Resonium A
Page 1 = Front
One level measuring spoon contains 15g of Resonium A.
Always read the leaflet attached before use and for details of dosage regime.
Use as directed by your doctor.
For oral or rectal administration after reconstitution. Sodium Cycle Ion Exchange Resin
Flavoured powder form of sodium polystyrene sulfonate for
removing excess potassium from the body.
• • • • •• •• •• •• • •
• • • • • • •.....
• • ••• • • •
454g powder SANOFI
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
MA Holder:
Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK PL 04425/0178
5 000283
506874 >
540177
02
£
Resonium A
sodium polystyrene sulfonate 99.934% w/w
For oral or rectal administration after reconstitution. Sodium Cycle Ion Exchange Resin
Flavoured powder form of sodium polystyrene sulfonate for removing excess potassium from the body.
454g powder SANOFI ^5
One level measuring spoon contains 15g of Resonium A.
Always read the leaflet attached before use and for details of dosage regime.
Use as directed by your doctor.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
MA Holder:
Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK PL 04425/0178
5
000283
506874
540177
>
r
PACKAGE LEAFLET: INFORMATION FOR THE USER
Resonium® A
sodium polystyrene sulfonate
Is this leaflet hard to see or read? Phone 0845 372 7101 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 Resonium A is and what it is used for
2. Before you are given Resonium A
3. How Resonium A is given
4. Possible side effects
5. How to store Resonium A
6. Further information
1. What Resonium A is and what it is used for
Resonium A contains a medicine called sodium polystyrene sulfonate. This belongs to a group of medicines called ‘ion exchange resins’.
Resonium A 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 Resonium A
Do not use this medicine and tell your doctor or nurse if:
x You are allergic (hypersensitive) to sodium polystyrene sulfonate or any of the other ingredients in this medicine (listed in section 6 below).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue x You have been told that you have a low level of potassium in your blood x Your gut is partially or completely blocked (obstructive bowel disease) x You are taking a sweetener called sorbitol (a «sugar-free» sweetener used to sweeten food). This is because taking sorbitol and Resonium A at the same time can cause narrowing of the gut wall (gastrointestinal stenosis) and reduced blood flow to the gut wall (intestinal ischemia) causing severe damage to your
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gut (necrosis and perforation). You must not take any sorbitol whilst using Resonium A.
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 Resonium A.
0Take special care and check with your doctor, nurse or pharmacist before using Resonium A if:
PYou have heart problems
PYou have high blood pressure
PYou have kidney problems
PYou have swelling in your arms or legs (oedema)
PIt 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 Resonium A.
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 Resonium A can affect the way other medicines work. Also some medicines can affect the way Resonium A 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 Resonium A.
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.
Your doctor or nurse will normally give you this medicine. If you are not sure why you are being given Resonium A or have any questions about how much Resonium A 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
• Resonium A 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
Resonium A 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 Resonium A 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 Resonium A 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
If you miss a dose of Resonium A
^ 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 Resonium A
Keep having Resonium A until your doctor tells you to stop. If you stop having Resonium A, 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.
Like all medicines, Resonium A 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
• 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
• Reduced blood flow to the gut wall causing severe abdominal (tummy) pain, or collapse
• 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 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
By reporting side effects you can help provide more information on the safety of this medicine.
What Resonium A looks like and contents of the pack
Resonium® A is a buff coloured powder. It is supplied in containers of 454g with a 15g scoop.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey, GUI 4YS, UK Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com Manufacturer
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 Resonium A 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.
Sanofi Winthrop Industrie, 196 avenue du Marechal 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.
What Resonium A contains
• 99.934% w/w of the active substance, sodium polystyrene sulfonate
• The other ingredients are saccharin and vanillin
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