Plenvu powder for oral solution

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/11/20

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 5/11/2020

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Norgine Limited

Norgine Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Dantrium Capsules 100mg Active Ingredients Dantrolene Sodium
Medicine Name Dantrium Capsules 25mg Active Ingredients Dantrolene Sodium
Medicine Name Dantrium Intravenous 20 mg Powder for Solution for Injection Active Ingredients Dantrolene Sodium
Medicine Name MOVICOL 13.8g sachet, powder for oral solution Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
Medicine Name Movicol Liquid Orange Flavour Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Chloride, Sodium Hydrogen Carbonate
Medicine Name MOVICOL PAEDIATRIC PLAIN 6.9g sachet, powder for oral solution Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Chloride, Sodium Hydrogen Carbonate
Medicine Name MOVIPREP Orange, powder for oral solution Active Ingredients Ascorbic acid, Macrogol 3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, Sodium sulfate anhydrous
Medicine Name MOVIPREP, powder for oral solution Active Ingredients Ascorbic acid, Macrogol 3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, Sodium sulfate anhydrous
Medicine Name NORMACOL Granules Active Ingredients Sterculia
Medicine Name NORMACOL PLUS Granules Active Ingredients Frangula, Sterculia
Medicine Name Plenvu powder for oral solution Active Ingredients Ascorbic acid, Macrogol 3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, Sodium sulfate anhydrous
Medicine Name TARGAXAN 550mg film-coated tablets Active Ingredients Rifaximin
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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 5 November 2020 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

The following section shave been updated:

section 4.4:

Ischaemic colitis

Post-marketing cases of ischaemic colitis, including serious, have been reported in patients treated with macrogol for bowel preparation. Macrogol should be used with caution in patients with known risk factors for ischaemic colitis or in case of concomitant use of stimulant laxatives (such as bisacodyl or sodium picosulfate). Patients presenting with sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis should be evaluated promptly.

Section 4.8:

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 HPRA Pharmacovigilance  Website: www.hpra.ie.

section 10:

3 November 2020

Updated on 5 November 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to other sources of information section

Free text change information supplied by the pharmaceutical company

The following sections have been updated:

Section 2:

If you experience sudden abdominal pain or rectal bleeding when taking PLENVU for bowel preparation, contact your doctor or seek medical advice immediately.

Section 4:

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance Website: www.hpra.ie.

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

This leaflet was last revised in November 2020

Other sources of information

If you need the information on this leaflet in an alternative format, such as large print, please ring 00 44 1895 826 606.

 

 

 

Updated on 20 February 2020 SPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • 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

6.4     Special precautions for storage

 Sachets: Store below 30oCDo not store above 25°C

Reconstituted solutions: Keep prepared solutions below 25°C and drink it within 24 hours. The solutions may be stored in a refrigerator. The solutions must be covered.

10.     DATE OF REVISION OF THE TEXT

01 December 201719th February 2020

Updated on 20 February 2020 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

5. How to store Plenvu

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the sachets and carton, after “EXP”.  The expiry date refers to the last day of that month.

Please note that the expiry dates may be different for each of the sachets and carton. 

Prior to opening do not store above 25°C.

Keep prepared solutions below 25°C and drink it within 24 hours. The solutions may be stored in a refrigerator.  The solutions must be covered.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

This leaflet was last revised in 02/2020

Updated on 11 November 2019 SPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

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

Updated on 11 November 2019 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 5 April 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 5 April 2019 SPC

Reasons for updating

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

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

Updated on 7 March 2018 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 6 March 2018 PIL

Reasons for updating

  • New PIL for new product