CLERON Film-coated tablet (2021)

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Περιεχόμενα

1. Name of the medicinal product

Cleron 250 mg film-coated tablets.

2. Qualitative and quantitative composition

Each film-coated tablet contains 250 mg of clarithromycin. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Film-coated tablets. Cleron 250 mg film-coated tablets are yellow, round, concave film-coated tablets, 12 mm in diameter, scored on one side and embossed with CLERON 250.

4.1. Therapeutic indications

Consideration should be given to official guidance on the appropriate use of antibacterial agents. Cleron 250 mg film-coated tablets are indicated in adults and children 12 years and older. Clarithromycin ...

4.2. Posology and method of administration

Patients with respiratory tract/skin and soft tissue infections Adults: The usual dose is 250 mg twice daily although this may be increased to 500 mg twice daily in severe infections. The usual ...

4.3. Contraindications

Hypersensitivity to macrolide antibiotic drugs or to any of the excipients listed in section 6.1. Concomitant administration of clarithromycin and ergot alkaloids (e.g. ergotamine or dihydroergotamine) ...

4.4. Special warnings and precautions for use

Use of any antimicrobial therapy, such as clarithromycin, to treat H. pylori infection may select for drug-resistant organisms. The physician should not prescribe clarithromycin to pregnant women ...

4.5. Interaction with other medicinal products and other forms of interaction

The use of the following drugs is strictly contraindicated due to the potential for severe drug interaction effects: Concomitant administration of clarithromycin with lomitapide is contraindicated ...

4.6. Fertility, pregnancy and lactation

Pregnancy The safety of clarithromycin for use during pregnancy has not been established. Based on variable results obtained from animal studies and experience in humans, the possibility of adverse effects ...

4.7. Effects on ability to drive and use machines

There are no data on the effect of clarithromycin on the ability to drive or use machines. The potential for dizziness, vertigo, confusion and disorientation, which may occur with the medication, should ...

4.8. Undesirable effects

a. Summary of the safety profile The most frequent and common adverse reactions related to clarithromycin therapy for both adult and paediatric populations are abdominal pain, diarrhoea, nausea, vomiting ...

4.9. Overdose

Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce gastro-intestinal symptoms. One patient who had a history of bipolar disorder ingested 8 grams of clarithromycin ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antibacterial for systemic use, macrolide ATC-Code: J01FA09 Mechanism of action Clarithromycin is an antibiotic belonging to the macrolide antibiotic group. It ...

5.2. Pharmacokinetic properties

H. pylori is associated with acid peptic disease including duodenal ulcer and gastric ulcer in which about 95% and 80% of patients respectively are infected with the agent. H. pylori ...

5.3. Preclinical safety data

In acute mouse and rat studies, the median lethal dose was greater than the highest feasible dose for administration (5 g/kg). In repeated dose studies, toxicity was related to dose, duration of treatment ...

6.1. List of excipients

Povidone, sodium starch glycolate, microcrystalline cellulose, starch, crospovidone, stearic acid, magnesium stearate, talc, colloidal silicon dioxide. Coating: opadry, quinoline yellow lake.

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store below 25ºC. Protect from light and humidity.

6.5. Nature and contents of container

PVC/Al blister strips: 7 tablets and 14 tablets. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

7. Marketing authorization holder

Delorbis Pharmaceuticals Ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union

8. Marketing authorization number(s)

018052

9. Date of first authorization / renewal of the authorization

Date of first authorization: 30 November 1998

10. Date of revision of the text

29/03/2021

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