Package Leaflet: Information for the User

Moxifloxacino Kern Pharma 400 mg Film-Coated Tablets EFG

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

• Keep this package 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 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 package leaflet. See section 4.

Moxifloxacino Kern Pharma contains moxifloxacino as the active ingredient, which belongs to the group of antibiotics known as fluoroquinolones. Moxifloxacino Kern Pharma acts by eliminating bacteria that cause infections.

Moxifloxacino Kern Pharma is indicated for patients 18 years of age and older for the treatment of bacterial infections when moxifloxacino is active against certain bacteria. Moxifloxacino Kern Pharma should only be used to treat these infections when standard antibiotics cannot be used or have not been effective.

Treatable infections are: sinusitis, sudden worsening of chronic inflammation of the airways, or pneumonia acquired outside the hospital (except for severe cases).

Mild to moderate upper genital tract infections in females (inflammatory pelvic disease), including fallopian tube infection and uterine mucous membrane infection. For this type of infection, Moxifloxacino Kern Pharma tablets are not sufficient as a single treatment, so your doctor will also prescribe another antibiotic for the treatment of mild to moderate upper genital tract infections.

If the following diseases have shown improvement during initial treatment with Moxifloxacino Kern Pharma solution for infusion, your doctor may prescribe Moxifloxacino Kern Pharma tablets to complete the treatment: pneumonia acquired outside the hospital, skin and soft tissue infections.

Moxifloxacino Kern Pharma tablets should not be used to initiate treatment for any type of skin and soft tissue infection or for severe pneumonia.

Consult your doctor if you are unsure 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 to other quinolones or to any of the other components of this medication (listed in section 6).
• If you are pregnant or breastfeeding.
• If you are under 18 years old.
• If you have a history of tendon damage or lesions related to antibiotic quinolone treatment.
• If you have a hereditary heart disease or have experienced an abnormal heart rhythm (observed on an electrocardiogram), have electrolyte imbalances in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (bradycardia), have heart failure, have a history of abnormal heart rhythm or are taking other medications that cause ECG disturbances (see sectionOther Medications and Moxifloxacino Kern Pharma). This is because moxifloxacinomay 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 theupper limit of normal.

Warnings and Precautions

Before starting to take this medication

Do not take fluoroquinolone or quinolone antibacterial medications, including moxifloxacino, if you have experienced 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 Kern Pharma.

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

• Moxifloxacinomaymodify the ECG of the heart, 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 takingthismedication.
• If you suffer fromepilepsyor another condition that may causeseizures, consult your doctor before takingmoxifloxacino.
• If you have or have ever had anymental health problems, consult your doctor before takingmoxifloxacino.
• If you havemyasthenia gravis(abnormal muscle fatigue that causes weakness and severe paralysis), your symptoms may worsen if you takemoxifloxacino. If you think this affects you, consult your doctor immediately.
• If you or a family member hasglucose-6-phosphate dehydrogenase deficiency(a rare hereditary disease), inform your doctor, who will indicate ifthismedicationis suitable for you.
• If you have acomplicated upper genital tract infection in females(associated with a fallopian tube and ovarian abscess or pelvic abscess), for which your doctor considers intravenous treatment necessary, oral treatment withmoxifloxacinois not appropriate.
• For the treatment of amild to moderate upper genital tract infection in females, your doctor must prescribe another antibiotic in addition tomoxifloxacino. If you do not notice an improvement in symptoms after three days of treatment, consult your doctor.
• If you have been diagnosed with an aortic aneurysm or a large peripheral artery aneurysm.
• If you have had a previous episode of aortic dissection (tear in the aorta wall).
• If you have a family history of aortic dissection or aneurysm, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., 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, hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• 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.
• If you have been diagnosed with heart valve insufficiency (regurgitation of heart valves).

During treatment withthismedication:

• If you noticepalpitations or irregular heartbeats during the treatment period, inform your doctor immediately. This may perform an ECG to measure heart rate.
• Therisk of heart problemsmay increase with increasing doses. Therefore, you should follow the recommended dose.
• In rare cases, you may experience asevere and sudden 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 case of these symptoms, stop takingthismedicationand consult your doctor immediately.
• Moxifloxacino Kern Pharma 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 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, itching, bleeding tendency, or liver damage-induced cerebral disease.
• Fluoroquinolone antibiotics, includingmoxifloxacino, may causeseizures. If this occurs, treatment withthismedicationmust be discontinued and you must contact your doctor immediately.
• Severe, long-lasting, and potentially irreversible side effects.Fluoroquinolone or quinolone antibacterial medications, including moxifloxacino, have been associated with rare but severe side effects, some of which have been persistent for months or years, disabling, or potentially irreversible. This includes tendon pain, muscle pain, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pinching, tingling, burning, or numbness (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.
• If you experience sudden and intense pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go to the emergency department immediately. You may increase the risk if you are receiving systemic corticosteroid treatment.

• If you start experiencing sudden shortness of breath, especially when lying down, or if you notice swelling in your ankles, feet, or abdomen, or palpitations, 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 discontinue treatment, considering also the use of another class of antibiotic.

• In rare cases, you may experiencenerve damage symptoms(neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in your 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 experiencemental health problemseven after the first administration of quinolone antibiotics, including moxifloxacino. In rare cases, mental health problems and depression have evolved into suicidal thoughts and self-harm behaviors such as attempted suicide (see section 4 “Possible side effects”). If you develop these reactions, treatment withthismedicationmust be discontinued and you must inform your doctor immediately.
• You may developdiarrheaduring or after taking antibiotics, including moxifloxacino. If diarrhea is severe or persistent, or if you notice blood or mucus in your stool, stop takingthismedicationimmediately and consult your doctor. In these situations, do not take medications that slow down or stop intestinal movement.
• In rare cases, you may experiencejoint pain and swelling, inflammation, or tendon rupture. 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. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking moxifloxacino Kern Pharma, contact your doctor, and keep the painful area at rest. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.
• If you experience asevere and sudden pain in the chest, abdomen, or back, go to the emergency department immediately.
• If you are an elderly person with kidney 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 withthismedication, consult an ophthalmologist immediately (see sections 2 “Driving and operating machinery” and 4 “Possible side effects”).
• Fluoroquinolone antibiotics may cause an increase in your blood sugar levels above normal levels (hyperglycemia), ordecrease in your blood sugar levelsbelow normal levels (hypoglycemia), which in severe cases may cause loss of consciousness (hypoglycemic coma) (see section 4. “Possible side effects”). If you have diabetes, your blood sugar levels must be carefully controlled.
• Quinolone antibiotics may increasesensitivity to sunlight or UV light. You must avoid prolonged exposure to sunlight or direct sunlight and not use sunbeds or any type of UV lamp during treatment withthismedication (see section 4. Possible side effects).
• 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 (NET), generalized acute pustular psoriasis (PEGA), and drug reaction with eosinophilia and systemic symptoms (DRESS or hypersensitivity syndrome), have been reported with the use of moxifloxacino.

• SSJ/NET may initially appear on the trunk as red, ring-shaped spots 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 widespread skin peeling and complications that may put your life at risk or be fatal.
• PEGA 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: primarily localized in skin folds, trunk, and upper limbs.
• DRESS initially appears with flu-like symptoms and a rash on the face, followed by a widespread rash with high body temperature, increased liver enzyme levels in blood tests, and increased eosinophil levels and lymph node enlargement.

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

Children and adolescents

Do not give this medication to children and adolescents under 18 years old because its efficacy and safety have not been established (see sectionDo not take Moxifloxacino Kern Pharma).

Other medications and Moxifloxacino Kern Pharma

Inform your doctor or pharmacist if you are using,have used recently, or may need to use any other medication.

With Moxifloxacino Kern Pharma, you should be aware of the following:

• If you are takingmoxifloxacinoand othermedications that affect the heart, there is a higher risk of abnormal heart rhythms. Therefore, do not takemoxifloxacinoat the same time with 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 (terfenadine, astemizole, mizolastine), and other medications (e.g., cisapride, vincamine intravenously, bepridil, and difemanil).
• While takingmoxifloxacino, inform your doctor if you are taking other medications that decrease blood potassium levels or cause a decrease in heart rate, as they may increase the risk of severe heart rhythm disturbances.
• Any othermedication containing magnesium or aluminum, such as antacids for indigestion, or anymedication containing iron or zinc, ormedications containing didanosineormedications containing sucralfate for gastrointestinal disordersmay reduce the action ofmoxifloxacinotablets. Therefore, take yourmoxifloxacinotablets 6 hours before or after taking other medications.
• The oral administration ofactivated charcoalat the same time asmoxifloxacinotablets reduces their action. Therefore, it is recommended not to use these medications simultaneously.
• If you are currently takingoral anticoagulants(e.g., warfarin), your doctor may need to monitor your blood clotting time.

Use of Moxifloxacino Kern Pharma with food and drinkandbeverages

The effect ofthismedicationis not altered by food, including dairy products.

Pregnancy, lactation, and fertility

Do not usethismedicationduring pregnancy or if you are breastfeeding.

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

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

Driving and operating machinery

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

Moxifloxacino Kern Pharma contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet, which is essentially “sodium-free”.

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 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 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 Kern Pharma is as follows:

• Acute exacerbation of chronic bronchitis (including 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.

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

• Community-acquired pneumonia: 7-14 days

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

• Soft tissue infections: 7-21 days

Most patients with soft tissue infections changed from intravenous to oral treatment after 6 days.

It is essential to complete the treatment, even if you start feeling 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, bring the remaining medication, the packaging, or this leaflet to show 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, 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 two tablets to make up for the missed dose.

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

If you interrupt the treatment with Moxifloxacino Kern Pharma

If you interrupt the treatment too soon, your infection may not be completely cured, the infection may recur, or your condition may worsen, and it may also cause bacterial resistance to the antibiotic. Consult your doctor if you plan to stop taking the tablets before completing the full 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. During treatment with moxifloxacino, the following side effects have been observed. The evaluation of side effects has been based on the following frequency data:

Frequent: between 1 and 10 in every 100 patients.

Infrequent: between 1 and 10 in every 1,000 patients.

Rare: between 1 and 10 in every 10,000 patients.

Very rare: in fewer than 1 in 10,000 patients.

Unknown: cannot be estimated from available data.

Infections

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

Blood and lymphatic system disorders

Infrequent:Low red blood cell count, low white 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)

Endocrine disorders

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

Allergic reactions

Infrequent:Allergic reactions.

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

Abnormal laboratory test results

Infrequent:Increased blood lipids (fats)

Rare:Increased blood glucose, increased uric acid in the blood.

Very rare:Coma due to severe decrease in blood sugar levels (hypoglycemic coma)

Mental health disorders

Infrequent:Anxiety, restlessness/agitation

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

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

Nervous system

Frequent:Headache, dizziness.

Infrequent:Prickling and/or numbness sensation, 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:Skin sensation disorders, olfactory alterations (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.

Eye disorders

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

Very rare:Transient loss of vision.

Ear disorders

Rare:Tinnitus/ringing in the ears, hearing loss (including deafness, usually reversible).

Cardiovascular system(see section 2 “What you need to know before starting to take Moxifloxacino Kern Pharma)

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

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

Rare:Abnormally fast heart rate, fainting.

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

Vascular system

Infrequent:vasodilation.

Rare:Hypertension, hypotension.

Respiratory system

Infrequent:Respiratory difficulty, including asthma-like states.

Gastrointestinal system

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

Infrequent:Decreased appetite and food intake, flatulence and constipation, gastrointestinal discomfort (indigestion/heartburn), stomach inflammation (gastritis), increased levels of a certain digestive enzyme in the blood (amylase).

Rare:Difficulty swallowing, mouth inflammation, severe diarrhea with blood and/or mucous (antibiotic-associated colitis, including pseudomembranous colitis) that, in very rare cases, can be life-threatening.

Liver

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

Infrequent:Liver function alteration (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).

Rare:Jaundice (yellow discoloration of the white of the eyes or skin), liver inflammation.

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

Skin

Themost 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 beginning of treatment (generalized acute pustular psoriasis) (the frequency of this side effect is “unknown”).
• A generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), increased lymph node size, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome) (the frequency of this side effect is “unknown”).

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

Very rare:vasculitis (the signs may be red patches on the skin, usually on the legs or effects such as joint pain).

Severe skin eruptions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red spots in the shape of a target or circular patches often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers and may be preceded by fever and flu-like symptoms (with possible life-threatening risk).

Unknown:Increased skin sensitivity to sunlight or UV radiation (see also section 2. Warnings and precautions).

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

Musculoskeletal system

Infrequent:Joint and muscle pain.

Rare:Tendon inflammation (tendinitis), muscle cramps, muscle contractures, muscle weakness.

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

Unknown:Muscle weakness, sensitivity or pain, particularly if you also feel unwell, have a fever, or your urine is dark. These symptoms may be caused by abnormal muscle breakdown that can be life-threatening and cause kidney problems (a condition called rhabdomyolysis).

Kidneys

Infrequent:Dehydration.

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

General side effects

Infrequent:Uncomfortable feeling (mainly weakness or fatigue), back, limb, pelvic, and chest pain, sweating.

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 pinching, tingling, burning, numbness, or pain (neuropathy), depression, fatigue, sleep disorders, memory decrease, and hearing, vision, taste, and smell decrease, 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 withmoxifloxacino: increased levels of sodium and calcium in the blood, reduced count of a certain type of red blood cells (hemolytic anemia), problems associated with the nervous system, such as pain, burning, tingling, numbness, and/or weakness in the limbs.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it ispossibleside effects that do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for human use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthismedicineout of sight and reach of children.

Do not usethismedicineafter the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

No specialconservationconditions are required.

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

Composition of Moxifloxacino Kern Pharma

• The active ingredient is moxifloxacino. Each film-coated tablet contains 400 mg of moxifloxacino in the form ofhydrochloride.
• The other components(excipients)are: mannitol (E-421),silica coloidal anhydrous (E-551),microcrystalline cellulose type 102 (E-460i),carboxymethylstarch sodium type A (from potato),hydroxypropylcellulose (E-463),magnesium stearate (E-470b) and talc. The tablets are coated with a mixture oftalc (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 of the product and content of the container

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

Each standard container contains blisters of aluminum/aluminum of 5 or 7 film-coated tablets.

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

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

Pharmathen Internacional S.A.

Industrial Park Sapes,

Rodopi Prefecture, Block N 5, 69300 Rodopi

Ellas -Greece

or

Pharmaten S.A.

Dervenakion, 6 Pallini, 15351 Attiki

Greece

Last review date of this leaflet:April 2024

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicaments and Sanitary Products (AEMPS)http://www.aemps.gob.es/.