BACLOPAR 25 Milligram Tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

BACLOFEN

זמין מ:

Generics (UK) Limited

INN (שם בינלאומי):

BACLOFEN

כמות:

25 Milligram

טופס פרצבטיות:

Tablets

מצב אישור:

Withdrawn

תאריך אישור:

2006-07-01

מאפייני מוצר

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Baclopar 25 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg of Baclofen
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Tablet
A white tablet, marked “BN” breakline “25” on
one side and “G” on the reverse.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
4.1.1
Relief of voluntary muscle spasticity as occurs in
conditions such as multiple sclerosis and spinal cord 
lesions including syringomelia, transverse myelitis and
motor neurone disease.
4.1.2
Management of spasticity of cerebral origin including meningitis,
cerebral palsy, traumatic head injury, 
cerebrovascular accident.
Baclofen is of most benefit in relief of spasticity which
is seriously interfering with activity.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
For oral administration only.
Relief of voluntary muscle spasticity in spinal cord lesions and
management of spasticity of cerebral origin.
_ADULTS: _A gradually increasing dosage regimen of baclofen
is recommended which should be adjusted to 
achieve satisfactory symptom control.
5mg three times a day for three days
10mg three times a day for three days
15mg three times a day for three days
20mg three times a day for three days
25mg three times a day for three days
Symptoms are usually adequately controlled with doses up to 60mg
daily. However, in order to meet 
individual patient needs, dosage adjustments should
be slow and careful. The dose should not exceed 100mg 
per day unless the patient is in
hospital under medical supervision. If therapeutic effect is not achieved
within 
6 weeks of reaching the maximum recommended dose, a decision
of whether to continue with therapy should 
be taken. In some cases, mobility is improved with
small frequent doses, especially if given 1 hour prior to 
performing manual task