Ciproxin 750mg Film-coated Tablets * Pharmacy Only: Prescription
Company:
Bayer LimitedStatus:
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 18 April 2022
File name
Cipro-ie-pil-750-cc-20220412_1650316542.pdf
Reasons for updating
- Change to section 3 - how to take/use
Free text change information supplied by the pharmaceutical company
Reason for change:
Update of PIL Section 3 to include information in case the patient is not able to swallow tablets, following a Health authority request.
PIL Section 3:
3. How to take Ciproxin
(…)
a. Swallow the tablets with plenty of fluid.
b. Do not chew and do not crush the tablets. If you are not able to swallow the tablet, please inform your doctor, so that he could prescribe another formulation more suitable for you.
c. Do not chew or crush the tablets because they do not taste nice.
b. d. c. Do try to take the tablets at around the same time every day.
c. e. d. You can take the tablets at mealtimes or between meals. Any calcium you take as part of a meal will not seriously affect uptake. However, do not take Ciprofloxacin Bayer tablets with dairy products such as milk or yoghurt or with fortified fruit juices (e.g. calcium-fortified orange juice).
(…)
Updated on 18 April 2022
File name
Cipro-ie-spc-750-cc-20220412_1650316432.pdf
Reasons for updating
- 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
Reason for change:
Update of SmPC section 4.2 to include information in case the patient is not able to swallow tablets, following a Health authority request
SmPC Section 4.2:
4.2 Posology and method of administration
(…)
Ciprofloxacin tablets should not be crushed and therefore are not suitable for the treatment of adult and pediatric patients who cannot swallow tablets. In those patients another formulation (e.g. oral suspension) can be used.
(…)
Updated on 11 November 2021
File name
202109_SPC_CC_CIP2_750_BP20080_Sadbh_+BEC18033 15801 10469_1636645954.pdf
Reasons for updating
- 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
Correction to date of revision of the text to September 2021.
Updated on 10 November 2021
File name
202108_PIL_CC_CIP2_750_BP20080_Sadbh_+BEC18033 15801 10469_1636552576.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Update to Section 3 to include instructions in case of missed dose, based on the update of the company core data sheet.
In addition, the opportunity is taken to introduce an editorial change:
1. a statement related to psychiatric reactions in Section 2, in line with already approved oral suspensions.
2. Inclusion of "Ireland" to MAH address in Section 6
4. Update to last revision date in Section 6
Updated on 10 November 2021
File name
202108_SPC_CC_CIP2_750_BP20080_Sadbh_+BEC18033 15801 10469_1636552504.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- 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)
Free text change information supplied by the pharmaceutical company
Update to Section 4.2 of the SmPC to include instructions in case of missed dose, based on the update of the company core data sheet.
In addition, the opportunity is taken to introduce an editorial change:
1. a statement related to psychiatric reactions in Section 4.4 of the SmPC, in line with already approved oral suspensions.
2. Inclusion of "Ireland" to MAH address in Section 7 of the SmPC
3. Reformatting of the PA number in Section 8 of the SmPC (removal of spaces and inclusion of additional zeros)
4. Update to last revision date in Section 10 of the SmPC
Updated on 28 October 2020
File name
20201015_PL_CC_CIP4_750_BP20103_1603892212.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
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 take Ciproxin
[….]
Talk to your doctor before taking 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 taking 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 2020.November 2019
Updated on 28 October 2020
File name
20201019_SPC_CC_CIP4_750_BP20103_1603891920.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)
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 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 |
|
[….] |
|
|
|
|
|
[….]
** 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 08 January 2020
File name
BP19118_PL_CC_CIP4_20191127_1578487935.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 08 January 2020
File name
BP19118_SPC_CC_CIP4_20191127_1578487689.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 10 December 2019
File name
BP19048_SPC_CC_CIP4_20191127_1575979112.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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 10 December 2019
File name
BP19048_PL_CC_CIP4_20191127_1575978932.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 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 09 September 2019
File name
19011_SPC_CC_CIP4_20190121_1568025291.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 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 09 September 2019
File name
19011_SPC_CC_CIP6_20190121_1568024862.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 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 09 September 2019
File name
19011_PL_CC_CIP4_20190121_1568024296.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 date of revision
Updated on 09 September 2019
File name
19011_SPC_CC_CIP4_20190121_1568024166.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 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 10 December 2018
File name
18289_PL_CIP4_CC_20181122_1544447067.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 10 December 2018
File name
18289_SPC_CC_CIP4_20181122_1544447046.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 07 November 2018
File name
18179_PL_CIP4_CC_20180712_1541522774.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 23 May 2017
File name
PIL_7841_351.pdf
Reasons for updating
- New PIL for new product
Updated on 23 May 2017
Reasons for updating
- Change to section 6 - manufacturer
Updated on 05 October 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 13 June 2016
Reasons for updating
- Correction of spelling/typing errors
Updated on 10 June 2016
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 09 June 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 June 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
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:
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
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 18 November 2015
Reasons for updating
- Change to warnings or special precautions for use
- Addition of information on reporting a side effect.
Updated on 02 January 2014
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 November 2013
Updated on 20 December 2013
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 14 November 2013
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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.
3. PHARMACEUTICAL form
The tablets can be divided into equal doseshalves.
4.2 Posology and method of administration
Posology
Paediatric populationChildren and adolescents
Indications |
Daily dose in mg |
Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin) |
Cystic fibrosis |
20 mg/kg body weight twice daily with a maximum of 750 mg per dose. |
10 to 14 days |
Complicated urinary tract infections and pyelonephritis |
10 mg/kg body weight twice daily to 20 mg/kg body weight twice daily with a maximum of 750 mg per dose. |
10 to 21 days |
Inhalation anthrax post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate. 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 500 mg per dose. |
60 days from the confirmation of Bacillus anthracis exposure |
Other severe infections |
20 mg/kg body weight twice daily with a maximum of 750 mg per dose. |
According to the type of infections |
Elderly Geriatric patients
Elderly Geriatric 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 |
Serum Creatinine |
Oral Dose |
> 60 |
< 124 |
See Usual Dosage. |
30‑60 |
124 to 168 |
250‑500 mg every 12 h |
< 30 |
> 169 |
250‑500 mg every 24 h |
Patients on haemodialysis |
> 169 |
250‑500 mg every 24 h (after dialysis) |
Patients on peritoneal dialysis |
> 169 |
250‑500 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
Urinary tract infections
Resistance to fluoroquinolones of Escherichia coli – the most common pathogen involved in urinary tract infections – varies across the European Union. Prescribers are advised to take into account the local prevalence of resistance in Escherichia coli to fluoroquinolones.
The single dose of ciprofloxacin, that may be used in uncomplicated cystitis in pre-menopausal women, is expected to be associated with lower efficacy than with the longer treatment duration. This is all the more to be taken into account as regards the increasing resistance level of Escherichia coli to quinolones.
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
Chelation Complex Formation
The simultaneous administration of ciprofloxacin (oral) and multivalent cation-containing drugs and mineral supplements (e.g. calcium, magnesium, aluminium, iron), polymeric phosphate binders (e.g. sevelamer or lanthanum carbonate), sucralfate or antacids, and highly buffered drugs (e.g. didanosine tablets) containing magnesium, aluminium, or calcium reduces the absorption of ciprofloxacin. Consequently, ciprofloxacin should be administered either 1‑2 hours before or at least 4 hours after these preparations. The restriction does not apply to antacids belonging to the class of H2 receptor blockers
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, |
Rare ≥ 1/10 |
Very Rare < 1/10 |
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 appetite |
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 |
|
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 01 October 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 information about pregnancy or lactation
- Change to date of revision
- Change to improve clarity and readability
- Addition of information on reporting a side effect.
Updated on 07 January 2013
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
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Section 4.1 Therapeutic indications
·
Gonococcal uretritis and cervicitis
·
Epididymo-orchitis including cases due to Neisseria gonorrhoeae
·
Pelvic inflammatory disease including cases due to Neisseria gonorrhoeae
In the above genital tract infections when thought or known to be due to Neisseria gonorrhoeae
it is particularly important to obtain local information on the prevalence of
resistance to ciprofloxacin and to confirm susceptibility based on laboratory
testing.
· Genital tract infections
· gonococcal uretritis and cervicitis due to susceptible Neisseria gonorrhoeae
· epididymo-orchitis including cases due to susceptible Neisseria gonorrhoeae
· pelvic inflammatory disease including cases due to susceptible Neisseria gonorrhoeae
…………………………………………………………
·
Treatment
of infections in neutropenic patients
·
Prophylaxis
of infections in neutropenic patients
.............................................................................................
Ciprofloxacin may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.
Section 4.2 Posology and method of administration
………………………………………………….
Indications |
Daily dose in mg |
Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin |
|
Urinary tract infections (see section 4.4) |
Uncomplicated cystitis |
250 mg twice daily to 500 mg twice daily |
3 days |
Complicated cystitis, Uncomplicated pyelonephritis |
In pre-menopausal women, 500 mg single dose may be used
|
||
Complicated pyelonephritis |
500 mg twice daily |
7 days |
|
Prostatitis |
500 mg twice daily to 750 mg twice daily |
2 to 4 weeks (acute) to 4 to 6 weeks (chronic) |
…………………………………………………..
Indications |
Daily dose in mg |
Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin |
Neutropenic patients with fever that is suspected to be due to a bacterial infection. Ciprofloxacin should be
co-administered with appropriate antibacterial agent(s) in accordance to
official guidance.
|
500 mg twice daily to 750 mg twice daily |
Therapy should be continued over the entire period of neutropenia |
…………………………………………………..
Section 4.4 Special warnings and precautions for use
…………………………………………………..
Genital tract infections
Epididymo-orchitis and
pelvic inflammatory diseases may be caused by fluoroquinolone-resistant Neisseria
gonorrhoeae. Ciprofloxacin should be co-administered with another
appropriate antibacterial agent unless ciprofloxacin-resistant Neisseria
gonorrhoeae can be excluded. If clinical improvement is not achieved after
3 days of treatment, the therapy should be reconsidered.
Gonococcal uretritis, cervicitis, epididymo-orchitis and pelvic inflammatory diseases may be caused by fluoroquinolone-resistant Neisseria gonorrhoeae isolates.
Therefore, ciprofloxacin should be administered for the treatment of gonococcal uretritis or cervicitis only if ciprofloxacin-resistant Neisseria gonorrhoeae can be excluded.
For epididymo-orchitis and pelvic inflammatory diseases, empirical ciprofloxacin should only be considered in combination with another appropriate antibacterial agent (e.g. a cephalosporin) unless ciprofloxacin-resistant Neisseria gonorrhoeae can be excluded. If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered.
Urinary tract infections
Resistance to fluoroquinolones of Escherichia coli – the most common pathogen involved in urinary tract infections – varies across the European Union. Prescribers are advised to take into account the local prevalence of resistance in Escherichia coli to fluoroquinolones.
The single dose of ciprofloxacin is expected to be associated with lower efficacy than with the longer treatment duration. This is all the more to be taken into account as regards the increasing resistance level of Escherichia coli to quinolones.
…………………………………………………………..
Musculoskeletal System
Ciprofloxacin should generally not be used in patients with a history of tendon disease/disorder related to quinolone treatment. Nevertheless, in very rare instances, after microbiological documentation of the causative organism and evaluation of the risk/benefit balance, ciprofloxacin may be prescribed to these patients for the treatment of certain severe infections, particularly in the event of failure of the standard therapy or bacterial resistance, where the microbiological data may justify the use of ciprofloxacin.
Tendinitis and tendon
rupture (especially Achilles tendon), sometimes bilateral, may occur with
ciprofloxacin, even within as soon as the
first 48 hours of treatment. Inflammation
and ruptures of tendon may occur even up to several months after
discontinuation of ciprofloxacin therapy. The risk of tendinopathy may
be increased in elderly patients or in patients concomitantly treated with
corticosteroids (see section 4.8).
……………………………………………………………
Central Nervous System
Ciprofloxacin
like other
Quinolones quinolones are known to trigger seizures or lower the
seizure threshold. Cases of
status epilepticus have been reported. Ciprofloxacin
should be used with caution in patients with CNS disorders which may be
predisposed to seizure. If seizures occur ciprofloxacin should be discontinued
(see section 4.8). Psychiatric reactions may occur even after the first
administration of ciprofloxacin. In rare cases, depression or psychosis can
progress to suicidal
ideations/thoughts culminating in attempted suicide or completed suicide self endangering behaviour. In the occurrence of such these cases,
ciprofloxacin should be discontinued.
Cases of polyneuropathy (based on neurological symptoms such as pain, burning, sensory disturbances or muscle weakness, alone or in combination) have been reported in patients receiving ciprofloxacin. Ciprofloxacin should be discontinued in patients experiencing symptoms of neuropathy, including pain, burning, tingling, numbness, and/or weakness in order to prevent the development of an irreversible condition (see section 4.8).
Cardiac disorders
Since
ciprofloxacin is associated with cases of QT prolongation (see section 4.8),
caution should be exercised when treating patients at risk for torsades de
pointes arrhythmia.
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)
· 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 Geriatric patients, section 4.5, section 4.8, section 4.9).
………………………………………………………….
Impaired renal function
Since ciprofloxacin is largely excreted unchanged via renal pathway dose adjustment is needed in patients with impaired renal function as described in section 4.2 to avoid an increase in adverse drug reactions due to accumulation of ciprofloxacin.
…………………………………………………………..
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). Co-administration of ciprofloxacin and tizanidine is contra-indicated. Therefore, patients taking these substances concomitantly with ciprofloxacin should be monitored closely for clinical signs of overdose, and determination of serum concentrations (e.g. of theophylline) may be necessary (see section 4.5).
………………………………………………….
Section 4.5 Interaction with other medicinal products and other forms of interactions
Effects of other products on ciprofloxacin:
Drugs known to prolong QT interval
Ciprofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong QT interval (e.g. Class IA and III anti-arrhythmics, tricyclic antidepressants, macrolides, antipsychotics) (see section 4.4).
…………………………………………..
Metoclopramide
Metoclopramide accelerates the absorption of ciprofloxacin (oral) resulting in a shorter time to reach maximum plasma concentrations. No effect was seen on the bioavailability of ciprofloxacin.
Omeprazole
Concomitant administration of ciprofloxacin and omeprazole containing medicinal products results in a slight reduction of Cmax and AUC of ciprofloxacin.
………………………………………………..
Cyclosporin
A transient rise in the concentration of serum creatinine was observed when ciprofloxacin and cyclosporin containing medicinal products were administered simultaneously. Therefore, it is frequently (twice a week) necessary to control the serum creatinine concentrations in these patients.
Vitamin K
antagonists Oral
Anticoagulants
Simultaneous administration of
ciprofloxacin with warfarin
a vitamin K antagonist may augment its anti-coagulant effects. There have been many reports of increases in oral anticoagulant activity
in patients receiving antibacterial agents, including fluoroquinolones. The
risk may vary with the underlying infection, age and general status of the
patient so that the contribution of the fluroquinoloneciprofloxacin to the increase in INR
(international normalised ratio) is difficult to assess. It is recommended thatThe INR should be monitored
frequently during and shortly after co-administration of ciprofloxacin with an oral anticoagulant
agent a vitamin K antagonist (e.g.,
warfarin, acenocoumarol, phenprocoumon, or fluindione).
Glibenclamide
In particular cases, concurrent administration of ciprofloxacin and glibenclamide containing medicinal products can intensify the action of glibenclamide (hypoglycaemia).
Duloxetine
In clinical studies, it was demonstrated that concomitant use of duloxetine with strong inhibitors of the CYP450 1A2 isozyme such as fluvoxamine, may result in an increase of AUC and Cmax of duloxetine. Although no clinical data are available on a possible interaction with ciprofloxacin, similar effects can be expected upon concomitant administration (see section 4.4).
………………………………………..
Lidocaine
It was demonstrated in healthy subjects that concomitant use of lidocaine containing medicinal products with ciprofloxacin, a moderate inhibitor of CYP450 1A2 isozyme, reduces clearance of intravenous lidocaine by 22%. Although lidocaine treatment was well tolerated, a possible interaction with ciprofloxacin associated with side effects may occur upon concomitant administration.
………………………………………….
Sildenafil
Cmax and AUC of sildenafil were increased approximately twofold in healthy subjects after an oral dose of 50 mg given concomitantly with 500 mg ciprofloxacin. Therefore, caution should be used prescribing ciprofloxacin concomitantly with sildenafil taking into consideration the risks and the benefits.
Section 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 available data) |
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 |
Peripheral neuropathy (see section 4.4) |
Eye Disorders |
|
|
Visual disturbances (e.g. diplopia) |
Visual colour distortions |
|
Cardiac Disorders |
|
|
|
|
Ventricular arrhythmia |
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) |
Investigations |
|
Increase in blood alkaline phosphatase |
Increased amylase |
|
International normalised ratio increased (in patients treated with Vitamin K antagonists) |
* These events were reported during the
postmarketing period and were observed predominantly among patients with
further risk factors for QT prolongation (see section 4.4).
Section 4.9 Overdose
…………………………
Apart from routine emergency measures, e.g. ventricular emptying followed by medical carbon, it is recommended to monitor renal function, including urinary pH and acidify, if required, to prevent crystalluria. Patients should be kept well hydrated. Calcium or magnesium containing antacids may theoretically reduce the absorption of ciprofloxacin in overdoses.
Only a small quantity of ciprofloxacin (<10%) is eliminated by haemodialysis or peritoneal dialysis.
In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.
Section 5.1 Pharmacodynamic properties
……………………………….
EUCAST Recommendations
Microorganisms |
Susceptible |
Resistant |
|
Enterobacteriaceae |
S ≤ 0.5 mg/L |
R > 1 mg/L |
|
Pseudomonas spp. |
S ≤ 0.5 mg/L |
R > 1 mg/L |
|
Acinetobacter spp. |
S ≤ 1 mg/L |
R > 1 mg/L |
|
Staphylococcus spp.1 |
S ≤ 1 mg/L |
R > 1 mg/L |
|
Haemophilus influenzae and Moraxella catarrhalis |
S ≤ 0.5 mg/L |
R > 0.5 mg/L |
|
Neisseria gonorrhoeae |
S ≤ 0.03 mg/L |
R > 0.06 mg/L |
|
Neisseria meningitidis |
S ≤ 0.03 mg/L |
R > 0.06 mg/L |
|
Non-species-related breakpoints* |
S ≤ 0.5 mg/L |
R > 1 mg/L |
|
1 Staphylococcus spp. - breakpoints for ciprofloxacin relate to high dose therapy. * Non-species-related breakpoints have been determined mainly on the basis of PK/PD data and are independent of MIC distributions of specific species. They are for use only for species that have not been given a species-specific breakpoint and not for those species where susceptibility testing is not recommended. |
|
||
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 20th December 1988
Date of last renewal: 20th December 2008 9th
October 2010
Section 10. Date of Revision of the text
September 2010
November 2012
Updated on 21 December 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to further information section
- Change to date of revision
- Change to improve clarity and readability
Updated on 23 January 2012
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 17 November 2010
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
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Superceded Text: June 2010 |
Updated text: October 2010 |
2. QUALITATIVE AND QUANTITATIVE COMPOSITION |
2. QUALITATIVE AND QUANTITATIVE COMPOSITION |
Each tablet contains 873.0mg ciprofloxacin hydrochloride equivalent to 750mg Ciprofloxacin. For a full list of excipients, see Section 6.1. |
Each film-coated tablet contains 750 mg ciprofloxacin (as hydrochloride). For a full list of excipients, see section 6.1. |
3. PHARMACEUTICAL form |
3. PHARMACEUTICAL form |
Film-coated tablet, oblong, white to slightly yellow, marked with 'Bayer' on one face and 'CIP 750' on the reverse. |
Film-coated tablet Oblong, nearly white to slightly yellowish tablets marked with “CIP 750” on one side and “BAYER” on the reverse side. |
6.1 List of excipients |
6.1 List of excipients |
Each tablet core contains: microcrystalline cellulose, maize starch, crospovidone, silica, colloidal anhydrous, magnesium stearate. The tablet film-coat consists of a mixture of: hypromellose 2910, Macrogol 4000, titanium dioxide (E171). |
Tablet core : Cellulose microcrystalline Crospovidone Maize starch Magnesium stearate Silica colloidal anhydrous Film-coat : Hypromellose Macrogol 4000 Titanium dioxide (E171) |
6.4 Special precautions for storage |
6.4 Special precautions for storage |
No special storage precautions are necessary. |
This medicinal product does not require any special storage conditions. |
6.5 Nature and contents of container |
6.5 Nature and contents of container |
Blister strips in cardboard outers comprising: a) 250µm, 40g/m2 PVC/PVDC foil with 20µm hard aluminium backing foil. Pack sizes: 10 tablets. b) 300µm polypropylene foil with 20µm hard aluminium backing foil with a 3.5g/m2 heat seal polypropylene coating. Pack sizes: 10 tablets. |
One of the following primary packaging materials is used: Transparent colourless or white opaque PVC/PVDC/Aluminum blister Transparent colourless or white opaque PP/Aluminum blister Aluminum/Aluminum blister Pack sizes of 6, 10, 12, 14, 16, 20, 28, 50, 100, 160 or 500 film-coated tablets Not all pack sizes may be marketed. |
10. DATE OF REVISION OF THE TEXT |
10. DATE OF REVISION OF THE TEXT |
June 2010 |
September 2010 |
Updated on 28 October 2010
Reasons for updating
- Change to storage instructions
- Change to further information section
- Change to date of revision
Updated on 29 September 2010
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 28 January 2010
Reasons for updating
- Change to storage instructions
- Change to date of revision
Updated on 21 April 2008
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 30 July 2007
Reasons for updating
- Change to drug interactions
- Change to dosage and administration
- Change to date of revision
Updated on 16 May 2007
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 23 February 2007
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 30 August 2006
Reasons for updating
- Change of contraindications
- Change to drug interactions
- Change to date of revision
Updated on 29 July 2004
Reasons for updating
- New PIL for new product