Stalevo 125mg31.25mg200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Entacapone; Carbidopa; Levodopa

Available from:

Orion Pharma (UK

INN (International Name):

Entacapone; Carbidopa; Levodopa

Dosage:

200mg ; 31.25mg ; 125mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04090100; GTIN: 6432100014047 6432100014030

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
STALEVO 125 MG/31.25 MG/200 MG FILM-COATED TABLETS
Levodopa/carbidopa/entacapone
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 or pharmacist.
-
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 side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Stalevo is and what it is used for
2.
What you need to know before you take Stalevo
3.
How to take Stalevo
4.
Possible side effects
5
How to store Stalevo
6.
Contents of the pack and other information
1.
WHAT STALEVO IS AND WHAT IT IS USED FOR
Stalevo contains three active substances (levodopa, carbidopa and
entacapone) in one film-coated
tablet. Stalevo is used for the treatment of Parkinson’s disease.
Parkinson’s disease is caused by low levels of a substance called
dopamine in the brain. Levodopa
increases the amount of dopamine and hence reduces the symptoms of
Parkinson’s disease. Carbidopa
and entacapone improve the antiparkinson effects of levodopa.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE STALEVO
DO NOT TAKE STALEVO IF YOU:
-
are allergic to levodopa, carbidopa or entacapone, or any of the other
ingredients of this
medicine (listed in section 6)
-
have narrow-angle glaucoma (an eye disorder)
-
have a tumour of the adrenal gland
-
are taking certain medicines for treating depression (combinations of
selective MAO-A and
MAO-B inhibitors, or non-selective MAO-inhibitors)
-
have ever had neuroleptic malignant syndrome (NMS – this is a rare
reaction to medicines used
to treat severe mental disorders)
-
have ever had non-traumatic rhabdomyolysis (a rare muscle disorder)
-
have a severe liver disease.
WARNINGS AND PRE

Summary of Product characteristics

STALEVO 125/31.25/200MG
Summary of Product Characteristics Updated 06-Feb-2015 | Orion Pharma
(UK) Limited
1. Name of the medicinal product
Stalevo 125 mg/31.25 mg/200 mg film-coated tablets
2. Qualitative and quantitative composition
Each tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200
mg of entacapone.
Excipient with known effect:
Each tablet contains 1.6 mg of sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Light brownish red, oval film-coated tablets marked with 'LCE 125' on
one side.
4. Clinical particulars
4.1 Therapeutic indications
Stalevo is indicated for the treatment of adult patients with
Parkinson's disease and end-of-dose motor
fluctuations not stabilised on levodopa/dopa decarboxylase (DDC)
inhibitor treatment.
4.2 Posology and method of administration
Posology
The optimum daily dose must be determined by careful titration of
levodopa in each patient. The daily
dose should be preferably optimised using one of the seven available
tablet strengths (50 mg/12.5 mg/200
mg, 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200
mg, 150 mg/37.5 mg/200
mg, 175 mg/43.75 mg/200 mg or 200 mg/50 mg/200 mg
levodopa/carbidopa/entacapone).
Patients should be instructed to take only one Stalevo tablet per dose
administration. Patients receiving
less than 70-100 mg carbidopa a day are more likely to experience
nausea and vomiting. While the
experience with total daily dose greater than 200 mg carbidopa is
limited, the maximum recommended
daily dose of entacapone is 2,000 mg and therefore the maximum dose is
10 tablets per day for the
Stalevo strengths of 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100
mg/25 mg/200 mg, 125
mg/31.25 mg/200 mg and 150 mg/37.5 mg/200 mg. Ten tablets of Stalevo
150 mg/37.5 mg/200 mg
equals 375 mg of carbidopa a day. According to this daily carbidopa
dose, the maximum recommended
daily Stalevo 175 mg/43.75 mg/200 mg dose is 8 tablets per day and
Stalevo 200 mg/50 mg/200 mg dose
is 7 tablets per day.
Usually