Package leaflet: information for the user

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.
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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 500mg/400IU Chewable Tablets are and what they are used for Before you take Calceos 500mg/400IU Chewable Tablets How to take Calceos 500mg/400IU Chewable Tablets How to store Calceos 500mg/400IU Chewable Tablets 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
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if you are allergic (hypersensitive) to calcium or vitamin D or any of the other ingredients in if you are allergic (hypersensitive) to peanut or soya (this product contains soybean oil) if you suffer from severe kidney problems 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:
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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.
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 500mg/400IU CHEWABLE TABLETS

Keep out of the reach and sight of children.
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 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 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 October 2012
Calceos is a Trade Mark

Source: http://preview.galen.co.uk/downloads/Calceos_Chewable_Tablets_PIL.pdf