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Cifloxager 250 mg Film-coated Tablets

*
Pharmacy Only: Prescription

  • Company:

    Gerard Laboratories

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Ciprofloxacin Hydrochloride

    *Additional information is available within the SPC or upon request to the company

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

 

 

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 available data)

 

 

Infections and infestations

 

Mycotic

 

superinfections

Antibiotic associated colitis

 

 

(very rarely with possible fatal outcome) (see section 4.4)

Blood and lymphatic system disorders

 

Eosinophilia

 

 

Leukopenia

Anaemia

Neutropenia

Leukocytosis

Thrombocytopenia

Thrombocythaemia

 

 

Haemolytic anaemia

Agranulocytosis

Pancytopenia (lifethreatening)

Bone marrow depression

 

(lifethreatening)

Immune system disorders

 

Allergic reaction

Allergic oedema / angiooedema

 

 

Anaphylactic reaction

Anaphylactic shock

 

(lifethreatening)(see section 4.4)

 

Serum sicknesslike reaction

 

 

Metabolism and nutrition disorders

 

Anorexia

 

 

Hyperglycaemia

Hypoglycaemia (see section 4.4)

 

 

Psychiatric disorders

 

Psychomotor hyperactivity / agitation

 

 

Confusion and disorientation

Anxiety reaction

 

 

Psychotic reactions

 

(potentially culminating in suicidal ideations/thoughts or suicide attempts and

Mania,

 

 

 

Vascular

tdisorders

Vasodilatation

Hypotension

Syncope

 

 

Vasculitis

 

 

Respiratory, thoracic and

m,mediastinal disorders

Dyspnoea

 

(including asthmatic condition)

Gastrointestinal disorders

 

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

 

 

Hepato-biliary disorders

 

Increase in transaminases

Increased bilirubin

 

 

Hepatic impairment

Cholestatic icterus

Hepatitis

 

 

Liver necrosis

 

(very rarely progressing to life-threatening hepatic failure) (see section 4.4)

Skin and subcutaneous tissue disorders

 

Rash

Pruritus

Urticaria

 

 

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

 

 

 

Musculoskeletal and connective tissue disorders

 

Musculoskeletal pain (e.g. extremity pain, back pain, chest pain)

 

 

Myalgia

Arthritis

Increased muscle tone

 

 

Muscular weakness

Tendinitis

Tendon

 

 














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

Extensive changes in line with Brand leader , PRAC recommendations and QRD template.

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

Section 4.4:
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
- cardiac disease (e.g. heart failure, myocardial infarction, bradycardia)

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 ElderlyGeriatric patients, section 4.5, section 4.8, section 4.9).

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

Section 4.3 to Section 4.9 - Sections updated extensively in line with Core Safety Profile.

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

sections 2, 3, 4.5, 5.1, 6.1, 6.4 - 6.6, 9 & 10 updated

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)