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CALCIUM CARBONATE 1250MG CHEWABLE TABLETS

Active substance(s): CALCIUM CARBONATE

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S678 LEAFLET Calcichew 20170412

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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.

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.

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

If you are taking any of the above-mentioned medicines, your
doctor will give you further instructions.

1. WHAT CALCICHEW IS AND WHAT IT IS USED FOR

Taking Calcichew with food and drink

Calcichew is orange flavoured chewable tablets containing the
active ingredient calcium. Calcium is found in the diet and is an
important substance in bone formation.

For treatment of calcium deficiency or use as an additional
osteoporosis therapy, Calcichew can be taken with or without food
and drink.

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.

For use as a phosphate binder, Calcichew should be taken just
before, during or just after each meal.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
CALCICHEW
Do not take Calcichew if you:

Pregnancy, breastfeeding 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 2500 mg
calcium (including food and supplementation). If you are pregnant,
you may use Calcichew in case of a calcium deficiency.
Calcichew can be used during breastfeeding. Calcium passes into
breast milk.



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)

Calcichew has no known influence on the ability to drive or use
machines.



have kidney stones.

Calcichew contains isomalt

Warnings and precautions
Talk to your doctor or pharmacist before taking Calcichew:


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:

Driving and using machines

Calcichew contains 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.
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.



kidney problems

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



you are on long-term treatment with Calcichew



you are already taking additional doses of calcium

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.

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.

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 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Calcichew contains



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



The other ingredients are: xylitol (E967), povidone, orange oil,
magnesium stearate, isomalt (E953), sucralose (E955) and
mono- and di-fatty acid glycerides.

If you forget to take Calcichew
Do not take a double dose to make up for a forgotten tablet.

What Calcichew looks like and contents of the pack

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

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

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):

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.
Manufacturer

This product is manufactured by

TAKEDA AS, Drammensveien 852, NO-1383 Asker, Norway.



Takeda Pharma AS, 55B jaama Street, 63308 Polva, Estonia.



Tjoapack B.V., Columbusstraat, 4, 7801 Emmen, The
Netherlands.

P

PL: 19488/0678

Leaflet revision date: 12 April 2017

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.



nausea



stomach ache



constipation



diarrhoea

Calcichew® is a registered trade mark of Shire Pharmaceuticals Ltd,
UK.



wind (flatulence)

Additional Information



heartburn (dyspepsia)

Calcichew contains calcium designed to keep bones healthy.
Calcium is an essential component of bones.

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 or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via:
United Kingdom
Yellow Card Scheme
Website: 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.

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.
The National Osteoporosis Society (NOS) in the UK and the Irish
Osteoporosis Society (IOS) in the Republic of Ireland, are national
charities 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. For patients in the Republic of Ireland, please
contact the Irish Osteoporosis Society, 114 Pembroke Road,
Garden Level, Ballsbridge, Dublin 4. Tel: 1890 252 751,
Fax: +353 (0)1 668 0098, email: info@irishosteoporosis.ie.
S678 LEAFLET Calcichew 20170412

S678 LEAFLET Calcium Carbonate 20170412

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 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.

Other medicines and Calcium Tablets
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
tablets:


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 Tablets.



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 Tablets.



Bisphosphonates should be taken at least one hour before
Calcium Tablets.



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 Tablets.

In this leaflet:
1. What Calcium Tablets are and what it is used for
2. What you need to know before you take Calcium Tablets
3. How to take Calcium Tablets
4. Possible side-effects
5. How to store Calcium Tablets
6. Contents of the pack and other information
1. WHAT CALCIUM TABLETS ARE AND WHAT IT IS USED FOR
Calcium Tablets are orange flavoured chewable tablets containing
the active ingredient calcium. Calcium is found in the diet and is an
important substance in bone formation.
Calcium Tablets are 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
TABLETS
Do not take Calcium Tablets if you:

If you are taking any of the above-mentioned medicines, your
doctor will give you further instructions.
Taking Calcium Tablets with food and drink
For treatment of calcium deficiency or use as an additional
osteoporosis therapy, Calcium Tablets can be taken with or without
food and drink.
For use as a phosphate binder, Calcium Tablets should be taken
just before, during or just after each meal.
Pregnancy, breastfeeding 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 Tablets.
During pregnancy the daily intake should not exceed 2500 mg
calcium (including food and supplementation). If you are pregnant,
you may use Calcium Tablets in case of a calcium deficiency.



are allergic (hypersensitive) to calcium or any of the other
ingredients of this medicine (listed in section 6)

Calcium Tablets can be used during breastfeeding. Calcium passes
into breast milk.



have a condition that causes excessive amounts of calcium in
your blood or urine (hypercalcaemia or hypercalciuria)

Driving and using machines



have kidney stones.

Calcium Tablets have no known influence on the ability to drive or
use machines.

Warnings and precautions

Calcium Tablets contain isomalt

Talk to your doctor or pharmacist before taking Calcium
Tablets:

Calcium Tablets contain 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.



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:

3. HOW TO TAKE CALCIUM TABLETS
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.



kidney problems

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



you are on long-term treatment with Calcium Tablets



you are already taking additional doses of calcium

Your doctor will decide how many Calcium Tablets you need. The
label the pharmacist puts on your medicine will tell you exactly how
many tablets to take.

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

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 Tablets than you should, talk to
your doctor or pharmacist immediately.
If you accidentally 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.

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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Calcium Tablet contains


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



The other ingredients are: xylitol (E967), povidone, orange oil,
magnesium stearate, isomalt (E953), sucralose (E955) and
mono- and di-fatty acid glycerides.

If you forget to take Calcium Tablets
Do not take a double dose to make up for a forgotten tablet.

What Calcium Tablet looks like and contents of the pack

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

Calcium Tablets are round, white, chewable tablet with yellow
specks.

4. POSSIBLE SIDE EFFECTS

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.

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

Product Licence holder

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



stomach ache



constipation



diarrhoea



wind (flatulence)



heartburn (dyspepsia)

Very rare side effects (may affect less than 1 in 10,000 people):


rash



hives



itching

If you are taking Calcium Tablets 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 or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via:
Yellow Card Scheme
Website: 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 Calcium Tablets 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.

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

TAKEDA AS, Drammensveien 852, NO-1383 Asker, Norway.



Takeda Pharma AS, 55B jaama Street, 63308 Polva, Estonia.



Tjoapack B.V., Columbusstraat, 4, 7801 Emmen, The
Netherlands.

P

PL: 19488/0678

Leaflet revision date: 12 April 2017

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.
Additional Information
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.
The National Osteoporosis Society (NOS) in the UK and the Irish
Osteoporosis Society (IOS) in the Republic of Ireland, are national
charities 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. For patients in the Republic of Ireland, please
contact the Irish Osteoporosis Society, 114 Pembroke Road,
Garden Level, Ballsbridge, Dublin 4. Tel: 1890 252 751,
Fax: +353 (0)1 668 0098, email: info@irishosteoporosis.ie.
S678 LEAFLET Calcium Carbonate 20170412

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