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KALCIPOS-D 500 MG/800 IU CHEWABLE TABLETS

Active substance(s): CALCIUM CARBONATE / CHOLECALCIFEROL / COLECALCIFEROL

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30 tablets

Kalcipos -D
TM

500 mg/800 IU chewable tablets
Calcium / Cholecalciferol (Vitamin D3)

This leaflet was last approved in: 2010-10-29
Meda Pharmaceuticals Ltd., Skyway House,
Parsonage Road, Takeley, Bishop´s Stortford

One chewable tablet contains:
Calcium carbonate corresponding to
500 mg calcium, cholecalciferol 20
microgram corresponding to Vitamin D3
800 IU. Glucose 200 mg, sucrose 3.8
mg, soya bean oil 0.8 mg and
excipients.

30 tablets

Kalcipos -D
TM

500 mg/800 IU chewable tablets

653539

EXP:
Batch:

Calcium / Cholecalciferol (Vitamin D3)

Keep out of the reach and sight
of children.
Store in original package, in order
to protect from light.
Keep the container tightly closed in
order to protect from moisture.
Read the package leaflet before use.
Oral use.

kalcipos-d
chewable tablet
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Kalcipos-D 500 mg/800 IU chewable tablets
Calcium/cholecalciferol (Vitamin D3)

Keep out of the reach and sight
of children.
Store in original package, in order
to protect from light.
Keep the container tightly closed in
order to protect from moisture.
Read the package leaflet before use.
Oral use.
PL 15142/0056

POM

Marketing Authorisation Holder
Meda AB
Box 906
SE-170 09 Solna
Sweden
tel: +46 8 630 1900
fax: +46 8 630 1950

What Kalcipos-D looks like and contents of the pack
Kalcipos-D is a chewable tablet, white, round and engraved R152
on one side.
20, 30, 40, 50, 60, 90, 100 and 180 tablets in plastic bottles.
Not all pack sizes may be marketed.

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kalcipos-d
chewable tablet

In this leaflet:
1. What Kalcipos-D is and what it is used for
2. Before you take Kalcipos-D
3. How to take Kalcipos-D
4. Possible side effects
5. How to store Kalcipos-D
6. Further information

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Ask your doctor, pharmacist or other health personal if you have
further questions and always follow their instructions.

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2. BEFORE YOU TAKE KALCIPOS-D
Do not take Kalcipos-D
- if you are allergic (hypersensitive) to the active substances or any
of the other ingredients.
- if you have hypercalcaemia (increased levels of calcium in the
blood) or hypercalciuria (increased levels in the urine).
- if you have hypervitaminosis D (increased levels of vitamin D in
the blood).

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Read all of this leaflet carefully before you start using this
medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
- 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.

• difficult to swallow
• hives and difficulty breathing

corresponding to 800 IU Vitamin D3 .
- The other ingredients are liquid spray dried glucose,
magnesium stearate, sodium citrate, xylitol, all-rac-alfatocoferol, acacia, sodium laurilsulphate, gelatine, sucrose,
maize starch, partially hydrogenated soya-bean oil.

- if you are immobilized with osteoporosis.

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1. WHAT KALCIPOS-D IS AND WHAT IT IS USED FOR
Kalcipos-D is used to prevent and treat calcium and vitamin D3
deficiency in the elderly, and as an additional treatment in the
management of osteoporosis, when a risk of deficiency of calcium
and vitamin D3 is suspected.

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Uncommon (occurs in less than 1 out of 100 patients): hypercalcaemia (increased levels of serum calcium) and/or hypercalciuria
(increased levels of urine calcium.
Rare (occurs in less than 1 out of 1 000 patients) constipation,
flatulence, nausea, abdominal pain, diarrhoea, pruritus, rash and
urticaria.
Not known (cannot be estimated from the available data): Serious
allergic reactions .

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Consult your doctor before taking Kalcipos-D if any of the
above points apply to you.
Taking other medicines
Tell your doctor or pharmacy staff if you take or recently have taken
other drugs, even non prescription drugs.
The effect of the treatment can be affected if this drug is taken
simultaneously with certain other drugs against:
- high blood pressure (thiazide diuretic)

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.

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The amount of calcium in Kalcipos-D is lower than the usually
recommended daily intake. Kalcipos-D is therefore meant for
patients with need for additional vitamin D, but with a dietary intake
of 500-1000 mg of calcium per day. The dietary intake of calcium
should be estimated by the prescriber.

Kalcipos-D are not intended for use in children and adolescents.

Kalcipos-D contains calcium and vitamin D3 which both are
important components for the formation of bone. Vitamin D3
regulates the uptake and metabolism of calcium as well as the
incorporation of calcium in bone tissue.

6. FURTHER INFORMATION
What Kalcipos-D contains
- The active substances are calcium carbonate 1300 mg corresponding to calcium 500 mg and cholecalciferol 20 microgram

PL 15142/0056
Meda Pharmaceuticals Ltd., Skyway House,
Parsonage Road, Takeley, Bishop´s Stortford

POM

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PACKAGE LEAFLET : INFORMATION FOR THE USER

Keep the container tightly closed in order to protect from
moisture.
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.

One chewable tablet contains:
Calcium carbonate corresponding to
500 mg calcium, cholecalciferol 20
microgram corresponding to Vitamin D3
800 IU. Glucose 200 mg, sucrose 3.8
mg, soya bean oil 0.8 mg and
excipients.

653539

23

ccllabel.dk

Manufacturer
Recipharm Stockholm AB
Lagervägen 7
SE-136 50 Jordbro
Sweden

If you take more Kalcipos-D than you should
If you may have taken more Kalcipos-D than you should, talk to
your doctor or pharmacist immediately.

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If you simultaneously use a certain drug for;
- osteoporosis (bisphosphonates)
you should take this at least one hour before you take Kalcipos-D.

5. HOW TO STORE KALCIPOS-D
Keep out of the reach and sight of children.
Keep container tightly closed. Do not use Kalcipos-D after the
expiry date which is stated on the label. The expiry date refers to the
last day of that month.
Store in the original package in order to protect from light.

If you simultaneously use certain drugs for;
- infection (quinolones)
you should take these two hours before or six hours after taking
Kalcipos-D.

- if you have kidney stones
- if you have kidney failure
- if you are allergic to soya or peanuts. One tablet Kalcipos-D
contains 0.8 mg hydrogenated soya bean oil.

Driving and using machines
Kalcipos-D has no known effects on ability to drive or use
machines.

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Take special care with Kalcipos-D
- if you suffer from sarcoidosis (a special type of connective tissue
disease that affects the lungs, skin and joints).
- if you are taking other drugs containing vitamin D or calcium.
- if you have poor kidney function or high tendency of renal stone
formation.

Some symptoms of overdose of Kalcipos-D are loss of appetite,
thirst, abnormal increased urine secretion, nausea, vomiting and
constipation.

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4. POSSIBLE SIDE EFFECTS
Like all medicines, Kalcipos-D can cause side effects, although not
everybody gets them.
You should stop taking Kalcipos-D and see your doctor immediately
if you experience symptoms of serious allergic reactions, such as
• swollen face, lips, tongue or throat

heart problems (cardiac glycosides such as digoxin)
high cholesterol (cholestyramine)
constipation (laxatives such as liquid paraffin)
epilepsy (phenytoin or barbiturates)
inflammatory conditions/suppression of immunity
(corticosteroids)

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Please make sure your doctor knows if you are taking any of the
medicines listed above. Your dosage may need to be adjusted.

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intolerance to some sugars, contact your doctor before taking this 14
medicinal product.
Kalcipos-D contains glucose that can be harmful to your teeth and it
is therefore important to maintain good oral hygiene.
3. HOW TO TAKE KALCIPOS-D
The dosage is individually decided for you by your doctor.
Usual dose: 1 tablet daily.
The chewable tablet should be chewed or slowly melted in the
mouth, never swallowed whole.

If you simultaneously use certain drugs for;
- infection (tetracyclines)

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Important information about some of the ingredients of
Kalcipos-D
One tablet of Kalcipos-D chewable tablet contains 0.8 mg hydrogenated soyabean oil. If you are allergic to soya or peanuts you should
not take this medicinal product.
One tablet Kalcipos-D chewable tablet contains 200 mg glucose and
3.8 mg sucrose. If you have been told by your doctor that you have

you should separate the intake with Kalcipos-D forte by at
least four hours.

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Taking Kalcipos-D with food and drink
The calcium absorption may be inhibited by food containing oxalic
acid (found in spinach and rhubarb) and phytic acid (found in whole
cereals). You should wait at least two hours before you take
Kalcipos-D if you have eaten food with high content of oxalic acid
or phytic acid.

you should take these two hours before or four to six hours after
taking Kalcipos-D.

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If you simultaneously take certain drugs for;
- dental caries (sodium fluoride)
- anaemia (iron)
you should take these drugs at least three hours before taking
Kalcipos-D.
If you simultaneously use a certain drug for;
- hypothyroidism (levothyroxine)

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Pregnancy and breast-feeding
During pregnancy the daily intake should not exceed 1500 mg
calcium and 600 IU vitamin D.
Kalcipos-D is therefore not recommended during pregnancy.
However, Kalcipos-D can be used during pregnancy, in case of a
calcium and vitamin D deficiency.
Kalcipos-D can be used during breast-feeding. Calcium and vitamin
D3 pass over 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.

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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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