TRANXENE 7.5 Milligram Capsule

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLORAZEPATE DIPOTASSIUM

Available from:

Boehringer Ingelheim Limited

INN (International Name):

CLORAZEPATE DIPOTASSIUM

Dosage:

7.5 Milligram

Pharmaceutical form:

Capsule

Authorization status:

Withdrawn

Authorization date:

2006-11-28

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tranxene Capsules 7.5 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains dipotassium clorazepate 7.5 mg.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Maroon/grey hard gelatin capsule imprinted with the product name, 7.5 mg and the company symbol.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Anxiety:
Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme
distress.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Anxiety:
Treatment should be as short as possible (2-4 weeks). The patient should be reassessed regularly and the need for
continued treatment should be evaluated, especially in case the patient is symptom free.
Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded.
Adults
One capsule (7.5 mg) up to 3 times daily.
Children
Not generally recommended for children under 16 years.
Elderly
Half the normal dose may be sufficient for a therapeutic response in the elderly.
The lowest dose which can control symptoms should be used, it should not be continued beyond 4 weeks.
Long term chronic use is not recommended.
Treatment should always be tapered off gradually.
Patients who have taken benzodiazepines for a long time may require a longer period during which doses are reduced.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 24/10/2006_
_CRN 2029339_
_page number: 1_
4.3 CONTRAINDICATIONS
Myasthenia gravis.
Hypersensitivity to benzodiazepines.
Severe respiratory insufficiency.
Sleep apnoea syndrome.
Severe hepatic insufficiency.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Tolerance
Some lo