Abbott Healthcare Products Limited

SmPC has been updated to align with the CSP. There are major changes to the following sections:

4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special Warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interactions
4.6 Pregnancy and lactation
4.7 Effects on the ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5.1 Pharmacodynamic properties

PLEASE NOTE THIS TEXT SHOULD NOT BE IN ITALIC BUT CANNOT CHANGE IT

4.1              Therapeutic indications

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Klaricid Adult Sachets 250mg are indicated in adults and children 12 years and older.

            Clarithromycin is indicated in the treatment of infections caused by one or more susceptible organisms.  Indications include:

            Lower respiratory tract infections for example, acute and chronic bronchitis, and pneumonia.

            Upper respiratory tract infections for example, sinusitus and pharyngitis.

            Clarithromycin is appropriate for initial therapy in community acquired respiratory infections and has been shown to be active in vitro against common and atypical respiratory pathogens as listed in the microbiology section.

            Clarithromycin is also indicated in skin and soft tissue infections of mild to moderate severity.

            Clarithromycin in the presence of acid suppression effected by lansoprazole or omeprazole is also indicated for the eradication of H. pylori in patients with duodenal ulcers.  See Dosage and Administration section.

            Clarithromycin is usually active against the following organisms in vitro:

            Gram-positive Bacteria:   Staphylococcus aureus (methicillin susceptible); Streptococcus pyogenes (Group A beta-hemolytic streptococci); alpha-hemolytic streptococci (viridans group); Streptococcus (Diplococcus) pneumoniae; Streptococcus agalactiae; Listeria monocytogenes.

            Gram-negative Bacteria:  Haemophilus influenzae; Haemophilus parainfluenzae; Moraxella (Branhamella) catarrhalis; Neisseria gonorrhoeae; Legionella pneumophila; Bordetella pertussis; Helicobacter pylori; Campylobacter jejuni.

            Mycoplasma:  Mycoplasma pneumoniae; Ureaplasma urealyticum.

            Other Organisms:  Chlamydia trachomatis; Mycobacterium avium; Mycobacterium leprae.

            Anaerobes:  Macrolide-susceptible Bacteroides fragilis; Clostridium perfringens; Peptococcus species; Peptostreptococcus species; Propionibacterium acnes.

            Clarithromycin has bactericidal activity against several bacterial strains.  These organisms include Haemophilus influenzae; Streptococcus pneumoniae; Streptococcus pyogenes; Streptococcus agalactiae; Moraxella (Branhamella) catarrhalis; Neisseria gonorrhoeae; Helicobacter pylori and Campylobacter spp.

            The activity of clarithromycin against H. pylori is greater at neutral pH than at acid pH.

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 for 7 days although this may be increased to 500mg twice daily for up to 14 days in severe infections. The usual duration of treatment is 6 to 14 days.

            Children older than 12 years:  As for adults.

            Children younger than 12 years: Use Clarithromycin Paediatric Suspension.

Children younger than 12 years: Use of Klaricid Adult Sachets 250mg are not recommended for children younger than 12 years. Use Klaricid Paediatric Suspension.

            Eradication of H. pylori in patients with duodenal ulcers (Adults)

The usual duration of treatment is 6 to 14 days.

            Triple Therapy (7 - 14 days)

            Clarithromycin 500mg twice daily and lansoprazole 30mg twice daily should be given with amoxycillin 1000mg twice daily for 7 - 14 days.

            Triple Therapy (7 days)

            Clarithromycin (500mg) twice daily and lansoprazole 30mg twice daily should be given with metronidazole 400mg twice daily for 7 days.

            Triple Therapy (7 days)

            Clarithromycin (500mg) twice daily and omeprazole 40mg daily should be given with amoxycillin 1000mg twice daily or metronidazole 400mg twice daily for 7 days.

            Triple Therapy (10 days)

            Clarithromycin (500mg) twice daily should be given with amoxycillin 1000mg twice daily and omeprazole 20mg daily for 10 days.

            Dual Therapy (14 days)

            The usual dose of Clarithromycin is 500 mg three times daily for 14 days.  Clarithromycin should be administered with oral omeprazole 40 mg once daily.  The pivotal study was conducted with omeprazole 40 mg once daily for 28 days.  Supportive studies have been conducted with omeprazole 40 mg once daily for 14 days.

            For further information on the dosage for omeprazole see the Astra data sheet.

            Elderly:  As for adults.

            Renal impairment:  Dosage adjustments are not usually required except in patients with severe renal impairment (creatinine clearance < 30 ml/min).  If adjustment is necessary, the total daily dosage should be reduced by half, e.g. 250 mg once daily or 250 mg twice daily in more severe infections.

Clarithromycin may be given without regard to meals as food does not affect the extent of bioavailability.

6.1       List of excipients

Carbomers (Carbopol 974P)

Povidone K90

Water purified

Hypromellose phthalate (HP-55)

Castor oil

Ethanol

Acetone

Silicon dioxide

Maltodextrin

Sucrose

Titanium dioxide

Ultrasperse modified starch

Orange Bramble Flavour

Ammonium glycyrrhizinate

Acesulfame potassium (Acesulfame K).

4.3 (See section 4.5).

4.4 There have been post-marketing reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency. Deaths have been reported ins ome such patients (see Section 4.5).

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 There have been post-marketed reports of Torsade de Pointes occurring with the concurrent use of clarithromycin and quinidine or disopyramide. Levels of these medications should be monitored during clarithromycin therapy.

As with other macrolide antibiotics the use of clarithromycin in patients concurrently taking drugs metabolized by the cytochrome P450 system (eg Cilostazol, methylprednisolone, oral anticoagulants (eg warfarin), quinidine, sildenafil, ergot alkaloids, alprazolam, triazolam, midazolam, disopyramide, lovastatin, rifabutin, pheyntoin, cyclosporine, vinblastine, valporate and tacrolimus) may be associated with elevations in serum levels of these other drugs.

Colchicine is a substrate for both CYP3A and the efflux transporter, P-glycoprotein (Pgp). Clarithromycin and other macrolides are known to inhibit CYP3A and Pgp. When clarithromycin and colchicine are administered together, inhibition of Pgp and/or CYP3A by clarithromycin may lead to increased exposure to colchicine. Patients should be monitored for clinical symptoms of colchicine toxicity (see Section 4.4).

Post-marketing reports indicate that co-administration of clarithromycin with ergotamine or dihydroergotamine has been associated with acute ergot toxicity characterized by vasospasm and ischaemia of the extremities and other tissues including the central nervous system (see section 4.3 Contra-indications).

4.8 There have been post-marketing reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency. Deaths have been reported in some such patients (see sections 4.4 and 4.5).

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal products and other handling of the product.