Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Calcium Polystyrene Sulfonate 99.934% w/w powder for Oral/Rectal suspension (called Calcium Polystyrene Sulfonate powder in this leaflet) contains the active substance calcium polystyrene sulfonate. This belongs to a group of medicines called 'ion exchange resins'.
Calcium Polystyrene Sulfonate powder is used when you have too much potassium in your blood, a condition called 'hyperkalaemia'. It works by removing this extra potassium to bring your levels back to normal. It is often given to people who have kidney problems and people on dialysis.
Do not use Calcium Polystyrene Sulfonate powder and tell your doctor, pharmacist or nurse if: • you are allergic to calcium polystyrene sulfonate or any of the other ingredients of this medicine (listed in section 6)
• you have a condition where the body fluids and tissues are unusually alkaline (metabolic or respiratory alkalosis)
• you have low levels of potassium in your blood
• you have a condition which results in high levels of calcium such as problems with your thyroid or some types of cancer
• your gut is blocked (obstructive bowel disease).
Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Calcium Polystyrene Sulfonate powder if:
• you are taking or using sorbitol, a sugar free sweetener used in food and drink. You must not take any sorbitol whilst using Calcium Polystyrene Sulfonate powder.
• it is for your baby, and they were premature, had a low birth-weight or have reduced gut movement.
• you suffer with constipation.
• 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.
Your doctor will monitor the balance of your, or your child's electrolytes in your body while using Calcium Polystyrene Sulfonate powder.
Children Do not give this medicine by mouth to babies up to four weeks old. Administration by the rectum (back passage) must be carefully considered by your doctor (see Section3).
Other medicines and Calcium Polystyrene Sulfonate powder Tell your doctor, pharmacist or nurse if you or your child are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you or your child are taking any of the following:
• Medicines that contain salts such as magnesium, potassium or calcium. Ask your doctor if you are not sure.
• Medicines for constipation (laxatives) that contain magnesium.
• 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.
Pregnancy and breast-feeding • If you are pregnant, might become pregnant, or think you are pregnant ask your doctor, pharmacist or nurse for advice before using this medicine.
• If you are breast-feeding ask your doctor for advice before using this medicine.
A doctor or nurse will usually give you this medicine.
You may be given this medicine by mouth or as an enema in your rectum (back passage).
Once prepared it should be taken immediately.
Your doctor will monitor you while you are taking this medicine and may adjust your dose.
Adults including the elderly By mouth (Oral)
• The usual dose is 15g (one level scoop) 3-4 times a day.
• Each dose should be made up as a suspension in approximately 45-60ml of water or syrup (not fruit juice).
• Take each dose at least 3 hours before or 3 hours after any other oral medicines you may be taking. If you suffer from gastroparesis (a condition where your stomach cannot empty itself in the normal way), leave at least 6 hours before or after taking other oral medicines.
Back passage (Rectal)
Your doctor will calculate the required dose.
• The usual dose is 30g (two level scoops) once a day.
• Each dose should be made up as a suspension in approximately 150ml of water or 10% dextrose.
• You should try to retain the enema for 9 hours. Your doctor or nurse will then wash it out.
• 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.
Children By mouth (Oral)
• Your doctor will calculate the required dose for your child based on their body weight.
• Each dose is made up as a suspension with water or syrup (3 to 4 ml per gram of powder) (not fruit juice) or as a paste with a little jam or honey.
• The daily dose is 1 g for each kilogram of body weight given in divided doses.
• Once the medicine has started working the daily dose may be lowered to 0.5 g for each kilogram of body weight given in divided doses.
Back passage (Rectal)
Your doctor will calculate the required dose for your child based on their body weight. When it has been kept in long enough your doctor or nurse will wash out any remaining dose from your child's back passage.
Newborns (0-4 weeks)
This medicine is not given by mouth (oral).
Back passage (Rectal)
• Your doctor will calculate the required dose for your baby based on their body weight.
• The daily dose is between 0.5 g and 1 g for each kilogram of body weight.
If you have more Calcium Polystyrene Sulfonate powder 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.
If you forget to take Calcium Polystyrene Sulfonate powder • It is unlikely that your doctor or nurse will forget a dose, if you think you have missed a dose, talk to your doctor or nurse.
• If you have any further questions on the use of this medicine, ask your doctor or nurse.
Like all medicines, Calcium Polystyrene Sulfonate powder can cause side effects, although not everybody gets them.
Stop taking Calcium Polystyrene Sulfonate powder immediately and see a doctor or go to hospital straightaway if: • You have an allergic reaction. Signs of an allergic reaction include: a rash, itching, breathing or swallowing problems, swelling of your lips, face, throat or tongue.
Talk to your doctor or nurse straightaway 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: • 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.
• Feeling jittery, having fits or muscle cramps. This may be due to low levels of calcium or magnesium in your body.
• Increased thirst or needing to go to the toilet more often
• High blood pressure, kidney problems, heart problems or swelling in your limbs. This may be due to high levels of sodium in your body.
• Stomach upset, pain in your gut, narrowing or blockage of the gut
• Loss of appetite
• Feeling sick, being sick, constipation or diarrhoea
• 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 particles of this medicine.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the jar or carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Once opened use within 30 days.
The suspension should be prepared immediately before use.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
What Calcium Polystyrene Sulfonate powder contains • Each 100g of Calcium Polystyrene Sulfonate powder contains 99.934g of calcium polystyrene sulfonate.
• The other ingredients are: vanillin and saccharin.
What Calcium Polystyrene Sulfonate powder looks like and contents of the pack Calcium Polystyrene Sulfonate powder is a cream or light brown coloured, fine powder.
Calcium Polystyrene Sulfonate powder is packed in jars containing 300g of powder with a plastic spoon, which, when filled level, contains approximately 15g of powder.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
ROMA Pharmaceuticals Limited
Gibraltar House
Centrum 100
Burton-upon-Trent
DE14 2WE
email: [email protected] Formats suitable for the blind and partially sighted are available on request from the Marketing Authorisation Holder
Manufacturer
LABOMED PHARMACEUTICAL COMPANY S.A.
84, Ioannou Metaxa Str.
Koropi
Attica, 19441
Greece
This leaflet was last revised in August 2023.
Roma Pharmaceuticals Limited
Address
Gibraltar House, Crown Square, First Avenue, Centrum 100, Burton upon Trent, Staffordshire, DE14 2WE
Telephone
01283 890091
Medical Information e-mail
[email protected]
Stock Availability
[email protected]
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http://www.romapharma.co.uk/
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Calcium Polystyrene Sulfonate 99.934% w/w Powder for Oral/Rectal Suspension comes as powder containing 99.934%. 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 99.934% w/w Powder for Oral/Rectal Suspension is calcium polystyrene sulfonate.
Medicines with the same active substance include: Calcium Polystyrene Sulfonate 99.75% 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 99.934% w/w 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 associated with anuria or severe oliguria. It is also used to treat hyperkalaemia in patients requiring dialysis and in patients on regular haemodialysis or on prolonged peritoneal dialysis.
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 15g 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 4ml per gram of resin.
Administer Calcium Polystyrene Sulfonate at least 3 hours before or 3 hours after other oral medications. For patients with gastroparesis, a 6 hour separation should be considered.
Rectal
This route should be reserved for the patient who is vomiting or who has upper gastrointestinal tract problems, including paralytic ileus. It may be used simultaneously with the oral route for more rapid initial results or in patients with gastroparesis, who have other orally administered medications that are administered within 6 hours of Calcium Polysterene Sulfonate. The resin may be given rectally as a suspension of 30g resin in 150ml 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 a 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.
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 1g/kg body weight daily in divided doses, in acute hyperkalaemia. Dosage may be reduced to 0.5g/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 0.5g/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 5mmol/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.
Orally administered medications: Calcium Polystyrene Sulfonate has the potential to bind to other orally administered medications. Binding of Calcium Polystyrene Sulfonate to other oral medications could cause decrease in their gastrointestinal absorption and efficacy. Dosing separation of Calcium Polystyrene Sulfonate from other orally administered medications is recommended.
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 Special warnings and precautions for use and Section 4.8 Undesirable effects).
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 Special warnings and precautions for use).
Lithium: Possible decrease of lithium absorption.
Levothyroxine: Possible decrease of levothyroxine absorption.
Pregnancy
There are no or limited data from the use of Calcium Polystyrene Sulfonate in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Calcium Polystyrene Sulfonate is not recommended during pregnancy.
Breast-feeding
It is unknown whether Calcium Polystyrene Sulfonate metabolites are excreted in human milk. A risk to newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Calcium Polystyrene Sulfonate therapy taking into account the benefit of breast-feeding for the child and the benefit of treatment for the woman.
Fertility
There are no or limited data from the use of Calcium Polystyrene Sulfonate in fertility.
There are no specific warnings.
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 99.934% w/w 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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