CALCIUM CARBONATE 500MG CHEWABLE TABLETS

Active substance: CALCIUM CARBONATE

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Calcichew 500mg Chewable Tablets/Calcium Carbonate 500mg Chewable Tablets
(calcium carbonate)
Your medicine is known by one of the above names, but will be referred to
as Calcichew 500mg throughout this:
Patient Information 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 Calcichew 500mg carefully to get the best results from it.
 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.
 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.
In this leaflet:
1) What Calcichew 500mg are and what they are used for
2) Before you take Calcichew 500mg
3) How to take Calcichew 500mg
4) Possible side effects
5) How to store Calcichew 500mg
6) Further information

1) What Calcichew 500mg are and what they are used for
Calcichew 500mg are orange flavoured chewable tablets. They contain the
active ingredients:
 Calcium (1250mg calcium carbonate: equivalent to 500mg calcium)
Calcium is found in the diet.
Calcichew 500mg 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 renal dialysis to remove the phosphate
from food that cannot be removed by dialysis.

2) Before you take Calcichew 500mg
Do not take Calcichew 500mg if you:
 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.
 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 Calcichew 500mg:
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 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 500mg should be reduced or the
treatment discontinued.
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 500mg
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
Calcichew 500mg may need to be increased
 tetracycline antibiotics; these should be taken at least two hours
before, or four to six hours afterwards.
 Hormones (levothyroxine); these should be taken at least four hours
before, or afterwards.
 Anti-infectives (Quinolones: Ciprofloxacin, lomefloxacin,
norfloxacin, sparfloxacin): please speak with your doctor.
 fluoride, or bisphosphonates; Calcichew 500mg should be taken at
least three hours afterwards.
Taking Calcichew 500mg with food and drink
Calcichew 500mg 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).
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice if you are pregnant or breastfeeding before taking Calcichew 500mg.
Driving and using machines
Calcichew 500mg has no known effect on your ability to drive or use
machines.
Important information about some of the ingredients of Calcichew
500mg
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 phenylketonuria (a deficiency in the enzyme which breaks
down phenylalanine).

3) How to take Calcichew 500mg
Always take Calcichew 500mg 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:
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 Calcichew 500mg is given to patients on kidney dialysis, the dose
will be different for each patient. Your doctor will decide how many
Calcichew 500mg 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 than you should
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, light-headedness,
muscle spasms, twitches and tingling sensation.
Do not take any more Calcichew 500mg 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 500mg
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.

Who makes and repackages your medicine?
Your medicine is manufactured by Takeda Nycomed AS Drammensveien
852, P.O.Box 205 1372 Asker, Norway. Procured from within the EU and
repackaged by Product Licence Holder: Primecrown Ltd, 4/5 Northolt
Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

4) Possible side effects
Like all medicines, Calcichew 500mg can cause side effects, although not
everybody gets them.

Leaflet date: 10.01.2014.

Side effects with Calcichew 500mg may include:

Additional Information
Calcichew 500mg contains calcium designed to keep bones healthy.
Calcium is an essential component of bones.

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)

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.

Rare side effects (affecting less than 1 in 1000 people):
 nausea
 stomach ache
 constipation
 diarrhoea
 wind (flatulence)
 rash
 hives
 itching

Calcichew 500mg 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.

Very rare side-effects (affecting less than 1 in 10000 people):
 Milk alkali syndrome – (usually only seen in overdose see “if you take
more than you should”)
If you are taking Calcichew 500mg 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 sideeffect(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 500mg
 Keep all medicines out of the sight and reach of children.
 Do not store above 30°C. Keep container tightly closed.
Protect from moisture.
 Do not use Calcichew 500mg after the expiry date which is stated on the
label after EXP. The expiry date refers to the last day of that month. If
the tablets have changed shape or colour do not use.
 If the tablets become discoloured or show signs of any deterioration, you
should ask 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.

6) Further information
What Calcichew 500mg contains:
Each chewable tablet contains 1250mg calcium carbonate equivalent to
500mg calcium.
The tablet also contains; sorbitol (E420), povidone, isomalt (E953), mono
and di-fatty acid glycerides, magnesium stearate, orange flavour, and
aspartame (E951).
This product is gluten and lactose free.
What Calcichew 500mg looks like and contents of the pack
The tablets are round, white, uncoated convex and orange flavoured; they
may have small specks.
The tablets are packed in white, plastic bottles of 90 tablets.
PL 10383/1965

Calcichew 500mg Chewable Tablets/
Calcium Carbonate 500mg Chewable Tablets

P

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

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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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