Updated on 15/11/2011 and displayed until Current
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 03-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 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
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Updated on 17/02/2011 and displayed until 15/11/2011
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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| Date of revision of text on the SPC: 02-Feb-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 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 XL or Clarithromycin 500 mg Modified Release Tablets are indicated in adults and children 12 years and older.
Klaricid XL or Clarithromycin 500 mg Modified Release Tablets is indicated for treatment of infections caused by susceptible organisms. Indications include:
Lower respiratory tract infections for example, acute and chronic bronchitis, and pneumonia.
Upper respiratory tract infections for example, sinusitis and pharyngitis.
Klaricid XL or Clarithromycin 500 mg Modified Release Tablets is also indicated in skin and soft tissue infections of mild to moderate severity, for example folliculitis, cellulitis and erysipelas.
4.2 Posology and method of administration
Adults: The usual recommended dosage of Klaricid XL or Clarithromycin 500 mg Modified Release Tablets in adults is one 500mg modified-release tablet daily to be taken with food.
In more severe infections, the dosage can be increased to two 500mg modified-release tablets daily. The usual duration of treatment is 7 6 to 14 days.
Children older than 12 years: As for adults.
Children younger than 12 years: Use Klaricid Paediatric Suspension or Clarithromycin 125 mg/5ml Granules for Oral Suspension.
Children younger than 12 years: Use of Klaricid XL or Clarithromycin 500 mg Modified Release Tablets are not recommended for children younger than 12 years. Use Klaricid Paediatric Suspension.
Klaricid XL or Clarithromycin 500 mg Modified Release Tablets should not be used in patients with renal impairment (creatinine clearance less than 30 mL/min). Clarithromycin immediate release tablets may be used in this patient population. (See 4.3 Contra-indications).
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Updated on 12/01/2010 and displayed until 17/02/2011
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 02-Jan-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 has been updated to change the address of the MAH from Queenborough, Kent, ME11 5EL to Abbott House, Vanwall business Park, Vanwall Road, Maidenhead, Berkshire, SL6 4XE.
Section 10 has been updated with a new date of revision.
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Updated on 18/09/2007 and displayed until 12/01/2010
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 09/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to section 6.1 of the SPC: change from polyethylene glycol 8000, USNF to polyethylene glycol (8000) Ph. Eur.
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Updated on 28/09/2006 and displayed until 18/09/2007
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 09/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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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 As with other macrolide antibiotics the use of clarithromycin in patients concurrently taking drugs metabolised by the cytochrome P450 system (eg. Cilostazol, methylprednisolone, anticoagulants (eg warfarin) quinidine, sildenafil, ergot alkaloids, alprazolam, triazolam, midazolam, disopyramide, lovastatin, rifabutin, phenytoin, cyclosporin, vinblastine, valproate and tacrolimus) may be associated with elevations in serum levels of these other drugs.
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.
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 reports of Stevens-Johnson syndrome / toxic epidermal necrolysis with orally administered clarithromycin.
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.
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Updated on 26/09/2006 and displayed until 28/09/2006
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 6 - Instruction for Use/Handling
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| Date of revision of text on the SPC: 09/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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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 As with other macrolide antibiotics the use of clarithromycin in patients concurrently taking drugs metabolised by the cytochrome P450 system (eg. Cilostazol, methylprednisolone, anticoagulants (eg warfarin) quinidine, sildenafil, ergot alkaloids, alprazolam, triazolam, midazolam, disopyramide, lovastatin, rifabutin, phenytoin, cyclosporin, vinblastine, valproate and tacrolimus) may be associated with elevations in serum levels of these other drugs.
4.8
There have been reports of Stevens-Johnson syndrome / toxic epidermal necrolysis with orally administered clarithromycin.
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.
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.
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).
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Updated on 20/09/2006 and displayed until 26/09/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 19/09/2006 and displayed until 20/09/2006
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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| Date of revision of text on the SPC: 01/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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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 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.
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.
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.
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Updated on 11/10/2005 and displayed until 19/09/2006
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 10 (date of (partial) revision of the text
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Updated on 30/09/2005 and displayed until 11/10/2005
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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