Package leaflet:

Information for the user

Sorbisterit®,

powder for oral/rectal suspension

Calcium polystyrene sulphonate

What is in this leaflet

1.    What Sorbisterit® is and what it is used for

2.    What you need to know before you use Sorbisterit®

3.    How to use Sorbisterit®

4.    Possible side effects

5.    How to store Sorbisterit®

6.    Contents of the pack and other information

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 or pharmacist.

-    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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Sorbisterit® is and what it is used for

Sorbisterit® is used in the treatment of hyperkalaemia (raised blood potassium content), in patients who have kidney problems and those on dialysis (removal of waste products from the blood).

Sorbisterit® is a cation exchange resin (insoluble structure which releases certain ions in exchange for other ions) that exchanges potassium for calcium in the gut. As a result, it reduces the uptake of potassium into the blood.

2. What you need to know before you use Sorbisterit®

Do not use Sorbisterit®

-    if your blood contains too little potassium, manifested in a severe form by muscle cramps or muscle weakness and fatigue

-    if your blood contains too much calcium

-    if you are allergic to calcium polystyrene sulphonate or any of the other ingredients of this medicine (listed in section 6)

-    if you suffer from constipation or complete blockage of the bowel

-    concomitant administration of sorbitol (a laxative)

-    in newborn babies by the oral route

-    in newborn babies with constipation

Warnings and precautions

Talk to your doctor or pharmacist before using Sorbisterit®

-    if used orally. You must use it sitting upright to prevent inhalation of the liquid.

-    if you are constipated, you must tell your doctor before using this medicinal product.

The electrolyte content of your blood must be checked daily.

Ask your doctor for advice if any of the above warnings applies to you now or has done so in the past.

Children

Special care is necessary when used in children and newborn babies, as too high a dosage or incorrect dilution may cause the resin to have too strong an effect. Particular caution is necessary in subjects with a low body weight especially neonates on account of gastrointestinal haemorrhages and the risk of death (necrosis of the colon).

Other medicines and Sorbisterit®

Tell your doctor if you are taking, have recently taken or might take any other medicines.

You should consult your doctor particularly if you are taking medicines that increase the efficiency of the heart, such as digoxin (cardiac glycosides), as their action may be enhanced;

medicines that remove fluid from tissues, such as hydrochlorothiazide (thiazide diuretics) or furosemide and torasemide (loop diuretics);

sorbitol must not be used as a laxative, as there is a risk of injury of the colon (necrosis);

potassium-containing medicines;

-    medicines to treat heartburn or laxatives, such as magnesium hydroxide, aluminium hydroxide or calcium carbonate.

These medicines and Sorbisterit® should be used at least three hours apart.

-    oral tetracycline, an antibiotic, as its effect is reduced by Sorbisterit®;

-    L-thyroxine: Sorbisterit® reduces the uptake and consequently the effect of this thyroid medicine. You must take L-thyroxine several hours after using Sorbisterit®.

-    lithium: an antidepressant, as its uptake may be reduced by Sorbisterit®.

- certain medicines which affect the nerve cells or nerve fibers

(anticholinergics) as there is an increased risk of side effects of Sorbisterit® on the stomach.

Sorbisterit® with food and drink

Sorbisterit® must not be used with fruit juices (e.g. pineapple, grapefruit, orange, tomato or grape juice) rich in potassium, as this may adversely affect the action of Sorbisterit®.

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 or pharmacist for advice before using this medicine.

You should not use Sorbisterit® during pregnancy or breast-feeding unless its use is considered essential by your doctor.

Driving and using machines

There are no known effects on the ability to drive or use machines.

Sorbisterit® contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to use Sorbisterit®

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

The necessary duration of treatment is dependent on the daily measurements of the potassium level in the blood.

The recommended dose is:

Oral use

- Adults and the elderly:

1 measuring spoonful (20 g powder)

1 - 3 times daily, stirred into approximately 150 ml of liquid.

-    Children:

0.5-1 g powder per kilogram of body weight per day, stirred into approximately 150 ml of liquid. This preparation is used in at least three divided doses over a period of 24 hours.

Suitable liquids are water, tea or soft drinks. Sorbisterit® must be used with the main meals with the upper body in an upright position.

Rectal use

-    Adults and the elderly:

After using an enema, 2 measuring spoonfuls of Sorbisterit® (40 g) are dispersed in 150 ml of 5% glucose solution and administered via the anus 1 - 3 times daily.

Retention time: 6 hours.

- Children:

Administration via the anus takes place if Sorbisterit® cannot be swallowed. 0.5-1 g powder per kilogram of body weight per day are dispersed in 150 ml of 5% glucose solution and administered in at least three divided doses over a period of 24 hours. Six hours after introduction into the anus, the colon should be irrigated to remove the resin.

If you feel that the effect of Sorbisterit® is too strong or too weak, ask your doctor or pharmacist for advice.

If you use more Sorbisterit® than you should

If you have used too much Sorbisterit®, tell your doctor or pharmacist immediately. In general, an over-dose of Sorbisterit® may lead to a reduced level of potassium in the blood (hypokalaemia) with symptoms of cramps, discomfort in the legs that is experienced while sitting still, extreme weakness of the body, and on occasion, paralysis. Abnormal heart beat may occur.

Other side effects of overdose may take the form of a raised calcium level in the blood (hypercalcaemia) with symptoms such as fatique, muscle weakness, frequent urination, constipation, abnormal heart beat, kidney failure or coma.

Further, an overdose may lead to constipation, complete bowel blockage and fluid accumulation.

If you forget to use Sorbisterit®

Ask your doctor or pharmacist for advice.

Do not take a double dose to make up for a forgotten dose.

If you stop using Sorbisterit®

This may lead to an increase in the potassium content of the blood.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Assessment of side effects was based on the following frequency data:

very common: may affect more than 1 per 10 people

common:    may affect up to 1 in

10 people

uncommon:    may affect up to 1 in

100 people

rare:    may affect up to 1 in

1,000 people

very rare:    may affect up to 1 in

10,000 people, including isolated reports

not known:    cannot be estimated from

the available data

common:

-    too much calcium in the blood

-    too little potassium in the blood, manifested in severe form by muscle cramps or muscle weakness and fatigue

-    too little magnesium in the blood

-    nausea

-    vomiting uncommon:

-    constipation

-    diarrhoea

-    stomach ulcers

-    injury of the colon, which may lead to perforation of the intestine

-    loss of appetite

-    bowel blockage

rare:

-    complete bowel blockage, resulting in severe cases from

- accumulation of the resin in the intestine

-    “thickening” of the stools after rectal use in children

-    formation of plugs after oral use in newborn babies

-    bleeding from the anus has been observed after rectal use in low-birth-weight premature and new born babies

very rare:

-    acute inflammation of the airways, manifested by coughing and bringing up of phlegm, and/or a particular type of pneumonia caused by inhalation of this medicine.

In case of oral use, you may have difficulties swallowing the rather large amount of dissolved powder.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

GB: the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard

M: ADR Reporting, The Medicines Authority, Post-Licensing Directorate,

203 Level 3, Rue, D’Argens, GZR-1368 Gzira, Website:

www.medicinesauthority.gov.mt,

e-mail:

postlicensing. medicinesauthority@gov.mt

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sorbisterit®

Keep this medicine out of the sight and reach of children.

Keep the container tightly closed in order to protect from moisture.

Do not use Sorbisterit® after the expiry date which is stated on the container after “EXP”. The expiry date refers to the last day of that month.

Expiry date after first opening: 3 months.

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 to protect the environment.

6. Contents of the pack and other information

What Sorbisterit® contains

-    The active substance is calcium polystyrene sulphonate.

1 g Sorbisterit® contains 759 to 949 mg calcium polystyrene sulphonate.

20 g Sorbisterit® contain 15.18 to 18.98 g calcium polystyrene sulphonate.

-    The other ingredients are sucrose and anhydrous citric acid.

What Sorbisterit® looks like and contents of the pack

Sorbisterit® is a cream to light brown fine powder and is available in a 500 g container with a measuring spoon.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Fresenius Medical Care Nephrologica Deutschland GmbH 61346 Bad Homburg v.d.H.,

Germany

Manufacturer:

Fresenius Medical Care Deutschland GmbH Else-Kroner-StraBe 1 61352 Bad Homburg v.d.H., Germany

Local representative

GB: Fresenius Medical Care (UK) Ltd Tel: +44 (0)1623 445100

M: Pharma-Cos Limited Telephone: (+356) 2144 1870

This leaflet was last revised in 10/2014.