Kalcipos-D 500 Mg/ 800 Iu Film-Coated Tablets

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30 tablets

Kalcipos®-D

500 mg/800 IU film-coated tablet

flEDA Meda Pharmaceuticals Ltd. UK

One tablet contains: Calcium carbonate corresponding to 500 mg calcium, cholecalciferol 20 microgram corresponding to Vitamin D3 800 IU. Sucrose 4 mg, soya bean oil 0.8 mg and excipients.

Keep out of 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 15142/0232

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30 tablets

Kalcipos®-D

500 mg/800 IU film-coated tablet

One tablet contains: Calcium carbonate corresponding to 500 mg calcium, chole-calcifero! 20 microgram corresponding to Vitamin D3 800 IU. Sucrose 4 mg, soya bean oil 0.8 mg and excipients.

Keep out of reach and sight of children. Store in original package in order to ^Calcium / Cholecalciferol (Vitamin D3) protect from light.

. Keep the container tightly closed in ¹ order to protect from moisture. o Read the package leaflet before use. ^ Oral use.

Meda Pharmaceuticals Ltd. UK PL 15142/0232

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gram corresponding to 800 IU Vitamin D3. 27

- The other ingredients are maltodextrin, gelatine, sucrose, maize starch, all-rac-alpha-tocopherol, crosscarmellose sodium, silica colloidalis anhydrous, magnesium stearate, partially hydrogenated soya-bean oil, hypro-mellose, macrogol and paraffin.

What Kalcipos-D looks like and contents of the pack

1. WHAT KALCIPOS-D IS AND WHAT IT IS 4

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. Kalcipos-D contains calcium and vitamin D3 which both

PACKAGE LEAFLET : INFORMATION FOR THE USER 1

Kalcipos-D 500 mg/800 IU film-coated tablets Calcium/cholecalciferol (Vitamin D3)

Manufacturer

Recipharm Stockholm AB

Lagervagen 7

Sweden

are important components for the formation of bone. 5 Vitamin D3 regulates the uptake and metabolism of calcium as well as the incorporation of calcium in bone tissue.

household waste. Ask your pharmacist how to dispose 26 of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION What Kalcipos-D contains

- The active substances are calcium carbonate corresponding to calcium 500 mg and cholecalciferol 20 micro-

Read all of this leaflet carefully before you start using this medicine.

- Keep this leaflet. You may need to read it again.

This leaflet was last approved in:

30 January 2012

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

Marketing Authorisation Holder 29	- If you have any further questions, ask your doctor or 2
Meda Pharmaceuticals Ltd	pharmacist.
Skyway House	- This medicine has been prescribed for you. Do not pass
Parsonage Road	it on to others. It may harm them, even if their symptoms
Takeley	are the same as yours.
Bishop’s Stortford	- If any of the side effects gets serious, or if you notice any
CM22 6PU	side effects not listed in this leaflet, please tell your
United Kingdom	doctor or pharmacist.

Do not use Kalcipos-D after the expiry date which is ²¹stated on the label after (Exp.). The expiry date refers to the last day of that month.

Store in the original package in order to protect from light. Keep the container tightly closed in order to protect from moisture.

Medicines should not be disposed of via wastewater or

2. BEFORE YOU TAKE KALCIPOS-D 6

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).

In this leaflet: 3	Kalcipos-D is a film-coated tablet, white, oval and 28
1. What Kalcipos-D is and what it is used for	engraved R150 on one side.
2. Before you take Kalcipos-D	20, 30,40, 50,60, 90,100 and 180 tablets in plastic bottles.
3. How to take Kalcipos-D	Not all pack sizes may be marketed.
4. Possible side effects
5. How to store Kalcipos-D
6. Further information

- if you have hypervitaminosis D (increased levels of ⁷	Serious allergic reactions. 24
vitamin D in the blood).	If any of the side effects gets serious, or if you notice any
- if you have kidney stones	side effects not listed in this leaflet, please tell your doctor
- if you have kidney failure	or pharmacist.
- if you are allergic to soya or peanuts. One tablet	5. HOW TO STORE KALCIPOS-D
Kalcipos-D contains 0.8 mg hydrogenated soya bean oil.	Keep out of the reach and sight of children.

Uncommon (occurs in less than 1 out of 100patients): 23 hypercalcaemia (increased levels of serum calcium) and/or hypercalciuria (increased levels of urine calcium.

Rare (occurs in less than 1 out of1 000patients) constipation, flatulence, nausea, abdominal pain, diarrhoea, pruritus, rash and urticaria.

Not known (cannot be estimatedfrom the available data):

Take special care with Kalcipos-D 8

- 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 kidney stone formation.

Usual dose: 1 tablet daily. 1⁹The tablets can be swallowed with water whole, divided or crushed.

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

you should take this at least one hour before you take 12 Kalcipos-D.

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 simultaneously use certain drugs for;

- if you are immobilized with osteoporosis ⁹Consult vour doctor before taking Kalcipos-D if anv of the above Doints aDDlv to vou.

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

although not everybody gets them. 22 You should stop taking Kalcipos-D and see your doctor immediately if you experience symptoms ofserious allergic reactions, such as

• swollen face, lips, tongue or throat

• difficult to swallow

• hives and difficulty breathing

- infection (tetracyclines) 13 you should take these two hours before or four to six hours after taking Kalcipos-D.

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.

or peanuts you should not take this medicinal product. 18 One tablet Kalcipos-D film-coated tablet contains 4 mg sucrose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE KALCIPOS-D

The dosage is individually decided for you by your doctor.

your doctor or emergency unit for judgement of the risk 21 and advice.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Kalcipos-D can cause side effects,

taken simultaneously with certain other drugs against: 10

- high blood pressure (thiazide diuretic)

- heart problems (cardiac glycosides such as digoxin)

- high cholesterol (cholestyramine)

- constipation (laxatives such as liquid paraffin)

- epilepsy (phenytoin or barbiturates)

Driving and using machines 1⁷

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

Important information about some of the ingredients of Kalcipos-D

One tablet of Kalcipos-D film-coated tablet contains 0.8 mg hydrogenated soya bean oil. If you are allergic to soya

If you simultaneously use a certain drug for; 14 - hypothyroidism (levothyroxine) you should separate the intake with Kalcipos-D forte by at least four hours.

Taking Kalcipos-D with food and drink

The calcium absorption may be inhibited by food containing oxalic acid (found in spinach and rhubarb) and

- inflammatory conditions/suppression of immunity 11 (corticosteroids)

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

If you simultaneously use a certain drug for;

- osteoporosis (bisphosphonates)

The dietary intake of calcium should be estimated by the 20 prescriber.

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

If you take more Kalcipos-D than you should

If you have taken more of this medicine than directed, or if a child accidentially has taken this medicine, please contact

phytic acid (found in whole cereals). You should wait at ¹⁵least two hours before you take Kalcipos-D if you have eaten food with high content of oxalic acid or phytic acid.

Pregnancy and breast-feeding

During pregnancy the daily intake should not exceed 1500 mg calcium and 600 IU vitamin D. Kalcipos-D can be used during pregnancy, in case of a calcium and vitamin D

deficiency under medical discretion. 16 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.