Skip to Content

UK Edition. Click here for US version.

MASTICAL 500MG CHEWABLE TABLETS

Active substance(s): CALCIUM CARBONATE / CALCIUM CARBONATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Ref: 1293070317/1/F

Calcichew 500mg Chewable Tablets
®

(calcium carbonate)
Patient Information 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.
Your medicine is called Calcichew 500mg Chewable Tablets, however
thourghout this leaflet it will be referred to as Calcichew 500mg.
In this leaflet:
1 What Calcichew 500mg is and what it is used for
2 What you need to know before you take Calcichew 500mg
3 How to take Calcichew 500mg
4 Possible side-effects
5 How to store Calcichew 500mg
6 Contents of the pack and other information

1

What Calcichew 500mg is and what it is used for

Calcichew 500mg Chewable 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.
Calcichew 500mg 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
500mg

Do not take Calcichew 500 mg Chewable Tablets 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 500 mg:
* 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 500 mg should be reduced or the treatment
discontinued.

Other medicines and Calcichew 500 mg
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 500mg
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 Calcichew 500mg.
* 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 500mg.
* Bisphosphonates should be taken at least one hour before Calcichew
500mg.
* 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 500mg.
If you are taking any of the above-mentioned medicines, your doctor will
give you further instructions.
Taking Calcichew 500mg with food and drink
For treatment of calcium deficiency or use as an additional osteoporosis
therapy, Calcichew 500mg can be taken with or without food and drink.
For use as a phosphate binder, Calcichew 500 mg 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
Calcichew 500 mg.
During pregnancy the daily intake should not exceed 2500mg calcium
(including food and supplementation). If you are pregnant, you may use
Calcichew 500mg in case of a calcium deficiency.
Calcichew 500mg can be used during breastfeeding. Calcium passes into
breast milk.
Driving and using machines
Calcichew 500mg has no known influence on the ability to drive or use
machines.
Calcichew 500mg contains isomalt
Calcichew 500mg 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 500mg

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 500mg Chewable Tablets 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 500mg than you should, talk to your
doctor or pharmacist immediately.

Ref: 1293/070317/1/B

®

Calcichew 500mg Chewable Tablets
(calcium carbonate)
Patient Information Leaflet (continued)
If you accidentally take more Calcichew 500mg 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 500mg Chewable Tablets
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 (atulence)
* constipation
* heartburn (dyspepsia)
Very rare side effects (may affect less than 1 in 10,000 people):
* rash
* hives
* itching
If you are taking Calcichew 500 mg Chewable 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, nurse or pharmacist. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the YellowCard 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 500mg

* Do not store above 30oC
* Keep container tightly closed to protect from moisture
* Keep out of the sight and reach of children
* Do not use this medicine after the expiry date which is stated on the pack
* If the tablets become discoloured or show signs of any deterioration, you
should seek the advice of your pharmacist who will advise 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

Contents of the pack and other information

6

What this medicine contains:
Each tablet contains calcium carbonate 1250mg equivalent to 500mg of
calcium. Also contains sorbitol (E420), povidone, isomalt (E953), orange
flavour unspecified, magnesium stearate, aspartame (E951) and fatty acids
mono- and di- glycerides.
What this medicine looks like and contents of the pack
Calcichew are round, white, uncoated, orange flavoured and convex tablets.
May have small specks. They come in a pack size of 90 tablets
Manufacturer and Licence Holder
This medicine is manufactured by Takeda Nycomed AS, Drammensveien
852, P.O. Box 205, 1372 Asker, Norway and is 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.

P

PL 15184/1293

Calcichew is a registered trademark of Shire Pharmaceuticals Limited.
Revision date: 07/03/17

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you
Additional Information
Calcichew 500 mg 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 500 mg 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.
*Registered Trademark

Ref: 1293/070317/2/F

®

Mastical 500mg Chewable Tablets
(calcium carbonate)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
This medicine is available without prescription. However, you still need to
take Mastical 500mg Chewable Tablets carefully to get the best results from
it.
* 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.
Your medicine is called Mastical 500mg Chewable Tablets, however
thourghout this leaflet it will be referred to as Mastical 500mg
In this leaflet:
1 What Mastical 500mg is and what it is used for
2 What you need to know before you take Mastical 500mg
3 How to take Mastical 500mg
4 Possible side-effects
5 How to store Mastical 500mg
6 Contents of the pack and other information

1

What Mastical 500mg is and what it is used for

Mastical 500mg Chewable 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.
Mastical 500mg 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
500mg

Do not take Calcichew 500 mg Chewable Tablets 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 500 mg:
* 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 500 mg should be reduced or the treatment
discontinued.

Other medicines and Calcichew 500 mg
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 Mastical 500mg
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 Mastical 500mg.
* 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 Mastical 500mg.
* Bisphosphonates should be taken at least one hour before Calcichew
500mg.
* 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 Mastical 500mg.
If you are taking any of the above-mentioned medicines, your doctor will
give you further instructions.
Taking Mastical 500mg with food and drink
For treatment of calcium deficiency or use as an additional osteoporosis
therapy, Mastical 500mg can be taken with or without food and drink.
For use as a phosphate binder, Calcichew 500 mg 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
Calcichew 500 mg.
During pregnancy the daily intake should not exceed 2500mg calcium
(including food and supplementation). If you are pregnant, you may use
Mastical 500mg in case of a calcium deficiency.
Mastical 500mg can be used during breastfeeding. Calcium passes into
breast milk.
Driving and using machines
Mastical 500mg has no known influence on the ability to drive or use
machines.
Mastical 500mg contains isomalt
Mastical 500mg 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 Mastical 500mg

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 Mastical 500mg Chewable Tablets 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 Mastical 500mg than you should, talk to your
doctor or pharmacist immediately.

Ref: 1293/070317/2/B

®

Mastical 500mg Chewable Tablets
(calcium carbonate)
Patient Information Leaflet (continued)
If you accidentally take more Mastical 500mg 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 Mastical 500mg Chewable Tablets
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 (atulence)
* constipation
* heartburn (dyspepsia)
Very rare side effects (may affect less than 1 in 10,000 people):
* rash
* hives
* itching
If you are taking Calcichew 500 mg Chewable 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, nurse or pharmacist. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the YellowCard 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 Mastical 500mg

* Do not store above 30oC
* Keep container tightly closed to protect from moisture
* Keep out of the sight and reach of children
* Do not use this medicine after the expiry date which is stated on the pack
* If the tablets become discoloured or show signs of any deterioration, you
*

should seek the advice of your pharmacist who will advise 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

Contents of the pack and other information

6

What this medicine contains:
Each tablet contains calcium carbonate 1250mg equivalent to 500mg of
calcium. Also contains sorbitol (E420), povidone, isomalt (E953), orange
flavour unspecified, magnesium stearate, aspartame (E951) and fatty acids
mono- and di- glycerides.
What this medicine looks like and contents of the pack
Calcichew are round, white, uncoated, orange flavoured and convex tablets.
May have small specks. They come in a pack size of 90 tablets
Manufacturer and Licence Holder
This medicine is manufactured by Takeda Nycomed AS, Drammensveien
852, P.O. Box 205, 1372 Asker, Norway and is 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.

P

PL 15184/1293

Revision date: 07/03/17

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you
Additional Information
Calcichew 500 mg 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 500 mg 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.
*Registered Trademark

Expand view ⇕

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.

Hide