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CALCEOS CHEWABLE TABLETS

Active substance: COLECALCIFEROL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

CALCEOS® 500mg/400IU CHEWABLE TABLETS
(calcium carbonate and colecalciferol (vitamin D3))
Read all of this leaflet carefully because it contains
important information for you.
This medicine is available without prescription.
However, you still need to take Calceos 500mg/400IU
Chewable Tablets carefully to get the best results
from them.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information
or advice.
- You must contact a doctor if your symptoms
worsen or do not improve.
- If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
In this leaflet:
1.What Calceos 500mg/400IU Chewable Tablets are
and what they are used for
2.Before you take Calceos 500mg/400IU Chewable
Tablets
3.How to take Calceos 500mg/400IU Chewable
Tablets
4.Possible side effects
5.How to store Calceos 500mg/400IU Chewable
Tablets
6.Further information
1. WHAT CALCEOS 500mg/400IU CHEWABLE
TABLETS ARE AND WHAT THEY ARE USED FOR
Calceos 500mg/400IU Chewable Tablets belong to a
group of medicines which act on the calcium and
vitamin D balance in your body. Calceos
500mg/400IU Chewable Tablets contain the active
substances calcium carbonate and colecalciferol
(vitamin D3). Calceos 500mg/400IU Chewable
Tablets are recommended for the treatment of
calcium and vitamin D deficiency in the elderly, for
use in combination with other medicines for the
treatment of osteoporosis and when a risk of
deficiency of calcium and vitamin D is suspected.
2. BEFORE YOU TAKE CALCEOS 500mg/400IU
CHEWABLE TABLETS
Do not take Calceos 500mg/400IU Chewable Tablets
- if you are allergic (hypersensitive) to calcium or
vitamin D or any of the other ingredients in Calceos
500mg/400IU Chewable Tablets
- if you are allergic (hypersensitive) to peanut or soya
(this product contains soybean oil)
- if you have high blood calcium levels
- if you have high urine calcium levels
- if you suffer from severe kidney problems
- if you have kidney stones
- if you have too much vitamin D in your body
- if you have any type of cancer of the bone
- if you are immobile for a great part of the day
Talk to your doctor before taking this product if any
of the above apply to you.
Take special care with Calceos 500mg/400IU
Chewable Tablets:
- if you are on long-term treatment, especially if you
are also elderly, take diuretics (used in treatment of
high blood pressure or oedema) or take cardiac
glycosides (used to treat heart disorders). Please
consult your doctor.
- if you are taking other products containing calcium
and/or vitamin D, even those you may have bought
yourself without prescription.
- if you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicinal product.
- if you have sarcoidosis (inflammation that produces
lumps of cells in various organs in the body). Your
doctor will be able to tell you if you do.
- if you have problems with your kidneys.

Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any medicines, including those
medicines obtained without a prescription.
This is especially important if you are taking:
- other medications containing vitamin D or calcium.
- other medications containing fluoride or iron
(calcium may impair the absorption of these
medicines), Calceos 500mg/400IU Chewable Tablets
should not be taken within three hours of taking
these medicines.
- cardiac glycosides, for example digitoxin and
digoxin (used to treat certain heart conditions).
- thiazide diuretics (used in treatment of high blood
pressure and oedema).
- tetracycline antibiotics (calcium may impair the
absorption of these medicines), Calceos
500mg/400IU Chewable Tablets should not be taken
within three hours of taking this medicine.
- disodium etidronate used to treat bone disorders
(calcium may impair the absorption of this
medicine), Calceos 500mg/400IU Chewable Tablets
should not be taken within three hours of taking
this medicine.
- strontium containing medicines (used to treat
osteoporosis) as calcium may reduce the effects of
these. Calceos 500mg/400IU Chewable Tablets
should not be taken at the same time as this
medicine.
- estramustine (a medicine used in chemotherapy)
and levothyroxine (used to treat thyroid deficiency)
as calcium may reduce the effects of these
medicines. For this reason, they should be taken at
least two hours before or after Calceos
500mg/400IU Chewable Tablets.
- orlistat (a medicine used to treat obesity) as it may
reduce the amount of vitamin D3 you absorb.
It may still be safe for you to take Calceos
500mg/400IU Chewable Tablets; your doctor or
pharmacist will be able to advise you further.
Taking Calceos 500mg/400IU Chewable Tablets with
food and drink
This product is likely to interact with some foods, for
example those containing oxalic acid (e.g. spinach,
rhubarb, sorrel, cocoa, tea), phosphate (e.g. ham,
sausages, cheese spread) or phytic acid (e.g. pulses,
whole cereals, chocolate). It is therefore
recommended that Calceos 500mg/400IU Chewable
Tablets should not be taken at the same time (e.g.
two hours before or after) as meals containing these
types of food.
Pregnancy and breast-feeding
During pregnancy and breast-feeding, the daily dose
should not exceed 1500mg of calcium and 600IU of
vitamin D3 i.e. one tablet a day.
Calceos 500mg/400IU Chewable Tablets 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.
Ask your doctor or pharmacist for advice before
taking any medicine during pregnancy or while
breast-feeding.
Driving and using machines
Calceos 500mg/400IU Chewable Tablets are not
expected to affect your ability to drive or use
machines.

Important information about some of the
ingredients of Calceos 500mg/400IU Chewable
Tablets
Calceos 500mg/400IU Chewable Tablets contain
sorbitol (E420) and sucrose. If you have been told
by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this
medicine.
Calceos 500mg/400IU Chewable Tablets contain
soybean oil. If you are allergic (hypersensitive) to
peanut or soya, do not take this medicinal product.
Talk to your doctor for further advice.
3. HOW TO TAKE CALCEOS 500mg/400IU
CHEWABLE TABLETS
Chew the tablets completely before swallowing. Then
drink a glass of water.
The usual dose for adults and the elderly is one
tablet, to be taken twice a day.
If this product has been prescribed by your doctor,
the label on the carton will tell you how many tablets
you should take and when. Always take Calceos
500mg/400IU Chewable Tablets exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
While you are taking these tablets, your doctor may
want to carry out regular tests on your blood and
urine.
If you take more Calceos 500mg/400IU Chewable
Tablets than you should
If you take too many tablets, contact your nearest
hospital casualty department or doctor immediately.
Take this leaflet and any remaining tablets with you to
show the doctor. If you take too many tablets the
following symptoms could occur: nausea (feeling
sick), vomiting, severe thirst, constipation, lack or
loss of appetite, excessive urination, dehydration,
hypertension (high blood pressure), vasomotor
disorders (resulting in dilation and constriction of the
blood vessels).
If you forget to take Calceos 500mg/400IU Chewable
Tablets
If you forget to take your tablet, take it as soon as
you remember and then continue with the next dose
as instructed. Do not take a double dose to make up
for a forgotten dose.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Calceos 500mg/400IU Chewable
Tablets can cause side effects, although not
everybody gets them.
Uncommon side effect (affecting 1 to 10 users in
1,000): excess calcium levels in the blood or urine.
Rare side effects (affecting 1 to 10 users in 10,000):
constipation, flatulence, feeling sick (nausea),
abdominal pain, diarrhoea, itching, skin rashes and
hives (urticaria).
Cases of serious allergic (hypersensitivity) reactions
such as swelling of the face, lips, tongue or throat
have been reported.
Due to the presence of sucrose, long-term use (for
two weeks or more) may be harmful to teeth.

Reporting of side effects
If you get any side effects, talk to your doctor,
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:
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 CALCEOS 500mg/400IU
CHEWABLE TABLETS
Keep out of the reach and sight of children.
The stopper contains small granules of silica gel to
keep the tablets dry. Keep the stopper out of the
sight and reach of children. Do not swallow the silica
gel granules.
Do not use Calceos 500mg/400IU Chewable Tablets
after the expiry date which is stated on the carton
and container. The expiry date refers to the last day
of that month.
Store in the original packaging in order to protect the
tablets from moisture.
Do not store above 25°C.
Do not take Calceos 500mg/400IU Chewable Tablets
if you notice that the pack or any of the tablets are
damaged.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.
6. FURTHER INFORMATION
What Calceos 500mg/400IU Chewable Tablets
contain
The active substances are calcium carbonate and
colecalciferol (vitamin D3). Each tablet contains
1250mg of calcium carbonate (equivalent to 500mg
elemental calcium) and 10 micrograms colecalciferol
(equivalent to 400IU vitamin D3).
The other ingredients in the tablet are: xylitol, sorbitol
(E420), povidone, magnesium stearate, alpha
tocopherol, partially hydrogenated soybean oil,
gelatin, sucrose, corn starch and lemon flavour
(containing essential oils of lemon, orange and litsea
cubeba, maltodextrin, acacia gum and sodium
citrate).
What Calceos 500mg/400IU Chewable Tablets look
like and contents of the pack
Calceos 500mg/400IU Chewable Tablets are greyish
white, square chewable tablets.
Calceos 500mg/400IU Chewable Tablets are available
in packs of 60 tablets.
Marketing Authorisation Holder:
Laboratoire Innotech International,
22 avenue Aristide Briand, 94110 Arcueil, France.
Manufactured by:
Innothéra Chouzy, Rue René Chantereau, L’Isle Vert,
41150 Chouzy-Sur-Cisse, France.
Distributed by:
Galen Limited, Seagoe Industrial Estate, Craigavon,
BT63 5UA, UK.
This leaflet was last revised in 03/2015
Calceos is a Trade Mark
09/02/15

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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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