Pleinvue powder for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pleinvue powder for oral solution

Macrogol 3350, sodium ascorbate, anhydrous sodium sulfate, ascorbic acid, sodium chloride and potassium chloride.

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Pleinvue is and what it is used for

Pleinvue contains a combination of active substances: macrogol 3350, sodium ascorbate, anhydrous sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride.

Pleinvue is a laxative.

Pleinvue is indicated for adults aged 18 years and older, prior to any clinical procedure requiring bowel cleansing.

Pleinvue achieves bowel cleansing by inducing diarrhea.

2. What you need to know before taking Pleinvue

Do not take Pleinvue:

• If you are allergic (hypersensitive) to the active substances or to any of the other components of this medicine (listed in section 6).
• If you have intestinal obstruction (blockage of the intestine).
• If you have a perforation (hole) in the wall of your stomach or intestine (intestinal perforation).
• If you have paralysis of the intestine (ileus).
• If you have problems with stomach emptying of liquids and food (e.g., gastroparesis, gastric retention).
• If you have phenylketonuria. This is an inherited condition in which the body cannot properly process a particular amino acid. Pleinvue contains a source of phenylalanine.
• If your body is unable to produce sufficient glucose-6-phosphate dehydrogenase.
• If you have significant dilation of the intestine (toxic megacolon).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Pleinvue if any of the following apply to you. If you:

• Have heart problems and/or cardiac rhythm disorders.
• Have kidney problems and/or dehydration.
• Have heart failure, severe kidney problems, or are taking medications for blood pressure.
• Have stomach or intestinal problems, including intestinal inflammation.
• Have difficulty swallowing (see also Taking Pleinvue with food and drink).
• Have high or low levels of salts in your blood (e.g., sodium, potassium).
• Suffer from other medical conditions (e.g., seizures).
• Have epilepsy or a history of seizures.

Pleinvue must not be administered to patients with impaired consciousness without medical supervision.

If your health condition is fragile or you have a serious illness, you should be especially aware of the possible adverse effects listed in section 4. Contact your doctor, pharmacist, or nurse if you are concerned.

If you experience sudden abdominal pain or rectal bleeding while taking Pleinvue for bowel preparation, contact your doctor or seek medical attention immediately.

If you experience vomiting (with blood) followed by sudden chest, neck, or abdominal pain, difficulty swallowing, or difficulty breathing while taking Pleinvue, stop taking the medicine and contact your doctor immediately.

Children and adolescents

Pleinvue is not recommended for use in individuals under 18 years of age.

Other medicines and Pleinvue

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

Orally administered medicines may be flushed through the gastrointestinal tract and not properly absorbed when taken within one hour before, during, or up to one hour after taking Pleinvue.

If you are taking oral contraceptives, additional contraceptive measures (e.g., condoms) may be necessary to prevent pregnancy.

Taking Pleinvue with food and drink

On the day before the clinical procedure, you may have a light breakfast followed by a light meal.

For split-dose administration over two days or administration the day before, you must stop eating at least 3 hours before starting to take Pleinvue; after this, you may only consume clear liquids.

For morning-only administration, you may have broth and/or plain yogurt for dinner (which should be completed by approximately 8:00 PM). After this dinner on the evening before the clinical procedure, you may only consume clear liquids.

Note: For information on dosing schedules, see section 3.

Breakfast is not permitted on the morning of the clinical procedure.

You must continue to drink clear liquids before, during, and after taking Pleinvue to prevent fluid loss (dehydration). It is important that you drink the additional prescribed amounts of clear liquids.

Water, broths, herbal infusions, black tea or coffee (without milk), clear sodas, filtered broth, and clear fruit juices (without pulp) are examples of clear liquids.

Important:

• Do not drink alcohol, milk, red or purple-colored drinks (e.g., blackcurrant juice), or any other drinks containing pulp.
• Do not eat during treatment with Pleinvue or before the clinical procedure.

Fluid intake must stop at least:

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

If you need to thicken liquids to swallow safely, Pleinvue may neutralize the effect of the thickening agent.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor, pharmacist, or nurse before using Pleinvue.

There are no data on the use of Pleinvue during pregnancy or breastfeeding, and therefore it is not recommended. It should only be used if your doctor considers it essential.

Driving and using machines

Pleinvue does not affect the ability to drive or operate machinery.

Pleinvue contains sodium, potassium, and a source of phenylalanine.

Patients on low-sodium diets should be aware that this medicine contains 10.5 g (458.5 mmol) of sodium per full treatment.

Patients with renal impairment or on low-potassium diets should be aware that this medicine contains 1.1 g (29.4 mmol) of potassium per full treatment.

This medicine may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

It also contains ascorbate, which may be harmful to people with glucose-6-phosphate dehydrogenase deficiency.

3. How to take Pleinvue

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

Read the following instructions carefully before taking Pleinvue. You need to know:

? When to take Pleinvue

? How to prepare Pleinvue

? How to drink Pleinvue

? What to expect

When to take Pleinvue

Your treatment with Pleinvue must be completed before the clinical procedure.

This treatment can be taken in divided doses as described below:

Dosing over two days

Dose 1 is taken in the afternoon, the day before the clinical procedure, and dose 2 is taken in the morning on the day of the clinical procedure, approximately 12 hours after starting the first dose, or

Morning dosing only

Doses 1 and 2 are both taken in the morning on the day of the clinical procedure; the second dose must be taken at least 2 hours after starting the first dose, or

Dosing the day before

Doses 1 and 2 are both taken in the afternoon the day before the clinical procedure;
the second dose must be taken at least 2 hours after starting the first dose.

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

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

For information on meal times before taking Pleinvue, see section 2.

How to prepare dose 1 of Pleinvue

1. Open the box and remove the dose 1 sachet.
2. Empty the contents of dose 1 into a graduated container with a capacity of 500 ml of liquid.
3. Add water up to the 500 ml mark and stir until all the powder is dissolved. This step may take up to approximately 8 minutes.

How to drink dose 1 of Pleinvue

Drink the 500 ml solution of dose 1 and an additional 500 ml of clear liquid over 60 minutes. It is acceptable to alternate between the reconstituted solution and the clear liquid. Try to drink one glass every 10 to 15 minutes.

Clear liquids may include water, broth, strained broth, clear fruit juice (without pulp), herbal teas, or black coffee.

How to prepare dose 2 of Pleinvue

1. When ready to take dose 2, empty the contents of sachets A and B of dose 2 into a graduated container with a capacity of 500 ml of liquid.
2. Add water up to the 500 ml mark and stir until all the powder is dissolved. This step may take up to approximately 8 minutes.

How to drink dose 2 of Pleinvue

Depending on the recommended dosing schedule, you should prepare 500 ml of solution with dose 2 and drink it together with an additional 500 ml of clear liquid over 60 minutes. It is acceptable to alternate between the reconstituted solution and the clear liquid.

Additional clear liquids may be consumed throughout the bowel preparation period—before, during, and after taking Pleinvue—but you must stop drinking them 2 hours before the clinical procedure. Drinking clear liquids helps prevent fluid loss (dehydration).

What to expect

When you start drinking the Pleinvue solution, it is important to stay close to a bathroom. At some point, you will begin to pass liquid stools. This is normal and indicates that the Pleinvue solution is working. You may experience stomach bloating before your first bowel movement.

If you follow these instructions, your bowel will be cleaned, which will help ensure your examination is effective. Allow sufficient time after bowel movements have stopped before going to the clinic or hospital.

If you take more Pleinvue than you should

If you take Pleinvue before or after other laxative products, you may experience excessive diarrhea, which can lead to dehydration. Drink plenty of clear liquids. If you are concerned, contact your doctor or go to the nearest hospital emergency department immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medication and the amount ingested.

It is recommended to bring the medicine packaging and leaflet to healthcare professionals.

If you forget to take Pleinvue

• If you forget to take Pleinvue as instructed, take it as soon as you remember and consult your doctor, pharmacist, or nurse before the clinical procedure.
• It is important to allow sufficient time to complete the Pleinvue treatment, to ensure the bowel is completely clean at least 2 hours before the clinical procedure.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

It is common to have diarrhoea when taking Pleinvue.

If you have not had a bowel movement within 6 hours after taking Pleinvue, stop taking it and contact your doctor immediately.

If you experience any of the following adverse effects, stop taking Pleinvue and contact your doctor immediately, as they may be symptoms of a severe allergic reaction: :

• Extreme fatigue
• Palpitations
• Skin rash or itching
• Difficulty breathing
• Swelling of the face, ankles, or other parts of the body

Stop taking Pleinvue and contact your doctor immediately if you experience any of the following adverse effects:

• Seizures

Inform your doctor immediately if you experience any of the following symptoms, which may indicate excessive fluid loss (dehydration), while taking Pleinvue:

• Dizziness
• Headache
• Urinating less than usual
• Vomiting

Also, contact your doctor immediately if you experience severe stomach (abdominal) pain.

Rarely, serious heart rhythm problems (e.g. the sensation that the heart is beating very strongly, palpitations, or irregular heartbeat, often lasting for a few seconds or possibly minutes) may occur with the use of laxatives for bowel preparation, especially in patients with underlying heart conditions or imbalances in the body's salt levels. Inform your doctor if symptoms persist.

Frequent adverse effects (may affect up to 1 in 10 people):

• Dehydration
• Nausea (feeling sick)
• Vomiting

Uncommon adverse effects (may affect up to 1 in 100 people):

• Abdominal bloating and pain
• Discomfort and pain
• Allergic reaction
• Chills
• Fatigue
• Headache or migraine
• Hot flushes
• Increased blood glucose levels in patients with diabetes
• Increased heart rate
• Palpitations
• Anal pain
• Drowsiness
• Temporary increase in blood pressure
• Transient increase in liver enzymes
• Thirst
• Electrolyte imbalance
• Weakness

Adverse effects of unknown frequency (cannot be estimated from available data):

• Oesophageal rupture caused by vomiting

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products. Website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pleinvue

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

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

Please note that expiry dates may differ between individual sachets and cartons.

Before opening, do not store above 25°C.

After preparing the solution, store below 25°C and use within 24 hours. The solution may be stored in the refrigerator. Keep the solution covered.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pleinvue

The active substances in sachet with dose 1 are:

Macrogol 3350	100 g
Anhydrous sodium sulfate	9 g
Sodium chloride	2 g
Potassium chloride	1 g

The concentration of electrolytes when the first dose is prepared up to 500 ml of solution is as follows:

Sodium	160.9 mmol/500 ml
Sulfate Chloride Potassium	63.4 mmol/500 ml 47.6 mmol/500 ml 13.3 mmol/500 ml

Dose 1 also contains 0.79 g of sucralose (E-955).

The active substances of dose 2 (pouches A and B) are:

Pouch A :

Macrogol 3350	40 g
Sodium chloride	3.2 g
Potassium chloride	1.2 g

AboutB:

Sodium ascorbate	48.11 g
Ascorbic acid	7.54 g

The concentration of electrolytes when the second dose (pouches A and B) is reconstituted to 500 ml of solution is as follows:

Sodium	297.6 mmol/500 ml
Ascorbate Chloride	285.7 mmol/500 ml 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 (E-951).

The other excipients are:

Mango flavour containing glycerol (E-422), flavouring preparations, acacia gum (E-414), maltodextrin (E-1400), and natural flavouring substances; and fruit juice flavour containing flavouring preparations, acacia gum (E-414), maltodextrin (E-1400), and flavouring substances. For more information, see section 2.

Appearance of the medicinal product and contents of the pack

This pack contains three sachets: dose 1, sachet A of dose 2, and sachet B of dose 2.

Pleinvue powder for oral solution is marketed in packs containing 1 treatment and in packs containing 40, 80, 160 and 320 treatments. Only certain pack sizes may be commercially available.

Marketing Authorisation Holder:

Norgine BV, Antonio Vivaldistraat 150, 1083 HP Amsterdam, The Netherlands.

Manufacturer:

Norgine Limited
New Road, Hengoed, Mid Glamorgan
CF82 8SJ, United Kingdom

or

Norgine BV
Antonio Vivaldistraat 150
1083 HP Amsterdam
The Netherlands

or

Norgine Pharma
29 rue Ethe Virton
Dreux 28100
France

For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:

Norgine de España, S.L.U.
Paseo de la Castellana, 91, 2nd floor
28046 Madrid
Spain

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

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

Austria, The Netherlands, Spain: PLEINVUE

Date of the most recent revision of this leaflet: 12/2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.es/