Duodopa 20 mg/ml + 5 mg/ml intestinal gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levodopa; Carbidopa

Available from:

AbbVie Limited

ATC code:

N04BA; N04BA02

INN (International Name):

Levodopa; Carbidopa

Dosage:

20/5 milligram(s)/millilitre

Pharmaceutical form:

Intestinal gel

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Dopa and dopa derivatives; levodopa and decarboxylase inhibitor

Authorization status:

Marketed

Authorization date:

2005-11-18

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DUODOPA 20 MG/ML + 5 MG/ML INTESTINAL GEL
levodopa/carbidopa monohydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Duodopa is and what it is used for
2.
What you need to know before you use Duodopa
3.
How to use Duodopa
4.
Possible side effects
5.
How to store Duodopa
6.
Contents of the pack and other information
1.
WHAT DUODOPA IS AND WHAT IT IS USED FOR
Duodopa belongs to a group of medicines for Parkinson’s disease.
Duodopa is a gel that goes through a pump and a tube into your gut
(small intestine). In the gel there
are two active substances:
•
Levodopa.
•
Carbidopa.
HOW DUODOPA WORKS
•
In the body, levodopa is made into something called ‘dopamine’.
This adds to the dopamine
already in your brain and spinal cord. Dopamine helps transfer signals
between nerve cells.
•
Too little dopamine causes Parkinson’s disease signs like tremor,
feeling stiff, slow movement,
and problems keeping your balance.
•
Treatment with levodopa increases the amount of dopamine in your body.
This means it reduces
these signs.
•
Carbidopa improves the effect of levodopa. It also reduces the side
effects of levodopa.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DUODOPA
DO NOT USE DUODOPA IF
•
You are allergic to levodopa, carbidopa or any of the other
ingredients of this medicine (listed in
section 6).
•
You have an eye problem called ‘narrow-angle glaucoma’.
•
You have severe heart problems.
•
You have a severe uneven he

Summary of Product characteristics

Health Products Regulatory Authority
10 November 2023
CRN00DYDF
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Duodopa 20 mg/ml + 5 mg/ml intestinal gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 20 mg levodopa and 5 mg carbidopa monohydrate.
100 ml contain 2000 mg levodopa and 500 mg carbidopa monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Intestinal gel.
Off white to slightly yellow gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of advanced levodopa-responsive Parkinson’s disease with
severe motor fluctuations and hyperkinesia or dyskinesia
when available combinations of Parkinson medicinal products have not
given satisfactory results.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Duodopa is a gel for continuous intestinal administration. For
long-term administration, the gel should be administered with a
portable pump directly into the duodenum or upper jejunum by a
permanent tube _via_ percutaneous endoscopic gastrostomy
with an outer transabdominal tube and an inner intestinal tube.
Alternatively, a radiological gastrojejunostomy may be
considered if percutaneous endoscopic gastrostomy is not suitable for
any reason. Establishment of the transabdominal port
and dose adjustments should be carried out in association with a
neurological clinic.
A temporary nasoduodenal/nasojejunal tube should be considered to
determine if the patient responds favourably to this
method of treatment before a permanent percutaneous endoscopic
gastrostomy with jejunal tube (PEG-J) is placed. In cases
where the physician considers this assessment is not necessary, the
nasojejunal test phase may be waived and treatment
initiated directly with placement of the PEG-J. The dose should be
adjusted to an optimal clinical response for the individual
patient, which means maximizing the functional ON-time during the day
by minimizing the number and duration of OFF
episodes (bradykinesia) and minimizing ON-time with disabling
dyskinesia. See