Moxican®

Moxican<sup>®</sup>

Moxican®

Moxifloxacin

Moxican®

Moxifloxacin 400 mg

Tablets for Oral Use

Product leaflet summary

 

Therapeutic Indications

Moxican is used in patients aged 18 years and above for treating the following bacterial infections when caused by bacteria against which moxifloxacin is active. Moxican should only be used to treat these infections when usual antibiotics cannot be used or have not worked:

Infection of the sinuses, sudden worsening of long term inflammation of the airways or infection of the lungs (pneumonia) acquired outside the hospital (except severe cases).

Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease), including infections of the fallopian tubes and infections of the uterus mucous membrane.

Moxican tablets are not sufficient on their own for treating this kind of infection. Therefore, another antibiotic in addition to Moxican tablets should be prescribed by your doctor for the treatment of infections of the female upper genital tract

 

Dosage and Administration

The recommended dose for adults is one 400mg film-coated tablet once daily.

 

Contraindications

If you are allergic to the active substance moxifloxacin, any other quinolone antibiotics or any of the other ingredients of this medicine (listed in section 6.).

If you are pregnant or are breast-feeding.

If you are under 18 years of age.

If you have previously had problems with your tendons related to treatment with quinolone antibiotics.

If you were born with or have any condition with abnormal heart rhythm (seen on ECG, electrical recording of the heart)

A salt imbalance in the blood (especially low levels of potassium or magnesium in the blood)

A very slow heart rhythm (called ‘bradycardia’)

A weak heart (heart failure)

A history of abnormal heart rhythms

Or

If you are taking other medicines that result in abnormal ECG changes. This is because Moxican can cause changes on the ECG that is a prolongation of the QT-interval, i.e., delayed conduction of electrical signals.

If you have a severe liver disease or increased liver enzymes (transaminases) higher than 5 times the upper normal limit.

 

Pregnancy and Lactation

Do not take Moxican if you are pregnant or breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Animal studies do not indicate that your fertility will be impaired by taking this medicine.

 

Pediatric Population:

Do not give this medicine to children and adolescents under the age of 18 because efficacy and safety have not been established for this age group

 

Ability to Drive and Use Machinery

Moxican may make you feel dizzy or light-headed, you may experience a sudden, transient loss of vision, or you may faint for a short period. If you are affected do not drive or operate machinery.

 

Package Presentation

Packs of 7 film coated tablets