Plenvu powder for oral solution

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse.

1. What Plenvu is and what it is used for
2. What you need to know before you take Plenvu
3. How to take Plenvu
4. Possible side effects
5. How to store Plenvu
6. Contents of the pack and other information

• if you are allergic (hypersensitive) to the active substances or any of the other ingredients of Plenvu (listed in section 6)
• if you have a blockage in your bowel (bowel obstruction)
• if you have an opening in the wall of your stomach or bowel (bowel perforation)
• if you have paralysis of the gut (ileus)
• if you experience problems with food and fluid emptying from your stomach (e.g. gastric paresis, gastric retention)
• if you suffer from phenylketonuria. This is a hereditary inability of the body to use a particular amino acid. Plenvu contains a source of phenylalanine
• if your body is unable to produce enough glucose-6-phosphate dehydrogenase
• if you have a very dilated bowel (toxic megacolon)

Talk to your doctor, pharmacist or nurse before taking Plenvu if any of the below are applicable to you. If you:

• have heart problems and/or heart rhythm problems
• have kidney problems and/or dehydration
• have stomach or bowel problems, including bowel inflammation
• have problems with swallowing
• have a high or low blood salt level (e.g. sodium, potassium)
• have any other medical conditions (e.g. seizures)

Plenvu should not be given to patients with impaired consciousness without medical supervision.

If you are in poor health or have a serious medical condition, you should be particularly aware of the possible side effects listed in section 4. Contact your doctor, pharmacist or nurse if you are concerned.

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

Plenvu is not recommended for use in children under 18 years of age.

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines (including oral contraceptives).

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

If taking oral contraceptives you may need to use additional forms of contraception (e.g. condom) to prevent pregnancy.

On the day before the clinical procedure you can eat a light breakfast followed by a light lunch.

For the Two-day split dosing schedule, OR the Day before dosing schedule you must finish eating lunch at least 3 hours before you start taking Plenvu, after which you may only consume clear fluids.

For the Morning only dosing schedule you may have clear soup and/or plain yogurt for dinner (which should be completed by approximately 20.00H). You may only consume clear fluids from after dinner on the evening before the clinical procedure.

Note: For information regarding the dosing schedules refer to section 3.

No breakfast is allowed on the morning of the clinical procedure.

Continue to drink clear fluids before, during, and after you take Plenvu to help prevent fluid loss (dehydration). It is important for you to drink the additional prescribed amounts of clear fluids.

Examples of clear fluids are water, clear soups, herbal tea, black tea or coffee (without milk), soft drinks/diluted cordials and clear fruit juices (without pulp).

Important:

• Do not drink alcohol, milk, anything coloured red or purple (e.g. blackcurrant juice) or any other drinks containing pulp material.
• Do not eat while taking Plenvu and until after your clinical procedure.

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.

There are no data on the use of Plenvu during pregnancy or breast-feeding and is therefore not recommended. It should only be used if considered essential by the doctor. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking Plenvu.

Plenvu does not affect your ability to drive or use machines.

This medicinal product contains 458.5 mmol (10.5 g) sodium per course of treatment. This is to be taken into consideration by patients on a controlled sodium diet.

This medicinal product contains 29.4 mmol (1.1 g) potassium per course of treatment. This should be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

Plenvu contains a source of phenylalanine which may be harmful for people with phenylketonuria. It also contains ascorbate which may be harmful for people with glucose-6-phosphate dehydrogenase deficiency.

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 and Dose 2 in the morning of the day of the clinical procedure approximately 12 hours after the start of the first dose, or

Morning only dosing schedule

Dose 1 and Dose 2 taken in the morning of the day of the clinical procedure; the second dose should be taken a minimum of 2 hours after the start of the first dose, or

Day before dosing schedule

Dose 1 and Dose 2 taken in the evening of the day before the clinical procedure; the second dose should be taken a minimum of 2 hours after the start of the first dose.

Your doctor will inform you which dosing schedule to follow. DO NOT add any other ingredients to the doses.

Do not eat while taking Plenvu and until after your clinical procedure.

For information regarding the timing of meals before taking Plenvu refer to section 2.

1. Open the carton and remove the Dose 1 sachet.
2. Pour the contents of Dose 1 into a measuring container that can hold 500 ml of fluid.
3. Add water to make up to 500 ml and stir until all the powder has dissolved. This may take up to approximately 8 minutes.

Drink the 500 ml Dose 1 and 500 ml of clear fluid over a period of 60 minutes.

Alternating between the reconstituted solution and clear fluid is acceptable. Try to drink a glassful every 10 to 15 minutes.

Clear fluid may include water, clear soup, diluted cordials/clear fruit juice (without pulp), tea or coffee without milk.

1. When you are ready to take Dose 2 pour the contents of Dose 2 Sachet A and Dose 2 Sachet B into a measuring container that can hold 500 ml of fluid.
2. Add water to make up to 500 ml and stir until all the powder has dissolved. This may take up to approximately 8 minutes.

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

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).

When you start drinking the Plenvu solution, it is important that you stay close to a toilet. At some point, you will start to experience watery bowel movements. This is quite normal and indicates that the Plenvu solution is working. You may have stomach area bloating before you have your first bowel movement.

If you follow these instructions, your bowel will be clear, and this will help you to have a successful examination. You should allow sufficient time after your bowel movements have subsided to travel to the clinic/hospital.

If you take Plenvu before or after taking other laxative products you may develop excessive diarrhoea, which can lead to dehydration. Take generous amounts of clear fluid. If you are worried contact your doctor or go to the nearest hospital accident and emergency department straight away.

• If you forget to take Plenvu as instructed, take as soon as you realise you have not taken it and contact your doctor, pharmacist or nurse for advice prior to the clinical procedure.
• It is important that you have allowed sufficient time to complete your course of Plenvu in order to ensure your bowel is fully cleaned at least 2 hours prior to the clinical procedure.

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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

Dose 1 sachet contains the following active substances:

Macrogol 3350 100 g

Sodium sulfate anhydrous 9 g

Sodium chloride 2 g

Potassium chloride 1 g

The concentration of electrolyte ions when the first dose is made up to 500 ml of solution is as follows:

Sodium 160.9 mmol/500 ml

Sulfate 63.4 mmol/500 ml

Chloride 47.6 mmol/500 ml

Potassium 13.3 mmol/500 ml

Dose 1 also contains 0.79 g of sucralose (E955).

Dose 2 (Sachets A and B) contains the following active substances:

Sachet A:

Macrogol 3350 40 g

Sodium chloride 3.2 g

Potassium chloride 1.2 g

Sachet B:

Sodium ascorbate 48.11 g

Ascorbic acid 7.54 g

The concentration of electrolyte ions when the second dose (Sachets A and B) is made up to 500 ml of solution is as follows:

Sodium 297.6 mmol/500 ml

Ascorbate 285.7 mmol/500 ml

Chloride 70.9 mmol/500 ml

Potassium 16.1 mmol/500 ml

Excipients with known effect

Dose 2 (Sachet A) also contains 0.88 g of aspartame (E951).

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 natural flavouring substances; and fruit punch flavour containing flavouring preparations, gum acacia (E414), maltodextrin (E1400) and flavouring substances. For further information refer to section 2.

This pack contains three sachets: Dose 1, Dose 2 Sachet A, and Dose 2 Sachet B.

Plenvu powder for oral solution is available in packs containing 1 treatment and in packs containing 40, 80, 160 and 320 treatments. Not all pack sizes may be marketed.

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