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CALCICHEW 500MG CHEWABLE TABLETS

Active substance(s): CALCIUM CARBONATE

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Calcichew
chewable

PL 16189/0023
PA 1547/7/1

Each tablet contains 1250mg calcium carbonate
(E420), isomalt (E953) and aspartame (E951).
Please read the patient information leaflet for
further information.
For oral administration.
5

Calcichew
chewable
to protect from moisture.
Takeda UK Ltd. Wooburn Green,
BUCKS, HP10 0DF, UK
*Registered Trademark

EXP

calcium carbonate
equivalent to 500mg calcium

100 Chewable Tablets

#ejj mg
tablets

6083706-06

035382 011332

to be chewed or sucked 2 or 3 times
a day or as directed by your doctor.
Keep out of the reach and sight
of children.
P
Do not store above 30ºC.

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

Peel here but do not remove

#ejj mg
calcium carbonate
tablets
equivalent to 500mg calcium

100 Chewable Tablets

PATIENT INFORMATION LEAFLET

CALCICHEW* 500 mg CHEWABLE TABLETS
calcium carbonate

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 500 mg is and what it is used for
2. What you need to know before you take Calcichew 500 mg
3. How to take Calcichew 500 mg

If you forget to take Calcichew 500 mg 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.

4. Possible side-effects
5. How to store Calcichew 500 mg
6. Contents of the pack and other information

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 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 or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects
directly via:

urine (hypercalcaemia or hypercalciuria)
• have kidney stones.

Calcichew 500 mg 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.

Warnings and precautions
Talk to your doctor or pharmacist before taking Calcichew 500 mg:
• if you have phenylketonuria (a deficiency in the enzyme which breaks down
phenylalanine) as these tablets contain aspartame, a source of phenylalanine
• 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.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCICHEW 500 MG
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

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

1. WHAT CALCICHEW 500 MG IS AND WHAT IT IS USED FOR
Calcichew 500 mg 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.

Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie

Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures
will help to protect the environment.

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

The other ingredients are: sorbitol (E420), povidone, isomalt (E953), fatty acid
mono- and di-glycerides, magnesium stearate, orange flavour, and aspartame
(E951) (see also end of Section 2 “Calcichew 500 mg contains isomalt, sorbitol
and aspartame”).

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Calcichew 500 mg Chewable Tablets contain
The active ingredient in each tablet is 1250 mg calcium carbonate (equivalent
to 500 mg calcium).

By reporting side effects you can help provide more information on the safety of
this medicine.
5. HOW TO STORE CALCICHEW 500MG
Keep this medicine out of the sight and reach of children.
Store in the original package to protect from moisture. Do not store above 30 ˚C.
Do not use this medicine after the expiry date which is stated on the label after
EXP. The expiry date refers to the last day of that month.

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 500 mg
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 500 mg.
• 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 500 mg.

Manufacturer
Takeda AS, Drammensveien 852, N-1385 Asker, Norway.

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.

This leaflet was last revised in October 2015.
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.

What Calcichew 500 mg look 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 100 tablets.

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.

Marketing Authorisation Holder
Takeda UK Ltd., Building 3, Glory Park, Glory Park Avenue, Wooburn Green,
BUCKS, HP10 0DF, United Kingdom

Calcichew 500 mg have been designed to give people, whose intake of calcium
is low, a boost to the recommended amounts.

• Bisphosphonates should be taken at least one hour before Calcichew
500 mg.
• 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 500 mg.
If you are taking any of the above-mentioned medicines, your doctor will give
you further instructions.
Taking Calcichew 500 mg with food and drink
For treatment of calcium deficiency or use as an additional osteoporosis
therapy, Calcichew 500 mg 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 2500 mg calcium
(including food and supplementation). If you are pregnant, you may use
Calcichew 500 mg in case of a calcium deficiency.

Calcichew 500 mg can be used during breastfeeding. Calcium passes into
breast milk.
Driving and using machines
Calcichew 500 mg has no known influence on the ability to drive or use
machines.
Calcichew 500 mg contains isomalt, sorbitol and aspartame
Calcichew 500 mg contains sorbitol (E420) and 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 500 mg 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 500 MG
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:

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

6083706-06

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 500 mg 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 500 mg than you should, talk to your doctor
or pharmacist immediately.
If you accidentally take more Calcichew 500 mg 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.

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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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