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CALCI-D 1000 MG/1000 IU CHEWABLE TABLETS

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

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Package leaflet: Information for the user

CALCI-D 1000 mg/1000 IU
chewable tablets
calcium / colecalciferol

Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
• 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.

What is in this leaflet

1. What CALCI-D is and what it is
used for
2. What you need to know before you
take CALCI-D
3. How to take CALCI-D
4. Possible side effects
5. How to store CALCI-D
6. Contents of the pack and other
information

Other medicines and CALCI-D
Tell your doctor or pharmacist if you
are taking, have recently taken or might
take any other medicines, especially:

Medicines that decrease the absorption
or effect of CALCI-D:
• orlistat (a medicine used to treat
obesity), bile acid sequestrants (used
to treat high blood cholesterol levels,
for example cholestyramine,
colestipol), steroids (such as
cortisone), mineral oils (such as
1. What CALCI-D is and what it
paraffin oil used as a laxative or
is used for
stool softener): these medicines may
CALCI-D chewable tablets contain two decrease the absorption of the
vitamin D3.
active substances, calcium carbonate
• phenytoin and barbiturates (for
and colecalciferol (vitamin D3). Both
example phenobarbital), which are
calcium and vitamin D3 are found in
used to treat epilepsy: they may
the diet and vitamin D is also produced
decrease the activity of vitamin D3.
in the skin after exposure to the sun.
• some diuretics (water pills for
CALCI-D chewable tablets may be
example furosemide and ethacrynic
prescribed by doctors to treat and
acid), antacids (used for indigestion)
prevent vitamin D/calcium deficiency.
that contain aluminium salts and
thyroid hormones: these medicines
CALCI-D is used:
can decrease the absorption of
• in the correction of calcium and
calcium and increase its elimination
vitamin D deficiencies in the elderly,
in the stools or urine.
• in combination with osteoporosis
treatments where calcium and vitamin Medicines that increase the absorption
D levels are too low or where there is or effect of CALCI-D:
a high risk of them being too low.
• some other diuretics (of the thiazide
kind, for example
2. What you need to know before hydrochlorothiazide) can decrease
the elimination of calcium in the
you take CALCI-D
urine and thus cause too high calcium
levels in the blood.
Do not take CALCI-D:
• antibiotic drugs, for example
• If you are allergic to calcium
penicillin, neomycin and
carbonate or colecalciferol (vitamin
chloramphenicol can increase the
D3) or any of the other ingredients of
absorption of calcium: your doctor
this medicine (listed in section 6);
may tell you to check your blood
• if you are inactive and have high
calcium during prolonged treatment
levels of calcium in your blood
with CALCI-D and any of these
(hypercalcaemia) or urine
medicines.
(hypercalciuria);
• if you have calcium deposits in the
Medicines whose absorption is
decreased by CALCI-D :
tissues of your body;
• if you have serious kidney problems; • tetracycline antibiotics: when taking
• if you have kidney stones or calcium
these leave at least three hours before
taking CALCI-D . Do not take them
stones in general;
at the same time.
• if you have abnormally high levels of
• bisphosphonates (medicines used to
vitamin D;
treat or prevent osteoporosis) and
• if you are less than 18 year of age.
sodium fluoride: when taking these
Warnings and precautions
leave at least three hours before
Talk to your doctor or pharmacist
taking CALCI-D.
before taking CALCI-D.
• The efficacy of levothyroxine can be
reduced by the concurrent use of
Take special care with CALCI-D if
you:
calcium, due to decreased
• if you have had kidney stones or other
levothyroxine absorption.
kidney problems (your doctor will
Administration of calcium and
need to monitor your treatment
levothyroxine should be separated by
carefully if your kidneys are not
at least four hours.
working properly to make sure you do •
The
effect of quinolone antibiotics
not build up too much calcium in your
may be reduced if taken at the same
blood)
time as calcium. Take quinolone
• if you stay in bed for a long period
(months) and if you have osteoporosis antibiotics two hours before or six
hours after taking CALCI-D.
(brittle bones) because you may have
high levels of calcium in your blood
• if you are taking any other medicines Medicines whose effect is increased by
containing calcium or vitamin D (your CALCI-D:
doctor or your pharmacist will be able • digitoxin (for example Lanoxin) or
other cardiac glycosides used to treat
to tell you if you do)
• if you have sarcoidosis (your doctor
heart disorders: calcium may increase
will be able to tell you if you do)
their effect on the heart.

Tell your doctor and ask for advice
before taking any other product
containing vitamin D or its derivatives
while taking CALCI-D.

The following effects are rare: (may
affect up to 1 in 1000 people)
• nausea;
• flatulence (dyspepsia);
• stomach ache;
• itching;
• constipation;
• rash;
• diarrhoea;
• hives.

CALCI-D with food and drink
Tell your doctor if you usually eat food
that contains oxalic acid (e.g. spinach
and rhubarb), phosphates (especially
from food additives) or phytinic acid
(whole cereals), since these may reduce
the absorption of calcium contained in The following effects are not known
CALCI-D.
(frequency cannot be estimated from
the available data):
Tell your doctor and ask for advice
Serious allergic (hypersensitivity)
before taking foodstuffs which may be
reactions such as swelling of the face,
fortified with vitamin D.
lips or tongue, kidney stone, blood
Pregnancy, breast-feeding and
phosphate level above normal
fertility
(hyperphosphatemia).
If you are pregnant or breast-feeding,
Reporting of side effects:
think you may be pregnant or are
If you get any side effects, talk to your
planning to have a baby, ask your
doctor or pharmacist or nurse. This
doctor or pharmacist for advice before
includes any possible side effects not
taking this medicine.
listed in this leaflet. You can also report
CALCI-D chewable tablets should only side effects directly via the Yellow Card
be used in pregnancy and breastScheme at: www.mhra.gov.uk/
feeding when it has been recommended yellowcard. By reporting side effects
by a doctor.
you can help provide more information
on the safety of this medicine.
Driving and using machines
CALCI-D has no influence on your
ability to drive or use machines.

5. How to store CALCI-D

• Keep this medicine out of the sight
and reach of children.
• Store below 25°C.
• Store in the original package in order
to protect from light and moisture.
• Stability has been demonstrated for
14 days after first opening.
• Do not use this medicine after the
expiry date which is stated on the
carton after EXP. The expiry date
3. How to take CALCI-D
refers to the last day of that month.
• Do not throw away any medicines via
Always take this medicine exactly as
your doctor or pharmacist has told you.
wastewater or household waste. Ask
Check with your doctor or pharmacist if your pharmacist how to throw away
you are not sure.
medicines you no longer use. These
measures will help protect the
The recommended dose:
environment.
Take 1 tablet of CALCI-D once a day,
preferably during the evening meal.
CALCI-D contains sucrose and
isomalt (isomaltitol, E953)
This medicine contains sucrose and
isomalt (isomaltitol , E953), if you have
been told by your doctor that you have
an intolerance to some sugars, contact
your doctor before taking this medicinal
product.

The tablets may be chewed or sucked,
they must not be swallowed whole.
The tablet can be divided into equal
doses.

6. Contents of the pack and other
information

What CALCI-D contains
• The active substances are: calcium
and colecalciferol (Vitamin D3).
If you take more CALCI-D than you
Each chewable tablet contains
should
calcium 1000 mg (as calcium
Contact your doctor or go to the nearest
carbonate) and colecalciferol
hospital emergency department if you
(Vitamin D3) 25 micrograms
or someone near you has taken too
(equivalent to 1000 I.U).
much CALCI-D. Remember to take
with you any remaining tablets and the • The other ingredients are: DL-alpha
tocopherol (E307), medium chain
box or this leaflet so that doctors know
triglycerides, modified food starch
what has been taken.
(E1450), sucrose, sodium ascorbate
If you forget to take CALCI-D
(E301), silicon dioxide (E551),
Take it as soon as you remember. Then
povidone K29/32, isomalt (E953),
take your next dose at the usual time.
sucralose, magnesium stearate,
However, if it is almost time for your
crospovidone and orange aroma.
next dose, skip the missed dose and
continue as usual. Never take two doses What CALCI-D looks like and
at the same time.
contents of the pack
CALCI-D chewable tablets are white to
Do not take a double dose to make up
almost white round tablet with a break
for a forgotten tablet.
mark.
The tablets are packed in plastic tubes.
4. Possible side effects
Each plastic tube contains 14 tablets.
Like all medicines, this medicines can CALCI-D is available in pack sizes of
cause side effects, although not
14, 28, 42, 56, 70, 84, 98, 112, 126,
everybody gets them.
140, 154 or 168 chewable tablets.
The following effects are uncommon:
(may affect up to 1 in 100 people)
• hypercalcaemia (too much calcium in
your blood) - the symptoms include
nausea, vomiting, lack of appetite,
constipation, stomach ache, bone
pain, extreme thirst, needing to pass
urine more often, muscle weakness,
drowsiness and confusion;
• hypercalciuria (too much calcium in
your urine).

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Consilient Health Limited,
5th Floor, Beaux Lane House, Mercer
Street Lower, Dublin 2, Ireland
Manufacturer:
SMB Technology S.A.
Rue du Parc Industriel 39
B-6900 Marche-en-Famenne, Belgium
This leaflet was last revised in August
2015

P0367

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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