Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
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 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
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Lamictal 25 mg tablets.
Lamictal 50 mg tablets.
Lamictal 100 mg tablets.
Lamictal 200 mg tablets.
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Each Lamictal 25 mg tablet contains 25 mg lamotrigine.
Excipient: Each tablet contains 23.5 mg lactose.
Each Lamictal 50 mg tablet contains 50 mg lamotrigine.
Excipient: Each tablet contains 46.9 mg lactose.
Each Lamictal 100 mg tablet contains 100 mg lamotrigine.
Excipient: Each tablet contains 93.9 mg lactose.
Each Lamictal 200 mg tablet contains 200 mg lamotrigine.
Excipient: Each tablet contains 109.0 mg lactose.
For a full list of excipients, see section 6.1.
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Tablet.
25 mg tablets:
Pale, yellowish brown, multifaceted, superelliptical tablet, marked “GSEC7” on one side and “25” on the other.
50 mg tablets:
Pale, yellowishbrown, multifaceted, superelliptical tablet, marked “GSEE1” on one side and “50” on the other.
100 mg tablets:
Pale, yellowishbrown, multifaceted, superelli |
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