SUMMARY CMI

Phosphate Phebra^®

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.

1. Why am I using Phosphate Phebra?

Phosphate Phebra provides extra phosphorus for people with low phosphorus levels in their blood, or with high calcium levels in their blood due to overactivity of the parathyroid glands (hyperparathyroidism), cancer in the bone marrow or bone disease caused by the spread of cancers.

For more information, see Section 1. Why am I using Phosphate Phebra? in the full CMI.

2. What should I know before I use Phosphate Phebra?

Do not take Phosphate Phebra if you have an allergy to any of the ingredients listed at the end of this CMI.

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

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 use Phosphate Phebra? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Phosphate Phebra 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 Phosphate Phebra?

• Follow your doctor's instructions on how much Phosphate Phebra to take.
• Follow all directions given to you by your doctor or pharmacist carefully.

More instructions can be found in Section 4. How do I use Phosphate Phebra? in the full CMI.

5. What should I know while using Phosphate Phebra?

For more information, see Section 5. What should I know while using Phosphate Phebra? in the full CMI.

6. Are there any side effects?

Phosphate Phebra effervescent tablets may cause stomach upsets, nausea, abdominal pain, vomiting, very little urination or no urine, diarrhoea and electrolyte disturbance.

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.

FULL CMI

Phosphate Phebra^®

Active ingredient(s): Phosphorus 500 mg (as monobasic sodium phosphate 1.936 g) effervescent tablets

Consumer Medicine Information (CMI)

This leaflet provides important information about using Phosphate Phebra. 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 Phosphate Phebra.

Where to find information in this leaflet:

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

1. Why am I using Phosphate Phebra?

Phosphate Phebra contains the active ingredient monobasic sodium phosphate.

Phosphate Phebra is used to treat people with low phosphorus levels in their blood (also known as hypophosphataemia), or with high calcium levels in their blood (hypercalcaemia) due to:

• overactivity of the parathyroid glands (hyperparathyroidism)
• cancer in the bone marrow (multiple myelomatosis); or
• bone disease caused by the spread of cancers.

Your doctor may have put you on Phosphate Phebra for another reason.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Phosphate Phebra is not addictive.

2. What should I know before I use Phosphate Phebra?

Warnings

Do not use Phosphate Phebra if:

• you are allergic to monobasic sodium phosphate, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you have or have had:

• kidney disease
• congestive cardiac failure
• pre-eclamptic toxaemia
• hypertension
• sodium restrictions in your diet
• 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.

If you become pregnant while taking this medicine, tell your doctor immediately.

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 Phosphate Phebra and affect how it works.

These include:

• calcium
• aluminium
• magnesium
• vitamin D supplements

Medicine that may reduce the effect of Phosphate Phebra:

• antacids

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

4. How do I use Phosphate Phebra?

How much to take

Follow your doctor's instructions on how much Phosphate Phebra effervescent tablets to take.

The number of tablets you need to take will depend on the reason that your doctor has prescribed Phosphate Phebra effervescent tablets and will also depend on your individual requirements.

If you are receiving it to reduce the calcium levels in your blood, you can take up to:

• 6 tablets daily (adults) or
• 3 tablets daily (children).

If you are taking it to increase your phosphate levels, you can take:

• 4-6 tablets daily (adults) or
• 2-3 tablets daily (children).

If you have kidney problems or are elderly, the dose may be reduced as directed by your doctor.

Do not change the dose yourself, without your doctor's advice, regardless of how well you may feel.

Follow the instructions provided and use Phosphate Phebra until your doctor tells you to stop.

When to take Phosphate Phebra

• Phosphate Phebra effervescent tablets should be taken at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

How to take Phosphate Phebra

• Always dissolve the Phosphate Phebra effervescent tablets in one third to half a glass of water.
• Drink the solution as soon as the fizzing has stopped.
• Never swallow the tablets whole.

If you forget to use Phosphate Phebra

If you miss a dose and then remember, take the missed dose right away. Then continue with your regular schedule.

Do not take a double dose to make up for the dose you missed.

If you use too much Phosphate Phebra

If you think that you have used too much Phosphate Phebra, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or the New Zealand National Poisons Centre (by calling 0800 POISON or 0800 764 766), 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.

5. What should I know while using Phosphate Phebra?

Things you should do

• If you become pregnant while taking this medicine, tell your doctor immediately.
• If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
• If you are going to have any diagnostic tests, tell your doctor that you are taking this medicine.
• If you are going to start on any new medicine, remind your doctor and pharmacist that you are taking this medicine.

Remind any doctor, dentist, pharmacist or nurse you visit that you are using Phosphate Phebra.

Keep all of your doctor's appointments so that your progress can be checked.

Things you should not do

• Do not give your medicine to anyone else, even if they have the same condition as you.
• Do not use it to treat any other complaints unless your doctor tells you to.
• Do not stop taking Phosphate Phebra suddenly or lower the dosage without checking with your doctor.

Things to be careful of

• Do not dissolve Phosphate Phebra effervescent tablets in warm or hot water.
• Always dissolve these tablets in drinking water at room temperature before taking them.
• Never swallow the tablets whole.
• Make sure that the lid on the tube is firmly closed at all times.

Looking after your medicine

• Keep your medicine in the original container until it is time to take your tablets.
• Store below 25°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 windowsills.

Keep it where young children cannot reach it.

When to discard your medicine

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.

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.

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

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 or the New Zealand Medicines and Medical Devices Safety Authority at www.medsafe.govt.nz/safety/report-a-problem.asp#Medicine. 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

What Phosphate Phebra contains

Phosphate Phebra contains sugars (as sucrose), sodium (as sodium phosphate and sodium bicarbonate) and potassium (as potassium bicarbonate)

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

Phosphate Phebra does not contain lactose, gluten, tartrazine, alcohol, dyes or any preservatives.

What Phosphate Phebra looks like

Phosphate Phebra effervescent tablets are large, white, flat, circular tablets with a slightly rough surface (AUST R 292515).

Phosphate Phebra is in cartons of 100 tablets.

Each carton contains 5 polypropylene tubes, each tube contains 20 tablets.

Who distributes Phosphate Phebra

Phosphate Phebra is supplied in Australia by:

Phebra Pty Ltd
19 Orion Road, Lane Cove West,
NSW 2066, Australia.
Telephone: 1800 720 020

Phosphate Phebra is distributed in New Zealand by:

Phebra NZ Limited
202 Ponsonby Road, Ponsonby,
Auckland, 1011, New Zealand.
Telephone: 0508 743 272

This leaflet was prepared in January 2022.

Phebra and the Phi symbol are trademarks of Phebra Pty Ltd, 19 Orion Road, Lane Cove West, NSW 2066, Australia.

Published by MIMS March 2022

1 Name of Medicine

Monobasic sodium phosphate.

2 Qualitative and Quantitative Composition

Each Phosphate Phebra effervescent tablet contains 1.936 g monobasic sodium phosphate which is equivalent to 500 mg phosphorus. The solution provides elemental phosphorus 500 mg (16.1 mmol phosphate). In addition each tablet provides sodium 469 mg (20.4 mmol Na⁺) and potassium 123 mg (3.1 mmol K⁺).

Excipients with known effect.

3 Pharmaceutical Form

Phosphate Phebra effervescent tablets are large, white, flat, circular uncoated tablets with a slightly rough surface. The tablets effervesce when placed in water and dissolve to give a palatable orange-flavoured solution. Each tablet has a calorific value of 2.5 kcals.

4 Clinical Particulars

4.1 Therapeutic Indications

Phosphate Phebra tablets are used as an oral phosphate supplement in the treatment of the following conditions:
1. Hypercalcaemia associated with such conditions as: hyperparathyroidism, multiple myelomatosis, and metastatic bone disease.
2. Hypophosphataemia associated with Vitamin D-resistant rickets.

4.2 Dose and Method of Administration

Phosphate Phebra effervescent tablets should be dissolved in 1/3 to 1/2 glass of water and taken orally.
The dosage should be adjusted to suit the requirements of individual patients.

Adults.

Hypercalcaemia.

Vitamin D-resistant rickets.

Children.

Hypercalcaemia.

Vitamin D-resistant rickets.

4.3 Contraindications

Phosphate Phebra tablets are contraindicated in patients with a known hypersensitivity to monobasic sodium phosphate or any of the components of the tablets.

4.4 Special Warnings and Precautions for Use

Consideration should be given to the sodium and potassium content of Phosphate Phebra tablets (see Section 2 Qualitative and Quantitative Composition) before administration to patients suffering from conditions associated with significant electrolyte imbalance, or impaired renal function. In cases where restricted sodium intake is indicated, e.g. in the treatment of congestive cardiac failure, hypertension, pre-eclamptic toxaemia, etc., the sodium and potassium content of Phosphate Phebra tablets should be taken into consideration.
Soft tissue calcification and nephrocalcinosis have been reported in isolated cases following intravenous therapy with phosphate. This is thought to be a function of dosage and rapidity of phosphate administration. While such effects appear less likely to occur following treatment with oral phosphates, careful surveillance of patients is recommended.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concurrent administrations of Phosphate Phebra tablets with antacids, containing agents such as aluminium hydroxide, calcium or magnesium salts, may result in the displacement of calcium from binding to oral phosphate, thus reducing the efficacy of this medication.
Parathyroid hormone (PTH) increases the urinary excretion of phosphate by blocking tubular reabsorption.
The risk of ectopic calcification may be increased by concurrent use of calcium supplements.
Vitamin D increases the gastrointestinal absorption of phosphates and therefore increases the potential for hyperphosphataemia.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Adverse drug reactions are listed according to system organ classes in MedDRA. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category, using the following convention (CIOMS III) is also provided for each adverse drug reaction: Very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data), including isolated reports. See Table 1.

Reporting suspected adverse effects.

4.9 Overdose

Excessive dosage has been reported to produce hypocalcaemia in isolated cases. This has proved reversible when dosage has been adjusted.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Phosphorous is one of the most abundant elements in the human body: nearly 85% is present in the skeleton, with the balance in soft tissues and extracellular fluid. Most phosphorous is complexed as phosphate, which is the body's major intercellular anion and an essential component of cell membrane phospholipids, DNA and RNA. It is also critical to most biochemical processes, including ATP synthesis and metabolic and enzymatic pathways. Phosphorous, as phosphate, also assists in maintaining normal physiological pH balance.
Phosphorous balance is regulated by several hormones, including parathyroid hormone (PTH), which controls the release of phosphate from bones and inhibits renal reabsorption. Serum phosphate levels are inversely proportional to serum calcium levels and their physiological requirements are the same.

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

The excipients are sodium bicarbonate, potassium bicarbonate, macrogol 4000, citric acid, sucrose, Orange 52570 TP0551 and saccharin sodium.

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 25°C. The tablets must be stored in the tightly closed original container. Keep out of reach of children.

6.5 Nature and Contents of Container

Phosphate Phebra is available in cartons of 100 tablets. Each carton contains 5 polypropylene tubes, each containing 20 tablets.
AUST R 292515.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

The empirical formula of monobasic sodium phosphate is NaH₂PO₄. The molecular weight is 119.98.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Summary Table of Changes