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LAMICTAL

25 Milligram Tablets

PCO ManufacturingPPA0465/092/011

Summary of Product Characteristics

7 PARALLEL PRODUCT AUTHORISATION HOLDER

PCO Manufacturing

Unit 10, Ashbourne Business Park,

Rath,

Ashbourne,

Co. Meath

Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/092/011
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.

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

Tablet.

Product imported from the UK and Czech Republic:

Pale, yellowish-brown, multifaceted, super-elliptical tablet, 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 of this product shall be the date shown on the container 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

PVC/Aluminium foil blister. Each pack contains 56 tablets.
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 for disposal.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09th May 2014
10 DATE OF REVISION OF THE TEXT

April 2015
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