Expiration date: 11/2025

Composition 

1 tablet of prolonged action covered with a film shell contains clarithromycin 500 mg. 

Auxiliary substances: sodium alginate, calcium sodium alginate, lactose monohydrate, povidone, Polysorbate 80, silicon dioxide colloidal anhydrous, magnesium stearate, talc, hypromellose, dye quinoline yellow (E104), titanium dioxide (E171), propylene glycol.

Packaging

14 PCs.

Pharmacological action

Fromilid UNO-semi-synthetic antibiotic from the group of macrolides. Inhibits protein synthesis in microbial cells, has a bacteriostatic (mostly) and bactericidal action.

Indications

• Infections of the upper respiratory tract including: tonsillopharyngitis, acute sinusitis. 
  
• Otitis media. 
  
• Infections of the lower respiratory tract. 
  
• Infections of the skin and soft tissues. 
  
• Infections caused by mycobacteria including: Mycobacterium avium complex, Mycobacterium kansasii, Mycobacterium mannum, Mycobacterium leprae. 
  
• Other infectious and inflammatory diseases caused by microorganisms sensitive to the drug. 
  
• Eradication of Nelicobacter pylori and reduction of duodenal ulcer recurrence (as part of combination therapy).
  

Contraindications

• Hepatic insufficiency of severe degree. 
  
• Hepatitis (in the anamnesis). 
  
• Porphyria. 
  
• I trimester of pregnancy. 
  
• Lactation. 
  
• Concomitant use with terfenadine, cisapride, pimozide or astemizole. 
  
• Hypersensitivity to clarithromycin or other antibiotics from the group of macrolides.
  

Application during pregnancy and breast-feeding

The use of the drug in the first trimester of pregnancy is contraindicated. The use of the drug in II and III trimestrah pregnancy is possible only in the case when expected benefit for mother exceeds the potential risk to the fetus. Clarithromycin is excreted in breast milk, so if you need to use the drug during lactation breastfeeding should be stopped.

Method of application and doses

The tablets should be taken with food: swallow whole, squeezed small amount of liquid, not to break. Adults and children over the age of 12 years appoint 500 mg/day (1 tablet). For the treatment of severe infections, the daily dose is increased to 1000 mg/day (2 tablets). The duration of treatment is usually 7-14 days.

Side effect

From the digestive system: nausea, vomiting, diarrhea (in severe and persistent diarrhea, which may be a consequence of pseudomembranous colitis, the drug should be abolished), abdominal pain, stomatitis, glossitis, transient change in taste sensations, very rarely - increased activity of liver enzymes, cholestatic jaundice. 

From the Central and peripheral nervous system: headache, in some cases - dizziness, confusion, fear, insomnia, nightmares. 

From the cardiovascular system: very rarely - lengthening of THE Qt interval, ventricular arrhythmia (including ventricular paroxysmal tachycardia, trembling or flickering of the ventricles). 

Allergic reactions: hypersensitivity reactions (including urticaria, anaphylaxis), very rarely - Stevens-Johnson syndrome. 

In most patients, adverse events of low intensity. In the case of side effects you should consult your doctor.

Special instruction

You should be wary of Fromilid UNO on the background of the drugs, metabolized by the liver (it is recommended to measure their concentration in the blood). With simultaneous use with warfarin or other indirect anticoagulants, prothrombin time must be controlled. Attention should be drawn to the possibility of cross-resistance between clarithromycin and other antibiotics from the macrolide group, as well as lincomycin and clindamycin. In severe persistent diarrhea, which may indicate pseudomembranous colitis should stop taking the drug and consult a physician.