PICOPREP POWDER FOR ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

PICOPREP Powder for Oral Solution

Sodium picosulfate/magnesium oxide/citric acid

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you

• Keep this leaflet, you may need to read it again. If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Picoprep and what is it used for

Picoprep is a powder that contains sodium picosulfate, a laxative that works by increasing intestinal activity. Picoprep also contains magnesium citrate, another type of laxative that works by retaining fluids in the intestine to provide a washing effect.

Picoprep is indicated in adults, adolescents, and children from 1 year of age for intestinal cleansing prior to a radiological examination, endoscopy, or surgery when clinically necessary.

2. What you need to know before you take Picoprep

Do not take Picoprep

• if you are allergic to sodium picosulfate, magnesium oxide, citric acid, or any of the other ingredients of this medicine (listed in section 6).
• if you have reduced stomach emptying ability (gastric retention)
• if you have stomach or intestinal ulcers
• if you have severe kidney problems
• if you have intestinal obstruction or perforation
• if you are currently ill or feel like you are going to be ill
• if you need abdominal surgery, such as acute appendicitis
• if your doctor has told you that you have heart failure (the heart is unable to pump blood efficiently around the body)
• if you have active inflammatory bowel disease, such as Crohn's disease or ulcerative colitis
• if your doctor has told you that you have too much magnesium in your blood
• if you are very thirsty or may be severely dehydrated
• if your doctor has told you that you have muscle damage that is releasing its contents into the blood
• if you suffer from a condition called:
• ileus (intestinal blockage or failure of normal intestinal movements)
• toxic colitis (damage to the intestinal wall)
• toxic megacolon (expansion of the large intestine)

In these conditions, the movement of intestinal contents may be affected or impaired. Symptoms include nausea, vomiting, diarrhea, abdominal pain, tenderness to palpation or inflammation, colic pain, and fever.

Warnings and precautions

Talk to your doctor or pharmacist before taking Picoprep

• if you have recently had abdominal surgery
• if you have heart disease or kidney problems
• if you have inflammatory bowel disease, such as ulcerative colitis or Crohn's disease
• if you are taking Picoprep before intestinal surgery.

You should make sure to drink enough fluids and electrolytes during the treatment period. This is especially important if you are under 18 years old, are elderly, or are physically weak.

If the test is performed early in the morning, you may need to take the second dose during the night, and sleep disturbances may occur.

The intestinal cleansing period should not exceed 24 hours, as a longer period may increase the risk of fluid and electrolyte imbalance.

Other medicines and Picoprep:

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

It is especially important that you tell your doctor if you are taking:

• bulk-forming laxatives, e.g., bran
• prescription medication that is taken orally, especially if it is prescribed regularly, as its effects may be altered, e.g., contraceptives, antibiotics, antidiabetics, iron, penicillamine, or antiepileptics. These medications should be taken at least 2 hours before and not less than 6 hours after taking Picoprep.
• prescription medication that may affect fluid and/or electrolyte balance, e.g., diuretics, steroids, lithium, digoxin, antidepressants, carbamazepine, or antipsychotics

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Picoprep has no influence on the ability to drive or use machines. However, you should make sure you have access to a toilet at all times after each dose, until the effects disappear.

Picoprep contains potassium, lactose, and sodium

Each sachet contains 5 mmol (or 195 mg) of potassium. You should talk to your doctor about this if you have kidney problems or if you have been put on a low-potassium diet.

This medicine also contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per sachet, i.e., it is essentially "sodium-free”.

3. How to take Picoprep

Follow the instructions for taking this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist again.

Picoprep powder should be dissolved in a glass of cold water (approximately 150 ml). Stir for 2-3 minutes and then drink the solution. Sometimes the solution becomes lukewarm when Picoprep dissolves. If this happens, wait until it cools enough to drink.

Adults (including the elderly) and children over 9 years:

The recommended dose is one sachet 10 to 18 hours before the test and another sachet 4 to 6 hours before the test.

The first sachet should be taken followed by at least five glasses of clear fluids (not just water) of 250 ml each, over several hours, and the second sachet should be taken followed by at least three glasses of clear fluids (not just water) of 250 ml each, distributed over several hours. You should drink clear fluids (not just water) until 2 hours before the test. Do not drink only water.

Children(under 9 years): To establish the dosing schedule in children, follow the instructions for adults.

A measuring spoon is provided with the medicine.

From 1 year to less than 2 years: the first dose is 1 spoonful, the second dose is 1 spoonful. From 2 years to less than 4 years: the first dose is 2 spoonfuls, the second dose is 2 spoonfuls.

From 4 years to less than 9 years: the first dose is 1 sachet (taken as described in "adults"), the second dose is 2 spoonfuls.

9 years and older: Dosage as for adults.

To measure the dose with the measuring spoon:

• Fill the measuring spoon with the powder from the sachet.
• Pass the edge of a knife over the top of the measuring spoon.
• The powder that remains in the measuring spoon is one spoonful (4 g of powder).
• Pour the powder from the measuring spoon into a glass of water. The glass should contain:

• Approximately 50 ml of water if you want to measure one spoonful of powder
• Approximately 100 ml of water if you want to measure two spoonfuls of powder

• Stir in the glass for 2-3 minutes.
• Drink the solution. Sometimes the solution becomes lukewarm when Picoprep dissolves. If this happens, wait until it cools enough to drink.
• Discard the rest of the powder from the sachet.

After taking the dose of Picoprep, you should expect frequent bowel movements with a feeling of evacuation. Please make sure you have access to a toilet at all times after each dose, until the effects disappear.

In order to replace the loss of fluids in the body, it is important to drink plenty of clear fluids (not just water) throughout the treatment with Picoprep until the bowel movements have stopped. In general, you should try to drink clear fluids (not just water) when you feel thirsty. Do not drink only water.

Clear fluids include fruit juices without pulp, soft drinks, broths, tea, coffee (without milk, soy, or cream), and water. Do not drink only water.

The success of the hospital procedure you are undergoing depends on the intestine being as clean as possible. You may need to repeat the hospital procedure if you do not achieve a clean intestine. You should always follow the dietary instructions given by your doctor.

Picoprep should not be used as a habitual laxative.

If you take more Picoprep than you should

If you have taken more Picoprep than you should, contact your doctor or the nearest hospital 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 medicine and the amount ingested)

If you forget to take Picoprep

Please consult your doctor, nurse, or pharmacist.

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

4. Possible side effects

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

Contact your doctor immediately if you experience any of the following serious side effects:

• Allergic reaction, including skin rash, skin redness, urticaria, itching, swelling of the throat, and/or difficulty breathing (uncommon)
• Change in consciousness, such as loss or decrease in level of consciousness (uncommon)
• Confusion/disorientation (uncommon)
• Fainting/syncope (uncommon)
• Dizziness/drowsiness (uncommon)
• Seizures (uncommon)
• Abdominal pain (frequent)
• Vomiting (frequent)

Other known side effects of Picoprep are described below:

Frequent (affects less than 1 in 10 but more than 1 in 100 patients)

• Headache
• Nausea
• HyperMagnesemia (high levels of magnesium in the blood)

Uncommon (affects less than 1 in 100 but more than 1 in 1,000 patients)

• Low levels of potassium in the blood ("hypokalemia")
• As the first clinical effects, loose stools or diarrhea may occur very regularly. However, if your bowel movements become problematic or worry you, you should talk to your doctor.

Rare (affects less than 1 in 1,000 but more than 1 in 10,000 patients):

• Low levels of sodium in the blood ("hyponatremia")
• Intestinal ulcers.
• Involuntary/accidental loss of intestinal contents ("anal incontinence")
• Anal pain

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Vigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Picoprep

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month stated.

Store in the original package to protect from moisture.

For single use only. Discard any unused contents.

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 protect the environment.

6. Contents of the pack and further information

Composition of Picoprep

The active ingredients are sodium picosulfate 10 mg, magnesium oxide 3.5 g, and citric acid 12 g.

The other ingredients are potassium hydrogen carbonate, sodium saccharin, and a natural orange flavoring that includes gum arabic, lactose, ascorbic acid, and butylhydroxyanisole.

Appearance of the product and pack contents

This medicine is called Picoprep. It is a powder for oral solution. It is available in packs containing 2, 100 sachets (50 packs of 2 sachets) and 300 sachets (150 packs of 2 sachets).

The pack includes a measuring spoon to ensure the correct dosage in children. The measuring spoon is used to measure 4 g of powder (4.75 ml). You should only use the measuring spoon if you want to dose for a child under 9 years old.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

FERRING S.A.U

C/ del Arquitecto Sánchez Arcas 3, 1º

Madrid 28040

Spain

Manufacturer

Ferring GmbH

Wittland 11

D-24109 Kiel

Germany

This medicine is authorised in the Member States of the European Economic Area under the following names:

PICOLAX United Kingdom

PICOPREP Germany, Austria, Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Norway, Netherlands, Portugal, Romania, Czech Republic, Slovakia, Sweden.

This leaflet was approved in April 2025.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://aemps.gob.es