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SPC Table of Contents

KALCIPOS - D FORTE

500/800 mg/IU Tablets Chewable

LTT Pharma LimitedPPA1562/161/001

Summary of Product Characteristics

7 PARALLEL PRODUCT AUTHORISATION HOLDER

LTT Pharma Limited

Unit 18

Oxleasow Road

East Moons Moat

Redditch

Worcestershire

B98 0RE

United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA1562/161/001
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 500 mg calcium, cholecalciferol (Vitamin D3) 800 IU (20 microgram).

Excipients with known effect: contains 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 United Kingdom.

White to off white, round, 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-tocopherol

Acacia

Sodium laurilsulfate

Sucrose

Medium chain triglycerides

Starch sodium octenyl succinate (E 1450)

Silicon dioxide

Sodium ascorbate
6.2 Incompatibilities

Not applicable.
6.3 Shelf life

The shelf life expiry date for this product shall be the date shown on outer package of the product on the market 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

30 chewable tablets in plastic containers of HDPE with screw caps made of HDPE.
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: 6th November 2015
10 DATE OF REVISION OF THE TEXT
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