Consumer medicine information

Phospho-Soda

Sodium phosphate

BRAND INFORMATION

Brand name

Phospho-soda

Active ingredient

Sodium phosphate

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Phospho-Soda.

What is in this leaflet

This leaflet answers some common questions about PHOSPHO-SODA.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking PHOSPHO-SODA against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Read this leaflet carefully before you take this medicine.

If you are having an operation or x-ray of the bowel or colonoscopy, read all of these instructions at least two days before your examination.

Keep this leaflet with the medicine. You may need to read it again.

What PHOSPHO-SODA is used for

This medicine is used as part of a bowel cleansing procedure before x-ray of the bowel, colonoscopy (looking into the bowel with an instrument) or before a bowel operation.

PHOSPHO-SODA is for use in adults.

It works by producing bowel motions which cleanse the bowel. It usually works within 30 minutes, although it may take as long as 6 hours. Expect frequent liquid stools.

Stop using this product and consult a doctor if you do not have a bowel movement within 6 hours.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

Do not drive, use machinery or tools if you feel tired or dizzy, or think you may be dehydrated, after taking PHOSPHO-SODA. You should also stay within easy reach of toilet facilities after taking this medicine. Children should be careful when riding bicycles or climbing trees.

Before you take PHOSPHO-SODA

When you must not take it

Do not take PHOSPHO-SODA if you:

  • have an allergy to any of the ingredients listed at the end of this leaflet
  • are under 18 years of age
  • have hard, solidified bowel motions (faecal impaction)
  • have non-functioning small bowel (paralytic ileus)
  • know or suspect you have an obstruction, perforation or paralysis of your bowels
  • have low movement of the intestines (hypomotility)
  • have large bowel which was present from birth (Hirschsprung’s disease/congenital megacolon)
  • have acquired enlargement of the large intestine (megacolon)
  • have the natural opening of the anus closed (imperforate anus)
  • have an abnormal buildup of fluid in the space between the lining of the abdomen and the abdominal organs, including around the stomach (ascitic conditions)
  • have overactive parathyroid glands (hyperparathyroidism)
  • have an active inflammatory bowel disease
  • have serious kidney problems (kidney disease)
  • have symptomatic heart disease
  • have an altered sense of smell or taste
  • do not tend to drink much liquid
  • feel sick (nausea)
  • are vomiting
  • have abdominal (stomach) pain.

Do not take PHOSPHO-SODA in combination with any other laxative products containing sodium phosphate.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

Before you start to take it

It is very important that you drink extra clear liquids, before, and after taking this medicine.

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you:

  • are in poor general health
  • are frail or elderly (65 years old or more). It may be that you will need special medical supervision
  • have a heart or kidney condition
  • suffer from changes to levels of salts in your body (electrolyte imbalances) or are at risk of such changes, for example if you are dehydrated
  • have low blood pressure or reduced movement in part or all of your intestines
  • have had a colostomy or an ileostomy
  • have had any other kind of operation or surgery on your stomach or intestines
  • are on a low-sodium (low-salt) diet as this medicine contains 5000 mg.sodium (main component of cooking/table salt) in each 45 mL dose. This is equivalent to 250% of recommended maximum daily dietary intake of sodium for an adult. (See also section “Product Description”)
  • you are pregnant or plan to become pregnant or are breast-feeding.

You should not use this medicine during pregnancy unless your doctor considers it necessary. If you are breast-feeding, it is advised that breast milk is expressed and discarded from the first dose to 24 hours after the second dose of the bowel cleansing solution. You should not breast-feed your child for 24 hours after taking the second dose of PHOSPHO-SODA.

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

Please consult your doctor before you start taking PHOSPHO-SODA. If you think any of the statements above are applicable to you now or at any time in the past. PHOSPHO-SODA could slightly alter the rhythm of the heart as a result of electrolyte imbalances, so you may need closer medical supervision during your treatment.

If you are elderly, tell the doctor your age. He or she may need to check if it is safe for you to take PHOSPHO-SODA. It is very important that you drink more liquids, before, and after taking PHOSPHO-SODA.

After taking PHOSPHO-SODA you should expect to produce frequent, liquid stools. You should drink as much clear liquid (see “Clear Liquids List” in “How & when to take it”) as possible so that you do not become dehydrated.

This product usually works within 30 minutes to 6 hours. If you have no bowel movement within 6 hours of taking either the first or the second dose, contact a doctor immediately because you could become dehydrated.

Taking other medicines

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

Some medicines and PHOSPHO-SODA may interfere with each other.

These include:

  • medicines which increase the volume of urine (diuretics)
  • medicines used to treat some types of mental disorders, depressions or mood swings (lithium preparations)
  • any medicine that could make you dehydrated or change various salt levels (potassium, sodium, phosphate or water) in your body (your electrolyte balance)
  • medicines used to treat high blood pressure, angina and some other heart conditions (e.g. angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers and calcium channel blockers)
  • medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis
  • Non-steroidal anti-inflammatory drugs (NSAIDs)- such as aspirin- that might cause fainting or irregular heartbeat (i.e. that can prolong the QT interval). There are many medicines that can have this effect, so please ask your doctor or pharmacist if any that you are taking might have this effect
  • medicines that alter the rhythm of your heart
  • parathyroid hormone medicines
  • medicines regularly taken by mouth: for example, oral contraceptives, and medicines for epilepsy or diabetes or antibiotics, because PHOSPHO-SODA may delay or completely prevent the absorption of these oral medicines, making them less effective or ineffective.

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

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

Ask your doctor or pharmacist if unsure.

If you are diabetic, the liquid diet recommended with this medication may affect your glucose blood levels and adjustment of your insulin or oral anti-diabetic medicine may be necessary.

How to take PHOSPHO-SODA

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box/bottle, ask your doctor or pharmacist for help.

Do not give this medicine to children under 18 years of age.

How much to take

Adults: The recommended dosage is 45 mL (one full bottle) as a 1st dose to be followed 10 to 12 hours later by a 2nd dose (another full bottle).

Depending on whether the medical procedure is intended to be performed at early morning or later, two alternative dosage regimens are set out below:

How & when to take it

Before you first start taking PHOSPHO-SODA up until after your examination, it is important that you drink only “clear liquid.” Do not eat any solid food.

The intake of clear liquids is an essential part of this regimen.

Please refer to clear liquids list below.

PHOSPHO-SODA must be diluted with water before use (see the instructions for dilution below).

First dose (1st bottle):
Take as follows:

  • Mix 15 mL (one third of the bottle) of PHOSPHO-SODA into a full glass (approximately 250 mL) of clear liquid (see list below) and drink.

Repeat this process two more times within the next 20 minutes.

Between the first and second doses:
Drink at least three more glasses (approximately 250 mL each) of clear liquids or more if desired to prevent dehydration and to ensure that the bowel remains easily examinable for the procedure.

Second dose (2nd bottle):
Take as follows:

  • Mix 15 mL (one third of the bottle) of PHOSPHO-SODA into a full glass (approximately 250 mL) of clear liquid (see list below) and drink.

Repeat this process two more times within the next 20 minutes.

If you are having an early morning x-ray or colonoscopy:
Take the first dose at 7 a.m. on the day before the procedure.

Take the second dose at 7 p.m. on the evening before the procedure.

For early morning procedures, on the day before the procedure, you should only take clear liquids (see below) for breakfast, lunch and dinner and between doses.

No solid food, milk or milk products should be taken on the day before the procedure. You should not drink anything coloured red or purple.

If you are having a mid-morning (or later) x-ray or colonoscopy:
Take the first dose at 7 p.m. on the evening before the procedure.

Take the second dose at 7 a.m. (or at least 3 hours before leaving for the appointment) on the morning of the procedure.

For mid-morning (or later) procedures, on the day before the procedure, you may have a light snack for lunch. After this time you should only take clear liquids (see below).

No solid food, milk or milk products should be taken after lunch on the day before the procedure. You should not drink anything coloured red or purple.

To help prevent you feeling sick while taking this medicine, you should drink as much clear liquid as you can.

Clear Liquids List:

Beverages:

  • Water, tea or coffee (no milk or non-dairy creamer). Sweeteners are acceptable
  • Carbonated or non-carbonated soft drinks (not coloured red or purple)
  • Fruit flavoured cordials (not coloured red or purple)
  • Strained fruit juices without pulp
  • Do not drink any alcoholic beverages.

Soups:

  • Strained low sodium chicken or beef soup without solid material.

Do not drink anything coloured red or purple.

If you have had no bowel movement within 6 hours of taking either the first dose or the second dose, you must contact a doctor immediately, because you could become dehydrated.

After the procedure: you should drink plenty of fluid to replace fluid lost during the preparation for the procedure.

If you are having an operation on the bowel, you will be given your doses of PHOSPHO-SODA in the hospital under medical and nursing supervision.

In some cases, your doctor may decide to modify the above dosage instructions. If this occurs and you have any questions, ask your doctor.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone Australia 13 11 26 or New Zealand 0800 764 766) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much PHOSPHO-SODA. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using PHOSPHO-SODA

Things you must do

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

Things you must not do

Do not take PHOSPHO-SODA 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.

Do not stop taking your medicine or lower the dosage without checking with your doctor.

Side effects

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

This medicine helps most people as part of a bowel cleansing procedure before x-ray of the bowel, colonoscopy or before a bowel operation, but it may have unwanted side effects in a few people. All medicines can have side effects.

Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

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

Ask your doctor or pharmacist to answer any questions you may have.

PHOSPHO-SODA may cause a temporary decrease in the volume of the blood and changes in the amounts of salts in the blood, which, in healthy and fit people, return to normal in 24 hours.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • if your hands, face, lips, throat or tongue start to swell or if you have difficulty in breathing or swallowing.

Very rarely (affects less than 1 user in 10,000) PHOSPHO-SODA can cause serious allergic reactions with or without a rash.

Tell your doctor as soon as possible if you notice any of the following:

Very common (may affect more than 1 in 10 people): feeling sick, abdominal pain, bloating and diarrhoea, chills, weakness and dizziness.

Common (may affect up to 1 in 10 people): Vomiting, chest pain and headache.

Uncommon (may affect up to 1 in 100 people): Dehydration.

Rare (may affect up to 1 in 1,000 people): A buildup of calcium in the kidneys.

Very rare (may affect up to 1 in 10,000 people): Heart attack, palpitations, low blood pressure, changes in the amounts of salts (electrolytes) in the blood (which may lead to twitches and spasms), muscle cramps, pins and needles, loss of consciousness, and kidney failure.

Not known (frequency cannot be estimated from the available data): Hyponatraemia (low sodium concentration in the blood which may lead neurological disorders, such as confusion, coma or convulsions).

There have been occasional reports of:

  • sleep loss
  • hunger
  • feeling thirsty
  • rash
  • anal irritation.

After using PHOSPHO-SODA

Storage

Keep PHOSPHO-SODA in a cool dry place where the temperature stays below 30°C.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

PHOSPHO-SODA is a clear, colourless, ginger-lemon odour, aqueous liquid.

Ingredients

Each 45 mL of PHOSPHO-SODA contains:

Active ingredients

Monobasic sodium phosphate 18.8 g (as 24.4 g monobasic sodium phosphate dihydrate)

Dibasic sodium phosphate 4.3 g (as 10.8 g dibasic sodium phosphate dodecahydrate)

It has a sodium content of 5 g per 45 mL (11.11% w/v).

Other ingredients

It also contains purified water, glycerol, saccharin sodium, sodium benzoate (15 mg in each 45 mL dose) and ginger lemon extract 5741-5G (comprising of Oleoresin Ginger; Ethanol (Alcohol); Oil Lemon; Partially Deterpinated Oil Lemon; Citric Acid and Purified Water).

This medicine also contains a very small amounts of ethanol (alcohol), less than 100 mg per dose.

Distributor

PHOSPHO-SODA is distributed in Australia by:

Chiesi Australia Pty Ltd
Suite 3, 22 Gillman Street
Hawthorn East VIC 3123
Email: [email protected]
Website: www.chiesi.com.au

PHOSPHO-SODA is distributed in New Zealand by:

Pharmaco (NZ) Ltd, Auckland.

AUST R 283520 – PHOSPHO-SODA oral solution bottle.

This leaflet was prepared in June 2021

Phospho®-soda is a registered trademark of Casen Recordati, S.L.

® = Registered Trademark

Published by MIMS August 2021

BRAND INFORMATION

Brand name

Phospho-soda

Active ingredient

Sodium phosphate

Schedule

S3

 

1 Name of Medicine

Phospho-soda (monobasic sodium phosphate and dibasic sodium phosphate).

2 Qualitative and Quantitative Composition

Active ingredients.

18.8 g monobasic sodium phosphate (as 24.4 g monobasic sodium phosphate dihydrate) and 4.3 g dibasic sodium phosphate (as 10.8 g dibasic sodium phosphate dodecahydrate) per 45 mL bottle.

Excipients with known effect.

Each 45 mL of bottle contains saccharin, benzoates and 5.0 g sodium.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Phospho-soda is a clear, colourless, ginger-lemon odour and flavour oral solution, free from precipitation and turbidity.

4 Clinical Particulars

4.1 Therapeutic Indications

For use as part of a bowel cleansing regimen in preparing adult patients for colon surgery or for preparing the colon for X-ray or endoscopic examination.

4.2 Dose and Method of Administration

See Section 4.4 Special Warnings and Precautions for Use; Section 4.3 Contraindications.
For use as part of a bowel cleansing regimen in preparing the patient for surgery or for preparing the colon for X-ray or endoscopic examination.
This product normally produces a bowel movement within ½ to 6 hours. Patients should be warned to expect frequent liquid stools.
Phospho-soda should not be taken by children under 18 years of age (see Section 4.3 Contraindications).

Adults.

The recommended dosage for adults is 45 mL (one full bottle) and repeated 10 to 12 hours later. The intake of clear liquids is an essential part of this regimen.
Please note that for:
Early morning procedures, on the day before the procedure, the patient should only take clear liquids (see below) for breakfast, lunch and dinner and between doses.
No solid food, milk or milk products should be taken on the day before the procedure. Please note that the patient should not drink anything coloured red or purple.
Mid-morning (or later) procedures, on the day before the procedure, the patient may have a light snack for lunch. After this time, patient should only take clear liquids (see below).
No solid food, milk or milk products should be taken after lunch on the day before the procedure. Please note that the patient should not drink anything coloured red or purple.
Depending on whether the medical procedure is intended to be performed at early morning, mid-morning or later, two alternative dosage regimens are set out below:

Early morning procedure.

The first dose is taken at 7 a.m. on the day before the procedure. The second dose is taken at 7 p.m. on the evening before the procedure.

Mid-morning (or later) procedure.

The first dose is taken at 7 p.m. on the evening before the procedure. The second dose is taken at 7 a.m. (or at least 3 hours before leaving for the appointment) on the morning of the procedure.

Method of administration.

First dose.

To be taken as follows:
Mix 15 mL (one third of the bottle) of Phospho-soda into a full glass (approximately 250 mL) of clear liquids (see list below) and drink.
Repeat two more times within the next 20 minutes.

Between doses.

Between the first and second doses, the patient should drink at least three more glasses (approximately 250 mL each) of clear liquids or more if desired to prevent dehydration and to ensure that their bowel remains easily examinable for the procedure.

Second dose.

The second dose is taken as follows:
Mix 15 mL (one third of the bottle) of Phospho-soda into a full glass (approximately 250 mL) of clear liquid (see list below) and drink. Repeat two more times within the next 20 minutes.

After the procedure.

In order to replace fluid lost during the preparation for the procedure patients should be encouraged to drink plenty of fluid afterwards.

Important.

Phospho-soda must be diluted with water before use (see the instructions above).
The intake of clear liquid is an essential part of this regimen. Please see Clear liquids list, below.
Clear liquids list.

Beverages.

Water, black tea or black coffee (no milk or non-dairy creamer). Sweeteners are acceptable.
Clear carbonated or non-carbonated soft drinks (not coloured red or purple).
Fruit flavoured cordials (not coloured red or purple).
Strained fruit juices without pulp.
Do not drink any alcoholic beverages.

Clear soups.

Strained low sodium chicken or beef soup without solid material.

Elderly patients.

Phospho-soda should be used with caution in elderly patients. No dose adjustment is necessary in this group of patients (see Section 4.4 Special Warnings and Precautions for Use).

4.3 Contraindications

Administration of Phospho-soda is contraindicated in children under 18 years of age, in patients who have demonstrated hypersensitivity to the active substances or to any of the excipients listed (see Section 6.1 List of Excipients), patients with faecal impaction, ileus, known or suspected gastrointestinal obstruction, when nausea, vomiting or abdominal pain are present, active inflammatory bowel disease, hypomotility, gastrointestinal perforation, Hirschsprung's disease (congenital megacolon), megacolon (acquired), imperforate anus, primary hyperparathyroidism associated with hypercalcaemia, symptomatic heart failure (NYHA grade III or IV), ascitic conditions, renal impairment and potentially pre-existing fluid/electrolyte disturbances, and patients at risk of dehydration due to altered senses and/or poor fluid intake.
Phospho-soda should not be used in combination with other laxative products containing sodium phosphate.

4.4 Special Warnings and Precautions for Use

Phospho-soda has been rarely associated with severe and potentially fatal cases of electrolyte disorders in elderly patients. The benefit/risk ratio of Phospho-soda needs to be carefully considered before initiating treatment in this at-risk population.
Special attention should be taken when prescribing Phospho-soda to any patient with regard to known contraindications and the importance of adequate hydration and, in at-risk populations (see below; see Section 4.2 Dose and Method of Administration; Section 4.3 Contraindications), the importance of also obtaining baseline and post-treatment electrolyte levels.

Identified precautions.

At risk patients.

Phospho-soda, which contains 4.82 mEq sodium and 12.45 mEq phosphate per mL, should be used with extreme caution, in the elderly, the frail or debilitated, patients with colostomy and patients on a low salt diet, as they are particularly at risk. These patients should receive additional fluids by mouth, both prior to, and after administration of Phospho-soda, to ensure that dehydration does not occur. Close attention should be paid to their hydration status and their electrolyte levels (particularly potassium, calcium and phosphorus) should be monitored. Patients undergoing major bowel procedures, who are on nil by mouth for significant periods of time, should have their electrolytes monitored and receive intravenous fluids containing potassium and calcium, prior to surgery.
Use with caution in patients with an increased risk for underlying renal impairment, pre-existing electrolyte disturbances, increased risk for electrolyte disturbances (e.g. dehydration, gastric retention, colitis, inability to take adequate oral fluid, hypertension or other conditions in which the patients are taking products that may result in dehydration, see below), hypotension with clinical impact or associated with hypovolaemia, heart disease, acute myocardial infarction, unstable angina or with debilitated or elderly patients. In these at-risk patients, baseline and post-treatment sodium, potassium, calcium, chloride, bicarbonate, phosphate, blood urea nitrogen and creatinine values should be obtained if clinically indicated.

Dehydration.

This product usually works within ½ to 6 hours. If there has been no bowel movement within 6 hours of taking Phospho-soda, instruct the patient to stop use and contact a doctor immediately as dehydration could occur.
Patients should be warned to expect frequent, liquid stools. Patients should be encouraged to drink as much liquid as possible to help prevent dehydration. Inadequate fluid intake when using any effective purgative may lead to excessive fluid loss possibly producing dehydration and hypovolemia. Dehydration and hypovolemia from purgation may be exacerbated by inadequate oral fluid intake, nausea, vomiting, loss of appetite, or use of antihypertensive drugs (e.g. angiotensin converting enzyme inhibitors (ACE-Is), angiotensin receptor blockers (ARBS), calcium channel blockers), diuretics, and non-steroidal anti-inflammatory drugs (NSAIDs) and may be associated with acute renal failure. There have been rare reports of acute renal failure with purgatives, including sodium phosphates and PEG-3350.
Patients with conditions that may predispose to dehydration or those taking medications which may decrease glomerular filtration rate, such as diuretics, angiotensin converting enzyme inhibitors (ACE-Is), angiotensin receptor blockers (ARBs), or non-steroidal anti-inflammatory drugs (NSAIDs) should be assessed for hydration status prior to use of purgative preparations and managed appropriately.

Nephrocalcinosis secondary to acute phosphate nephropathy.

Nephrocalcinosis associated with acute renal failure and deposits of calcium-phosphate crystals in the renal tubules has been rarely reported in patients using sodium phosphates for bowel cleansing. Nephrocalcinosis is a serious adverse event that may result in permanent renal function impairment and the requirement of long-term dialysis. The majority of these reports occurred in elderly female patients taking drugs to treat hypertension or other drug products, such as diuretics or NSAIDs, that may result in dehydration.
Care should be taken to prescribe Phospho-soda per recommendations with a particular attention to known contraindications, adequate hydration prior to, during the preparation and after the procedure and adherence to recommended spacing of doses.

Use in diabetics.

Adjustments of a diabetic patient's insulin or oral anti-diabetic medication may be necessary as the liquid diet during the period of administration and prior to bowel surgery, X-ray of the colon or colonoscopy may affect the diabetic patient's glucose blood levels.

Hypomotility.

Use with caution in patients with hypomotility disorders or who have had gastro-intestinal surgery or have other medical conditions predisposing them to hypomotility disorders. If the patient has had a colostomy or ileostomy, or must keep to a salt-free diet, the preparation must be used with caution, since a disturbance of electrolyte balance, dehydration or a disturbance of acid balance may arise.

Electrolyte disorders.

There is a risk of elevated serum levels of sodium and phosphate and decreased levels of calcium and potassium; consequently hypernatraemia, hyperphosphataemia, hypocalcaemia, hypokalaemia, and acidosis may occur.
Hyponatraemia possibly complicated by neurological disorders, such as confusion, coma or convulsions, may occur.
Slight QT interval prolongation may rarely occur as a result of electrolyte imbalances such as hypocalcaemia or hypokalaemia. These changes are clinically insignificant.

Lesions.

Single or multiple aphthoid-like punctiform lesions located in the rectosigmoid region have been observed by endoscopy. These were either lymphoid follicles or discrete inflammatory infiltrates or epithelial congestions/changes revealed by the colonic preparation. These abnormalities are not clinically significant and disappear spontaneously without any treatment.

Sodium, benzoates and ethanol content.

This medicinal product contains 5000 mg sodium per 45 mL dose equivalent to 250% of the WHO recommended maximum daily intake of 2 g sodium for an adult. Consideration should therefore be given to the potential harm to patients requiring a low-sodium diet.
This medicinal product contains 15 mg sodium benzoate in each 45 mL dose.
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per 45 mL.

Patients with hepatic impairment.

The safety and efficacy of Phospho-soda in patients with hepatic impairment has not been established. Phospho-soda is contraindicated in patients with ascites (see Section 4.3 Contraindications).

Patients with renal impairment.

Phospho-soda is contraindicated in patients with renal impairment (see Section 4.3 Contraindications).

Use in the elderly.

Phospho-soda should be used with caution in elderly patients. No dose adjustment is necessary in this group of patients (see Section 4.2 Dose and Method of Administration).

Paediatric use.

Phospho-soda is contraindicated in children below 18 years (see Section 4.3 Contraindications).

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Use with caution in patients taking antihypertensives (e.g. calcium channel blockers, angiotensin converting enzyme inhibitors (ACE-Is), angiotensin receptor blockers (ARBS)), diuretics and lithium preparations or other medication that might affect electrolyte levels, as hyperphosphataemia, hypocalcaemia, hypernatraemic dehydration and acidosis may occur.
During the intake of Phospho-soda the absorption of drugs from the gastrointestinal tract may be delayed or even completely prevented. The efficacy of regularly taken oral drugs (e.g. oral contraceptives, antiepileptic drugs, antidiabetics, antibiotics) may be reduced or completely absent. Caution is also advised when taking medicines known to prolong the QT interval.
Use with caution in patients who are taking parathyroid hormone medications.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No animal studies on reproduction toxicity have been conducted with Phospho-soda. No data is available on the effect of Phospho-soda on male and female fertility.
For Phospho-soda, no clinical data on exposed pregnancies and no data from animal studies with respect to effects on pregnancy, embryonal/foetal development, parturition and postnatal development are available. The potential risk for humans is unknown.
Because of potential harm to the foetus from phosphate absorbed across the placenta, the use of this product is not recommended in pregnant women unless clearly necessary and the probable clinical benefit outweighs the possible risk.
Because of potential harm to the infant from phosphate excreted in breast milk, the use of this product is not recommended in nursing mothers unless the probable clinical benefit outweighs the possible risk.
It is not known whether Phospho-soda is excreted in human milk. As sodium phosphate may pass into the breast milk, it is advised that breast milk is expressed and discarded from the first dose to 24 hours after the second dose of the bowel cleansing solution. Women should not breast-feed their infants until 24 hours after receiving the second dose of Phospho-soda.

4.7 Effects on Ability to Drive and Use Machines

Phospho-soda may cause dizziness, probably as a result of dehydration.
Phospho-soda has minor to moderate influence on the ability to drive and use machines.

4.8 Adverse Effects (Undesirable Effects)

Oral sodium phosphate products can cause dehydration (between 1 and 4 L fluid loss), hyperphosphataemia, hypocalcaemia, other electrolyte abnormalities and associated complications.
Severe adverse reactions (serious serum electrolyte disturbances and hypokalaemia) and fatalities have been reported in patients who belonged to the 'at risk' groups (the elderly, the frail, those with renal impairment and cardiac failure), patients with known contraindications (including children under 18 years) and concurrent administration with polyethylene glycol bowel cleansing preparation.
Transient hyperphosphataemia, some degree of hypovolaemia and significant differences in serum electrolyte levels have been noted in clinical trials. In healthy and fit patients these have returned to initial pre-treatment levels within 24 hours.
In addition, there have been occasional reports of nausea, vomiting, abdominal pain, bloating, fatigue, anal irritation, allergic reactions with or without rash, hunger and sleep loss.
The following adverse reactions were reported with frequencies corresponding to:
Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (≤ 1/10,000), not known (cannot be estimated from the available data).
See Table 1.

Reporting suspected adverse effects.

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 www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia) or 0800 764 766 (New Zealand).
There have been fatal cases of hyperphosphataemia with concomitant hypocalcaemia, hypernatraemia and acidosis when Phospho-soda has been used in excessive doses, given to children or to obstructed patients.
Patients experiencing overdose have presented the following symptoms: dehydration, hypotension, tachycardia, bradycardia, tachypnoea, cardiac arrest, shock, respiratory failure, dyspnoea, convulsions, ileus paralytic, anxiety, and pain. Overdoses can lead to elevated serum levels of sodium and phosphate and decreased levels of calcium and potassium. In those cases, hypernatremia, hyperphosphatemia, hypocalcaemia, hypokalaemia, and acidosis may occur.
There are also documented cases of complete recovery from overdoses in both children accidentally given Phospho-soda, and also in patients with obstruction, one of whom received a six-fold overdose.
Recovery from the toxic effects of accidental excess ingestion can normally be achieved by rehydration, although the intravenous administration of 10% calcium gluconate may be necessary if there is significant hypocalcaemia or tetany has occurred.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Pharmacotherapeutic group: osmotically acting laxative. ATC code: A06AD17.
Phospho-soda is a saline mixture which acts by osmotic processes to increase fluid retention in the lumen of the small intestine. Fluid retention in the ileum produces distension, in turn promoting peristalsis and evacuation. It has a purgative effect. Individual responses vary. It usually acts shortly after 30 minutes but may take as long as 6 hours. If there has been no bowel movement within 6 hours of taking Phospho-soda, instruct the patient to stop use and contact a doctor immediately as dehydration could occur.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Administration of oral sodium phosphates solution caused transient serum electrolyte shifts in healthy volunteers. An open-label study was performed with twenty-four healthy adult volunteers who received oral sodium phosphates solution to evaluate the time course and degree of electrolyte shifts in two age and two gender groups. The study was designed to mimic the bowel preparation regimen commonly used prior to colonoscopy, including a clear liquid diet, timing of sodium phosphate doses and proper hydration. The followed regimen of 2 x 45 mL of oral sodium phosphate and additional clear liquids was in line with the approved dosing regimen of the product. The study population was balanced for gender and gender and age. One-half of the study participants were aged 65 years or older.
Results showed an increase in serum concentrations of sodium and phosphate but a decrease of potassium and calcium after each dose.
The mean serum phosphate concentration for all subjects was 3.33 mg/dL at baseline, then it peaked at 6.26 mg/dL at hour 3, decreased to 4.70 mg/dL just prior to the second dose (hour 12), and peaked again at 6.86 mg/dL at hour 14. By hour 36, all serum phosphate concentrations had returned to normal.
Figure 1 shows the time-course of mean serum phosphate concentration for each age-gender subgroup. Elderly females suffered the most altered values.
Mean serum sodium concentration fluctuated within the normal range (134-147 mmol/L), however 4 subjects had sodium values above the upper limit of normal.
The fall in serum potassium and calcium concentrations fluctuated within the normal individual range and then returned to baseline values by 12 hours after administration of the second dose. 29% of subjects reported serum calcium values below the normal lower limit (8.5 mg/dL) for up to 36 hours after the administration of the first dose. Nevertheless, no clinical cases of hypocalcaemia were noted.
In conclusion, the serum electrolyte concentration shifts in healthy adults volunteers associated with the administration of 2 x 45 mL of NaP were clinically insignificant, were transient and resolved within 12 to 24 hours after completing the bowel preparation regimen.
The effect on the pharmacokinetic of Phospho-soda for patients with renal impairment has not been studied. Extrapolation of these data from healthy volunteers to at risk patients (e.g. renal patients) is not possible (see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use).

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Glycerol, saccharin sodium, sodium benzoate, purified water, ginger lemon extract 5741-5G containing oleoresin ginger, ethanol (alcohol), oil lemon, partially deterpinated oil lemon, citric acid and purified water.

6.2 Incompatibilities

See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

36 months.

6.4 Special Precautions for Storage

Store below 30°C.
Once opened, use immediately. Discard any unused portion.

6.5 Nature and Contents of Container

Phospho-soda is available in a carton containing 1 x 45 mL polyethylene bottle. Each bottle (45 mL) contains 18.8 g monobasic sodium phosphate (as 24.4 g monobasic sodium phosphate dihydrate) and 4.3 g dibasic sodium phosphate (as 10.8 g dibasic sodium phosphate dodecahydrate).

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

Chemical structure.


CAS number.

Monobasic sodium phosphate dihydrate.

Molecular formula: NaH2PO4, 2H2O, MW: 156.0, CAS: 13472-35-0.

Dibasic sodium phosphate dodecahydrate.

Molecular formula: Na2HPO4,12H2O, MW: 358.1, CAS: 10039-32-4.

7 Medicine Schedule (Poisons Standard)

Pharmacist Only Medicine (S3).

Summary Table of Changes