DORMICUM 7.5 mg film-coated tablet

Country: Finland

Language: English

Source: Fimea (Suomen lääkevirasto)

Active ingredient:

Midazolami maleas

Available from:

Roche Oy

ATC code:

N05CD08

INN (International Name):

Midazolami maleas

Dosage:

7.5 mg

Pharmaceutical form:

film-coated tablet

Prescription type:

Prescription only

Therapeutic area:

Midazolam

Product summary:

Suitability for use in older adult patients Midazolami maleas Avoid using in older persons. Sedative. A short-acting. Significant adverse effects include drug addiction, rebound insomnia, cognitive disorder and risk for falls and traffic accidents. Paradoxically, may increase anxiety, restlessness and aggression. Take several interactions into account. Avoid consuming grapefruit juice during treatment.

Authorization status:

Marketing authorization granted

Authorization date:

2008-03-20

Summary of Product characteristics

1
DORMICUM
®
Midazolam
1.
DESCRIPTION
1.1.
THERAPEUTIC/ PHARMACOLOGIC CLASS OF DRUG
Dormicum Tablet is a sleep-inducing agent belonging to the
benzodiazepines.
ATC code: N05CD08
1.2.
TYPE OF DOSAGE FORM
Tablets.
1.3.
ROUTE OF ADMINISTRATION
Oral use.
1.4.
STERILE / RADIOACTIVE STATEMENT
Not applicable.
1.5.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient: _midazolam as the maleate.
Tablets containing midazolam maleate equivalent to 7.5 mg
and 15 mg of midazolam.
_Excipients: _ described as per local requirements (Dormicum
tablets
contain
anhydrous
lactose.
For
warning
related
to
lactose
monohydrate,
see
2.4.1
General
(Warnings
and
Precautions)).
2.
CLINICAL
PARTICULARS
2.1.
THERAPEUTIC INDICATIONS
-
Short-term treatment of insomnia
Benzodiazepines are only indicated when the disorder is
severe, disabling or subjecting the individual to extreme
distress.
-
Sedation in premedication before surgical or diagnostic
procedures.
2.2.
DOSAGE AND ADMINISTRATION
Duration
of
treatment
should
be
as
short
as
possible.
Generally the duration of treatment varies from a few days to
a maximum of 2 weeks. The tapering-off process should be
tailored to the individual. Treatment with Dormicum should
not
be
terminated
abruptly
(see
2.4.2
Drug
Abuse
and
Dependence).
In certain cases extension beyond the maximum treatment
period may be necessary; if so, it should not take place
without reevaluation of the patient’s status. Owing to the
rapid
onset
of
action
Dormicum
tablets
should
be
taken
immediately before going to sleep, and swallowed whole with
fluid. Dormicum can be taken any time of the day, provided
the patient is subsequently assured of at least 7 – 8 hours
undisturbed sleep.
_Standard Dosage _
Dosage range: 7.5 – 15 mg
Treatment should be started with the lowest recommended
dose. The maximum dose should not be exceeded because of
the increased risk of CNS adverse effects possibly including
clinically relevant respiratory and cardiovascular depression.
_Premedication _
In premedication, Dormicum should be giv