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Product Description

. Name of the medicinal product

Mogadon 5 mg Tablets

2. Qualitative and quantitative composition

Each tablet contains 5 mg of nitrazepam.

There is 301 mg lactose per tablet.

For the full list of excipients, See section 6.1

3. Pharmaceutical form

Tablets

Round, white tablets with “” imprinted on one face with a single break bar on the other.

The tablet can be divided into equal doses.

4. Clinical particulars
4.1 Therapeutic indications

Short-term treatment of insomnia when it is severe, disabling or subjecting the individual to unacceptable distress, where daytime sedation is acceptable.

An underlying cause for insomnia should be sought before deciding upon the use of benzodiazepines for symptomatic relief.

Benzodiazepines are not recommended for the primary treatment of psychotic illness.

4.2 Posology and method of administration

Posology:

Adults

5 mg before retiring. This dose may, if necessary, be increased to 10 mg.

Elderly

Elderly or debilitated patients: the elderly or patients with impaired renal and/or hepatic function will be particularly susceptible to the adverse effects of Mogadon. Doses should not exceed half those normally recommended.

If organic brain changes are present, the dosage of Mogadon should not exceed 5mg in these patients.

Other populations

In patients with chronic pulmonary insufficiency and in patients with chronic renal or hepatic disease, the dosage may need to be reduced.

Paediatric population

Mogadon tablets are contraindicated for use in children.

Dosage should be adjusted on an individual basis. Treatment should, if possible, be on an intermittent basis.

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. It may be useful to inform the patient when treatment is started that it will be of limited duration and to explain precisely how the dosage will be decreased. Moreover, it is important that the patient should be aware of the possibility of rebound phenomena (see Undesirable Effects) thereby minimising anxiety over such symptoms should they occur while the medicinal product is being discontinued. Mogadon therapy should not be stopped abruptly, but the dose tapered off.

The product should be taken just before going to bed.

In addition, for long acting benzodiazepines, it must be stated that the patient should be checked regularly at the start of treatment in order to decrease, if necessary, the dose or frequency of administration to prevent overdose due to accumulation.

Method of administration:

Mogadon tablets are for oral administration.

4.3 Contraindications

Patients with hypersensitivity to benzodiazepines, nitrazepam or to any of the excipients listed in section 6.1

Hypersensitivity reactions with the benzodiazepines including rash, angioedema and hypertension have been reported on rare occasions in susceptible patients.

Use of this drug is also contraindicated in patients with acute pulmonary insufficiency; respiratory depression; phobic or obsessional states; chronic psychosis; myasthenia gravis; sleep apnoea syndrome; severe hepatic insufficiency; use in children

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