4.4     Special warnings and precautions for use

If patients experience severe bloating, abdominal distension, or abdominal pain, administration should be slowed or temporarily discontinued until the symptoms subside.

In people with swallowing problems, who need the addition of a thickener to solutions to enhance an appropriate intake, interactions should be considered, see section 4.5.

4.5     Interaction with other medicinal products and other forms of interaction

Medicinal products taken orally (e.g. oral contraceptive pill) within one hour of starting colonic lavage with Plenvu may be flushed from the gastrointestinal tract unabsorbed. The therapeutic effect of drugs with a narrow therapeutic index or short half-life may be particularly affected.

PLENVU may result in a potential interactive effect if used with starch-based food thickeners. Macrogol ingredient counteracts the thickening effect of starch, effectively liquefying preparations that need to remain thick for people with swallowing problems.

Food and drink with Plenvu

Consumption of all fluids should be stopped at least:

• two hours before the clinical procedure when under general anaesthesia, or
• one hour before the clinical procedure without general anaesthesia.

If you need to thicken fluids in order to swallow them safely, Plenvu may counteract the effect of the thickener.

This leaflet was last revised in  03/2021

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

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.

6.4     Special precautions for storage

 Sachets: Store below 30^oCDo 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 201719^th February 2020

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