CLAREM Film-coated tablet (2021)

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Περιεχόμενα

1. Name of the medicinal product

Clarem 250 mg film-coated tablets. Clarem 500 mg film-coated tablets.

2. Qualitative and quantitative composition

Clarem 250 mg film-coated tablets: Each film-coated tablet contains 250 mg clarithromycin. Clarem 500 mg film-coated tablets: Each film-coated tablet contains 500 mg clarithromycin. For the ...

3. Pharmaceutical form

Film-coated tablet. Clarem 250 mg film-coated tablets: Yellow, parallel, capsule shaped, film-coated tablets with Remedicas logo on both sides. Clarem 500 mg film-coated tablets: Yellow, ...

4.1. Therapeutic indications

Clarithromycin is indicated for the treatment of infections caused by susceptible organisms. Such infections include: 1. Lower respiratory tract infections (e.g. bronchitis, pneumonia) (see section 4.4 ...

4.2. Posology and method of administration

Posology Adults The usual dosage of clarithromycin in adults is 250 mg tablet twice daily. In more severe infections, the dosage can be increased to 500 mg twice daily. The usual duration of therapy is ...

4.3. Contraindications

Hypersensitivity to macrolide antibiotic drugs or to any of its excipients (see section 6.1). Concomitant administration of clarithromycin and any of the following drugs is contraindicated: astemizole, ...

4.4. Special warnings and precautions for use

The physician should not prescribe clarithromycin to pregnant women without carefully weighing the benefits against risk, particularly during the first three months of pregnancy (see section 4.6). Clarithromycin ...

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 Cisapride, pimozide, astemizole, domperidone and terfenadine Elevated cisapride levels ...

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: Antibacterials for systemic use; Macrolides, lincosamides and streptogramins ATC code: J01FA09 Clarithromycin is a semi-synthetic derivative of erythromycin A. ...

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 is also implicated ...

5.3. Preclinical safety data

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

6.1. List of excipients

Core: Povidone Cellulose, microcrystalline Sodium starch glycolate (Type A) Silica, colloidal anhydrous Magnesium stearate Coating: Hypromellose Macrogol 400 Titanium Dioxide Talc Quinoline ...

6.2. Incompatibilities

None known.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store below 25°C. Protect from light and moisture.

6.5. Nature and contents of container

Clarem 250 mg film-coated tablets: PVC-PVDC/Aluminium blisters. Pack sizes of 14 and 100 film-coated tablets. Clarem 500 mg film-coated tablets: PVC-PVDC/Aluminium blisters. Pack sizes of ...

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

7. Marketing authorization holder

Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus

8. Marketing authorization number(s)

Clarem 250 mg film-coated tablets: 19180 Clarem 500 mg film-coated tablets: 19181

9. Date of first authorization / renewal of the authorization

Clarem 250 mg film-coated tablets: Date of first authorization: 12 March 2001 Date of latest renewal: 29 March 2013 Clarem 500 mg film-coated tablets: Date of first authorization: 13 March 2001 Date of ...

10. Date of revision of the text

12/03/2021

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