Fromilid uno 500 mg prolonged-release tablets – clarithromycin once daily

Fromilid uno contains clarithromycin, a macrolide antibiotic, as a modified-release (prolonged-release) film-coated tablet. Thanks to this form, usually only one tablet a day is taken.

In Serbia it is authorised as Fromilid® uno, 500 mg, modified-release film-coated tablets, in packs of 7 and 14 tablets. It is used to treat lower and upper respiratory tract infections and mild to moderate skin and soft tissue infections in adults and children over 12 years.

What is Fromilid uno used for and how should it be taken correctly?

Key facts about the medicine

What is Fromilid uno used for?

According to the package leaflet, Fromilid uno is used to treat:

• lower respiratory tract infections – acute and chronic bronchitis and pneumonia;
• upper respiratory tract infections such as throat and sinus infections;
• mild to moderate skin and soft tissue infections such as cellulitis, folliculitis or erysipelas.

The medicine is intended for adults and children over 12 years of age.

How is it taken and dosed?

• Take the tablet with a meal and swallow it whole with at least half a glass of liquid – do not break or chew it, as this would destroy the prolonged release.
• The doctor decides the duration of treatment; do not stop without agreement, as the symptoms may return.

Special patient groups

• Children: the tablets are not intended for children under 12.
• Kidneys and liver: severe kidney disease and severe liver disease combined with kidney disease are contraindications; milder forms require caution.
• Heart disease: bradycardia, any heart disease and low magnesium require a discussion with the doctor.
• Controlled sodium intake: one tablet contains 12.85 mg sodium; the medicine also contains lactose.

Contraindications – when the medicine must not be used

Do not take Fromilid uno:

• if you are allergic to clarithromycin, other macrolides (erythromycin, azithromycin) or any ingredient of the medicine;
• if you take ergot alkaloids (ergotamine, dihydroergotamine), including inhaled migraine products;
• if you take terfenadine, astemizole, cisapride, domperidone or pimozide;
• if you take oral midazolam;
• if you take lovastatin or simvastatin;
• if you have low potassium (hypokalaemia) or low magnesium (hypomagnesaemia) in the blood;
• if you have severe kidney disease, or severe liver disease combined with kidney disease;
• if you or a family member have had ventricular arrhythmias (including torsades de pointes) or long QT syndrome;
• if you take ticagrelor or ranolazine, other medicines that cause serious rhythm disorders, colchicine or lomitapide.

Warnings and precautions

Talk to your doctor before taking the medicine if:

• you have liver or kidney disease;
• you have or are prone to fungal infections (thrush);
• severe or prolonged diarrhoea develops during or after treatment – it may be a sign of pseudomembranous colitis (Clostridium difficile);
• you have any heart disease or a slow heart rate; you have low magnesium;
• you are pregnant or breast-feeding.

In case of a severe acute hypersensitivity reaction (shortness of breath, swelling of the face, throat or tongue, rash, peeling skin) stop the medicine immediately. Long-term use may lead to overgrowth of non-susceptible bacteria and fungi. Cross-resistance with other macrolides, lincomycin and clindamycin is possible.

Interactions with other medicines, food and drink

Tell your doctor, as they may change the dose or request tests, if you take:

• digoxin, quinidine or disopyramide; warfarin or other anticoagulants;
• carbamazepine, valproate, phenobarbital or phenytoin;
• atorvastatin or rosuvastatin (risk of rhabdomyolysis);
• nateglinide, pioglitazone, repaglinide, rosiglitazone or insulin;
• theophylline; triazolam, alprazolam or intravenous/oromucosal midazolam;
• cilostazol, omeprazole, methadone, methylprednisolone;
• vinblastine, ibrutinib; ciclosporin, sirolimus, tacrolimus;
• HIV medicines (etravirine, efavirenz, nevirapine, ritonavir, zidovudine, atazanavir, saquinavir);
• rifabutin, rifampicin, rifapentine, fluconazole, itraconazole; tolterodine;
• verapamil, amlodipine, diltiazem; sildenafil, vardenafil, tadalafil;
• St John’s wort; quetiapine and other antipsychotics;
• other macrolides, lincomycin, clindamycin, aminoglycosides and other medicines toxic to hearing.

If you use oral contraceptives and get diarrhoea or vomiting, tell your doctor – additional contraception (e.g. a condom) may be needed.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant, are planning a pregnancy or are breast-feeding, ask your doctor or pharmacist before taking the medicine, as safety in pregnancy and breast-feeding has not been established.

Driving and using machines

Fromilid uno may cause dizziness and drowsiness. If you notice these effects, do not drive or use machines.

Possible side effects

Stop taking the medicine and contact your doctor immediately in case of: severe and prolonged diarrhoea with blood or mucus (even up to two months after treatment); rash, difficulty breathing, fainting or swelling of the face, tongue, lips, eyes and throat; jaundice, pale stools, dark urine or loss of appetite; blisters on the skin, in the mouth, on the lips, eyes and genitals; red scaly rash with blisters; DRESS syndrome (rash, fever, inflammation of internal organs); muscle pain or weakness (rhabdomyolysis).

• common (up to 1 in 10): headache, insomnia, taste changes, nausea, vomiting, abdominal pain, heartburn, diarrhoea, liver function changes, rash, increased sweating;
• uncommon (up to 1 in 100): fever, weakness, swelling, redness or itching of the skin, oral or vaginal thrush, blood count changes, loss of appetite, bloating, constipation, wind, nervousness, drowsiness, dizziness, tremor, ringing in the ears, palpitations, asthma, nosebleed, pulmonary embolism, inflammation of the oesophagus or stomach, dry mouth, joint pain, muscle pain and cramps, liver enzyme changes, cholestasis;
• frequency not known: colitis, skin infection, confusion, hallucinations, depression, nightmares, mania, convulsions, tingling, loss of taste or smell, hearing loss, torsades de pointes, ventricular tachycardia and fibrillation, pancreatitis, discoloration of tongue or teeth, acne, jaundice, kidney inflammation or impaired kidney function.

Overdose, missed dose and stopping treatment

• Overdose: if you have taken too much or a child has swallowed the tablets, contact a doctor or emergency service immediately; vomiting and abdominal pain are likely.
• Missed dose: take it as soon as you remember; do not take a double dose and do not exceed the prescribed number of tablets per day.
• Stopping treatment: do not stop the medicine yourself even if you feel better.

Related information

For support of the gut flora during and after antibiotic treatment, see also the category Products with probiotics – products in this category do not replace the medicine prescribed for you.

Composition, pack and manufacturer

• Active substance: clarithromycin 500 mg per modified-release tablet.
• Tablet core: sodium alginate (E401), sodium calcium alginate, lactose monohydrate, povidone, polysorbate 80 (E433), colloidal anhydrous silica, talc (E553b), magnesium stearate (E572).
• Film coating: hypromellose, yellow iron oxide (E172), titanium dioxide (E171), propylene glycol (E1520), talc (E553b).
• Pack: PVC/PVDC/Al blister with 7 tablets; carton with 1 blister (7 tablets) or 2 blisters (14 tablets).
• Marketing authorisation holder: Krka-Farma d.o.o., Jurija Gagarina 26/V/II, Belgrade. Manufacturer: Krka, d.d., Novo mesto, Slovenia.

Storage

• Store below 30 °C in the original package to protect from moisture.
• Keep out of the sight and reach of children.
• Do not use after the expiry date; return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

What is the difference between Fromilid uno and Fromilid 500 mg?

Both contain 500 mg of clarithromycin. Fromilid uno is a modified-release tablet usually taken once daily with a meal, whereas regular Fromilid tablets are taken twice daily, with or without food. Do not switch between them without your doctor’s advice.

May I split the tablet?

No. The tablet should be swallowed whole, without breaking or chewing, to preserve the prolonged release of the medicine.

How long is Fromilid uno taken for?

Usually 6 to 14 days, as decided by the doctor. Do not stop treatment early just because you feel better.

Does Fromilid uno affect contraception?

The leaflet advises telling your doctor if you get diarrhoea or vomiting while taking oral contraceptives, as additional contraception, e.g. a condom, may then be needed.

Sources

• ALIMS – Summary of Product Characteristics, Fromilid® uno 500 mg modified-release film-coated tablets (SmPC, Serbian, 7 tablets)
• ALIMS – Package leaflet, Fromilid® uno 500 mg (PIL, Serbian, 7 tablets)
• ALIMS – Summary of Product Characteristics, Fromilid® uno 500 mg (SmPC, Serbian, 14 tablets)
• ALIMS – Package leaflet, Fromilid® uno 500 mg (PIL, Serbian, 14 tablets)

Sources checked on: 25 October 2026.