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CALCIUM RESONIUM POWDER

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Page 1

240 mm

10 mm

Calcium Resonium Powder
®

(calcium polystyrene sulphonate )

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 THE SIGHT AND REACH OF CHILDREN.

For oral or rectal administration after reconstitution.
Calcium Cycle Ion Exchange Resin
80mm

P

STORE IN A DRY PLACE

Flavoured powder form of calcium polystyrene sulphonate
for removing excess potassium from the body.

Procured from within the EU and repackaged by the
Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.
PL 15184/1188
Ecma: 6433213.00.00
Manufactured by
Sanofi Winthrop Industrie, 82, Avenue Raspail,
94255 Gentilly, France.

Your medicines is called Calcium Resonium Powder, but will be referred to
as Calcium Resonium throughout this leaflet.

Calcium Resonium
300g powder

Calcium Resonium is a registered trademark of
Sanofi-Synthelabo Inc.

225 mm

Final cutter guide
Colour bleed
Maximum text area
Glue area - no print

Font Size - 20pt, 14pt, 10pt, 8pt & 7.5pt
Font - Arial
Leaflet Size - 80mm x 220mm
Colours 3 + Braille
PMS Progress Black
PMS 1785
PMS 285
Braille Magenta

The Braille on the carton label states:
Calcium Resonium
The imprint of the Braille code will not affect the legibility of the labels by
sighted people and that the labels will be the same (material, etc) as those
already approved by the MHRA.

Ref: 16/13/1188/CL/01

Page 8
®

Calcium Resonium Powder
(calcium polystyrene sulphonate )

SPINE

For oral or rectal administration after reconstitution.

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.

P

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Calcium Cycle Ion Exchange Resin

STORE IN A DRY PLACE

Flavoured powder form of calcium polystyrene sulphonate
for removing excess potassium from the body.

Procured from within the EU and repackaged by the
Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.
PL 15184/1188
Ecma: 6433213.00.00
Manufactured by
Sanofi Winthrop Industrie, 82, Avenue Raspail,
94255 Gentilly, France.

Your medicines is called Calcium Resonium Powder, but will be referred to
as Calcium Resonium throughout this leaflet.

300g powder

Calcium Resonium is a registered trademark of
Sanofi-Synthelabo Inc.

Ref: 12/13/1188/CL/01

Page 2

240 mm

PACKAGE LEAFLET:
INFORMATION FOR THE USER
Calcium Resonium® Powder
(calcium polystyrene sulphonate)

4. Possible side effects
5. How to store Calcium Resonium
6. Further information

Is this leaflet hard to see or read?
Phone 01527 505414 for help

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.

1. What Calcium Resonium is and what it is used for

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.

2. Before you are given Calcium Resonium
Do not use this medicine and tell your doctor or nurse if:
X 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
X You have been told that you have a low level of potassium in your blood

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

225 mm

Page 3

SPINE

80mm

X 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
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 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:
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.

220mm

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.

Page 4

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

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.

220mm

80mm

How much is normally given:
Adults (including the elderly)
By mouth
• The usual dose is 15g (one spoonful) three or four times a day

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

SPINE

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

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.

Page 5

SPINE

80mm

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

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.
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
If you stop being given Calcium Resonium
may be due to having low levels of potassium in your body
Keep having Calcium Resonium until your doctor tells you to stop. If you stop having Calcium
• Feeling jittery, having fits or muscle cramps. This may be due to low levels of calcium or
Resonium, your illness may come back.
magnesium in your body
Blood Tests
• Increased thirst or needing to go to the toilet more often
Your doctor may do regular blood tests while you are taking this medicine. This is to check
• High blood pressure, kidney problems, heart problems or swelling in your limbs. This
the levels of salts (potassium, sodium, calcium and magnesium) in your blood.
may be due to high levels of sodium in your body
• Stomach upset, pain in your gut or blockage of the gut
If you have any further questions on the use of this product, ask your doctor, nurse
• Severe abdominal (tummy) pain, or collapse
or pharmacist.
• Loss of appetite
• Feeling sick, being sick, constipation or diarrhoea

220mm

Page 6

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 (see details below). By reporting side effects you can help
provide more information on the safety of this medicine.

Keep out of the sight and reach of children
Do not store above 25°C. 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.
If your powder become discoloured or show any other signs of deterioration, consult
your pharmacist who will tell you what to do.
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.

United Kingdom
The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

6. Further Information
What Calcium Resonium contains
Each gram contains 99.934% w/w of calcium polystyrene sulphonate as the active ingredient.
The other ingredients: vanillin and saccharin.
What Calcium Resonium looks like and contents of the pack
Calcium Resonium is a yellow powder in a tamper evident white plastic container with
measuring spoon. Calcium Resonium is available in containers of 300g.

220mm

80mm

5. How to store Calcium Resonium

SPINE

• 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

Manufacturer and Licence Holder:
Manufactured by Sanofi Winthrop Industrie, 82, Avenue Raspail, 94255 Gentilly,
France and procured from within the EU and repackaged by the Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist.
They will have additional information about this medicine and will be able to advise you.

P
PL 15184/1188
Calcium Resonium is a registered trademark of Sanofi-Synthelabo Inc.
Revision date: 16/12/13

Page 9

80mm

SPINE

220mm

Page 1

240 mm

10 mm

Calcium Polystyrene
Sulphonate Powder

One level measuring spoon contains 15g of Calcium Polystyrene Sulphonate.
Always read the leaflet attached before use and for details of
P
dosage regime.
Use as directed by your doctor.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

For oral or rectal administration after reconstitution.
STORE IN A DRY PLACE

80mm

Calcium Cycle Ion Exchange Resin
Flavoured powder form of calcium polystyrene sulphonate
for removing excess potassium from the body.

Procured from within the EU and Re-packaged by the
Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.
PL 15184/1188
Ecma: 6433213.00.00
Manufactured by
Sanofi Winthrop Industrie, 82, Avenue Raspail,
94255 Gentilly, France.

Calcium Polystyrene
300g powder
Sulphonate
Your medicines is called Calcium Polystyrene Sulphonatel Powder, but will
be referred to as Calcium Polystyrene Sulphonate throughout this leaflet.

Ref: 16/13/1188/CL/02

225 mm

Final cutter guide
Colour bleed
Maximum text area
Glue area - no print

Font Size - 20pt, 14pt, 10pt, 8pt & 7.5pt
Font - Arial
Leaflet Size - 80mm x 220mm
Colours 3 + Braille
PMS Progress Black
PMS 1785
PMS 285
Braille Magenta

The Braille on the carton label states:
Calcium Polystyrene Sulphonate
The imprint of the Braille code will not affect the legibility of the labels by
sighted people and that the labels will be the same (material, etc) as those
already approved by the MHRA.

Page 7

Calcium Polystyrene
Sulphonate Powder

One level measuring spoon contains 15g of Calcium Polystyrene Sulphonate.
Always read the leaflet attached before use and for details of
P
dosage regime.
Use as directed by your doctor.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

SPINE

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.
Your medicines is called Calcium Polystyrene Sulphonatel Powder, but will
be referred to as Calcium Polystyrene Sulphonate throughout this leaflet.

300g powder

STORE IN A DRY PLACE
Procured from within the EU and Re-packaged by the
Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.
PL 15184/1188
Ecma: 6433213.00.00
Manufactured by
Sanofi Winthrop Industrie, 82, Avenue Raspail,
94255 Gentilly, France.
Ref: 16/13/1188/CL/02

Page 2

240 mm
4. Possible side effects
5. How to store Calcium Polystryrene Sulphonate
6. Further information

PACKAGE LEAFLET:
INFORMATION FOR THE USER
Calcium Polystryrene Sulphonate Powder

1. What Calcium Polystryrene Sulphonate is and what it is used for

Is this leaflet hard to see or read?
Phone 01527 505414 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.

Calcium Polystryrene Sulphonate contains a medicine called calcium polystyrene sulphonate. This belongs
to a group of medicines called ‘ion exchange resins’.
Calcium Polystryrene Sulphonate 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 Polystryrene Sulphonate

• 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.

Do not use this medicine and tell your doctor or nurse if:

In this leaflet:
1. What Calcium Polystryrene Sulphonate is and what it is used for
2. Before you are given Calcium Polystryrene Sulphonate
3. How Calcium Polystryrene Sulphonate is given

X 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
X You have been told that you have a low level of potassium in your blood

225 mm

Page 3

SPINE

80mm

X 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
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 Calcium Polystryrene
Sulphonate at the same time can cause severe damage to your gut. You must not
take any sorbitol whilst using Calcium Polystryrene Sulphonate.
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 Polystryrene Sulphonate.
Take special care and check with your doctor, nurse or pharmacist before
using Calcium Polystryrene Sulphonate if:
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 Polystryrene Sulphonate.

220mm

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 Polystryrene Sulphonate can affect the way other
medicines work. Also some medicines can affect the way Calcium Polystryrene Sulphonate 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 Polystryrene Sulphonate.
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.

Page 4
3. How Calcium Polystryrene Sulphonate is given
Your doctor or nurse will normally give you this medicine. If you are not sure why you are
being given Calcium Polystryrene Sulphonate or have any questions about how much Calcium
Polystryrene Sulphonate 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

New-born babies
Calcium Polystryrene Sulphonate 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 Polystryrene Sulphonate 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.

220mm

80mm

How much is normally given:
Adults (including the elderly)
By mouth
• The usual dose is 15g (one spoonful) three or four times a day

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

SPINE

Having the medicine
• Calcium Polystryrene Sulphonate 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

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.

Page 5

SPINE

80mm

If you are given too much Calcium Polystryrene Sulphonate 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 Polystryrene Sulphonate 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

If you miss a dose of Calcium Polystryrene Sulphonate
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.
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
If you stop being given Calcium Polystryrene Sulphonate
may be due to having low levels of potassium in your body
Keep having Calcium Polystryrene Sulphonate until your doctor tells you to stop. If you stop
• Feeling jittery, having fits or muscle cramps. This may be due to low levels of calcium or
having Calcium Polystryrene Sulphonate, your illness may come back.
magnesium in your body
Blood Tests
• Increased thirst or needing to go to the toilet more often
Your doctor may do regular blood tests while you are taking this medicine. This is to check
• High blood pressure, kidney problems, heart problems or swelling in your limbs. This
the levels of salts (potassium, sodium, calcium and magnesium) in your blood.
may be due to high levels of sodium in your body
• Stomach upset, pain in your gut or blockage of the gut
If you have any further questions on the use of this product, ask your doctor, nurse
• Severe abdominal (tummy) pain, or collapse
or pharmacist.
• Loss of appetite
• Feeling sick, being sick, constipation or diarrhoea

220mm

Page 7

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 (see details below). By reporting side effects you can help
provide more information on the safety of this medicine.

Keep out of the sight and reach of children.
Do not store above 25°C. Store in a dry place.
Do not use Calcium Polystryrene Sulphonate after the expiry date which is stated on the container. The
expiry date refers to the last date of that month.
If your powder become discoloured or show any other signs of deterioration, consult
your pharmacist who will tell you what to do.
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.

United Kingdom
The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

6. Further Information
What Calcium Polystryrene Sulphonate contains
Each gram contains 99.934% w/w of calcium polystyrene sulphonate as the active ingredient.
The other ingredients: vanillin and saccharin.
What Calcium Polystryrene Sulphonate looks like and contents of the pack
Calcium Polystryrene Sulphonate is a yellow powder in a tamper evident white plastic container
with measuring spoon. Calcium Polystryrene Sulphonate is available in containers of 300g.

220mm

80mm

5. How to store Calcium Polystryrene Sulphonate

SPINE

• 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

Manufacturer and Licence Holder:
Manufactured by Sanofi Winthrop Industrie, 82, Avenue Raspail, 94255 Gentilly,
France and procured from within the EU and repackaged by the Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist.
They will have additional information about this medicine and will be able to advise you.

P
PL 15184/1188
Revision date: 16/12/13

Page 8

80mm

SPINE

220mm

Expand Transcript

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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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