Leaflet: information for the user

Dexamethasone TAD 4 mg tablets

Dexamethasone TAD 8 mg tablets

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

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

Dexametasona TAD is a synthetic glucocorticoid. Glucocorticoids are hormones produced by the cortex of the adrenal glands. This medication has anti-inflammatory, analgesic, and antiallergic effects, and suppresses the immune system.

Dexametasona TAD is recommended for the treatment of rheumatic and autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, juvenile idiopathic arthritis, polyarteritis nodosa), respiratory tract disorders (e.g., bronchial asthma, croup), skin disorders (e.g., erythrodermia, pemphigus vulgaris), tuberculous meningitis only in combination with anti-infective treatment, blood disorders (e.g., idiopathic thrombocytopenic purpura in adults), cerebral edema, symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin's disease, and non-Hodgkin lymphoma in combination with other medications, palliative treatment of neoplastic diseases, prophylaxis and treatment of nausea and vomiting caused by chemotherapy, and prevention and treatment of vomiting after surgery, as part of antiemetic treatment.

Dexametasona TAD 4 mg tablets

Dexametasona TAD is used for the treatment of coronavirus disease 2019 (COVID-19) in adult and adolescent patients (at least 12 years of age with a body weight of at least 40 kg) with difficulty breathing and requiring supplemental oxygen therapy.

Do not takeDexamethasone TAD:

• if you are allergic to dexamethasone or any of the other components of this medication (listed in section 6).
• if you have a whole-body infection (unless you are receiving treatment).
• if you have a stomach or duodenal ulcer.
• if you are to be vaccinated with live vaccines

Warnings and precautions

If you are being treated for COVID-19, do not stop taking any other steroid medication unless your doctor tells you to.

Consult your doctor, pharmacist, or nurse before starting to take Dexamethasone TAD:

• if you have ever had a severe depression or manic depression (bipolar disorder). This includes having had depression before or while taking steroid medications like dexamethasone.
• if a close relative has suffered from this condition.

Problems with your mind may occur while you are taking steroids like Dexamethasone TAD:

• These conditions can be serious.
• They usually start a few days or weeks after starting treatment.
• It is more likely to happen at high doses.
• Most of these problems go away if you lower the dose or stop treatment. However, if problems occur, you may need treatment.

Consult your doctor if you (or someone taking this medication), show any signs of mental problems.

This is especially important if you are depressed, or you might be thinking about suicide. In a few cases, mental problems have occurred when doses were reduced or stopped.

Consult your doctor before starting to take this medication:

• if you have kidney or liver problems (cirrhosis hepática or severe renal failure),
• if you have or suspect you have pheochromocytoma (a tumor of the adrenal glands).
• if you have high blood pressure, heart problems, or if you have recently had a heart attack (myocardial rupture),
• if you have diabetes or a family history of diabetes,
• if you have osteoporosis (bone weakening), particularly if you are a woman who has gone through menopause,
• if you have muscle weakness with this or other steroids in the past,
• if you have glaucoma (elevated intraocular pressure) or a family history of glaucoma, cataracts (opacity of the crystalline lens of the eye that causes vision loss),
• if you have myasthenia gravis (a disease that causes muscle weakness),
• if you have an intestinal problem or stomach ulcer (peptic),
• if you have psychiatric problems or have had psychiatric disorders that have been worsened by this type of medication,
• if you have epilepsy (a disease in which you have seizures or repeated attacks),
• if you suffer from migraines,
• if you have a less active thyroid gland,
• if you have a parasitic infection,
• if you have tuberculosis, septicemia, or fungal eye infection,
• if you have cerebral malaria,
• if you have herpes (mouth ulcers or genital herpes and simple ocular herpes due to possible corneal perforation),
• if you have asthma,
• if you are being treated for blood vessel obstruction by blood clots (thromboembolism),
• if you have corneal ulcers and corneal damage.

Treatment with this medication may cause a pheochromocytoma crisis, which can be fatal. Pheochromocytoma is a rare tumor of the adrenal glands. The crisis may have the following symptoms: headaches, sweating, palpitations, and hypertension. Contact your doctor immediately if you experience any of these signs.

Treatment with corticosteroids may reduce your body's ability to fight infections. This can lead to infections caused by germs that rarely cause infection in normal circumstances (called opportunistic infections). If you have any type of infection during treatment with this medication, contact your doctor immediately. This is especially important if you notice signs of pneumonia: cough, fever, difficulty breathing, and chest pain. You may also feel confused, especially if you are an elderly patient. You should also inform your doctor if you have had tuberculosis or if you have been in areas where intestinal worm infections are common.

It is essential to avoid contact with someone who has had chickenpox, shingles, or measles while taking this medication. If you believe you have been exposed to any of these diseases, you should consult your doctor immediately. You should also inform your doctor if you have ever had infectious diseases such as measles or chickenpox and if you have been vaccinated.

Contact your doctor if you experience symptoms of tumor lysis syndrome such as muscle cramps, muscle weakness, confusion, vision loss or alteration, and difficulty breathing, in the case of a malignant hematological process.

Contact your doctor if you experience blurry vision or other visual disturbances.

Treatment with this medication may cause central serous chorioretinopathy, an eye disorder that causes blurry or distorted vision. This usually occurs in one of the two eyes.

Treatment with this medication may cause tendon inflammation. In extremely rare cases, the tendon may rupture. This risk is increased with certain antibiotics and kidney problems. Contact your doctor if you experience pain, swollen or stiff joints, or tendons.

Treatment with Dexamethasone TAD may cause a condition called adrenal insufficiency. This can cause a change in the effectiveness of the medication after stress and trauma, surgery, childbirth, or illness, and your body may not be able to respond normally to severe stress, such as accidents, surgery, childbirth, or illness.

If you have had an accident, are ill, have any other specific physical stress, or require any surgery (even at the dentist) or are to be vaccinated (particularly with live viral vaccines) while taking or having finished taking dexamethasone, you must inform the person treating you that you are taking or have taken steroids.

If you need to have suppression tests (tests for hormone levels in the body), skin allergy tests, or bacterial infection tests, you must inform the person performing the test that you are taking dexamethasone, as it may interfere with the results.

Your doctor may reduce the amount of salt in your diet and give you some potassium supplements while taking this medication.

If you are an elderly patient, some of the side effects of this medication may be more severe, especially bone thinning (osteoporosis), high blood pressure, low potassium levels, diabetes, and susceptibility to infections and skin thinning. Your doctor will monitor you more closely.

Children

If a child is taking this medication, it is essential that your doctor monitor their growth and development at frequent intervals.Dexamethasone TAD should not be used routinely in premature babies with respiratory problems.

Other medications and Dexamethasone TAD

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

• Anticoagulant medications that thin the blood (e.g., warfarin)
• Acid acetilsalicilic or similar (non-steroidal anti-inflammatory drugs) e.g., indometacina
• Medications used to treat diabetes
• Medications used to treat high blood pressure
• Medications used to treat heart problems
• Diuretics (tablets that promote water elimination)
• Anfotericina B injection
• Fenitoína, carbamazepina, primidona (medications for epilepsy)
• Rifabutina, rifampicina, isoniazida (antibiotics used to treat tuberculosis)
• Anti-acids – particularly those containing trisilicato de magnesio
• Barbiturates (medications used to help sleep and alleviate anxiety)
• Aminoglutetimida (cancer treatment)
• Carbenoxolona (used in stomach ulcer treatment)
• Efedrina (nasal decongestant)
• Acetazolamida (used for glaucoma and epilepsy)
• Hidrocortisona, cortisona, and other corticosteroids
• Ketoconazol, itraconazol (for fungal infections)
• Ritonavir (for HIV)
• Antibiotics including eritromicina, fluoroquinolonas
• Medications that help muscle movement in patients with myasthenia gravis (e.g., neostigmina)
• Colestiramina (for high cholesterol levels)
• Hormones estrógenos including birth control pills
• Tetracosactida used in adrenal function tests
• Sultoprida used to calm emotions
• Ciclosporina used to prevent transplant rejection
• Talidomida used e.g., for multiple myeloma
• Praziquantel administered for certain intestinal worm infections
• Vaccination with live vaccines
• Cloroquina, hidroxicloroquina, and mefloquina (for malaria)
• Somatotropina
• Protirelina

Inform your doctor if you are taking or have taken recently other medications, even those purchased without a prescription. You may have an increased risk of severe side effects if you take dexamethasone with these medications

• Some medications may increase the effects of Dexamethasone TAD and your doctor may want to monitor you closely if you are taking these medications (including some HIV medications: ritonavir, cobicistat).
• Acid acetilsalicilic or similar (non-steroidal anti-inflammatory drugs) e.g., indometacina
• Medications used to treat diabetes
• Medications used to treat heart problems
• Diuretics (tablets that promote water elimination)
• Anfotericina B injections
• Acetazolamida (used for glaucoma and epilepsy)
• Tetracosactida used in adrenal function tests
• Carbenoxolona (used in stomach ulcer treatment)
• Cloroquina, hidroxicloroquina, and mefloquina (for malaria)
• Medications used to treat high blood pressure
• Talidomida used e.g., for multiple myeloma
• Vaccination with live vaccines
• Medications that help muscle movement in myasthenia gravis (e.g., neostigmina)
• Antibiotics including fluoroquinolonas.

You should read the prospectus of all medications you take with Dexamethasone TAD, regarding the information of these medications before starting treatment with Dexamethasone TAD. When using talidomida, lenalidomida, or pomalidomida, special attention should be paid to pregnancy tests and prevention needs.

Dexamethasone TAD with food, drinks, and alcohol

Dexamethasone should be taken with or after meals to minimize gastrointestinal irritation. Avoid drinks containing alcohol or caffeine. It is recommended to eat small, frequent meals, and the possibility of taking anti-acids, if recommended by your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Dexamethasone TAD should only be prescribed during pregnancy and particularly in the first trimester, if the benefits outweigh the risks for the mother and the baby. If you become pregnant while taking the medication, do not stop taking Dexamethasone TAD, but inform your doctor immediately that you are pregnant. Corticosteroids can pass into breast milk. It cannot be ruled out that there is a risk in newborns/babies. The decision to continue or discontinue breastfeeding or continue or discontinue dexamethasone treatment should be made considering the benefit of breastfeeding for the child and the benefit of dexamethasone treatment for the woman.

Driving and operating machines

Do not drive, use tools or machines, or perform any hazardous tasks if you experience side effects such as confusion, hallucinations, dizziness, fatigue, sleepiness, fainting, or blurry vision.

Dexamethasone TAD contains lactose

This medication contains lactose. If your doctor has told you that you are intolerant to certain sugars, consult with him before taking this medication.

Take Dexametasona TAD only as directed by your doctor. Your doctor will tell you how long you should take dexametasona. If you are unsure, consult your doctor or pharmacist again.

Dexametasona TAD is available in the form of 4 mg, 8 mg, 20 mg, and 40 mg tablets. The tablet can be divided into equal halves and provide additional doses of 2 mg and 10 mg or to facilitate swallowing.

Dexametasona is usually taken at doses of 0.5 to 10 mg per day, depending on the disease being treated.

In more severe diseases, doses above 10 mg per day may be required.The dose should be adjusted according to the individual patient's response and the severity of the disease. To minimize adverse effects, the lowest effective dose should be used.

Unless otherwise indicated, the following dose recommendations apply:

The dose recommendations mentioned below are for guidance only. The initial and daily doses should always be determined based on the individual patient's response and the severity of the disease.

• Cerebral edema:The initial dose and duration of treatment depend on the cause and severity, 6-16 mg (up to 24 mg)/day administered orally, divided into 3-4 individual doses.
• Asthma:Adults: 16 mg/day for 2 days. Children: 0.6 mg/kg body weight for 1 or 2 days.
• Croup:Children: 0.15 mg/kg-0.6 mg/kg in a single dose.
• Acute skin diseases:Depending on the nature and severity of the disease, daily doses of 8-40 mg, in some cases up to 100 mg, followed by a titration to the lowest clinical needs.
• Active phase of systemic rheumatic diseases:Lupus erythematosus systemic 6-16 mg/day.
• Severe progressive rheumatoid arthritis:If it is accompanied by rapid destructive forms, 12-16 mg/day, with extra-articular manifestations 6-12 mg/day.
• Idiopathic thrombocytopenic purpura:40 mg for 4 days in cycles.
• Tuberculous meningitis:Patients with grade II or III disease receive intravenous treatment for four weeks (0.4 mg/kg/day for week 1, 0.3 mg/kg/day for week 2, 0.2 mg/kg/day for week 3, and 0.1 mg/kg/day for week 4) and then oral treatment for four weeks, starting with a total dose of 4 mg/day and decreasing 1 mg each week. Patients with grade I disease are treated with intravenous treatment for two weeks (0.3 mg/kg/day for week 1 and 0.2 mg/kg/day for week 2) and then four weeks of oral treatment (0.1 mg/kg/day for 3 weeks, then a total of 3 mg/day, decreasing 1 mg each week).
• Palliative treatment of neoplastic diseases:The initial dose and duration of treatment depend on the cause and severity, 3-20 mg/day. High doses of up to 96 mg may also be used for palliative treatment. To optimize dosing and reduce the number of tablets, combinations of lower doses (4 and 8 mg) and higher doses (20 mg or 40 mg) can be used.
• Prevention and treatment of chemotherapy-induced emesis, chemotherapy-induced emesis with antiemetic treatment:8-20 mg of dexametasona before chemotherapy, then 4-16 mg/day on days 2 and 3.
• Prevention and treatment of postoperative vomiting, within antiemetic treatment:A single dose of 8 mg before surgery.
• Treatment of multiple myeloma, acute lymphoblastic leukemia, Hodgkin's disease, and non-Hodgkin's lymphoma in combination with other medications:The usual dosage is 40 mg or 20 mg once a day.

The dose and frequency of administration vary according to the therapeutic protocol and associated treatment(s). Dexametasona administration should follow the instructions for dexametasona administration as described in the technical data sheet of the associated treatments. If this is not the case, local or international treatment protocols and guidelines should be followed. Prescribing physicians should carefully evaluate what dose of dexametasona should be used, taking into account the patient's situation and disease status.

Long-term treatment

For long-term treatment of various diseases, after initial therapy, treatment with glucocorticoids should be changed from dexametasona to prednisona/prednisolona to reduce adrenal cortex function suppression.

Dexametasona 4 mg tablets

• Treatment of COVID-19:In adult patients, it is recommended to administer 6 mg once a day for a maximum of 10 days.

Use in adolescents: It is recommended to administer to pediatric patients (adolescents of at least 12 years of age and 40 kg body weight) a dose of 6 mg once a day for a maximum of 10 days.

Use in children

If a child is taking this medication, it is essential that the doctor monitor their growth and development at frequent intervals.

If you take more Dexametasona TAD than you should

If you take too much medication, contact your doctor or hospital immediately.

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 ingested.

If you forget to take Dexametasona TAD

If you forget to take a dose, take it as soon as you remember, unless it is almost time for the next dose.

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

If you interrupt treatment with Dexametasona TAD

If your treatment is to be interrupted, you should follow your doctor's recommendations. They may recommend that you gradually reduce the amount of medication you are taking until you stop taking it completely. Different symptoms have been reported when treatment is stopped too quickly, such as low blood pressure and, in some cases, relapse of the disease for which you took the treatment.

You may also experience a "withdrawal syndrome" that includes fever, muscle pain, and joint pain, inflammation of the nasal mucosa (rhinitis), weight loss, itching skin, and eye inflammation (conjunctivitis). If you stop treatment too soon and any of the mentioned symptoms appear, you should consult your doctor as soon as possible.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Consult your doctor immediately if you experience severe mental problems. These can affect 5 out of 100 people who take medicines like dexamethasone. These problems include:

• Feeling depressed, including suicidal thoughts,
• Feeling extremely euphoric (manic) or experiencing mood swings,
• Feeling anxious, having trouble sleeping, difficulty thinking or being confused, and memory loss,
• Feeling, seeing, or hearing things that do not exist. Having strange or terrifying thoughts, changing your behavior, or feeling lonely.

Consult your doctor immediately if you experience:

• Severe abdominal pain, nausea, vomiting, diarrhea, deep muscle weakness, and fatigue, extremely low blood pressure, weight loss, and fever, as these may be signs of adrenal insufficiency,
• Sudden abdominal pain, sensitivity, nausea, vomiting, fever, and blood in stool, which may be signs of intestinal perforation, especially if you have or have had an intestinal disease.

This medicine may worsen existing heart problems. If you experience shortness of breath or swelling of the ankles, consult your doctor immediately.

Other side effects may be (unknown frequency):

• Increased risk of infections, including viral and fungal infections, for example, cold sores; recurrence of tuberculosis or other infections, for example, eye infections if you have already had them
• Reduction in the number of white blood cells or increase in the number of white blood cells, abnormal coagulation,
• Medication allergy, including potentially fatal allergic reactions (which may appear as skin rash and swelling of the throat and tongue, and in severe cases, difficulty breathing or dizziness)
• Hormonal regulation problems, swelling, and weight gain, moon face (Cushing's syndrome), change in the effectiveness of the endocrine system after stress and trauma, surgery, childbirth, or disease, your body may not be able to respond in the usual way to severe stress, such as accidents, surgery, childbirth, or diseases, delayed growth in children and adolescents, irregular or absent menstrual cycles, excessive hair growth on the body (particularly in women)
• Weight gain, protein loss, and calcium imbalance, increased appetite, electrolyte imbalance, fluid retention in the body, potassium loss that can cause arrhythmias, increased medication requirements for diabetes, unknown diabetes that becomes apparent, high levels of cholesterol and triglycerides in the blood (hypercholesterolemia and hypertriglyceridemia)
• Extreme mood swings, schizophrenia (mental disorder) that may worsen, depression, inability to sleep
• Severe and unusual headache with vision changes due to treatment withdrawal, seizures, and worsening of epilepsy, dizziness
• Increased eye pressure, papilledema, reduction of ocular membranes, increased viral, bacterial, and fungal eye infections, worsening of corneal ulcer symptoms, worsening of existing eye infections, eyeball protrusion, cataracts, blurred vision, visual disturbances, vision loss,
• Heart failure in susceptible individuals, heart muscle rupture after a recent heart attack, cardiac decompensation
• High blood pressure, blood clots: formation of blood clots that may block blood vessels, for example, in legs or lungs (thromboembolic complications)
• Hiccups
• Nausea, vomiting, stomach discomfort, and swollen abdomen, inflammation, and ulcers in the esophagus, peptic ulcers that may rupture and bleed, inflamed pancreas (which may appear as back and abdominal pain), flatulence, esophageal candidiasis
• Delicate skin thinning, unusual skin marks, bruises, redness, and inflammation of the skin, stretch marks, visible inflammation, capillaries, acne, increased sweating, skin rash, swelling, hair loss, unusual fatty deposits, excessive hair growth, fluid retention in the body, capillary weakness that facilitates observed bleeding under the skin (increased capillary fragility), skin irritation around the mouth (perioral dermatitis)
• Weakened bones with an increased risk of fractures (osteoporosis), bone necrosis, tendinitis, tendon rupture, muscle loss, myopathy, muscle weakness, premature closure of bone growth (premature epiphyseal closure)
• Changes in sperm count and movement, impotence
• Reduced reaction to vaccines and skin tests, slow wound healing, discomfort
• A "withdrawal syndrome" may also occur, including fever, muscle and joint pain, inflammation of the nasal mucosa (rhinitis), weight loss, painful skin nodules with itching, and eye inflammation (conjunctivitis)

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 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: https://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 packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special temperature for conservation.

Store in the original packaging to protect it from light and humidity.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Dexamethasone TAD

• The active ingredient is dexamethasone.

Dexametasona TAD 4 mg tablets

• Each tablet contains 4 mg of dexamethasone.

Dexametasona TAD 8 mg tablets

• Each tablet contains 8 mg of dexamethasone.

• The other components (excipients) are lactose monohydrate, maize starch pregelatinised, anhydrous colloidal silica and magnesium stearate (E470b). See section 2 “Dexametasona TAD contains lactose”

Appearance of the product and contents of the pack

4 mg tablets: white or almost white, round tablets with bevelled edges and scored on one face (Thickness: 2.5-3.5 mm; Diameter 5.7-6.3 mm). The tablet can be divided into equal doses.

8 mg tablets: white or almost white, oval tablets with scored on one face (Thickness: 3.5-5.5 mm; Length 8.7-9.3 mm). The tablet can be divided into equal doses.

Dexametasona TAD 4 mg is available in packs containing 10, 20, 28, 30, 50, 56, 60, 100, 10 x 1, 20 x 1, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1 and 100 x 1 tablets, in blisters.

Dexametasona TAD 8 mg is available in packs containing 10, 20, 30, 50, 60, 100, 10 x 1, 20 x 1, 30 x 1, 50 x 1, 60 x 1 and 100 x 1 tablets, in blisters.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Ó

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain,

This medicine is authorised in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Hungary:Dexamethasone Krka 4 mg tabletta / Dexamethasone Krka 8 mg tabletta

Bulgaria:?e??????????????4 mg????????/?e??????????????8 mg????????

Czech Republic:Dexamethasone Krka 4 mg / Dexamethasone Krka 8 mg

Estonia:Dexamethason Krka

Croatia:Dexamethason Krka 4 mg tablete / Dexamethason Krka 8 mg tablete

Latvia:Dexamethason Krka 4 mg tabletes / Dexamethason Krka 8 mg tabletes

Lithuania:Dexamethasone Krka 4 mg tabletes / Dexamethasone Krka 8 mg tabletes

Poland:Dexamethasone Krka

Romania:Dexametazona Krka 4 mg comprimate / Dexametazona Krka 8 mg comprimate

Slovenia:Dexamethason Krka 4 mg tablete / Dexamethason Krka 8 mg tablete

Slovakia:Dexametazon Krka 4 mg tablety / Dexametazon Krka 8 mg tablety

Germany:Dexamethason TAD 4 mg Tabletten / Dexamethason TAD 8 mg Tabletten

Spain:Dexametasona TAD 4 mg comprimidos / Dexametasona TAD 8 mg comprimidos

United Kingdom:Dexamethasone 4 mg tablets / Dexamethasone 8 mg tablets

Portugal:Dexametasona Krka 4 mg comprimidos/ Dexametasona Krka 8 mg comprimidos

Last revision date of this leaflet:July 2021

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