Ciproxin 750mg Film-coated Tablets

  • Name:

    Ciproxin 750mg Film-coated Tablets

  • Company:
    info
  • Active Ingredients:

    Ciprofloxacin hydrochloride

  • Legal Category:

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

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Bayer Limited

Bayer Limited

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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 9 September 2019 SmPC

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 9 September 2019 SmPC

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 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 SmPC

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 PIL

Reasons for updating

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

Updated on 10 December 2018 SmPC

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 7 November 2018 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 23 May 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 23 May 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 5 October 2016 PIL

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 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 10 June 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 9 June 2016 SmPC

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 SmPC

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 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Addition of information on reporting a side effect.

Updated on 18 November 2015 SmPC

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 2 January 2014 SmPC

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 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 14 November 2013 SmPC

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
[mL/min/1.73 m²]

Serum Creatinine
[
µmol/L]

Oral Dose
[mg]

> 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, 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 1 October 2013 PIL

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 7 January 2013 SmPC

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

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

Free text change information supplied by the pharmaceutical company

Red text = text removed

Blue text = text added in

 

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

Treatment of infections or prophylaxis of infections in neutropenic patients

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

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

Prothrombin level abnormal

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 PIL

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 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 17 November 2010 SmPC

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)

Free text change information supplied by the pharmaceutical company

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 PIL

Reasons for updating

  • Change to storage instructions
  • Change to further information section
  • Change to date of revision

Updated on 29 September 2010 SmPC

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)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 28 January 2010 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 21 April 2008 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 30 July 2007 PIL

Reasons for updating

  • Change to drug interactions
  • Change to dosage and administration
  • Change to date of revision

Updated on 16 May 2007 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 23 February 2007 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 30 August 2006 PIL

Reasons for updating

  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision

Updated on 29 July 2004 PIL

Reasons for updating

  • New PIL for new product