powder for oral solution
sodium picosulfate / magnesium oxide / citric acid
What Picoprep is and what it is used for
Picoprep is a powder that contains sodium picosulfate, a laxative that works by increasing bowel movements. Picoprep also contains magnesium citrate, another type of laxative that works by retaining fluid in the intestines and providing a cleansing of the intestines.
Picoprep is used in adults, adolescents, and children from one year of age to clean the intestines before an X-ray, endoscopy (an examination that looks at the inside of the intestine using a long, flexible instrument that the doctor inserts through the anal opening) or surgery.
What you need to know before using Picoprep
Do not take Picoprep again
- you are allergic to sodium picosulphate, magnesium oxide or citric acid, or any of the other ingredients of this medicine (listed in section 6)
- your stomach is not emptied properly (gastric retention)
- you have ulcers in the stomach or intestines
- you have severe kidney problems
- you have a blockage in the intestine or a hole in the intestinal wall
- you vomit or feel unwell
- you have a condition that requires surgery such as acute appendicitis
- the doctor has told you that you have chronic heart failure (your heart can not pump around the blood in the body properly)
- you suffer from an active inflammatory bowel disease such as Crohn’s disease or ulcerative colitis
- Your doctor has told you that you have too much magnesium in your blood
- you are very thirsty or think you may be severely dehydrated
- your doctor has told you that you have damaged muscles whose contents are leaking into the bloodstream
- you have any of the following conditions:
- bowel movements (blockage in the bowel or non-functioning normal bowel movements)
- toxic colitis (damaged intestinal wall)
- toxic megacolon (swollen colon)
In these conditions, bowel movements may be impaired or absent. Symptoms include nausea, vomiting, diarrhea, abdominal pain, tenderness or swelling, colic-like pain, and fever.
Warnings and cautions
Talk to your doctor or pharmacist before taking Picoprep
- has recently undergone abdominal surgery
- have heart disease or kidney problems
- suffers from an inflammatory bowel disease such as Crohn’s disease or ulcerative colitis
- taking Picoprep before bowel surgery
Make sure you drink enough fluids and electrolytes (salts) during treatment. This is especially important if you are younger than 18, older, or physically weak.
If you have an appointment for surgery/surgery early in the day, you may need to take the second dose during the night. Sleep disorders may occur then.
Other medicines and Picoprep
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must inform your doctor if you are taking;
- bulk laxatives eg bran
- medicines that you have received on prescription and take by mouth, especially those that you take regularly, such as birth control pills, antibiotics, medicines for diabetes, iron, penicillamine, or medicines for epilepsy, as the effect of these can be changed. These medicines should be taken at least 2 hours before and not less than 6 hours after administration of Picoprep
- prescription drugs that can affect water and/or electrolyte balance in the body, such as 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 does not affect your ability to drive or use machines. However, make sure that you have access to a toilet after taking this medicine until the effect has subsided.
Picoprep contains potassium, lactose, and sodium
One sachet contains 5 mmol (or 195 mg) of potassium . You should discuss this with your doctor if you have kidney problems or if you are on a low potassium diet.
This medicine also contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per sachet, ie it is essentially ‘sodium-free’.
How to take Pioprep
Always take Picoprep exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Mix the contents of a sachet in a cup of cold water (about 150 ml). Stir for 2-3 minutes and drink the solution. Sometimes the solution gets hot when Picoprep dissolves, wait until it cools down enough before drinking it.
Adults (including the elderly) and children aged 9 and over
The recommended dose is a sachet 10 – 18 hours before the examination/operation and a sachet 4 – 6 hours before the examination/operation. After taking the first sachet, 250 ml of clear drink (not just water) should be drunk on at least five occasions over several hours (a total of at least 1250 ml). The second sachet should be followed by at least three times 250 ml of clear drink (not just water) spread over several hours. You can drink clear drinks up to 2 hours before the examination/operation. Do not drink only water.
Children (under 9 years)
For children, the same times for intake apply as for adults, see above.
A dose spoon is included in the package.
≥1- <2 years: First dose one is 1 dose spoon, second dose one is 1 dose spoon
≥2- <4 years: First dose one is 2 dose spoons, second dose one is 2 dose spoons
≥4- <9 years: First dose one is 1 dose bag (in the same way as for adults described above), second dose one is 2 dose spoons
from 9 years and older: Adult dos
To measure the dose with a dose spoon:
- fill the dosing spoon with powder from the dosing bag
- pull the back of a knife over the dosing spoon
- the powder that is now left in the dosing spoon is one spoonful (4 g powder)
- pour the powder from the dosing spoon into a cup with
- about 50 ml of water if you have a tablespoon of powder
- about 100 ml of water if you have two tablespoons of powder
- Stir in the cup for 2-3 minutes
- drink the solution. Sometimes the solution gets hot when Picoprep dissolves, wait until it cools down enough before drinking it
- throw away the sachet with leftover contents
Be prepared for frequent and loose bowel movements at any time after taking a dose of Picoprep. Make sure you have access to a toilet until the effect has subsided.
Drink copious amounts of clear liquids (not just water). during treatment with Picoprep until bowel movements have subsided, to replace the body’s fluid loss. You should generally try to drink clear drinks (not just water) when you are thirsty. Do not drink only water.
Ready drinks should consist of different types of juices without pulp, soda, broth, tea, coffee (without milk, soy milk, or cream), and water. Do not drink only water.
For the examination/operation to go well, the intestine must be as clean as possible. The examination/operation may need to be redone if the intestine is not clean. You should always follow the instructions regarding the food and drink that you have received from your doctor.
If you take more Picoprep than you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice.
If you forget to take Picoprep
Contact a doctor, nurse, or pharmacist for advice.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if any of the following side effects occur as they may be serious:
- allergic reaction such as rash, redness of the skin, hives, swelling of the throat, and / or difficulty breathing (uncommon)
- change in the level of consciousness such as unconsciousness or decreased level of consciousness (uncommon)
- confusion / disorientation (less common)
- fainting (uncommon)
- dizziness/feeling of instability (uncommon)
- seizures (less common)
- abdominal pain (common)
- vomiting (common)
Other known side effects of Picoprep are described below:
Common (may affect up to 1 in 10 people):
- Headache
- Nausea
Uncommon (may affect up to 1 in 100 people):
- Low levels of potassium in the blood ( hypokalaemia )
- Because the clinical effect usually increases bowel movements, diarrhea may occur. If bowel movements become troublesome, consult a doctor.
Rare (may affect up to 1 in 1,000 people):
- Low levels of sodium in the blood ( hyponatremia )
- Sores in the intestine
- Involuntary / sudden bowel movement (anal incontinence )
- Pain in the anus
How to store Picoprep
Keep this medicine out of the sight and reach of children.
Store in the original package. Moisture sensitive.
For single use only. Discard unused content.
Do not use this medicine after the expiry date which is stated on the carton and sachet. The expiration date is the last day of the specified month.
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 package and other information
Content declaration
- The active substances in a sachet are sodium picosulphate 10 mg, light magnesium oxide 3.5 g and anhydrous citric acid 12 g
- The other ingredients are potassium bicarbonate, saccharin sodium, natural spray-dried orange flavor containing acacia gum, lactose, ascorbic acid, and butyl hydroxyanisole.
What the medicine looks like and the contents of the pack
Your medicine is called Picoprep. It is a powder for oral solution.
The product is available in pack sizes of 2 sachets, 100 sachets (50 packs containing 2 sachets), or 300 sachets (150 packs containing 2 sachets).
For children to receive the correct dose, a dosing spoon is included in the package. The spoon is used to measure 4 g of powder (4.75 ml). You should only use the spoons if you are giving the powder to children under 9 years of age.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Ferring Läkemedel AB
Box 4041
203 11 Malmö
Manufacturer:
Ferring GmbH
Wittland 11
24109 Kiel
Germany
This medicinal product is authorized under the European Economic Area under the names:
Picolax
UK
Picoprep
Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Greece, Iceland, Italy Latvia, Lithuania, Luxembourg, Netherlands, Norway, Portugal, Romania, Slovakia, Spain, Sweden, Czech Republic, Germany, Hungary, Austria