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SPC Table of Contents

LAMICTAL

25 Milligram Tablets

Lexon (UK) LtdPPA1097/007/007

Summary of Product Characteristics

7 PARALLEL PRODUCT AUTHORISATION HOLDER

Lexon (UK) Ltd

Unit 18

Oxleasow Road

East Moons Moat

Redditch

Worcestershire

B98 0RE

United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1097/007/007
1 NAME OF THE MEDICINAL PRODUCT

Lamictal 25 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each Lamictal 25 mg tablet contains 25 mg lamotrigine.

Excipient: Each tablet contains lactose monohydrate.

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

Tablet.

Product imported from Bulgaria

Pale, yellowish-brown, multifaceted, super-elliptical tablets of 6.0 mm marked “GSEC7” on one side and "25" on the other.
4 CLINICAL PARTICULARS

As per PA1077/061/001

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 PA1077/061/001

5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients

Lactose monohydrate

Microcrystalline cellulose

Povidone K30

Sodium starch glycolate (Type A)

Iron oxide yellow (E172)

Magnesium stearate
6.2 Incompatibilities

Not applicable.
6.3 Shelf life

The shelf life expiry date for this product shall be the date shown on the blister and outer package of the product on the market in the country of origin.
6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container

Blister packs of 56 tablets.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 5th May 2017
10 DATE OF REVISION OF THE TEXT
6.6 Special precautions for disposal

Special precautions for disposal and other handling.
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