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CALCICHEW-D3 500 MG/400 IU CAPLETS

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

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Product name

Calcichew D3 500
mg/400 IU 100 tabl
New MID (Item No) GBR F.7/0XXX/6083720

Reason of change

Code

Braille

CR xxxx (CCDS)
old MID: GBR F.6/0416/6083720

xxx
130 x 50 mm

Dimensions
Printed colours

yellow black PMS 2748,
PMS 185 C
Not printed colours Braille Kontur varnish

Reference for
CMYK colours

SCA / A. Dohmen
Ready for print.

Total of label / Braille placement only – CCL work area

BRAILLE EXPLANATIONS AND TRANSLATIONS

13 mm

calcichew d#3
#500 mg / #400
iu caplets

calcichew d#c
#ejj mg | #djj
iu caplets

65 mm

12 mm
Tab

C
500 mg/400 IU
calcichew
Caplets
#ejj mg |
iu caplets

40 mm
For oral use: 1 tablet contains:
500 mg calcium (as calcium
carbonate) 400 IU vitamin D3
(10 microgram cholecalciferol)
Sorbitol (E420) and sucrose.
Read the package leaflet before
use. The tablet may be swallowed
or chewed.
Keep out of the sight
and reach of children.
Do not store above 25°C. Keep the
container tightly closed in order to
protect from moisture.
Takeda UK Ltd.
Wooburn Green, BUCKS,
HP10 0DF, UK
GBR F.7/xxxx/

alcichew*-D3

d#c
#djj

calcium/colecalciferol
(vitamin D3)

PL 16189/0027

For proofreading of Braille

Leaflet outside (Prima)
65 mm
Page 13

Rare side effects (may affect up to 1 in 1,000
people): constipation, dyspepsia, flatulence, nausea,
gastric pain, diarrhoea.
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 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.
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.
5. How to store Calcichew-D3 Caplets
Do not store above 25°C. Keep the container tightly
closed in order to protect from moisture.
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.
Do not throw any medicines via wastewater or

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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
What Calcichew-D3 Caplets contains
The active ingredients are 500 mg calcium (as
calcium carbonate) and 400 IU vitamin D3 (equivalent
to 10 micrograms colecalciferol).
The other ingredients are
tablet core: sorbitol E420, mannitol, acesulfame potassium,
flavouring (lemon), croscarmellose sodium, microcrystalline
cellulose, magnesium stearate, maltodextrin, tocopherol-rich
extract, all-rac-alpha-tocopherol, sucrose, modified maize
starch, medium chain triglycerides, sodium ascorbate and
anhydrous colloidal silica
film-coating: talc, hypromellose, propylene glycol.
(see also end of Section 2 “Important information about

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some of the ingredients of Calcichew-D3 500mg/400IU
Caplets”).
What Calcichew-D3 Caplets looks like and contents
of the pack
Calcichew-D3 Caplets are white/off white, oval filmcoated tablets.
Pack size: 100 tablets
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Takeda UK Ltd
Building 3, Glory Park,
Glory Park Avenue,
Wooburn Green,
BUCKS, HP10 0DF,
UK

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Manufacturer:
Takeda GmbH Lehnitzstr. 70-98 DE-16515
Oranienburg, Germany

Latvia: Calcigran Forte Flex 500 mg / 400 IU
apvalkotās tabletes
Lithuania:
Calcigran Forte Flex

This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria: Cal-D-or 500 mg/400 I.E. - Filmtabletten
Belgium: Steovit D3 500 mg/400 I.E., filmomhulde
tabletten
Denmark: Calcichew-D3 Forte Flex
Estonia:
Calcigran Forte Flex
Finland: Calcichew D3 Forte sitruuna
500 mg/10 mikrog – kalvopäällysteinen
tabletti
Greece: Calcioral D3®, 500 mg + 10 µg (400 IU),
επικαλυμμένο με λεπτό υμένιο δισκίο
Ireland: Calcichew-D3 Forte 500 mg / 400 IU
Film-coated Tablets

Luxembourg: Steovit D3 500 mg/400 U.I., comprimés
pelliculés
Netherlands: Calci-Chew D3 FLEX 500 mg/400 I.E.
Norway: Calcigran Forte 500 mg/400 IE tabletter,
filmdrasjerte
Poland:
Orocal D3 Tab
Sweden: Calci-D3 Citron 500 mg/400 IE
filmdragerad tablett
UK: Calcichew-D3 500 mg/400IU Caplets
This leaflet was revised in October 2015.

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Additional Information
Calcichew-D3 Caplets 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.
Calcichew-D3 Caplets 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.

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Glue

For patients in the UK, 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.
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

65 mm
Front page outside

alcichew -D3
C
500 mg/400 IU

12 mm
Tab

Caplets

calcium/colecalciferol
(vitamin D3)

GBR F.7/xxxx/6083720
Code xxx

Leaflet inside (Sekunda)

65 mm

12 mm
Tab

40 mm

calcichew
#ejj mg |
iu caplets

d#c
#djj

Base label (Selfadhesive)

Package leaflet: Information for the user
Calcichew-D3 500mg/400IU Caplets
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.

You must contact a doctor if your symptoms worsen or
do not improve after two weeks.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
What is in this leaflet:
1. What Calcichew-D3 Caplets are and what they are
used for
2. What you need to know before you take
Calcichew-D3 Caplets
3. How to take Calcichew-D3 Caplets
4. Possible side effects
5. How to store Calcichew-D3 Caplets
6. Contents of the pack and other information

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1. What Calcichew-D3 Caplets are and what they
are used for
Calcichew-D3 Caplets are film-coated tablets
containing calcium and vitamin D3, which both are
important substances in bone formation. Calcichew-D3
Caplets is used in the prevention and treatment of
calcium and vitamin D deficiency in the elderly, and as
a supplement to specific treatment of osteoporosis.
2. What you need to know before you take
Calcichew-D3 Caplets
Do not take Calcichew-D3 Caplets:
- 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

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blood or in the urine
- if you have kidney stones
- if you have excessive amounts of vitamin D in the
blood.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Calcichew-D3 Caplets
- if you are on long-term treatment, especially if you
also take diuretics (used in treatment of high blood
pressure or oedema) or cardiac glycosides (used to
treat heart disorders)
- if you have signs of impaired renal function or high
tendency of renal stone formation
- if you have sarcoidosis (an immune system disorder
which may cause increased levels of vitamin D in the
body)
- if you have osteoporosis and at the same time are

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unable to move around
- if you take other products containing vitamin D.
Additional doses of calcium and vitamin D should be
taken under close medical supervision.
Children
Calcichew-D3 Caplets are not intended for use in
children.

intake of Calcichew-D3 Caplets.
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 Caplets.
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 Caplets.
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 Caplets.
Other medicines that may influence or be influenced
by Calcichew-D3 Caplets are: thiazide diuretics (used
in treatment of high blood pressure and oedema) and
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 Caplets with food and drink
Calcichew-D3 Caplets 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
doctor or pharmacist before taking this medicine.
Pregnancy
Calcichew-D3 Caplets can be used during pregnancy,
in case of 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.

Breast-feeding
Calcichew-D3 Caplets can be used during
breastfeeding. Calcium and vitamin D3 pass into breast
milk. This should be considered when giving additional
vitamin D to the child.
Driving and using machines
Calcichew-D3 Caplets has no known influence on your
ability to drive or use machines.
Calcichew-D3 Caplets contains sorbitol and sucrose
Calcichew-D3 Caplets contains sorbitol 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.

told you. Check with your doctor or pharmacist if you
are not sure.
Dosage:
The recommended dose is one tablet twice daily. The
tablet may be swallowed or chewed.
Use in children
Calcichew-D3 Caplets are not intended for use in
children.
If you take more Calcichew-D3 Caplets than you should
If you may have taken more Calcichew-D3 Caplets
than you should, talk to your doctor or pharmacist
immediately.
If you forget to take Calcichew-D3 Caplets
Do not take a double dose to make up for a forgotten
tablet.
If you have any further questions on the use of this

Other medicines and Calcichew-D3 Caplets
Tell your doctor or pharmacist if you are taking, or have
recently taken or might take any other medicines.
Calcium carbonate may interfere with the absorption of
tetracyclines (a type of antibiotics) if taken at the same
time. For this reason, tetracycline preparations should
be taken at least 2 hours before or 4-6 hours after
intake of Calcichew-D3 Caplets.
Medicines containing bisphosphonates (used to treat
osteoporosis) should be taken at least one hour before

3. How to take Calcichew-D3 Caplets
Always take this medicine exactly as your doctor has

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Page 10
medicine, ask your doctor or pharmacist.

13 mm

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 (hypercalciuria) may
occur with large doses.

10 mm
Glue

55 mm

alcichew -D3
C
500 mg/400 IU
*

Caplets

BATCH

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Page 2

EXP

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Page 1 (Front page inside)

6083720_F7_V02_0516.indd 1

13 mm

*

lllIllIl

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Page 12

Peel here but do not remove

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12 mm
Tab/Glue

6083720
Code xxx

calcium/colecalciferol
(vitamin D3)

12 mm
Tab/Glue

40 mm
For oral use: 1 tablet contains:
500 mg calcium (as calcium
carbonate) 400 IU vitamin D3
(10 microgram cholecalciferol)
Sorbitol (E420) and sucrose.
Read the package leaflet before
use. The tablet may be swallowed
or chewed.
Keep out of the sight
and reach of children.
Do not store above 25°C. Keep the
container tightly closed in order to
protect from moisture.
Takeda UK Ltd.
Wooburn Green, BUCKS,
HP10 0DF, UK
GBR F.7/xxxx/
PL 16189/0027

6083720
Code xxx

31.05.16 12:20

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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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