COMPOSITION 
Each tablet contains: Midazolam 7.5mg.

PROPERTIES AND EFFECTS
DORMICUM is a sleep –inducing agent characterized by rapid onset of action, short sojourn in the body, constant efficacy and ease of dosage. Controlled clinical trials and sleep laboratory tests have shown that DORMICUM shortens sleep onset and prolongs duration of sleep without any quantitative impairment of REM sleep. The wake phases are reduced, and the quality of sleep is improved. In general, the time elapsing between taking DORMICUM and falling asleep is less than twenty minutes, and the duration of sleep generally returns to what is normal for the patient’s age . On waking the patients feel fresh and rested. After appropriate dosage and duration of sleep no impairment of either performance or reaction has been observed. Midazolam, the active ingredient of DORMICUM , also possesses anticonvulsive, anxiolytic and muscle-relaxant properties. In some cases midazolam was given over a period of up to hundred and fifty days without any signs of accumulation. Toxicological investigations have demonstrated the wide therapeutic margin of this drug. There are no reports of embryotoxic, teratogenic or mutagenic effects.

PHARMACOKINETICS
After oral administration of DORMICUM, the active ingredient midazolam is absorbed extremely rapidly and completely. 30-50 % of the active ingredient is already metabolized in the course of its first passage through the liver. The concentration in the plasma falls in two stages, with half-life values of ten minutes (distribution phase) and one and a half to two and a half hours (elimination phase). Midazolam is metabolized rapidly and completely. The metabolites formed undergo rapid conjugation with glucuronic acid and are eliminated as glucuronides via the kidneys. The main pharmacologically active metabolite is α-hydroxy – midazolam, the elimination half-life of which is shorter than that of the parent substance. Even after prolonged administration no accumulation of the active ingredient occurs; the pharmacokinetic profile and the metabolism remain constant. Hepatic dysfunction and advanced age have little or no influence on the pharmacokinetics of midazolam . 95% of midazolam becomes bound to plasma proteins.

INDICATIONS
Disturbances of sleep rhythm and all forms of insomnia, particularly difficulty in falling asleep either initially or after premature awakening. Sedation in premedication before surgical or diagnostic procedures.

STANDARD DOSAGE
The usual adult dose is 1-2 tablets (7.5 -15 mg). Because of the short sojourn of midazolam in the body, DORMICUM can be taken anytime of day, provided the patient is subsequently assured of at least four hours undisturbed sleep. Then there is hardly any need to fear residual effects. Owing to the rapid onset of action, DORMICUM should be taken immediately before retiring. The tablet should be swallowed whole with fluid.

SPECIAL DOSAGE INSTRUCTIONS
In elderly and debilitated patients, the recommended dose is 7.5 mg. This dosage applies also to patients with impaired liver and/or kidney function. In premedication, 2 tablets of DORMICUM should be given orally thirty to sixty minutes before the operation, unless the parenteral route is preferred.

RESTRICTIONS ON USE
DORMICUM is not indicated for primary therapy of insomnia in psychosis and severe depression. In such cases the underlying disorder should be treated first. As with other sedative drugs, caution is recommended in patients with organic brain damage, severe respiratory insufficiency or whose general health is not good (increased drug sensitivity). In patients with myasthenia gravis who are prescribed DORMICUM, care should be taken on account of preexisting muscle weakness. Attention is also drawn to the general, medical principle that no drugs should be administered in the early stages of pregnancy except where absolutely necessary. When used in accordance with instructions no negative residual effects have been observed. Patients should be warned not to drive a vehicle or operate dangerous machinery in the first six hours after taking the drug.

UNDESIRABLE EFFECTS
DORMICUM is well tolerated and has a wide therapeutic margin .No changes in the blood picture or in hepatic or renal function have been observed. The rare side effects are due to the sedative effect of the drug, and are dose-dependent. They generally disappear on reduction of the dose. When therapy is continued over long period, habituation may develop in predisposed patients, as with all sleep-inducing agents, sedatives and tranquilizers. In rare cases, patients who are woken by unusual stimuli during the first two or three hours of sleep after taking the tablet may notice a loss of memory (amnesic episodes) with regard to day-to-day activities during these wake phases (e.g. preparation of a meal, letter-writing ).In order to establish the patient’s susceptibility to this phenomenon, it is preferable for the first dose of DORMICUM to be taken in familiar surroundings

INTERACTIONS
During the clinical –testing stage, DORMICUM was administered together with various drugs, such as oral antidiabetics, anticoagulants and cardiovascular agents. No interactions were observed. Caution is recommended when DORMICUM is taken together with central sedative drugs and/or alcohol since they have a mutually potentiating effect.

OVERDOSAGE
In the event of an overdose, the following symptoms may occur: fatigue, ataxia, amnesia and respiratory depression .Such cases call for general supportive measures and gastric lavage if it can be performed within a short time of ingestion of the drug . As in the case of overdosage with other sedatives or sleep-inducing agents, it is essential to keep the respiratory tract free and to monitor functioning of vital organs.

STABILITY
This medicine should be used before the date shown after EXP on the pack

PACKS
20 Tablets 7.5 mg.