DUODOPA 20MG/ML + 5MG/ML INTESTINAL GEL

Active substance: LEVODOPA

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaet carefully before you start taking this medicine. Keep this leaet. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist.

Label Center Ludwigshafen

In this leaet: 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. How to store Duodopa 6. Further information 1

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LCR No.: Commodity No.: MKP-12-XXX1 Draft No.: 3 Revision date: 2. Nov. 2012 Graphic Artist: Th. Wrzburger
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FOR POSITION ONLY

Customer: Fresenius Kabi Product name/Country: Duodopa Gel, GB Size: 85 x 120 mm Pharma code: Collating mark: -

Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel Levodopa and carbidopa monohydrate

Min. text size: 8 pt Colors: Black Cutting die

1.

What Duodopa is and what it is used for



What Duodopa is used for Duodopa belongs to a group of medicines for treatment of Parkinsons disease. Duodopa contains two medicines in a gel: levodopa and carbidopa monohydrate. How Duodopa works Levodopa is made into dopamine in the body. Dopamine is present in your brain and in your spinal cord. It helps transfer signals between nerve cells. Too little dopamine causes Parkinsons disease signs like tremor, feeling rigid, slow movements, and problems keeping your balance. Treatment with levodopa increases the amount of dopamine in your body and so reduces these signs Carbidopa monohydrate is added to improve the effect and reduce the undesirable effects of levodopa. 2. Before you take Duodopa



You have depression and have recently (within the previous two weeks) been treated with either a medicine called a non-selective MAO inhibitor or a selective MAO A inhibitor You have a growth in your adrenal gland (adrenocortical tumour) You have hormonal problems (such as overproduction of adrenocortical or thyroid hormones)

Do not take Duodopa if: You are allergic (hypersensitive) to levodopa, carbidopa monohydrate or any of the other ingredients of Duodopa (listed in Section 6) You have an eye problem called narrow-angle glaucoma You have severe liver or kidney problems You have severe heart disease You have a severe irregular heart beat (arrhythmia) You have an acute stroke 2

Take special care with Duodopa: Check with your doctor before or while taking Duodopaif: You have a severe heart disease or have had a heart attack You have a lung problem (such as bronchial asthma) You have a hormonal problem You have depression with suicidal tendencies or any mental problem You are taking medicines used to treat depression or other mental disorders (antipsychotics) You have an eye problem called wide-angle glaucoma You have ever had a stomach ulcer You have ts (convulsions) You experience failure to resist gambling impulses (pathological gambling), altered sexual interest and behaviour (increased sex drive and hypersexuality) You have had previous upper abdominal surgery You experience a reduced ability to handle the device system (pump or tube connections) 3

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You experience worsening of execution of movements (bradykinesia) which may indicate a malfunction of the device system Having a PEG-J tube in your intestine may result in the risk of undigested food getting stuck around the tube. If you have the following symptoms, please contact your doctor immediately: abdominal pain, nausea and vomiting. Duodopa should not be given to children or adolescents under the age of 18 years. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Duodopa. Duodopa contains a substance called hydrazine, a breakdown product of one of the ingredients (carbidopa). This substance can cause damage to the genetic material which could theoretically lead to cancer. The risk for humans when exposed to hydrazine at recommended doses of Duodopa is not known. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. In particular, talk to your doctor or pharmacist before starting Duodopa if you are taking medicines for: Parkinsons disease, severe allergic reactions, asthma, chronic bronchitis, heart diseases and low blood pressure (such as Anticholinergics and Sympathicomimetics) Fits (convulsions) or epilepsy 4



High blood pressure Mental problems Depression (such as tricyclic antidepressants or non-selective monoamine oxidase inhibitors) Tuberculosis (such as isoniazide) Anxiety (such as benzodiazepines) Anaemia (such as iron tablets) Sickness (such as metoclopramide) Spasms in the blood vessels (such as papaverine). If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Duodopa. Pregnancy and breast-feeding Do not use Duodopa if: You are pregnant or are planning to become pregnant while taking Duodopa. Unless you have discussed it with your doctor and he or she has clearly told you to do so. You are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding. Driving and using machines Duodopa may cause you to feel dizzy, sleepy or to fall asleep suddenly. Do not drive or use any tools or machines until you are sure how the medicine affects you. 3. How to take Duodopa

Always take Duodopa exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. 5

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How Duodopa is given Duodopa is a gel which comes in a plastic cassette. These are connected to a pump. The pump is connected to a tube which is placed into the small intestine. You are given a small dose continuously during day-time. This means that the level of the medicines in your blood is more constant and also some of the movement side effects are lower. How much Duodopa is given Your doctor will decide how much Duodopa you should be given and for how long Usually, a larger morning dose is given using the pump (bolus dose) to quickly reach the correct blood level. After that dose, a continuous (maintenance) dose is given If needed, extra doses may be given. If you have more Duodopa than you should If you have had more Duodopa than you should, talk to your doctor or go to a hospital straight away. Take the medicine pack with you. The following effects may happen: problems opening your eye (blepharospasm), uncontrollable muscle spasms affecting your eyes, head, neck and body (dystonia), involuntary movements (dyskinesia),unusual fast, slow or uneven heart beats (arrhythmia). If you stop or lower your dose of Duodopa It is important that you do not stop having Duodopa or lower your dose until told to do so by your doctor. Suddenly stopping or lowering your Duodopa dose may result in a serious problem called Neuroleptic Malignant 6

Syndrome. The signs may include: Fast heart beat, changing blood pressure and sweating followed by fever Faster breathing, muscle stiffness, lower consciousness and coma Higher levels of a protein in your blood (an enzyme called creatine phosphokinase). This is measured by your doctor. This problem is more likely to happen if you are also taking a medicine called an antipsychotic. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects

Like all medicines, Duodopa can cause side effects, although not everybody gets them. Stop taking Duodopa and tell your doctor straight away if you notice any of the following side effects you may need urgent medical treatment: Swelling of the face, tongue or throat which may make it difcult to swallow or breathe; nettle type skin rash. These may be signs of an allergic type reaction called angioedema Fever, sore throat or mouth or trouble passing water. These may be signs of a white blood cell problem called agranulocytosis. Your doctor will take a blood sample to check the levels of your white blood cells. The following side effects have also been observed with drugs containing levodopa and carbidopa monohydrate: Common (affects 1 to 10 users in 100) Loss of appetite 7

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Seeing, hearing or feeling things that are not there (hallucinations), confusion, nightmares, feeling sleepy, fatigue, sleeplessness, euphoria (abnormal elation), loss of memory, and other mental problems such as psychotic episodes or elevated mood Depression with very rare thoughts of suicide Involuntary movements and muscle cramps (dyskinesias and dystonias), slow movement Increased, rapid or irregular heart beat (palpitations) Feeling dizzy, especially when you stand up (orthostatic hypotension) Feeling like you want to faint and fainting (syncope) Feeling sick (nausea), being sick (vomiting), dry mouth, taste disturbance (bitter taste).





Uncommon (affects 1 to 10 users in 1,000) Loss of weight, increased weight Difculty in controlling movements, increased tremor of the hands High blood pressure Hoarseness, chest pain Constipation, diarrhoea, increased saliva, difculty swallowing, wind (atulence) Swelling caused by excess uid (oedema) Muscle spasms Dark urine Feeling weak, feeling tired or generally unwell. Rare/very rare (affects 1 to 10 users in 10,000) Agitation, fear, reduced thinking capacity, being disorientated, increased sex drive, headache Numbness, pins and needles, neuroleptic malignant syndrome (see If you stop taking Duodopa in 8





Section 3 for signs of this effect) Change in blood values (shown in blood tests) including agranulocytosis Swelling in the vein (phlebitis) or inammation of the blood vessels Feeling very sleepy, falling asleep suddenly. If this happens, you should not drive or operate machinery. Blurred vision, double vision or other eye problems Shortness of breath, abnormal breathing pattern Indigestion (dyspepsia), abdominal pain, dark saliva, hiccups, perforation or bleeding of the stomach or bowel, burning sensation of the tongue, lockjaw, grinding of the teeth Skin problems such as itching, rash, facial redness, bleeding, hair loss, dark sweat, increased sweating, tumour of the skin (malignant melanoma) Difculty urinating, urinary incontinence, prolonged and painful erection Falling or problems walking Fits (convulsions).

Other possible side effects (not known: frequency cannot be estimated from the available data) 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 signicant concern to the patient or to others). These side effects are generally reversible upon reduction of the dose or treatment discontinuation. 9

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The following very common complications have been reported for the tube delivery system: Leaks at the connections and leakage of gastric uid Blockade of ow of Duodopa due to occlusion, kinking and knotting of the tubing. Should complete failure of the tube or pump occur see your doctor immediately. The doctor will treat you with oral levodopa/carbidopa until the problem is solved. Dislocation of the tube e.g. to the stomach (resulting in decreased treatment response) Local infection around the site of tube entering the stomach area (stoma), inammation of the abdominal cavity (peritonitis), and perforation of adjacent organs, bleeding and abdominal pain, especially during tube placement. If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. 5. How to store Duodopa

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. Used cassettes should not be re-used but returned to your nearest pharmacy. 6. Further information

What Duodopa contains The active substances are levodopa and carbidopa monohydrate. 1 ml of gel contains 20 mg levodopa and 5 mg carbidopa monohydrate. The other ingredients are carmellose sodium and puried water. What Duodopa looks like and contents of the pack Duodopa is available in cassettes (bags of PVC with a protective hard plastic cover) containing 100 ml with 7 cassettes in each pack. The gel is white to slightly yellow. Marketing Authorisation Holder Abbott Products GmbH Hans-Boeckler-Allee 20, D-30173 Hannover, Germany Manufacturer Abbott Products GmbH Justus-von-Liebig-Strasse 33, 31535 Neustadt, Germany Fresenius Kabi Norge AS P.O. Box 430, N-1753 Halden, Norway This medicinal product is authorised in the Member states of the EEA under the following name: Duodopa 11

Keep the cassettes with gel out of the reach and sight of children. Do not use Duodopa after the expiry date which is stated on the carton label after EXP. Store in a refrigerator (2 C8 C). Keep the cassettes in the outer carton in order to protect from light. 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. By the end of the storage time the gel might become slightly yellow. This does not inuence the treatment with Duodopa. Do not re-use an opened cassette. 10

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Local representative Duodopa is distributed in the UK by Abbott Healthcare Products Ltd, Mansbridge Road, Southampton, SO18 3JD, and in Ireland by Abbott Laboratories Ireland Ltd., 4051 Kingswood Drive, Citywest Business Campus, Dublin 24, Ireland This leaet was last approved in October 2012 For information in large print, tape, CD or Braille, phone 02380 467000 (UK) or 014691500 (Ireland).

FOR POSITION ONLY

MKP-12-XXX1 01-58-04-018B

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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