Package Leaflet: Information for the User

MoxifloxacinoQualigen 400 mg Film-Coated 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

MoxifloxacinoQualigen contains moxifloxacino as the active ingredient, which belongs to the group of antibiotics known as fluoroquinolonas. MoxifloxacinoQualigen acts by eliminating bacteria that cause infections.

MoxifloxacinoQualigen is indicated for patients 18 years of age and older for the treatment of the following bacterial infections when caused by bacteria, when moxifloxacino is active against such bacteria. MoxifloxacinoQualigen should be used only to treat such infections when usual antibiotics cannot be used or have not been effective.

Acute exacerbation of chronic inflammation of the airways or community-acquired pneumonia (excluding severe cases), sinusitis, and pneumonia acquired outside the hospital.

Mild to moderate upper genital tract infections in females (pelvic inflammatory disease), including fallopian tube infection and uterine mucous membrane infection. For this type of infection, MoxifloxacinoQualigen is not sufficient as a single treatment, therefore, in addition toMoxifloxacino Qualigen, your doctor should prescribe another antibiotic for the treatment of mild to moderate upper genital tract infections (see2. What you need to know before starting to take Moxifloxacino Qualigen,Adverse reactions and precautions,Consult your doctor or pharmacist before starting to take Moxifloxacino Qualigen).

If the following diseases have shown improvement during the initial treatment with moxifloxacino infusion solution, your doctor may prescribe MoxifloxacinoQualigento complete the treatment: Community-acquired pneumonia, skin and soft tissue infections. MoxifloxacinoQualigen should not be used to initiate treatment for any type of skin and soft tissue infection or severe pneumonia.

sConsult your doctor if you are unsure if you belong to one of the patient groups described below.

Do not take Moxifloxacino Qualigen:

• If you are allergic (hypersensitive) to the active ingredient moxifloxacino or to other quinolones or to any of the other components of Moxifloxacino Qualigen 400 mg film-coated tablets (see section6. Contents of the pack and special precautions for use).
• If you are pregnant or breastfeeding.
• If you are under 18 years old.
• If you have a history of tendon damage or tendon rupture related to treatment with quinolone antibiotics (see sectionsWarnings and precautionsand4).
• If you have a hereditary disease or have suffered from a disease related to an abnormal heart rhythm (observed on ECG, heart electrical recording), have electrolyte imbalances in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called “bradycardia”), have a weak heart (heart failure), have a history of heart rhythm disorders or are taking other medications that cause ECG disturbances (see sectionTaking Moxifloxacino Qualigen with other medicines).

This is because Moxifloxacino Qualigen may 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 a severe liver disease or increased levels of liver enzymes (transaminases) 5 times above the upper limit of normal.

Warnings and precautions

Before starting to take this medicine

Do not take antibacterial medications that contain fluoroquinolones or quinolones, including Moxifloxacino Qualigen, if you have had a severe reaction to a quinolone or fluoroquinolone in the past. If this is the case, inform your doctor as soon as possible.

Consult your doctor or pharmacist before starting to take Moxifloxacino Qualigen:

• Moxifloxacino Qualigen maymodify the heart ECG, especially if you are a woman or an elderly patient. If you are currently taking anymedication that causes a decrease in blood potassium levels,consult your doctor before taking Moxifloxacino Qualigen (see also sectionsDo not take Moxifloxacino QualigenandTaking Moxifloxacino Qualigen with other medicines).
• If you have been diagnosed with an enlarged or “bulge” of a large blood vessel (aortic aneurysm or aneurysm of a large peripheral vessel).
• If you have had a previous episode of aortic dissection (tear in the aortic wall).
• If you have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• If you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., Marfan syndrome or Ehlers-Danlos vascular syndrome, Turner syndrome or Sjögren's syndrome (an autoimmune inflammatory disease) or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).
• If you suffer fromepilepsyor another condition that may causeseizures, consult your doctor before taking Moxifloxacino Qualigen.
• If you have or have ever had anymental health problems, consult your doctor before taking Moxifloxacino Qualigen.
• If you havemyasthenia gravis, your symptoms may worsen if you take Moxifloxacino Qualigen. If you think this affects you, consult your doctor immediately.
• If you or a family member has a deficiency ofglucose-6-phosphate dehydrogenase(a rare hereditary disease), inform your doctor, who will indicate whether Moxifloxacino Qualigen is suitable for you.
• If you have acomplicated upper genital tract infection in women(associated with an abscess in the fallopian tubes and ovaries or pelvis), for which your doctor considers intravenous treatment, it is not suitable to treat with Moxifloxacino Qualigen.
• For the treatment of a mild to moderate upper genital tract infection in women, your doctor must prescribe another antibiotic in addition to Moxifloxacino Qualigen. If you do not notice an improvement in symptoms after three days of treatment, consult your doctor.
• If you are diabetic because you may experience a risk of changes in blood sugar levels with moxifloxacino.
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking moxifloxacino.

During treatment with Moxifloxacino Qualigen

• If you noticepalpitations or irregular heartbeatsduring the treatment period, you must inform your doctor immediately. Your doctor may perform an ECG to measure your heart rate.
• Therisk of heart problemsmay increase with increasing doses. Therefore, the recommended dose should be taken.
• If you experience a strong and sudden pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go to an emergency service immediately. The risk may increase if you are receiving systemic corticosteroid treatment.
• If you start to experience a sudden onset of shortness of breath, especially when lying down, or if you notice swelling in the ankles, feet, or abdomen, or the onset of palpitations (sensation of rapid or irregular heartbeat), you must inform your doctor immediately.
• In rare cases, you may experience asevere allergic reaction(anaphylactic reaction) even with the first dose, and develop the following symptoms: chest tightness, dizziness, nausea, or fainting, or feeling dizzy when standing up.In the event of these symptoms, discontinue administration of Moxifloxacino Qualigen and consult your doctor immediately..
• Moxifloxacino Qualigen may cause arapid and severe inflammation of the liver, which may lead to liver failure that puts your life at risk (including fatal cases, see section4. Possible side effects).
• Antibiotics, including Moxifloxacino Qualigen, may causeseizures. If this occurs, treatment with Moxifloxacino Qualigen should be discontinued and you should contact your doctor immediately.
• Severe, prolonged, and potentially irreversible adverse effects.Fluoroquinolone-containing antibacterial medications, including Moxifloxacino Qualigen, have been associated with rare but severe adverse effects, some of which have been persistent for months or years, incapacitating, or potentially irreversible. This includes pain in the tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, numbness, tingling, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

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

• In rare cases, you may experiencenerve 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 Qualigen and inform your doctor immediately to prevent the development of a potentially irreversible disorder.
• You may experiencemental health problemseven after the first administration of quinolone antibiotics, including Moxifloxacino Qualigen. In rare cases, mental health problems and depression have evolved into suicidal thoughts and self-harm behaviors such as attempted suicide (see section4. Possible side effects). If you develop these reactions, treatment with Moxifloxacino Qualigen should be discontinued and you should inform your doctor immediately.
• You may developdiarrheaduring or after taking antibiotics, including Moxifloxacino Qualigen. If the diarrhea is severe or persistent, or if you notice blood or mucus in the stool, discontinue Moxifloxacino Qualigen immediately and consult your doctor. In these situations, you should not take medications that slow down or stop intestinal movement.
• In rare cases, you may experiencepain and swelling in the joints and inflammation or rupture of tendons. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after discontinuing treatment with Moxifloxacino Qualigen. If you experience any signs of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), discontinue Moxifloxacino Qualigen, contact your doctor, and keep the affected area at rest. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.
• If you are an elderly person and havekidney problems, be careful to ensure adequate fluid intake, as dehydration may increase the risk of kidney failure.
• If your vision worsens or if you experience any othereye problemsduring treatment with Moxifloxacino Qualigen, consult an ophthalmologist immediately (see sections2. Driving and the use of machines and 4. Possible side effects).
• Fluoroquinolone antibiotics may cause an increase in your blood sugar levels above normal levels (hyperglycemia), or a decrease in your blood sugar levels below normal levels (hypoglycemia), which in severe cases may cause a loss of consciousness (hypoglycemic coma) (see section 4. Possible side effects). If you have diabetes, your blood sugar levels should be carefully controlled.
• Quinolone antibiotics may increase thesensitivity of the skin to sunlight or UV. You should avoid prolonged exposure to sunlight or direct sunlight and not use sunbeds or any type of UV lamp during Moxifloxacino Qualigen administration.
• The efficacy of moxifloxacino solution for infusion in the treatment of severe burns, deep tissue infections, and diabetic foot infections with osteomyelitis (bone marrow infections) has not been established.

Severe skin reactions

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), and generalized acute pustular psoriasis (GAP), have been reported with the use of moxifloxacino.

• SSJ/TEN may initially appear on the trunk as red, ring-shaped lesions or circular patches often with central blisters. They may also appear as ulcers in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin eruptions often precede fever and/or flu-like symptoms. The eruptions may progress to generalized skin peeling and complications that may put your life at risk or be fatal.
• GAP appears at the beginning of treatment as a red, scaly, and generalized rash with subcutaneous nodules and blisters accompanied by fever. The most common location: mainly localized in skin folds, trunk, and upper limbs.

If you develop a severe skin rash or any of these skin symptoms, discontinue 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, as its safety and efficacy have not been established for this age group (see sectionDo not take Moxifloxacino Qualigen).

Taking Moxifloxacino Qualigen with other medicines

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

With Moxifloxacino Qualigen, you should be aware of the following:

• If you are taking Moxifloxacino Qualigen and other medications that affect the heart, there is a higher risk of heart rhythm disorders. Therefore, do not take Moxifloxacino Qualigen at the same time as the following medications: Antiarrhythmic medications (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sulpiride), tricyclic antidepressants, some antimicrobials (e.g., saquinavir, sparfloxacin, erythromycin administered intravenously, pentamidine, antimalarials, particularly halofantrine), some antihistamines (e.g., terfenadine, astemizole, mizolastine), and other medications (e.g., cisapride, vincamine intravenously, bepridil, and difemanil).
• While taking Moxifloxacino Qualigen, inform your doctor if you are taking other medications that may decrease blood potassium levels (e.g., some diuretics, some laxatives and enemas [high doses] or corticosteroids [anti-inflammatory medications], amphotericin B) or cause a decrease in heart rate, as these may also increase the risk of severe heart rhythm disorders.
• Any other medication that contains magnesium or aluminum (such as antacids for indigestion) or any medication that contains iron or zinc, medications that contain didanosine, or medications that contain sucralfate for gastrointestinal disorders may reduce the action of Moxifloxacino Qualigen tablets. Therefore, take your Moxifloxacino Qualigen tablets 6 hours before or after taking other medications.
• The oral administration of activated charcoal at the same time as Moxifloxacino Qualigen tablets reduces their action. Therefore, it is recommended not to use these medications simultaneously.
• If you are currently taking oral anticoagulants (e.g., warfarin), your doctor may need to monitor your blood clotting time.

Moxifloxacino Qualigen with food and drinks

The effect of Moxifloxacino Qualigen is not altered by food, including dairy products.

Pregnancy, lactation, and fertility

Do not use Moxifloxacino Qualigen during pregnancy or if you are breastfeeding.

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

Studies in animals do not suggest that this medicine affects your fertility.

Driving and the use of machines

Moxifloxacino Qualigen may cause dizziness or vertigo or a brief loss of vision. You may experience a sudden, temporary loss of vision. If you experience these symptoms, do not drive vehicles or operate machinery.

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

The recommended doseinadults is one 400 mg film-coated tablet, once a day.

Moxifloxacino Qualigen tablets are for oral use. Take the tablet whole without chewing (to mask the bitter taste) and with plenty of liquid. Moxifloxacino Qualigen can be taken with or without food. It is recommended to take the tablet approximately at 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 told you otherwise, the duration of treatment with Moxifloxacino Qualigen is as follows:

• Acute exacerbation of chronic obstructive pulmonary disease (including bronchitis): 5-10 days.
• Community-acquired pneumonia, except for severe cases: 10 days.
• Acute bacterial sinusitis: 7 days.
• Mild to moderate upper genital tract infections in females (pelvic inflammatory disease), including fallopian tube infection and uterine mucous membrane infection: 14 days.

If Moxifloxacino Qualigen is used to complete a course of therapy initiated with moxifloxacino solution for infusion, the duration of treatment is:

• Community-acquired pneumonia: 7-14 days.

Most patients with pneumonia switch to oral treatment with Moxifloxacino Qualigen at 4 days.

• Skin and soft tissue infections: 7-21 days.

Most patients with severe skin and soft tissue infections have a mean duration of intravenous treatment of around 6 days.

It is essential to complete the treatment, even if you start feeling better after a few days. If you interrupt the treatment too soon, the infection may not be completely cured, the infection may recur, your condition may worsen, and you may also develop antibiotic resistance.

Do not exceed the recommended dose and duration of treatment (see section2. What you need to know before starting to take Moxifloxacino Qualigen).

If you take more Moxifloxacino Qualigen than you should

If you take more than the prescribed daily tablet, consult your doctor immediately and, if possible, bring the remaining medication, the packaging, or this leaflet to show the doctor or pharmacist what you have taken.

Incase of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 0420, indicating the medication and the amount ingested.

If you forget to take Moxifloxacino Qualigen

In case of forgotten dose, take the tablet as soon as you remember on the same day. If you miss a dose, take the normal dose (one tablet) the next day. Do not take a double dose to compensate for the missed doses.

If you are unsure of what to do, consult your doctor or pharmacist.

If you interrupt the treatment with Moxifloxacino Qualigen

If you interrupt the treatment too soon, your infection may not be completely cured. Consult your doctor if you plan to stop taking the tablets before completing the treatment.

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.

Themost serious side effectsobserved during treatment with Moxifloxacino Qualigen are listed below:

If you notice

• Severe skin eruptions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red target-shaped macules or circular patches often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms (very rare, potentially life-threatening)
• A red, scaly, and generalized rash with protuberances under the skin and blisters accompanied by fever at the start of treatment (acute generalized pustular psoriasis) (the frequency of this side effect is "unknown")
• Syndrome associated with alterations in water elimination and low sodium levels (SIADH) (very rare side effect)
• Loss of consciousness due to severe decrease in blood sugar levels (hypoglycemic coma) (very rare side effect)
• Tendon pain and inflammation (tendinitis) (rare side effect) or tendon rupture (very rare side effect)
• Muscle weakness, sensitivity, or pain, particularly if accompanied by discomfort, fever, or dark urine. These symptoms may be caused by abnormal muscle degradation that can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (frequency "unknown")

Below, other side effects observed during treatment with Moxifloxacino Qualigen are listed according to the probability that they present:

:

• Frequent: mayaffectbetween 1 and 10 in every 100 patients
• Rare: mayaffectbetween 1 and 10 in every 10,000 patients
• Very rare: mayaffectless than 1 in every 10,000 patients
• Frequency unknown (cannot be estimated from available data)

Infections

Frequent: Infections caused by resistant bacteria or fungi, e.g., oral and vaginal infections caused byCandida.

Blood and lymphatic system disorders

Rare: Low white blood cell count, low red blood cell count, low levels of certain white blood cells (neutrophils), decreased or increased levels of certain blood cells necessary for blood clotting, increased levels of certain white blood cells (eosinophils), decreased blood clotting.

Very rare: Increased blood clotting, significant decrease in certain white blood cells (agranulocytosis), decreased number of red and white blood cells and platelets (pancytopenia).

Allergic reactions

Rare: Allergic reactions.

Very rare: Severe, sudden, and generalized allergic reaction, including 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

Rare: Increased blood lipids (fats).

Very rare: Increased blood glucose, increased uric acid in the blood.

Mental health disorders

Rare: Anxiety, restlessness/agitation.

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

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

Nervous system

Frequent: Headache, dizziness.

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

Very rare: Abnormal skin sensation, alterations of smell (including loss of smell), abnormal dreams, balance and coordination disorders (due to dizziness), convulsions, concentration disorders, alteration of speech, total or partial loss of memory, problems associated with the nervous system, such as pain, burning, tingling, numbness, and/or weakness in the limbs.

Very rare: Increased skin sensitivity.

Eye

Rare: Eye disorders, including double vision and blurred vision.

Very rare: Transient loss of vision.

Ear

Very rare: Ringing in the ears, hearing loss (including deafness, usually reversible).

Cardiovascular system(see section2. What you need to know before starting to take Moxifloxacino Qualigen)

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

Rare: Change in heart rhythm (ECG), palpitations, irregular and rapid heart rate, severe alteration of heart rhythm, angina pectoris.

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

Vascular system

Rare: Vasodilation.

Very rare: Hypertension, hypotension.

Respiratory system

Rare: Respiratory difficulty, including asthma-like states.

Gastrointestinal system

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

Rare: Decreased appetite and food intake, flatulence, constipation, gastric discomfort (indigestion/heartburn), stomach inflammation, increased levels of a certain digestive enzyme in the blood (amylase).
Very rare: Difficulty swallowing, mouth inflammation, severe diarrhea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis) that, in very rare cases, can lead to life-threatening complications.

Liver

Frequent: Increased levels of certain liver enzymes in the blood (transaminases).

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

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

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

Skin

Rare: Itching, rash, urticaria, dry skin.

Very rare: Alterations of the skin and mucous membranes (painful vesicles in the mouth/nose or penis/vagina) or Stevens-Johnson syndrome (toxic epidermal necrolysis) with possible life-threatening risk.

Swelling of blood vessels (the signs may be red patches on the skin, usually on the legs or effects such as joint pain) (very rare side effect).

Musculoskeletal system

Rare: Joint and muscle pain.

Very rare: Tendon pain and inflammation (tendinitis), muscle cramps, muscle contractures, muscle weakness. Very rare: Tendon rupture, joint inflammation, muscle stiffness, worsening of myasthenia gravis symptoms.

Kidneys

Rare: Dehydration.

Very rare: Kidney alterations (including increased levels of kidney function tests, such as urea and creatinine), kidney failure.

General side effects

Rare: Discomfort (mainly weakness or fatigue), back, limb, pelvic, and chest pain, sweating.

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

The administration of quinolone and fluoroquinolone antibiotics has been associated with very rare cases of long-lasting or permanent adverse reactions (including months or years) such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinpricks, tingling, numbness, burning, or pain (neuropathy), depression, fatigue, sleep disorders, memory decline, and hearing, vision, taste, and smell loss, in some cases regardless of the presence of pre-existing risk factors.

Additionally, very rare cases of the following side effects have been reported, described after treatment with other quinolone antibiotics and that may also occur during treatment with Moxifloxacino Qualigen: increased sodium and calcium levels in the blood, reduced count of a certain type of red blood cell (hemolytic anemia), increased skin sensitivity to sunlight or UV.

Cases of increased size and weakening or tearing of the aortic wall (aneurysms and dissections) that could lead to rupture and be fatal, and heart valve insufficiency in patients who have received fluoroquinolones have been reported. See section 2.

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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products 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 blister pack andinthe boxafterCAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, 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 Moxifloxacino Qualigen

• The active ingredient is moxifloxacino. Each film-coated tablet contains 400 mg of moxifloxacino in the form of hydrochloride.
• The other components are:

• Tablet core: microcrystalline cellulose, mannitol (E-421), colloidal silicon dioxide, sodium starch glycolate (potato), hydroxypropyl cellulose, magnesium stearate.
• Coating film: microcrystalline cellulose, sodium starch glycolate (potato), talc, magnesium stearate.

Appearance of the product and contents of the packaging

Film-coated tablets of pink color, oblong and biconvex.

The tablets are supplied in Aluminio/Aluminio blisters.

The tablets are presented in packaging of 5 and 7 film-coated tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for manufacturing

Pharmathen, S.A.

Devernakion, 6

Pallini 15351

Attiki

(Greece)

or

Pharmathen International, S.A.

Sapes Industrial Park,

Block No. 5

Rodopi 69300

(Greece)

Last review date of this leaflet November 2020

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