Plenvu uses, dose and side effects

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

Plenvu is a laxative.

Plenvu is intended for adults over the age of 18 before a procedure or examination that requires a clean bowel.

Plenvu cleanses the intestines by causing diarrhea.

What you need to know before taking Plenvu

Do not take Plenvu

if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).
if you have a blockage in your bowel (bowel obstruction)
if you have a hole in your stomach or intestinal wall (intestinal perforation) – if you have an intestinal knot ( ileus )
if you have problems emptying your stomach (eg gastroparesis, gastric retention) if you suffer from phenylketonuria. This is a hereditary metabolic disease which means that the body cannot use a specific amino acid. Plenvu contains a source of phenylalanine
if your body does not produce enough glucose -6-phosphate dehydrogenase
if you have a very enlarged intestine (toxic megacolon)

Warnings and cautions

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

have heart problems and/or problems with heart rhythm
have kidney problems and/or are dehydrated
have gastrointestinal problems, including intestinal inflammation
have difficulty swallowing (see also Plenvu with food and drink)
have high or low salinity in the blood (eg sodium, potassium )
have any other medical condition (eg seizures)

Plenvu should not be given to patients with a reduced level of consciousness without medical supervision.

If your general condition is bad or you have a serious illness, you should pay special attention to any side effects listed in section 4. If you have any further questions, ask your doctor, pharmacist, or nurse.

If you experience sudden abdominal pain or rectal bleeding while taking Plenvu for bowel cleansing, contact a doctor immediately or seek medical attention.

Children and young people

Plenvu should not be given to children under 18 years of age.

Other medicines and Plenvu

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

Medicines to be swallowed may not be taken properly if you take them within 1 hour before taking Plenvu.

If you are using oral contraceptives, you may need to supplement with another form of contraception (such as a condom) to prevent pregnancy.

Plenvu with food and drink

The day before the procedure/examination, you can have a light breakfast and a light lunch.

For two-day dosing OR one-day dosing the day before the procedure/examination, you must have finished eating your lunch at least 3 hours before you start taking Plenvu, after which you may only take clear liquids.
For one-day dosing on the same day as the procedure/examination, you can eat ready-made soup and/or natural yogurt for dinner (which should be ready around 20.00). After dinner the night before the procedure/examination, you should only take clear liquids.
Note: Information on dosing schedules can be found in section 3.

Breakfast is not allowed in the morning on the day of the procedure/examination.

Continue to drink clear liquids before, during, and after taking Plenvu to prevent dehydration (dehydration). You must drink the extra amount of clear liquids that are recommended.

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

Important :

You should not drink alcohol, milk, red or purple beverages (eg blackcurrant juice), or any other beverage that contains pulp.
You should not eat anything from the time you start taking Plenvu until after the procedure/examination.

You are not allowed to drink anything from:

two hours before the procedure/examination if you are to be anesthetized, or
one hour before the procedure/examination if you are not to be anesthetized.

If you need to thicken liquids to be able to swallow them safely, Plenvu can counteract the effect of the thickener.

Pregnancy, breastfeeding, and fertility

There is no information on the use of Plenvu during pregnancy or lactation, therefore use is not recommended in pregnant and lactating women. Plenvu should only be used if your doctor thinks it is necessary. 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 using Plenvu.

Driving and using machines

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

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Plenvu contains sodium, potassium, and a source of phenylalanine

This medicine contains 458.5 mmol (10.5 g) sodium (the main ingredient in common salt/table salt) per treatment. This should be considered by patients prescribed a low-salt (sodium-poor) diet.

This medicine contains 29.4 mmol (1.1 g) of potassium per treatment. This should be considered by patients with impaired renal function or patients on a low-potassium diet.

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

How to take Plenvu

Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.

Carefully read the instructions below before taking Plenvu. You need to know:

when to take Plenvu
how Plenvu should be prepared
how to drink Plenvu
what you can expect to happen

When to take Plenvu

You must have completed your treatment with Plenvu before the procedure/examination.

The treatment is taken in two doses according to one of the following schedules:

Two-day dosingDose 1 is taken in the evening before the procedure/examination (approximately 18.00) and Dose 2 is taken early in the morning on the day of the procedure/examination (approximately 06.00).
or
One-day dosing on the same day as the procedure / examinationDose 1 and Dose 2 are taken in the morning on the day of the procedure/examination ( Dose 1 at approximately 05.00); take the two doses at least 1 hour apart,
or
One-day dosing the day before the procedure / examinationDose 1 and Dose 2 are taken in the evening the day before the procedure/examination ( dose 1 at approximately 18.00); take the two doses at least 1 hour apart,

Your doctor will tell you which dosing schedule to follow. DO NOT add anything else to the doses.

You should not eat anything from the time you start taking Plenvu until after the procedure/examination. Information on when to eat before taking Plenvu can be found in section 2.

How to prepare Plenvu Dos 1

Open the carton and take out the sachet with Dos 1.
Pour the contents of Dose 1 into a measuring vessel that holds at least 500 ml of liquid.
Pour in water to 500 ml and stir until all the powder has dissolved. This can take up to about 8 minutes.

How to drink Plenvu Dos 1

Drink the 500 ml Plenvu Dose 1 solution for 30 minutes. Try to drink a glass every 10-15 minutes.
Drink another 500 ml of clear liquid for the next 30 minutes. Water, clear soup, juice / clear fruit juices (without pulp), herbal tea, black tea, or coffee (without milk) are all good to drink.

How to prepare Plenvu Dos 2

When it’s time to take Dose 2, pour the powder into Dose 2, Dose Bag A, and Dose Bag B into a measuring vessel that holds at least 500 ml.
Pour in water to 500 ml and stir until all the powder has dissolved. This can take up to about 8 minutes.

How to drink Plenvu Dos 2

When it is time according to the recommended dosing schedule, prepare and drink 500 ml of Plenvu Dose 2 solution for 30 minutes.
Drink another 500 ml of clear liquid for the next 30 minutes.

You can drink more clear fluid before, during, and after taking Plenvu, but you must stop drinking 1-2 hours before your procedure/examination. Drinking clear liquid helps prevent dehydration (dehydration).

What you can expect to happen

When you start drinking the Plenvu solution, you must stay close to a toilet. You will get watery diarrhea. This is perfectly normal and shows that the Plenvu solution works. Your stomach may feel swollen before your first bowel movement.

If you follow these instructions, your bowel will be cleansed and it will help you undergo a successful examination. Make sure you have enough time after your stomach has calmed down to travel to the clinic/hospital.

If you take more laxatives than you should

If you take Plenvu before or after taking other laxatives, you may develop violent diarrhea, which may lead to dehydration. Drink plenty of clear liquids. If you have any further questions, ask your doctor or the nearest emergency department.

If you have ingested too much medicine or if e.g. a child ingested the medicine accidentally contact a doctor, hospital, or the Poison Information Center (tel.112) for risk assessment and advice.

If you forget to take Plenvu

If you forget to take Plenvu according to the instructions, take it as soon as you realize it and contact your doctor, pharmacist, or nurse for advice before your procedure/examination.
You must complete your treatment with Plenvu in good time so that your bowel is completely cleansed at least 2 hours before your procedure/examination.

If you have any further questions on the use of this product, ask your or, pharmacist or nurse.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

It is normal to get diarrhea while taking Plenvu.

If you have not had a bowel movement within 6 hours of taking Plenvu, stop treatment and contact your doctor immediately.

If you experience any of the following side effects, stop taking Plenvu and tell your doctor immediately, as these symptoms may be a sign of a severe allergic reaction:

Extreme fatigue
Palpitation
Rash or itching
Shortness of breath
Swelling of the face, ankles, or other body parts

Tell your doctor immediately if you get any of these symptoms while taking Plenvu as this may indicate loss of too much fluid, dehydration ( dehydration ):

Dizziness
Headache
Urination more rarely than normal
Vomiting

Also, tell your doctor immediately if you have very severe abdominal or stomach pain.

In rare cases, serious problems with the heart rhythm may occur (ie it may feel as if the heart is pounding, fluttering, or beating irregularly, usually for a few seconds or possibly a few minutes) in connection with the use of laxatives to cleanse the bowel, especially in patients with underlying heart disease or salt disorder. Talk to your doctor if symptoms persist.

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

Dehydration
Nausea
Vomiting

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

Swelling and pain in the abdomen
Pain and pain
Allergic reaction
Overindulge
Fatigue
Headache or migraine
Hot flashes
Elevated blood sugar levels in patients with diabetes
Elevated heart rate
Palpitation
Tenderness around the rectum
Somnolence
Temporarily high blood pressure
Temporarily elevated levels of liver enzymes
Thirst
Altered salinity (electrolyte levels) in the blood
Weakness

How to store Plenvu

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

Use before the expiry date which is stated on the sachet and carton after “EXP”. The expiration date is the last day of the specified month.

Note that the expiration dates may be different for the individual sachets and cartons.

Unopened packaging should not be stored above 25 ° C.

Store the reconstituted solution at a maximum of 25 ° C and drink it within 24 hours. The solution can be stored in the refrigerator. The solution must be covered.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

Dose 1 ( sachet ) contains the following active substances:

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

The concentration of the electrolyte ions for dose 1, after reconstitution with 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:

Dose bag A:

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

Dose bag B:

Sodium ascorbate	48.11 g
Ascorbic acid	7.54 g

The concentration of electrolyte ions for dose 2 ( sachets A and B) after reconstitution in 500 ml solution are 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 ( Dose bag A) contains 0.88 g of aspartame (E951).

Other ingredients are Encapsulated citric acid containing citric acid (E330) and maltodextrin (E1400). Mango aromas contain glycerol (E422), flavorings, acacia gum (E414), maltodextrin (E1400), and nature-identical flavors. Fruit juice aromas contain flavorings, acacia gum (E414), maltodextrin (E1400), and nature-identical flavors.

For further information see section 2.

What the medicine looks like and the contents of the pack

One treatment consists of three sachets: Dosage 1, Dosage 2 sachet A, and Dosage 2 sachet B. Plenvu powder for oral solution is available in packs of 1, 40, 80, 160, and 320 treatments.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Norgine BV

Antonio Vivaldi Street 150

1083 HP Amsterdam

Netherlands

Manufacturer:

Norgine Limited

New Road, Hengoed

Mid Glamorgan CF82 8SJ