Lamictal 5 mg dispersible/chewable tablets.Lamictal 25 mg di - Ireland[爱尔兰药品]

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Lamictal 5 mg dispersible/chewable tablets.Lamictal 25 mg di

2014-06-03 18:27:51 来源: 作者: 【大中小】浏览:548次评论:0条

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

1. NAME OF THE MEDICINAL PRODUCT

Lamictal 5 mg dispersible/chewable tablets.

Lamictal 25 mg dispersible/chewable tablets.

Lamictal 50 mg dispersible/chewable tablets.

Lamictal 100 mg dispersible/chewable tablets.

Lamictal 200 mg dispersible/chewable tablets.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each Lamictal 5 mg dispersible/chewable tablet contains 5 mg lamotrigine.

Each Lamictal 25 mg dispersible/chewable tablet contains 25 mg lamotrigine.

Each Lamictal 50 mg dispersible/chewable tablet contains 50 mg lamotrigine.

Each Lamictal 100 mg dispersible/chewable tablet contains 100 mg lamotrigine.

Each Lamictal 200 mg dispersible/chewable tablet contains 200 mg lamotrigine.

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Dispersible/chewable tablet.

5 mg dispersible/chewable tablets:

White to offwhite, elongated, biconvex tablet with a blackcurrant odour, marked “GS CL2” on one side and “5” on the other. The tablets may be slightly mottled.

25 mg dispersible/chewable tablets:

White to offwhite multifaceted, superelliptical, tablet with a blackcurrant odour, marked “GSCL5” on one side “25” on the other. The tablets may be slightly mottled.

50 mg dispersible/chewable tablets:

White to offwhite multifaceted, superelliptical, tablet with a blackcurrant odour, marked “GSCX7” on one side and “50” on the other. The tablets may be slightly mottled.

100 mg dispersible/chewable tablets:

White to offwhite multifaceted, superelliptical, tablet with a blackcurrant odour, marked “GSCL7” on one side and “100” on the other. The tablets may be slightly mottled.

200 mg dispersible/chewable tablets:

White to offwhite multifaceted, superelliptical, tablet with a blackcurrant odour, marked “GSEC5” on one side and “200” on the other. The tablets may be slightly mottled.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Epilepsy

Adults and adolescents aged 13 years and above

- Adjunctive or monotherapy treatment of partial seizures and generalised seizures, inclu