DORMONOCT Tablet (2019)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

DORMONOCT 2 mg Tablets.

2. Qualitative and quantitative composition

Each tablet contains: 2 mg loprazolam as loprazolam mesylate. Contains sugar (lactose monohydrate): 83,9 mg per tablet.

3. Pharmaceutical form

Tablet. Light yellow, biconvex round tablets. “B” and “026” are engraved and separated by a score line on one side. The other side is neutral.

4.1. Therapeutic indications

Short-term treatment of insomnia. Sleep disturbances in the geriatric patient. Pre-operative sleep disturbances. DORMONOCT is only indicated when the disorder is severe, disabling or when the individual ...

4.2. Posology and method of administration

Dosage The usual adult dose is 1-2 mg at bedtime, the higher dose being recommended for patients who have previously been treated with benzodiazepines for severe persistent insomnia. An initial dose of ...

4.3. Contraindications

Hypersensitivity to loprazolam or to any of the other ingredients in DORMONOCT Severe respiratory insufficiency Myasthenia gravis Sleep apnoea syndrome Severe hepatic insufficiency Safety and efficacy ...

4.4. Special warnings and precautions for use

Caution should be exercised in the following patients: In patients with pulmonary disease and limited pulmonary reserve. Particular caution should be exercised with the elderly and debilitated who are ...

4.5. Interaction with other medicinal products and other forms of interaction

Concomitant use not recommended Concomitant intake with alcohol: the sedative effect may be enhanced when DORMONOCT is used in combination with alcohol. This affects the ability to drive or use machines ...

4.6. Pregnancy and lactation

Safety in pregnancy has not been established. Pregnancy During labour it crosses the placenta and may cause the floppy-infant syndrome characterised by central respiratory depression, hypothermia and poor ...

4.7. Effects on ability to drive and use machines

Patients should be advised, particularly at the initiation of therapy, not to drive a motor vehicle or perform potentially hazardous tasks where impaired decision making could lead to accidents.

4.8. Undesirable effects

The following CIOMS frequency rating is used, when applicable: Very common: (≥1/10); common: (≥1/100, <1/10 ; uncommon: (≥1/1000, <1/100); rare: (≥1/10 000, <1/1000); very rare: (<1/10000), including isolated ...

4.9. Overdose

Manifestations of overdosage include somnolence, confusion, coma, respiratory and cardiovascular depression and hypotension. Intravenous fluids should be administered and an adequate airway maintained. ...

5.1. Pharmacodynamic properties

Pharmacological classification: A 2.2 Sedatives, hypnotics. Loprazolam is a short-acting benzodiazepine with hypnotic properties. Loprazolam has little effect on paradoxical sleep patterns (REM). ...

5.2. Pharmacokinetic properties

Absorption The absolute bioavailability following a single oral dose of 1 mg is 80%. The maximum concentration (Cmax) is 5,5-6,0 µg/ml per one hour (Tmax) following a single oral ...

6.1. List of excipients

Colloidal anhydrous silica Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Povidone

6.4. Special precautions for storage

Store at or below 25°C. Protect from light, heat and humidity. Keep tablets in blister pack until required for use. KEEP OUT OF REACH OF CHILDREN.

6.5. Nature and contents of container

2 mg tablets packed in blister packs of 30’s and 100’s.

7. Marketing authorization holder

Sanofi-aventis south africa (pty) ltd, 2 Bond Street, Midrand, 1685, South Africa

8. Marketing authorization number(s)

Q/2.2/355

9. Date of first authorization / renewal of the authorization

Date registered: 15.01.1984

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