CALCIUM RESONIUM 99.934% W/W POWDER FOR ORAL/RECTAL SUSPENSION
Active substance: CALCIUM POLYSTYRENE SULPHONATE
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482304
Calcium Resonium 99.934% w/w Powder for Oral/Rectal Suspension
calcium polystyrene sulphonate Ink jet printing area
For oral or rectal administration after reconstitution. Calcium Cycle Ion Exchange Resin Flavoured powder form of calcium polystyrene sulphonate for removing excess potassium from the body.
calcium resonium
300g powder
One level measuring spoon contains 15g of Calcium Resonium. Always read the leaflet attached before use and for details of dosage regime. Use as directed by your doctor. KEEP OUT OF SIGHT AND REACH OF CHILDREN STORE IN A DRY PLACE MA Holder: Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK PL: 04425/0620 Malta MA: 082/04101 MAH: Sanofi-Aventis Malta Triq Kan. K. Pirotta, BKara, BKR 1114, Malta Sanofi UK and Sanofi-Aventis Malta are members of the Sanofi Group.
*482304*
482304
Calcium Resonium 99.934% w/w Powder for Oral/Rectal Suspension
calcium polystyrene sulphonate
For oral or rectal administration after reconstitution. Calcium Cycle Ion Exchange Resin Flavoured powder form of calcium polystyrene sulphonate for removing excess potassium from the body.
300g powder
One level measuring spoon contains 15g of Calcium Resonium. Always read the leaflet attached before use and for details of dosage regime. Use as directed by your doctor. KEEP OUT OF SIGHT AND REACH OF CHILDREN STORE IN A DRY PLACE MA Holder: Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK PL: 04425/0620 Malta MA: 082/04101 MAH: Sanofi-Aventis Malta Triq Kan. K. Pirotta, BKara, BKR 1114, Malta Sanofi UK and Sanofi-Aventis Malta are members of the Sanofi Group.
5:AKKCIN=ZU[VXX:>
Braille :
calcium resonium
5:AKKCIN=ZU[VXX:>
PACKAGE LEAFLET: INFORMATION FOR THE USER Calcium Resonium 99.934% w/w Powder for Oral/Rectal Suspension calcium polystyrene sulphonate
Is this leaflet hard to see or read? Phone 01483 505515 for help
Read all of this leaflet carefully 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, nurse or pharmacist. This medicine is only 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, nurse or pharmacist. In this leaflet: 1. What Calcium Resonium is and what it is used for 2. Before you are given Calcium Resonium 3. How Calcium Resonium is given 4. Possible side effects
5. How to store Calcium Resonium 6. Further information 1. What Calcium Resonium is and what it is used for Calcium Resonium contains a medicine called calcium polystyrene sulphonate. This belongs to a group of medicines called ion exchange resins. Calcium Resonium is used to treat something called hyperkalaemia. This is when there is too much potassium in your blood. 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. Before you are given Calcium Resonium Do not use this medicine and tell your doctor or nurse if: You are allergic (hypersensitive) to calcium polystyrene sulphonate or any of the other ingredients in this medicine (listed in section 6 Further Information). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue You have been told that you have a low level of potassium in your blood You have been told you have problems that result in high levels of calcium in your body such as thyroid problems or some types of cancer
Your gut is partially or completely blocked (obstructive bowel disease) You are taking a sweetener called sorbitol (a sugar-free sweetener used to sweeten food). This is because taking sorbitol and Calcium Resonium at the same time can cause severe damage to your gut. You must not take any sorbitol whilst using Calcium Resonium. Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor, nurse or pharmacist before using Calcium Resonium. Take special care and check with your doctor, nurse or pharmacist before using Calcium Resonium if: p It is for your baby, and they were premature, had a low birth-weight or have reduced gut movement If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before using Calcium Resonium. Taking other medicines Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you can buy without prescription, including herbal medicines. This is because Calcium Resonium can affect the way other medicines work. Also some medicines can affect the way Calcium Resonium works. In particular, check with your doctor if you are taking the following medicines:
Medicines that contain salts such as magnesium, potassium or calcium. Ask your doctor if you are not sure Some medicines for constipation (laxatives) that contain magnesium Some 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 If you are not sure if any of the above applies to you, talk to your doctor, nurse or pharmacist before using Calcium Resonium. Pregnancy and breast-feeding Talk to your doctor before using this medicine if: You are pregnant, might become pregnant, or think you may be pregnant You are breast-feeding or planning to breast-feed Ask your doctor or pharmacist for advice before taking any medicine. 3. How Calcium Resonium is given Your doctor or nurse will normally give you this medicine. If you are not sure why you are being given Calcium Resonium or have any questions about how much Calcium Resonium is being given to you, speak to your doctor, nurse or pharmacist.
The dose will depend on the results of blood tests For children the dose is also worked out according to how much the child weighs Having the medicine Calcium Resonium can be given by mouth or put into the back passage (rectum) If given by mouth the powder can be swallowed with a little water or be made into a paste with something sweet, such as jam or honey It should not be mixed with fruit juice, this will stop the medicine working properly If given by mouth, it is important to sit up while taking the medicine so that you do not breathe in any powder into your lungs If given by the back passage you should try to keep the medicine in your back passage for at least 9 hours. Then it needs to be thoroughly washed out How much is normally given: Adults (including the elderly) By mouth The usual dose is 15g (one spoonful) three or four times a day Into the back passage The usual dose is 30g (two spoonfuls) once a day
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 If your child cannot take the medicine by mouth, it may be given into the back passage. The daily dose is 1g for each kilogram of bodyweight Once the medicine has started working the dose may be lowered to 0.5g daily for each kilogram of bodyweight New-born babies Calcium Resonium is only given into the back passage The daily dose is between 0.5g and 1g for each kilogram of bodyweight It is important to give the right dose for children and babies. If too much is given, children and babies could get serious constipation. If you have more Calcium Resonium 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. Ask them if you are not sure why you are getting a dose of medicine. If you are given too much Calcium Resonium the following effects may happen: Feeling irritable or confused
Being unable to concentrate Muscle weakness and poor reflexes leading to paralysis Breathing problems Faster or pounding heartbeat Muscle cramps
4. Possible side effects Like all medicines, Calcium Resonium can cause side effects, although not everybody gets them. Tell a doctor or nurse straight away if you notice any of the following serious side effects: You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue Blood in your sick (vomit) or black tarry stools 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 or blockage of the gut Severe abdominal (tummy) pain, or collapse Loss of appetite Feeling sick, being sick, constipation or diarrhoea
If you miss a dose of Calcium Resonium 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. If you stop being given Calcium Resonium Keep having Calcium Resonium until your doctor tells you to stop. If you stop having Calcium Resonium, your illness may come back. Blood Tests Your doctor may do regular blood tests while you are taking this medicine. This is to check the levels of salts (potassium, sodium, calcium and magnesium) in your blood. If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.
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 this medicine Talk to your doctor, nurse or pharmacist if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet. 5. How to store Calcium Resonium This medicine will be kept by your doctor or pharmacist in a safe place where children cannot see or reach it. Store in a dry place. Do not use Calcium Resonium after the expiry date which is stated on the container. The expiry date refers to the last date of that month. 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 Calcium Resonium contains 99.934% w/w of the active substance, calcium polystyrene sulphonate The other ingredients are saccharin and vanillin
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK Tel: 01483 505515 Fax: 01483 535432 email: uk-medicalinformation@sanofi.com Manufacturer Sanofi Winthrop Industrie, 196 avenue du Marchal Juin, 45200 Amilly, France This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor, nurse or pharmacist. This leaflet was last revised in 08/2012 Sanofi 1990 - 2012
482304
What Calcium Resonium looks like and contents of the pack Calcium Resonium is a cream or light brown coloured, fine powder. It is supplied in containers of 300g with a 15g scoop.
Calcium Resonium 99.934% w/w Powder for Oral/Rectal Suspension
calcium polystyrene sulphonate Ink jet printing area
For oral or rectal administration after reconstitution. Calcium Cycle Ion Exchange Resin Flavoured powder form of calcium polystyrene sulphonate for removing excess potassium from the body.
calcium resonium
300g powder
One level measuring spoon contains 15g of Calcium Resonium. Always read the leaflet attached before use and for details of dosage regime. Use as directed by your doctor. KEEP OUT OF SIGHT AND REACH OF CHILDREN STORE IN A DRY PLACE MA Holder: Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK PL: 04425/0620 Malta MA: 082/04101 MAH: Sanofi-Aventis Malta Triq Kan. K. Pirotta, BKara, BKR 1114, Malta Sanofi UK and Sanofi-Aventis Malta are members of the Sanofi Group.
*482304*
482304
Calcium Resonium 99.934% w/w Powder for Oral/Rectal Suspension
calcium polystyrene sulphonate
For oral or rectal administration after reconstitution. Calcium Cycle Ion Exchange Resin Flavoured powder form of calcium polystyrene sulphonate for removing excess potassium from the body.
300g powder
One level measuring spoon contains 15g of Calcium Resonium. Always read the leaflet attached before use and for details of dosage regime. Use as directed by your doctor. KEEP OUT OF SIGHT AND REACH OF CHILDREN STORE IN A DRY PLACE MA Holder: Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK PL: 04425/0620 Malta MA: 082/04101 MAH: Sanofi-Aventis Malta Triq Kan. K. Pirotta, BKara, BKR 1114, Malta Sanofi UK and Sanofi-Aventis Malta are members of the Sanofi Group.
5:AKKCIN=ZU[VXX:>
Braille :
calcium resonium
5:AKKCIN=ZU[VXX:>
PACKAGE LEAFLET: INFORMATION FOR THE USER Calcium Resonium 99.934% w/w Powder for Oral/Rectal Suspension calcium polystyrene sulphonate
Is this leaflet hard to see or read? Phone 01483 505515 for help
Read all of this leaflet carefully 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, nurse or pharmacist. This medicine is only 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, nurse or pharmacist. In this leaflet: 1. What Calcium Resonium is and what it is used for 2. Before you are given Calcium Resonium 3. How Calcium Resonium is given 4. Possible side effects
5. How to store Calcium Resonium 6. Further information 1. What Calcium Resonium is and what it is used for Calcium Resonium contains a medicine called calcium polystyrene sulphonate. This belongs to a group of medicines called ion exchange resins. Calcium Resonium is used to treat something called hyperkalaemia. This is when there is too much potassium in your blood. 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. Before you are given Calcium Resonium Do not use this medicine and tell your doctor or nurse if: You are allergic (hypersensitive) to calcium polystyrene sulphonate or any of the other ingredients in this medicine (listed in section 6 Further Information). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue You have been told that you have a low level of potassium in your blood You have been told you have problems that result in high levels of calcium in your body such as thyroid problems or some types of cancer
Your gut is partially or completely blocked (obstructive bowel disease) You are taking a sweetener called sorbitol (a sugar-free sweetener used to sweeten food). This is because taking sorbitol and Calcium Resonium at the same time can cause severe damage to your gut. You must not take any sorbitol whilst using Calcium Resonium. Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor, nurse or pharmacist before using Calcium Resonium. Take special care and check with your doctor, nurse or pharmacist before using Calcium Resonium if: p It is for your baby, and they were premature, had a low birth-weight or have reduced gut movement If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before using Calcium Resonium. Taking other medicines Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you can buy without prescription, including herbal medicines. This is because Calcium Resonium can affect the way other medicines work. Also some medicines can affect the way Calcium Resonium works. In particular, check with your doctor if you are taking the following medicines:
Medicines that contain salts such as magnesium, potassium or calcium. Ask your doctor if you are not sure Some medicines for constipation (laxatives) that contain magnesium Some 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 If you are not sure if any of the above applies to you, talk to your doctor, nurse or pharmacist before using Calcium Resonium. Pregnancy and breast-feeding Talk to your doctor before using this medicine if: You are pregnant, might become pregnant, or think you may be pregnant You are breast-feeding or planning to breast-feed Ask your doctor or pharmacist for advice before taking any medicine. 3. How Calcium Resonium is given Your doctor or nurse will normally give you this medicine. If you are not sure why you are being given Calcium Resonium or have any questions about how much Calcium Resonium is being given to you, speak to your doctor, nurse or pharmacist.
The dose will depend on the results of blood tests For children the dose is also worked out according to how much the child weighs Having the medicine Calcium Resonium can be given by mouth or put into the back passage (rectum) If given by mouth the powder can be swallowed with a little water or be made into a paste with something sweet, such as jam or honey It should not be mixed with fruit juice, this will stop the medicine working properly If given by mouth, it is important to sit up while taking the medicine so that you do not breathe in any powder into your lungs If given by the back passage you should try to keep the medicine in your back passage for at least 9 hours. Then it needs to be thoroughly washed out How much is normally given: Adults (including the elderly) By mouth The usual dose is 15g (one spoonful) three or four times a day Into the back passage The usual dose is 30g (two spoonfuls) once a day
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 If your child cannot take the medicine by mouth, it may be given into the back passage. The daily dose is 1g for each kilogram of bodyweight Once the medicine has started working the dose may be lowered to 0.5g daily for each kilogram of bodyweight New-born babies Calcium Resonium is only given into the back passage The daily dose is between 0.5g and 1g for each kilogram of bodyweight It is important to give the right dose for children and babies. If too much is given, children and babies could get serious constipation. If you have more Calcium Resonium 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. Ask them if you are not sure why you are getting a dose of medicine. If you are given too much Calcium Resonium the following effects may happen: Feeling irritable or confused
Being unable to concentrate Muscle weakness and poor reflexes leading to paralysis Breathing problems Faster or pounding heartbeat Muscle cramps
4. Possible side effects Like all medicines, Calcium Resonium can cause side effects, although not everybody gets them. Tell a doctor or nurse straight away if you notice any of the following serious side effects: You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue Blood in your sick (vomit) or black tarry stools 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 or blockage of the gut Severe abdominal (tummy) pain, or collapse Loss of appetite Feeling sick, being sick, constipation or diarrhoea
If you miss a dose of Calcium Resonium 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. If you stop being given Calcium Resonium Keep having Calcium Resonium until your doctor tells you to stop. If you stop having Calcium Resonium, your illness may come back. Blood Tests Your doctor may do regular blood tests while you are taking this medicine. This is to check the levels of salts (potassium, sodium, calcium and magnesium) in your blood. If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.
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 this medicine Talk to your doctor, nurse or pharmacist if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet. 5. How to store Calcium Resonium This medicine will be kept by your doctor or pharmacist in a safe place where children cannot see or reach it. Store in a dry place. Do not use Calcium Resonium after the expiry date which is stated on the container. The expiry date refers to the last date of that month. 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 Calcium Resonium contains 99.934% w/w of the active substance, calcium polystyrene sulphonate The other ingredients are saccharin and vanillin
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK Tel: 01483 505515 Fax: 01483 535432 email: uk-medicalinformation@sanofi.com Manufacturer Sanofi Winthrop Industrie, 196 avenue du Marchal Juin, 45200 Amilly, France This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor, nurse or pharmacist. This leaflet was last revised in 08/2012 Sanofi 1990 - 2012
482304
What Calcium Resonium looks like and contents of the pack Calcium Resonium is a cream or light brown coloured, fine powder. It is supplied in containers of 300g with a 15g scoop.
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.
