20 mg / ml + 5 mg / ml intestinal gel 
levodopa / carbidopamon monohydrate

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

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 packaging 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 via a pump and a probe into the gastrointestinal tract (small intestine). Gel one contains two active substances:

  • Levodopa.
  • Carbidopa.

How Duodopa works

  • In the body, levodopa is converted to a substance called dopamine. This adds to the dopamine that is already present in the brain and spinal cord and helps with the transmission of impulses between the nerve cells.
  • Too little dopamine can cause symptoms that are the same as in Parkinson’s disease, such as tremors, muscle stiffness, slow movements, and difficulty maintaining balance.
  • The treatment with levodopa increases the amount of dopamine in the body, these symptoms decrease.
  • Carbidopa improves the effect and reduces the side effects of levodopa.

2. What you need to know before using Duodopa

Do not re-use Duodopa

  • You are allergic to levodopa, carbidopa, or any of the other ingredients of this medicine (listed in section 6).
  • You have an eye disease called narrow-angle glaucoma ( glaucoma ).
  • You have a serious heart defect.
  • You have severe cardiac arrhythmia (irregular heartbeat).
  • You have had a severe stroke.
  • You are taking antidepressants called “selective MAO-A inhibitors” and non-selective MAO inhibitors such as moclobemide or phenelzine.
  • You have an adrenal cortex tumor ( pheochromocytoma ).
  • You have hormone problems, such as too much cortisol (Cushing’s syndrome), or your thyroid hormone levels are too high ( hyperthyroidism ).
  • You have previously had skin cancer, or if you have any abnormal birthmarks or rashes on the skin that have not been examined by a doctor.

Do not use Duodopa if any of the above apply to you. If you are not sure, talk to your doctor before taking Duodopa.

Warnings and cautions

Talk to your doctor before taking Duodopa if:

  • Have you ever had a heart attack, congested blood vessels in your heart, or other heart problems that include irregular heartbeat ( arrhythmia )?
  • You have lung problems such as asthma.
  • You’ve ever had a hormone problem.
  • Have you ever been depressed with suicidal thoughts or have had other mental health problems?
  • You have an eye problem called wide-angle glaucoma.
  • You’ve had a stomach ulcer at some point.
  • You’ve ever had a seizure.
  • You have undergone surgery on the upper abdomen.
  • Increasing weakness, pain, numbness, or loss of sensation in the fingers or feet ( polyneuropathy ) have been reported in patients treated with levodopa/carbidopa intestinal gel. Before starting treatment with levodopa/carbidopa intestinal gel, and regularly during treatment, your doctor will check for signs and symptoms of neuropathy. Tell your doctor if you already have neuropathy or any medical condition associated with neuropathy.

If any of the above apply to you (or you feel unsure), talk to your doctor before taking Duodopa.

Be alert for the following side effect s

Malignant neuroleptic syndrome

Do not stop taking Duodopa or lower your dose unless your doctor tells you to.

If you suddenly stop taking or lowering your Duodopa dose, it may cause a serious

a condition called ‘neuroleptic malignant syndrome’ (see section 4, Serious side effects).

You feel sleepy or dizzy

If you suddenly fall asleep (sleep attacks) or feel very sleepy, or if you feel dizzy or dizzy:

  • Wait until you feel properly awake again or until the dizziness has disappeared before driving or using tools or machines (see section 2, Driving and using machines).

Skin changes

Tell your doctor, pharmacist, or nurse if you notice any abnormal birthmarks or rashes on your skin that you have not seen before or that have gotten worse (see section 4, Other side effects ).

Disrupted impulse control – changes in your behavior

Tell your doctor if you, your family, or your carer notice that you develop a strong desire or desire to behave in ways that are unusual for you. Or if you can not resist the impulse, drive, or temptation to perform certain activities that may harm you or others. These behaviors are called “disrupted impulse control” and may include:

  • Gambling addiction.
  • Compulsive eating or buying.
  • An abnormally high sex drive or an increase in sexual thoughts and feelings.

Your doctor may need to re-evaluate your treatment. Your doctor will discuss with you how these symptoms can be managed or reduced (see section 4, Impaired Impulse Control – Changes in Your Behavior).

Dopaminergic dysregulation syndrome

Tell your doctor if you or your family/caregiver notice that you are developing addictive symptoms that lead to a craving for higher doses of Duodopa and other medicines used to treat Parkinson’s disease.

Problems with the pump or probe

There may be problems with the use of the pump and the probe:

  • Your ability to handle the pump and probe may deteriorate, your Parkinson’s symptoms may worsen or you may have difficulty moving ( bradykinesia ), the pump or probe may not work properly.
  • You have abdominal pain, feeling unwell, and vomiting – contact a doctor immediately if this happens (see section 4, Serious side effects ).
  • You may experience other side effects that affect your gastrointestinal tract and the cutting surface of the probe (see section 4, Problems with the pump or probe).

Duodopa and cancer

In the body, carbidopa (an active substance in Duodopa) is broken down into something called hydrazine. Hydrazine may cause damage to the genetic material that could lead to cancer. It is not known whether the amount of hydrazine produced during the recommended dosage of Duodopa can cause these injuries.

Laboratory tests

Blood tests may be needed if you are being treated with this medicine.

Operations

Before undergoing surgery (including dental surgery), tell your doctor (or dentist) that you are using Duodopa.

Children and young people

Duodopa should not be given to children or adolescents under 18 years of age.

Other medicines and Duodopa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription or (traditional) herbal and herbal medicines.

Do not use Duodopa if you are taking:

  • Antidepressants so-called “selective MAO-A inhibitors” and non-selective MAO inhibitors such as moclobemide or phenelzine.

Before starting Duodopa, tell your doctor or pharmacist that you are taking medicines for:

  • Anemia (such as iron tablets).
  • Tuberculosis (such as isoniazid ).
  • Anxiety (such as benzodiazepines ).
  • Nausea (such as metoclopramide).
  • High blood pressure (such as antihypertensive drugs).
  • Spasm is in blood vessels (such as papaverine).
  • Seizures or epilepsy (such as phenytoin ).
  • Parkinson’s disease (eg tolcapone, entacapone or amantadine).
  • Mental health problems (medicines for psychosis, such as phenothiazines, butyrophenone derivatives, and risperidone ).
  • Severe allergic reactions, asthma, chronic bronchitis, heart disease, and low blood pressure (eg anticholinergics or sympathomimetics).
  • You are taking a medicine that can cause low blood pressure. This can cause something called orthostatic hypotension that makes you dizzy when you get up from a chair or bed. You should be aware that Duodopa may aggravate this reaction. Remember to move slowly.

Duodopa with food and drink

For some patients, Duodopa may be less well absorbed when ingested or immediately after consuming high protein foods (eg meat, fish, dairy products, cereal,s, and nuts). Talk to your doctor if you think this is affecting you.

Pregnancy and breastfeeding

  • If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking Duodopa.
  • Do not use Duodopa while breast-feeding.

Driving and using machines

Do not drive or use any tools or machines until you know how Duodopa affects you.

  • Duodopa can make you feel very sleepy, or you may sometimes suddenly fall asleep (sleep attacks).
  • Duodopa can cause lowered blood pressure, which can make you feel dizzy or dizzy.

Wait until you feel properly awake or do not feel dizzy before driving or using tools or machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Duodopa

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Ask your doctor or pharmacist if you are unsure.

About Duodopa gel and the pump

  • Duodopa is a gel that passes through a pump and a probe into your gastrointestinal tract (small intestine).
  • Gel one is provided in plastic cassettes. The cassettes are connected to a pump.
  • The pump is connected to a probe that is placed in the small intestine.
  • During the day, a small dose is added continuously. This means that the level of drugs in the blood becomes more even and the risk of side effects, such as movement disorders, is less.

How much Duodopa is used

  • Doctors will decide how much Duodopa to use and for how long.
  • A larger morning dose is usually given with the pump (so-called bolus dose ) to quickly reach the right blood levels. Thereafter, a continuous maintenance dose is given.
  • If necessary, extra doses can be given, this will be decided by the doctor.

If you use more Duodopa than you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Take the medicine pack with you.

Overdose can have the following effects:

  • Problems opening the eyes.
  • Uncontrollable muscle cramps that affect your eyes, head, neck, and body ( dystonia ).
  • Involuntary movements ( dyskinesia ).
  • Unusually fast, slow or irregular heartbeat ( arrhythmia ).

If you forget to use Duodopa

  • Start the pump, as prescribed as soon as possible.
  • Do not increase dose one to compensate for a missed dose 

If you stop taking Duodopa or lower your dose

You mustn’t stop taking Duodopa or lower your dose without consulting your doctor.

In case of sudden dose reduction or sudden discontinuation of Duodopa, a serious condition (malignant neuroleptic syndrome) may occur. This is more likely to happen if you are being treated with antipsychotics at the same time (see section 4, Serious side effects ).

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects are with Duodopa

Stop using Duodopa immediately and contact a doctor immediately if you notice any of the following side effects – you may need urgent medical attention:

  • Acute pain in the eyes, headache, blurred vision, nausea, and vomiting. These may be symptoms of narrow-angle glaucoma (increased pressure in the eye). Uncommon: may affect up to 1 in 100 people.
  • Fever, sore throat, sore mouth, or difficulty urinating. This may be a sign that the white blood cells are affected, so-called agranulocytosis. Doctors will take a blood test to check this. Very rare: may affect up to 1 in 10,000 people.
  • Swelling of the face, tongue, and throat may make it difficult to swallow or breathe, and hives. These symptoms may be a sign of a severe allergic reaction ( anaphylactic reaction ). No known frequency. Cannot be calculated from available data.

Tell your doctor immediately if you notice any of the following serious side effects:

  • Neuroleptic Malignant Syndrome – Symptoms may include:
    • rapid heartbeat, varying blood pressure, and sweating followed by fever.
    • rapid breathing, muscle stiffness, decreased level of consciousness, and coma .high levels of a protein in the blood (an enzyme called creatine phosphokinase and measured by doctors). Rare: may affect up to 1 in 1,000 people. See section 3 “If you stop taking Duodopa or lower your dose” for more information on the neuroleptic malignant syndrome.

Other side effects include Duodopa

Talk to your doctor, pharmacist, or nurse if you notice any of the following side effects:

Very common (may affect more than 1 in 10 people):

  • Case
  • Weight loss
  • Nausea, constipation.
  • Anxiety, depression, insomnia ( insomnia ).
  • Involuntary movements ( dyskinesia ), exacerbation of Parkinson’s disease.
  • Dizziness, when you stand up or change position ( orthostatic hypotension ), due to low blood pressure. Remember to move slowly, do not stand up quickly.

Common (may affect up to 1 in 10 people):

  • Weight gain
  • Irregular heartbeat
  • Loss of appetite
  • Fatigue, weakness.
  • High or low blood pressure.
  • Anemia (low levels of iron in the blood).
  • Pain, neck pain, muscle cramps, muscle weakness.
  • Sleep attacks, drowsiness, sleep disorders.
  • Increased levels of amino acids or homocysteine in the blood, deficiency of vitamins B6 and B12.
  • Dizziness, fainting, and fainting ( syncope ).
  • Difficulty swallowing, dry mouth, bitter taste in the mouth.
  • Headache.
  • Increasing weakness or pain or numbness or loss of sensation in fingers or feet ( polyneuropathy ).
  • Rash, itching, increased sweating, swelling due to fluid retention ( edema ).
  • Urinary incontinence or incontinence (inability to control urination), urinary retention.
  • See, hear or feel something that does not really exist (hallucinations), confusion, abnormal dreams, anxiety, impulsive behavior, psychotic disorders.
  • Swollen stomach, diarrhea, flatulence ( flatulence ), indigestion ( dyspepsia ), vomiting.
  • Parkinson’s symptoms recur quickly or unexpectedly – this is called an “on and off phenomenon”.
  • The decreased sensation on touch, uncontrolled muscle spasms that affect the eyes, head, neck, and body ( dystonia ), tremors.

Disrupted impulse control – changes in your behavior. These are common (may affect up to 1 in 10 people):

Inability to resist an impulse to perform an act that may be harmful to you or others, such as:

  • A strong impulse to excessive gambling despite serious consequences for you personally or for your family.
  • Changed or increased sexual interest or behavior that makes you or others noticeably worried, such as increased sexual drive.
  • Uncontrollable and excessive need to buy things and spend money.
  • Binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger).

Talk to your doctor if you, your family, or carers notice any of these behaviors. Your doctor may need to re-evaluate your treatment and will discuss ways to manage or reduce your symptoms.

Uncommon (may affect up to 1 in 100 people):

  • Dark-colored urine.
  • Hoarseness, chest pain.
  • Hair loss, redness of the skin, hives.
  • An increased amount of saliva.
  • Swollen veins ( phlebitis ).
  • Gait disorders
  • Suicide attempt – suicide
  • Fatigue, feeling sick.
  • Fast and irregular heartbeat ( palpitation ).
  • Low levels of white blood cells, changes in the number of blood cells can cause bleeding.
  • Confusion, strong feelings of happiness ( euphoria ), increased sexual interest, nightmares, dementia, fear.
  • Difficulty controlling movements and making strong movements you can not control.
  • Difficulty opening the eyes, double vision, blurred vision, nerve damage to the eyes (ischemic optic neuropathy ).

Rare (may affect up to 1 in 1,000 people):

  • Abnormal thinking.
  • Uneven breathing pattern.
  • Persistent and painful erection.
  • Abnormal birthmarks or rashes on the skin that you have not seen before or that have gotten worse, or skin cancer (malignant melanoma ).
  • Dark saliva or dark-colored sweat, hiccups, burning sensation in the tongue, gnashing of teeth.

Has been reported (occurs in an unknown number of users):

  • Request a higher dose of Duodopa that is greater than that required to control motor systems, known as dopaminergic dysregulation syndrome. Some patients experience severe abnormal involuntary movements ( dyskinesias ), mood swings, or other side effects after taking larger doses of Duodopa.

Talk to your doctor, pharmacist, or nurse if you notice any of the side effects listed above.

A side effect of the pump or probe

The following side effects have been reported for the pump and probe. Talk to your doctor or nurse if you notice any of these side effects.

  • Your ability to handle the pump and probe deteriorate, your Parkinson’s symptoms worsen or you have difficulty moving ( bradykinesia ) – the pump or probe may not work properly.
  • You have stomach pain, feel unwell and vomit – talk to a doctor immediately if this happens. You may have a problem with the pump or probe.

Very common (may affect more than 1 in 10 people):

  • Stomach pain.
  • Infection in the wound after surgery.
  • Thick scarring at the point where the probe enters the abdomen.
  • Problems with tube insertion such as pain or swelling in the mouth or throat, difficulty swallowing, stomach discomfort, pain or swelling, damage to the throat, mouth or stomach, internal bleeding, vomiting, flatulence, anxiety.
  • Problems at the site where the probe enters the abdomen, redness, sores, discharge of fluid, pain, or irritation.

Common (may affect up to 1 in 10 people):

  • Infection at the surgical incision, infection after surgery when the probe has been placed in the intestine.
  • Inflammation of the stomach wall.
  • Infection in the intestine or at the site where the probe enters the stomach.
  • The probe changes position from the intestine to, for example, the stomach or becomes blocked, which can lead to a worsened treatment response.
  • Painful breathing, shortness of breath, pneumonia (pneumonia, including aspiration pneumonia).

Uncommon (may affect up to 1 in 100 people):

  • Inflammation of the colon ( colitis ).
  • Inflammation of the pancreas ( pancreatitis ).
  • The tube passes through the colon wall.
  • Blockage of the intestines, bleeding, or ulcers on the small intestine.
  • A part of the intestine is inserted into another, the adjacent part of the intestine (invagination).
  • Blockage of the probe due to undigested food stuck around the probe.
  • Boil after insertion of the probe into the intestine.

Has been reported (occurs in an unknown number of users):

  • Reduced blood flow in the small intestine.
  • The probe placed in the intestine passes through the stomach wall or small intestine.
  • Infection in the blood ( sepsis ).

A side effect is when levodopa and carbidopa are taken by mouth

The following side effects have been reported when levodopa and carbidopa (the same active substances as in Duodopa) are taken orally. These side effects may also occur with Duodopa.

Rare (may affect up to 1 in 1,000 people):

  • Anemia (low level of iron in the blood).
  • Eye disease is called Horner’s syndrome.
  • Inability to open the mouth completely (gap difficulty).
  • Red or purple rash that looks like small bruises (Schoenlein-Henoch’s purpura).
  • Neuroleptic malignant syndrome (see section 4, Serious side effects ).
  • Excessive or prolonged dilation of the pupil in the eye ( mydriasis ), worsening of eye movement.

Very rare (may affect up to 1 in 10,000 people):

  • Altered blood levels.

5. How to store Duodopa

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton after EXP.
  • Store and transport cold (2 ° C to 8 ° C). Store the cassettes in the outer carton. Sensitive to light. A gel cassette can be used up to 24 hours after being taken out of the refrigerator.
  • The cassettes are for single use only. A cartridge should not be used for more than 24 hours even if there are medicines left.
  • Do not reuse an already opened cartridge.
  • Gel one may turn yellow towards the end of the storage period – this does not affect the effectiveness of the medicine.
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. The used cassette should not be reused but left to the nearest pharmacy.

6. Contents of the packaging and other information

Content declaration

  • The active substances are levodopa and carbidopa monohydrate. 1 ml gel contains 20 mg levodopa and 5 mg carbidopamon monohydrate.
  • The other ingredients are caramel sodium and purified water.

What the medicine looks like and the contents of the pack

Duodopa is supplied in cassettes (PVC plastic bags with protective hard plastic casing) containing 100 ml with 7 cassettes in each package. Gel one is yellowish-white to pale yellow

Marketing Authorisation Holder

AbbVie AB

Box 1523

171 29 Solna

Manufacturer

Fresenius Kabi Norge AS

Svinesundsveien 80 
1788 Halden 
Norway

This medicine is authorized in the European Economic Area under the name Duodopa.

Muhammad Nadeem

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