SORBISTERIT POWDER FOR ORAL/RECTAL SUSPENSION
Active substance: CALCIUM POLYSTYRENE SULPHONATE
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Package leaflet: information for the user
Sorbisterit
Powder for oral/rectal suspension Calcium polystyrene sulphonate
Read all of this leaflet carefully before you start taking this medicine.
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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
1. What Sorbisterit is and what Sorbisterit 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. 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 (hypersensitive) to calcium polystyrene sulphonate or any of the other ingredients of Sorbisterit 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
In this leaflet:
1. What Sorbisterit is and what it is used for 2. Before you use Sorbisterit 3. How to use Sorbisterit 4. Possible side effects 5. How to store Sorbisterit 6. Further information
Take special care with Sorbisterit if it is to be taken orally. You must take it sitting upright to prevent inhalation of the liquid. if you are constipated, you must tell your doctor before you are taking this medicinal product. if you are taking other medicines: see Using other medicines 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.
Using other medicines Please tell your doctor if you are taking or have recently taken other medicines, including medicines obtained without a prescription. 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.
Taking 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 You should not use Sorbisterit during pregnancy or breast-feeding unless its use is considered essential by your doctor. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines There are no known effects on the ability to drive or use machines.
Important information about some of the ingredients of Sorbisterit 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 Sorbisterit exactly as your doctor has told you. You should 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 usual 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, stirred into approximately 150 ml of liquid.
This preparation is taken in at least three divided doses over a period of 24 hours. Suitable liquids are water, tea or soft drinks. Sorbisterit must be taken 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. The dosage is the same as for oral use.
Dilution takes place in exactly the same way as already described for use in adults. Six hours after introduction into the anus, the colon should be irrigated to remove the resin. 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. 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 overdose 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 of Sorbisterit to make up for a forgotten dose. If you stop taking Sorbisterit This may lead to an increase in the potassium content of the blood.
4. Possible side effects
Like all medicines, Sorbisterit can cause side effects, although not everybody gets them. Assessment of side effects was based on the following frequency data: very common: more than 1 per 10 treated subjects
rare:
less than 1 per 1,000 but more than 1 per 10,000 treated subjects less than 1 per 10,000 treated subjects, including isolated reports cannot be estimated from the available data
very rare:
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-birthweight premature and newborn 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 Sorbisterit In case of oral use, you may have difficulties swallowing the rather large amount of dissolved powder. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Sorbisterit
Keep out of the reach and sight 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. Expiry date after first opening: three months Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further 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 look 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 MA Holder: Fresenius Medical Care Nephrologica Deutschland GmbH
Manufacturer: Fresenius Medical Care Deutschland GmbH 61346 Bad Homburg v.d.H., Germany Local Representatives POM Fresenius Medical Care (UK) Ltd. Nunn Brook Road, Huthwaite Nottinghamshire NG17 2HU, England Tel.: 0044 (0) 1623445 100 Pharma-Cos Ltd Pharma-Cos House, Triq C.Portanier Santa Venera SVR 1732, Malta Tel.: +356 2144 1870
This medicinal product is authorised in the Member States of the EEA under the following names:
A Sorbisterit 1,8 mmol/g Pulver zur Herstellung einer Suspension zum Einnehmen oder einer Rektalsuspension B Sorbisterit, 1,8 mmol Ca/gram, poeder voor orale suspensie of suspensie voor rectaal gebruik CY GR Sorbisterit, / CZ Resical prek pro ppravu perorln nebo rektln suspenze D L Resical, Pulver zur Herstellung einer Suspension zum Einnehmen oder zur Herstellung einer Rektalsuspension DK Sorbisterit, pulver til oral suspension/rektal vske, suspension
not known:
common:
less than 1 per 10 but more than 1 per 100 treated subjects
uncommon:
less than 1 per 100 but more than 1 per 1,000 treated subjects
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
E Sorbisterit, polvo para suspensin oral/rectal EST Sorbisterit, suukaudse- vi rektaalsuspensiooni pulber F ResiKali, poudre pour suspension buvable ou rectale FIN Sorbisterit, jauhe oraalisuspensiota/ perruiskesuspensiota varten GB Sorbisterit, powder for oral/rectal suspension H Resical por belsleges szuszpenzihoz vagy vgblszuszpenzihoz I Sorbisterit, polvere per sospensione orale o per sospensione rettale IS Sorbisterit mixtruduft, dreifa/endaarmsdreifa, stofn LT Sorbisterit milteliai geriamajai/tiesiosios arnos suspensijai
LV Sorbisterit pulveris iekgi lietojamas vai rektls suspensijas pagatavoanai M Sorbisterit N Sorbisterit, pulver til mikstur/rektalvske, suspensjon NL Sorbisterit, poeder voor orale/rectale suspensie 90 % m/m P Resical, p para suspenso oral/rectal PL Sorbisterit, proszek do sporzdzania zawiesiny doustnej lub doodbytniczej S Sorbisterit, pulver till oral/rektal suspension SK Sorbisterit, prok na perorlnu/rektlnu suspenziu SLO Sorbisterit praek za peroralno/rektalno suspenzijo
This leaflet was last approved in December 2012 010M0104/03UK-M
Sorbisterit
Powder for oral/rectal suspension Calcium polystyrene sulphonate
Read all of this leaflet carefully before you start taking this medicine.
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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
1. What Sorbisterit is and what Sorbisterit 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. 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 (hypersensitive) to calcium polystyrene sulphonate or any of the other ingredients of Sorbisterit 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
In this leaflet:
1. What Sorbisterit is and what it is used for 2. Before you use Sorbisterit 3. How to use Sorbisterit 4. Possible side effects 5. How to store Sorbisterit 6. Further information
Take special care with Sorbisterit if it is to be taken orally. You must take it sitting upright to prevent inhalation of the liquid. if you are constipated, you must tell your doctor before you are taking this medicinal product. if you are taking other medicines: see Using other medicines 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.
Using other medicines Please tell your doctor if you are taking or have recently taken other medicines, including medicines obtained without a prescription. 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.
Taking 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 You should not use Sorbisterit during pregnancy or breast-feeding unless its use is considered essential by your doctor. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines There are no known effects on the ability to drive or use machines.
Important information about some of the ingredients of Sorbisterit 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 Sorbisterit exactly as your doctor has told you. You should 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 usual 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, stirred into approximately 150 ml of liquid.
This preparation is taken in at least three divided doses over a period of 24 hours. Suitable liquids are water, tea or soft drinks. Sorbisterit must be taken 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. The dosage is the same as for oral use.
Dilution takes place in exactly the same way as already described for use in adults. Six hours after introduction into the anus, the colon should be irrigated to remove the resin. 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. 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 overdose 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 of Sorbisterit to make up for a forgotten dose. If you stop taking Sorbisterit This may lead to an increase in the potassium content of the blood.
4. Possible side effects
Like all medicines, Sorbisterit can cause side effects, although not everybody gets them. Assessment of side effects was based on the following frequency data: very common: more than 1 per 10 treated subjects
rare:
less than 1 per 1,000 but more than 1 per 10,000 treated subjects less than 1 per 10,000 treated subjects, including isolated reports cannot be estimated from the available data
very rare:
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-birthweight premature and newborn 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 Sorbisterit In case of oral use, you may have difficulties swallowing the rather large amount of dissolved powder. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Sorbisterit
Keep out of the reach and sight 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. Expiry date after first opening: three months Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further 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 look 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 MA Holder: Fresenius Medical Care Nephrologica Deutschland GmbH
Manufacturer: Fresenius Medical Care Deutschland GmbH 61346 Bad Homburg v.d.H., Germany Local Representatives POM Fresenius Medical Care (UK) Ltd. Nunn Brook Road, Huthwaite Nottinghamshire NG17 2HU, England Tel.: 0044 (0) 1623445 100 Pharma-Cos Ltd Pharma-Cos House, Triq C.Portanier Santa Venera SVR 1732, Malta Tel.: +356 2144 1870
This medicinal product is authorised in the Member States of the EEA under the following names:
A Sorbisterit 1,8 mmol/g Pulver zur Herstellung einer Suspension zum Einnehmen oder einer Rektalsuspension B Sorbisterit, 1,8 mmol Ca/gram, poeder voor orale suspensie of suspensie voor rectaal gebruik CY GR Sorbisterit, / CZ Resical prek pro ppravu perorln nebo rektln suspenze D L Resical, Pulver zur Herstellung einer Suspension zum Einnehmen oder zur Herstellung einer Rektalsuspension DK Sorbisterit, pulver til oral suspension/rektal vske, suspension
not known:
common:
less than 1 per 10 but more than 1 per 100 treated subjects
uncommon:
less than 1 per 100 but more than 1 per 1,000 treated subjects
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
E Sorbisterit, polvo para suspensin oral/rectal EST Sorbisterit, suukaudse- vi rektaalsuspensiooni pulber F ResiKali, poudre pour suspension buvable ou rectale FIN Sorbisterit, jauhe oraalisuspensiota/ perruiskesuspensiota varten GB Sorbisterit, powder for oral/rectal suspension H Resical por belsleges szuszpenzihoz vagy vgblszuszpenzihoz I Sorbisterit, polvere per sospensione orale o per sospensione rettale IS Sorbisterit mixtruduft, dreifa/endaarmsdreifa, stofn LT Sorbisterit milteliai geriamajai/tiesiosios arnos suspensijai
LV Sorbisterit pulveris iekgi lietojamas vai rektls suspensijas pagatavoanai M Sorbisterit N Sorbisterit, pulver til mikstur/rektalvske, suspensjon NL Sorbisterit, poeder voor orale/rectale suspensie 90 % m/m P Resical, p para suspenso oral/rectal PL Sorbisterit, proszek do sporzdzania zawiesiny doustnej lub doodbytniczej S Sorbisterit, pulver till oral/rektal suspension SK Sorbisterit, prok na perorlnu/rektlnu suspenziu SLO Sorbisterit praek za peroralno/rektalno suspenzijo
This leaflet was last approved in December 2012 010M0104/03UK-M
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
