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CALCICHEW 500MG TABLETS

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

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Calcichew® 500mg Tablets/ Calcioral® 500mg Tablets
(calcium carbonate) equivalent to 500mg Calcium
Your medicine is available using one of the above names but will be referred
to as Calcichew 500mg throughout the following:
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.
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 is it 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 500mg 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 500mg:
• 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 500mg should be reduced or the treatment
discontinued.
Other medicines and Calcichew 500mg
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 500mg 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 500mg.
During pregnancy the daily intake should not exceed 2500 mg 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.
Calcichew 500mg 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 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.

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.

(E951) (see also end of Section 2 “Important information about some of the
ingredients of Calcichew 500mg”).
What Calcichew 500mg look like and contents of the pack
The tablets are unmarked, round, white and chewable.
Calcichew 500mg Tablets are available in bottles of 60 tablets.

Very rarely in addition: irritability, continuing headache, lightheadedness,
muscle spasms, twitches and tingling sensation.

PL 10383/1236

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.

Who makes and repackages your medicine?
Your medicine is manufactured by Takeda Nycomed AS, Drammensveien
852, P.O. Box 205, 1372 Asker, Norway or Takeda Pharma AS, 55B Jaama
Street, 63308 Polva, Estonia. Procured from within the EU and repackaged by
the Product Licence holder: Primecrown Ltd, 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.

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 500mg 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, 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 out of the sight and reach of children.
• Do not store above 25°C. Keep the container tightly closed to protect from
moisture.
• Don’t use after the expiry date which is stated on the carton or container
label. The expiry date refers to the last day of that month.
• 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
• 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
What Calcichew 500mg Tablets contain
Each tablet contains 1250mg calcium carbonate (equivalent to 500mg
calcium).
The other ingredients are: sorbitol (E420), povidone, isomalt (E953), mono,
di-fatty acid glycerides, magnesium stearate, orange flavour, and aspartame

P

Leaflet date: 06.04.2017
Calcichew is a registered trademark of Takeda AS, Norway.
Additional Information
Calcichew 500mg 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 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.
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.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8839 3000 to obtain the
leaflet in a format suitable for you.

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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