Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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.
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.
e Calcium Polystyrene Sulfonate
Do not use Calcium Polystyrene Sulfonate
Warnings and precautions Talk to your doctor or pharmacist before taking the Calcium Polystyrene Sulfonate:
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.
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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:
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.
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.
What Calcium Polystyrene Sulfonate contains
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PL 06464/3119 Calcium Polystyrene Sulfonate 99.75% w/w powder for oral/rectal suspension. This leaflet was last revised in June 2024.
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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.
The active substance in Calcium Polystyrene Sulfonate 99.75% Powder for Oral/Rectal Suspension is calcium polystyrene sulfonate.
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.
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.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Calcium Polystyrene Sulfonate is an ion-exchange resin that is recommended for the treatment of hyperkalaemia.
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.
- 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.
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).
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.
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.
There are no specific warnings.
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.
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 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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