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CALCICHEW - D3 CHEWABLE TABLETS

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

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EAMS

2. Colour PMS: 2975
• Braille

4. proof:
08.08.2016

• Size/Die cut: 200

Graphic:

Tom Haugen

OS:

Mac OS X

Software:

Adobe CC 2015

E-mail: tom.haugen@takeda.com

100%

CALCICHEW*-D3
500 mg/200 IU
CHEWABLE TABLETS

PL 16189/0025

Each tablet contains 1250mg calcium carbonate
(equivalent to 500mg calcium) and 200IU
colecalciferol (equivalent to 5 micrograms Vitamin D3).
Also includes isomalt (E953) and sucrose.
Please read the patient information leaflet for
further information. For oral administration.
Adults and elderly: One tablet to be
chewed or sucked 2 or 3 times a day
or as directed by your doctor.
Children: One tablet to be chewed or
sucked 1 or 2 times a day or as directed
by the doctor.
Keep out of the sight and reach of
children.
Do not store above 30ºC.
P
Keep the container tightly closed
to protect from moisture.
Takeda UK Ltd. Wooburn Green,
BUCKS, HP10 0DF, UK
*Registered Trademark
EXP

1. Colour: Black

Calcichew*D3
500 mg/200 IE
1OO Tablets
1105264
QI000007046
NA
6083708-06
UK
170 x 60
200 ml

calcium/colecalciferol

calcichew d#c
chewable
Tablets

BATCH No.

Side effects include:

Peel here but do not remove

CALCICHEW*-D3
500 mg/200 IU
CHEWABLE TABLETS

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

calcichew d#c
chewable
tablets
calcium/colecalciferol

100 Chewable Tablets

PATIENT INFORMATION LEAFLET
CALCICHEW*-D3 500 mg/200 IU CHEWABLE TABLETS
calcium / colecalciferol
Read all of this leaflet carefully 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-D3 is and what it is used for
2. What you need to know before you take Calcichew-D3
3. How to take Calcichew-D3
4. Possible side-effects
5. How to store Calcichew-D3
6. Contents of the pack and other information

Rare side effects (may affect up to 1 in 1,000 people):
• nausea
• wind (flatulence)
• stomach ache
• rash
• constipation
• hives
• heartburn (dyspepsia)
• itching
• diarrhoea

Reporting of side effects
If you get any side effects talk to your doctor or pharmacist. This includes any
side effects not listed in this leaflet. You can also report side effects directly via
the national reporting system listed in United Kingdom as Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

Very rare side-effects (may affect up to 1 in 10,000 people):
• Milk alkali syndrome (also called Burnett’s Syndrome and usually
only seen when excessive amounts of calcium have been
ingested), symptoms are 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 with frequency not known (cannot be estimated from
the available data):

1. WHAT CALCICHEW-D3 IS AND WHAT IT IS USED FOR
Calcichew-D3 Chewable Tablets are orange flavoured chewable tablets
containing calcium and vitamin D3 which are both important substances in bone
formation. Both are found in the diet and vitamin D is also produced in the skin
after exposure to the sun.
Calcichew-D3 is used to treat and prevent vitamin D/calcium deficiency, which
may occur when 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.
2. BEFORE YOU TAKE CALCICHEW-D3
Do not take Calcichew-D3 Chewable Tablets if you:
• are allergic to calcium, vitamin D, or any of the other ingredients of this
medicine (listed in section 6).
• have severe kidney problems
• have a condition that causes excessive amounts of calcium in your blood or
urine (hypercalcaemia or hypercalciuria) e.g.
• renal (kidney) failure
• cancer that has affected your bones

• Hypersensitivity reactions such as swelling of the face, tongue, lips
(angioedema) or swelling of the throat (laryngeal oedema).
• If you have impaired renal function, you may be at risk of increased amounts
of phosphate in the blood, renal stone formation and increased amounts of
calcium in the kidneys.

5. HOW TO STORE CALCICHEW-D3 CHEWABLE TABLETS
Keep out of the sight and reach of children.
Store in the original package. Keep the container tightly closed to protect from
moisture Do not store above 30*C.
Do not use Calcichew-D3 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

• have excessive amounts of Vitamin D in your blood
• have kidney stones.
Warnings and precautions
Talk to your doctor or pharmacist before taking Calcichew-D3:
• 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 renal function or a high tendency to kidney
stone (calculus) formation
• if you have cancer or any other conditions that may have affected your
bones.
• if you have sarcoidosis (an immune system disorder which may cause
increased levels of vitamin D in the body).
If you have any of the following conditions your serum calcium or phosphate
levels, or urinary calcium excretion must be monitored. Calcichew should be
taken under close medical supervision.
• sarcoidosis (an immune system disorder which may affect your liver, lungs,
skin or lymph nodes)
• kidney problems
• you are on long-term treatment with Calcichew
• you are already taking additional doses of calcium or vitamin D.

changed shape or colour do not use.
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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION

The active ingredients in each tablet are:
• 1250mg calcium carbonate (equivalent to 500 mg calcium)
• 200IU colecalciferol (equivalent to 5 micrograms Vitamin D3)

This leaflet was last revised in July 2016.

The other ingredients are: xylitol (E967), povidone, isomalt (E953), fatty acid
mono- and di-glycerides, magnesium stearate, orange flavour, sucralose (E955),
sucrose, tocopherol, modified maize starch, medium chain triglycerides, sodium
ascorbate and anhydrous colloidal silica (see also end of Section 2
“Calcichew-D3 contains isomalt and sucrose”).
What Calcichew-D3 look like and contents of the pack
The tablets are round, white, uncoated convex and orange flavoured; they may
have small specks.

Other medicines and Calcichew D3
Please inform your doctor or pharmacist if you are taking or have recently taken
or might take any other medicines.
In particular, the following medicines may interact with Calcichew-D3 chewable
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-D3.
• quinolone antibiotics (ciprofloxacin, iomefloxacin, 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-D3.

Marketing Authorisation Holder
Takeda UK Ltd., Building 3, Glory Park, Glory Park Avenue, Wooburn Green,
BUCKS, HP10 0DF, United Kingdom
Manufacturer
Takeda AS, Drammensveien 852, N-1385 Asker, Norway.

What Calcichew-D3 Chewable Tablets contain

If you have increased calcium levels in the blood or develop signs of kidney
problems, the dose of Calcichew-D3 should be reduced or the treatment
discontinued.

The tablets are packed in white, plastic bottles of 100 tablets.

Additional Information
Calcichew-D3 are a combination of calcium and vitamin D designed to keep
bones healthy. Calcium is an essential component of bones while vitamin D
plays an important role in the absorption of calcium from food.
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. Vitamin
D is produced largely from the action of sunlight Certain foodstuffs do contain
vitamin D in reasonable amounts but it is not always possible to obtain all the
vitamin D you need from your diet. People who do not get out and about, for

instance those who are housebound or people living in nursing and residential
homes, may not receive all the vitamin D they need.
People with diets and lifestyles that mean they will obtain less than the
recommended intake of calcium and vitamin D are at risk of weakened bones.
Prolonged lack of adequate calcium and vitamin D 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.

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.
*Registered Trademark

Calcichew-D3 has been designed to give people, whose intakes of calcium and
vitamin D are 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
vitamin D and, for some people, advice on how to prevent falls which may lead
to fracture.
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.

• bisphosphonates; should be taken at least one hour before Calcichew-D3.
• 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-D3.
• Orlistat (used to treat obesity) may disturb the absorption of fat-soluble
vitamins, e.g. vitamin D3.

Calcichew-D3 can be used during breast-feeding. Calcium and vitamin D3 pass
into breast milk. This should be considered when giving additional vitamin D to
the child.

Children
The recommended dose is two tablets a day, preferably one tablet in the
morning and one tablet in the evening. The tablet may be chewed or sucked.

Driving and using machines
Calcichew- D3 has no known influence on the ability to drive or use machines.

If you take more than you should
If you have taken more Calcichew-D3 than you should, talk to your doctor or
pharmacist immediately.

If you are taking any of the above-mentioned medicines, your doctor will give
you further instructions.

Calcichew-D3 contains isomalt and sucrose.
Calcichew-D3 contains isomalt (E953) and sucrose (E420): 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.

If you forget to take Calcichew-D3 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.

3. HOW TO TAKE CALCICHEW-D3 CHEWABLE TABLETS

4. POSSIBLE SIDE-EFFECTS

Always take Calcichew-D3 exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.

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:
• 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.

Taking Calcichew-D3 with food and drink
Calcichew-D3 can be taken with or without food and drink.
Pregnancy and breastfeeding
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-D3 .
If you are pregnant, you may use Calcichew-D3 in case of a calcium and vitamin
D deficiency. During pregnancy you should not take more than 2500 mg calcium
and 4000 IU vitamin D per day, as overdoses may harm the unborn child.

Dosage
The recommended dose is two or three tablets a day, preferably one tablet in
the morning, one at midday and one in the evening. The tablet may be chewed
or sucked.

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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