Citrafleet

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/12/19

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Summary of Product Characteristics last updated on medicines.ie: 3/12/2019

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Recordati Ireland Limited

Recordati Ireland Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Betaloc 1 mg/ml Solution for Injection Active Ingredients Metoprolol Tartrate
Medicine Name Citrafleet Active Ingredients Citric Acid (Anhydrous), Magnesium Oxide Light, Sodium picosulfate
Medicine Name Cleenema Ready-to-Use 21.4g / 9.4g Enema Active Ingredients Disodium Phosphate Dodecahydrate, Sodium Dihydrogen Phosphate Dihydrate
Medicine Name Kentera oxybutynin transdermal patch Active Ingredients Oxybutynin
Medicine Name Lercaril 10 mg/10 mg Film-coated Tablets Active Ingredients Enalapril Maleate, Lercanidipine Hydrochloride
Medicine Name Lercaril 20 mg/10 mg Film-coated Tablets Active Ingredients Enalapril Maleate, Lercanidipine Hydrochloride
Medicine Name Lercaril 20 mg/20 mg Film-coated Tablets Active Ingredients Enalapril Maleate, Lercanidipine Hydrochloride
Medicine Name Phospho-soda 24.4g / 10.8g oral solution Active Ingredients Disodium Phosphate Dodecahydrate, Sodium Dihydrogen Phosphate Dihydrate
Medicine Name Reagila 1.5 mg hard capsules Active Ingredients Cariprazine hydrochloride
Medicine Name Reagila 3 mg hard capsules Active Ingredients Cariprazine hydrochloride
Medicine Name Reagila 4.5 mg hard capsules Active Ingredients Cariprazine hydrochloride
Medicine Name Reagila 6 mg hard capsules Active Ingredients Cariprazine hydrochloride
Medicine Name Urispas 200mg film-coated tablets Active Ingredients Flavoxate Hydrochloride, Lactose
Medicine Name Urorec 4 mg capsules Active Ingredients Silodosin
Medicine Name Urorec 8 mg capsules Active Ingredients Silodosin
Medicine Name Urorec capsules Active Ingredients Silodosin
Medicine Name Vitaros 3mg/g Cream Active Ingredients Alprostadil
Medicine Name Zanidip 10mg and 20mg Tablets Active Ingredients Lercanidipine Hydrochloride
Medicine Name Zanidip 10mg Tablets Active Ingredients Lercanidipine Hydrochloride
Medicine Name Zanidip 20mg Tablets Active Ingredients Lercanidipine Hydrochloride
1 - 0 of 20 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 3 December 2019 SmPC

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

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 3 December 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 11 September 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.2 the following sentence has been added -For instructions on reconstitution of medicinal product before administration, see section 6.6  


Updated on 11 September 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 19 January 2017 SmPC

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 9, Date of Last Renewal changed to 7 June 2015
In section 10. Date of revision of the text  changed to October 2016
   

Updated on 19 January 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 January 2017 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 15 March 2016 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

4.1     Therapeutic indications

 

For bowel cleansing prior to any diagnostic procedures requiring a clean bowel e.g. colonoscopy or x-ray examination.

CitraFleet is indicated in adults (including the elderly) aged 18 years and over.

 

4.2     Posology and method of administration

 

Posology

Adults (including the elderly) aged 18 years and over

The treatment can be administered in one of the following ways:

·                Usually, one sachet on the evening prior to the procedure and the second sachet in the morning of the day of the procedure.

·                Alternatively, both sachets on the afternoon and evening prior to the procedure. This schedule is more suitable when the procedure is early in the morning.

 

The time elapsed between the two sachets should be at least 5 hours.

 

Method of administration

Route of administration: Oral use.

 

A low residue diet or only clear liquids on the day before the procedure is recommended. No solid food should be taken from the start of the course of treatment until after the procedure.

 

Because the osmolarity of the product needs to be maintained in order to obtain the desired effect, each sachet should be reconstituted in a cup of water. Do not further dilute the product by drinking liquid immediately after the intake of each sachet.

After a period of ten minutes following the administration of each reconstituted sachet, it is recommended to drink approximately 1.5-2 litres of a variety of clear fluids at a rate of approximately 250-400 ml/h. Clear soups and/or balanced electrolyte solutions would be recommended. It is advisable not to drink clear or demineralised water alone.

The patient should be nil-by-mouth prior to the procedure (usually for at least 2 hours) in accordance with anaesthesia requirements.

 

5.1     Pharmacodynamic properties

 

Pharmacotherapeutic group: Sodium picosulfate, combinations, ATC code: A06A B58.

The active components of CitraFleet are sodium picosulfate, a stimulant cathartic, active locally in the colon, and magnesium citrate which acts as an osmotic laxative by retaining moisture in the colon. The action is of a potent 'washing out' effect combined with peristaltic stimulation to clear the bowel prior to radiography, colonoscopy or surgery. The product is not intended for use as a routine laxative.

 

In a randomized, multicentre, rater-blinded study in adults, bowel cleansing prior to colonoscopy using two different regimens of CitraFleet was compared with that following Klean-Prep (each sachet containing 59 g polyethylene glycol 3350, 5.685 g anhydrous sodium sulfate, 1.685 g sodium bicarbonate, 1.465 g sodium chloride and 0.7425 g potassium chloride; to be dissolved in 1 litre of water) The treatment groups were: late prior-day CitraFleet (2 sachets, 5 hours apart during the afternoon and evening the day before colonoscopy, n=229); late prior-day Klean-Prep (4 sachets administered during the afternoon and evening the day before colonoscopy, n=227); same-morning CitraFleet (2 sachets, 3 hours apart on the morning before colonoscopy, n=56). Bowel cleansing was assessed using a categorical scale (excellent, good, fair and poor). Good/excellent cleansing was reported in 68.1% of patients on the late prior-day CitraFleet regimen (not statistically different from  Klean-Prep), while a significantly higher proportion of patients had good/excellent cleansing with same-morning CitraFleet  compared with either late prior-day regimen (p<0.05). Both CitraFleet regimens were rated as significantly easier to complete by patients than Klean-Prep (p<0.001). All regimens were well tolerated, with only 2.2% of patients on the late prior-day CitraFleet regimen having adverse drug reactions. There were no serious adverse drug reactions.

 

In a randomized, multicentre, rater-blinded study in adults, bowel cleansing prior to colonoscopy was compared using two different regimens of CitraFleet: split-dose (1 sachet in the evening the day before colonoscopy, and another sachet on the morning before colonoscopy, n=159); early prior-day regimen (1 sachet before 0800h the day before colonoscopy and another sachet 6-8 hours later, n=156). Bowel cleansing was assessed using a categorical scale (excellent, good, fair and poor). A significantly higher proportion of patients on the split-dose regimen had good/excellent cleansing (79.9% vs 30.8% for early prior-day,  p<0.0001). Over 93% of patients in both groups rated the regimens as ‘easy’ or ‘very easy’ to take. Both regimens were well tolerated, with 1.9% and 2.5% of patients having adverse drug reactions in the split-dose and early prior-day groups, respectively. More patients in the split-dose group than in the early prior-day group reported nausea (23.3% vs 13.5%) and overall physical discomfort (29.6% vs 17.3%), while more patients in the early prior-day group  reported hunger (46.2% vs 32.1% with split-dose). There were no serious adverse drug reactions. Overall, changes in electrolyte levels and other laboratory parameters were minor in both groups.

 

 

10      DATE OF REVISION OF THE TEXT

 

            February 2016

Updated on 12 November 2015 PIL

Reasons for updating

  • Change of manufacturer
  • Change of licence holder
  • Change to marketing authorisation holder

Updated on 12 November 2015 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7 MA holder has been changed to Casen Recordati S.L.
Section 8 MA number has been changed to PA2028/002/001
Section 10 Revision of text is date July 2015

Updated on 26 May 2015 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 21 May 2015 PIL

Reasons for updating

  • New PIL for medicines.ie