BACLOFEN Tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Baclofen Tablets 10 mg.
Qualitative and quantitative composition
Each tablet contains baclofen 10 mg. Excipient with known effect: Each tablet contains 40 mg lactose monohydrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. A 7 mm flat bevelled edge tablet marked BN breakline 10 on one side and G on the reverse.
Therapeutic indications
Baclofen is indicated for the relief of spasticity of voluntary muscle resulting from such disorders as multiple sclerosis, other spinal lesions e.g. tumours of the spinal cord, syringomyelia, motor neurone ...
Posology and method of administration
Dosage Baclofen is given orally in either tablet or liquid form. These two formulations are bioequivalent. The liquid may be particularly suitable for children or those adults who are unable to take tablets. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Peptic ulceration.
Special warnings and precautions for use
Psychiatric and nervous system disorders Porphyria, history of alcoholism, hypertension, psychotic disorders, schizophrenia, depressive or manic disorders, confusional states or Parkinsons disease may ...
Interaction with other medicinal products and other forms of interaction
Drugs causing Central Nervous System (CNS) depression Increased sedation may occur when baclofen is taken concomitantly with other drugs causing CNS depression including other muscle relaxants (such as ...
Fertility, pregnancy and lactation
During pregnancy, especially in the first 3 months, baclofen should only be employed if its use is of vital necessity. The benefits of the treatment for the mother must be carefully weighed against the ...
Effects on ability to drive and use machines
Baclofen may be associated with adverse effects such as dizziness, sedation, somnolence and visual impairment (see section 4.8) which may impair the patients reaction. Patients experiencing these adverse ...
Undesirable effects
Adverse effects occur mainly at the start of treatment (e.g. sedation, somnolence and nausea), if the dosage is raised too rapidly, if large doses are employed, or in elderly patients. They are often transitory ...
Overdose
Symptoms Prominent features are signs of central nervous depression: somnolence, depressed level of consciousness, respiratory depression, coma. Also liable to occur are: confusion, hallucinations, agitation, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antispastic with spinal site attack ATC code: M03BX01 Baclofen is an antispastic agent acting at the spinal level. A gamma-aminobutyric acid (GABA) derivative, chemically unrelated ...
Pharmacokinetic properties
Absorption Baclofen is rapidly and completely absorbed from the gastrointestinal tract. Following oral administration of single doses (10-30 mg) peak plasma concentrations are recorded after 0.5 to 1.5 ...
Preclinical safety data
Baclofen increases the incidence of omphaloceles (ventral hernias) in the foetuses of rats given approximately 13 times the maximum oral dose (on mg/kg basis) recommended for human use. This was not seen ...
List of excipients
The tablet contains: Microcrystalline cellulose Lactose monohydrate Anhydrous calcium hydrogen phosphate Colloidal anhydrous silica Magnesium stearate Sodium starch glycollate (type A)
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store in a dry place below 25°C in order to protect from light.
Nature and contents of container
Baclofen Tablets are available either in polypropylene containers with polyethylene caps (with optional polyethylene ullage filler, or in PVDC aluminium foil blisters. The pack sizes available in both ...
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts, EN6 1TL
Marketing authorization number(s)
PL 04569/0158
Date of first authorization / renewal of the authorization
Date of first authorisation: 10/10/1986 Date of latest renewal: 05/10/2005
Date of revision of the text
19/08/2019
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