FutValium 10mg Roche Made in UK
Each tablet contains 10mg Diazepam Ph.Eur.
Excipient with known effect
Each tablet contains 147.00mg lactose
For the full list of excipients, see section 6.1.
1. Pharmaceutical form
Blue uncoated tablets.
2. Clinical particulars
2.1 Therapeutic indications of Valium 10mg Roche
Adults
Firstly, the short-term relief (2-4 weeks) only, of anxiety which is severe, disabling, or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic or psychotic illness.
Secondly, cerebral palsy.
Thirdly, muscle spasm.
Fourthly, as an adjunct to certain types of epilepsy (eg myoclonus).
Fifthly, symptomatic treatment of acute alcohol withdrawal.
Sixthly, as oral premedication for the nervous dental patient.
Seventhly, for premedication before surgery
Children
1) Control of tension and irritability in cerebral spasticity in selected cases
2) As an adjunct to the control of muscle spasm in tetanus
3) Oral premedication (see section 4.4)
2.2 Posology and method of administration of Valium 10mg Roche
Posology
Do not exceed a dosage regimes beyond 4 weeks and gradually withdraw it since it’s a anxiolytic with the lowest effective dose..
Patients who have received benzodiazepines for a long time may require an extended withdrawal period.
Adults:
Firstly, Anxiety states, obsessive-compulsive neuroses, and other psychiatric disorders: 5-30mg daily in divided doses.
Secondly, Insomnia associated with anxiety: 5-15mg before retiring.
Thirdly, Cerebral palsy: 5-60mg daily in divided doses.
Most important, Upper motor neuronic spasticity: 5-60mg daily in divided doses.
Moreover, Muscle spasm of varied aetiology, fibrositis, cervical spondylosis: 5-15mg daily in divided doses.
Adjunct to the management of some types of epilepsy: 2-60 mg daily in divided doses.
Alcohol withdrawal: 5-20mg, repeated if necessary in 2 to 4 hours.
Oral premedication in dental patients: 5mg the night before, 5mg on waking and 5mg two hours before the appointment.
Oral Premedication before surgery: 5mg-20mg.
Children:
In addition, Alternative presentations of diazepam are recommended for paediatric usage in order to obtain suitable doses of less than 5mg.
Spastic children with minimal brain damage: 5-40mg daily in divided doses.
After that, Oral Premedication before surgery (see section 4.4): 2mg-10mg
Elderly and debilitated patients:
Doses should be half the above recommended doses.
Renal and hepatic impairment (see section 4.4):
Above all, The use of diazepam in hepatic impairment may precipitate coma, therefore the dose should be reduced or an alternative drug considered. In severe renal impairment the dose should be reduced.
Method of Administration
For oral administration.
2.3 Contraindications of Valium 10mg Roche
In conclusion, Diazepam is contra-indicated for patients with:
• Hypersensitivity to the active substance, benzodiazepines or to any of the excipients listed in section 6.1.
• Phobic or obsessional states; chronic psychosis, hyperkinesis
• Acute pulmonary insufficiency; respiratory depression, acute or chronic severe respiratory insufficiency
• Sleep apnoea
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