Gabapentin Rosemont 50mg/ml Oral Solution

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Gabapentin

Tersedia dari:

Rosemont Pharmaceuticals Ltd

Kode ATC:

N03AX; N03AX12

INN (Nama Internasional):

Gabapentin

Dosis:

50 milligram(s)/millilitre

Bentuk farmasi:

Oral solution

Jenis Resep:

Product subject to prescription which may be renewed (B)

Area terapi:

Other antiepileptics; gabapentin

Status otorisasi:

Marketed

Tanggal Otorisasi:

2012-10-26

Selebaran informasi

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JOB INFORMATION
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JOB SPECIFICATION
MAIN BODY TEXT
Univers Roman
UNIVERS BOLD
50mg/ml
BLACK
KEYLINE
UKL468
378
300 x 330mm
N/A
150 x 37mm
1
9pt
YES
150ml
150ml
N/A
C4VD1RBJ3
C4VD1RBJ2
N/A
1 of 2
Gabapentin Rosemont 50mg/ml Oral Solution (UK)
12/10/17
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DH
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1
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APPROVALS
THIRD PARTY APPROVAL REQUIRED
Name:
Name:
Signature:
Signature:
Date:
Date:
AUTHORITY APPROVAL SUPPLIED
REGULATORY SIGN-OFF
YES
YES
NO
N/A
TICK APPLICABLE BOX
TICK APPLICABLE BOX
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 THAN 1 IN 100 PEOPLE):
n
allergic reactions such as hives
n
decreased movement
n
racing heartbeat
n
swelling that may involve the face, trunk and limbs
n
abnormal blood test results suggesting problems with the liver
n
mental impairment
n
fall
n
increase in blood glucose levels (most often observed in patients with
diabetes)
n
agitation (a state of chronic restlessness and unintentional and
purposeless
motions.
RARE (MAY AFFECT

Karakteristik produk

Health Products Regulatory Authority
28 September 2018
CRN008L5S
Page 1 of 18
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
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
Health Products Regulatory Authority
28 September 2018
CRN008L5S
Page 2 of 18
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