Roclarin belongs to a group of antibiotics called macrolides.
Roclarin is indicated for the treatment of the following infections caused by susceptible microorganisms:
- infections of the lower respiratory tract, such as acute and chronic bronchitis, pneumonia;
- upper respiratory tract infections, such as sinusitis and pharyngitis;
- community-acquired respiratory infections with common and atypical respiratory pathogens;
- mild to moderate skin and soft tissue infections;
- Helicobacter pylori infections in patients with duodenal ulcer, in combination with other drugs.

Do not use Roclarin:
- if you are allergic to clarithromycin, other macrolides or any of the other ingredients of this medicine.

Talk to your doctor or pharmacist before using Roclarin.

Pregnancy, fertility and breastfeeding:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
The safety and efficacy of clarithromycin administration during pregnancy have not been established, therefore the drug can only be administered in exceptional cases, when the benefit to the mother outweighs the risk to the fetus.
Breastfeeding is not recommended during treatment with clarithromycin.

Driving and using machines:
There are no data available on the effect of clarithromycin on the ability to drive or use machines. However, the possible occurrence of adverse reactions such as dizziness, vertigo, confusion and disorientation should be taken into account.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Talk to your doctor or pharmacist if you are not sure.

The doses and duration of treatment depend on the type of infection, the site of infection, the patient's age and the response to treatment.

Swallow Roclarin tablets whole, without chewing, with a sufficient amount of water.

Patients with respiratory, skin and soft tissue infections:
Adults and adolescents
The usual recommended dose is 250 mg of clarithromycin twice daily for 7 days; in severe infections, the dose may be increased to 500 mg of clarithromycin twice daily for up to 14 days.

In acute sinusitis, exacerbations of chronic bronchitis, community-acquired pneumonia, the usual dose is 500 mg twice a day.
The duration of treatment depends on the clinical condition of the patients and will be determined individually.
The usual duration of treatment is 7 - 14 days.

Treatment should be continued for at least 2 days after the disappearance of any symptoms.
In infections with Streptococcus pyogenes (group A beta-haemolytic streptococcus) the duration of treatment should be at least 10 days.

Children under 12 years of age:
It is recommended to use other pharmaceutical forms.

Eradication of Helicobacter pylori infection in patients with duodenal ulcer (adults)

Triple therapy (7-14 days): 500 mg clarithromycin twice daily in combination with lansoprazole 30 mg twice daily and amoxicillin 1000 mg twice daily, for 7-14 days.

Triple therapy (7 days): 500 mg clarithromycin twice daily in combination with lansoprazole 30 mg twice daily and metronidazole 400 mg twice daily, for 7 days.

Triple therapy (7 days): 500 mg clarithromycin twice daily in combination with omeprazole 40 mg once daily and amoxicillin 1000 mg twice daily or metronidazole 400 mg twice daily, for 7 days.

Triple therapy (10 days): 500 mg clarithromycin twice daily in combination with amoxicillin 1000 mg twice daily and omeprazole 20 mg once daily, for 10 days.

Dual therapy (14 days): The usual dose is 500 mg of clarithromycin 3 times a day for 14 days.
Clarithromycin should be administered in combination with omeprazole 40 mg orally once daily.

Elderly:
It is recommended to use the same doses and therapeutic regimens as in adults.

Patients with renal insufficiency:
Dosage adjustment is not usually necessary, except in patients with severe renal impairment (creatinine clearance <30 ml/minute), in which case the total daily dose should be halved, i.e. 250 mg clarithromycin once daily for mild to moderate infections or 250 mg clarithromycin twice daily for severe infections.

If you have any further questions on this medicine, ask your doctor or pharmacist.

- The active substance is clarithromycin. One film-coated tablet contains 500 mg of clarithromycin.
- The other ingredients are: core - croscarmellose sodium, maize starch, copovidone, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate and film - partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, quinoline yellow aluminium lake (E 104), yellow iron oxide (E 172)

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

20 film-coated tablets