Entacapone 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Entacapone

Available from:

Wockhardt UK Ltd

ATC code:

N04BX02

INN (International Name):

Entacapone

Dosage:

200mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04090100; GTIN: 5012727907789 5012727907796

Patient Information leaflet

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READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor,
pharmacist or nurse.
−
This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
−
If you get any of the side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Entacapone Tablets are and what they are used for
2.
What you need to know before you take Entacapone Tablets
3.
How to take Entacapone Tablets
4.
Possible side effects
5.
How to store Entacapone Tablets
6.
Contents of the pack and other information
1. WHAT ENTACAPONE TABLETS ARE AND WHAT THEY ARE USED FOR
Entacapone Tablets contain entacapone and are used together with
levodopa to treat
Parkinson’s disease. Entacapone Tablets aids levodopa in relieving
the symptoms of
Parkinson's disease. Entacapone Tablets has no effect on relieving
the symptoms of
Parkinson´s disease unless taken with levodopa.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENTACAPONE TABLETS
DO NOT TAKE ENTACAPONE TABLETS
•
if you are allergic to entacapone or any of the other ingredients of
this medicine (listed in
Section 6);
•
if you have a tumour of the adrenal gland (known as pheochromocytoma;
this may
increase the risk of severe high blood pressure);
•
if you are taking certain antidepressants (ask your doctor or
pharmacist whether your
antidepressive medicine can be taken together with Entacapone
Tablets);
•
if you have liver disease;
•
if you have ever suffered from a rare reaction to antipsychotic
medicines called
neuroleptic malignant syndrome (NMS). See section 4 Possible side
effects for the
characteristics of NMS;
•
if you have ever suffered from a rare muscle disorder called
rhabdomyolysis which was
not caused by injury.
WARNIN

Summary of Product characteristics

OBJECT 1
ENTACAPONE 200 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 11-Mar-2016 | Wockhardt UK
Ltd
1. Name of the medicinal product
Entacapone 200 mg Film-Coated Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 200mg entacapone.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Brownish-orange, oval, biconvex film-coated tablet with “W477“
engraved on one side and plain 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 antiparkinsonian
treatments, especially levodopa, to achieve a sufficient level of
control of the parkinsonian symptoms.
Entacapone increases the bioavailability of levodopa from standard
levodopa/benserazide preparations
slightly (5-10%) more than from