Consumer medicine information

Chlorvescent

Potassium chloride; Potassium carbonate; Potassium bicarbonate

BRAND INFORMATION

Brand name

Chlorvescent

Active ingredient

Potassium chloride; Potassium carbonate; Potassium bicarbonate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Chlorvescent.

What is in this leaflet

This leaflet answers some common questions about Chlorvescent.

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 using this medicine against the benefits they expect it will have for you.

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

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

What Chlorvescent is used for

Chlorvescent tablets are 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 essential 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.

Before you take it

When you must not take it

Do not take Chlorvescent:

  • if you have an allergy to it or to any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips or tongue, skin rash, itching or hives.
  • if 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
  • if you are taking any medicine for:
    - high potassium levels
    - fluid (e.g. diuretics)
  • if the expiry date on the pack has passed.
If you take it after the expiry date has passed it may not work as well.
  • if the packaging is torn or shows signs of tampering or the tablets do not look quite right.

Before you start to take it

You must tell your doctor if:

  • you are allergic to any other medicines, foods, preservatives or dyes.
  • if you have or have had any other medical conditions, in particular:
    - any problems with your kidneys, liver or adrenal glands
    - heart disease
    - peptic ulcer or other problems with your stomach or gut.
  • you 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.
  • if you are pregnant or plan to become pregnant.
The possibility of side effects can be increased during pregnancy.
  • you are breastfeeding or plan to breastfeed.
Chlorvescent passes into breast milk. Your doctor will discuss the risks and benefits of you taking this medicine when breastfeeding.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any 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.

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

Do not give Chlorvescent to children. The safety of this medicine in children has not been established.

How to take it

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 label, ask your doctor or pharmacist for help.

How much to take

Do not take more than your doctor tells you to.

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.

When to take it

Take Chlorvescent at meal times. 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. 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

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 take it

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

Do not try to make up for missed doses by taking more than one dose at a time. 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 take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) 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 Chlorvescent.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking it

Things you must do

Tell all doctors, dentists and pharmacists who are treating you that you are taking Chlorvescent.

Tell your doctor or pharmacist 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.

Things you must 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.

Side effects

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. This medicine helps most people needing a potassium supplement 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 treatment if you get some of the side effects.

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

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • feeling sick (nausea) or vomiting
  • diarrhoea or discomfort in your stomach or gut

These common side effects may be reduced by drinking a fully dissolved Chlorvescent dose at meal times.

Tell your doctor as soon as possible if you experience:

  • slow, irregular heart beat
  • mental confusion
  • unexplained anxiety
  • numbness or tingling in hands, feet or lips
  • shortness of breath or difficult breathing
  • unusual tiredness or weakness
  • weakness or heaviness of legs.

These serious side effects may mean that you are getting too much potassium and you may need medical attention. These serious side effects are rare.

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. These are very rare side effects. You may need urgent medical attention or hospitalisation.

Other side effects not listed above may also occur in some people.

After using it

Storage

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 as well.

Keep your tablets in a cool dry place where the temperature stays below 30°C. Do not expose them to direct sunlight.

Do not store Chlorvescent or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep Chlorvescent tablets where children cannot reach them. 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

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).

Ingredients

Each Chlorvescent tablet contains:

Active ingredients:

  • potassium chloride 595 mg
  • potassium carbonate 152 mg
  • potassium bicarbonate 384 mg.

Inactive ingredients:

  • acesulfame potassium
  • aspartame
  • citric acid
  • leucine
  • macrogol 6000
  • sorbitol
  • blackcurrant flavour 502009 AP0551.

Chlorvescent does not contain lactose, gluten, sucrose or azo dyes.

Supplier

Australia:

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

New Zealand:

Pharmacy Retailing (NZ) t/a Healthcare Logistics
58 Richard Pearse Drive,
Airport Oaks, Auckland

Australian Registration Number: AUST R 71981.

This leaflet was revised in September 2017.

Published by MIMS November 2017

BRAND INFORMATION

Brand name

Chlorvescent

Active ingredient

Potassium chloride; Potassium carbonate; Potassium bicarbonate

Schedule

S4

 

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.

Dissolve 1 or 2 tablets in one-half to one glass of cold water (120 - 240 mL) two to three times a day, or as directed by your doctor. Take with or immediately after food. Not for use in children under 12 years of age.

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.

The use of potassium salts in patients with chronic renal disease, or any other condition which impairs potassium excretion, requires particularly careful monitoring of the serum potassium concentration and appropriate dosage adjustment.

Use in the elderly.

No data available.
The diagnosis of potassium depletion is ordinarily made by demonstrating hypokalaemia in a patient with a clinical history suggesting some cause for potassium depletion. When interpreting the serum potassium level, the physician should bear in mind that acute alkalosis per se can produce hypokalaemia in the absence of a deficit of total body potassium, while acute acidosis per se can increase the serum potassium concentration into the normal range even in the presence of reduced total body potassium. Since the extent of potassium deficiency cannot be accurately determined, it is prudent to proceed cautiously in undertaking potassium replacement, particularly in patients with cardiac disease and those receiving digitalis. Therefore, the treatment of potassium depletion requires careful attention to acid-base balance and appropriate monitoring of serum electrolytes, the ECG, and the clinical status of the patient.

Advice to patients.

To minimise the possibility of gastric irritation associated with oral ingestion of concentrated potassium salt preparations, patients should be carefully directed to dissolve each dose completely in the stated amount of water and to take the medication immediately after food.

Paediatric use.

The safety and effectiveness of this product in children have not been established.

Effects on laboratory tests.

No data available.

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.

The treatment of severe hyperkalaemia should focus on reducing the serum potassium concentration by promoting the transfer of potassium from the extracellular to the intracellular space. The measures taken may include the following: administration of 10% or 25% glucose solution containing 10 units of insulin per 20 g glucose, given intravenously in a dose of 300 to 500 mL/hour; in the acidotic patient, intravenous administration of 150 mmol to 300 mmol of sodium bicarbonate. Other measures should include the elimination of potassium-containing medications and potassium sparing diuretics and frequently the oral administration of a cation exchange resin (such as sodium polystyrene sulfonate) to remove gastrointestinal potassium. To assure rapid movement of the resin through the gastrointestinal tract, a non-absorbable polyhydric alcohol (e.g. sorbitol) should be given in sufficient quantities to induce a soft to semi-liquid bowel movement every few hours. Haemodialysis and peritoneal dialysis are alternative means of removing excess potassium.
Treatment should also involve the administration of calcium to counteract the negative effects of hyperkalaemia on cardiac excitability. If cardiac manifestations of hyperkalaemia are present, then first-line therapy should be with a calcium salt administered intravenously; 10 mL to 30 mL of calcium gluconate 10% may be given by slow intravenous injection, the dosage being titrated and adjusted based on the ECG improvement. Calcium will not, however, reduce the plasma-potassium concentration.

Warning.

In digitalised patients lowering potassium increases the effect and toxicity of digoxin. Expert advice should be sought.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Potassium is the predominant intracellular cation. It plays a vital role in the maintenance of the electrical excitability of nerve and muscle, acid-base balance, and isotonicity. Potassium is an important activator in many enzymatic reactions and is essential to a number of physiological processes including transmission of nerve impulses; contraction of cardiac, smooth, and skeletal muscle; gastric secretion; renal function; tissue synthesis; and carbohydrate metabolism.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Potassium chloride is well absorbed from the gastrointestinal tract.

Distribution.

It diffuses into extracellular fluid and is then actively transported into cells, achieving an intracellular:extracellular concentration ratio of approximately 40.

Metabolism.

The normal potassium levels in adults are 3.5 - 5 mmol/L.

Excretion.

Potassium is excreted primarily by the kidneys, by the processes of filtration, re-absorption and secretion. Excretion of potassium ions is influenced by chloride ion concentration, hydrogen ion exchange, acid-base equilibrium and adrenal mineralocorticoids.

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