Cifloxager 250 mg Film-coated Tablets
*Company:
Gerard LaboratoriesStatus:
UpdatedLegal 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 28 November 2024
File name
ie-spc-250mg-cifloxager-MAT-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- 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 28 November 2024
File name
ie-pl-cifloxager-MAT-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 23 September 2024
File name
ie-spc-250mg-cifloxager-MIC Eucast-clean.pdf
Reasons for updating
- 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 01 July 2022
File name
ie-pl-cifloxager-clean-BL Updates May2022.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 01 July 2022
File name
ie-spc-250mg-cifloxager-clean-BL May2022.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 4.8 – Undesirable effects - how to report a side effect
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 February 2021
File name
ie-spc-250mg-cifloxager-clean-prac Nov2020.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 24 February 2021
File name
ie-pl-cifloxager-clean-pracNov2020.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 21 July 2020
File name
ie-spc-250mg-cifloxager-clean BL Feb20.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.5 - 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 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 7 - Marketing authorisation holder
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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 21 July 2020
File name
Cifloxager PIL clean BL -rtq Jun2020.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- 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 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 11 December 2019
File name
ie-spc-250mg-cifloxager-clean PSUSA NOV19.pdf
Reasons for updating
- 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 11 December 2019
File name
Cifloxager PIL clean PSUSA NOV19.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 15 May 2019
File name
ie-pl-5776912-clean-art31.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 14 May 2019
File name
ie-spc-250mg-cifloxager-art31-clean.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 07 May 2019
File name
ie-pl-5776912-clean-prac-rtq1.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 07 May 2019
File name
ie-spc-250mg-cifloxager-prac-clean-rtq1_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 26 February 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 February 2016
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 - how to report a side effect
- Change to section 10 - Date of revision of the text
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.2 Posology and method of administration
Elderly
Older people
ElderlyOlder people should receive a dose selected according to the severity of the infection and the patient’s creatinine clearance.
4.4 Special warnings and precautions for use
Paediatric population
The use of ciprofloxacin in children and adolescents should follow available official guidance. Ciprofloxacin treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents.
Treatment should be initiated only after a careful benefit/risk evaluation, due to possible adverse events related to joints and/or surrounding tissue (see section 4.8).
Cardiac disorders
Older people
Elderly and women may be more sensitive to QTc-prolonging medications. Therefore, caution should be taken when using fluoroquinolones, including ciprofloxacin, in these populations.
(See section 4.2
Older peopleElderly, section 4.5, section 4.8, section 4.9).
4.5 Interaction with other medicinal products and other forms of interaction
Agomelatine
In clinical studies, it was demonstrated that fluvoxamine, as a strong inhibitor of the CYP450 1A2 isoenzyme, markedly inhibits the metabolism of agomelatine resulting in a 60-fold increase of agomelatine exposure. Although no clinical data are available for a possible interaction with ciprofloxacin, a moderate inhibitor of CYP450 1A2, similar effects can be expected upon concomitant administration
(‘Cytochrome P450’ in section ‘Special warnings and precautions for use).
Zolpidem
Co-administration ciprofloxacin may increase blood levels of zolpidem, concurrent use is not recommended.
4.8 Undesirable effects
Common ≥ 1/100 to < 1/10
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Uncommon ≥ 1/1, 000 to < 1/100
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Rare ≥ 1/10, 000 to < 1/1, 000
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Very rare < 1/10, 000
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Not known (cannot be estimated from available data)
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Infections and infestations
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Mycotic
superinfections |
Antibiotic associated colitis
(very rarely with possible fatal outcome) (see section 4.4) |
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Blood and lymphatic system disorders
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Eosinophilia
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Leukopenia Anaemia Neutropenia Leukocytosis Thrombocytopenia Thrombocythaemia
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Haemolytic anaemia Agranulocytosis Pancytopenia (lifethreatening) Bone marrow depression
(lifethreatening) |
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Immune system disorders
|
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Allergic reaction Allergic oedema / angiooedema
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Anaphylactic reaction Anaphylactic shock
(lifethreatening)(see section 4.4)
Serum sicknesslike reaction
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Metabolism and nutrition disorders
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Anorexia
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Hyperglycaemia Hypoglycaemia (see section 4.4)
|
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Psychiatric disorders
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Psychomotor hyperactivity / agitation
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Confusion and disorientation Anxiety reaction
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Psychotic reactions
(potentially culminating in suicidal ideations/thoughts or suicide attempts and |
Mania,
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Vascular tdisorders |
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Vasodilatation Hypotension Syncope
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Vasculitis
|
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Respiratory, thoracic and m,mediastinal disorders |
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Dyspnoea
(including asthmatic condition) |
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Gastrointestinal disorders
|
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Nausea Diarrhoea
|
Vomiting Gastrointestinal and abdominal pains Dyspepsia Flatulence
|
Antibiotic associated colitis incl. pseudomembraneous colitis (very rarely with possible fatal outcome) (see section 4.4)
|
Pancreatitis
|
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Hepato-biliary disorders
|
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Increase in transaminases Increased bilirubin
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Hepatic impairment Cholestatic icterus Hepatitis
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Liver necrosis
(very rarely progressing to life-threatening hepatic failure) (see section 4.4) |
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Skin and subcutaneous tissue disorders
|
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Rash Pruritus Urticaria
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Photosensitivity reactions
(see section 4.4) |
Petechiae Erythema multiforme Erythema nodosum Stevens-Johnson syndrome (potentially lifethreatening) Toxic epidermal necrolysis (potentially lifethreatening)
|
Acute generalised exanthematous pustulosis (AGEP) DRESS
|
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Musculoskeletal and connective tissue disorders
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Musculoskeletal pain (e.g. extremity pain, back pain, chest pain)
|
Myalgia Arthritis Increased muscle tone
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Muscular weakness Tendinitis Tendon
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Updated on 25 February 2016
File name
PIL_10968_989.pdf
Reasons for updating
- New PIL for new product
Updated on 25 February 2016
Reasons for updating
- Change of contraindications
- Change to side-effects
- Change to date of revision
Updated on 26 November 2014
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.8 – Undesirable effects - how to report a side effect
- 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 6.1 - List of excipients
- Change to section 9 - Date of renewal of authorisation
- 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 26 November 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about missed dose
- Change to instructions about overdose
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to further information section
- Change to date of revision
Updated on 04 November 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 09 October 2013
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)
Free text change information supplied by the pharmaceutical company
Cardiac disorders
Caution should be taken when using fluoroquinolones, including ciprofloxacin, 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 anti-arrhythmics, tricyclic antidepressants, macrolides, antipsychotics)
- uncorrected electrolyte imbalance (e.g. hypokalaemia, hypomagnesaemia)
Elderly patients and women may be more sensitive to QTc-prolonging medications. Therefore, caution should be taken when using fluoroquinolones, including ciprofloxacin, in these populations.
(See section 4.2 Elderly
Updated on 02 April 2013
Reasons for updating
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- 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 11 March 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 30 November 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to information about drinking alcohol
- Change to date of revision
- Change to dosage and administration
Updated on 20 July 2011
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 03 December 2008
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- 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
Section 3: 250mg strength only - tablet form corrected to "round-tablets".
Section 4.1 - 4.6 , 4.8, 5.1-5.3- updated in line with Brand leaders - included info on Inhalation Anthrax and Cystic fibrosis.
Section 10 - date of revision updated.Updated on 16 October 2008
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change of contraindications
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to side-effects
- Change to name of manufacturer
- Change to date of revision
Updated on 08 November 2007
Reasons for updating
- Change to date of revision
- Change to further information section
Updated on 06 November 2007
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- 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 21 March 2007
Reasons for updating
- Change of manufacturer
- Change to date of revision
Updated on 29 August 2006
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 June 2006
Reasons for updating
- New PIL for medicines.ie
Updated on 05 May 2006
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)