SUMMARY CMI

APOHEALTH Picosulfate Prep

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.
Life threatening dehydration and/or electrolyte disturbances may occur in some people.
Read the section with the heading "Before you take APOHEALTH Picosulfate Prep".

1. Why am I using APOHEALTH Picosulfate Prep?

APOHEALTH Picosulfate Prep contains the active ingredients: sodium picosulfate, magnesium oxide heavy and citric acid. APOHEALTH Picosulfate Prep is used for clearance of the bowel before examination by x-ray, endoscopy or surgery.

For more information, see Section 1. Why am I using APOHEALTH Picosulfate Prep? in the full CMI.

2. What should I know before I use APOHEALTH Picosulfate Prep?

Do not use if you have ever had an allergic reaction to APOHEALTH Picosulfate Prep or any of the ingredients listed at the end of the CMI.

Talk to your doctor or pharmacist 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 use APOHEALTH Picosulfate Prep in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APOHEALTH Picosulfate Prep 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 use APOHEALTH Picosulfate Prep?

Follow all directions given to you by your doctor or pharmacist carefully. The timing of each dose can vary and may depend on the time of the examination. The sachets must be made up in water before drinking.

More instructions can be found in Section 4. How do I use APOHEALTH Picosulfate Prep? in the full CMI.

5. What should I know while using APOHEALTH Picosulfate Prep?

For more information, see Section 5. What should I know while using APOHEALTH Picosulfate Prep? in the full CMI.

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking APOHEALTH Picosulfate Prep or if you experience one or more of these side effects: headache, tiredness, nausea, vomiting, griping, sore anus, severe diarrhoea, allergic reactions, rash, convulsions or mild ulcers in the small bowel. You may need 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 APOHEALTH Picosulfate Prep".

FULL CMI

APOHEALTH Picosulfate Prep

Active ingredients: sodium picosulfate, heavy magnesium oxide and citric acid

Consumer Medicine Information (CMI)

This leaflet provides important information about using APOHEALTH Picosulfate Prep. 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 APOHEALTH Picosulfate Prep.

Where to find information in this leaflet:

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

1. Why am I using APOHEALTH Picosulfate Prep?

APOHEALTH Picosulfate Prep contains the active ingredients: sodium picosulfate, magnesium oxide heavy and citric acid. APOHEALTH Picosulfate Prep is classified as Schedule 3 Pharmacist Only Medicine and is available from a pharmacist without a prescription.

APOHEALTH Picosulfate Prep is used for clearance of the bowel before examination by x-ray, endoscopy or surgery. APOHEALTH Picosulfate Prep produces a watery stool or bowel motion which empties and cleans the bowel before the procedure.

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

2. What should I know before I use APOHEALTH Picosulfate Prep?

Warnings

APOHEALTH Picosulfate Prep is not to be used as a routine laxative.

APOHEALTH Picosulfate Prep is not for use in children under 9 years of age.

Do not use APOHEALTH Picosulfate Prep if:

• you are allergic to sodium picosulfate, magnesium oxide and citric acid, or any of the ingredients listed at the end of this leaflet.
  Always check the ingredients to make sure you can use this medicine.

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin.

Do not take APOHEALTH Picosulfate Prep if 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.

Check with your doctor or pharmacist if you have any other medical conditions:

• recent gastrointestinal surgery
• kidney problems
• heart problems
• inflammatory bowel disease
• electrolyte disturbances
• diabetes

Tell your doctor if you are on potassium restricted diet.
APOHEALTH Picosulfate Prep contains 282.9 mg potassium per sachet. This should be taken into consideration if you have reduced kidney function or you are on a controlled potassium diet.

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?

Do not take APOHEALTH Picosulfate Prep after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.

Your doctor can discuss with you the risks and benefits involved.

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

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 APOHEALTH Picosulfate Prep. 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 APOHEALTH Picosulfate Prep or may affect how it works.

APOHEALTH Picosulfate Prep 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 APOHEALTH Picosulfate Prep.

4. How do I use APOHEALTH Picosulfate Prep?

How much to take

The success of your examination depends on the bowel being as clear as possible. Otherwise, the examination may need to be repeated. Follow all instructions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

For FULL instructions on how to use APOHEALTH Picosulfate Prep, please refer to the ‘Patient Information Leaflet’ enclosed with APOHEALTH Picosulfate Prep.

• If you have been provided different instructions for using this medicine from your doctor or a clinic, you should follow those instructions.
• If you have not been provided any instructions by your doctor, or you are not sure which regimen to use, speak to your pharmacist or doctor before using this medicine.

Adults and children 9 years and over

• For adults and children 9 years and over, the usual dose of APOHEALTH Picosulfate Prep is two sachets.
• Do not exceed the recommended dosage.

When to take APOHEALTH Picosulfate Prep

For FULL instructions on when to use APOHEALTH Picosulfate Prep, please refer to the ‘Patient Information Leaflet’ enclosed with APOHEALTH Picosulfate Prep.

• The timing of each dose can vary and may depend on the time of your examination.
• The contents of each sachet may be taken several hours apart on the day before the examination (DAY BEFORE regimen) or over two days (SPLIT-DOSE regimen).
• In some circumstances, your doctor may choose to modify these dose instructions. Follow the doctor's instructions carefully.
• On the day before the procedure, stop solid foods at the time instructed by your doctor. Thereafter, drink only clear liquids. DO NOT DRINK JUST WATER ALONE

Here are some examples of clear liquids your doctor my recommend:

• Water, clear soft drinks, fruit juices (pulp free)
• Isotonic drinks (e.g. Gatorade)
• Clear broth, clear soups, clear meat extracts
• Black tea or coffee (may be sweetened)
• Jellies
• Frozen juice bars.

Do NOT drink any of the following:

• Red or purple liquids
• Alcoholic beverages
• Liquids that you cannot see through (e.g. milk, soy or dairy products).

How to reconstitute APOHEALTH Picosulfate Prep

The sachets must be made up in water before drinking. The detailed instructions for reconstituting the sachets are in the 'Patient Information Leaflet' enclosed with APOHEALTH Picosulfate Prep.

Your doctor would 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 doctor and that you drink plenty of clear fluids.

Directions For Reconstitution:

Immediately before use, mix the contents of one sachet in approximately 150mL (2/3^rd of a cup) of water. Stir for 2-3 minutes. The solution should now become an off-white, cloudy liquid. Sometimes the solution becomes warm as the powder dissolves. If this happens, wait until it cools sufficiently before drinking. Do not prepare the solution in advance.

If you use too much APOHEALTH Picosulfate Prep

If you think that you have used too much APOHEALTH Picosulfate Prep, 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 using APOHEALTH Picosulfate Prep?

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 APOHEALTH Picosulfate Prep 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 your doctor and pharmacist that you are taking APOHEALTH Picosulfate Prep.
• Tell any other doctors, dentists, and pharmacists who treat you that you are taking APOHEALTH Picosulfate Prep.
• 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 APOHEALTH Picosulfate Prep 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

Be careful before you drive or use any machines or tools until you know how APOHEALTH Picosulfate Prep affects you.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

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.
• Keep this medicine in a cool dry place where the temperature stays below 30°C.

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

Store it in a cool dry place 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.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

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

Do not use 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.

If you are over 65 years of age you may have an increased chance of getting side effects.

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

Less serious side effects

Serious side effects

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

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

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.

7. Product details

This medicine is available over-the-counter without a doctor's prescription.

What APOHEALTH Picosulfate Prep contains

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

What APOHEALTH Picosulfate Prep looks like

APOHEALTH Picosulfate Prep sachets contain a white powder. It is supplied in boxes containing 2, 3 or 4 sachets. (Aust R 405192).

Who distributes APOHEALTH Picosulfate Prep

Arrotex Pharmaceuticals Pty Ltd
15 – 17 Chapel Street,
Cremorne VIC 3121
arrotex.com.au

This leaflet was prepared in February 2023.

Published by MIMS August 2024

1 Name of Medicine

Sodium picosulfate, magnesium oxide heavy, citric acid.

2 Qualitative and Quantitative Composition

Active ingredients.

Excipients.

3 Pharmaceutical Form

White 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.

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

APOHealth Picosulfate Prep 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.
APOHealth Picosulfate Prep 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 gastro-intestinal 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 hyponatremia 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, APOHealth Picosulfate Prep 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).
APOHealth Picosulfate Prep 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 anti-epileptics, with previously controlled epilepsy.
This medicine contains 282.9 mg potassium per sachet. This should be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
APOHealth Picosulfate Prep contains 967.3 mg lactose per sachet. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
APOHealth Picosulfate Prep contains sucralose.
APOHealth Picosulfate Prep is not intended for use as a routine laxative.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

As a purgative, APOHealth Picosulfate Prep 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 APOHealth Picosulfate Prep 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 APOHealth Picosulfate Prep.
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 APOHealth Picosulfate Prep is used in patients on NSAIDs or drugs known to induce SIADH (Syndrome of Inappropriate Antidiuretic Hormone secretion) e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, antipsychotic drugs and carbamazepine as these drugs may increase the risk of water retention and/or electrolyte imbalance.
The efficacy of APOHealth Picosulfate Prep is lowered by bulk-forming laxatives.

4.6 Fertility, Pregnancy and Lactation

Effects 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 APOHealth Picosulfate Prep.
Hyponatraemia has been reported with or without associated convulsions.

Reporting suspected adverse effects.

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 Poisons Information Centre on 13 11 26 (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

Lactose, povidone, potassium carbonate, sucralose.

6.2 Incompatibilities

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

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C. Store in dry place.

6.5 Nature and Contents of Container

APOHealth Picosulfate Prep sachets contain a white powder. It is supplied in boxes containing 2 sachets, 3 sachets and 4 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.

CAS number.

Magnesium oxide heavy.

CAS number.

Citric acid.

CAS number.

7 Medicine Schedule (Poisons Standard)

S3 (Pharmacist Only Medicine).

Summary Table of Changes