Meprobamate 400mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Meprobamate

Dostopno od:

Thornton & Ross Ltd

Koda artikla:

N05BC01

INN (mednarodno ime):

Meprobamate

Odmerek:

400mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

Schedule 3 (CD No Register Exempt Safe Custody)

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 04010200; GTIN: 5030451001122

Lastnosti izdelka

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