Label: information for the patient

Pleinvue powder for oral solution

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

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this label. See section4

6. Contents of the pack and additional information

Pleinvue contains a combination of active ingredients such as 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 above, before any clinical intervention requiring intestinal cleansing.

Pleinvue performs intestinal cleansing by causing diarrhea.

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 section6).
• If you have intestinal obstruction (intestinal blockage).
• If you have a hole in the wall of the stomach or intestine (intestinal perforation).
• If you have intestinal paralysis (ileus).
• If you have problems with emptying the stomach of liquids and food (e.g. gastroparesia, 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 enough 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 circumstances. If you:

• Have heart problemsand/orcardiac rhythm problems.
• 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 blood salt levels (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 adverse effects listed in section4. 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 immediate medical attention.

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 individuals under 18years.

Other medications and Pleinvue

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

Medications taken orally may be expelled by the gastrointestinal tract and not be absorbed correctly when taken from one hour before, during, and until one 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 procedure, you may take a light breakfast followed by a light meal.

Fordivided administration over two daysoradministration the day beforeyou must stop eating food at least 3hours before starting to take Pleinvue; afterwards, you will only be able to consume clear liquids.

Foradministration only in the morningyou may take broth and/or natural yogurt for dinner (which should be finished approximately before 20:00h). After dinner the night before the clinical procedure, you will only be able to consume clear liquids.

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

You are not allowed to have breakfast on the day of the clinical procedure.

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

Water, broths, infusions, black tea or coffee (without milk), soft drinks, or filtered broth and clear fruit juices (without pulp) 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 procedure.

Fluid intake should cease at least:

• two hours before the clinical procedure with general anesthesia or
• one hour before the clinical procedure without general anesthesia

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you 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 the doctor considers it essential.

Driving and operating machines

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

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

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

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

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

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of 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 you should expect to happen

When to take Pleinvue

Your treatment with Pleinvue should have ended before the clinical procedure.

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

Divided administration 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 same day of the clinical procedure, 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 procedure; the second dose must 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 afternoon the day before the clinical procedure;

the second dose must be taken at least 2 hours after the start of the first dose.

Your doctor will indicate which administration schedule you should 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, consult section 2.

How to prepare dose 1 of Pleinvue

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

How to drink dose 1 of Pleinvue

Drink the 500 ml solution with dose 1 and 500 ml of 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 15minutes.

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 packets A and B of dose 2 into a graduated container with a capacity of 500 ml of liquid.
2. Add water to reach 500 ml and stir until all the powder has dissolved. This step may take up to 8minutes approximately.

How to drink dose 2 of Pleinvue

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

You can drink clear liquids over the entire bowel preparation period, that is, before, during, and after taking Pleinvue, but you must stop drinking them 2 hours before the clinical procedure. Drinking clear liquids helps to prevent fluid loss (dehydration).

What you should expect to happen

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

If you follow these instructions, the intestine will be cleaned, and this will help your examination to be valid.You should allow sufficient time to pass once you have stopped defecating before moving to the clinic or hospital.

If you take more Pleinvue than you should

If you take Pleinvue before or after taking other laxatives, you may experience excessive diarrhea, which can cause dehydration. Drink an abundance 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, 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 bring the packaging and the medication leaflet to the healthcare staff.

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 procedure.
• It is essential to have had sufficient time to complete the treatment with Pleinvue, in order to ensure that the intestine is completely clean at least 2 hours before the clinical procedure.

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

Like all medicines, this medicine may 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 in the 6hours after taking Pleinvue,stop taking 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
• Rash on the skin 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
• Decreased urine output
• Vomiting.

Also, inform your doctor immediately if you have intense pain in the abdominal area.

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

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

• Dehydration
• Nausea (feeling like vomiting)
• Vomiting.

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

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

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

• Esophageal rupture caused by vomiting.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly throughtheSpanish System for the Pharmacovigilance of Medicines for Human Use.Website:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and the box, after EXP. The expiration date is the last day of the month indicated.

Be aware that expiration dates may be different for each package and box.

Before opening, do not store at a temperature above 25°C.

Once you have prepared the solution, 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 through drains or trash. Deposit the containers and medications you no longer need at the SIGRE drop-off point at the pharmacy. Ask your pharmacist how to dispose of containers and medications you no longer need.This will help protect the environment.

Composition of Pleinvue

The active ingredients ofthe dose 1are:

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

Dose1 also contains 0.79g of sucralose (E-955).

The active ingredients ofdose 2 (packs A and B)are:

Pack A:

Pack B:

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

Known effect excipients

Dose2 (pack A) also contains 0.88g of aspartame (E-951).

The other excipients are:

Encapsulated citric acid containing citric acid (E-330) and maltodextrin (E-1400), mango flavor containing glycerol (E-422), flavor preparations, gum arabic (E-414), maltodextrin (E-1400), and natural and fruit juice flavorings that contain flavor preparations, gum arabic (E-414), maltodextrin (E-1400), and flavorings. For more information, see section2.

Appearance of the product and contents of the package

This package contains three packs: dose1, pack A of dose2, and pack B of dose2.

Pleinvue powder for oral solution is marketed in packages containing 1treatment and in packages containing 40, 80, 160, and 320treatments. Only some package sizes may be marketed.

Marketing authorization holder:

Norgine BV, Antonio Vivaldi Street 150, 1083 HP Amsterdam, Netherlands.

Responsible for manufacturing:

Norgine Limited

New Road, Hengoed, Mid Glamorgan

CF82 8SJ, United Kingdom

or

Norgine BV

Antonio Vivaldi Street 150

1083 HP Amsterdam

Netherlands

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Norgine de España, S.L.U.

Paseo de la Castellana, 91, 2nd Floor

28046 Madrid

Spain

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with 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

Last review date of this leaflet:12/2024

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/