Plenvu powder for oral solution

SmPC

4.5    Interaction with other medicinal products and other forms of interaction

The interaction of Plenvu with other medicinal products has not been studied. Theoretically, Mmedicinal products taken orally (e.g. oral contraceptive pill) one hour before, during and one hour after Plenvu administration 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.

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 1^st December 2017

Date of latest renewal: 30^th November 2022

10.    DATE OF REVISION OF THE TEXT

June 2023 May 2024

2. What you need to know before you take Plenvu

Other medicines and Plenvu

Medicines taken by mouth could be flushed through the gastrointestinal tract and may not be absorbed properly when taken within 1 hour before the start of one hour before, during and one hour after you have taken Plenvu.

6. Contents of the pack and other information

The other ingredients are:

Encapsulated citric acid containing citric acid (E330) and maltodextrin (E1400); mango flavour containing glycerol (E422), flavouring preparations, gum acacia (E414), maltodextrin (E1400) and natureal flavouring substances; and fruit punch flavour containing flavouring preparations, gum acacia (E414), maltodextrin (E1400) and nature identical flavouring substances. For further information refer to section 2.

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

This leaflet was last revised in June/2023 04/2022

4.5     Interaction with other medicinal products and other forms of interaction

Medicinal products taken orally (e.g. oral contraceptive pill) one hour before, during and one hour after within one hour of starting colonic lavage with Plenvu administration 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.

6.1     List of excipients

Mango flavour containing glycerol (E422), flavouring preparations, gum acacia (E414), maltodextrin (E1400) and natureal identical flavouring substances

Fruit punch flavour containing flavouring preparations, gum acacia (E414), maltodextrin (E1400) and nature identical flavouring substances.

10.     DATE OF REVISION OF THE TEXT

December 2022 June 2023

4.8 Undesirable effects

Data from clinical studies are available in a population of over a thousand subjects treated with Plenvu in which undesirable effect data were actively elicited.

Very common (≥1/10)

Common (≥1/100 to <1/10) 'Data from clinical studies are available in a population of over a thousand subjects treated with Plenvu in which undesirable effect data were actively elicited.'

Uncommon (≥1/1,000 to <1/100)

Rare (≥1/10,000 to <1/1,000)

Very rare (<1/10,000)

Not known (cannot be estimated from the available data)

7. MARKETING AUTHORISATION HOLDER

Norgine B.V.

Antonio Vivaldistraat 150,

1083 HP

The Netherlands

8. MARKETING AUTHORISATION NUMBERS

PA 1336/005/001

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 1^st December 2017

Date of latest renewal: 30^th November 2022

10. DATE OF REVISION OF THE TEXT

29 September 16 December 2022

4.2       Posology and method of administration

Two-day dosing schedule:

• The first dose taken in the evening before the clinical procedure (approximately 18.00H) and the second dose in the early morning of the day of the clinical procedure, approximately 12 hours after the start of the first dose (approximately 06.00H).

One-day dosing schedules:

• Morning only dosing schedule with both doses taken in the morning of the day of the clinical procedure (the first dose taken at approximately 05.00H); the second dose should be taken a minimum of 2 hours after the start of the first dose two doses should be separated by a minimum 1 hour interval, or
• Day before dosing schedule with both doses taken in the evening before the clinical procedure (the first dose taken at approximately 05.00H); the second dose should be taken a minimum of 2 hours after the start of the first dose two doses should be separated by a minimum 1 hour interval.

The appropriate dosing schedule should be selected according to the timing of the clinical procedure.

Method of administration

For oral use.

Dose 1: The contents of the single sachet for dDose 1 should be made up to 500 ml with water. The reconstituted solution, plus an additional 500 ml of clear fluid, should be taken over a period of 630 minutes, followed by 500 ml of clear fluid over the next 30 minutes. Alternating between the reconstituted solution and clear fluid is acceptable.

Dose 2: The contents of the two sachets (sachets A and B together) for dDose 2 should be made up to 500 ml with water. The reconstituted solution, plus an additional 500 ml of clear fluid, should be taken over a period of 630 minutes. Alternating between the reconstituted solution and clear fluid is acceptable. , followed by 500 ml of clear fluid over the next 30 minutes

In some instances, the intake of the reconstituted solution may be slowed or temporarily discontinued (see section 4.4).

In addition to the fluids taken as part of the course of treatment, any amount of supplementary clear fluid (e.g. water, clear soup, fruit juice without pulp, soft drinks, tea and/or coffee without milk) may be taken throughout the bowel preparation process. Note: Avoid any fluid coloured red or purple (e.g. blackcurrant juice) as this can stain the bowel.

4.5      Interaction with other medicinal products and other forms of interaction

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

10        DATE OF REVISION OF THE TEXT

15 March 2021 29 September 2022

3. How to take Plenvu

…

 When to take Plenvu

Your treatment with Plenvu must be completed before your clinical procedure.

This course of treatment may be taken as divided doses as described below:

Two-day split dosing schedule

Dose 1 taken in the evening before the clinical procedure (approximately 18.00H) and Dose 2 in the early morning of the day of the clinical procedure approximately 12 hours after the start of the first dose (approximately 06.00H), or

Morning only dosing schedule

Dose 1 and Dose 2 taken in the morning of the day of the clinical procedure (Dose 1 at approximately 05.00H); the second dose should be taken a minimum of 2 hours after the start of the first dose the two doses separated by a minimum 1 hour interval, or

Day before dosing schedule

Dose 1 and Dose 2 taken in the evening of the day before the clinical procedure (Dose 1 at approximately 18.00H); the second dose should be taken a minimum of 2 hours after the start of the first dose the two doses separated by a minimum 1 hour interval.

How to drink Plenvu Dose 1

1. Drink the 500 ml Plenvu Dose 1 and 500 ml of clear fluid over a period of 60 minutes. Alternating between the reconstituted solution and clear fluid is acceptable solution over 30 minutes. Try to drink a glassful every 10 to 15 minutes. 
2. Drink a further 500 ml of clear fluid over a further 30 minutes. Clear fluid may include Wwater, clear soup, diluted cordials/clear fruit juice (without pulp), herbal tea, black tea or coffee (without milk) are all suitable.

How to drink Plenvu Dose 2

1. When directed based on the recommended dosing schedule, make up and drink the 500 ml Plenvu Dose 2 and 500 ml of clear fluid over a period of 60 minutes. Alternating between the reconstituted solution and clear fluid is acceptable solution over 30 minutes.

1. Drink a further 500ml of clear fluid over a further 30 minutes.

Additional clear fluid may be drunk throughout the bowel preparation process, i.e. before, during, and after you take Plenvu, but you must stop drinking 1-2 hours prior to your clinical procedure. Drinking clear fluids will help prevent fluid loss (dehydration).

6.Contents of the pack and other information

This medicineal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Norther Ireland) under the following names:

a)        

Belgium, Bulgaria, Czech Republic, Croatia, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Luxembourg, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden, United Kingdom (Northern Ireland): PLENVU

This leaflet was last revised in 0403/20212.

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