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CALCICHEW-D3 1000MG/800IU ONCE DAILY CHEWABLE TABLETS

Active substance(s): CALCIUM CARBONATE / CHOLECALCIFEROL CONCENTRATE (POWDER FORM) / COLECALCIFEROL

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Calcichew*D3
1000 mg / 800 IU
30 tablets
6108519
QI000007044
6108530-04
6108530-03
50 x 155
110 ml
UK
5035382011554
225
100%

035382 0 1 1 5 5 4

EXP

BATCH No.

Peel here but do not remove

C

Takeda UK Ltd.
Wooburn Green,
BUCKS, HP10 0DF, UK.
*Registered Trademark

alcichew*-D

3

1000 mg/800 IU

Once Daily Chewable Tablets
1000 mg calcium (as calcium carbonate)
800 IU vitamin D3 (20µg colecalciferol)

30 chewable tablets

Package leaflet: Information for the user

Calcichew-D3 1000 mg/800 IU Once Daily
chewable tablets
calcium / colecalciferol (vitamin D3 )
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.
• 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.

EAMS

2. Colour: Yellow

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3. Colour: PMS 531

Graphic:

20.05.2016

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• Size/Die cut:

Calcichew*-D

3

1000 mg/800 IU
Once Daily Chewable Tablets
1000 mg calcium (as calcium carbonate)
800 IU vitamin D3 (20µg colecalciferol)

30 chewable tablets

may occur with large doses.
Rare side effects (may affect up to 1 in
1,000 people):
• constipation;
• nausea;
• dyspepsia;
• gastric pain;
• flatulence;
• diarrhoea;

PL 16189/0028 14981 V3 (13070410092302)
6108530-04

5

Each tablet contains 1000 mg calcium (as calcium carbonate) and
800 IU vitamin D3 (equivalent to 20 microgram colecalciferol). Also
includes isomalt (E953) and sucrose.
Read the package leaflet before use.
Oral use. Adults and elderly: One chewable tablet
once daily. The tablet may be chewed or sucked.
Keep out of the sight and reach of children.
Do not store above 30°C. Store in the original
package in order to protect from light. Keep the
container tightly closed in order to protect from
moisture.

1. Colour: Black

or vomiting, unusual tiredness or weakness, along
with elevated levels of calcium in the blood and
kidney impairment.
If you have impaired renal function, you may be at
risk of increased amounts of phosphate in the
blood, kidney stone formation and increased
amounts of calcium in the kidneys.

Very rare side effects (may affect up to 1 in
10,000 people):
• itching, rash and hives.
• 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

What is in this leaflet
1. What Calcichew-D3 Once Daily is and what it is used for
2. What you need to know before you take
Calcichew-D3 Once Daily
3. How to take Calcichew-D3 Once Daily
4. Possible side effects
5. How to store Calcichew-D3 Once Daily
6. Contents of the pack and other information
1. What Calcichew-D3 Once Daily is and
what it is used for
Calcichew-D3 Once Daily are chewable tablets
containing calcium and vitamin D3, which both
are important substances in bone formation.
Calcichew-D3 Once Daily is used in the prevention
and treatment of calcium and vitamin D deficiency in

Calcichew
Once
Daily

the elderly, and as a supplement to specific treatment
of osteoporosis.
2. What you need to know before you take
Calcichew-D3 Once Daily
Do not take Calcichew-D3 Once Daily:
• if you are allergic to calcium, vitamin D, or any of
the other ingredients of this medicine (listed in
section 6).
• if you have severe kidney problems
• if you have excessive amounts of calcium in the
blood or in the urine.
• if you have kidney stones.
• if you have excessive amounts of vitamin D in the
blood.

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 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.

5. How to store Calcichew-D3 Once Daily
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which
is stated on the label. The expiry date refers to the
last day of that month.
Tablet container: Do not store above 30°C. Store in
the original container in order to protect from light.
Keep the container tightly closed in order to protect
from moisture.
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.

Warnings and precautions
• if you take other products containing vitamin D.
Talk to your doctor or pharmacist before taking
Additional doses of calcium and vitamin D should
Calcichew-D3 Once Daily
be taken under close medical supervision.
• if you are on long-term treatment, especially if
Children and adolescents
you also take diuretics (used in treatment of high
Calcichew-D3 Once Daily are not intended for use in
blood pressure or oedema) or cardiac glycosides
children and adolescents.
(used to treat heart disorders).
Other medicines and Calcichew-D3 Once Daily
• if you have signs of impaired renal function or high
Tell your doctor or pharmacist if you are taking,
tendency of renal stone formation.
or have recently taken or might take any other
• if you have sarcoidosis (an immune system
medicines.
disorder which may cause increased levels of
If you also take tetracyclines (a type of antibiotics),
vitamin D in the body).
you should take these at least 2 hours before or
• if you have osteoporosis and at the same time are
4-6 hours after intake of Calcichew-D3 Once Daily.
unable to move around.
Calcium carbonate may interfere with the absorption
of tetracycline preparations if taken at the same time.

6. Content of the pack and other
information
What Calcichew-D3 Once Daily contains
The active substances in one tablet are:
• calcium carbonate 2500mg (equivalent to
1000 mg calcium)
• colecalciferol (vitamin D3) 800 IU (20 microgram)
• The other ingredients are xylitol (E967), povidone,
isomalt (E953), flavouring (lemon), magnesium
stearate, sucralose (E955), mono-and diglycerides
of fatty acids, all-rac-alpha-tocopherol, sucrose,
modified maize starch, medium chain triglycerides,
sodium ascorbate and anhydrous colloidal silica (see
also end of Section 2 “Important information about
some of the ingredients of Calcichew-D3 Once Daily”).

Medicines containing bisphosphonates (used to
treat osteoporosis) should be taken at least one hour
before intake of Calcichew-D3 Once Daily.
Calcium can reduce the effect of levothyroxine
(used to treat thyroid deficiency). For this reason,
levothyroxine should be taken at least four hours
before or four hours after Calcichew-D3 Once Daily.
The effect of quinolone antibiotics may be reduced if
taken at the same time as calcium. Take quinolone
antibiotics two hours before or six hours after taking
Calcichew-D3 Once Daily.
Calcium salts may decrease the absorption of iron,
zinc and strontium ranelate. Consequently, these
preparations should be taken at least two hours
before or after the calcium preparation.

What Calcichew-D3 Once Daily looks like
and contents of the pack
Calcichew-D3 Once Daily are white, round
chewable tablets. May have small specks.

Pack sizes:
Tablet container with HDPE screw cap:
15, 30, 40, 60 and 90 tablets. Not all pack sizes
may be marketed.
Marketing Authorisation Holder
Takeda UK Limited
Building 3, Glory Park, Glory Park Avenue,
Wooburn Green, BUCKS, HP10 0DF, UK

Other medicines that may influence or be influenced
by Calcichew-D3 Once Daily are:
• thiazide diuretics (used in treatment of high blood
pressure or oedema)
• cardiac glycosides (used to treat heart disorders)
Orlistat (used to treat obesity) may disturb the
absorption of fat-soluble vitamins, e.g. vitamin D3.
If you are taking any of the above-mentioned
medicines, your doctor will give you further
instructions.
Calcichew-D3 Once Daily with food and drink
Calcichew-D3 Once Daily can be taken with or without
food and drink.
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

Manufacturer
Takeda AS
Drammensveien 852
P.O.Box 205
NO-1372 Asker, Norway
This leaflet was last revised in 10/2015.
Additional Information
Calcichew-D3 Once Daily 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

doctor or pharmacist before taking this medicine.
If you are pregnant, you may use Calcichew-D3
Once Daily 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.
Calcichew-D3 Once Daily can be used during
breastfeeding. Calcium and vitamin D3 pass into breast
milk. This should be considered
when giving additional
3
vitamin D to the child.
Driving and using machines
Calcichew-D3 Once Daily has no known influence on the
ability to drive and use machines.

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

Calcichew-D3 Once Daily contains isomalt and
sucrose
Calcichew-D 3 Once Daily contains isomalt (E953)
and sucrose. If you have been told by your
doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal
product. May be harmful to the teeth.
3. How to take Calcichew-D3 Once Daily
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
Dosage:
The recommended dose is one tablet once daily. The
tablet may be chewed or sucked.

minimal trauma (for example, a fall) can result
in a fracture, most typically at the hip, spine
or wrist.

For patients in the UK, the National
Osteoporosis Society (NOS) is a national
charity dedicated to improving the diagnosis,
prevention and treatment of osteoporosis.

Calcichew-D3 Once Daily have 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 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
*Registered Trademark
6108530-04

Use in children and adolescents
Calcichew-D3 Once Daily chewable tablets are not
intended for use in children and adolescents.
If you take more Calcichew-D3 Once Daily than
you should
If you may have taken more Calcichew-D3 Once Daily
than you should, talk to your doctor or pharmacist
immediately.
If you forget to take Calcichew-D3 Once Daily
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.

14981 V3 (13070410092302)

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Hypersensitivity reactions have occurred with
unknown frequency (cannot be estimated from
the available data). If you experience the following
symptoms, you should immediately contact a
doctor:
• Swelling of the face, tongue, lips (angioedema) or
swelling of the throat (laryngeal oedema).
Uncommon side effects (may affect up to 1 in 100
people):
• excessive amounts of calcium in the blood
• (hypercalcaemia) or in the urine (hypercalcuria)

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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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