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SPC Table of Contents

KALCIPOS-D FORTE

500mg/800 International Unit Tablets Chewable

Imbat LimitedPPA1151/162/001

Summary of Product Characteristics

7 PARALLEL PRODUCT AUTHORISATION HOLDER

Imbat Limited

Unit L2

North Ring Business Park

Santry

Dublin 9

Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1151/162/001
1 NAME OF THE MEDICINAL PRODUCT

Kalcipos-D forte 500 mg/800 IU chewable tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each chewable tablet contains calcium carbonate equivalent to 500mg calcium and cholecalciferol 20 microgramcorresponding to 800 IU Vitamin D3.

Excipients of known effect: glucose 200mg and sucrose 1.8mg.

For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM

Chewable Tablet

Product imported from the UK

White to off-white, round, chewable tablet engraved R152 on one side, diameter 17 mm.
4 CLINICAL PARTICULARS

As per PA1051/008/002
4.1 Therapeutic Indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5 PHARMACOLOGICAL PROPERTIES

As per PA1051/008/002
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients

Liquid spray dried glucose

Magnesium stearate

Sodium citrate

Xylitol

All-rac-alfa-tocoferol

Acacia

Sodium laurilsulphate

Sucrose

Medium chain triglycerides

Starch sodium octenyl succinate (E1450)

Silicon dioxide

sodium ascorbate
6.2 Incompatibilities

Not applicable.
6.3 Shelf life

The shelf life expiry date of this product shall be the date shown on the container and outer package of the product as marketed in the country of origin.

Shelf-life after first opening container: 6 months
6.4 Special precautions for storage

Store in the original container, in order to protect from light.

Keep container tightly closed in order to protect from moisture.
6.5 Nature and contents of container

Plastic container with screw cap

Pack size: 30
6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

No special requirements.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16th January 2015
10 DATE OF REVISION OF THE TEXT
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