Tavager 500 mg film-coated tablets
*Company:
Gerard LaboratoriesStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 11 September 2023
File name
ie-pl-nl1129-500mg-clean-var038g-var039.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Change to name of medicinal product
Updated on 13 May 2022
File name
ie-pl-nl1129-500mg-clean-var035.pdf
Reasons for updating
- Change to name of medicinal product
Updated on 06 April 2022
File name
ie-spc-500mg-nl1129-v034-clean.pdf
Reasons for updating
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 May 2021
File name
ie-spc-500mg-nl1129-v031-clean rtq .pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 May 2021
File name
ie-pl-nl1129-500mg-clean var031rtq2.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 26 January 2021
File name
ie-spc-500mg-nl1129-v032-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 January 2021
File name
ie-pl-nl1129-500mg-v032-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 13 December 2019
File name
SPC 500mg IE clean-v027 Aug19.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 December 2019
File name
Leaflet 500mg IE v027 clean Aug19.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 24 June 2019
File name
ie-pl-nl1129-clean-v025-rtq2.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 24 June 2019
File name
ie-spc-nl1129-500mg-clean-v025-rtq.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 March 2019
File name
ie-pl-nl1129-clean-v024_2.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 14 March 2019
File name
ie-spc-nl1129-500mg-clean-v024.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 December 2018
File name
ie-pl-nl1129-clean-v023.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 17 December 2018
File name
ie-spc-nl1129-500mg-clean-v023_2.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 August 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 August 2017
File name
PIL_17270_518.pdf
Reasons for updating
- New PIL for new product
Updated on 22 August 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4. CLINICAL PARTICULARS
4.2 Posology and method of administration
Special populations
Impaired renal functionRenal impairment (creatinine clearance 50ml/min)
Hepatic impairment Impaired liver function
No adjustment of dose is required since levofloxacin is not metabolised to any relevant extent by the liver and is mainly excreted by the kidneys.
Elderly population
Method of administration
For oral use.
4.3 Contraindications
Tavager tablets must not be used:
• in patients hypersensitive to the active substance or other quinolones or to any of the excipients listed in section 6.1,
4.5 Interactions with other medicinal products and other forms of interaction
Effect of other medicinal products on Tavagerlevofloxcin
Iron salts, zinc salts, magnesium- or aluminium-containing antacids, didanosine
Levofloxacin absorption is significantly reduced when iron salts, or magnesium- or aluminium-containing antacids, or didanosine (only didanosine formulations with aluminium or magnesium containing buffering agents) are administered concomitantly with Tavager tablets. Concurrent administration of fluoroquinolones with multi-vitamins containing zinc appears to reduce their oral absorption. It is recommended that preparations containing divalent or trivalent cations such as iron salts, zinc salts or magnesium- or aluminium-containing antacids, or didanosine (only didanosine formulations with aluminium or magnesium containing buffering agents) should not be taken 2 hours before or after Tavager tabletlevofloxacin administration (see section 4.2). Calcium salts have a minimal effect on the oral absorption of levofloxacin.
Sucralfate
The bioavailability of Tavagerlevofloxacin tablets is significantly reduced when administered together with sucralfate. If the patient is to receive both sucralfate and Tavager, it is best to administer sucralfate 2 hours after the Tavagerlevofloxacin tablet administration (see section 4.2).
Effect of Tavagerlevofloxacin on other medicinal products
4.8 Undesirable effects
The information given below is based on data from clinical studies in more than 8300 patients and on extensive post marketing experience.
Frequencies are defined using the following convention: very common (≥1/10), common (≥1/100, to <1/10), uncommon (≥1/1,000, to <1/100), rare (≥1/10,000, to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
|
System organ class |
Common (≥1/100 to <1/10) |
Uncommon (≥1/1,000 to <1/100) |
Rare (≥1/10,000 to <1/1,000) |
Not known (cannot be estimated from the available data) |
|
Eye disorders
|
|
|
Visual disturbances such as blurred vision (see section 4.4)
|
Transient vision loss (see section 4.4), uveitis |
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacokinetic/pharmacodynamicPK/PD relationship
The degree of the bactericidal activity of levofloxacin depends on the ratio of the maximum concentration in serum Cmax or the area under the curve (AUC) and the minimal inhibitory concentration (MIC).
5.2 Pharmacokinetic properties
Special populations
Subjects with renal insufficiency Renal impairment
Elderly subjects10. DATE OF REVISION OF THE TEXT
JanuaryAugust 20157
Updated on 02 November 2015
Reasons for updating
- Change to separate SPCs covering individual presentations
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 25 March 2015
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:medsafety@hpra.ie.
Section 5.1:
Pharmacokinetic/pharmacodynamic
Section 9:
Date of first authorisation: 6th March 2009
Date of last renewal: 26th January 2014
Updated on 19 March 2013
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4 - Clinical particulars
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5 - Pharmacological properties
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 06 December 2011
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Cardiac disorders
Caution should be taken when using fluoroquinolones, including levofloxacin, in patients with known risk factors for prolongation of the QT interval such as, for example:
- congenital long QT syndrome
- concomitant use of drugs that are known to prolong the QT interval (e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics).
- uncorrected electrolyte imbalance (e.g. hypokalemia, hypomagnesemia)
- elderly
- cardiac disease (e.g. heart failure, myocardial infarction, bradycardia)
(See section 4.2 Elderly, section 4.5, section 4.8, and section 4.9).
Section 4.5:
Drugs known to prolong QT interval
Tavager, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the QT interval (e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics). (See section 4.4).
Section 4.8:
Cardiac disorders
Rare: tachycardia
Not known: ventricular arrhythmia and torsades de pointes (reported predominantly in patients with risk factors for QT prolongation), ECG QT prolonged (see section 4.4 and section 4.9)
Updated on 23 August 2011
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)