Picoprep

Package leaflet: Information for the patient

PICOPREP, powder for oral solution

Sodium picosulfate / Magnesium oxide / Citric acid
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What PICOPREP is and what it is used for

PICOPREP is a powder containing sodium picosulfate, a laxative that works by increasing intestinal activity.
PICOPREP also contains magnesium citrate, another type of laxative that works by drawing water into the intestine to produce a cleansing effect.
PICOPREP is used in adults, adolescents, and children from the age of 1 year onwards to clean the bowel before a radiological, endoscopic examination, or before a surgical procedure, if considered clinically necessary.

2. What you need to know before using PICOPREP

Do not use PICOPREP if:

• you are allergic to sodium picosulfate/magnesium oxide/citric acid or to any of the other ingredients of this medicine (listed in section 6)
• you have reduced ability of stomach emptying (gastric retention)
• you have stomach or intestinal ulcers
• you suffer from severe kidney disease
• you have intestinal obstruction or intestinal perforation
• you are currently ill or feel unwell
• you are scheduled for abdominal surgery, for example due to acute appendicitis
• your doctor has informed you that you have congestive heart failure (the heart does not pump blood effectively)
• you suffer from active inflammatory bowel disease such as Crohn's disease or ulcerative colitis
• your doctor has informed you that you have abnormally high levels of magnesium in your blood
• you are very thirsty or think you are severely dehydrated
• your doctor has informed you that you have damaged muscles releasing their contents into the blood
• you suffer from:

For Internal Use - Internal

• ileus (intestinal blockage or failure of normal intestinal motility),
• toxic colitis (damage to the intestinal walls),
• toxic megacolon (dilation of the large intestine). In these conditions, intestinal movement may be reduced or prevented. Symptoms include nausea, vomiting, diarrhoea, abdominal pain, tenderness or distension, colicky pain, and fever.

Warnings and precautions
Talk to your doctor or pharmacist before taking PICOPREP:

• if you have recently undergone abdominal surgery
• if you suffer from heart or kidney problems
• if you suffer from inflammatory bowel diseases such as ulcerative colitis or Crohn's disease
• if you need to take PICOPREP before intestinal surgery.

You must ensure that you drink sufficient amounts of fluids and electrolytes during treatment. This is
particularly important if you are under 18 years of age, elderly, or physically weak.
If the procedure is scheduled for early morning, you may need to take the second dose during the night, which
could lead to possible sleep disturbances.
The duration of bowel cleansing should not exceed 24 hours, as a longer preparation may increase the risk of
fluid and electrolyte imbalance in the body.
Other medicines and PICOPREP
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
It is particularly important to inform your doctor if you are already taking:

• bulk-forming laxatives, for example bran
• oral medicines prescribed by your doctor, especially those taken regularly, as their effectiveness may be altered, for example contraceptives, antibiotics, antidiabetics, iron, penicillamine, or antiepileptics. These medicines should be taken at least 2 hours before and not less than 6 hours after taking PICOPREP
• medicines that may disturb fluid and/or electrolyte balance, such as diuretics, steroids, lithium, digoxin, antidepressants, carbamazepine, or antipsychotics.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding,
please consult your doctor or pharmacist before using this medicine.
Driving and using machines
PICOPREP has no effect on the ability to drive or operate machinery. However, ensure you have
immediate access to a toilet throughout the duration of the medicine's action after each dose, until the effect
has ended.
PICOPREP contains potassium, lactose and sodium
Each sachet contains 5 mmol (or 195 mg) of potassium. If you have kidney problems or are on a diet
controlling potassium intake, discuss this with your doctor.
This medicine also contains lactose. If your doctor has told you that you have an intolerance to certain sugars,
inform your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per sachet, i.e. essentially "sodium-free".

3. How to use PICOPREP

For Internal Use - Internal
Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
PICOPREP powder must be dissolved in a cup of cold water (approximately 150 ml). Stir for 2-3 minutes and
then drink the solution. Sometimes the solution warms up when PICOPREP dissolves. If this occurs, wait before
drinking until the solution becomes sufficiently cool.
Adults (including elderly) and children aged 9 years and older
The recommended dose is one sachet to be taken 10 to 18 hours before the start of the procedure and one
sachet 4 to 6 hours before the start of the procedure.
After taking the first sachet, drink at least five 250 ml doses of clear fluids (not water only) over several hours. After taking the second sachet, drink at least three 250 ml doses of clear fluids (not water only) over several hours. Clear fluids (not water only) may be consumed up to 2 hours before the start of the procedure. Do not drink water only.
Children (under 9 years of age)
For dosing schedule in children, refer to the instructions provided for adults.
A dosing spoon is provided with the product.
From 1 up to 2 years: first dose of 1 spoonful, second dose of 1 spoonful
From 2 up to 4 years: first dose of 2 spoonfuls, second dose of 2 spoonfuls
From 4 up to 9 years: first dose of 1 sachet (taken as described under “Adults”), second dose of 2 spoonfuls
From 9 years and older: adult dose
To measure the dose with the dosing spoon:

• Fill the spoon with some powder from the sachet.
• Run the back of a knife across the surface of the dosing spoon.
• The powder remaining in the spoon corresponds to one spoonful (4 g of powder).
• Pour the powder from the spoon into a cup of water. The cup should contain:
  • approximately 50 ml of water if measuring one spoonful of powder
  • approximately 100 ml of water if measuring two spoonfuls of powder
• Stir in the cup for 2-3 minutes.
• Drink the solution. Sometimes the solution becomes warm when PICOPREP dissolves. If this happens, wait before drinking until the solution becomes sufficiently cool.
• Discard any residual powder remaining in the sachet.

Frequent bowel movements are expected, which may occur at any time after taking a dose of PICOPREP. Therefore, ensure easy access to a toilet throughout the treatment period with PICOPREP, until the effect has subsided.
To replace lost fluids, it is important to drink plenty of clear fluids (not water only) during treatment with PICOPREP until bowel movements have ceased. In general, you should drink clear fluids (not water only) whenever you are thirsty. Do not drink water only.
Clear fluids should include a variety of pulp-free fruit juices, soft drinks, broth, tea, coffee (without milk, soy or cream), and water. Do not drink water only.
The success of the hospital procedure you are undergoing depends on how clean your bowel is, which must be as complete as possible. The procedure may need to be repeated if the bowel is not sufficiently clean. Always follow the dietary instructions provided by your doctor.
PICOPREP must not be used as a routine laxative.
If you take more PICOPREP than you should
If you take more PICOPREP than you should, contact your doctor immediately or go to the nearest emergency department.
For Internal Use - Internal
If you forget to take PICOPREP
Consult your doctor, pharmacist, or nurse for advice.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Contact your doctor immediately if you experience any of the following side effects, as they may be serious:

• allergic reaction, including for example skin rash, redness of the skin, urticaria, itching, swelling of the throat and/or difficulty breathing (uncommon)
• change in consciousness, such as loss or reduced level of consciousness (uncommon)
• confusion/disorientation (uncommon)
• fainting/syncope (uncommon)
• dizziness/mental stupor (uncommon)
• seizures (uncommon)
• abdominal pain (common)
• vomiting (common)

Other known side effects of PICOPREP are listed below:
Common (affects less than 1 in 10 people but more than 1 in 100):

• Headache
• Nausea
• Hypermagnesemia (elevated magnesium levels in the blood)

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

• Low potassium levels in the blood (hypokalaemia)
• As the main clinical effect, pronounced and frequent bowel movements or diarrhoea may occur. However, if these become bothersome or cause concern, contact your doctor.

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

• Low sodium levels in the blood (hyponatraemia)
• Intestinal ulcers
• Involuntary or accidental loss of bowel contents (anal incontinence)
• Anal pain

If any side effect worsens, contact your doctor or nurse. If you notice any side effect not listed in this leaflet, inform your doctor, nurse, or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PICOPREP

Keep this medicine out of the sight and reach of children.
For Internal Use - Internal
Store in the original packaging to protect the medicine from moisture.
Single use. Dispose of any unused residue.
Do not use this medicine after the expiry date stated on the box and sachet after "Exp".
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What PICOPREP contains
The active substances in one sachet are: 10 mg sodium picosulfate, 3.5 g light magnesium oxide, and 12 g
citric acid.
The other components are: potassium bicarbonate, sodium saccharin, and natural orange dry spray flavour
containing acacia gum, lactose, ascorbic acid, butylated hydroxyanisole.

Description of the appearance of PICOPREP and contents of the pack
Your medicine is called PICOPREP and is a powder for oral solution.
It is supplied in packs of 2 sachets, 100 sachets (50 packs, each containing 2 sachets), or 300 sachets (150 packs, each containing 2 sachets).
A dosing spoon is included in the pack to ensure accurate dosing for children. The spoon is used to measure 4 g of powder (4.75 ml). The spoon should only be used for dosing in children under 9 years of age.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Ferring S.p.A.
Via C. Imbonati, 18
20159 - MILAN, ITALY

Manufacturers
Ferring GmbH, Wittland 11, D-24109 Kiel, Germany

This medicinal product is authorised in the European Economic Area countries under the following
names:
PICOLAX
United Kingdom
PICOPREP
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany,
Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Portugal, Romania,
Slovakia, Spain, Sweden

For Internal Use - Internal
For Internal Use - Internal