Download EU PSUR Work Sharing Summary Assessment Report

EU PSUR Work Sharing
Summary Assessment Report
Lendormin (brotizolam)
PT/H/PSUR/0001/003
P-RMS
Portugal
Invented name of the medicinal product(s)
Lendormin
INN (or common name) of the active
substance(s)
Brotizolam
MAHs whose PSURs were included in this
work-sharing
Unilfarma - União Internacional Laboratórios
Farmacêuticos, Lda. (Boehringer Ingelheim)
Pharmaco-therapeutic group (ATC Code)
N05CD09
Indications authorised in the P-RMS for the
product
Pharmaceutical form(s) and strength(s)
Insomnia requiring pharmacological intervention.
Benzodiazepines are only indicate when the disease
is severe, incapacitating, or when the patient is
subject to an extreme distress.
Tablet
0,25 mg
PSUR Period
The period covered by this work sharing assessment was 01 Jan 2011 to 01 Dec 2013.
Final Conclusion
When prescribed and used properly, LENDORMIN remains a safe and effective mainstay of treatment
in its authorised indication for the short-term treatment of moderate to severe insomnia.
The benefit-risk profile of the brotizolam remains positive.
During the reporting interval, no new information relevant to the overall evaluation of the benefit-risk
balance arose. Yet, exposure patient data suggests a pattern of misuse considering that brotizolam is
authorized for short treatments (up to two weeks). Thus, even though there is no formal RMP, this
pattern of misuse should be further characterized in the next PSUR and measures aiming to reduce it
should be proposed.
The following adverse events should continue to be closely monitored and discussed in the next
PSUR:




Depression/self-injury and suicide
Dysgeusia
Drug abuse or misuse
Dysarthria
There is no need for changes to the frequency of PSUR submission, nor inclusion in the additional
monitoring list.
In the light of the information provided in the reviewed PSUR, the P-RMS/ CMDh considers there
were no new major findings affecting the overall safety profile of brotizolam and the benefit-risk
profile of the medicinal product(s) remains favourable.
Recommendations:

Amendments to the Product Information
N/A

Agreed topics for close monitoring are:
The following adverse events should be closely monitored by the MAHs having marketing
authorisation for products containing brotizolam:




Depression/self-injury and suicide
Dysgeusia
Drug abuse or misuse
Dysarthria
In case generic PSURs are not requested, the generic companies are asked to report to NCAs and to the
P-RMS if a signal for any of these adverse events is strengthened.

In addition, the MAH should also address the following issues in the next PSUR:
 Depression/self-injury and suicide
 Dysgeusia
Additionally, the MAH should clarify whether there was any case of permanent dysgeusia of the
27 cases relating to the narrow SMQ “Taste and smell disorders” (PSUR, page 21), whether there
was any positive rechallenge and whether the ADR caused the patients to quit therapy.
 Drug abuse or misuse
 Dysarthria
 Analysis of patient exposure data and misuse; the pattern of misuse should be further
characterized and measures aiming to reduce it should be proposed. Also we suggest that the
MAH considers the harmonization of the wording of the therapeutic indication in EU by
including the expression “short-term treatment of” in the section 4.1 of the SmPC and section 1
of the PL.