País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Meprobamate
Thornton & Ross Ltd
N05BC01
Meprobamate
400mg
Oral tablet
Oral
Schedule 3 (CD No Register Exempt Safe Custody)
Valid as a prescribable product
BNF: 04010200; GTIN: 5030451001122
OBJECT 1 MEPROBAMATE TABLETS 400MG Summary of Product Characteristics Updated 03-Jun-2014 | Genus Pharmaceuticals 1. Name of the medicinal product Meprobamate Tablets 400mg 2. Qualitative and quantitative composition Meprobamate 400mg. Meprobamate (INN, BAN) is chemically described as 2-Methyl-2- propyltrimethylene dicarbamate. 3. Pharmaceutical form Tablet. 4. Clinical particulars 4.1 Therapeutic indications For the short-term treatment of anxiety states, muscle tension and associated conditions where anxiety is present. 4.2 Posology and method of administration _POSOLOGY_ _Adults: _The recommended dose is 400mg three times daily, with an additional tablet before bed-time. _Elderly_: May respond to lower doses, with half the normal adult dose or less may be sufficient. _Children: _Not recommended. _ADMINISTRATION_ For oral administration. 4.3 Contraindications Use in patients known to be hypersensitive to the active ingredient or to related compounds such as carisprodol or carbromal. Use in patients with a known propensity for dependence on drugs including alcohol. Use in patients susceptible to attacks of acute intermittent porphyria. Meprobamate should not be used during lactation. There is no evidence as to drug safety in human pregnancy, nor is there evidence that it is free from hazard. Meprobamate should not be used during pregnancy, especially during the first trimester, unless there are compelling reasons. Acute pulmonary insufficiency. Respiratory Depression. 4.4 Special warnings and precautions for use Patients should be advised that since their tolerance for alcohol and other central nervous depressants may be diminished in the presence of meprobamate, these substances should be avoided or taken in reduced dosage. The concurrent use of other CNS depressant drugs should be avoided in hepatic or renal insufficiency. Individual response in overdosage is variable, but in some cases the symptoms may be severe. It is therefore advisable that caution should be observed in prescribing meprobamate to patients Leer el documento completo