DUODOPA intestinal gel
Levodopa 20mg/ml, carbidopa monohydrate 5mg/ml
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
In this leaflet:
- 1. WHAT DUODOPA IS AND WHAT IT IS USED FOR
- 2. BEFORE YOU TAKE DUODOPA
- 3. HOW TO TAKE DUODOPA
- 4. POSSIBLE SIDE EFFECTS
- 5. STORING DUODOPA
- 6. OTHER INFORMATION (ingredients, manufacturer, leaflet revision date)
What Duodopa Is And What It Is Used For
Duodopa contains a combination of levodopa and carbidopa for treatment of Parkinson’s disease.
Levodopa is transformed in the body to dopamine, a substance present in the brain and in the spinal cord where it assists in the transfer of impulses between the nerve cells. Too little dopamine can give symptoms like those in Parkinson’s disease, e.g. tremor, rigidity, slow movements, difficulty keeping one’s balance. The treatment with levodopa increases the amount of dopamine and hence reduces these symptoms.
Carbidopa is added to improve the effect and reduce the undesirable effects of levodopa.
Duodopa is a gel that is administered with a pump via a tube directly into the duodenum (the first part of the gut). This means that the two active ingredients are supplied continuously in small doses. Consequently, the content of drug in the blood becomes more constant and the risk of symptoms such as movement disorders is reduced.
Before You Take Duodopa
Do not take Duodopa:
- if you are hypersensitive (allergic) to levodopa, carbidopa or any of the other ingredients of Duodopa.
- if you have narrow-angle glaucoma (an eye disease)
- if your liver or kidney function is severely reduced
- if you have severe heart failure or severely abnormal heart rhythm
- if you have recently had a stroke
- if you have been taking medicines called MAOIs (monoamine oxidase inhibitors) within the last two weeks for depression. Examples of MAOIs include phenelzine, tranylcypromine and isocarboxazid
- if you have a pheochromocytoma (a tumour of the adrenal gland)
- if you have hyperthyroidism (over-production of the thyroid gland) or Cushing’s syndrome (caused by over-production of the adrenal gland)
Take special care with Duodopa:
- It is important that before starting treatment with Duodopa you tell your doctor about any medical problems that you have or have had, in particular: if you have had a heart attack; serious heart or lung disease; bronchial asthma; kidney or liver disease; endocrine disease; depression or any other psychiatric disorder; stomach ulcer; or convulsions (fits).
Pregnancy
If you are pregnant or think you may be pregnant, tell your doctor.
Breast-feeding
You should not breast-feed while under treatment with Duodopa.
Driving and using machines
Duodopa can cause somnolence (drowsiness) and/or sudden sleep episodes. You should therefore refrain from driving a car or engaging in activities such as operating machines where impaired alertness may put you, or others, at risk of serious injury or death until you are certain that you are not affected in this way.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those which are not prescribed.
It is particularly important for you to tell your doctor if you are already taking iron tablets or certain medicines used for the treatment of depression, schizophrenia, tuberculosis (TB), high blood pressure, tremor (muscle twitches) or epilepsy. Your doctor may wish to change you to a different medicine or adjust the dose of Duodopa.
How To Take Duodopa
Always take Duodopa exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure.
Usually, a larger morning dose is administered with the pump (bolus dose) to quickly reach the correct blood level. After that a lower maintenance dose is given. If needed, extra doses may be given. The dose is different for each patient and may need regular fine-tuning.
Do not change the dosage or discontinue the treatment without consulting your doctor. Abrupt interruption of treatment may result in complications.
If you take more Duodopa than you should
If you have taken too large a dose of Duodopa, always contact a doctor or hospital.
Possible Side Effects
Like all medicines, Duodopa can have side effects.
If you experience any of these side effects, contact your doctor as soon as you can. Many of the side effects can be relieved by adjusting the dose.
Common (occur in more than 1 patient in 100):
- loss of appetite
- hallucinations, confusion, nightmares, sleepiness, fatigue, sleeplessness, depression (with very rare suicide attempts), euphoria, dementia, delusions (mistaken beliefs or ideas), feeling of stimulation
- dyskinesias (involuntary movements) and muscle cramps, ‘ON-OFF’ episodes
- palpitations, irregular heartbeat
- dizziness, feeling faint on standing up, fainting
- nausea, vomiting, dry mouth, bitter taste
Uncommon:
- weight changes, up or down
- ataxia (difficulty in controlling movements), increased tremor of the hands
- high blood pressure
- hoarseness, chest pain
- constipation, diarrhoea, increased salivation, difficulty swallowing, flatulence (wind)
- oedema (swelling caused by excess fluid)
- muscle spasms
- dark urine
- weakness, malaise (feeling unwell)
Rare/very rare:
- agitation, fear, reduced thinking capacity, disorientation, numbness
- daytime drowsiness and sudden sleep onset
- vision disturbances (eg blurred vision, double vision)
- phlebitis (inflammation of veins)
- shortness of breath, abnormal breathing pattern
- indigestion, abdominal pain, dark saliva, grinding of teeth while sleeping, hiccups, abdominal bleeding, burning sensation of the tongue, ulcers in the gut
- angioedema (serious allergic reaction causing swelling of the face or throat), itching, rash, facial redness, increased and dark perspiration (sweating), hair loss
- difficulty urinating, urinary incontinence, prolonged and painful erection
- Other side effects that have been reported are pathological gambling (failure to resist gambling impulses despite serious personal or family consequences), increased sex drive and hypersexuality (altered sexual interest and behaviour of significant concern to the patient or to others)
The following very common complications have been reported for the tube system: dislocation of the intestinal tube to the stomach (which leads to an irregular response to treatment); local infection around the tube through the abdominal wall; and stomach pain. If any problem occurs with the pump or the tube system, please contact your doctor.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Storing Duodopa
Do not use Duodopa after the expiry date printed on the carton. Used cassettes should not be re-used but returned to your nearest pharmacy.
Store at 2ºC - 8ºC (in a refrigerator). Duodopa is sensitive to light, so always keep the cassettes in the outer carton, and close it carefully.
The drug cassettes are for single use only and should not be used for longer than one day (up to 16 hours) even if some intestinal gel remains.
Keep Duodopa out of the reach and sight of children.
Other Information
The active ingredients in Duodopa are levodopa and carbidopa (as monohydrate). The other ingredients are carmellose sodium and purified water. 1 ml of intestinal gel contains 20 mg levodopa and 5 mg carbidopa (as monohydrate). One cassette (100 ml) of Duodopa intestinal gel contains 2000 mg levodopa and 500 mg carbidopa (as monohydrate).
The other ingredients are carmellose sodium and purified water.
The Marketing Authorisation Holder is
Duodopa is made by
and also by
Duodopa is distributed in the UK by
and in Ireland by
This leaflet was last approved in October 2008
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