Label: information for the user

PICOPREP Oral Solution Powder

Picosulfate sodium/magnesium oxide/citric acid

Read this label carefully before starting to take this medication because 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 or pharmacist
• 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 or pharmacist, even if they are not listed in this label. See section 4.

1. What Picoprep is and for what it is used

2. What you need to know before starting to take Picoprep

3. How to take Picoprep

4. Possible adverse effects

5. Storage of Picoprep

6. Contents of the package and additional information

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

Picoprep is indicated for adults, adolescents, and children aged 1 year and older for intestinal emptying prior to a radiological examination, endoscopy, or surgery when clinically necessary.

Do not take Picoprep

• if you are allergic to sodium picosulfate, magnesium oxide, citric acid, or any of the other components of this medication (listed in section 6).
• if you have reduced ability to empty your stomach (gastroparesis)
• if you have stomach or intestinal ulcers
• if you have severe kidney problems
• if you have intestinal obstruction or perforation
• if you are currently or have a feeling of being nauseous
• if you present a need for abdominal surgery, such as acute appendicitis
• if your doctor has informed you that you suffer from 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 informed 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 damaged muscles that are leaking their 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, intestinal content movement may be affected or prevented. Symptoms include nausea, vomiting, diarrhea, abdominal pain, tenderness to the touch or inflammation, colic pain, and fever.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Picoprep

• if you have recently had abdominal surgery
• if you suffer from 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 ensure that you drink enough liquid and electrolytes during the duration of treatment. This is especially important if you are under 18 years old, elderly, or physically weak.

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

Other medications and Picoprep:

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

It is especially important to inform your doctor if you are taking:

• bulk-forming laxatives, e.g. psyllium
• prescription medication taken orally, especially if prescribed regularly, as its effects may be modified, e.g. contraceptives, antibiotics, antidiabetics, iron, penicillamine, or antiepileptics. These medications should be taken at least 2 hours before and no less than 6 hours after the administration of 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Picoprep has no influence on the ability to drive or operate machinery. However, you should ensure that you have access to a toilet at all times after each dose until the effects have worn off.

Picoprep contains potassium, lactose, and sodium

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

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

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Adults (including elderly) and children 9 years and older:

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

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

Children(under 9 years): To establish dosing times in children, consult the instructions for adults

A measuring spoon is provided with the medication.

From 1 year to under 2 years: the first dose is 1 teaspoon, the second dose is 1 teaspoon From 2 years to under 4 years: the first dose is 2 teaspoons, the second dose is 2 teaspoons

From 4 years to under 9 years: the first dose is 1 packet (taken as described in “adults”,), the second dose is 2 teaspoons.

9 years and older: Dosage as adults

To measure the dose with the measuring spoon:

• Filling the measuring spoon with the powder from the packet.
• Passing the edge of a knife over the top of the measuring spoon.
• The powder left in the measuring spoon is one teaspoon (4 g of powder).
• Adding the powder from the measuring spoon to a glass of water. The glass should contain:

• Approximately 50 ml of water if you want to measure one teaspoon of powder
• Approximately 100 ml of water if you want to measure two teaspoons of powder

• Shaking the glass for 2-3 minutes.
• Drinking the solution. Sometimes the solution becomes lukewarm when Picoprep dissolves. If this occurs, wait until it cools down enough to drink it.
• Discarding the remaining powder from the packet.

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

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

Clear liquids 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 undergo depends on the intestine being as clean as possible. You may need to repeat the hospital procedure if you do not manage to get a clean intestine. You should always follow the dietary instructions given by your doctor.

If you take more Picoprep than you should

If you have taken more Picoprep than you should, contact your doctor or nearest hospital immediately.

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

If you forgot to take Picoprep

Please consult your doctor, nurse or pharmacist.

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

Like all medications, this medication may produce adverse effects,although not all people will experience them.

Immediately contact your doctor if the following adverse effects may be severe

• Allergic reaction including skin rash, skin redness, hives, itching, throat swelling, and/or difficulty breathing (infrequent)

• Change in consciousness, such as loss or decrease in level of consciousness (infrequent)

• Confusion/disorientation (infrequent)
• Syncope/fainting (infrequent)
• Dizziness/drowsiness (infrequent)
• Seizures (infrequent)
• Abdominal pain (frequent)
• Vomiting (frequent)

Other known adverse effects of Picoprep are described below:

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

• Headache
• Nausea

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

• Low levels of potassium in the blood ("hypokalemia")
• As initial clinical effects, loose, very regular bowel movements or diarrhea may occur. However, if your intestinal evacuations become problematic or concern you, contact 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 content ("anal incontinence")
• Anal pain

If any of the side effects worsen, report to your doctor or nurse. If you notice any side effect not listed in this prospectus, report to your doctor, nurse, or pharmacist.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult with your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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 after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

For single use only. Dispose of any unused content.

Medications should not be disposed of through drains or trash. Deposit empty containers and unused medications at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Picoprep

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

The other components are potassium hydrogen carbonate, sodium saccharin and a natural orange flavor based on dehydrated orange, which includes gum arabic, lactose, ascorbic acid and butylhydroxyanisole.

Appearance of the product and content of the packaging

This medicine is called Picoprep. It is an oral powder.It is presented in packaging that contains 2, 100 sachets (50 packs of 2 sachets) and 300 sachets (150 packs of 2 sachets).

The packaging includes a measuring spoon to ensure correct dosing 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.

You may only find some sizes of packaging commercially available.

Holder of the marketing authorization

FERRING S.A.U

C/ del Arquitecto Sánchez Arcas 3, 1st

Madrid 28040

- Spain

Responsible for manufacturing

Ferring GmbH

Wittland 11

D-24109 Kiel

Germany

This medicine is authorized in the Member States of the European Economic Area with the following names:

PICOLAXUnited Kingdom

PICOPREPAustria, 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 February 2021.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://aemps.gob.es