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Calcium Polystyrene Sulfonate 99.934% w/w Powder for Oral/Rectal Suspension

Active Ingredient:
calcium polystyrene sulfonate
Company:  
Roma Pharmaceuticals Limited See contact details
ATC code: 
V03AE01
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About Medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 25 Oct 2023

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 49578/0011 .

Calcium Polystyrene Sulfonate 99.934% w/w Powder for Oral/Rectal Suspension

Package leaflet: Information for the user

Calcium Polystyrene Sulfonate 99.934% w/w

Powder for Oral/Rectal Suspension

Calcium polystyrene sulfonate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Calcium Polystyrene Sulfonate powder is and what it is used for
2. What you need to know before you take Calcium Polystyrene Sulfonate powder
3. How to take Calcium Polystyrene Sulfonate powder
4. Possible side effects
5. How to store Calcium Polystyrene Sulfonate powder
6. Contents of the pack and other information

1. WHAT CALCIUM POLYSTYRENE SULFONATE POWDER IS AND WHAT IT IS USED FOR

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.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCIUM POLYSTYRENE SULFONATE POWDER
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.

3. HOW TO TAKE CALCIUM POLYSTYRENE SULFONATE POWDER

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.

4. POSSIBLE SIDE EFFECTS

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.

5. HOW TO STORE CALCIUM POLYSTYRENE SULFONATE POWDER

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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
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

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
Company image
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]