Gabapentin Rosemont 50mg/ml Oral Solution

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Gabapentin

可用日期:

Perrigo Pharma International Designated Activity Company

ATC代码:

N03AX; N03AX12

INN（国际名称）:

Gabapentin

剂量:

50 milligram(s)/millilitre

药物剂型:

Oral solution

治疗领域:

Other antiepileptics; gabapentin

授权状态:

Marketed

授权日期:

2012-10-26

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Univers Roman
UNIVERS BOLD
50mg/ml
BLACK
7474
PANTONE
PANTONE
265
KEYLINE
UKL468
544
300 x 330mm
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150 x 37mm
1
1 of 2
9pt
Yes
150ml
150ml
N/A
C4VD1QDJ3
C4VD1QDJ2
N/A
1079939
Gabapentin Rosemont 50mg/ml Oral Solution (IRE)
27/11/19
-
NH
-
2
-
n
anger towards others, confusion, mood changes, depression, anxiety,
nervousness, difficulty with thinking
n
jerky movements, difficulty speaking, loss of memory, tremor,
difficulty sleeping, headache, sensitive
skin, decreased sensation (numbness), difficulty with coordination,
unusual eye movement, increased,
decreased or absent reflexes
n
blurred vision, double vision
n
vertigo
n
high blood pressure, flushing or dilation of your blood vessels
n
difficulty breathing, bronchitis, sore throat, cough, dry nose
n
vomiting (being sick), nausea (feeling sick), problems with teeth,
inflamed gums, diarrhoea, stomach
pain, indigestion, constipation, dry mouth or throat, flatulence
n
joint pain, muscle pain, back pain, twitching
n
facial swelling, bruises, rash, itch, acne
n
difficulty with erection (impotence)
n
swelling in your legs and arms, difficulty with walking,
weakness, pain, feeling unwell, flu-like symptoms
n
decrease in your white blood cells, increase in weight
n
accidental injury, fracture, abrasion.
Additionally in clinical studies in children, aggressive
behaviour and jerky movements were reported commonly.
UNCOMMON SIDE EFFECTS (AFFECTS LESS TH

产品特点

Health Products Regulatory Authority
03 June 2020
CRN009SDF
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gabapentin Rosemont 50mg/ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml contains 50mg Gabapentin.
Excipients with known effect:
Methyl parahydroxybenzoate – 1.2mg/1ml
Ethyl parahydroxybenzoate – 0.6mg/1ml
Potassium – 3.8mg/1ml
Sodium – 0.72mg/1ml
Propylene glycol - 35mg/1ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
A clear, colourless solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Epilepsy
Gabapentin is indicated as adjunctive therapy in the treatment of
partial seizures with and without secondary generalization in
adults and children aged 6 years and above (see section 5.1).
Gabapentin is indicated as monotherapy in the treatment of partial
seizures with and without secondary generalization in
adults and adolescents aged 12 years and above.
Treatment of peripheral neuropathic pain
Gabapentin is indicated for the treatment of peripheral neuropathic
pain such as painful diabetic neuropathy and
post-herpetic neuralgia in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For all indications a titration scheme for the initiation of therapy
is described in Table 1, which is recommended for adults and
adolescents aged 12 years and above. Dosing instructions for children
under 12 years of age are provided under a separate
sub-heading later in this section.
Table 1
Dosing chart – initial titration
Day 1
Day 2
Day 3
300 mg (6ml) once a day
300 mg (6ml) two times a day
300 mg (6ml) three times a day
Discontinuation of gabapentin
In accordance with current clinical practice, if gabapentin has to be
discontinued it is recommended this should be done
gradually over a minimum of 1 week independent of the indication.
Epilepsy
Epilepsy typically requires long-term therapy. Dosage is determined by
the treating physician according to individual tolerance
and efficacy.
_Adults and adolescents:_
In cl