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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1. NAME OF THE MEDICINAL PRODUCT
Trobalt 50 mg film-coated tablets
Trobalt 100 mg film-coated tablets
Trobalt 200 mg film-coated tablets
Trobalt 300 mg film-coated tablets
Trobalt 400 mg film-coated tablets
Treatment initiation pack
Trobalt 50 mg film-coated tablets
Trobalt 100 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of retigabine.
Each film-coated tablet contains 100 mg of retigabine.
Each film-coated tablet contains 200 mg of retigabine.
Each film-coated tablet contains 300 mg of retigabine.
Each film-coated tablet contains 400 mg of retigabine.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet (tablet).
50 mg tablets:
Purple, round, film-coated tablets, marked with “RTG 50” on one side.
100 mg tablets:
Green, round, film-coated tablets, marked with “RTG 100” on one side.
200 mg tablets:
Yellow, oblong, film-coated tablets, marked with “RTG-200” on one side.
300 mg tablets:
Green, oblong, film-coated tablets, marked with “RTG-300” on one side.
400 mg tablets:
Purple, oblong, film-coated tablets, marked with “RTG-400” on one side.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Trobalt is indicated as adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and above with epilepsy.
4.2 Posology and method of administration
Posology
Trobalt must be titrated, according to individual patient response, in order to optimise the balance between efficacy and tolerability.
The maximum total daily starting dose is 300 mg (100 mg three times daily). Thereafter, the total daily dose is increased by a maximum of 150 mg every week, according to the individual patient response and tolerability. An effective maintenance dose is expected to be between 600 mg/day and 1,200 mg/day.
The maximum total maintenance dose is 1,200 mg/day. The safety and efficacy of doses higher than 1,200 mg/day have not been established.
If patients miss one dose or more, it is recommended
