Indications:
For Acute Bacterial Sinusitis and Acute Exacerbation of Chronic Bronchitis, they should only be prescribed when other antibiotics cannot be used or have failed. For Community Acquired Pneumonia, they should only be given when treatment with other antibiotics cannot be used.
As Moxifloxacin-containing medicines have a risk of Diarrhea, Heart Failure in women and older patients, Severe Skin Reactions and Fatal Liver Injury.

Dosage:

Side effect:
•Very Frequently: more than 1 in 10 treated patients.
•Frequently: fewer than 1 in 10 but more than 1 in 100 treated patients.
•0ccasionally: fewer than 1 in 100 but more than 1 in 1,000 treated patients.
•Rarely: fewer than 1 in 1,000 but more than 1 in 10,000 treated patients.
•Very Rarely: fewer than 1 in 10,000 treated patients, including isolated cases.
With the exception of Nausea and Diarrhea, the reported incidence of all side effects was lower than 3%.
-General:
•Frequently: Abdominal pain, Headache.
•0ccasionally: Weakness, Pain, Back ache, General malaise, Chest pain, Allergic reactions, Leg pain.
•Very Rarely: Hypersensitivity, Severe Allergic Reactions, Possible ranging up to life-threatening Shock (Anaphylactic Shock), in some cases after first use, in these cases, stop using Actimoxiflox 400 mg Film-Coated Tablets immediately and inform the attending doctor.
The signs of shock include Cold Sweat, Gasping Breath, a Drop in Blood Pressure, a Racing Pulse, Dizziness and Stupor, Swelling of Skin and Mucous Membranes (including swelling of the Larynx, potentially life-threatening).
- Nervous System:
•Frequently: Drowsiness.
•Occasionally: Insomnia, Dizziness, Nervousness, Sleepiness, Anxiety, Trembling, Paraesthesias (Pins and Needles in the arms and legs), Confusion and Depression.
•Rarely: Hallucinations, Depersonalization (Alteration in the perception of the self), Impaired Coordination, Restlessness, Sleep Disorders, Abnormal Dreams, Convulsions.
•Very Rarely: Psychotic Reactions.
- Gastrointestinal Tract:
•Frequently: Nausea, Diarrhea, Vomiting, Dyspepsia (Digestion Disorders).
•Occasionally: Dry mouth, nausea with Vomiting, Flatulence, Constipation, Mouth Ulcers, Loss of Appetite, Inflammation of the Mucous Membranes of the Mouth and Inflammation of the Tongue.
•Very Rarely: Pseudo membranous Colitis (Inflammation of the Colon caused by Clostridium Difficile, a specific bacterium; in extremely rare cases, with life-threatening complications) and Hepatitis (Inflammation of the Liver, primarily caused by Obstruction of Bile).
- Cardiovascular:
•Frequently: In patients with pre-existing Hypokalaemia (Decreased Potassium Level): Prolongation of the QT interval (E.C.G. Abnormality).
•Occasionally: Tachycardia (Racing Pulse), Peripheral Edema (Accumulation of Watery Fluid in the Legs), High Blood Pressure, Palpitations, Atrial Fibrillation (Disturbance of Heart Rhythm), Angina Pectoris.
In patients with Normal Potassium Levels: QT Prolongation.
•Rarely: Vasodilatation (Dilatation of the Blood Vessels), Hypotension (Low Blood Pressure), Syncopes (Brief Fainting).
•Very Rarely: Ventricular Arrhythmia (Specific type of Cardiac Arrhythmia), Torsade de Pointes (Specific type of Cardiac Arrhythmia) and Cardiac Arrest (Particularly in patients with Severe underlying conditions that predispose them to Cardiac Arrhythmia).
- Respiratory Organs:
•Occasionally: Difficult Breathing.
- Loco motor System:
•Occasionally: Joint or Muscle Pain.
•Rarely: Tendinitis (Inflammation of the Tendons);
•Very Rarely: Ruptured Tendons.
- Skin:
•Occasionally: Rash, Pruritus (Itching), Perspiration, Urticaria (Nettle Rash).
•Rarely: Dry Skin.
•Very Rarely: Stevens-Johnson syndrome (Severe skin rash involving the mucous membranes and taking a feverish course).
- Sensory Organs:
•Frequently: Impaired Taste Perception.
•Occasionally: Impaired Vision.
•Rarely: Tinnitus, Impaired Vision because of C.N.S. reactions (e.g. Drowsiness or Confusion), Impairment or Loss of the sense of Smell or Loss of the sense of Smell and/or Taste.
- Urinary Tract and Sex Organs:
•Occasionally: Candidal Infection of the Vagina (Thrush) and Vaginitis.
- Laboratory Findings:
•Frequently: Changed Liver Function Tests (Mainly moderate increase in certain enzymes and/or bile pigments).
•Occasionally: Increase in certain enzymes (gamma-GT, amylase), Leucocytopenia (Reduction in the number of White Blood Cells), reduction in levels of Prothrombin / Increase in the I.N.R. (Specific Blood Coagulation Parameters), Eosinophilia (Increase in levels of certain Blood Cells), Thrombocythaemia (Increase in Number of Platelets in the blood), Thrombocytopenia (Decrease in Number of Platelets in the Blood) and Anaemia.
•Rarely: Hyperglycaemia (Elevated Blood Glucose Level), Hyperlipidaemia (Elevated Blood Lipid Level), Increased Prothrombin levels / reduced I.N.R. (Specific Blood Coagulation Parameters), Jaundice (Icterus mainly caused by Obstruction of Bile) in connection with changed Liver Function, elevated levels of a specific Liver Enzyme (LDH), elevated levels of Creatinine or Urea.
- On the basis of clinical experience with Actimoxiflox 400 mg Film-Coated Tablets so far, it is not possible to tell exactly what side effects might occur, isolated cases of the following side effects have been reported during treatment with other Fluoroquinolones, and these may also occur during treatment with Actimoxiflox 400 mg Film-Coated Tablets:
•Transitory Loss of Vision, Problems with Balance including Ataxia (Interference with Ability to Execute Movements), Hypernatraemia (Increased levels of Sodium in the Blood), Hypercalcaemia (Increased Levels of Calcium in the Blood), Neutropenia (Reduction in numbers of certain types of White Blood Cell), Haemolysis (Increased Breakdown of Red Blood Cells).
•Inform your doctor or pharmacist if you notice any side effects that are not listed in this patient information leaflet.

Drug interaction:
You must not use Actimoxiflox 400 mg Film-Coated Tablets:
-If you are allergic to Moxifloxacin, other Quinolones or any of the other ingredients.
-If you have previously suffered from Tendinitis or Tendon Damage after therapy with similar active substances (Quinolones).
-If you have a congenital or documented, acquired condition associated with certain electrocardiogram (E.C.G.) abnormalities (Prolongation of the QT Interval).
- If you suffer from salt imbalances, particularly if you have low concentrations of potassium in your blood (Hypokalaemia).
- If you have clinically significant bradycardia (Slow Heart Rate).
- If your doctor has diagnosed you as having clinically significant heart failure with reduced left ventricular ejection fraction (weak heart).
- If you have a history of symptomatic cardiac arrhythmias Actimoxiflox should not be taken concomitantly with other drugs which cause certain E.C.G. abnormalities (Prolongation of the QT Interval).
- If you suffer from Impaired Liver Function (Child-Pugh Class C) or an elevated transaminase level > 5 times the upper normal limit.
- Pregnant women, breast-feeding mothers, children and growing adolescents should not take Actimoxiflox 400 mg Film-Coated Tables.
Particular caution is required when using Actimoxiflox 400 mg Film-Coated Tablets in the following cases:
- If you have ever had a convulsion, you should consult your doctor before taking Actimoxiflox 400 mg Film-Coated Tablets.
- If you experience any visual disturbances or effects on your eyes, you should consult an eye specialist immediately.
- Tendinitis and ruptured tendons may occur during treatment with Quinolones, including Moxifloxacin (The active ingredient of Actimoxiflox 400 mg Film-Coated Tablets), particularly in elderly patients or patients receiving concomitant treatment with certain Anti-inflammatory drugs (Corticosteroids). At the first signs of pain or inflammation, you should stop taking Actimoxiflox 400 mg Film-Coated Tablets, rest the affected limb(s) and consult your doctor immediately regarding further treatment.
- Moxifloxacin causes a certain E.C.G. Abnormality known as, Prolongation of the QTc interval" in some patients. Although the effect is not very pronounced, Actimoxiflox400 mg Film-Coated Tablets should be used with caution if you are taking other drugs that can reduce the level of potassium in the blood. Patients with an elevated risk of Arrhythmia (e.g. Acute Myocardial Ischaemia) should exercise caution when taking Actimoxiflox. Prolongation of the QTc interval can increase the risk of certain types of cardiac arrhythmia (Ventricular Arrhythmia including Torsades de Pointes).
- As the extent of QTc prolongation increases in proportion to the dosage, the recommended dose should not be exceeded. Consult your doctor if you are in doubt.
- If symptoms of cardiac arrhythmia occur during treatment with Actimoxiflox, discontinue treatment and consult your doctor.
- If you experience Impaired Liver Function, ask your doctor to carry out an examination.
- Broad-spectrum antibiotics including Moxifloxacin can cause severe Diarrhea (Pseudo membranous Colitis). In this situation, suitable therapeutic measures should be implemented without delay. In the event of severe diarrhea occurring during or after use of antibiotics, please consult your doctor without delay. Do not take drugs that inhibit gastric motility (peristalsis).
- lf you or any member of your family have been diagnosed as having glucose-6-phosphate dehydrogenase deficiency (A congenital or acquired metabolic disorder), please tell your doctor about this before you start taking Actimoxiflox 400 mg Film-Coated Tablets.
- In contrast to other Quinolones, Moxifloxacin has not exhibited any significant risk of inducing photosensitivity in tests.
- Nonetheless, during treatment with Actimoxiflox 400 mg Film-Coated Tablets, you should avoid U.V. radiation (High-altitude sunshine, solarium) and not expose yourself to excessive and/or strong sunlight.
- Hypersensitivity and allergic reactions (e.g. skin rash) can occur after the very first administration of Quinolones. In extremely rare cases, severe immediate allergic reactions ranging up to life-threatening shock can develop. In these cases, use of Moxifloxacin must be discontinued immediately and medical treatment (e.g. therapy for shock) must be initiated.
* Pregnancy
You should always consult your doctor or pharmacist before taking medicines.
Do not take Actimoxiflox 400 mg Film-Coated Tablets if you are pregnant.
* Breast-feeding
You should always consult your doctor or pharmacist before taking medicines.
Do not take Actimoxiflox 400 mg Film-Coated Tablets if you are breast-feeding.
* Driving and operating machinery
If you feel drowsy after taking Actimoxiflox 400 mg Film-Coated Tablets, avoid driving or operating machinery.
* Important information about certain other constituents of Actimoxiflox 400 mg Film-Coated Tablets:
Actimoxiflox 400 mg Film-Coated Tablets contain lactose, you should therefore not take this medicine without first consulting your doctor if you know that you suffer from glucose intolerance.
* Interactions with other drugs
Please inform your doctor or pharmacist if you are taking/using other medicines or have taken/used other medicines recently, even if they are non-prescription medicines.
Please note the following when taking other medicines:
- Actimoxiflox can affect the heart rate (QT interval). This effect can be intensified in the event of concomitant administration of the following drug products: Class la (e.g. Quinidine, Hydroquinidine, Disopyramide) and Class III (e.g. Amiodarone, Sotalol, Dofetilide, Ibutilide) Anti-arrhythmics (Drugs to Treat Cardiac Arrhythmia) Neuroleptics (Drugs to treat mental disorders, such as Phenothiazine, Pimozide, Sertindole, Haloperidol, Sultopride), Tri-cyclic Antidepressants, certain Anti-infective Drugs (Sparfloxacin, Intravenously administered Erythromycin, Pentamide, Anti-malarial drugs, in particular Halofantrine), certain drugs used to treat allergy symptoms (Terfenadine, Astemizole, Mizolastine) and others (Cisapride, a drug used to stimulate peristaltic activity, intravenously administered Vincamine, Bepridil, Diphemanil). Moxifloxacin should therefore not be administered together with these drug products.
- An interval of around 6 hours should be left between taking drugs that contain certain metals (Bivalent or Trivalent Cations) and taking Actimoxiflox 400 mg Film-Coated Tablets.
These include Antacids containing Magnesium or Aluminium (Drugs used to prevent Hyperacidity of the stomach), certain Antiviral tablets containing Didanosine, Sucralfate and drugs containing Iron or Zinc.
- Concomitant administration of Actimoxiflox 400 mg Film-Coated Tablets and Activated carbon considerably reduces the absorption of Moxifloxacin into the body, Concomitant administration of these two products is therefore not recommended.
- In studies carried out in healthy volunteers, Concomitant administration of Actimoxiflox 400 mg Film-Coated Tablets with Digoxin (A drug used to treat Heart Failure) led to an approx. 30% increase in the peak plasma concentrations of Digoxin.
No particular precautionary measures are required for concomitant administration of Actimoxiflox and Digoxin.
- In studies carried out in patients with Diabetes, concomitant administration of Actimoxiflox 400 mg Film-Coated Tablets with Glibenclamide (A drug used to treat Diabetes) led to a 21% decrease in the peak plasma concentrations of Glibenclamide. The blood glucose and insulin values were not affected, however.
- An enhanced Anticoagulant effect was reported in a large number of cases in which patients were treated concurrently with Antibiotics and Anticoagulants. However, no clinically significant interaction was reported in a study involving Moxifloxacin and Warfarin (an Anticoagulant).
The patient's coagulation values can be monitored more frequently and the Anticoagulant dosage adapted if necessary as a precautionary measure.
- No interactions occurred when Actimoxiflox 400 mg Film-Coated Tablets were taken concomitantly with drugs containing the following active ingredients; Ranitidine (Used to treat Peptic Ulcers), Probenecid (Used to reduce Serum Uric Acid Levels), Oral Contraceptives (Birth Control Pills), Calcium supplements, Morphine (Narcotic Analgesic), Theophylline (Used to treat Asthma) or Itraconazole (Used to treat Fungal Infections).
- When taking Actimoxiflox 400 mg Film-Coated Tablets together with food and drinks:
The effects of Actimoxiflox 400 mg Film-Coated Tablets are not influenced by food, including dairy products.

Packages:
5 Film-Coated Tablets

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