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Calcium Polystyrene Sulfonate 99.75% Powder for Oral/Rectal Suspension

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Calcium polystyrene sulfonate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Calcium polystyrene sulfonate

Equivalent medicines (same active substance, strength and form)

and 1 more with the same active substance, strength and form

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for

Calcium Polystyrene Sulfonate 99.75% w/w powder for oral/rectal suspension contains a medicine called calcium polystyrene sulfonate (referred to as Calcium Polystyrene Sulfonate in this leaflet). This belongs to a group of medicines called "ion exchange resins". This medicine is used to treat something called "hyperkalaemia". This is when there is too much potassium in your blood. It works by attaching to potassium in your gut. This prevents potassium from entering your bloodstream and lowers potassium levels in your blood back to normal. It is often given to people who have kidney problems and people on dialysis. 2.

What you need to know before you take it

e Calcium Polystyrene Sulfonate

Do not use Calcium Polystyrene Sulfonate

  • if you are allergic to calcium polystyrene sulfonate or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
  • if you have been told that you have a low level of potassium in your blood
  • if you have been told you have problems that result in high levels of calcium in your body such as thyroid problems or some types of cancer
  • if your gut is partially or completely blocked (obstructive bowel disease)
  • if you are taking a sweetener called sorbitol (a «sugar-free» sweetener used to sweeten food). This is because taking sorbitol and Calcium Polystyrene Sulfonate at the same time can cause narrowing of the gut wall (gastrointestinal stenosis) and reduced blood flow to the gut wall (intestinal ischemia) causing severe damage to your gut (necrosis and perforation). You must not take any sorbitol whilst using Calcium Polystyrene Sulfonate. Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor, pharmacist or nurse before usingCalcium Polystyrene Sulfonate. Page 1 of 6

Warnings and precautions Talk to your doctor or pharmacist before taking the Calcium Polystyrene Sulfonate:

  • if it is for your baby, and they were premature, had a low birth-weight or have reduced gut movement,
  • if you suffer from constipation.
  • if you have abnormal bowel movements due to your medical condition (including conditions after surgery or drug usage) as these may cause a variety of disorders including bloating, severe constipation, reduced blood supply to your gut or ruptured bowel. If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before using Calcium Polystyrene Sulfonate. Other medicines and Calcium Polystyrene Sulfonate Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines. This includes medicines you can buy without prescription, including herbal medicines. This is because Calcium Polystyrene Sulfonate can affect the way other medicines work. Also, some medicines can affect the way Calcium Polystyrene Sulfonate works. In particular, check with your doctor if you are taking the following medicines:
  • Medicines that contain salts such as magnesium, potassium or calcium. Ask your doctor if you are not sure
  • Some medicines for constipation (laxatives) that contain magnesium
  • Some medicines for indigestion (antacids) that contain magnesium or aluminium
  • Digoxin or similar medicines from digitalis – for heart problems
  • Levothyroxine or thyroxine – for an under-active thyroid
  • Lithium – for mental illness If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Calcium Polystyrene Sulfonate. Calcium Polystyrene Sulfonate with food and drink Do not mix this medicine with fruit juice, this will stop this medicine from working properly. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Driving and using machines It is not known whether the administration of calcium polystyrene sulfonate may impair your ability to drive or use machines. This medicine contains a maximum of 35 mg sodium benzoate per dose. This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially "sodium-free". To be taken into consideration by patients on a controlled sodium diet. 3.

How to take it

Calcium Polystyrene Sulfonate

Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

  • The dose will depend on the results of blood tests
  • For children the dose is also worked out according to how much the child weighs Using this medicine
  • Calcium Polystyrene Sulfonate can be given by mouth or put into the back passage (rectum). Page 2 of 6
  • The suspension should be prepared immediately before use.
  • If given by mouth, mix with a small amount of water and stir until it is thoroughly mixed. The powder does not dissolve but forms a suspension. You may add more water to the mixture to help you swallow the medicine. If powder remains in the glass after drinking, add more water, stir and drink immediately. You may need to do this again to make sure that you have taken all the powder.
  • Calcium Polystyrene Sulfonate can also be made into a paste with something sweet, such as jam or honey.
  • Do not mix the powder with fruit juice, this will stop the medicine from working properly.
  • If given by mouth, it is important to sit up while taking the medicine so that you do not breathe in any powder into your lungs.
  • If given by the back passage you should try to keep the medicine in your back passage for at least 9 hours. Then it needs to be thoroughly washed out. The recommended dose: Adults (including the elderly) By mouth
  • The usual dose is 15 g (one spoonful) three or four times a day Into the back passage
  • The usual dose is 30 g (two spoonfuls) once a day In some cases, the medicine may be given both by mouth and into the back passage. This is where your potassium levels need to be lowered more quickly. Use in children If your child cannot take the medicine by mouth, it may be given into the back passage.
  • The daily dose is 1 g for each kilogram of bodyweight
  • Once the medicine has started working the dose may be lowered to 0.5 g daily for each kilogram of bodyweight New-born babies Calcium Polystyrene Sulfonate is only given into the back passage.
  • The daily dose is between 0.5 g and 1 g for each kilogram of bodyweight. It is important to give the right dose for children and babies. If too much is given, children and babies could get serious constipation. If you use more Calcium Polystyrene Sulfonate than you should It is unlikely that your doctor or nurse will give you too much medicine. Your doctor and nurse will be checking your progress and checking the medicine that you are given. Ask them if you are not sure why you are getting a dose of medicine. If you are given too much Calcium Polystyrene Sulfonate the following effects may happen:
  • Feeling irritable or confused
  • Being unable to concentrate
  • Muscle weakness and poor reflexes leading to paralysis
  • Breathing problems
  • Faster or pounding heartbeat
  • Muscle cramps If you forget to use Calcium Polystyrene Sulfonate

Page 3 of 6

Your doctor or nurse will give instructions about when to have your medicine. It is unlikely that a dose will be missed. If you think that you may have missed a dose, talk to your doctor or nurse. Do not use a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or nurse. 4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Talk to your doctor or nurse straight away if you notice any of the following serious side effects:

  • Severe stomach pain, rectal pain
  • Bloating, severe constipation
  • Severe nausea and vomiting
  • Black, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds. Talk to your doctor or nurse if you get any of the following side effects: Common (may affect up to 1 in 10 people)
  • feeling tired, confused, having muscle weakness, cramps or a change in heart rate. These may be due to having low levels of potassium in your body
  • high levels of calcium in your blood
  • low levels of magnesium in your blood
  • nausea
  • vomiting
  • constipation Uncommon (may affect up to 1 in 100 people)
  • loss of appetite
  • diarrhoea
  • stomach upset, pain in your gut or blockage of the gut
  • gastrointestinal ulcer
  • intestinal obstruction Rare (may affect up to 1 in 1,000 people)
  • large, hard, dry stool mass (faecalomas) in severe cases, particularly in children following rectal administration.
  • a mass found trapped in the gastrointestinal system (bezoars) following oral administration.
  • necrosis (death of the cells) of the colon, which could lead to intestinal perforation which is sometimes fatal, especially if it is administered together with sorbitol (a laxative). Very rare (may affect up to 1 in 10,000 people)
  • feeling short of breath or coughing. This could be the first sign of a serious chest infection. This can be caused by accidentally breathing in this medicine. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

Possible side effects

not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine. Page 4 of 6

5.

How to store it

Calcium Polystyrene Sulfonate

Keep this medicine out of the sight and reach of children. This medicine does not require any special storage conditions. Do not use this medicine after the expiry date which is stated on the bottle or carton label after "Exp". The expiry date refers to the last day of that month. Shelf life after first opening the 400 g or 300 g multi-dose container: 1 month. Storage conditions after first opening of the 400 g or 300 g multidose container: Do not store above 25°C and keep the container tightly closed. The single use 15 g sachets should be used immediately after opening. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.

Contents of the pack and other information

What Calcium Polystyrene Sulfonate contains

  • The active substance is calcium polystyrene sulfonate. Each 100 g powder for suspension contain 99.75 g calcium polystyrene sulfonate.
  • The other ingredients are: vanilla flavour (it contains sodium benzoate E 211). What Calcium Polystyrene Sulfonate looks like and contents of the pack Calcium Polystyrene Sulfonate is a golden or brown fine powder with slight vanilla flavour. Calcium Polystyrene Sulfonate is supplied in:
  • Plastic multi-dose container with 400 g or 300 g of powder fitted with a screw cap with a safety seal, and with a plastic measuring spoon, which, when filled level, contains 15 g of powder.
  • Box of 26 sachets containing 15 g of powder. Not all pack sizes may be marketed. Marketing Authorisation Holder Waymade PLC, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, UK Manufacturer Laboratorios Rubió, S.A. Industria, 29 Pol. Ind. Comte de Sert 08755 Castellbisbal – Barcelona Spain

Page 5 of 6

PL 06464/3119 Calcium Polystyrene Sulfonate 99.75% w/w powder for oral/rectal suspension. This leaflet was last revised in June 2024.

Page 6 of 6

Frequently asked questions about Calcium Polystyrene Sulfonate 99.75% Powder for Oral/Rectal Suspension

How do I take Calcium Polystyrene Sulfonate 99.75% Powder for Oral/Rectal Suspension?

Calcium Polystyrene Sulfonate 99.75% Powder for Oral/Rectal Suspension comes as oral solution. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Calcium Polystyrene Sulfonate 99.75% Powder for Oral/Rectal Suspension?

The active substance in Calcium Polystyrene Sulfonate 99.75% Powder for Oral/Rectal Suspension is calcium polystyrene sulfonate.

Are there equivalent medicines to Calcium Polystyrene Sulfonate 99.75% Powder for Oral/Rectal Suspension?

Medicines with the same active substance, strength and form include: Resonium A 99.934% w/w Powder for Oral/Rectal Suspension, Calcium Polystyrene Sulfonate 99.934% w/w Powder for Oral/Rectal Suspension, Calcium Resonium 99.934% w/w Powder for Oral/Rectal Suspension. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Calcium Polystyrene Sulfonate 99.75% Powder for Oral/Rectal Suspension, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Calcium Polystyrene Sulfonate 99.75% Powder for Oral/Rectal Suspension without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Calcium polystyrene sulfonate (2 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Calcium Polystyrene Sulfonate is an ion-exchange resin that is recommended for the treatment of hyperkalaemia.

4.2. Posology and method of administration

Posology

Calcium Polystyrene Sulfonate is for oral or rectal administration only.

The dosage recommendations detailed below are a guide only; the precise requirements should be decided on the basis of regular serum electrolyte determinations.

Adults, including the elderly:

Oral

The usual dose is 15 g three or four times a day. Each dose should be given as a suspension in a small amount of water or, for greater palatability, in syrup (but not fruit juices which contain potassium), in the ratio of 3 to 4 ml per gram of resin.

Rectal

This route should be reserved for the patient who is vomiting or who has upper gastrointestinal tract problems, including paralytic ileus or it may be used simultaneously with the oral route for more rapid initial results. The resin may be given rectally as a suspension of 30 g resin in 150 ml of water or 10% dextrose, as a daily retention enema. In the initial stages administration by this route as well as orally may help to achieve a rapid lowering of the serum potassium level.

The enema should, if possible, be retained for at least nine hours, then the colon should be irrigated to remove the resin. If both routes are used initially it is probably unnecessary to continue rectal administration once the oral resin has reached the rectum.

Paediatric population

Children:

Oral

In smaller children and infants, correspondingly smaller doses should be employed by using as a guide a rate of 1mEq of potassium per gram of resin as the basis for calculation. An appropriate initial dose is 1 g/kg body weight daily in divided doses, in acute hyperkalaemia. Dosage may be reduced to 0.5 g/kg body weight daily in divided doses for maintenance therapy.

The resin is given orally, preferably with a drink (not a fruit squash because of the high potassium content) or a little jam or honey.

Rectal

When refused by mouth it should be given rectally using a dose at least as great as that which would have been given orally, diluted in the same ratio as described for adults. Following retention of the enema, the colon should be irrigated to ensure adequate removal of the resin.

Neonates:

Calcium Polystyrene Sulfonate should not be given by the oral route. With rectal administration, the minimum effective dosage within the range 0.5 g/kg to 1g/kg should be employed, diluted as for adults with adequate irrigation to ensure recovery of the resin.

4.3. Contraindications

- In patients with plasma potassium levels below 5 mmol/litre.

- Conditions associated with hypercalcaemia (e.g. hyperparathyroidism, multiple myeloma, sarcoidosis or metastatic carcinoma).

- History of hypersensitivity to polystyrene sulfonate resins.

- Obstructive bowel disease.

- Calcium Polystyrene Sulfonate should not be administered orally to neonates and is contraindicated in neonates with reduced gut motility (post-operatively or drug induced).

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Gastrointestinal stenosis and ischaemia: Gastrointestinal stenosis, intestinal ischemia and its complications (necrosis and perforation), some of them fatal, were reported in patients treated with polystyrene sulfonate alone or in combination with sorbitol. Concomitant use of sorbitol with polystyrene sulfonate is not recommended (see section 4.5 and section 4.8).

Due to the risk of severe gastrointestinal disorders (such as bowel obstruction, ischaemia, necrosis or perforation) the use of polystyrene sulfonate is not recommended in patients with compromised gastrointestinal motility (including immediate post-surgery or drug-induced).

Patients should be advised to seek prompt medical advice in case of newly developed severe abdominal pain, nausea and vomiting, stomach distension and rectal bleeding.

Lesions seen in polystyrene sulfonate-induced gastrointestinal damage may overlap with those seen in inflammatory bowel disease, ischemic colitis, infectious colitis, and microscopic colitis.

Hypokalaemia: The possibility of severe potassium depletion should be considered, and adequate clinical and biochemical control is essential during treatment, especially in patients on digitalis. Administration of the resin should be stopped when the serum potassium falls to 5mmol/litre.

Other electrolyte disturbances: Like all cation-exchange resins, calcium polystyrene sulfonate is not totally selective for potassium. Hypomagnesaemia and/or hypercalcaemia may occur. Accordingly, patients should be monitored for all applicable electrolyte disturbances. Serum calcium levels should be estimated at weekly intervals to detect the early development of hypercalcaemia, and the dose of resin adjusted to levels at which hypercalcaemia and hypokalaemia are prevented.

Other risks: In the event of clinically significant constipation, treatment should be discontinued until normal bowel movement has resumed. Magnesium-containing laxatives should not be used (see section 4.5).

The patient should be positioned carefully when ingesting the resin, to avoid aspiration, which may lead to bronchopulmonary complications.

Children and neonates: In neonates, calcium polystyrene sulfonate should not be given by the oral route. In children and neonates, particular care is needed with rectal administration as excessive dosage or inadequate dilution could result in impaction of the resin. Due to the risk of digestive haemorrhage or colonic necrosis, particular care should be observed in premature infants or low birth weight infants.

Calcium Polystyrene Sulfonate contains sodium benzoate: This medicine contains a maximum of 35 mg sodium benzoate in each dosage unit (15 g).

4.5. Interaction with other medicinal products and other forms of interaction

Concomitant use not recommended

Sorbitol (oral or rectal): Concomitant use of Sorbitol with calcium polystyrene sulfonate is not recommended due to cases of intestinal necrosis and other serious gastrointestinal adverse reactions, which may be fatal (see section 4.4 and section 4.8).

To be used with caution

Cation-donating agents: may reduce the potassium binding effectiveness of Calcium Polystyrene Sulfonate.

Non-absorbable cation-donating antacids and laxatives: There have been reports of systemic alkalosis following concurrent administration of cation-exchange resins and non-absorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminium carbonate.

Aluminium hydroxide: Intestinal obstruction due to concretions of aluminium hydroxide has been reported when aluminium hydroxide has been combined with the resin (sodium form).

Digitalis-like drugs: The toxic effects of digitalis on the heart, especially various ventricular arrhythmias and A-V nodal dissociation, are likely to be exaggerated if hypokalaemia and/or hypercalcaemia are allowed to develop (see section 4.4).

Lithium: Possible decrease of lithium absorption.

Levothyroxine: Possible decrease of levothyroxine absorption.

4.6. Fertility, pregnancy and lactation

Pregnancy

There is a limited amount of data from the use of calcium polystyrene sulfonate in pregnant women. Calcium Polystyrene Sulfonate is not recommended during pregnancy and in woman of childbearing potential not using contraception.

Breast-feeding

There is insufficient information on the excretion of calcium polystyrene sulfonate in human milk. A risk to the newborns/infants cannot be excluded.

Fertility

There is no data available on fertility.

4.7. Effects on ability to drive and use machines

There are no specific warnings.

4.8. Undesirable effects

The undesirable effects are classified as follows:

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)

Table 1: Calcium Polystyrene Sulfonate undesirable effects

Metabolism and nutrition disorders

Common

Hypokalaemia, hypercalcaemia, hypomagnesaemia

Uncommon

Decreased appetite

Respiratory, thoracic and mediastinal disorders

Very rare

Acute bronchitis and/or bronchopneumonia associated with inhalation of particles of calcium polystyrene sulfonate

Gastrointestinal disorders

Common

Nausea, vomiting, constipation

Uncommon

Diarrhoea, gastric irritation, gastrointestinal ulcer, intestinal obstruction

Rare

Faecaloma (faecal impaction) following rectal administration particularly in children and gastrointestinal concretions (bezoars) following oral administration.

Gastrointestinal necrosis (colon necrosis), which could lead to intestinal perforation which is sometimes fatal (see sections 4.4 and 4.5).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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 via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9. Overdose

Biochemical disturbances from overdosage may give rise to clinical signs or symptoms of hypokalaemia, including irritability, confusion, delayed thought processes, muscle weakness, hyporeflexia and eventual paralysis. Apnoea may be a serious consequence of this progression. Electrocardiographic changes may be consistent with hypokalaemia or hypercalcaemia; cardiac arrhythmia may occur. Appropriate measures should be taken to correct serum electrolytes and the resin should be removed from the alimentary tract by appropriate use of laxatives or enemas.

💬 Ask about this leaflet

Ask anything about Calcium Polystyrene Sulfonate 99.75% Powder for Oral/Rectal Suspension. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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