving and operating machinery

No effects on the ability to drive and operate machinery have been observed in users of Climen.

Climen contains lactose and sucrose

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Remember to take your medication.

• Adult women, including those of advanced age

If you still have menstrual cycles, treatment should start on the fifth day of the cycle (first day of menstrual bleeding = first day of the cycle).

If you have amenorrhea (lack of menstruation) or very infrequent periods or are postmenopausal, you can start treatment at any time, once a previous pregnancy has been ruled out.

Dosage

Take one white tablet once a day for the first 11 days, followed by one pink tablet once a day for 10 days. After these 21 days of treatment, there will be a 7-day interval without taking tablets.

Administration

Each package allows for 21 days of treatment. After the 7-day interval without medication, you should start a new package of Climen on the same day of the week that you started with the previous one. The tablets should be taken without chewing, with some liquid.

To help you follow the taking order, 7 adhesive strips with the 7 days of the week are provided.

Choose the adhesive strip of the week that starts with the day you take the first tablet. For example, if you take your first tablet on a Wednesday, use the adhesive strip that starts with “WED”.

Stick the adhesive strip of the week on the top of the Climen blister, where it is indicated “Put the adhesive strip here”, so that the first day is placed above the tablet marked with the word “Start”. Now you will have a day marked above each tablet and you will be able to check visually if you have taken the tablet on a given day.

Take one tablet each day, following the direction of the arrows, until you finish the 21 tablets in the blister. In this way, you will take a white tablet daily for the first 11 days and, subsequently, a pink tablet daily for the next 10 days.

It is indifferent what time of day you take the tablet, but once you have selected a specific time, you must maintain it every day.

During the 7-day interval without taking tablets, bleeding usually appears a few days after stopping the last tablet.

For both the start and continuation of treatment for climacteric symptoms, you should use the minimum effective dose in all cases during the treatment period, as short as possible.

If you estimate that the action of Climen is too strong or too weak, inform your doctor or pharmacist.

Your doctor will indicate the duration of your treatment with Climen. Do not suspend treatment beforehand, as it may not have the desired effect.

If you take more Climen than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service. Telephone 915 620 420, indicating the medication and the amount used.

Overdose may cause nausea, vomiting, and irregular bleeding. No specific treatment is required, but you should consult your doctor if you are concerned.

If you forgot to take Climen

Do not take a double dose to compensate for the missed doses.

If you have forgotten to take a tablet and less than 24 hours have passed, take the tablet as soon as possible and take the next tablet at your usual time. If more than 24 hours have passed, leave the forgotten tablet in the blister. Continue taking the remaining tablets at your usual time every day. If treatment is suspended for a longer period, irregular bleeding may appear.

If you need surgical intervention

If you are about to undergo surgical intervention, inform the surgeon that you are taking Climen. You may need to interrupt treatment with Climen for 4 to 6 weeks before the intervention to reduce the risk of blood clot formation (see also section 2 “Blood clots in a vein”). Ask your doctor when you can resume treatment with Climen.

If you have any other doubts 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 occur more frequently in women who use THS compared to women who do not take THS:

• breast cancer
• abnormal growth or cancer of the inner wall of the uterus (endometrial hyperplasia or cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism)
• coronary disease
• stroke
• probable memory loss if THS has been initiated after the age of 65.

For more information about these side effects, see section 2

In addition to the side effects listed in the section "Be careful with Climen", the following possible side effects, according to the part of the body affected and their frequency of occurrence, have been reported in users of different oral preparations of THS:

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

• Weight gain, weight loss.
• Headache.
• Abdominal pain, nausea.
• Skin rash, pruritus.
• Vaginal bleeding including spotting.

• Rare side effects(may affect up to 1 in 100 users):

• Allergic reaction.
• Depressive mood.
• Dizziness.
• Visual disturbances.
• Palpitations.
• Indigestion (difficult digestion).
• Erythema nodosum (a type of skin inflammation with the appearance of nodules on the legs).
• Urticaria (pruritus).
• Mastalgia, breast tension.
• Edema (fluid retention).

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

• Anxiety, increased libido (sex drive), decreased libido.
• Migraine.
• Intolerance to contact lenses.
• Swelling, vomiting.
• Hirsutism (excessive hair growth), acne.
• Muscle cramps.
• Dysmenorrhea (painful menstruation), vaginal discharge, premenstrual syndrome-like syndrome, breast enlargement.
• Fatigue.

In women with hereditary angioedema (allergic type swelling or edema that usually appears on the face), exogenous estrogens such as those contained in Climen may induce or worsen symptoms (see "Be careful with Climen").

The following side effects have been reported in relation to other medications used in THS:

• Estrogen-dependent neoplasms, benign or malignant, e.g. endometrial cancer.
• Venous thromboembolism, e.g. deep vein thrombosis in legs or pelvis and pulmonary thromboembolism, worsening of varicose veins, hypertension (see sections "Do not take Climen" and "Be careful with Climen").
• Myocardial infarction.
• Stroke.
• Subcutaneous and skin alterations:
• skin discoloration, especially on the face or neck, known as "pregnancy spots" (chloasma) (skin spots),
• skin rash with redness in the form of a target or sores (erythema multiforme) (a type of skin inflammation),
• red, painful nodules on the skin (erythema nodosum),
• vascular purpura (red spots on the skin),
• contact dermatitis, pigment alterations,
• generalized pruritus and
• exanthema (skin rash).
• Biliary vesicle alteration.
• Probable dementia in women over 65 years old (see section "Be careful with Climen").

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

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

No special storage conditions are required.

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

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

Composition of Climen

• The active principles are valerato de estradiol and acetato de ciproterona.

Each white coated tablet contains 2.0 mg of valerato de estradiol.

Each pink coated tablet contains 2.0 mg of valerato de estradiol and 1.0 mg of acetato de ciproterona.

• The other components (excipients) are lactose monohydrate, cornstarch, povidone 25, talc, magnesium stearate, saccharose, povidone 90, macrogol 6.000, calcium carbonate, glycol montanate, glycerol 85% (E-422), titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172).

Appearance of the product and contents of the packaging

Climen is presented as coated tablets in a blister pack. Each blister pack contains 21 tablets (11 white tablets and 10 pink tablets).

Holder of the marketing authorization and responsible for manufacturing

Bayer Hispania, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing

Delpharm Lille SAS

Parc d'Activités Roubaix-Est

22 Rue de Toufflers - CS 50070

59452 Lys-Lez-Lannoy

France

or

Bayer AG

Müllerstraße 178

13353 Berlin

Germany

or

Bayer Weimar GmbH und Co. KG

Döbereinerstraße 20

99427 Weimar

Germany

Last revision date of this leaflet:January 2024

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