Azigyl (Azithromycin) 500mg

Composition: 1 tablet contains – active substance: 500mg

Packaging: Azigyl, coated tablets, 500mg – 10 tablets in a blister

What Azigyl is and what it is used for?

Azigyl coated tablets contain Azithromycin, an antibiotic belonging to the group of the macrolides. Azithromycin is a broad spectrum antibiotic and shows in-vitro effect on most strains of the following micro-organisms: Gram-positive aerobic bacteria:
Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pyogenes, Erythromycin-resistant Gram-positive strains and majority of methicillin-resistant Staphylococcus spp. strains show cross-resistance to Azithromycin.

Gram-negative aerobic bacteria: Haemophilius ducrei, Haemophilus influenza, Haemophilus parainfluenza, Moraxella catharralis, Neisseria gonorrhoeae, Bordetella pertusis, Bordetella parapertusis, legionella pneumophilia.
Anaerobic bacteria: Bacteriodes bivius, clostridium perfringens, Peptostreptococcus spp.
Other micro-organisms: Chlamydia pneumonia, Chlamydia trachomatis, Mycoplasma pneumonia, Mycoplasma hominis, Ureaplasma Urealyticum, Borrelia burgdorferi, Treponema pallidum.
Upon oral administration Azithromycin reaches its maximum concentration in the blood within 2-3 hours. It penetrates into cells, where it reaches concentrations higher than in the serum;
Elimination half life of the drug product is long (2 to 4 Days) and tissue wash out is slow.
The drug product is excreted mainly with bile and to a small extent with urine.

Indications for use of Azigyl:
. Upper respiratory tract infections: bacterial pharyngitis, tonsillitis, sinusitis, and otitis media
. Lower respiratory tract infections: bacterial bronchitis, interstitial pneumonia and bronchopneumonia
. Skin and soft tissue infections; erythema migrans (initial symptoms of lyme borreliosis), erysipelas, impetigo
. Sexually transmitted diseases (STDs): uncomplicated non-gonococcal urethritis, cervicitis.
Before you use Azigyl:
The medicinal product should not be administered if you had in the past any allergic reaction to macrolide antibiotics or any other infections caused by resistant micro-organisms, especially by fungi.
As in the case of treatment with other antibiotics, the risk of occurrence of pseudomembraneous enteritis cannot be excluded. You could immediately see a doctor or pharmacist if diarrhoea (in particular persistent one) occurs during the treatment with the medicinal product. The doctor or pharmacist may decide to discontinue Azigyl treatment and apply additional treatment with appropriate medicinal products (e.g administer metronidazole or vancomycin orally). Drugs slowing bowel movement should not be taken.

The Azigyl drug product should not be used in patients with pneumonia who are not able to take the medicine properly, their condition is severe , they suffer from cystic fibrosis, acquired hospital infection or diagnosed /suspected bacteraemia.
The drug product should not be used by patients who require hospitalization, by weakened patients, elderly patients, patients with immunological disorders or dysfunction of the spleen (asplenia)

The medicine should be used with special care in persons with kidney or liver dysfunction.

Pregnancy: There are no sufficient data concerning safety of use of the drug in pregnant women

Lactation:
There are no sufficient data concerning penetration of Azithromycin into the milk of breastfeeding women. A doctor or pharmacist may use the drug product in breastfeeding women if it is believed necessary.

How to use Azigyl:
Azigyl should be used according to a doctor’s or pharmacist’s advice.
The medicine should be taken once daily at least before meals or 2 hours after meals.

Usual Dose of Azigyl:
In adults and children of body weight up to 45kg:
Infections of the lower/upper respiratory tract and skin/soft tissue infections
500mg as a single daily dose administered for 3 days.
Sexually transmitted diseases: 1g as a single dose

In elderly persons change of dose is not necessary
In children of body weight up to 45kg:
Infections of the lower/upper respiratory tract and skin/soft tissue infections
Entire dos is 30mg/kg body weight, i.e. 10mg/kg body weight administered once daily for 3 days.
The Azigyl coated tablets may be used only in those children that can swallow tablets.

There are no sufficient data concerning the use of the drug product in infants below six months of age.
If you took more of the drug product than the administered dose:

Undesirable symptoms observed after taking doses higher than recommended were similar to those occurring during proper use of Azithromycin. Typical symptoms of macrolide antibiotics overdose are: temporary hearing loss, severe nausea, vomiting, diarrhea.

If you omitted a dose of the drug product:

Take the omitted dose as soon as possible and take next dose as prescribed by the doctor or the pharmacist.
Do not take a double dose in order to make up for the omitted dose.

Possible undesirable effects:
Azithromycin is generally well tolerated.
However during the use of Azithromycin cases of the following undesirable effects were observed:
Blood and lymphatic system disorders: thrombocytopenia, transient neutropenia
Infections: vaginitis, candidiasis; Immunologic system disorder: anaphylaxis; Metabolism and nutrition disorders loss of apetite.

Mental disorders: aggression, nervousness, agitation anxiety; Nervous system disorders: vertigo, convulsions, headaches, insomnia; Hearing and balance disorders: labyrinth vertigo, hearing disorders including hearing impairment, deafness, ear buzzing.
Gastrointestinal disorders: nausea, vomiting, loose stool, indigestion, abdominal pain and contractions, constipation, distension with gas.
Renal and urinary tract disorders: interstitial nephritis, acute renal failure.

Tell your Doctor or Pharmacist if you notice any undesirable symptoms, even those not mentioned in this writeup