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Package leaflet: Information for the user

CALCI-D 1000 mg/1000 IU chewable tablet
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

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
paraffin oil used as a laxative or
1. What CALCI-D is and what it
stool softener): these medicines may
decrease the absorption of the
is used for
vitamin D3.
CALCI-D chewable tablets contain two • phenytoin and barbiturates (for
example phenobarbital), which are
active substances, calcium carbonate
used to treat epilepsy: they may
and colecalciferol (vitamin D3). Both
decrease the activity of vitamin D3.
calcium and vitamin D3 are found in
the diet and vitamin D is also produced • some diuretics (water pills for
example furosemide and ethacrynic
in the skin after exposure to the sun.
acid), antacids (used for indigestion)
CALCI-D chewable tablets may be
that contain aluminium salts and
prescribed by doctors to treat and
thyroid hormones: these medicines
prevent vitamin D/calcium deficiency.
can decrease the absorption of
calcium and increase its elimination
CALCI-D is used:
in the stools or urine.
• in the correction of calcium and
vitamin D deficiencies in the elderly, Medicines that increase the absorption
• in combination with osteoporosis
or effect of CALCI-D:
treatments where calcium and vitamin • some other diuretics (of the thiazide
D levels are too low or where there is
kind, for example
a high risk of them being too low.
hydrochlorothiazide) can decrease

the elimination of calcium in the
urine and thus cause too high calcium
levels in the blood.
• antibiotic drugs, for example
penicillin, neomycin and
Do not take CALCI-D:
chloramphenicol can increase the
• If you are allergic to calcium
absorption of calcium: your doctor
carbonate or colecalciferol (vitamin
may tell you to check your blood
D3) or any of the other ingredients of
calcium during prolonged treatment
this medicine (listed in section 6);
with CALCI-D and any of these
• if you are inactive and have high
levels of calcium in your blood
(hypercalcaemia) or urine
Medicines whose absorption is
decreased by CALCI-D :
• if you have calcium deposits in the
• tetracycline antibiotics: when taking
tissues of your body;
these leave at least three hours before
• if you have serious kidney problems;
taking CALCI-D . Do not take them
• if you have kidney stones or calcium
at the same time.
stones in general;
• bisphosphonates (medicines used to
• if you have abnormally high levels of
treat or prevent osteoporosis) and
vitamin D;
sodium fluoride: when taking these
• if you are less than 18 year of age.
leave at least three hours before
taking CALCI-D.
Warnings and precautions
• The efficacy of levothyroxine can be
Talk to your doctor or pharmacist
reduced by the concurrent use of
before taking CALCI-D
calcium, due to decreased
Take special care with CALCI-D if
levothyroxine absorption.
Administration of calcium and
• if you have had kidney stones or other
levothyroxine should be separated by
kidney problems (your doctor will
at least four hours.
need to monitor your treatment
• The effect of quinolone antibiotics
carefully if your kidneys are not
working properly to make sure you do may be reduced if taken at the same
not build up too much calcium in your time as calcium. Take quinolone
antibiotics two hours before or six
• if you stay in bed for a long period
(months) and if you have osteoporosis hours after taking CALCI-D.

2. What you need to know before
you take CALCI-D

(brittle bones) because you may have
high levels of calcium in your blood
• if you are taking any other medicines
containing calcium or vitamin D (your
doctor or your pharmacist will be able
to tell you if you do)
• if you have sarcoidosis (your doctor
will be able to tell you if you do)
Other medicines and CALCI-D
Tell your doctor or pharmacist if you

Medicines whose effect is increased by
• digitoxin (for example Lanoxin) or
other cardiac glycosides used to treat
heart disorders: calcium may increase
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.

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
Tell your doctor and ask for advice
before taking foodstuffs which may be
fortified with vitamin D.
Pregnancy, breast-feeding and
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 this medicine.

• constipation;
• rash;
• diarrhoea;
• hives.

The following effects are not known
(frequency cannot be estimated from
the available data):
Serious allergic (hypersensitivity)
reactions such as swelling of the face,
lips or tongue, kidney stone, blood
phosphate level above normal

Reporting of side effects:
If you get any side effects, talk to your
doctor or pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. You can also report
side effects directly via the Yellow Card
Scheme at:
CALCI-D chewable tablets should only
yellowcard. By reporting side effects
be used in pregnancy and breastyou can help provide more information
feeding when it has been recommended
on the safety of this medicine.
by a doctor.
Driving and using machines
CALCI-D has no influence on your
ability to drive or use machines.
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

3. How to take CALCI-D
Always take this medicine exactly as
your doctor or pharmacist has told you.
Check with your doctor or pharmacist if
you are not sure.
The recommended dose:
Take 1 tablet of CALCI-D once a day,
preferably during the evening meal.
The tablets may be chewed or sucked,
they must not be swallowed whole.
The tablet can be divided into equal

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
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

6. Contents of the pack and other

What CALCI-D contains
• The active substances are: calcium
and colecalciferol (Vitamin D3).
Each chewable tablet contains
If you take more CALCI-D than you
calcium 1000 mg (as calcium
carbonate) and colecalciferol
Contact your doctor or go to the nearest
(Vitamin D3) 25 micrograms
hospital emergency department if you
(equivalent to 1000 I.U).
or someone near you has taken too
• The other ingredients are: DL-alpha
much CALCI-D. Remember to take
tocopherol (E307), medium chain
with you any remaining tablets and the
triglycerides, modified food starch
box or this leaflet so that doctors know
(E1450), sucrose, sodium ascorbate
what has been taken.
(E301), silicon dioxide (E551),
If you forget to take CALCI-D
povidone K29/32, isomalt (E953),
Take it as soon as you remember. Then
sucralose, magnesium stearate,
take your next dose at the usual time.
crospovidone and orange aroma.
However, if it is almost time for your
What CALCI-D looks like and
next dose, skip the missed dose and
continue as usual. Never take two doses contents of the pack
CALCI-D chewable tablets are white to
at the same time.
almost white round tablet with a break
Do not take a double dose to make up
for a forgotten tablet.
The tablets are packed in plastic tubes.
Each plastic tube contains 14 tablets.

4. Possible side effects

Like all medicines, this medicines can
cause side effects, although not
everybody gets them.
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.)
The following effects are rare: (may
affect up to 1 in 1000 people)
• nausea;
• flatulence (dyspepsia);
• stomach ache;
• itching;

CALCI-D is available in pack sizes of
14, 28, 42, 56, 70, 84, 98, 112, 126,
140, 154 or 168 chewable tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder:
Laboratoires SMB S.A.
Rue de la Pastorale 26-28
B-1080 Brussels, Belgium
SMB Technology S.A.
Rue du Parc Industriel 39
B-6900 Marche-en-Famenne, Belgium
This leaflet was last revised in July


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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.