PLEINVUE POWDER FOR ORAL SOLUTION

2. What you need to know before taking Pleinvue

Do not take Pleinvue:

• If you are allergic (hypersensitive) to the active ingredients or to any of the other components of this medication (listed in section 6).
• If you have an intestinal obstruction (blockage of the intestine).
• If you have a hole in the stomach or intestinal wall (intestinal perforation).
• If you suffer from intestinal paralysis (ileus).
• If you have problems with stomach emptying of liquids and food (e.g., gastroparesis, gastric retention).
• If you have phenylketonuria. This is a hereditary inability of the body to use 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 a large dilation of the intestine (toxic megacolon).

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to take Pleinvue if you are in any of the following situations. If you:

• Have heart problems and/or cardiac arrhythmias.
• Have kidney problems and/or dehydration.
• Have heart failure, severe kidney problems, or are taking medications for high blood pressure.
• Have stomach or intestinal problems, including inflammatory bowel disease.
• Have difficulty swallowing (see also Taking Pleinvue with food and drinks).
• Have high or low salt levels in the blood (e.g., sodium, potassium).
• Suffer from other diseases (e.g., seizures).
• Have epilepsy or a history of seizures.

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

If your health is fragile or you have a serious illness, you should be especially 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 while taking Pleinvue for intestinal preparation, contact your doctor or go to the emergency room 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 medication and contact your doctor immediately.

Children and Adolescents

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

Other Medications and Pleinvue

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

Medications taken orally may be expelled from the gastrointestinal tract and not be absorbed properly when taken from 1 hour before, during, and up to 1 hour after taking Pleinvue.

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

Taking Pleinvue with Food and Drinks

The day before the clinical intervention, you can have a light breakfast followed by a light meal.

For divided administration over two daysor administration the day before, you must finish eating at least 3 hours before starting to take Pleinvue; after that, you can only consume clear liquids.

For administration only in the morning, you can have broth and/or plain yogurt for dinner (which should finish approximately before 8:00 PM). After dinner the night before the clinical intervention, you can only consume clear liquids.

Note: For information on the administration schedule, see section 3.

You are not allowed to have breakfast on the morning of the clinical intervention.

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

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

Important:

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

Fluid intake should stop at least:

• 2 hours before the clinical intervention with general anesthesia or
• 1 hour before the clinical intervention without general anesthesia.

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

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 use machines.

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

Patients on low-sodium diets should note that this medication contains 10.5 g (458.5 mmol) of sodium per complete treatment.

Patients with kidney failure or on low-potassium diets should note that this medication contains 1.1 g (29.4 mmol) of potassium per complete treatment.

This medication 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 the administration instructions for this medication exactly as indicated 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 to happen

When to Take Pleinvue

Your treatment with Pleinvue should be completed before the clinical intervention.

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

Divided Administration over Two Days

Dose 1 is taken in the evening, the day before the clinical intervention, and Dose 2 is taken in the morning on the day of the clinical intervention, approximately 12 hours after the start of the first dose, or

Administration Only in the Morning

Dose 1 and Dose 2 are taken in the morning on the day of the clinical intervention; the second dose should be taken at least 2 hours after the start of the first dose, or

Administration the Day Before

Dose 1 and Dose 2 are taken in the evening, the day before the clinical intervention; the second dose should be taken at least 2 hours after the start of the first dose.

Your doctor will indicate which administration schedule to follow.DO NOT add any other ingredients to the doses.

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

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

How to Drink Dose 1 of Pleinvue

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

Clear liquids that can be taken include water, broth, filtered broth, or clear fruit juice (without pulp), infusions, or coffee without milk.

How to Prepare Dose 2 of Pleinvue

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

How to Drink Dose 2 of Pleinvue

Based on the recommended administration schedule, you should prepare the 500 ml solution with Dose 2 and 500 ml of additional clear liquid and take them over 60 minutes. It is acceptable to alternate between the reconstituted solution and clear liquid.

You can drink additional clear liquids throughout the entire intestinal preparation, i.e., before, during, and after taking Pleinvue, but you must stop drinking them 2 hours before the clinical intervention. Drinking clear liquids helps prevent fluid loss (dehydration).

What to Expect to Happen

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

If you follow these instructions, your intestine will be cleaned, and this will help your examination to be valid. You should allow enough time to pass after your 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 taking other laxative products, you may experience excessive diarrhea, which can cause dehydration. Drink plenty of clear liquids. If you are concerned, contact your doctor or go to the emergency room immediately.

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

It is recommended to take the medication packaging and package leaflet to the healthcare personnel.

If You Forget to Take Pleinvue

• If you forget to take Pleinvue according to the instructions, take it as soon as you remember and consult your doctor, pharmacist, or nurse before the clinical intervention.
• It is essential to have had enough time to complete the treatment with Pleinvue to ensure that the intestine is completely clean at least 2 hours before the clinical intervention.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

It is normal to have diarrhea when taking Pleinvue.

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

If you experience any of the following side effects, stop taking Pleinvue and inform 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 side effects:

• Seizures

Inform your doctor immediately if you experience any of these symptoms, which are indicative of excessive fluid loss (dehydration), while taking Pleinvue:

• Dizziness
• Headache
• Less frequent urination than usual
• Vomiting.

Also, inform your doctor immediately if you have severe abdominal pain.

In rare cases, serious heart rhythm problems (e.g., the sensation that the heart is beating very hard, palpitations, or an irregular heartbeat, often for a few seconds or possibly minutes) can occur with the use of laxatives for intestinal preparation, especially in patients with underlying heart disease or electrolyte imbalances. Inform your doctor if the symptoms persist.

Common side effects (may affect up to 1 in 10 people):

• Dehydration
• Nausea (feeling sick)
• Vomiting.

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

• Abdominal bloating and pain
• Discomfort and pain
• Allergic reaction
• Chills
• Fatigue
• Headache or migraine
• Hot flashes
• Increased blood sugar 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.

Rare side effects (frequency cannot be estimated from the available data):

• Esophageal rupture caused by vomiting.

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use. Website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Pleinvue

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

Do not use this medication after the expiration date stated on the envelopes and carton, after EXP. The expiration date is the last day of the month indicated.

Note that the expiration dates may be different for each of the envelopes and cartons.

Before opening, do not store above 25°C.

Once the solution is prepared, store below 25°C and consume within 24 hours. The solution can be stored in the refrigerator. Keep the solution covered.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container contents and additional information

Composition of Pleinvue

The active ingredients of the dose 1 sachetare:

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

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

The active ingredients of dose 2 (sachets A and B)are:

Sachet A:

Sachet B:

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

Excipients with known effect

Dose 2 (sachet A) also contains 0.88 g of aspartame (E-951).

The other excipients are:

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

Appearance and container contents

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

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

Marketing authorization holder:

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

Manufacturer:

Norgine Limited

New Road, Hengoed, Mid Glamorgan

CF82 8SJ, United Kingdom

or

Norgine BV

Antonio Vivaldistraat 150

1083 HP Amsterdam

Netherlands

or

Norgine Pharma

29 rue Ethe Virton

Dreux 28100

France

Further information about this medicinal product can be obtained from the local representative of the marketing authorization holder:

Norgine de España, S.L.U.

Paseo de la Castellana, 91, 2ª Planta

28046 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area 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, Netherlands, Spain: PLEINVUE

Date of last revision of this leaflet:12/2024

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