SUMMARY CMI

Chlorvescent^®

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 CHLORVESCENT?

CHLORVESCENT contains the active ingredient potassium (as potassium chloride, bicarbonate, and carbonate. CHLORVESCENT is used to provide extra potassium for people who have lost potassium from their bodies because of illness or treatment with certain medicines.

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

2. What should I know before I use CHLORVESCENT?

Do not use if you have ever had an allergic reaction to CHLORVESCENT 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 use CHLORVESCENT? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with CHLORVESCENT 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 CHLORVESCENT?

• The usual dose is 1 or 2 tablets taken two to three times a day (i.e. 2 to 6 tablets each day). The amount you need will depend on your condition.
• Take CHLORVESCENT during mealtimes
• Dissolve the tablet completely in one-half to one glass of cold water then drink.

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

5. What should I know while using CHLORVESCENT?

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

6. Are there any side effects?

The most common side effects of CHLORVESCENT include feeling sick (nausea) and vomiting, and diarrhoea or discomfort in the stomach or gut. These side effects may be reduced if you take CHLORVESCENT with food. More serious side effects include a slow and/or irregular heartbeat; mental confusion; unexplained anxiety; numbness or tingling in hands, feet or lips; shortness of breath or difficult breathing; unusual tiredness or weakness; or weakness or heaviness of legs. These serious side effects may indicate that your dose is too high and 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.

FULL CMI

Chlorvescent^®

Active ingredients: Potassium chloride, potassium bicarbonate, potassium carbonate

Consumer Medicine Information (CMI)

This leaflet provides important information about using CHLORVESCENT. 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 CHLORVESCENT.

Where to find information in this leaflet:

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

1. Why am I using CHLORVESCENT?

CHLORVESCENT contains the active ingredient potassium (as potassium chloride, bicarbonate, and carbonate).

CHLORVESCENT is used to provide extra potassium for people who have lost potassium from their bodies because of illness or treatment with certain medicines. It is also used for people who do not have enough potassium in their regular diet or cannot replace the potassium they have lost from their diet alone.

Potassium is an essential mineral for life and health. Vegetables, potatoes and fruit are good sources of dietary potassium.

However, as too much potassium can be harmful, do not change your dose without first checking with your doctor.

The dose of CHLORVESCENT may need to be adjusted if your diet is rich in natural sources of potassium.

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

Your doctor may have prescribed it for another purpose.

2. What should I know before I use CHLORVESCENT?

Warnings

Do not use CHLORVESCENT if:

• You are allergic to it, or any of the ingredients listed at the end of this leaflet.
  - Some symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue, or any other parts of the body; rash, itching or hives on the skin.
  - Always check the ingredients to make sure you can use this medicine.
• You have any of the following medical conditions:
  - High potassium levels
  - Kidney impairment
  - Stomach ulcers
  - Severe burns or other serious injury
  - Significant dehydration or heat cramps
  - Addison's Disease – a disease where the adrenal glands don't work properly
• You are taking any medicine for:
  - High potassium levels
  - Fluid (e.g. diuretics)
• The expiry date on the pack has passed. If you take it after the expiry date has passed it may not work as well.
• The packaging is torn or shows signs of tampering or the tablets do not look quite right.

Check with your doctor if you:

• Have any other medical conditions, especially the following:
  - any problems with your kidneys, liver or adrenal glands
  - heart disease
  - peptic ulcer or other problems with your stomach or gut
• Are on any type of special diet and in particular, if you use salt substitutes on your food.
  Salt substitutes containing potassium should be avoided when taking CHLORVESCENT.
• Take any medicines for any other condition.
• Have had any allergy to any other medicines, or any other substances, such as foods, preservatives, or dyes.

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

Talk with your doctor if you are pregnant or intend to become pregnant. The possibility of side effects can be increased during pregnancy.

Talk to your doctor if you are breastfeeding or intend to breastfeed. CHLORVESCENT passes into breast milk. Your doctor will discuss the risks and benefits of you taking this medicine when breastfeeding.

Use in children

Do not use in children under 12 years of age. The safety of this medicine in children has not been established.

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 be affected by CHLORVESCENT or may affect how well it works. These include:

• Some types of fluid tablets, also known as "diuretics" e.g. spironolactone, triamterene, or amiloride
• Certain types of heart medicines, known as ACE-inhibitors and beta-blockers
• Anti-inflammatory medicines e.g. NSAIDS

You may need to take different amounts of your medicines, or you may need to take different medicines.

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

4. How do I use CHLORVESCENT?

How much to take

• The usual dose is 1 or 2 tablets taken two to three times a day (i.e. 2 to 6 tablets each day). The amount you need will depend on your condition.
• Do not take more than your doctor tells you to.

When to take CHLORVESCENT

• Take CHLORVESCENT at mealtimes.
  Taking it with food or immediately after food will reduce the chance of you having a stomach irritation.

How to take it

• Dissolve the tablet completely in one-half to one glass of cold water then drink.
  CHLORVESCENT tablets are effervescent and need to be dissolved completely in water before swallowing.
• Do not crush or chew the tablets.

How long to take it for

• Continue taking CHLORVESCENT until your doctor tells you to stop. Your doctor may need to check the potassium levels in your blood to help decide when you should stop taking CHLORVESCENT.

If you forget to use CHLORVESCENT

If you forget to take your medicine, take your dose as soon as you remember.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you use too much CHLORVESCENT

If you think that you have used too much CHLORVESCENT, 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.

5. What should I know while using CHLORVESCENT?

Things you should do

• Tell your doctor or pharmacist that you are using CHLORVESCENT before you start any new medicine.
• Keep all of your doctor's appointments so that your progress can be checked. Your doctor may do blood tests from time to time to make sure the medicine is working and to prevent unwanted side effects.
• Tell your doctor if you become pregnant while taking CHLORVESCENT. Your doctor can discuss with you the risks and benefits of taking it during pregnancy.

Remind any doctor, dentist or pharmacist you visit that you are using CHLORVESCENT.

Things you should not do

• Do not take it to treat any other complaints unless your doctor tells you to.
• Do not stop taking your medicine or increase the dose even if you think it is not working.
• Do not start taking salt substitutes without first discussing this with your doctor or pharmacist. It may be necessary to avoid salt substitutes containing potassium when taking CHLORVESCENT.
• Do not give this medicine to anyone else, even if they have the same symptoms or conditions as you.

Looking after your medicine

• Keep your tablets in the closed tube until it is time to take them. If you take the tablets out of the tube they may not keep well.
• Keep CHLORVESCENT in a cool dry place, away from moisture, heat, or sunlight where the temperature stays below 30°C. 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 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

Stop taking CHLORVESCENT and tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you suspect any problems with your kidneys.

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

Tell your doctor if you notice anything unusual or if you are concerned about any aspect of your health, even if you think the problems are not connected with this medicine and are not referred to in this leaflet.

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.

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 CHLOREVESCENT contains

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

What CHLORVESCENT looks like

CHLORVESCENT tablets are flat, round, white or white to yellow. They are available in packs of 60 tablets (2 plastic tubes with 30 tablets in each).

(AUST R 71981)

Who distributes CHLORVESCENT

Aspen Pharmacare Australia Pty Ltd
34-36 Chandos St
St Leonards NSW 2065
Australia

This leaflet was revised in August 2024

Published by MIMS November 2024

1 Name of Medicine

Potassium chloride, potassium bicarbonate and potassium carbonate.

2 Qualitative and Quantitative Composition

Each effervescent tablet contains potassium chloride, potassium bicarbonate and potassium carbonate, providing 14 mmol potassium (548 mg) and 8 mmol chloride (283 mg) in the form of an acceptable drink.
Excipients include citric acid, sorbitol, aspartame, acesulfame potassium, leucin, macrogol 6000 and blackcurrant flavour.

3 Pharmaceutical Form

Flat, round, white or white to yellow tablet.

4 Clinical Particulars

4.1 Therapeutic Indications

For the treatment and specific prevention of hypokalaemia.

4.2 Dose and Method of Administration

Adults and children 12 years and over.

4.3 Contraindications

Potassium supplements should not be used in any of the following conditions: hyperkalaemia; chronic renal impairment; potassium-sparing diuretic therapy (such as triamterene, spironolactone, amiloride); acute peptic ulcer or gastritis; acute dehydration or heat cramps; extensive tissue breakdown (such as burns or crush injuries); adrenal insufficiency (such as Addison's disease) or if on therapy with any drugs that may cause hyperkalaemia (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

4.4 Special Warnings and Precautions for Use

Potassium salts should be administered with caution to patients with chronic renal disease, liver cirrhosis, cardiac disease. Potassium salts should be given with caution to patients in whom passage through the gastro-intestinal tract may be delayed as in pregnant patients or in those receiving anti-muscarinic agents. Attention should be paid to the concurrent use of other drugs that either contain potassium or have the potential for hyperkalaemia.
In patients with impaired mechanisms for excreting potassium, the administration of potassium salts can produce hyperkalaemia and cardiac arrest. This occurs most commonly in patients given potassium by the intravenous route but may also occur in patients given potassium orally.
Potentially fatal hyperkalaemia can develop rapidly and may be asymptomatic.

Use in renal impairment.

Use in the elderly.

Advice to patients.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The simultaneous administration of potassium supplements and a potassium-sparing diuretic can produce severe hyperkalaemia (see Section 4.3 Contraindications).
Potassium salts should be used with caution in patients who are using salt substitutes because most of the latter contain substantial amounts of potassium. Such concomitant use could result in hyperkalaemia.
Concurrent use of a potassium supplement with any of the ACE inhibitors or potassium-sparing diuretics may result in severe hyperkalaemia.
Interactions may also occur in patients simultaneously taking NSAIDs or beta-blockers.

4.6 Fertility, Pregnancy and Lactation

It is not known whether this product can cause harm to the foetus or affect reproductive capacity when it is administered to a pregnant woman. It should only be given to a pregnant woman if clearly needed.
Many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from oral potassium supplements, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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)

The most common adverse reactions to oral potassium supplements are nausea, vomiting, diarrhoea, and abdominal discomfort. These side effects occur more frequently when the medication is not taken with food or is not diluted properly or dissolved completely. Hyperkalaemia occurs only rarely in patients with normal renal function receiving potassium supplements orally. Signs and symptoms of hyperkalaemia include the following: cardiac arrhythmias; mental confusion; unexplained anxiety; numbness or tingling in hands, feet or lips; shortness of breath or difficult breathing; unusual tiredness or weakness; and weakness or heaviness of legs (see also Section 4.4 Special Warnings and Precautions for Use and Section 4.9 Overdose).
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

The administration of oral potassium salts to persons with normal renal function rarely causes serious hyperkalaemia. However, in patients with chronic renal disease (or any other condition which impairs potassium excretion), potentially fatal hyperkalaemia can result (see Section 4.3 Contraindications and Section 4.4 Special Warnings and Precautions for Use). The earliest clinical manifestations of this condition may only be increased serum potassium levels and characteristic ECG changes such as peaking of T-waves, loss of P-wave, depression of S-T segment and prolongation of the QT interval.
These changes in the ECG usually appear when serum potassium concentration reaches 7 to 8 mmol/L. Other clinical manifestations, occurring at a concentration of 9 to 10 mmol/L, may include muscle paralysis and death from cardiac arrest.

Treatment of overdosage.

Warning.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

No data available.

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

2 Years.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

PE-LD cap; Alu Tube.
Pack size - 60 (30 X 2 Tubes).
White or white to yellow, round and flat tablets.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Not applicable.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes