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CALCIUM CARBONATE 1250MG CHEWABLE TABLETS

Active substance(s): CALCIUM CARBONATE

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S678 LEAFLET Calcichew 20140122

PACKAGE LEAFLET: INFORMATION FOR THE USER

CALCICHEW 500mg TABLETS
(calcium carbonate)
Your medicine is known as Calcichew 500mg Tablets but will be
referred to as Calcichew throughout the following leaflet.

Taking other medicines
Please inform your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
In particular, the following medicines may interact with Calcichew:


Read all of this leaflet carefully because it contains important
information for you.

diuretics (water tablets); your serum calcium levels should be
monitored regularly.



This medicine is available without prescription. However, you still
need to take Calcichew carefully to get the best results from it.

Heart medicines (cardiac glycosides; you should be monitored
by electrocardiogram and your serum calcium levels measured.



Corticosteroids (e.g. prednisolone, dexamethasone); your
dose of Calcichew may need to be increased



Tetracycline antibiotics; these should be taken at least two
hours before, or four to six hours afterwards.



Keep this leaflet. You may need to read it again.



Ask your pharmacist if you need more information or advice.



You must contact a doctor if your symptoms worsen or do not
improve after two weeks.



Anti-infectives (Quinolones: Ciprofloxacin, lomefloxacin,
norfloxacin, sparfloxacin); please speak with your doctor.



If any of the side effects become serious, or if you notice any
side effect(s) not listed in this leaflet, please talk to your doctor
or pharmacist.



Fluoride, or biphosphates; Calcichew should be taken at least
three hours afterwards.

In this leaflet:
1. What Calcichew is and what it is used for
2. Before you take Calcichew
3. How to take Calcichew

Taking Calcichew with food and drink
Calcichew should not be taken within 2 hours of eating foods rich in
oxalic acid (found in spinach and rhubarb) or phytic acid (found in
whole cereals).

4. Possible side-effects
5. How to store Calcichew

Pregnancy and breast-feeding

6. Further information

Ask your doctor or pharmacist for advice if you are pregnant or
breast-feeding before taking Calcichew.

1. WHAT CALCICHEW IS AND WHAT IT IS USED FOR
Calcichew is orange flavoured chewable tablet. It contains the
active ingredients:


Calcium (1250mg calcium carbonate: equivalent to 500mg
calcium)

Calcium is found in the diet.
Calcichew may be prescribed by doctors or recommended by
pharmacists to treat and prevent calcium deficiency, or when the
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 in pregnancy. It may also be given to patients
receiving kidney dialysis to remove the phosphate from food that
cannot be removed by dialysis.

Driving and using machines
Calcichew has no known effect on your ability to drive or use
machines.
Important information about some of the ingredients of
Calcichew
The following are ingredients in this product:


Sorbitol and isomalt: if you have been told by your doctor that
you have an intolerance to some sugars, talk to your doctor
before taking this medicine.



Aspartame contains a source of phenylalanine and may be
harmful for people with pheylketonuria (a deficiency in the
enzyme which breaks down phenylalanine).

2. BEFORE YOU TAKE CALCICHEW

3. HOW TO TAKE CALCICHEW

Do not take Calcichew if you:

Always take Calcichew exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
For use as additional osteoporosis therapy:



are allergic (hypersensitive) to any of the ingredients (see end
of Section 2 and Section 6)



have a condition causing high levels of calcium in your blood or
urine (hypercalcaemia or hypercalciuria) e.g.

Adults and the elderly: Chew or suck one tablet 2 or 3 times a day.

-

severe kidney failure in people not on dialysis – you should
not take this medicine unless advised by your doctor

-

cancer which has affected your bones

Adults, the elderly and children: Chew or suck one tablet 2 or 3
times a day.

 have kidney stones.
Take special care with Calcichew:

For calcium deficiency:

For osteomalacia (a softening of the bones):
Adults and the elderly: Chew or suck two to six chewable tablets a
day.

If any of the following applies to you, please tell your doctor:

As a phosphate binder (for kidney failure patients on dialysis):



phenylketonuria (a deficiency in the enzyme which breaks
down phenylalanine) as these tablets contain aspartame, a
source of phenylalanine

When Calcichew is given to patients on kidney dialysis, the dose
will be different for each patient. Your doctor will decide how many
Calcichew 500mg Tablets you need.



brittle bones (osteoporosis) as a result of being immobile



taking medicines for your heart, or diuretics



a high tendency to kidney stone (calculus) formation

The tablets should be taken just before, during or just after each
meal to make sure that the calcium binds to the phosphate in the
stomach.



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 level in the blood or develop signs of
kidney problems, the dose of Calcichew should be reduced or the
treatment discontinued.

If you take more Calcichew than you should
If you accidently 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.
Do not take any more Calcichew and contact your doctor or
emergency department as soon as possible. Take the packet
and any remaining tablets with you.

If you forget to take Calcichew
If you forget to take a dose, leave out that dose completely.
Take your next dose when it is due.
Do not take a double dose to make up for a forgotten dose.
4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION
What Calcichew contains


Each tablet contains 1250mg of the active ingredient, calcium
carbonate, equivalent to 500mg of calcium.



The other ingredients are: sorbitol, povidone, orange oil,
magnesium stearate, isomalt, aspartame and mono- and di-fatty
acid glycerides.

Like all medicines, Calcichew can cause side effects, although not
everybody gets them.
Side effects with Calcichew may include:
Uncommon side effects (affecting less than 1 in 100 people):

What Calcichew looks like and contents of the pack



Too much calcium in your blood (hypercalcaemia) - the
symptoms include nausea, vomiting, lack of appetite,
constipation, stomach ache, bone pain, extreme thirst, a need
to pass more water than usual, muscle weakness, drowsiness
and confusion.

Calcichew is available in bottles of 60 and 90 tablets. Calcichew
may also be marketed in boxes containing 2 bottles of 60 tablets in
a single box.



too much calcium in your urine (hypercalciuria)

Rare side effects (affecting less than 1 in 1000 people):

Calcichew is round, white, chewable tablet with yellow specks.

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.



nausea



stomach ache

Manufacturer



constipation



diarrhoea

This product is manufactured by Takeda Nycomed AS,
Drammensveien 852, P. O. Box 205, 1372 Asker, Norway.



wind (flatulence)



rash



hives



itching

Very rare side-effects (affecting less than 1 in 10000 people):


milk akali syndrome – (usually only seen in overdose see “if you
take more Calcichew than you should”)

If you are taking Calcichew because you are having kidney dialysis,
tell your doctor if you notice any white deposits on your skin.
If any of these side-effects become serious, or if you notice
any side-effect(s) not listed in this leaflet, please talk to your
doctor or pharmacist.
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.
5. HOW TO STORE CALCICHEW


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store Calcichew above 30°C. Store in the original
container. Keep the container tightly closed to protect from
moisture.



Do not use after the expiry date printed on the carton label or
bottle.



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.



If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

P

PL No: 19488/0678

Leaflet revision date: 22 January 2014
Calcichew is a registered trade mark of Shire Pharmaceuticals Ltd,
UK.
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 has 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.
For patients in the UK, the National Osteoporosis Society (NOS) is
a national charity dedicated to improving the diagnosis, prevention
and treatment of osteoporosis. The NOS offers support to people
with osteoporosis and raises awareness of the importance of
healthy bones.
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.
For patients in the Republic of Ireland, please contact the Irish
Osteoporosis Society, 33 Pearse Street, Dublin 2.
Tel/Fax: 01 677 4267 email: info@irishosteoporosis.ie
S678 LEAFLET Calcichew 20140122

S678 LEAFLET Calcium Carbonate 20140122

PACKAGE LEAFLET: INFORMATION FOR THE USER

CALCIUM CARBONATE 1250mg CHEWABLE TABLETS
Your medicine is known as Calcium Carbonate 1250mg Chewable
Tablets but will be referred to as Calcium Tablets throughout the
following leaflet.
Read all of this leaflet carefully because it contains important
information for you.
This medicine is available without prescription. However, you still
need to take Calcium Tablets carefully to get the best results from
it.

Taking other medicines
Please inform your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
In particular, the following medicines may interact with Calcium
Tablets:


diuretics (water tablets); your serum calcium levels should be
monitored regularly.



Heart medicines (cardiac glycosides; you should be monitored
by electrocardiogram and your serum calcium levels measured.



Corticosteroids (e.g. prednisolone, dexamethasone); your
dose of Calcium Tablets may need to be increased



Tetracycline antibiotics; these should be taken at least two
hours before, or four to six hours afterwards.



Keep this leaflet. You may need to read it again.



Ask your pharmacist if you need more information or advice.



You must contact a doctor if your symptoms worsen or do not
improve after two weeks.





Anti-infectives (Quinolones: Ciprofloxacin, lomefloxacin,
norfloxacin, sparfloxacin); please speak with your doctor.

If any of the side effects become serious, or if you notice any
side effect(s) not listed in this leaflet, please talk to your doctor
or pharmacist.



Fluoride, or biphosphates; Calcium Tablets should be taken
at least three hours afterwards.

In this leaflet:
1. What Calcium Tablets are and what they are used for
2. Before you take Calcium Tablets

Taking Calcium Tablets with food and drink
Calcium Tablets should not be taken within 2 hours of eating foods
rich in oxalic acid (found in spinach and rhubarb) or phytic acid
(found in whole cereals).

3. How to take Calcium Tablets
4. Possible side-effects

Pregnancy and breast-feeding

5. How to store Calcium Tablets
6. Further information

Ask your doctor or pharmacist for advice if you are pregnant or
breast-feeding before taking Calcium Tablets.

1. WHAT CALCIUM TABLETS ARE AND WHAT THEY ARE
USED FOR

Driving and using machines

Calcium Tablets are orange flavoured chewable tablets. It contains
the active ingredients:

Calcium Tablets have no known effect on your ability to drive or use
machines.



Calcium (1250mg calcium carbonate: equivalent to 500mg
calcium)

Calcium is found in the diet.
Calcium Tablets may be prescribed by doctors or recommended by
pharmacists to treat and prevent calcium deficiency, or when the
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 in pregnancy. It may also be given to patients
receiving kidney dialysis to remove the phosphate from food that
cannot be removed by dialysis.
2. BEFORE YOU TAKE CALCIUM TABLETS
Do not take Calcium Tablets if you:

Important information about some of the ingredients of
Calcium Tablets
The following are ingredients in this product:


Sorbitol and isomalt: if you have been told by your doctor that
you have an intolerance to some sugars, talk to your doctor
before taking this medicine.



Aspartame contains a source of phenylalanine and may be
harmful for people with pheylketonuria (a deficiency in the
enzyme which breaks down phenylalanine).

3. HOW TO TAKE CALCIUM TABLETS



are allergic (hypersensitive) to any of the ingredients (see end
of Section 2 and Section 6)

Always take Calcium Tablets exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure.



have a condition causing high levels of calcium in your blood or
urine (hypercalcaemia or hypercalciuria) e.g.

For use as additional osteoporosis therapy:



-

severe kidney failure in people not on dialysis – you should
not take this medicine unless advised by your doctor

-

cancer which has affected your bones

have kidney stones.

Take special care with Calcium Tablets:
If any of the following applies to you, please tell your doctor:


phenylketonuria (a deficiency in the enzyme which breaks
down phenylalanine) as these tablets contain aspartame, a
source of phenylalanine



brittle bones (osteoporosis) as a result of being immobile



taking medicines for your heart, or diuretics



a high tendency to kidney stone (calculus) formation



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 Tablets



you are already taking additional doses of calcium

If you have increased calcium level in the blood or develop signs of
kidney problems, the dose of Calcium Tablets should be reduced or
the treatment discontinued.

Adults and the elderly: Chew or suck one tablet 2 or 3 times a day.
For calcium deficiency:
Adults, the elderly and children: Chew or suck one tablet 2 or 3
times a day.
For osteomalacia (a softening of the bones):
Adults and the elderly: Chew or suck two to six chewable tablets a
day.
As a phosphate binder (for kidney failure patients on dialysis):
When Calcium Tablets are given to patients on kidney dialysis, the
dose will be different for each patient. Your doctor will decide how
many Calcium Tablets you need.
The tablets should be taken just before, during or just after each
meal to make sure that the calcium binds to the phosphate in the
stomach.
If you take more Calcium Tablets than you should
If you accidently take more Calcium Tablets 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.
Do not take any more Calcium Tablets and contact your doctor or
emergency department as soon as possible. Take the packet
and any remaining tablets with you.

If you forget to take Calcium Tablets
If you forget to take a dose, leave out that dose completely.
Take your next dose when it is due.
Do not take a double dose to make up for a forgotten dose.
4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION
What Calcium Tablets contain


Each tablet contains 1250mg of the active ingredient, calcium
carbonate, equivalent to 500mg of calcium.



The other ingredients are: sorbitol, povidone, orange oil,
magnesium stearate, isomalt, aspartame and mono- and di-fatty
acid glycerides.

Like all medicines, Calcium Tablets can cause side effects,
although not everybody gets them.
Side effects with Calcium Tablets may include:
Uncommon side effects (affecting less than 1 in 100 people):




Too much calcium in your blood (hypercalcaemia) - the
symptoms include nausea, vomiting, lack of appetite,
constipation, stomach ache, bone pain, extreme thirst, a need
to pass more water than usual, muscle weakness, drowsiness
and confusion.
too much calcium in your urine (hypercalciuria)

Rare side effects (affecting less than 1 in 1000 people):

What Calcium Tablets look like and contents of the pack
Calcium Tablets are round, white, chewable tablet with yellow
specks.
Calcium Tablets are available in bottles of 60 and 90 tablets.
Calcium Tablets may also be marketed in boxes containing 2
bottles of 60 tablets in a single box.
Product Licence holder
Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.



nausea



stomach ache



constipation



diarrhoea



wind (flatulence)



rash



hives



Leaflet revision date: 22 January 2014

itching

Additional information

Very rare side-effects (affecting less than 1 in 10000 people):


milk akali syndrome – (usually only seen in overdose see “if you
take more Calcium Tablets than you should”)

If you are taking Calcium Tablets because you are having kidney
dialysis, tell your doctor if you notice any white deposits on your
skin.
If any of these side-effects become serious, or if you notice
any side-effect(s) not listed in this leaflet, please talk to your
doctor or pharmacist.
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.
5. HOW TO STORE CALCIUM TABLETS


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store Calcichew above 30°C. Store in the original
container. Keep the container tightly closed to protect from
moisture.



Do not use after the expiry date printed on the carton label or
bottle.



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.



If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

Manufacturer
This product is manufactured by Takeda Nycomed AS,
Drammensveien 852, P. O. Box 205, 1372 Asker, Norway.
P

PL No: 19488/0678

Calcium Tablets contain 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 Tablets 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.
For patients in the UK, the National Osteoporosis Society (NOS) is
a national charity dedicated to improving the diagnosis, prevention
and treatment of osteoporosis. The NOS offers support to people
with osteoporosis and raises awareness of the importance of
healthy bones.
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.
For patients in the Republic of Ireland, please contact the Irish
Osteoporosis Society, 33 Pearse Street, Dublin 2.
Tel/Fax: 01 677 4267 email: info@irishosteoporosis.ie
S678 LEAFLET Calcium Carbonate 20140122

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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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