Package Insert: Information for the User

Melodene-15 0.06 mg / 0.015 mgCoated Tablets

Gestodeno / Ethinylestradiol

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for 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 package insert. See section 4.

Important things you should know about combined hormonal contraceptives (CHCs):

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

1.What is Melodene-15 and for what it is used

2.What you need to know before starting to take Melodene-15

3.How to take Melodene-15

4.Possible adverse effects

5.Storage of Melodene-15

6.Contents of the package and additional information

Melodene-15 is an oral hormonal contraceptive pill, usedto prevent pregnancy.

• Each of the 24 pale yellow tablets contains a small amount of two different female hormones,calledgestodene and ethinylestradiol.
• The 4 white tablets do not contain active ingredients and are called placebo tablets.
• Contraceptive pills that contain two hormones are called "combined" pills.

General Considerations

Before starting to use Melodene-15, 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 Melodene-15, 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 personal situation, may perform some other tests.

In this prospectus, several situations are described in which you should interrupt the use of Melodene-15, or in which the reliability of Melodene-15 may decrease. In these situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions, for example, use of a condom or other barrier method. Do not use the rhythm or temperature method. These methods may not be reliable because Melodene-15 alters the monthly changes in body temperature and cervical mucus.

Melodene-15, like other hormonal contraceptives, does not protect against HIV (AIDS) or any other sexually transmitted disease.

Do not use Melodene-15

You should not use Melodene-15 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 are allergic to the active principles (gestodeno or ethinylestradiol) or to any of the other components of this medication (including in section 6).

• If you have (or have ever had) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.
• If you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need surgery or if you spend a lot of time without 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, symptoms of a stroke).

• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:

• Diabetes with severe vascular 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 ever had) a heart disease or vascular disease, especially:

• A heart rhythm disorder or a heart valve disorder.
• Disorders of certain heart blood vessels (coronary arteries).

• If you have (or have ever had) a benign tumor (called focal nodular hyperplasia or liver adenoma) or a malignant tumor of the liver, or if you have recently had liver disease. In these cases, your doctor will order you to stop taking the pills until your liver is functioning normally.
• If you have unexplained vaginal bleeding.
• If you have breast cancer or uterine cancer, or any cancer that is sensitive to female sex hormones, or if you suspect that you may have it.

Do not use Melodene-15 if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section “Other Medications and Melodene-15”).

Warnings and Precautions

In some situations, you should be particularly careful while using Melodene-15 or any other combined hormonal contraceptive, and it may be necessary for your doctor to examine you periodically.

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

If the condition develops or worsens while you are using Melodene-15, you should also inform your doctor.

• If any blood test has shown that you have high levels of sugar, high cholesterol, or high prolactin (a hormone that stimulates milk production).
• If you are obese.
• If you have a benign tumor of the breast or if a close relative has ever had breast cancer.
• If you have uterine disease (uterine dystrophy).
• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• If you have sickle cell anemia (a hereditary disorder 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 surgery or spend a lot of time without getting up (see section 2 “Blood Clots”).
• If you are at increased risk of blood clots after giving birth. You should ask your doctor when you can start taking Melodene-15 after childbirth.
• If you have superficial vein inflammation under the skin (thrombophlebitis).
• If you have varicose veins.
• If you or a close relative (parents, grandparents, siblings, etc.) has ever had a condition that tends to produce blood clots (in the leg, lung, or other organs, heart attacks, strokes).
• If you have epilepsy (see also ‘Other Medications and Melodene-15’).
• If you have migraines.
• If you have hearing loss due to a condition called otosclerosis.
• If you have asthma.
• If you have had skin disease that causes itching, red patches, and blisters (herpes gestationis) during pregnancy or while using another contraceptive pill.
• If you have had skin discoloration patches on your face (melasma) during pregnancy or while using another contraceptive pill. In this case, avoid direct sun exposure while taking Melodene-15.
• If you have gallstones.
• If you have heart, liver, or kidney disease.
• If you have depression.
• If you have high blood pressure.
• If you have a condition called chorea, characterized by involuntary, irregular, and sudden movements.
• If you experience symptoms of angioedema such as facial swelling, tongue, and/or throat swelling, 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.

Consult your doctor or pharmacist before starting to take Melodene-15.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Melodene-15 increases your risk of suffering 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 veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• In arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or ATE).

The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.

It is essential to remember that the overall risk of a harmful blood clot due to Melodene-15 is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek immediate medical attentionif 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 veins (venous thromboembolism). However, these adverse effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism (PE).
• In very rare cases, a blood clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).

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

The risk of a blood clot in a vein is higher during the first year in which you take a combined hormonal contraceptive for the first time. The risk may be higher if you restart taking a combined hormonal contraceptive (the same medication or a different medication) after a break 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 Melodene-15, your risk of a blood clot returns to normal in a few weeks.

What is the risk of a blood clot?

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

The overall risk of a blood clot in the leg or lung (DVT or PE) with Melodene-15 is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone, or norgestimato, about 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing gestodeno like Melodene-15, about 9-12 will develop a blood clot in a year.

• The risk of a blood clot will depend on your personal factors (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 Melodene-15 is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index (BMI) of 30 kg/m2 or higher).
• If a close relative has had a blood clot in the leg, lung, or other organs at a young age (before about 50 years). In this case, you may have a hereditary disorder of blood clotting.
• If you need surgery or spend a lot of time without getting up due to an injury or illness, or if you have your leg immobilized. You may need to stop taking Melodene-15 for several weeks before the operation or while you have less mobility. If you need to stop taking Melodene-15, ask your doctor when you can start taking it again.
• As you get older (especially over about 35 years).
• If you have given birth recently.

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

Long flights (over 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 have any of the conditions listed above, even if you are unsure. Your doctor may decide that you need to stop taking Melodene-15.

If any of the conditions listed above change while you are using Melodene-15, for example, a close relative experiences a blood clot without a known cause or you gain a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a blood clot in an artery can cause serious problems. 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 Melodene-15 is very small, but it may increase:

• With age (over about 35 years).
• If you smoke.When using a combined hormonal contraceptive like Melodene-15, you are advised to quit smoking. If you are unable to quit 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 a close relative has had a heart attack or stroke at a young age (before about 50 years). In this case, you may also be at increased risk of a heart attack or stroke.
• If you or a close relative has high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (heart 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 increased even further.

If any of the conditions listed above change while you are using Melodene-15, for example, you start smoking, a close relative experiences a blood clot without a known cause, or you gain a lot of weight, inform your doctor.

Melodene-15 and Cancer

The detection of breast cancer is slightly higher in women who use combined pills, but it is not known whether it is caused by the pill. It is possible that these women are simply being examined more thoroughly and more frequently, or that breast cancer is detected earlier.

Studies indicate cases of cervical cancer in women who use combined pills for a relatively long time. Currently, it is unknown whether it is caused by the pill or if it is related to sexual behavior (e.g., frequent changes of partner) and other factors.

In rare cases, benign liver tumors and, in even fewer cases, malignant liver tumors have been reported in users of the pill. Consult your doctor if you experience unusual abdominal pain.

Mental Health Disorders

Some women who use hormonal contraceptives like Melodene-15 have reported depression or a depressed mood. Depression can be severe and sometimes may induce suicidal thoughts. If you experience mood changes and depressive symptoms, consult your doctor for additional medical advice as soon as possible.

Spotting between periods

During the first few months while you are taking Melodene-15, you may experience unexpected bleeding (bleeding outside of the placebo days). If these bleeding persists beyond a few months or starts after a few months, your doctor should investigate the cause.

What to do if you do not have your period during the placebo days

If you have taken all the active yellowish pills correctly, have not had severe vomiting or diarrhea, and have not taken other medications, it is highly unlikely that you are pregnant.

If your expected period does not come in two consecutive occasions, you may be pregnant. Consult your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Other Medications and Melodene-15

Some medications:

• may affect the blood levels of Melodene-15
• may make itless effective in preventing pregnancy
• may cause unexpected bleeding

These include:

• medications used to treat:

• infections caused by HIV and hepatitis C (called protease inhibitors and non-nucleoside reverse transcriptase inhibitors)
• epilepsy (e.g., phenobarbital, phenytoin, primidone, carbamazepine, topiramate, or felbamate)
• tuberculosis (e.g., rifabutin, rifampicin)
• fungal infections (griseofulvin, azole antifungals, e.g., itraconazole, voriconazole, fluconazole)
• bacterial infections (macrolide antibiotics, e.g., clarithromycin, erythromycin)
• heart disease, high blood pressure (calcium channel blockers, e.g., verapamil, diltiazem)
• arthritis, osteoarthritis (etoricoxib)
• sleep disorders (modafinil)

• the herbal medicine St. John's Wort, used to treat certain types of depression
• grapefruit juice

The troleandomycin may increase the risk of intrahepatic cholestasis (retention of bile in the liver) during administration with combined oral contraceptives (COCs).

Melodene-15 mayinfluence the effectof other medications, e.g.:

• lamotrigine
• ciclosporin
• theophylline
• tizanidine

Do not take Melodene-15 if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increased liver enzyme levels (elevated ALT). Your doctor will prescribe another type of contraceptive before starting treatment with these medications. Melodene-15 can be restarted approximately 2 weeks after completion of this treatment. See the section “Do not use Melodene-15”.

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

Pregnancy

If you are pregnant, there is no reason for your doctor to prescribe contraceptives.

If you discover that you are pregnant while taking Melodene-15, stop taking the pill and consult your doctor.

If you plan to become pregnant, consult your doctor.

Consult your doctor or pharmacist before using any medication.

Lactation

It is not recommended that you use Melodene-15 during lactation.

If you wish to breastfeed, your doctor will recommend the appropriate form of contraception.

Consult your doctor or pharmacist before using any medication.

Melodene-15 contains lactose

If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

Dosage

• Start taking Melodene-15 with the first tablet, located next to the word "INICIO".
• To help you keep track of the dosage, 7 adhesive strips with the 7 days of the week are provided. Choose the strip for 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 strip that starts with “WED”. Attach the strip to the top of the Melodene-15 blister pack, where it says "Attach the strip here!".
• Each blister pack contains 28 tablets. Take one tablet at the same time every day for 28 consecutive days, following the direction indicated by the arrows, without missing one, as follows: take one active yellowish tablet every day for the first 24 days, and then one white placebo tablet every day for the last 4 days.
• After taking the last tablet, continue taking Melodene-15 the next day, starting a new blister pack, without leaving a break between the blister packs. Each blister pack should be started on the same day of the week. Since there is no break in medication, it is essential that you have the next blister pack available before finishing the previous one.
• Menstruation usually starts two or three days after taking the last yellowish tablet from the blister pack, and may not have finished before starting the next blister pack.

Method and route of administration

Swallow each tablet with a large glass of water.

If you have not used any hormonal contraceptives in the previous month

Take the first tablet on the first day of your period.

If you are changing from another hormonal contraceptive

Finish the blister pack you have started (if your current pill pack also contains hormone-free tablets, do not take them). Start the Melodene-15 blister pack the next day, without missing a day.

If you were using a progestin-only method (progestin-only pill, injectable, or implant)

• Changing from a progestin-only pill, you can start Melodene-15 at any time during your menstrual cycle, the day after stopping the progestin-only pill.
• Changing from an implant: start Melodene-15 on the day of the implant removal.
• Changing from an injectable: start Melodene-15 on the day of the next scheduled injection.

In any case, it is necessary to use a barrier method of contraception (e.g., a condom) during the first 7 days of taking the pill.

If you are starting Melodene-15 after a first-trimester abortion

Normally, you can start immediately, but follow your doctor's advice before doing so.

If you are starting Melodene-15 after giving birth or a second-trimester abortion

Like any other hormonal contraceptive, Melodene-15 should not be started before 21-28 days after giving birth or an abortion, due to an increased risk of blood clots. If you start later, it is recommended to use a barrier method of contraception during the first 7 days of taking the pill. If you have had sex before starting Melodene-15, make sure you are not pregnant or wait until your next period.

Always consult your doctor.

Duration of use

Your doctor will tell you for how long you should use this pill.

If you take more Melodene-15 than you should

Overdose may cause gastrointestinal problems (e.g., nausea, vomiting, abdominal pain), breast tenderness, dizziness, drowsiness/fatigue, and menstrual cycle disturbances (vaginal bleeding). This bleeding may occur even in girls who have not yet had their first menstrual period, if they accidentally take this medication.

Consult your doctor. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Melodene-15

If you realize you have forgotten a yellowish tablet within 12 hours of the time you normally take it, take the forgotten tablet immediately and continue normally, taking the next one at the usual time until you finish the blister pack.

If you realize you have forgotten a yellowish tablet more than 12 hours after the time you normally take it, there is a risk of becoming pregnant. In this case:

• Take the last forgotten tablet as soon as possible, even if this means taking 2 tablets on the same day.
• Continue taking the contraceptive until you finish the blister pack.
• Also, use a barrier method of contraception (condom, spermicides, etc.) for the next 7 days.
• If this 7-day period ends after the last yellowish tablet, discard the remaining tablets and start the next blister pack.

If you have forgotten one or more yellowish tablets in a blister pack and do not get the bleeding that should occur when taking the white tablets, you may be pregnant.

If you have forgotten one or more white tablets, you are still protected as long as no more than 4 days pass between the last yellowish tablet of the current blister pack and the first yellowish tablet of the next blister pack. Consult your doctor.

If you experience vomiting or acute diarrhea within 4 hours of taking the pill, a situation similar to forgetting a tablet occurs. After vomiting or diarrhea, you should take another tablet from a spare blister pack as soon as possible. If possible, take itwithin 12 hours of 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 forgot to take Melodene-15”.

If these episodes of vomiting or acute diarrhea recur over several days, you should use a barrier method of contraception (condom, spermicides, etc.) until the start of the next blister pack. Consult your doctor.

Like all medicines, Melodene-15 may cause side effects, although not everyone will experience them. If you experience any side effect, especially if it is severe and persistent, or if you have any health change that you think may be due to Melodene-15, consult your doctor.

All women taking combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section2 “What you need to know before starting to take Melodene-15”.

Severe side effects

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

The most frequently reported side effects (more than 10%) among women using Melodene-15 are the absence or reduced frequency of menstrual periods during use or after stopping, intermenstrual bleeding, or headache including migraine.

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

• vaginal infection including vaginal candidiasis
• mood changes including depression and changes in sexual appetite
• nervousness or dizziness
• nausea, vomiting, or abdominal pain
• acne
• breast pain, tenderness, swelling, or discharge
• menstrual cramps or changes in menstrual flow
• changes in vaginal discharge or cervical changes (ectropion)
• fluid retention in tissues or edema (acute fluid retention)
• weight gain or loss

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

• changes in appetite
• colic or gas
• hives, excessive body hair, hair loss, or facial discoloration (chloasma)
• changes in laboratory test results: increased levels of cholesterol, triglycerides, or blood pressure

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

• allergic reactions (such as rare cases of urticaria or severe respiratory or circulatory disorders)
• glucose intolerance
• contact lens intolerance
• jaundice
• a type of skin reaction called erythema nodosum
• 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.
  • Transient ischemic attack (TIA) or temporary symptoms similar to a stroke.
  • blood clots in the liver, stomach/intestine, kidneys, or eye.

The risk of developing blood clots may be higher if you have any other condition that increases this risk (see section2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

Very rare side effects (may affect up to 1 in 10,000 people):

• focal nodular hyperplasia or benign liver tumor (hepatic adenoma) or malignant liver tumor
• exacerbation of an autoimmune disease (lupus), a liver disease (porphyria), or a disease called chorea characterized by irregular, sudden, and involuntary movements
• certain types of eye disorders such as optic nerve inflammation that may cause partial or total loss of vision, or retinal thrombosis
• pancreatic disorders
• increased risk of gallstones or bile duct obstruction
• liver or bile disorders (such as hepatitis or abnormal liver function)
• blood or urinary disorders (hemolytic-uremic syndrome)
• a certain type of skin reaction called erythema multiforme

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is possible side effects that do not appear in this leaflet. 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 on the safety of this medicine.

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 blister pack after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Melodene-15

Pale yellow tablet:

• The active principles are: 0.06 mg of gestodene and 0.015 mg of ethinylestradiol.
• The other components are: lactose monohydrate, microcrystalline cellulose, magnesium stearate, potassium polacrilinate, OPADRY yellow YS-1-6386-G [hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172)],macrogol 1450, E wax (glicolated montan wax).

White tablet:

• There is no active principle.
• The other components are:lactose monohydrate, microcrystalline cellulose, magnesium stearate, potassium polacrilinate, OPADRY white Y-5-18024-A [hypromellose, hydroxypropylcellulose, titanium dioxide (E 171), macrogol 400], macrogol 1500, E wax (glicolated montan wax).

Appearance of the product and content of the packaging

Melodene-15 is presented in the form of coated tablets.

Each pack contains 1, 3 or 6 blisters, each with 28 tablets (24 active pale yellow tablets and 4 inactive white tablets).

Only some packaging sizes may be commercially available.

Marketing authorization holder

Bayer Hispania, S.L.

Avenida Baix Llobregat, 3 - 5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing

BayerWEIMAR GmbH und Co. KG

Doebereinerstrasse 20

99427 Weimar

Germany

Last review date of this leaflet:10/2022

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