MOXIFLOXACIN KERN PHARMA 400 mg FILM-COATED TABLETS

2. What you need to know before taking Moxifloxacino Kern Pharma

Consult your doctor if you are not sure if you belong to one of the patient groups described below.

Do not take Moxifloxacino Kern Pharma

• If you are allergic (hypersensitive) to moxifloxacino or other quinolones or to any of the other components of this medicine (included in section 6).
• If you are pregnant or breastfeeding.
• If you are under 18 years old.
• If you have a history of tendon disorders or injuries related to treatment with quinolone antibiotics.
• If you have a hereditary heart condition or have suffered from a condition related to an abnormal heart rhythm (observed in an electrocardiogram), suffer from electrolyte imbalances in the blood (especially low potassium or magnesium levels in the blood), have a very slow heart rate (bradycardia), have a weak heart (heart failure), have a history of heart rhythm disorders or are taking other medications that cause ECG disorders (see section Other medicines and Moxifloxacino Kern Pharma). This is because moxifloxacino can cause changes in the ECG, such as a prolongation of the QT interval, i.e., a delay in the conduction of electrical signals in the heart.
• If you have severe liver disease or elevated liver enzyme levels (transaminases) 5 times above the upper limit of normal.

Warnings and precautions

Before starting to take this medicine

You should not take antibacterial medicines that contain fluoroquinolones or quinolones, including moxifloxacino, if you have experienced a severe adverse reaction previously when taking a quinolone or a fluoroquinolone. If this is the case, you should inform your doctor as soon as possible.

Consult your doctor or pharmacist before starting to take Moxifloxacino Kern Pharma.

Consult an ophthalmologist immediately if you experience any vision changes or have any eye problems.

• Moxifloxacino may modify the heart's ECG, especially if you are a woman or an elderly patient. If you are currently taking any medication that lowers potassium levels in the blood, consult your doctor before taking this medicine.
• If you suffer from epilepsyor another condition that may cause seizures, consult your doctor before taking moxifloxacino.
• If you have or have ever had any mental health problems, consult your doctor before taking moxifloxacino.
• If you have myasthenia gravis(abnormal muscle fatigue that causes weakness and severe paralysis), your symptoms may worsen if you take moxifloxacino. If you think this affects you, consult your doctor immediately.
• If you or a family member has glucose-6-phosphate dehydrogenase deficiency(a rare hereditary disease), inform your doctor, who will indicate if this medicine is suitable for you.
• If you have a complicated upper female genital tract infection(associated with an abscess in the fallopian tubes and ovary or pelvis), for which your doctor considers intravenous treatment necessary, moxifloxacino tablets are not appropriate.
• For the treatment of a mild to moderate upper female genital tract infection, your doctor should prescribe another antibiotic along with moxifloxacino. If you do not notice an improvement in symptoms after three days of treatment, consult your doctor.
• If you have been diagnosed with an enlargement or "lump" of a large blood vessel(aortic aneurysm or large peripheral vessel aneurysm).
• If you have suffered a previous episode of aortic dissection(tear in the aortic wall).
• If you have a family history of aortic dissection or aneurysm, congenital heart valve disease, or other risk factors or predisposing disorders (e.g., connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, arterial hypertension, atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• If you are diabetic because you may experience a risk of change in blood sugar levels with moxifloxacino.
• If you have ever developed a severe skin rash or peelingafter taking moxifloxacino.
• If you have been diagnosed with heart valve insufficiency(heart valve regurgitation).

During treatment withthismedicine:

• If you notice palpitations or irregular heartbeatsduring the treatment period, you should inform your doctor immediately. Your doctor may perform an ECG to measure your heart rate.
• The risk of heart problemsmay increase with an increase in dose. Therefore, you should follow the recommended dose.
• In rare cases, you may experience a sudden severe allergic reaction(anaphylactic shock) even with the first dose and develop symptoms such as chest tightness, dizziness, nausea, or fainting, or feel dizzy when standing up. If you experience these symptoms, stop takingthismedicineand consult your doctor immediately.
• Moxifloxacino Kern Pharma may cause rapid and severe liver inflammation, which can lead to life-threatening liver failure (including fatal cases, see section 4 "Possible side effects"). Please consult your doctor before continuing treatment if you develop symptoms such as sudden discomfort and/or discomfort associated with yellowing of the whites of the eyes, dark urine, skin itching, tendency to bleed, or brain disease induced by liver damage (symptoms of reduced liver function or severe liver inflammation).
• The quinolone antibiotics, including moxifloxacino, may cause seizures. If this occurs, treatment with this medicine should be discontinued, and you should contact your doctor immediately.
• Severe, disabling, and potentially irreversible side effects. Antibacterial medicines that contain fluoroquinolones or quinolones, including moxifloxacino, have been associated with very rare but severe side effects, some of which were long-lasting (persistent for months or years), disabling, or potentially irreversible. This includes pain in the tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pinching, tingling, prickling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.
• If you feel a sudden and severe pain in the abdomen, chest, or back, which can be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. The risk may increase if you are receiving systemic corticosteroid treatment.

• If you start to experience sudden shortness of breath, especially when lying down, or if you notice swelling in the ankles, feet, or abdomen, or the appearance of heart palpitations (feeling of rapid or irregular heartbeat), you should inform your doctor immediately.

If you experience any of these side effects after taking moxifloxacino Kern Pharma, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not, also considering the use of an antibiotic of another class.

• In rare cases, you may experience nerve damage symptoms(neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms. If this happens, stop taking moxifloxacino Kern Pharma and inform your doctor immediately to prevent the development of a potentially irreversible disorder.
• You may experience mental health problemseven after the first administration of quinolone antibiotics, including moxifloxacino. In very rare cases, mental health problems and depression have evolved into suicidal thoughts and self-harming behaviors such as suicide attempts (see section 4 "Possible side effects"). If you develop these reactions, you should discontinue treatment with this medicine and inform your doctor immediately.
• You may develop diarrheaduring or after taking antibiotics, including moxifloxacino. If the diarrhea is severe or persistent, or if you notice blood or mucus in the stool, stop taking this medicine immediately and consult your doctor. In these situations, you should not take medications that interrupt or slow down intestinal movement.
• In rare cases, pain and swelling in the joints and inflammation or rupture of the tendonsmay occur. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after discontinuing treatment with moxifloxacino. At the first sign of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking moxifloxacino Kern Pharma, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this could increase the risk of tendon rupture.
• If you feel a strong and sudden pain in the chest, abdomen, or back, go to the emergency room immediately.
• If you are elderly and have kidney problems, be careful to drink enough fluids, as dehydration can increase the risk of kidney failure.
• If your vision worsens or if you have any other eye disordersduring treatment with this medicine, consult an ophthalmologist immediately (see sections 2 "Driving and using machines" and 4 "Possible side effects").
• Fluoroquinolone antibiotics may cause an increase in your blood sugar levelsabove normal levels (hyperglycemia) or a decrease in your blood sugar levelsbelow normal levels (hypoglycemia), which in severe cases can cause loss of consciousness (hypoglycemic coma) (see section 4 "Possible side effects"). If you have diabetes, your blood sugar levels should be carefully monitored.
• Quinolone antibiotics may increase skin sensitivity to sunlight or UV. You should avoid prolonged exposure to sunlight or direct sunlight and should not use sunbeds or any type of UV lamp during treatment with this medicine (see section 4 "Possible side effects").
• The efficacy of moxifloxacino solution for infusion has not been established in the treatment of severe burns, deep tissue infections, and diabetic foot infections with osteomyelitis (bone marrow infections).

Severe skin reactions

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS or drug hypersensitivity syndrome), have been reported with the use of moxifloxacino.

• SSJ/TEN may initially appear on the trunk as reddish targets or circular spots often with central blisters. Ulcers may also appear in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes can progress to widespread skin peeling and life-threatening complications.
• AGEP appears at the start of treatment as a red, scaly, and generalized rash with bumps under the skin and blisters, accompanied by fever. The most common location is mainly localized in skin folds, trunk, and upper limbs.
• Drug reaction with eosinophilia and systemic symptoms (DRESS) initially appears with flu-like symptoms and a rash on the face, later followed by a widespread rash with high body temperature, elevated liver enzyme levels in blood tests, and increased eosinophilia and lymph node enlargement.

If you develop a severe rash or any of these skin symptoms, stop taking moxifloxacino and contact your doctor or seek medical attention immediately.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years old because the efficacy and safety have not been established for this age group (see section Do not take Moxofloxacino Kern Pharma).

Other medicines and Moxifloxacino Kern Pharma

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

With Moxifloxacino Kern Pharma, you should consider the following:

• If you are taking moxifloxacino and other medicines that affect the heart, there is a greater risk of heart rhythm disorders. Therefore, you should not take moxifloxacino at the same time as the following drugs: medicines that belong to the class of antiarrhythmics (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressants, some antimicrobials (e.g., saquinavir, sparfloxacin, erythromycin administered intravenously, pentamidine, antimalarials, particularly halofantrine), some antihistamines (terfenadine, astemizole, mizolastine), and other drugs (e.g., cisapride, intravenous vincamine, bepridil, and difemanil).
• While taking moxifloxacino, you should inform your doctor if you are taking other medicines that lower potassium levels in the blood or cause a decrease in heart rate, as they may increase the risk of severe heart rhythm disorders.
• Any other medicine that contains magnesium or aluminum, such as antacids for indigestion, or any medicine that contains iron or zinc, medicines that contain didanosine, or medicines that contain sucralfate for gastrointestinal disorders may reduce the effect of moxifloxacino tablets. Therefore, take your moxifloxacino tablets 6 hours before or after taking other medicines.
• Taking oral activated charcoal at the same time as moxifloxacino tablets reduces the effect of these tablets. Therefore, it is recommended not to use these medicines simultaneously.
• If you are currently taking oral anticoagulants (e.g., warfarin), your doctor may need to monitor your blood coagulation time.

Using Moxifloxacino Kern Pharma with food and drinks

The effect of this medicine is not altered by food, including dairy products.

Pregnancy, breastfeeding, and fertility

Do not use this medicine during pregnancy or breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Animal studies do not indicate that fertility may be altered by taking this medicine.

Driving and using machines

Moxifloxacino may cause dizziness or vertigo or a brief fainting spell; you may experience a sudden transient loss of vision. If you experience these symptoms, do not drive vehicles or operate machinery.

Moxifloxacino Kern Pharma contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e., it is essentially "sodium-free".

3. How to take Moxifloxacino Kern Pharma

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

The recommended dose in adults is one 400 mg film-coated tablet, once a day.

Moxifloxacino tablets are for oral use. Take the tablet whole without chewing (to mask the bitter taste) and with plenty of liquid. This medication can be taken with or without food. It is recommended that you take the tablet at approximately the same time every day.

No dose adjustment is necessary in elderly patients, in patients with low body weight, or in patients with kidney problems.

The duration of treatment depends on the type of infection. Unless your doctor has indicated otherwise, the duration of treatment with Moxifloxacino Kern Pharma is as follows:

• Sudden worsening of chronic bronchitis (acute exacerbation of chronic obstructive pulmonary disease, including bronchitis): 5-10 days.
• Lung infections (pneumonia) acquired outside the hospital, except in severe cases: 10 days.
• Acute infections of the paranasal sinuses (acute bacterial sinusitis): 7 days.
• Mild or moderate infections of the upper female genital tract (pelvic inflammatory disease), including infection of the fallopian tubes and infection of the uterine mucous membrane: 14 days.

When moxifloxacino is used to complete a treatment started with moxifloxacino solution for infusion, the recommended durations are:

• Community-acquired lung infections (pneumonia): 7-14 days

Most patients with pneumonia switched from intravenous to oral treatment after 4 days.

• Skin and soft tissue infections: 7-21 days

Most patients with skin and soft tissue infections switched from intravenous to oral treatment after 6 days.

It is important to complete the full treatment, even if you start to feel better after a few days.

Do not exceed the recommended dose and duration of treatment.

If you take more Moxifloxacino Kern Pharma than you should

If you take more than one of the recommended tablets per day, consult your doctor immediately and, if possible, take the remaining medication, packaging, or this leaflet and show it to your doctor or pharmacist what you have taken.

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

If you forget to take Moxifloxacino Kern Pharma

In case of forgetting a dose, you should take the tablet as soon as you remember it on the same day. If you do not take your tablet one day, take the normal dose (one tablet) the next day. Do not take two tablets to make up for the forgotten dose.

If you are not sure what to do, consult your doctor or pharmacist.

If you interrupt treatment with Moxifloxacino Kern Pharma

If you interrupt the treatment too early, your infection may not be completely cured, the infection may return, or your condition may worsen, and you may also develop bacterial resistance to the antibiotic. Consult your doctor if you intend to stop taking the tablets before completing the full treatment.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them. During treatment with moxifloxacino, the following side effects have been observed. The assessment of side effects is based on the following frequency data:

Frequent: between 1 and 10 out of 100 patients.

Uncommon: between 1 and 10 out of 1,000 patients

Rare: between 1 and 10 out of 10,000 patients

Very rare: in less than 1 out of 10,000 patients

Not known: cannot be estimated from available data

Infections

Frequent: Infections caused by resistant bacteria or fungi, such as oral and vaginal infections caused by Candida.

Blood and lymphatic system disorders

Uncommon: Low red blood cell count, low white blood cell count, low levels of certain white blood cells (neutrophils), decrease or increase in certain blood cells necessary for blood coagulation, increase in certain white blood cells (eosinophils), decrease in blood coagulation.

Very rare: Increase in blood coagulation, significant decrease in certain white blood cells (agranulocytosis).

Decrease in the number of red and white blood cells and platelets (pancytopenia)

Endocrine disorders

Very rare: Syndrome associated with alterations in water elimination and low sodium levels (SIADH).

Allergic reactions

Uncommon: Allergic reactions.

Rare: Severe, sudden, and generalized allergic reaction, including very rarely life-threatening shock (e.g., difficulty breathing, decreased blood pressure, rapid pulse), swelling (including possible swelling of the airways that can be life-threatening).

Abnormal laboratory test results

Uncommon: Increase in blood lipids (fats)

Rare: Increase in blood glucose, increase in blood uric acid.

Very rare: Loss of consciousness due to a severe decrease in blood sugar levels (hypoglycemic coma)

Psychiatric disorders

Uncommon: Anxiety, restlessness/agitation

Rare: Emotional instability, depression (in very rare cases leading to self-harm, such as suicidal thoughts or attempts), hallucinations.

Very rare: Depersonalization disorder (feeling of not being oneself), dementia (possibly leading to self-harm, such as suicidal thoughts or attempts).

Nervous system

Frequent: Headache, dizziness.

Uncommon: Tingling sensation (pins and needles) and/or numbness, alteration of taste (in very rare cases, loss of taste), confusion and disorientation, sleep disorders (predominantly insomnia), tremors, sensation of vertigo (feeling of spinning and falling), somnolence.

Rare: Disorders of skin sensation, alterations of smell (including loss of smell), abnormal dreams, concentration disorders, speech alteration, total or partial loss of memory, balance and coordination disorders (due to dizziness).

Very rare: Increased skin sensitivity.

Eyes

Uncommon: Vision disorders, including double and blurred vision.

Very rare: Transient loss of vision.

Ears

Rare: Ringing/noise in the ears, hearing impairment including deafness (usually reversible).

Cardiac system(see section 2 "What you need to know before taking Moxifloxacino Kern Pharma)

Frequent: Change in heart rhythm (ECG), in patients with low potassium levels in the blood.

Uncommon: Change in heart rhythm (ECG), palpitations, irregular and rapid heart rate, severe heart rhythm disorders, angina pectoris.

Rare: Abnormally rapid heart rate, fainting.

Very rare: Heart rhythm disorders, irregular heart rate that can be life-threatening, cardiac arrest.

Vascular system

Uncommon: Dilation of blood vessels.

Rare: Hypertension, hypotension.

Respiratory system

Uncommon: Difficulty breathing, including asthmatic conditions.

Gastrointestinal system

Frequent: Nausea, vomiting, abdominal and stomach pain, diarrhea.

Uncommon: Decreased appetite and food intake, flatulence and constipation, gastric discomfort (indigestion/acid reflux), stomach inflammation (gastritis), increase in a certain digestive enzyme in the blood (amylase).

Rare: Difficulty swallowing, mouth inflammation, severe diarrhea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis) that, in very rare circumstances, can lead to life-threatening complications.

Liver

Frequent: Increase in certain liver enzymes in the blood (transaminases).

Uncommon: Alteration of liver function (including increase in a liver enzyme in the blood, LDH), increase in bilirubin in the blood, increase in a liver enzyme in the blood (gamma-glutamyltransferase and/or alkaline phosphatase).

Rare: Jaundice (yellowing of the whites of the eyes or skin), liver inflammation.

Very rare: Fulminant liver inflammation with life-threatening liver failure (including fatal cases).

Skin

The most serious side effectsobserved during treatment with moxifloxacino are listed below:

• A red, scaly, and generalized rash with bumps under the skin and blisters accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis) (the frequency of this side effect is "not known").
• Generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), increased lymph node size, and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome) (the frequency of this side effect is "not known").

Uncommon: Itching, rash, urticaria, dry skin, skin rashes.

Very rare: Inflammation of blood vessels (signs can be red spots on the skin, usually on the legs or effects such as joint pain).

Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear on the trunk as reddish spots in a target shape or circular patches, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and can be preceded by fever and flu-like symptoms (with possible life-threatening consequences).

Not known: Increased skin sensitivity to sunlight or UV radiation (see also section 2. Warnings and precautions).

Clearly defined erythematous patches with/without blisters that appear in the hours following the administration of moxifloxacino and disappear with residual post-inflammatory hyperpigmentation; they usually reappear in the same place on the skin or mucous membrane with subsequent exposure to moxifloxacino.

Musculoskeletal system

Uncommon: Joint and muscle pain.

Rare: Tendon pain and inflammation (tendinitis), muscle cramps, muscle spasms, muscle weakness.

Very rare: Tendon rupture, joint inflammation, muscle stiffness, worsening of myasthenia gravis symptoms.

Not known: Muscle weakness, sensitivity, or pain, particularly if you also feel unwell, have a fever, or your urine is dark. These symptoms can be caused by abnormal muscle breakdown that can be life-threatening and cause kidney problems (a condition called rhabdomyolysis).

Kidneys

Uncommon: Dehydration.

Rare: Kidney disorders (including increased laboratory test results for the kidneys, such as urea and creatinine), kidney failure.

General disorders

Uncommon: Malaise (mainly weakness or fatigue), back, limb, pelvis, and thorax pain, sweating.

Rare: Swelling (of hands, feet, ankles, lips, mouth, and throat).

Very rare cases of long-lasting (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations (such as pins and needles, tingling, burning, numbness, or pain), fatigue, decreased memory and concentration, effects on mental health (including sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), as well as decreased hearing, vision, taste, and smell, have been associated with the administration of quinolone and fluoroquinolone antibiotics, in some cases regardless of the presence of pre-existing risk factors.

Additionally, very rare cases of the following side effects, described after treatment with other quinolone antibiotics and which may also occur during treatment with moxifloxacino, have been reported: increased sodium and calcium levels in the blood, reduced count of a certain type of red blood cell (hemolytic anemia), problems associated with the nervous system, such as pain, burning, tingling, numbness, and/or weakness in the limbs.

There have been reports of increased size and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and be fatal, and heart valve disorders in patients who have received fluoroquinolones. See also section 2.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for human use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Moxifloxacino Kern Pharma

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after "EXP". The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Moxifloxacino Kern Pharma

• The active ingredient is moxifloxacino. Each film-coated tablet contains 400 mg of moxifloxacino in the form of hydrochloride.
• The other ingredients (excipients) are: mannitol (E-421), colloidal anhydrous silica (E-551), microcrystalline cellulose type 102 (E-460i), sodium carboxymethyl starch type A (potato), hydroxypropylcellulose (E-463), magnesium stearate (E-470b), and talc. The tablets are coated with a mixture of talc (E-553b), partially hydrolyzed polyvinyl alcohol (E-1203), titanium dioxide (E-171), macrogol, yellow iron oxide (E-172), and red iron oxide (E-172).

Appearance and packaging of the product

Rosa-colored, oblong, and biconvex film-coated tablets.

Each normal package contains aluminum/aluminum blisters of 5 or 7 film-coated tablets.

Each clinical package contains aluminum/aluminum blisters of 100 film-coated tablets.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Pharmathen International S.A.

Industrial Park Sapes,

Rodopi Prefecture, Block N 5, 69300 Rodopi

Greece

or

Pharmaten S.A.

Dervenakion, 6 Pallini, 15351 Attiki

Greece

Date of the last revision of this leaflet:May 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.