Calcichew 500 mg chewable tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Calcium
Available from:
PCO Manufacturing Ltd.
ATC code:
A12AA; A12AA04
INN (International Name):
Calcium
Dosage:
500 milligram(s)
Pharmaceutical form:
Chewable tablet
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Calcium; calcium carbonate
Authorization status:
Authorised
Authorization number:
PPA0465/156/001
Authorization date:
2005-12-02

Package leaflet: Information for the user

CALCICHEW

®

500 mg CHEWABLE TABLETS

calcium

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:

What Calcichew 500 mg is and what it is used for

What you need to know before you take Calcichew 500 mg

How to take Calcichew 500 mg

Possible side-effects

How to store Calcichew 500mg

Contents of the pack and other information

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.

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.

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 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

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.

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, breast-feeding 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 breast-feeding. 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

Calcium 500 mg 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 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:

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. Very rarely in addition: irritability,

continuing headache, light-headedness, muscle spasms, twitches

and tingling sensation.

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.

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 (hypercalciuria) 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 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. This includes any

possible side effects not listed in this leaflet. You can also report

side effects directly to HPRA Pharmacovigilance, Earlsfort Terrace,

IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie;

E-mail: medsafety@hpra.ie. By reporting side effects you can help

provide more information on the safety of this medicine.

5.

How to store Calcichew 500 mg

Keep this medicine out of the sight and reach of children.

Keep the bottle tightly closed in order 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.

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 protect the environment.

6.

Contents of the pack and other information

What Calcichew 500 mg Chewable Tablets contain

The active substance is calcium. Each tablet contains 1250 mg

calcium carbonate equivalent to 500 mg calcium.

The other ingredients are: xylitol (E967), povidone, isomalt (E953),

fatty acid mono- and diglycerides, magnesium stearate, orange

flavour, and sucralose (E955) (see also end of Section 2 “Calcichew

500 mg contains isomalt”).

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 60 tablets.

Product procured from within the EU, repackaged and

distributed by the parallel product authorisation holder who is:

PCO Manufacturing, Unit 10, Ashbourne Business Park, Rath,

Ashbourne, Co. Meath, Ireland.

Manufacturer

Takeda AS/Takeda Nycomed AS, Drammensveien 852,

NO-1383 Asker, Norway or Takeda Pharma AS, 55B Jaama Street

63308 Polva, Estonia or Nycomed Danmark ApS, Langebjerg 1,

4000 Roskilde, Denmark

Parallel Product Authorisation Number: PPA 465/156/1

Calcichew is a registered trademark of TAKEDA AS

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 Irish Osteoporosis Society (IOS) is a national charity dedicated

to reducing the incidence of osteoporosis and promoting bone

health. The IOS offers information and support to people with

osteoporosis, their families and everyone at risk from the disease.

If you are concerned about osteoporosis, please contact the Irish

Osteoporosis Society, 114 Pembroke Road, Garden Level,

Ballsbridge, Dublin 4, Tel: 1890 252 751, Fax: +353 (0)1 6680098,

Email: info@irishosteoporosis.ie

Date of leaflet preparation by PCO Manufacturing:

November 2018

Health Products Regulatory Authority

15 November 2018

CRN008MKX

Page 1 of 2

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Calcichew 500 mg chewable tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 1250 mg calcium carbonate, equivalent to 500 mg elemental

calcium.

Excipient(s) with known effect

Isomalt (E953)

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Chewable tablet.

Product imported from Greece

White, round chewable tablets with orange flavour.

4 CLINICAL PARTICULARS

As per PA2229/005/001

5 PHARMACOLOGICAL PROPERTIES

As per PA2229/005/001

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Xylitol (E967)

Povidone

Flavouring (orange)

Magnesium stearate

Sucralose (E955)

Isomalt (E953)

Monoglycerides and diglycerides of fatty acids

6.2 Incompatibilities

Not applicable.

Health Products Regulatory Authority

15 November 2018

CRN008MKX

Page 2 of 2

6.3 Shelf life

The shelf-life expiry date of this product is the date shown on the container and

outer package of the product on the market in the country of origin.

6.4 Special precautions for storage

Do not store above 30°C.

Keep the bottle tightly closed in order to protect from moisture.

6.5 Nature and contents of container

Bottles of 60 chewable tablets contained in an outer cardboard carton.

6.6 Special precautions for disposal of a used medicinal product or waste

materials derived from such medicinal product and other handling of the

product

No special requirements.

7 PARALLEL PRODUCT AUTHORISATION HOLDER

PCO Manufacturing

Unit 10, Ashbourne Business Park

Rath

Ashbourne

Co. Meath

Ireland

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA0465/156/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 02 December 2005

Date of last renewal: 02 December 2010

10 DATE OF REVISION OF THE TEXT

November 2018

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