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CALCIUM 500MG CHEWABLE TABLETS

Active substance(s): CALCIUM CARBONATE / CALCIUM CARBONATE / CALCIUM CARBONATE

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PATIENT INFORMATION LEAFLET

CALCICHEW® 500mg CHEWABLE TABLETS
(calcium carbonate)
equivalent to 500mg calcium
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
-

Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must talk to a doctor if you do not feel better or if you feel worse
after two weeks.
- 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.
The name of your medicine is CALCICHEW 500mg CHEWABLE
TABLETS but will be referred to as Calcichew throughout this leaflet.
In this leaflet:
1. What Calcichew is and what it is used for
2. What you need to know before you take Calcichew
3. How to take Calcichew
4. Possible side-effects
5. How to store Calcichew
6. Contents of the pack and other information
1. WHAT CALCICHEW IS AND WHAT IT IS USED FOR
Calcichew is orange flavoured chewable tablet containing the active
ingredient calcium. Calcium is found in the diet and is an important
substance in bone formation.
Calcichew is used to treat and prevent calcium deficiency which may
occur if your diet or lifestyle does not provide enough, or when body
requirements are increased. This medicine may also be prescribed or
recommended for certain bone conditions, for example osteoporosis, or
during pregnancy. It may also be given to patients receiving kidney
dialysis to remove the phosphate from the blood that cannot be removed
by dialysis.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCICHEW
Do not take Calcichew if you:
are allergic (hypersensitive) to calcium or any of the other ingredients
of this medicine (listed in section 6)
have a condition that causes excessive amounts of calcium in your
blood or urine (hypercalcaemia or hypercalciuria)
have kidney stones.
Warnings and precautions
Talk to your doctor or pharmacist before taking Calcichew:
if you have phenylketonuria (a deficiency in the enzyme which
breaks down phenylalanine) as these tablets contain aspartame, a
source of phenylalanine
if you have osteoporosis (brittle bones) and are also unable to
move around
if you are on long-term treatment, especially if you are taking
medicines for a heart disorder (cardiac glycosides), or diuretics
(used in the treatment of high blood pressure or oedema)
if you have signs of impaired kidney function or a high tendency to
kidney stone (calculus) formation
if you have cancer or any other conditions that may have affected
your bones.
Your serum calcium or phosphate levels, or urinary calcium
excretion must be monitored if you have any of the following
conditions:
kidney problems
you are on long-term treatment with Calcichew
you are already taking additional doses of calcium
If you have increased calcium levels in the blood or develop signs of
kidney problems, the dose of Calcichew should be reduced or the
treatment discontinued.
Other medicines and Calcichew
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
In particular, the following medicines may interact with Calcichew:
thiazide diuretics (water tablets); your serum calcium levels should
be monitored regularly.
cardiac glycosides (heart medicines); you should be monitored by
electrocardiogram (ECG) and your serum calcium levels measured.

tetracycline antibiotics; these should be taken at least two hours
before, or four to six hours afterwards. Calcium carbonate may
interfere with the absorption of tetracycline preparations if taken at
the same time.
levothyroxine (hormone used to treat thyroid deficiency); these
should be taken at least four hours before, or after taking Calcichew.
Quinolone antibiotics (ciprofloxacin, lomefloxacin, norfloxacin,
sparfloxacin); the effect of these medicines may be reduced if taken
at the same time as calcium. Take quinolone antibiotics two hours
before or six hours after taking Calcichew.
Bisphosphonates should be taken at least one hour before
Calcichew.
Calcium salts may decrease the absorption of iron, zinc and
strontium ranelate. Consequently iron, zinc or strontium ranelate
preparations should be taken at least two hours before or after
Calcichew.
If you are taking any of the above-mentioned medicines, your doctor will
give you further instructions.
Taking Calcichew with food and drink
For treatment of calcium deficiency or use as an additional osteoporosis
therapy, Calcichew can be taken with or without food and drink.
For use as a phosphate binder, Calcichew should be taken just before,
during or just after each meal.
Pregnancy, breast-feeding and fertility
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
taking Calcichew.
During pregnancy the daily intake should not exceed 2500mg calcium
(including food and supplementation). If you are pregnant, you may use
Calcichew in case of a calcium deficiency.
Calcichew can be used during breast-feeding. Calcium passes into breast
milk.
Driving and using machines
Calcichew has no known influence on the ability to drive or use
machines.
Calcichew contains isomalt, sorbitol and aspartame
Calcichew contains sorbitol (E420) and isomalt (E953): if you have been
told by your doctor that you have an intolerance to some sugars, talk to
your doctor before taking this medicine. May be harmful to teeth.
Calcichew contains aspartame (E951), a source of phenylalanine which
may be harmful for people with phenylketonuria (a deficiency in the
enzyme which breaks down phenylalanine).
3. HOW TO TAKE CALCICHEW
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
Dosage
The recommended dose is:
For use as an additional osteoporosis therapy: One tablet 2 or 3
times a day.
For calcium deficiency:
One tablet 2 or 3 times a day.
As a phosphate binder (for kidney failure patients on dialysis):
Your doctor will decide how many Calcichew you need. The label the
pharmacist puts on your medicine will tell you exactly how many tablets
to take.
Use in children
The recommended dose for children is one tablet 2 or 3 times a day.
The tablets can be chewed or sucked.
If you take more than you should
If you have taken more Calcichew than you should, talk to your doctor or
pharmacist immediately.
If you accidentally take more Calcichew than you should, you may have
an increase in your blood calcium levels. Symptoms of this are:
excessive thirst, nausea, vomiting, constipation, abdominal pain, muscle
weakness, tiredness, mental disturbances, lack of appetite, bone pain,
having to pass more water than usual, kidney problems and, in severe
cases, irregular heartbeat.
Very rarely in addition: irritability, continuing headache, lightheadedness,
muscle spasms, twitches and tingling sensation.
If you forget to take Calcichew
Do not take a double dose to make up for a forgotten tablet. 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.
Stop taking your medicine and see a doctor immediately if you
experience any of the following side effects. These side effects may be a
sign of milk-alkali syndrome (also called Burnett’s Syndrome) that is
reported to occur very rarely (affects less than 1 in 10,000 people):
Frequent urge to urinate
Headache
Loss of appetite, nausea or vomiting
Unusual tiredness or weakness, along with elevated levels of calcium
in the blood and kidney impairment.
Side effects may include:
Uncommon side effects (may affect up to 1 in 100 people):
excessive amounts of calcium in your blood (hypercalcaemia) or
in your urine (hypercalcuria) may occur with large doses
Rare side effects (may affect up to 1 in 1,000 people):
nausea
diarrhoea
stomach ache
wind (flatulence)
constipation
heartburn (dyspepsia)
Very rare side effects (may affect less than 1 in 10,000 people):
rash
hives
itching
If you are taking Calcichew because you are having kidney dialysis, tell
your doctor if you notice any white deposits on your skin.
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 any 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.
5. HOW TO STORE CALCICHEW
Keep out of the sight and reach of children.
Do not store above 30°C. Store in the original package to protect from
moisture.
Do not take the tablets after the expiry date which is stated on the carton
and bottle label after 'Exp'. The expiry date refers to the last day of that
month.
If tablets become discoloured or show any signs of deterioration, seek the
advice of your pharmacist.
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. CONTENTS OF THE PACK AND OTHER INFORMATION
7.
What Calcichew contain
The active ingredients in each tablet are:
1250mg calcium carbonate (equivalent to 500mg calcium)
The other ingredients are: sorbitol (E420), povidone, isomalt (E953),
fatty acid mono- and di-glycerides, magnesium stearate, orange flavour,
and aspartame (E951) (see also end of Section 2 'Calcichew contains
isomalt, sorbitol and aspartame').
This product is gluten and lactose free.
What Calcichew look like and contents of the pack
The tablets are round, white, uncoated biconvex and orange flavoured;
they may have small specks.
The tablets are packed in white, plastic bottles of 60 and 90 tablets.
Manufactured by:
For Pack Size 60: Nycomed Pharma As, Norway.
For Pack Size 90: Takeda Nycomed AS, Norway.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
CALCICHEW ® 500mg CHEWABLE TABLETS; PL 18799/1967
Leaflet date: 24.10.2016

P

Calcichew is a registered trademark of Nycomed Pharma.

Additional Information
Calcichew contains calcium designed to keep bones healthy. Calcium
is an essential component of bones.
Requirements for calcium increase with age and, although many people
obtain enough calcium from their diet, some people may require a
supplement in order that their body has all the calcium it needs to
maintain healthy bones.
People with diets and lifestyles that mean they will obtain less than the
recommended intake of calcium are at risk of weakened bones.
Prolonged lack of adequate calcium intake can lead to the development
of osteoporosis, a condition where bones become weak to a level that
minimal trauma (for example, a fall) can result in a fracture, most typically
at the hip, spine or wrist.
Calcichew have been designed to give people, whose intake of calcium
is low, a boost to the recommended amounts.
Maintaining healthy bones and helping to avoid osteoporosis is an
important issue for many people. There are many ways that people can
help themselves: regular exercise, a balanced diet with an adequate
intake of calcium and, for some people, advice on how to prevent falls
which may lead to fracture.
The National Osteoporosis Society (NOS) in the UK is national charity
dedicated to improving the diagnosis, prevention and treatment of
osteoporosis. The NOS and IOS offer support to people with
osteoporosis and raise awareness of the importance of healthy bones.
For patients in the UK, if you are concerned about osteoporosis, please
contact the National Osteoporosis Society, Camerton, Bath BA2 0PJ. Tel:
01761 471 771, Fax: 01761 471 104 or email: info@nos.org.uk.

PATIENT INFORMATION LEAFLET

CALCIUM 500mg CHEWABLE TABLETS
(calcium carbonate)
equivalent to 500mg calcium
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
-

Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must talk to a doctor if you do not feel better or if you feel worse
after two weeks.
- 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.
The name of your medicine is CALCIUM 500mg CHEWABLE TABLETS
but will be referred to as Calcium throughout this leaflet.
In this leaflet:
1. What Calcium is and what it is used for
2. What you need to know before you take Calcium
3. How to take Calcium
4. Possible side-effects
5. How to store Calcium
6. Contents of the pack and other information
1. WHAT CALCIUM IS AND WHAT IT IS USED FOR
Calcium is orange flavoured chewable tablet containing the active
ingredient calcium. Calcium is found in the diet and is an important
substance in bone formation.
Calcium is used to treat and prevent calcium deficiency which may occur
if your diet or lifestyle does not provide enough, or when body
requirements are increased. This medicine may also be prescribed or
recommended for certain bone conditions, for example osteoporosis, or
during pregnancy. It may also be given to patients receiving kidney
dialysis to remove the phosphate from the blood that cannot be removed
by dialysis.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCIUM
Do not take Calcium if you:
are allergic (hypersensitive) to calcium or any of the other ingredients
of this medicine (listed in section 6)
have a condition that causes excessive amounts of calcium in your
blood or urine (hypercalcaemia or hypercalciuria)
have kidney stones.
Warnings and precautions
Talk to your doctor or pharmacist before taking Calcium:
if you have phenylketonuria (a deficiency in the enzyme which
breaks down phenylalanine) as these tablets contain aspartame, a
source of phenylalanine
if you have osteoporosis (brittle bones) and are also unable to
move around
if you are on long-term treatment, especially if you are taking
medicines for a heart disorder (cardiac glycosides), or diuretics
(used in the treatment of high blood pressure or oedema)
if you have signs of impaired kidney function or a high tendency to
kidney stone (calculus) formation
if you have cancer or any other conditions that may have affected
your bones.
Your serum calcium or phosphate levels, or urinary calcium
excretion must be monitored if you have any of the following
conditions:
kidney problems
you are on long-term treatment with Calcium
you are already taking additional doses of calcium
If you have increased calcium levels in the blood or develop signs of
kidney problems, the dose of Calcium should be reduced or the treatment
discontinued.
Other medicines and Calcium
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
In particular, the following medicines may interact with Calcium:
thiazide diuretics (water tablets); your serum calcium levels should
be monitored regularly.
cardiac glycosides (heart medicines); you should be monitored by
electrocardiogram (ECG) and your serum calcium levels measured.

tetracycline antibiotics; these should be taken at least two hours
before, or four to six hours afterwards. Calcium carbonate may
interfere with the absorption of tetracycline preparations if taken at
the same time.
levothyroxine (hormone used to treat thyroid deficiency); these
should be taken at least four hours before, or after taking Calcium.
Quinolone antibiotics (ciprofloxacin, lomefloxacin, norfloxacin,
sparfloxacin); the effect of these medicines may be reduced if taken
at the same time as calcium. Take quinolone antibiotics two hours
before or six hours after taking Calcium.
Bisphosphonates should be taken at least one hour before Calcium.
Calcium salts may decrease the absorption of iron, zinc and
strontium ranelate. Consequently iron, zinc or strontium ranelate
preparations should be taken at least two hours before or after
Calcium.
If you are taking any of the above-mentioned medicines, your doctor will
give you further instructions.
Taking Calcium with food and drink
For treatment of calcium deficiency or use as an additional osteoporosis
therapy, Calcium can be taken with or without food and drink.
For use as a phosphate binder, Calcium should be taken just before,
during or just after each meal.
Pregnancy, breast-feeding and fertility
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
taking Calcium.
During pregnancy the daily intake should not exceed 2500mg calcium
(including food and supplementation). If you are pregnant, you may use
Calcium in case of a calcium deficiency.
Calcium can be used during breast-feeding. Calcium passes into breast
milk.
Driving and using machines
Calcium has no known influence on the ability to drive or use machines.
Calcium contains isomalt, sorbitol and aspartame
Calcium contains sorbitol (E420) and isomalt (E953): if you have been
told by your doctor that you have an intolerance to some sugars, talk to
your doctor before taking this medicine. May be harmful to teeth.
Calcium contains aspartame (E951), a source of phenylalanine which
may be harmful for people with phenylketonuria (a deficiency in the
enzyme which breaks down phenylalanine).
3. HOW TO TAKE CALCIUM
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
Dosage
The recommended dose is:
For use as an additional osteoporosis therapy: One tablet 2 or 3
times a day.
For calcium deficiency:
One tablet 2 or 3 times a day.
As a phosphate binder (for kidney failure patients on dialysis):
Your doctor will decide how many Calcium you need. The label the
pharmacist puts on your medicine will tell you exactly how many tablets
to take.
Use in children
The recommended dose for children is one tablet 2 or 3 times a day.
The tablets can be chewed or sucked.
If you take more than you should
If you have taken more Calcium than you should, talk to your doctor or
pharmacist immediately.
If you accidentally take more Calcium than you should, you may have an
increase in your blood calcium levels. Symptoms of this are: excessive
thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness,
tiredness, mental disturbances, lack of appetite, bone pain, having to
pass more water than usual, kidney problems and, in severe cases,
irregular heartbeat.
Very rarely in addition: irritability, continuing headache, lightheadedness,
muscle spasms, twitches and tingling sensation.
If you forget to take Calcium
Do not take a double dose to make up for a forgotten tablet. 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.
Stop taking your medicine and see a doctor immediately if you
experience any of the following side effects. These side effects may be a
sign of milk-alkali syndrome (also called Burnett’s Syndrome) that is
reported to occur very rarely (affects less than 1 in 10,000 people):
Frequent urge to urinate
Headache
Loss of appetite, nausea or vomiting
Unusual tiredness or weakness, along with elevated levels of calcium
in the blood and kidney impairment.
Side effects may include:
Uncommon side effects (may affect up to 1 in 100 people):
excessive amounts of calcium in your blood (hypercalcaemia) or
in your urine (hypercalcuria) may occur with large doses
Rare side effects (may affect up to 1 in 1,000 people):
nausea
diarrhoea
stomach ache
wind (flatulence)
constipation
heartburn (dyspepsia)
Very rare side effects (may affect less than 1 in 10,000 people):
rash
hives
itching
If you are taking Calcium because you are having kidney dialysis, tell
your doctor if you notice any white deposits on your skin.
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 any 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.
5. HOW TO STORE CALCIUM
Keep out of the sight and reach of children.
Do not store above 30°C. Store in the original package to protect from
moisture.
Do not take the tablets after the expiry date which is stated on the carton
and bottle label after 'Exp'. The expiry date refers to the last day of that
month.
If tablets become discoloured or show any signs of deterioration, seek the
advice of your pharmacist.
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. CONTENTS OF THE PACK AND OTHER INFORMATION
7.
What Calcium contain
The active ingredients in each tablet are:
1250mg calcium carbonate (equivalent to 500mg calcium)
The other ingredients are: sorbitol (E420), povidone, isomalt (E953),
fatty acid mono- and di-glycerides, magnesium stearate, orange flavour,
and aspartame (E951) (see also end of Section 2 'Calcium contains
isomalt, sorbitol and aspartame').
This product is gluten and lactose free.
What Calcium look like and contents of the pack
The tablets are round, white, uncoated biconvex and orange flavoured;
they may have small specks.
The tablets are packed in white, plastic bottles of 60 and 90 tablets.
Manufactured by:
For Pack Size 60: Nycomed Pharma As, Norway.
For Pack Size 90: Takeda Nycomed AS, Norway.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
CALCIUM 500mg CHEWABLE TABLETS; PL 18799/1967
Leaflet date: 24.10.2016

P

Additional Information
Calcium contains calcium designed to keep bones healthy. Calcium
is an essential component of bones.
Requirements for calcium increase with age and, although many people
obtain enough calcium from their diet, some people may require a
supplement in order that their body has all the calcium it needs to
maintain healthy bones.
People with diets and lifestyles that mean they will obtain less than the
recommended intake of calcium are at risk of weakened bones.
Prolonged lack of adequate calcium intake can lead to the development
of osteoporosis, a condition where bones become weak to a level that
minimal trauma (for example, a fall) can result in a fracture, most typically
at the hip, spine or wrist.
Calcium have been designed to give people, whose intake of calcium
is low, a boost to the recommended amounts.
Maintaining healthy bones and helping to avoid osteoporosis is an
important issue for many people. There are many ways that people can
help themselves: regular exercise, a balanced diet with an adequate
intake of calcium and, for some people, advice on how to prevent falls
which may lead to fracture.
The National Osteoporosis Society (NOS) in the UK is national charity
dedicated to improving the diagnosis, prevention and treatment of
osteoporosis. The NOS and IOS offer support to people with
osteoporosis and raise awareness of the importance of healthy bones.
For patients in the UK, if you are concerned about osteoporosis, please
contact the National Osteoporosis Society, Camerton, Bath BA2 0PJ. Tel:
01761 471 771, Fax: 01761 471 104 or email: info@nos.org.uk.

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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