CALCEOS CHEWABLE TABLETS

Active substance: CHOLECALCIFEROL CONCENTRATE (POWDER FORM)

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PACKAGE LEAFLET: INFORMATION FOR THE USER

CALCEOS® 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 carefully to
get the best results from it.
- 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 any of the side effects gets serious, or if you
notice any side effect not listed in this leaflet, please
tell your doctor or pharmacist.
In this leaflet:
1. What Calceos is and what it is used for
2. Before you take Calceos
3. How to take Calceos
4. Possible side effects
5. How to store Calceos
6. Further information
1. WHAT CALCEOS IS AND WHAT IT IS USED FOR
Calceos belongs to a group of medicines which act
on the calcium and vitamin D balance in your body.
Calceos Chewable Tablets contain the active
substances calcium carbonate and colecalciferol
(vitamin D3). Calceos is recommended for the
treatment of calcium and vitamin D deficiency in the
elderly and for use in combination with other
medicines for the treatment of osteoporosis.
2. BEFORE YOU TAKE CALCEOS
Do not take Calceos
- if you are allergic (hypersensitive) to calcium or
vitamin D or any of the other ingredients in Calceos
- 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 any kidney problems, for example
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.

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 should not be taken within
three hours of taking this medicine
- digitalis glycosides, for example digitoxin and
digoxin (used to treat certain heart conditions)
- thiazide diuretics (diuretic drugs help to turn excess
body water into urine)
- tetracycline antibiotics (calcium may impair the
absorption of these medicines), Calceos 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 should not be taken within three
hours of taking this medicine
It may still be safe for you to take Calceos; your doctor
or pharmacist will be able to advise you further.
Taking Calceos 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 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
Ask your doctor or pharmacist for advice before
taking any medicine during pregnancy or while
breast-feeding.
Driving and using machines
Calceos is not expected to affect your ability to drive
or use machines.
Important information about some of the
ingredients of Calceos
Calceos 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.

530786-09-12

Calceos Chewable Tablets PIL Innotech:Layout 1 03/10/2012 16:57 Page 1

Calceos Chewable Tablets PIL Innotech:Layout 1 02/10/2012 17:32 Page 5

PACKAGE LEAFLET: INFORMATION FOR THE USER

CALCEOS® CHEWABLE TABLETS

530787

(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 carefully to
get the best results from it.
- 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 any of the side effects gets serious, or if you
notice any side effect not listed in this leaflet, please
tell your doctor or pharmacist.
In this leaflet:
1. What Calceos is and what it is used for
2. Before you take Calceos
3. How to take Calceos
4. Possible side effects
5. How to store Calceos
6. Further information
1. WHAT CALCEOS IS AND WHAT IT IS USED FOR
Calceos belongs to a group of medicines which act
on the calcium and vitamin D balance in your body.
Calceos Chewable Tablets contain the active
substances calcium carbonate and colecalciferol
(vitamin D3). Calceos is recommended for the
treatment of calcium and vitamin D deficiency in the
elderly and for use in combination with other
medicines for the treatment of osteoporosis.
2. BEFORE YOU TAKE CALCEOS
Do not take Calceos
- if you are allergic (hypersensitive) to calcium or
vitamin D or any of the other ingredients in Calceos
- 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 any kidney problems, for example
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.

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 should not be taken within
three hours of taking this medicine
- digitalis glycosides, for example digitoxin and
digoxin (used to treat certain heart conditions)
- thiazide diuretics (diuretic drugs help to turn excess
body water into urine)
- tetracycline antibiotics (calcium may impair the
absorption of these medicines), Calceos 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 should not be taken within three
hours of taking this medicine
It may still be safe for you to take Calceos; your doctor
or pharmacist will be able to advise you further.
Taking Calceos 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 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
Ask your doctor or pharmacist for advice before
taking any medicine during pregnancy or while
breast-feeding.
Driving and using machines
Calceos is not expected to affect your ability to drive
or use machines.
Important information about some of the
ingredients of Calceos
Calceos 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.

530787

Calceos Chewable Tablets PIL Innotech:Layout 1 02/10/2012 17:32 Page 6

Calceos 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
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.

530787

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
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 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
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 can cause side effects,
although not everybody gets them.
The following side effects have been reported: nausea
(feeling sick), abdominal discomfort and constipation.
Due to the presence of sucrose, long-term use (for
two weeks or more) may be harmful to teeth.
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.

5. HOW TO STORE CALCEOS
Keep out of the reach and sight of children.
Do not use Calceos 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 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 contains
The active substances are calcium carbonate and
colecalciferol (vitamin D3). Each tablet contains
1250mg of calcium carbonate (equivalent to 500mg
or 12.5mmol elemental calcium) and 10 micrograms
colecalciferol (equivalent to 400 IU 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 looks like and contents of the pack
Calceos are greyish white, square chewable tablets.
Calceos 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.
Date of leaflet preparation: July 2012.
Calceos is a Trade Mark

31/07/12

530787
530787-09-12

Fold Configuration:

PIL: Calceos Chewable Tablets
Ink Colour:

Black

Dimensions: 270 x 170mm
PX No:

530787-09-12

Code:

NOTI-CRUANAS

Supplied:

Folded

Folded Size: 36x170mm

Paper Weight: 60g/m2

APPROVED BY:

Date:

100mm verification bar

Calceos Chewable Tablets PIL Innotech:Layout 1 03/10/2012 16:57 Page 2

Calceos 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
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.

Keep out of the reach and sight of children.
Do not use Calceos 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.

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
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 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
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 can cause side effects,
although not everybody gets them.
The following side effects have been reported: nausea
(feeling sick), abdominal discomfort and constipation.
Due to the presence of sucrose, long-term use (for
two weeks or more) may be harmful to teeth.
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.

PIL: Calceos Chewable Tablets
Ink Colour:

5. HOW TO STORE CALCEOS

Do not take Calceos 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 contains
The active substances are calcium carbonate and
colecalciferol (vitamin D3). Each tablet contains
1250mg of calcium carbonate (equivalent to 500mg
or 12.5mmol elemental calcium) and 10 micrograms
colecalciferol (equivalent to 400 IU 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 looks like and contents of the pack
Calceos are greyish white, square chewable tablets.
Calceos 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.
Date of leaflet preparation: July 2012.
Calceos is a Trade Mark

Fold Configuration:

Black

Dimensions: 270 x 170mm
PX No:

530786-09-12

Code:

STIC-WIERB-GF-A

Supplied:

Folded

Folded Size: 36x170mm

Paper Weight: 50g/m2

APPROVED BY:

Date:

100mm verification bar

31/07/12

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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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