1 What is this medicine
and what is it used for?
Stalevo is a triple fixed-dose combination tablet for
Parkinson's disease. It combines three complementary medicines that work
together to maximise the availability of levodopa in the brain:
• Levodopa: the main active ingredient;
converted to dopamine in the brain to replace the dopamine that is
progressively lost in Parkinson's disease.
• Carbidopa: a peripheral decarboxylase
inhibitor — prevents levodopa from being broken down in the bloodstream before
it can cross into the brain, reducing peripheral side effects and the amount of
levodopa needed.
• Entacapone: a COMT (catechol-O-methyl
transferase) inhibitor — blocks an additional enzyme that breaks down levodopa,
extending the duration of each levodopa dose and reducing 'wearing-off'
episodes.
Stalevo 75/18.75/200 mg is used for: adults with Parkinson's
disease and end-of-dose motor fluctuations ('wearing-off') not adequately
controlled by levodopa/carbidopa alone. The patient must already be stabilised
on an equivalent dose of levodopa/carbidopa plus entacapone given as separate
tablets.
2 How to take this
medicine
Take as prescribed by your neurologist — the number of
tablets per day varies depending on your individual levodopa requirements.
Usually one tablet per dose, taken at regular intervals through the day.
Swallow whole with water. May be taken with a light snack but avoid
high-protein meals close to dosing (protein competes with levodopa absorption
in the gut and brain).
|
Take at the same times
every day — consistent timing is critical for maintaining stable dopamine
levels. Avoid high-protein
meals immediately before or after your Stalevo doses — protein reduces
absorption of levodopa. Never stop Stalevo
suddenly — abrupt discontinuation can trigger a dangerous syndrome called
neuroleptic malignant-like syndrome (hyperpyrexia, muscle rigidity). Taper
gradually under medical supervision. |
3 Possible side effects
|
Frequency |
Side Effect |
What to Do |
|
Very Common (>10%) |
Dyskinesia
(involuntary movements) |
Usually means levodopa
dose may be slightly high; discuss dose adjustment with your neurologist. |
|
Very Common (>10%) |
Urine discolouration
(dark orange/brownish-red) |
Harmless — caused by
entacapone metabolites. Not blood. |
|
Very Common (>10%) |
Nausea |
Take with a light
snack (not high-protein); usually improves after the first few weeks. |
|
Very Common (>10%) |
Diarrhoea |
Stay hydrated; usually
mild; inform your neurologist if severe or persisting. |
|
Common (1–10%) |
Orthostatic
hypotension (dizziness on standing) |
Rise slowly from
sitting; hold onto a stable surface; keep hydrated. |
|
Common (1–10%) |
Sleep disturbance /
vivid dreams |
Discuss timing of
doses with neurologist; avoid evening doses close to bedtime if possible. |
|
Common (1–10%) |
Hallucinations/confusion |
Report to neurologist
promptly — dose adjustment may be needed. |
|
Common (1–10%) |
Elevated liver enzymes
(entacapone) |
Regular LFT
monitoring. Report jaundice or abdominal pain. |
|
Rare |
Impulse control
disorders (gambling, hypersexuality) |
Caregivers: report new
compulsive behaviours to neurologist immediately. |
|
Seek help urgently |
High fever, severe
muscle rigidity, confusion — signs of neuroleptic malignant-like syndrome |
Emergency admission
required — do not stop Stalevo suddenly without medical supervision. |
4 Who should not take
this medicine
|
Do NOT use Stalevo if: You are taking non-selective MAO inhibitors
(phenelzine, tranylcypromine) — risk of hypertensive crisis. Selegiline and
rasagiline at approved doses are generally safe. You have narrow-angle glaucoma. You have a phaeochromocytoma or paraganglioma
(catecholamine-secreting tumours). You have severe hepatic impairment — entacapone
is contraindicated. You are pregnant or breastfeeding. You have known hypersensitivity to levodopa,
carbidopa, entacapone, or excipients. |
5 Medicines that interact
with this treatment
• Non-selective MAOIs: absolutely
contraindicated.
• Antipsychotics (haloperidol,
phenothiazines, risperidone): antagonise levodopa — avoid or use with caution.
• Antihypertensives: additive
hypotension — monitor blood pressure.
• Iron supplements: form chelate with
levodopa reducing absorption — separate by at least 2 hours.
• Metoclopramide: increases levodopa
absorption but may worsen dyskinesia; also antagonises effects of levodopa.
• High-protein diet: reduces levodopa
absorption — space doses away from high-protein meals.
6 How to store this
medicine
Store below 30°C. Keep in original packaging. Keep out of
reach of children. Do not use after the expiry date. Each bottle/blister should
be resealed after opening. Return unused medicine to pharmacy.
7 Prescription
requirement
|
PRESCRIPTION-ONLY
MEDICINE (POM) — Neurologist prescription required. Dose titration must be
performed by a physician experienced in Parkinson's disease management. |
8 Guidance for patients
& caregivers
Stalevo simplifies the Parkinson's medication regimen by
combining three medicines in one tablet. The most important thing is to take it
consistently at prescribed times. Small fluctuations in timing can lead to
'wearing-off' symptoms (stiffness, tremor, slow movement returning between
doses).
The dark orange-brown discolouration of urine caused by
entacapone is harmless — it is expected and should not be a cause for concern.
If the urine turns bright red or there is blood visible, contact your doctor.
Compulsive or impulsive behaviours (gambling, shopping,
eating, or sexual urges) are a recognised side effect of dopaminergic therapy.
Caregivers and family members should watch for and promptly report these
behaviours — they are not a personality change but a medication effect that can
be managed.
9 Pharmacist &
prescriber notes
Stalevo comes in multiple strengths (50, 75, 100, 125, 150,
200 mg of levodopa) — confirm the prescribed strength carefully, as all tablets
look similar. The carbidopa:levodopa ratio is always 1:4 (approximately).
Entacapone 200 mg is fixed regardless of levodopa dose.
Before switching from standard levodopa/carbidopa to Stalevo, confirm the
current levodopa/carbidopa dose is stable and entacapone is warranted.
Entacapone can cause a rise in plasma levodopa levels by up to 35% — watch for
increased dyskinesia after initiation.
Entacapone is hepatically metabolised; avoid in severe
hepatic impairment. For mild/moderate hepatic impairment, no dose adjustment
required but monitor LFTs.
10 Frequently asked
questions
Why is my urine dark orange or brownish?
This is caused by entacapone (one of
the three medicines in Stalevo) and its metabolites. It is completely harmless.
If you see bright red urine or notice blood, contact your doctor, but
orange-brown discolouration is expected and normal.
Why can't I eat a high-protein meal close to my Stalevo
dose?
Levodopa and dietary amino acids
(from protein) compete for the same transporters in the gut wall and across the
blood-brain barrier. High-protein meals close to dosing can reduce the amount
of levodopa reaching your brain, worsening Parkinson's symptoms.
Can I stop Stalevo if I have to go to the hospital?
No — do not stop suddenly. If you are
admitted to the hospital, make sure the medical team knows you are taking Stalevo
and that it must be continued. Abrupt withdrawal can cause a dangerous syndrome
of extreme rigidity and high fever.
What is 'wearing off'?
Wearing off describes the return of
Parkinson's symptoms (stiffness, tremor, slow movement) before your next
Stalevo dose is due. This is why entacapone is added — it extends each dose so
symptoms remain controlled for longer.
Can I take vitamins with Stalevo?
Vitamin B6 (pyridoxine) in large
doses can enhance peripheral levodopa breakdown, but carbidopa protects against
this at usual vitamin B6 supplement doses. Iron supplements should be separated
from Stalevo by at least 2 hours as they reduce absorption.