ZITMYC Tablets Azithromycin 500 mg

 

1. WHAT ZITMYC is and what is it used for? 

Therapeutic Classification

This drug is an antibacterial, which is one of a group of antibiotics called macrolides. 

Therapeutic indications

It is indicated for the treatment of certain bacterial and other micro-organisms which include,

• Acute bacterial otitis media (adequately diagnosed).
• Pharyngitis, tonsillitis.
• Acute exacerbation of chronic bronchitis (adequately diagnosed).
• Mild to moderately severe community acquired pneumonia.
• Skin and soft tissue infections.
• Urethritis and cervicitis uncomplicated Chlamydia trachomatis.
• Consideration must be given to official guidance on the appropriate use of agents antibacterials.

2. What you need to know before you take ZITMYC? 

Contraindications

Do not take ZITMYC if you are allergic to this medication, erythromycin, to any other macrolide antibiotic in the ketolide or to any excipients listed in this leaflet, 

• when used in combination with dihydroergotamine and ergotamine (migraine drugs) 
• When used in combination with cisapride (anti-reflux drug).
• When combined with colchicine (gout treatment).
• In patients with severe hepatic impairment.

Precautions; special warnings

If you experience swelling of the face or neck (edema) or severe rash with blisters on the skin, sores in the mouth, or inflammation of the eyes, you must stop treatment and contact your doctor immediately as these effects can be life-threatening or cause death.

If you notice your skin a symptom corresponding to a rash even without any associated effect, yellowing of the skin, dark urine, bleeding tendency, changes your state of consciousness or your behavior, the occurrence of severe diarrhea, myasthenia gravis (muscle autoimmune disease that mainly involves muscle weakness) or cardiac problems, tell your doctor immediately, so that tells you whether you should stop your treatment and replace it with another antibiotic.

Before taking this medicine, tell your doctor if during a previous antibiotic treatment, you presented urticaria or other rash, itching, angioedema (sudden swelling of the face and neck of allergic origin).

Before taking this medicine, tell your doctor if:

kidney disease, severe liver disease, prolongation of the QT interval (anomalies observed on electrocardiogram), hypokalemia, hypomagnesemia (low potassium or magnesium in the blood) bradycardia, cardiac arrhythmia, severe cardiac insufficiency, concomitant treatment with treatment QT: including certain antiarrhythmic drugs (e.g. quinidine, amiodarone, sotalol), antipsychotics (e.g. phenothiazines, pimozide), tricyclic antidepressants (e.g., citalopram) or other antibiotics (e.g. moxifloxacin levofloxacin).

Interactions with other drugs

This medicine is against-indicated in combination with dihydroergotamine, ergotamine. cisapride and colchicine.

In order to avoid possible interactions with several drugs, including bromocriptine (medicine against the flow of milk, against Parkinson's disease), cabergoline (drug against excess prolactin hormone causing lactation), pergolide (medicament indicated for the treatment of Parkinson's disease), lisuride (drug used in Parkinson's disease or against excess prolactin hormone causing lactation), atorvastatin and simvastatin (medicines to decrease the rate of cholesterol), cyclosporine (immunosuppressant), digoxin (a medicine used in certain heart disorders), medicines that can cause torsades de pointes (heart rhythm disorder) and vitamin K (medicine preventing blood clotting), it must systematically report any ongoing treatment with your doctor or pharmacist.

Pregnancy and breast feeding

It is best not to use this medicine during the first three months of pregnancy. From the beginning of the 4th month of pregnancy, the drug will be used only on the advice of your

doctor.

If you discover you are pregnant during treatment, consult your doctor as only he can judge the need to continue.

Ask your doctor or pharmacist before taking any medicine.

3. How to take ZITMYC?

Oral route:

Dosage, Mode and/or route (s) of administration, frequency of administration and Duration of treatment.

Dosage:

As a guide, the usual dose is in adults:

For the treatment of angina and some oral infections: 1 tablet in a single dose per day for 3 days.

For the treatment of bronchitis: 1 tablet as a single dose on day 1, then 1/2 tablet daily the following 4 days.

Strictly comply with the doctor's prescription.

Administration mode

The tablets can be taken with or without food in a single daily dose.

Duration of the treatment

The duration of treatment is:

• 3 days for the treatment of certain throat infections and oral infections.
• 5 days for the treatment of bronchitis.

To be effective, this antibiotic should be used regularly with the prescribed doses, and as long as your doctor has advised you.

The disappearance of fever or other symptoms does not mean that you are completely healed.

The potential feeling of fatigue is not due to antibiotic treatment but the infection itself Reducing or suspend your treatment would have no effect on the printing and delay your healing.

Symptoms and instructions in case of overdosage

If you take more of ZITMYC than you should, check with your doctor or pharmacist.

Instructions in case of failure of one or more doses:

If you forget to take ZITMYC, do not take a double dose to make up the dose you missed.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, ZITMYC 500 mg can cause side effects, although everyone there is no subject.

Very common side effects (may affect more than 1 in 100).

Common side effects (may affect up to 1 to 10 patients in 100).

headache, vomiting, abdominal pain, nausea, decreased lymphocytes (white blood cells in the blood, increased blood levels of eosinophils, basophils, monocytes, neutrophils (white blood cells), decreased bicarbonate in the blood.

Uncommon side effects (may affect up to 1 to 10 patients in 1000).  Infection by fungi especially in the mouth, pneumonia, infection due to bacteria, pharyngitis gastroenteritis, breathing disorder, rhinitis, decreased number of white blood cells (leukocytes, neutrophils, eosinophils), allergy, nervousness, insomnia, dizziness, sleepiness taste disturbance, tingling sensation, blurred vision, hearing impairment, dizziness, loss of appetite, palpitations, flushing, difficulty breathing, nose bleeds, constipation, flatulence, discomfort abdominal, indigestion, difficulty swallowing abdominal distension, dry mouth, rot, mouth ulceration, salivary hypersecretion, rash, itching, hives, skin inflammation, dry skin, excessive sweating, osteoarthritis, muscle pain, back pain, neck pain, difficulty urinating, pain in the kidneys, vaginal bleeding (between periods), issue to the testicles, fatigue, malaise, swelling (edema especially in terms of edema facial angioedema), chest pain, fever, pain, swelling of limbs and extremities, increased blood levels of liver enzymes (aspartate aminotransferase, alanine aminotransferase), bilirubin, urea, creatinine, alkaline phosphatase chloride, glucose, platelets, bicarbonates, decreased blood levels of red blood cells, abnormal blood levels of potassium, sodium, post-procedure complications.

Rare side effects (may affect up to 1 to 10 patients in 10000).

Agitation, liver disorder, cholestatic hepatitis (liver disease characterized by fever and pain), photosensitivity (skin reaction upon exposure to sunlight or UV) adverse events, the frequency is not known.

Severe diarrhea (pseudomembranous colitis, decreased levels of platelets in the blood (important for clotting), hemolytic anemia (destruction of red blood cells in the blood). allergic reaction, aggression, anxiety, delirium, hallucination, syncope, convulsion, decreased skin sensitivity, hyperactivity, loss of smell or taste, gum disease, myasthenia (muscle autoimmune disease), hearing disorders, including deafness and/or tinnitus, heart rhythm disorders (torsades de pointes, arrhythmia, prolongation of the QT interval on the electrocardiogram visible), low blood pressure, inflammation of the pancreas, tongue discoloration, liver damage can rarely jeopardize the patient's life, fulminant hepatitis (acute hepatitis severe), hepatic necrosis, skin peeling can quickly spread throughout the body including the mucous membranes (Stevens-Johnson syndrome and toxic epidermal necrolysis), erythema multiforme, pain in the joints, acute renal failure, interstitial nephritis (inflammation of the kidney).

Reporting Side Effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to any possible side effects not listed in this leaflet.

5. How to store ZITMYC?

Keep out of the reach and sight of children.

Do not store above 30°C, store in the original package in order to protect from light. 

Do not use ZITMYC after the expiry date stated on the box.

Classification: This drug is under medical prescription. Respect the prescribed doses.

6. Further information on ZITMYC.

What ZITMYC contain?

Each tablet contains 500mg of azithromycin (the active ingredient).

The tablets also contain:

Core: hyprolose, starch, magnesium stearate, talc

Coating premix for coating, 95% ethanol, purified water.

What ZITMYC looks like and contents of the pack?

ZITMYC (3 tablets/blister/ box) are white film-coated tablet with an oblong, convex shape. and a scoreline on one side.

Marketing authorization holder: B&O PHARM

ZAC de la Masquère-500 rue de l'Hers-31750 ESCALQUENS France.

Manufacturer: CSPC Ouyl Pharmaceutical Co., Ltd.

No.88 Yangzi Road, Economic and Technological Development Zone, Shijiazhuang, Hebel

China.