Zencin 250 Mg 6 Film-Coated Tablet

1. What Zencin is and what it is used for

• • Zencin contains azithromycin which is one of a group of antibiotics known as macrolides.
    It is used to treat bacterial infections caused by micro organisms such as bacteria. These
    infections include:

• • Chest infections such as bronchitis and pneumonia.
    Infections in your sinuses, throat, tonsils or ears.

• • Mild to moderate skin and soft tissue infections, e.g. infection of the hair follicles (folliculitis),
    bacterial infection of the skin and its deeper layers (cellulitis), skin infection with shiny red
    swelling (erysipelas).

• • Sexually transmitted disease caused by organisms called Chlamydia trachomatis and
    Neisseria gonorrhoea.

2. What you need to know before you take Zencin

• • Do not take Zencin

• • if you are allergic to azithromycin, any other macrolide (such as erythromycin or clarithromycin) or ketolide antibiotic or any of the ingredients of this medicine (listed in section 6). An allergic reaction may cause skin rash or wheezing.
  • Warnings and precautions

• • Talk to your doctor or pharmacist before taking Zencin if you:
    have ever had a serious allergic reaction causing swelling of the face and throat, possibly
    with breathing problems, rash, fever, swollen glands or increase in eosinophils (certain type
    of white blood cells).

• • have severe kidney problems: your doctor may alter the dose.

• • have liver problems: your doctor may need to monitor your liver function or stop the treatment.

• • have myasthenia gravis (localized muscle weakness).

• • have been diagnosed with a neurological disease, which is a disease of the brain or
    nervous system.

• • have mental, emotional or behavioral problems.
    are taking medicines known as ergot alkaloids (such as ergotamine), which are used to treat
    migraine: azithromycin is not recommended (see ‘Other medicines and Zencin below).

• • Since azithromycin may increase the risk of abnormal heart rhythm please tell your
    doctor if you have any of the following problems before taking this medicine (especially you are female or elderly):

• • you are aware of ever being diagnosed to have prolonged QT interval (a heart condition, shown on an electro-cardiogram or ECG machine): azithromycin is not recommended.
    are aware that you have a slow or irregular heart beat, or reduced heart function (heart
    failure): azithromycin is not recommended.

• • know that you have low levels of potassium or magnesium in your blood: azithromycin is
    not recommended.
    are taking medicines known as antiarrhythmics (e.g. quinidine, procainamide, dofetilide,
    amiodarone, sotalol: used to treat abnormal heart rhythms), cisapride (used to treat stomach
    problems) or terfenadine (an antihistamine that is used to treat allergies), or antipsychotic
    agents (e.g. pimozide), antidepressants (e.g. citalopram), some antibiotics (e.g. moxifloxacin,
    levofloxacin) that can affect the heart rhythm: Zencin is not recommended (see ‘Other
    medicines and Zencin below)

• • If you develop severe and persistent diarrhea during or after treatment, especially if
    you notice blood or mucus, tell your doctor immediately.

• • If your symptoms persist after the end of your treatment with Zencin, or if you notice
    any new and persistent symptoms, contact your doctor.
    Other medicines and Zencin
    Tell your doctor before taking Zencin, if you are taking any of the medicines listed
    below:

• • Warfarin or any similar medicine to prevent blood clots: concomitant use can increase the
    risk of bleeding.

• • Ergotamine, dihydroergotamine (used to treat migraine): ergotism (ie. itching in the limbs,
    muscle cramps and gangrene of hands and feet due to poor blood circulation) may occur.
    Concomitant use is therefore not recommended.
    Ciclosporin (used to suppress the immune system to prevent and treat rejection of an organ
    or bone marrow transplant): if concomitant use is required, your doctor will check your blood
    levels regularly and may adapt the dose.

• • Digoxin (for heart failure): digoxin levels may increase. Your doctor will check your blood levels.
    Colchicine (used for gout and familial Mediterranean fever).

• • Antacids (for indigestion): Zencin should be taken at least 1 hour before or 2 hours after
    the antacid.

• • Cisapride (for stomach problems), terfenadine (used to treat hay fever): concomitant use
    with azithromycin may cause heart disorders.
    Medicines for irregular heart beat (called anti-arrythmics), or to lower cholesterol (called
    statins) such as atorvastatin.
    Alfentanil (used for narcosis) or astemizole (used to treat hay fever): concomitant use with
    azithromycin may increase the effect of these medicinal products.

• • Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
    medicines.

• • Pregnancy and 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.
    Pregnancy

• • There is insufficient information regarding the safety of azithromycin during pregnancy.
    Consequently, Azithromycin is not recommended if you are pregnant or planning to become
    pregnant. However,your doctor may prescribe it under serious circumstances.
    Breast-feeding