Levetiracetam 100mgml oral solution sugar free

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levetiracetam

Available from:

Rosemont Pharmaceuticals Ltd

ATC code:

N03AX14

INN (International Name):

Levetiracetam

Dosage:

100mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04080100

Patient Information leaflet

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JOB INFORMATION
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JOB SPECIFICATION
MAIN BODY TEXT
Univers Roman
UNIVERS BOLD
100mg/ml
BLACK
7474
PANTONE
PANTONE
265
KEYLINE
BRAILLE
N/A
N/A
190 x 420mm
N/A
N/A
1
8pt
No
300ml
300ml
N/A
C9X4SRBJ4
C9X4SJWJ3
23LF01524PW
1 of 2
Levetiracetam Rosemont 100mg/ml Oral Solution
09/01/18
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DH
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3
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THIRD PARTY APPROVAL REQUIRED
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Name:
Signature:
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AUTHORITY APPROVAL SUPPLIED
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TICK APPLICABLE BOX
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Continued overleaf
C9X4SRBJ4 (23LF01524PW)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START
TAKING THIS MEDICINE.
n
Keep this leaflet. You may need to read it again.
n
If you have any further questions, ask your doctor or pharmacist.
n
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as yours.
n
If you get any side effects please tell your doctor or pharmacist.
This includes possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
1.
What Levetiracetam Rosemont is and what it is used for
2.
What you need to know before you take Levetiracetam Rosemont
3.
How to take Levetiracetam Rosemont
4.
Possible side effects
5.
How to store Levetiracetam Rosemont
6.
Contents of the pack and other information
1. WHAT LEVETIRACETAM ROSEMONT IS AND WHAT IT IS USED FOR
Levetiracetam Rosemont 100mg/ml Oral Solution contains the active
ingredient levetiracetam, which is an antiepileptic medicine (a
medicine used
to treat seizures in epilepsy)
Levetiracetam is used:
n
on its own in adults and adolescents from 16 years of age with newly
diagnosed epilepsy, to treat

Summary of Product characteristics

OBJECT 1
LEVETIRACETAM ROSEMONT 100MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 18-Jan-2018 | Rosemont
Pharmaceuticals Limited
1. Name of the medicinal product
Levetiracetam Rosemont 100mg/ml Oral Solution
2. Qualitative and quantitative composition
Each 1 ml contains 100 mg Levetiracetam
Excipients with known effect:
Each ml also contains liquid maltitol 269.4mg (approx 106mg/ml
maltitol), methyl parahydroxybenzoate
(E218) 1.4mg and propyl parahydroxybenzoate (E216) 0.2 mg.
For a full list of excipients_,_ see section 6.1
3. Pharmaceutical form
Clear to slightly yellow oral solution
4. Clinical particulars
4.1 Therapeutic indications
Levetiracetam 100mg/ml Oral Solution is indicated as monotherapy in
the treatment of partial onset
seizures with or without secondary generalisation in patients from 16
years of age with newly diagnosed
epilepsy.
Levetiracetam 100mg/ml Oral Solution is indicated as adjunctive
therapy
• in the treatment of partial onset seizures with or without
secondary generalisation in adults, children and
infants from 1 month of age with epilepsy.
• in the treatment of myoclonic seizures in adults and adolescents
from 12 years of age with Juvenile
Myoclonic Epilepsy.
• in the treatment of primary generalised tonic-clonic seizures in
adults and adolescents from 12 years of
age with Idiopathic Generalised Epilepsy.
4.2 Posology and method of administration
For oral administration.
The oral solution may be diluted in a glass of water and may be taken
with or without food. A graduated
oral syringe and instructions for use in the package leaflet are
provided with Levetiracetam 100mg/ml
Oral Solution. The daily dose is administered in two equally divided
doses.
_Monotherapy for Adults and adolescents from 16 years of age_
The recommended starting dose is 250 mg twice daily which should be
increased to an initial therapeutic
dose of 500 mg twice daily after two weeks. The dose can be further
increased by 250 mg twice daily
every two weeks depending upon the clinical response. The