Ciproxin Solution for Infusion 2mg/ml, 200ml

  • Name:

    Ciproxin Solution for Infusion 2mg/ml, 200ml

  • Company:
    info
  • Active Ingredients:

    Ciprofloxacin

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 28/10/20

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 28/10/2020

Click on this link to Download PDF directly

Bayer Limited

Bayer Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Adalat LA 20 Active Ingredients Nifedipine
Medicine Name Adalat LA 30 Active Ingredients Nifedipine
Medicine Name Adalat LA 60 Active Ingredients Nifedipine
Medicine Name Alka Seltzer Effervescent Tablets Active Ingredients Acetylsalicylic acid (Aspirin), Citric Acid, Sodium Hydrogen Carbonate
Medicine Name Androcur 100 Active Ingredients Cyproterone Acetate
Medicine Name Angeliq 1 mg / 2 mg film-coated tablets Active Ingredients Drospirenone, Estradiol Hemihydrate
Medicine Name Aspirin 300mg Effervescent Tablets Active Ingredients Acetylsalicylic acid (Aspirin)
Medicine Name Avelox 400mg Film-coatedTablets Active Ingredients Moxifloxacin hydrochloride
Medicine Name Avelox 400mg/250ml Solution for Infusion Active Ingredients Moxifloxacin hydrochloride
Medicine Name Bepantiseptic First Aid Cream Active Ingredients Chlorhexidine digluconate, Phenol
Medicine Name Betaferon 250 microgram/ml, powder and solvent for solution for injection Active Ingredients Interferon beta-1b
Medicine Name Canesten 200mg Pessary Active Ingredients Clotrimazole
Medicine Name Canesten 500mg Pessary Active Ingredients Clotrimazole
Medicine Name Canesten Combi Pessary and Cream Active Ingredients Clotrimazole
Medicine Name Canesten Cream Active Ingredients Clotrimazole
Medicine Name Canesten Duopak Active Ingredients Clotrimazole
Medicine Name Canesten HC Cream Active Ingredients Clotrimazole, Hydrocortisone
Medicine Name Canesten Soft Vaginal Capsule Combi Active Ingredients Clotrimazole
Medicine Name Canesten Thrush Cream Active Ingredients Clotrimazole
Medicine Name Ciproxin 500mg Film-coated Tablets Active Ingredients Ciprofloxacin hydrochloride
Medicine Name Ciproxin 750mg Film-coated Tablets Active Ingredients Ciprofloxacin hydrochloride
Medicine Name Ciproxin Solution for Infusion 2mg/ml, 200ml Active Ingredients Ciprofloxacin
Medicine Name Clarityn 10 mg Tablets Active Ingredients Loratadine
Medicine Name Cystopurin 3g Granules for Oral Solution Active Ingredients Potassium Citrate
Medicine Name Dianette 2mg/35 micrograms coated tablets Active Ingredients Cyproterone Acetate, Ethinylestradiol
1 - 0 of 65 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 28 October 2020 PIL

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

Free text change information supplied by the pharmaceutical company

Reason for update:

PRAC: Implementation of label changes after PRAC recommendation on signal of heart valve regurgitation, cervical artery & aortic aneurysm and dissection (EPITT 19522)

2. What you need to know before you are given Ciproxin

[….]

Talk to your doctor before you are given Ciproxin

[….]

  • if you have been diagnosed with leaking heart valves (heart valve regurgitation).
  • if you have a family history of aortic aneurysm or aortic dissection or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or vascular Ehlers-Danlos syndrome, Turner syndrome, Sjögren’s syndrome [an inflammatory autoimmune disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet´s disease, high blood pressure, or known atherosclerosis, rheumatoid arthritis [a disease of the joints] or endocarditis [an infection of the heart]).

[….]

 

While under treatment with Ciproxin

[….]

  • If you feel sudden, severe pain in your abdomen, chest or back, which can be symptoms of aortic aneurysm and dissection, go immediately to an emergency room. Your risk may be increased if you are being treated with systemic corticosteroids.

 

  • If you start experiencing a rapid onset of shortness of breath, especially when you lie down flat in your bed, or you notice swelling of your ankles, feet or abdomen, or a new onset of heart palpitations (sensation of rapid or irregular heartbeat), you should inform a doctor immediately.

 

4. Possible side effects

[….]

Cases of an enlargement and weakening of the aortic wall or a tear in the aortic wall (aneurysms and dissections), which may rupture and may be fatal, and of leaking heart valves have been reported in patients receiving fluoroquinolones. See also section 2.

[….]

 

This leaflet was last revised in October 2020November 2019.

 

Updated on 28 October 2020

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

Free text change information supplied by the pharmaceutical company

Reason for update:

PRAC: Implementation of label changes after PRAC recommendation on signal of heart valve regurgitation, cervical artery & aortic aneurysm and dissection (EPITT 19522)

4.4 Special warnings and precautions for use

[….]

Aortic aneurysm and dissection, and heart valve regurgitation/incompetence

Epidemiologic studies report an increased risk of aortic aneurysm and dissection, particularly in elderly patients, and of aortic and mitral valve regurgitation after intake of fluoroquinolones, particularly in the older population. Cases of aortic aneurysm and dissection, sometimes complicated by rupture (including fatal ones), and of regurgitation/incompetence of any of the heart valves have been reported in patients receiving fluoroquinolones (see section 4.8).

Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease or congenital heart valve disease, or in patients diagnosed with pre-existing aortic aneurysm and/or dissection or heart valve disease, or in presence of other risk factors or conditions predisposing:

- for both aortic aneurysm and dissection and heart valve regurgitation/incompetence (e.g. connective tissue disorders such as Marfan syndrome or, vascular Ehlers-Danlos syndrome, Turner syndromeTakayasu arteritis, giant cell arteritis, Behcet´s disease, hypertension, rheumatoid arthritisknown atherosclerosis). or additionally

- for aortic aneurysm and dissection (e.g. vascular disorders such as Takayasu arteritis or giant cell arteritis, or known atherosclerosis, or Sjögren’s syndrome) or additionally

- for heart valve regurgitation/incompetence (e.g. infective endocarditis).

The risk of aortic aneurysm and dissection, and their rupture may also be increased in patients treated concurrently with systemic corticosteroids.

In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.

Patients should be advised to seek immediate medical attention in case of acute dyspnoea, new onset of heart palpitations, or development of oedema of the abdomen or lower extremities.

 

4.8 Undesirable effects

 

System Organ Class

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

Frequency not known

(cannot be estimated from the available data)

[….]

 

 

 

 

 

Cardiac Disorders**

 

 

Tachycardia

 

Ventricular arrhythmia, torsades de pointes (reported predominantly in patients with risk factors for QT prolongation), ECG QT prolonged (see sections 4.4 and 4.9)

Vascular Disorders**

 

 

Vasodilatation

Hypotension

Syncope

Vasculitis

 

[….]

 

 

 

 

 

 

[….]

** Cases of aortic aneurysm and dissection, sometimes complicated by rupture (including fatal ones), and of regurgitation/incompetence of any of the heart valves have been reported in patients receiving fluoroquinolones (see section 4.4).

 

 

10. DATE OF REVISION OF THE TEXT

 

October 2020November 2019

 

 

 

 

Updated on 8 January 2020 PIL

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 8 January 2020

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Updated on 10 December 2019 PIL

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 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 10 December 2019

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 10 - Date of revision of the text

Updated on 9 September 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to date of revision

Updated on 9 September 2019

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Updated on 10 December 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 10 December 2018

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Updated on 23 May 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 9 June 2016 SPC

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

Section 4.4 - was amended as follows:

Reference added to section 4.8, in the final line of the ‘Paediatric population’ paragraph

 

Cytochrome P450

Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e.g. theophylline, clozapine, olanzapine, ropinirole, tizanidine, duloxetine, agomelatine).


Section 4.5 - the following text was added:  

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 (see ‘Cytochrome P450’ in section 4.4).

 

Zolpidem

Co-administration of ciprofloxacin may increase blood levels of zolpidem, concurrent use is not

recommended.

Section 4.8 - was amended as follows:

- Antibiotic associated colitis deleted under SOC “Infections and Infestations” and moved to SOC

“Gastrointestinal disorders”

-Addition of mania/hypomania

- Addition of DRESS to ADR list

- “arthralgia” and “arthritis” in brackets after the term “arthropathy”

Updated on 9 June 2016

Reasons for updating

  • New SmPC for new product

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

Updated on 9 June 2016 PIL

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

Free text change information supplied by the pharmaceutical company

Section 4.4 - was amended as follows:

Reference added to section 4.8, in the final line of the ‘Paediatric population’ paragraph

 

Cytochrome P450

Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e.g. theophylline, clozapine, olanzapine, ropinirole, tizanidine, duloxetine, agomelatine).


Section 4.5 - the following text was added:  

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 (see ‘Cytochrome P450’ in section 4.4).

 

Zolpidem

Co-administration of ciprofloxacin may increase blood levels of zolpidem, concurrent use is not

recommended.

Section 4.8 - was amended as follows:

- Antibiotic associated colitis deleted under SOC “Infections and Infestations” and moved to SOC

“Gastrointestinal disorders”

-Addition of mania/hypomania

- Addition of DRESS to ADR list

- “arthralgia” and “arthritis” in brackets after the term “arthropathy”

Updated on 18 November 2015 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company



In section 4.4 Special warnings and precautions for use, the following section has been added:

Vision disorders

If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.

In section 4.8, the following text has been added:

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. By reporting side effects you can help provide more information on the safety of this medicine.

Updated on 18 November 2015 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company



In section 4.4 Special warnings and precautions for use, the following section has been added:

Vision disorders

If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.

In section 4.8, the following text has been added:

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. By reporting side effects you can help provide more information on the safety of this medicine.

Updated on 3 January 2014 PIL

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 4.8:

Update to the wording of section 4.8, subsection Reporting of suspected adverse reactions to:

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 the online reporting option (preferred method) accessible from the IMB homepage (www.imb.ie). A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’ (see details below). Alternatively, the traditional post-paid ‘yellow card’ option may also be used.  

 

FREEPOST

Pharmacovigilance Section

Irish Medicines Board

Kevin O'Malley House

Earlsfort Centre

Earlsfort Terrace

Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

 

 

Section 10:

Update of date of revision of the text to December 2013

Updated on 3 January 2014 SPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 4.8:

Update to the wording of section 4.8, subsection Reporting of suspected adverse reactions to:

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 the online reporting option (preferred method) accessible from the IMB homepage (www.imb.ie). A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’ (see details below). Alternatively, the traditional post-paid ‘yellow card’ option may also be used.  

 

FREEPOST

Pharmacovigilance Section

Irish Medicines Board

Kevin O'Malley House

Earlsfort Centre

Earlsfort Terrace

Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

 

 

Section 10:

Update of date of revision of the text to December 2013

Updated on 13 November 2013 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 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

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

For thea full list of excipients, see section 6.1.

 

 

4.2       Posology and method of administration

 

Posology

 

 

Paediatric populationChildren and adolescents

 

Indication

Daily dose in mg

Total duration of treatment (including switch to oral therapy as soon as possible)

Cystic fibrosis

10 mg/kg body weight three times a day with a maximum of 400 mg per dose.

10 to 14 days

Complicated urinary tract infections and pyelonephritis

6 mg/kg body weight three times a day to 10 mg/kg body weight three times a day with a maximum of 400 mg per dose.

10 to 21 days

Inhalation anthrax post-exposure curative treatment for persons requiring parenteral treatment

Drug administration should begin as soon as possible after suspected or confirmed exposure.

10 mg/kg body weight twice daily to 15 mg/kg body weight twice daily with a maximum of 400 mg per dose.

60 days from the confirmation of Bacillus anthracis exposure

Other severe infections

10 mg/kg body weight three times a day with a maximum of 400 mg per dose.

According to the type of infections

                                    

ElderlyGeriatric patients

ElderlyGeriatric patients should receive a dose selected according to the severity of the infection and the patient`s creatinine clearance.

 

Patients with rRenal and hepatic impairment

Recommended starting and maintenance doses for patients with impaired renal function:

 

Creatinine Clearance
[mL/min/1.73 m²]

Serum Creatinine
[
µmol/L]

Intravenous Dose
[mg]

> 60

< 124

See Usual Dosage.

30‑60

124 to 168

200‑400 mg every 12 h

< 30

> 169

200‑400 mg every 24 h

Patients on haemodialysis

> 169

200‑400 mg every 24 h (after dialysis)

Patients on peritoneal dialysis

> 169

200‑400 mg every 24 h

 

 

4.3     Contraindications

 

·                Hypersensitivity to the active substance, to other quinolones or to any of the excipients listed in (see section 6.1).

·                Concomitant administration of ciprofloxacin and tizanidine (see section 4.5).

 

4.4     Special warnings and precautions for use

 

 

 

Paediatric populationChildren and adolescents

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.

 

Musculoskeletal System

Ciprofloxacin should be used with caution in patients with myasthenia gravis, because symptoms can be exacerbated (see section 4.8).

 

 

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).

 

Hypoglycemia

As with other quinolones, hypoglycemia has been reported most often in diabetic patients, predominantly in the elderly population. In all diabetic patients, careful monitoring of blood glucose is recommended (see section 4.8).

 

4.5     Interaction with other medicinal products and other forms of interaction

 

 

Glibenclamide

In particular cases, concurrent administration of ciprofloxacin and glibenclamide containing medicinal products can intensify the action of glibenclamide (hypoglycaemia).

 

4.6     Pregnancy and lactation

Breast-feedingLactation

Ciprofloxacin is excreted in breast milk. Due to the potential risk of articular damage, ciprofloxacin should not be used during breast-feeding.

 

 

4.8       Undesirable effects

 

The most commonly reported adverse drug reactions (ADRs) are nausea and diarrhoea.

ADRs derived from clinical studies and post-marketing surveillance with Ciproxin (oral, intravenous, and sequential therapy) sorted by categories of frequency are listed below. The frequency analysis takes into account data from both oral and intravenous administration of ciprofloxacin.

 

System Organ Class

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

Frequency not known

(cannot be estimated from the 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

Thrombocytaemia

Haemolytic anaemia

Agranulocytosis

Pancytopenia (life-threatening)

Bone marrow depression (life-threatening)

 

Immune System Disorders

 

 

Allergic reaction

Allergic oedema / angiooedema

Anaphylactic reaction

Anaphylactic shock (life-threatening) (see section 4.4)

Serum sickness-like reaction

 

Metabolism and Nutrition Disorders

 

Decreased appetiteAnorexia

Hyperglycaemia

Hypoglycaemia (see section 4.4)

 

 

Psychiatric Disorders

 

Psychomotor hyperactivity / agitation

Confusion and disorientation

Anxiety reaction

Abnormal dreams

Depression (potentially culminating in suicidal ideations/thoughts or suicide attempts and completed suicide) (see section 4.4)

Hallucinations

Psychotic reactions (potentially culminating in suicidal ideations/thoughts or suicide attempts and completed suicide) (see section 4.4)

 

Nervous System Disorders

 

Headache

Dizziness

Sleep disorders

Taste disorders

Par- and Dysaesthesia

Hypoaesthesia

Tremor

Seizures (incl. status epilepticus see section 4.4)

Vertigo

Migraine

Disturbed coordination

Gait disturbance Olfactory nerve disorders

Intracranial hypertension and pseudotumor cerebri

Peripheral neuropathy and polyneuropathy (see section 4.4)

Eye Disorders

 

 

Visual disturbances (e.g. diplopia)

Visual colour distortions

 

Ear and Labyrinth Disorders

 

 

Tinnitus

Hearing loss / Hearing impaired

 

 

Cardiac Disorders

 

 

Tachycardia

 

Ventricular arrhythmia and torsades de pointes (reported predominantly in patients with risk factors for QT prolongation), ECG QT prolonged (see sections 4.4 and 4.9)

Vascular Disorders

 

 

Vasodilatation

Hypotension

Syncope

Vasculitis

 

Respiratory, Thoracic and Mediastinal Disorders

 

 

Dyspnoea (including asthmatic condition)

 

 

Gastrointestinal Disorders

Nausea

Diarrhoea

Vomiting

Gastrointestinal and abdominal pains

Dyspepsia

Flatulence

 

Pancreatitis

 

Hepatobiliary 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 life-threatening)

Toxic epidermal necrolysis (potentially life-threatening)

Acute generalised exanthematous pustulosis (AGEP)

Musculoskeletal, and Connective Tissue and Bone Disorders

 

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

Arthralgia

Myalgia

Arthritis

Increased muscle tone and cramping

Muscular weakness

Tendinitis

Tendon rupture (predominantly Achilles tendon) (see section 4.4)

Exacerbation of symptoms of myasthenia gravis (see section 4.4)

 

Renal and Urinary Disorders

 

Renal impairment

Renal failure

Haematuria

Crystalluria (see section 4.4)

Tubulointerstitial nephritis

 

 

General Disorders and Administration Site Conditions

 

Asthenia

Fever

Oedema

Sweating (hyperhidrosis)

 

 

Investigations

 

Increase in blood alkaline phosphatase

Increased amylase

 

International normalised ratio increased (in patients treated with Vitamin K antagonists)

 

Paediatric populationpatients

The incidence of arthropathy, mentioned above, is referring to data collected in studies with adults. In children, arthropathy is reported to occur commonly (see section 4.4).

 

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 to the Irish Medicines Board (online at www.imb.ie, telephone 01-6764971 or using the yellow card system).

 

FREEPOST

Pharmacovigilance Section

Irish Medicines Board

Kevin O'Malley House

Earlsfort Centre

Earlsfort Terrace

Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

via the national reporting system listed in Appendix V*

[*For the printed material, please refer to the guidance of the annotated QRD template.]

5.       PHARMACOLOGICAL PROPERTIES

 

5.1     Pharmacodynamic properties

 

Pharmacokinetic/pharmacodynamicPK/PD relationship:

Efficacy mainly depends on the relation between the maximum concentration in serum (Cmax) and the minimum inhibitory concentration (MIC) of ciprofloxacin for a bacterial pathogen and the relation between the area under the curve (AUC) and the MIC.

 

5.2     Pharmacokinetic properties

BiotransformationMetabolism

Low concentrations of four metabolites have been reported, which were identified as: desethyleneciprofloxacin (M 1), sulphociprofloxacin (M 2), oxociprofloxacin (M 3) and formylciprofloxacin (M 4). The metabolites display in-vitro antimicrobial activity but to a lower degree than the parent compound.

 

10.     DATE OF REVISION OF THE TEXT

 

November 2012September 2013

 

Updated on 13 November 2013 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

For thea full list of excipients, see section 6.1.

 

 

4.2       Posology and method of administration

 

Posology

 

 

Paediatric populationChildren and adolescents

 

Indication

Daily dose in mg

Total duration of treatment (including switch to oral therapy as soon as possible)

Cystic fibrosis

10 mg/kg body weight three times a day with a maximum of 400 mg per dose.

10 to 14 days

Complicated urinary tract infections and pyelonephritis

6 mg/kg body weight three times a day to 10 mg/kg body weight three times a day with a maximum of 400 mg per dose.

10 to 21 days

Inhalation anthrax post-exposure curative treatment for persons requiring parenteral treatment

Drug administration should begin as soon as possible after suspected or confirmed exposure.

10 mg/kg body weight twice daily to 15 mg/kg body weight twice daily with a maximum of 400 mg per dose.

60 days from the confirmation of Bacillus anthracis exposure

Other severe infections

10 mg/kg body weight three times a day with a maximum of 400 mg per dose.

According to the type of infections

                                    

ElderlyGeriatric patients

ElderlyGeriatric patients should receive a dose selected according to the severity of the infection and the patient`s creatinine clearance.

 

Patients with rRenal and hepatic impairment

Recommended starting and maintenance doses for patients with impaired renal function:

 

Creatinine Clearance
[mL/min/1.73 m²]

Serum Creatinine
[
µmol/L]

Intravenous Dose
[mg]

> 60

< 124

See Usual Dosage.

30‑60

124 to 168

200‑400 mg every 12 h

< 30

> 169

200‑400 mg every 24 h

Patients on haemodialysis

> 169

200‑400 mg every 24 h (after dialysis)

Patients on peritoneal dialysis

> 169

200‑400 mg every 24 h

 

 

4.3     Contraindications

 

·                Hypersensitivity to the active substance, to other quinolones or to any of the excipients listed in (see section 6.1).

·                Concomitant administration of ciprofloxacin and tizanidine (see section 4.5).

 

4.4     Special warnings and precautions for use

 

 

 

Paediatric populationChildren and adolescents

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.

 

Musculoskeletal System

Ciprofloxacin should be used with caution in patients with myasthenia gravis, because symptoms can be exacerbated (see section 4.8).

 

 

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).

 

Hypoglycemia

As with other quinolones, hypoglycemia has been reported most often in diabetic patients, predominantly in the elderly population. In all diabetic patients, careful monitoring of blood glucose is recommended (see section 4.8).

 

4.5     Interaction with other medicinal products and other forms of interaction

 

 

Glibenclamide

In particular cases, concurrent administration of ciprofloxacin and glibenclamide containing medicinal products can intensify the action of glibenclamide (hypoglycaemia).

 

4.6     Pregnancy and lactation

Breast-feedingLactation

Ciprofloxacin is excreted in breast milk. Due to the potential risk of articular damage, ciprofloxacin should not be used during breast-feeding.

 

 

4.8       Undesirable effects

 

The most commonly reported adverse drug reactions (ADRs) are nausea and diarrhoea.

ADRs derived from clinical studies and post-marketing surveillance with Ciproxin (oral, intravenous, and sequential therapy) sorted by categories of frequency are listed below. The frequency analysis takes into account data from both oral and intravenous administration of ciprofloxacin.

 

System Organ Class

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

Frequency not known

(cannot be estimated from the 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

Thrombocytaemia

Haemolytic anaemia

Agranulocytosis

Pancytopenia (life-threatening)

Bone marrow depression (life-threatening)

 

Immune System Disorders

 

 

Allergic reaction

Allergic oedema / angiooedema

Anaphylactic reaction

Anaphylactic shock (life-threatening) (see section 4.4)

Serum sickness-like reaction

 

Metabolism and Nutrition Disorders

 

Decreased appetiteAnorexia

Hyperglycaemia

Hypoglycaemia (see section 4.4)

 

 

Psychiatric Disorders

 

Psychomotor hyperactivity / agitation

Confusion and disorientation

Anxiety reaction

Abnormal dreams

Depression (potentially culminating in suicidal ideations/thoughts or suicide attempts and completed suicide) (see section 4.4)

Hallucinations

Psychotic reactions (potentially culminating in suicidal ideations/thoughts or suicide attempts and completed suicide) (see section 4.4)

 

Nervous System Disorders

 

Headache

Dizziness

Sleep disorders

Taste disorders

Par- and Dysaesthesia

Hypoaesthesia

Tremor

Seizures (incl. status epilepticus see section 4.4)

Vertigo

Migraine

Disturbed coordination

Gait disturbance Olfactory nerve disorders

Intracranial hypertension and pseudotumor cerebri

Peripheral neuropathy and polyneuropathy (see section 4.4)

Eye Disorders

 

 

Visual disturbances (e.g. diplopia)

Visual colour distortions

 

Ear and Labyrinth Disorders

 

 

Tinnitus

Hearing loss / Hearing impaired

 

 

Cardiac Disorders

 

 

Tachycardia

 

Ventricular arrhythmia and torsades de pointes (reported predominantly in patients with risk factors for QT prolongation), ECG QT prolonged (see sections 4.4 and 4.9)

Vascular Disorders

 

 

Vasodilatation

Hypotension

Syncope

Vasculitis

 

Respiratory, Thoracic and Mediastinal Disorders

 

 

Dyspnoea (including asthmatic condition)

 

 

Gastrointestinal Disorders

Nausea

Diarrhoea

Vomiting

Gastrointestinal and abdominal pains

Dyspepsia

Flatulence

 

Pancreatitis

 

Hepatobiliary 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 life-threatening)

Toxic epidermal necrolysis (potentially life-threatening)

Acute generalised exanthematous pustulosis (AGEP)

Musculoskeletal, and Connective Tissue and Bone Disorders

 

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

Arthralgia

Myalgia

Arthritis

Increased muscle tone and cramping

Muscular weakness

Tendinitis

Tendon rupture (predominantly Achilles tendon) (see section 4.4)

Exacerbation of symptoms of myasthenia gravis (see section 4.4)

 

Renal and Urinary Disorders

 

Renal impairment

Renal failure

Haematuria

Crystalluria (see section 4.4)

Tubulointerstitial nephritis

 

 

General Disorders and Administration Site Conditions

 

Asthenia

Fever

Oedema

Sweating (hyperhidrosis)

 

 

Investigations

 

Increase in blood alkaline phosphatase

Increased amylase

 

International normalised ratio increased (in patients treated with Vitamin K antagonists)

 

Paediatric populationpatients

The incidence of arthropathy, mentioned above, is referring to data collected in studies with adults. In children, arthropathy is reported to occur commonly (see section 4.4).

 

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 to the Irish Medicines Board (online at www.imb.ie, telephone 01-6764971 or using the yellow card system).

 

FREEPOST

Pharmacovigilance Section

Irish Medicines Board

Kevin O'Malley House

Earlsfort Centre

Earlsfort Terrace

Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

via the national reporting system listed in Appendix V*

[*For the printed material, please refer to the guidance of the annotated QRD template.]

5.       PHARMACOLOGICAL PROPERTIES

 

5.1     Pharmacodynamic properties

 

Pharmacokinetic/pharmacodynamicPK/PD relationship:

Efficacy mainly depends on the relation between the maximum concentration in serum (Cmax) and the minimum inhibitory concentration (MIC) of ciprofloxacin for a bacterial pathogen and the relation between the area under the curve (AUC) and the MIC.

 

5.2     Pharmacokinetic properties

BiotransformationMetabolism

Low concentrations of four metabolites have been reported, which were identified as: desethyleneciprofloxacin (M 1), sulphociprofloxacin (M 2), oxociprofloxacin (M 3) and formylciprofloxacin (M 4). The metabolites display in-vitro antimicrobial activity but to a lower degree than the parent compound.

 

10.     DATE OF REVISION OF THE TEXT

 

November 2012September 2013

 

Updated on 21 December 2012 PIL

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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

Free text change information supplied by the pharmaceutical company