SUMMARY CMI

PICOSALAX^® Powder for Oral Solution

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine.

1. Why am I taking PICOSALAX?

PICOSALAX contains the active ingredient sodium picosulfate with magnesium citrate. PICOSALAX is used for clearance of the bowel before x-ray, endoscopy or surgery.

For more information, see Section 1. Why am I taking PICOSALAX? in the full CMI.

2. What should I know before I take PICOSALAX?

Do not take if you have ever had an allergic reaction to PICOSALAX or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I take PICOSALAX? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with PICOSALAX and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take PICOSALAX?

• For adults and children 9 years and over, the usual dose is two sachets but the timing of each dose can vary and may depend on the time of your examination.
• The sachets must be made up in water before drinking.

More instructions can be found in Section 4. How do I take PICOSALAX? in the full CMI.

5. What should I know while taking PICOSALAX?

For more information, see Section 5. What should I know while taking PICOSALAX? in the full CMI.

6. Are there any side effects?

All medicines can have side effects. Most of them are minor and temporary but some may need medical attention.

Tell your doctor if you experience any side effects, including rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing. These are very serious side effects. You may need urgent medical attention.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

WARNING: Life threatening dehydration and/or electrolyte disturbances may occur in some people. Read the section with the heading "Before you take Picosalax".

FULL CMI

PICOSALAX^® Powder for Oral Solution

Active ingredient(s): sodium picosulfate with magnesium citrate

Consumer Medicine Information (CMI)

This leaflet provides important information about using PICOSALAX. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using PICOSALAX.

Where to find information in this leaflet:

1. Why am I taking PICOSALAX?
2. What should I know before I take PICOSALAX?
3. What if I am taking other medicines?
4. How do I take PICOSALAX?
5. What should I know while taking PICOSALAX?
6. Are there any side effects?
7. Product details

1. Why am I taking PICOSALAX?

PICOSALAX contains the active ingredient sodium picosulfate with magnesium citrate.

PICOSALAX is used for clearance of the bowel before x-ray, endoscopy, or surgery.

Picosalax produces a watery stool or bowel motion which empties and cleans the bowel before the procedure.

Each dose of Picosalax usually produces a bowel movement within 2 to 3 hours, depending on your individual response.

2. What should I know before I take PICOSALAX?

Warnings

Picosalax is not to be used as a routine laxative.

Picosalax is not for use in children under 9 years of age.

Do not take PICOSALAX if:

• you are allergic to any medicine containing sodium picosulfate or magnesium citrate or any of the ingredients listed at the end of this leaflet.
• you are suffering from:
  - heart failure
  - perforation of the stomach or stomach obstruction
  - delayed emptying of stomach contents into the small intestine
  - holes in the lining of the stomach
  - damage to the entire thickness of the intestinal wall
  - severe distension in the colon
  - blockage in the bowel
  - nausea and vomiting
  - inflammation of the appendix
  - severe dehydration
  - muscle damage causing muscle pains, vomiting, confusion
  - high magnesium levels
  - active inflammatory bowel disease
  - severe kidney disease
  - undiagnosed abdominal symptoms
• the expiry date printed on the pack has passed
• the packaging is torn or shows signs of tampering.

Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

• have any other medical conditions especially the following:
  - recent gastrointestinal surgery
  - kidney problems
  - heart problems
  - inflammatory bowel disease
  - electrolyte disturbances
  - diabetes
• take any medicines for any other condition

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Tell your doctor if you are on potassium restricted diet.

• Picosalax contains 195 mg potassium per sachet. This should be taken into consideration if you have reduced kidney function or you are on a controlled potassium diet.

If you have not told your doctor about any of the above, tell him/her before you start taking Picosalax.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with PICOSALAX and affect how it works. These include:

• birth control medications (oral contraceptives)
• medicines used to treat infections (antibiotics)
• medicines used to help the kidneys get rid of salt and water by increasing the amount of urine produced (diuretics)
• corticosteroids
• medicines used to treat depression (antidepressants) or psychosis (antipsychotics)
• bulk-forming laxatives
• iron supplements
• medicines used to treat heart failure and the associated symptoms of shortness of breath when lying flat (e.g digoxin)
• medicines used to treat epilepsy (anti-epileptics)
• medicines used to treat diabetes
• medicines such as ibuprofen, used to treat pain and inflammation (NSAIDs)
• penicillamine.

These medicines may be affected by Picosalax or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Picosalax may prevent absorption of oral medication taken within one hour of its administration.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect PICOSALAX.

4. How do I take PICOSALAX?

The following is a summary of how to take Picosalax and explains the different regimens that your doctor may tell you to follow. For FULL instructions on how to take Picosalax, please refer to the ‘Patient Information Leaflet’ enclosed with Picosalax.

The success of your examination depends on the bowel being as clear as possible. Otherwise, the examination may need to be repeated. So it is important to take all the medicine and follow all your doctor's instructions.

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

How much to take

Adults and children 9 years and over

For adults and children 9 years and over, the usual dose is two sachets but the timing of each dose can vary and may depend on the time of your examination. The contents of each of two sachets may be taken several hours apart on the day before the examination (DAY BEFORE regimen) or over two days (SPLIT-DOSE regimen). Your doctor will advise you which way to take your Picosalax.

In some circumstances, your doctor may choose to modify these dose instructions. Follow the doctor's instructions carefully.

How to take PICOSALAX

The sachets must be made up in water before drinking. The detailed instructions for reconstituting the sachets are in the carton.

Your doctor will have informed you of the dose that you should take and when to take it.

It is important that you follow the instructions specifically given by the hospital and that you drink plenty of clear fluids.

If you take too much PICOSALAX

If you think that you have taken too much PICOSALAX, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Symptoms of an overdose may include profuse diarrhoea with dehydration and fluid/electrolyte imbalance.

5. What should I know while taking PICOSALAX?

You should expect frequent, loose bowel movements at any time after taking a dose. Please ensure that you have access to a toilet at all times following each dose, until the effects wear off.

Things you should do

In order to replace the fluid lost from the body, it is important to drink plenty of clear fluids whilst the effects of Picosalax persist. In general you should try to drink at least 250 mL (approximately one large glass) of clear fluid every hour during the treatment day/days.

If you are about to be started on any new medicine, remind any doctor, dentist or pharmacist you visit that you are taking PICOSALAX.

If you are about to have any blood tests, tell your doctor that you are taking this medicine.

It may interfere with the results of some tests.

Things you should not do

Do not take Picosalax to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Things to be careful of

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.

Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.

Driving or using machines

This medicine is not expected to affect your ability to drive a car or operate machinery.

Looking after your medicine

Keep this medicine in the pack until it is time to take it.

If you open the sachets too soon the powder may not keep well.

Store it in a cool dry place, where the temperature stays below 30°C, away from moisture, heat or sunlight;

For example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Heat and dampness can destroy some medicines.

Follow the instructions in the carton on how to take care of your medicine properly.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Getting rid of any unwanted medicine

If you no longer need to take this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not take this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Side effects

Serious side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Picosalax.

This medicine helps most people who require a bowel preparation but it may have unwanted side effects in a few people.

You may need medical attention if you get some of the side effects.

If you experience one or more of these side effects, or any other undesirable effects, please tell your doctor or pharmacist.

Other side effects not listed here may occur in some people.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What PICOSALAX contains

Do not take this medicine if you are allergic to any of these ingredients.

What PICOSALAX looks like

PICOSALAX is a white crystalline powder. It is supplied in boxes containing 2 sachets.

Picosalax powder for oral administration (Aust R 138775).

Who distributes PICOSALAX

Ferring Pharmaceuticals Pty Ltd
Suite 2, Level 1, Building 1
20 Bridge Street
Pymble 2073 NSW

This leaflet was prepared in December 2024.

PICOSALAX and FERRING are registered trademarks of Ferring B.V.

AU-PX-2400003_v.2.0

Published by MIMS February 2025

1 Name of Medicine

Citric acid.
Light magnesium oxide.
Sodium picosulfate.

2 Qualitative and Quantitative Composition

Active ingredients.

Inactive.

3 Pharmaceutical Form

White crystalline powder for solution.

4 Clinical Particulars

4.1 Therapeutic Indications

For clearance of the bowel prior to examination by radiography, endoscopy or surgery.

4.2 Dose and Method of Administration

Instructions for timing of dose and dietary and fluid restrictions vary greatly between centres and may over-ride the recommendations given below. Clinical studies with Picosalax have shown the following regimens to be effective.

Adults (including the elderly) and children aged 9 years of age and older.

On the day before the procedure - 1 sachet.

On the day of the procedure - 1 sachet.

On the day before the procedure - 2 sachets.

Directions for reconstitution.

Further information.

4.3 Contraindications

Picosalax is contraindicated in patients with congestive heart failure, clinically significant renal impairment, known or suspected gastrointestinal obstruction or perforation, gastric retention, gastro-intestinal ulceration, toxic colitis, toxic megacolon, ileus, those with a stoma, nausea and vomiting, acute surgical abdominal conditions such as acute appendicitis, severe dehydration, rhabdomyolysis, hypermagnesemia, active inflammatory bowel disease or hypersensitivity to any of the ingredients.
In patients with severely reduced renal function, accumulation of magnesium in plasma may occur. Another preparation should be used in such cases.
Picosalax should not be used in patients with undiagnosed abdominal symptoms.

4.4 Special Warnings and Precautions for Use

Use with caution in patients with recent gastrointestinal surgery, renal impairment, heart disease or inflammatory bowel disease. Those patients with kidney disease or impaired renal function should be monitored, as should those with pre-existing electrolyte disturbances. Diabetics may need adjustment of their medication and careful monitoring of their blood glucose.
Patients using diuretics or other medications (such as corticosteroids, lithium) that may affect water and/or electrolyte balance should also be monitored (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
In all patients, adequate fluid intake should be maintained. An insufficient or excessive oral intake of water and electrolytes could create clinically significant deficiencies, particularly in less fit patients. In this regard, patients with low bodyweight, children, the elderly, debilitated individuals, and patients at risk of hypokalaemia or hyponatraemia may need particular attention. Prompt corrective action should be taken to restore fluid/ electrolyte balance in patients with signs or symptoms of hypokalemia or hyponatraemia. Drinking only water to replace the fluid losses may lead to electrolyte imbalance which may in severe cases lead to complications such as seizures and coma. In rare cases, Picosalax can cause severe or life-threatening electrolyte problems or impaired renal function in fragile or debilitated patients. Nephrocalcinosis and renal impairment may occur following use of oral sodium phosphate products in 'at risk' or inappropriate patient groups.
The period of bowel cleansing should not exceed 24 hours because longer preparation may increase the risk of water and electrolyte imbalance (see Section 4.2 Dose and Method of Administration).
Picosalax may modify the absorption of regularly prescribed oral medication and should be used with caution e.g. there have been isolated reports of seizures in patients on antiepileptics, with previously controlled epilepsy.
This medicine contains 5 mmol (or 195 mg) potassium per sachet. This should be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
Picosalax contains lactose as a component of the flavour (4.5 mg per sachet). Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Picosalax is not intended for use as a routine laxative.

Use in the elderly.

Use in children.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

As a purgative, Picosalax increases gastrointestinal transit rate. The absorption of other orally administered medicines (e.g. anti-epileptics, contraceptives, anti-diabetics, antibiotics) may therefore be modified during the treatment period.
Broad spectrum antibiotics may decrease the effect of Picosalax by interfering with the colonic bacteria needed to break down sodium picosulfate to form its active substance.
Medicines with the potential to chelate with magnesium (e.g. tetracyclines and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine and penicillamine) should be taken at least 2 hours before and not less than 6 hours after administration of Picosalax.
Care should be taken with patients already receiving drugs which may be associated with hypokalaemia (such as diuretics or corticosteroids or drugs where hypokalaemia is a particular risk, i.e. cardiac glycosides).
Caution is also advised when Picosalax is used in patients on NSAIDs or drugs known to induce SIADH (syndrome of inappropriate antidiuretic hormone secretion), e.g. tricyclic antidepressants, selective serotonin reuptake inhibitors, antipsychotic drugs and carbamazepine as these drugs may increase the risk of water retention and/or electrolyte imbalance.
The efficacy of Picosalax is lowered by bulk forming laxatives.

4.6 Fertility, Pregnancy and Lactation

Effect on fertility.

4.7 Effects on Ability to Drive and Use Machines

Not relevant.

4.8 Adverse Effects (Undesirable Effects)

The most common adverse reactions are vomiting, nausea, abdominal pain, and headache. Hyponatraemia is rare but is the most commonly reported serious adverse reaction. Adverse reactions from spontaneous reports are presented by frequency category based on incidence in clinical trials when known. Frequency from spontaneous reports for adverse reactions never observed in clinical trials is based on an algorithm as recommended in the European Commission SmPC guideline, 2009, rev 2. See Table 1.
Diarrhoea and faecal incontinence are the primary clinical effect of Picosalax.
Hyponatraemia has been reported with or without associated convulsions.
Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems.

4.9 Overdose

Overdosage would lead to profuse diarrhoea with dehydration and fluid/ electrolyte imbalance. Treatment is by general supportive measures and correction of fluid and electrolyte imbalance.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

3 years. The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

Picosalax sachets contain a white crystalline powder. It is supplied in boxes containing 2 sachets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Sodium picosulfate.

Light magnesium oxide.

Citric acid.

7 Medicine Schedule (Poisons Standard)

S3 (Pharmacist Only Medicine).

Summary Table of Changes