MOGADON Tablet (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. 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.

4.1. 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 ...

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 ...

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 ...

4.4. Special warnings and precautions for use

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

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

Enhancement of the central depressive effect may occur if benzodiazepines are combined with centrally-acting drugs such as neuroleptics, tranquillisers, antidepressants, hypnotics, analgesics and anaesthetics, ...

4.6. Pregnancy and lactation

Pregnancy There is no evidence as to drug safety in human pregnancy, nor is there evidence from animal work that it is free from hazard. Do not use during pregnancy, especially during the first and last ...

4.7. Effects on ability to drive and use machines

Patients should be advised that, like all medicaments of this type, Mogadon may modify patients' performance at skilled tasks. Sedation, amnesia, impaired concentration and impaired muscle function may ...

4.8. Undesirable effects

Common adverse effects include drowsiness during the day, numbed emotions reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia and double vision. These phenomena are dose ...

4.9. Overdose

When taken alone in overdosage Mogadon presents few problems in management and should not present a threat to life unless combined with other CNS depressants (including alcohol). In the management of overdose ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Hypnotics and Sedatives, Benzodiazepine derivatives ATC Code: N05CD02 Mogadon is a benzodiazepine compound with sedative properties. It acts in 30 to 60 minutes ...

5.2. Pharmacokinetic properties

Absorption The drug is well absorbed form the GI tract with peak blood levels being achieved within 2 hours of administration. Two hours after administration, the concentration of nitrazepam in the cerebrospinal ...

5.3. Preclinical safety data

None stated.

6.1. List of excipients

Each 5 mg tablet contains the following excipients: Lactose Starch maize white Magnesium stearate

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

HDPE or glass bottles: 5 years. PVC/Aluminium blisters: 5 years. Clic-loc containers and polypropylene mini kegs: 2 years.

6.4. Special precautions for storage

The recommended maximum storage temperature for Mogadon tablets is 25°C. All packs should be protected from light and the blister packs should be protected from moisture i.e. stored in a dry place.

6.5. Nature and contents of container

HDPE or glass bottles, in packs of 30 or 100. PVC/Aluminium blister packs, containing 30 or 50 tablets. Clic-loc containers, in a pack of 10. Polypropylene mini-kegs, containing 5000 tablets. Not all pack ...

6.6. Special precautions for disposal and other handling

Any unused product should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

8. Marketing authorization number(s)

PL 46302/0135

9. Date of first authorization / renewal of the authorization

3 May 1999

10. Date of revision of the text

June 2021

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