Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FLUNITRAZEPAM
Roche Products Limited
FLUNITRAZEPAM
1 Milligram
Tablets
Product subject to prescription which may not be renewed (A)
Withdrawn
2013-03-31
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rohypnol 1 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mg tablet contains 1 mg of the active ingredient flunitrazepam. For a full list of excipients see section 6.1. Each tablet contains 117 mg of lactose. For warnings related to lactose, see section 4.4 _Special warnings and_ _precautions for use_. 3 PHARMACEUTICAL FORM Film-coated tablets (tablets). Greyish-green oval shaped tablet with a breakline on one side and '542' on the other side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the short-term management of disabling or severely distressful insomnia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be as short as possible and should be started with the lowest recommended dose. The maximum dose should not be exceeded. Generally the duration of treatment varies from a few days to two weeks with a maximum of four weeks, including the tapering off process. Patients who have taken benzodiazepines for a prolonged time may require a longer period during which doses are reduced. Specialist help may be appropriate. Little is known regarding the efficacy or safety of benzodiazepines in long-term use. In certain cases, extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient's status. Long-term chronic use is not recommended. The product should be taken just before going to bed. Rohypnol tablets are for oral administration. _ADULTS_ Usual dose 0.5 - 1mg; in exceptional circumstances the dose may be increased to 2mg. _ELDERLY OR DEBILITATED PATIENTS_ Usual dose 0.5mg; in exceptional circumstances, the dose may be increased to 1mg. If organi Read the complete document