Entacapone 200mg tablets

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Entacapone

Доступна з:

Mylan

Код атс:

N04BX02

ІПН (Міжнародна Ім'я):

Entacapone

Дозування:

200mg

Фармацевтична форма:

Tablet

Адміністрація маршрут:

Oral

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 04090100; GTIN: 5016695004945 5016695004990

Характеристики продукта

OBJECT 1
ENTACAPONE MYLAN 200 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 14-Dec-2017 | Generics UK
T/A Mylan
1. Name of the medicinal product
Entacapone Mylan 200 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 200 mg entacapone.
Excipient with known effect
Each film-coated tablet contains 0.136 mg sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
Light orange, oval-shaped, biconvex, film coated tablet debossed with
“EE200” on one side of the tablet
and “M” on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Entacapone is indicated as an adjunct to standard preparations of
levodopa/benserazide or
levodopa/carbidopa for use in adult patients with Parkinson's disease
and end-of-dose motor fluctuations,
who cannot be stabilised on those combinations.
4.2 Posology and method of administration
Entacapone should only be used in combination with
levodopa/benserazide or levodopa/carbidopa.
The prescribing information for these levodopa preparations is
applicable to their concomitant use with
entacapone.
Posology
One 200 mg tablet is taken with each levodopa/dopa decarboxylase
inhibitor dose. The maximum
recommended dose is 200 mg ten times daily, i.e. 2,000 mg of
entacapone.
Entacapone enhances the effects of levodopa. Hence, to reduce
levodopa-related dopaminergic adverse
reactions, e.g. dyskinesias, nausea, vomiting and hallucinations, it
is often necessary to adjust levodopa
dosage within the first days to first weeks after initiating
entacapone treatment. The daily dose of
levodopa should be reduced by about 10–30% by extending the dosing
intervals and/or by reducing the
amount of levodopa per dose, according to the clinical condition of
the patient.
If entacapone treatment is discontinued, it is necessary to adjust the
dosing of other anti-Parkinsonian
treatments, especially levodopa, to achieve a sufficient level of
control of the Parkinsonian symptoms.