APOMORPHINE HYDROCHLORIDE 10MG/ML SOLUTION FOR INJECTION/INFUSION
Active substance: APOMORPHINE HYDROCHLORIDE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Apomorphine hydrochloride 10mg/ml solution for injection/ infusion (apomorphine hydrochloride) 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, nurse or pharmacist. - This medicine has been prescribed for you. Do not give it to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects get serious, or if you notice any side effects not listed in this leaet, please tell your doctor. In this leaet: 1. What Apomorphine is and what it is used for 2. Before you use Apomorphine 3. How to use Apomorphine 4. Possible side effects 5. How to store Apomorphine 6. Further information 1. WHAT APOMORPHINE IS AND WHAT IT IS USED FOR Apomorphine belongs to a group of medicines called dopamine agonists. It is used to treat Parkinsons disease in patients who are already being treated with other dopamine agonists and/or levodopa. Apomorphine helps to reduce the amount of time spent in an off state (periods of immobility). Your doctor or nurse will help you to recognise when you need to use this medicine. 2. BEFORE YOU USE APOMORPHINE You MUST NOT use Apomorphine: Pregnancy and breast-feeding Apomorphine should not be used if you are pregnant, planning to become pregnant or breast-feeding. Ask your doctor or pharmacist before taking any medicine. Driving and using machines Apomorphine may make you feel sleepy. If you become drowsy, do not drive or operate machinery because the medicine could make you less alert and put you or others at serious risk of injury. Important information about some of the ingredients of Apomorphine Sodium metabisulphite - may rarely cause severe allergic reactions and breathing Sodium - Apomorphine contains less than 1mmol sodium (23mg) per ml and is essentially sodium-free. Apomorphine should be used with great caution. Please inform your doctor, nurse or pharmacist: 3. HOW TO USE APOMORPHINE Always use Apomorphine exactly as your doctor has told you. You should check with your doctor, pharmacist or nurse if you are not sure. It is essential that you have already taken domperidone to stop you feeling or being sick. The dose is usually 20mg three times a day for at least 2 days, before starting apomorphine therapy. How much Apomorphine to use The amount of Apomorphine you should use and the number of injections you require each day will depend on your personal needs. Your doctor will discuss this with you and tell you how much of your medicine you should inject and how often. The amount that will work best for you will have been determined during your visit to the specialist clinic. 30mg per day, injected 1 to 10 times a day period. you should inject and how often, ask your doctor. 100mg. time, unless advised by your doctor. If your symptoms are not controlled well that you are requiring more than 10 injections per day, you may require a continuous infusion of Apomorphine. Your doctor will decide if you need this form of treatment and which dose is best for you. For continuous infusion hour. awake and stopped before you go to sleep. be used every 12 hours. The choice of which minipump and/or syringe driver to use will be decided by your doctor. You should check with your doctor, nurse or pharmacist if you are unsure. This medicine should not be used in children Where to inject Apomorphine: (subcutaneously) under the skin of your upper arms, thighs or stomach, as directed by your doctor or nurse. too much Apomorphine, contact the doctor or go to your nearest hospital emergency department immediately. Remember to take any remaining medicine, the container and this leaet with you if possible. What you need to inject Apomorphine For an injection you will need: A bin called a sharps bin to dispose safely of the used needles and glass ampoules. These are available from your doctor or nurse. break the ampoules and use the equipment to administer your medicine. Breaking the Ampoules: - Locate the ring(s) on the thinnest part of the neck. This score is the breaking point of the ampoule. - Hold the bottom of the ampoule in one hand. - Grasp the neck of the ampoule just above the ring. - Apply pressure in a backward direction. This will snap off the top of the ampoule. - Carefully dispose of the top of the ampoule in a sharps bin. immediately Injecting Apomorphine Ampoules syringe dose as advised by your doctor or nurse ml solution before use. Your doctor or nurse will have told you if you need to do this and how to do it doctor or nurse into an area under the skin (subcutaneously) ampoules in a sharps bin (available from your doctor or pharmacist) or other suitable container. onto yourself or the carpet as it may stain green. If you use more Apomorphine than you should prescribed dose.
(confusion, hallucinations)
by pathological gambling or by compulsive sexual drive. Please consult your doctor. Check with your doctor or pharmacist before taking your medicine if: to affect the way your heart beats. This includes medicines used for heart rhythm problems (such as quinidine and amiodarone), for depression (including tricyclic antidepressants such as amitriptyline and imipramine) and for bacterial infections (macrolide antibiotics clarithromycin) and domperidone. Speak to your doctor about having regular blood tests if you are already taking levodopa with apomorphine treatment. Caution: Take care not to spill apomorphine on clothing or household surfaces and textiles as spillages may turn green. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. These include other drugs for Parkinsons disease as well as antipsychotic
to apomorphine hydrochloride or any of the other ingredients in the product (see Section 6 and end of Section 2)
serious illnesses that affect the mind)
Parkinsons disease, which affects the brain or spinal cord movements) or dystonia (movement disorder with spasms and muscle contractions) Take special care with Apomorphine Do not take this medicine and tell your doctor if: have an abnormality of electrocardiogram (ECG) called long QT syndrome.
particularly when you stand up due to low blood pressure. An abnormally slow heart beat.
If you forget to use Apomorphine Take it when you next require it. Do not take a double dose to make up for a forgotten dose. If you stop using Apomorphine may get symptoms of muscular rigidity, high fever, changes in mental function (neuroleptic malignant syndrome). If you have any further questions on the use of this product, ask your doctor, nurse or pharamacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Apomorphine can cause side effects, although not everybody gets them. These adverse effects were reverisble when doses were reduced or treatment was stopped. Skin rashes and itching suggest an allergic reaction, in which case you should stop using Apomorphine immediately and seek urgent medical assistance. Very common side effects (affects more than 1 user in 10) which are sore and troublesome. Common side effects (affects 1 to 10 users in 100)
5. HOW TO STORE APOMORPHINE Keep out of the reach and sight of children. Do not use Apomorphine after the expiry date which is stated Exp on the ampoule label and carton. The expiry date refers to the last day of that month. Do not store above 25C. Keep the ampoules in the outer carton, in order to protect from light. Apomorphine should be used immediately after opening. After dilution, chemical and physical in-use stability has been demonstrated for 24 hours diluted with sodium chloride 0.9% solution for injection or Water for Injections in polypropylene syringes. From a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer and dilution has taken place in controlled and validated aseptic conditions. Do not use Apomorphine if:
Marketing Authorisation Holder Archimedes Pharma UK Ltd Green Park Reading RG2 6UG UK Manufacturer Recipharm Ltd. Vale of Bardsley Ashton-under-Lyne Lancashire This medicinal product is authorised in the Member States of the EEA under the following names: Austria Apomorphin Archimedes 10 mg/ml Injektionslsung/Infusionslsung France Apomorphine Archimedes Pharma France 10 mg/ml solution injectable/pour perfusion Germany Apomorphin Archimedes 10 mg/ml Injektionslsung/Infusionslsung Ireland Apomorphine hydrochloride 10mg/ml soluton for injection/infusion Italy iniettabile/per infusione Netherlands voor injectie of infusie Spain
confusion or hallucinations. Uncommon side effects (affects 1 to 10 users in 1000) light-headedness)
particles in it Any unused solution should be discarded. Used syringes, needles and vials should be discarded in a sharps bin or other suitable container. 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. 6. FURTHER INFORMATION
United Kingdom Apomorphine hydrochloride 10mg/ml soluton for injection/infusion This leaet was last approved in December 2009
(when Apomorphine is working and you feel less rigid)
and Apomorphine: anaemia and positive Coombs test results for antibodies. Rare side effects (affects 1 to 10 users in 10,000) The following side effects have also been reported: impulse to gamble despite serious personal or family consequences)
What Apomorphine contains The active substance is apomorphine hydrochloride. Each ml contains 10 mg apomorphine hydrochloride. 2ml contains 20mg apomorphine hydrochloride 5ml contains 50mg apomorphine hydrochloride The other ingredients are: Sodium metabisulphite (E223), Hydrochloric acid (37%) for pH adjustment, Sodium hydroxide (99%) for pH adjustment, Water for Injections What Apomorphine looks like Apomorphine is a solution for injection or infusion. It is a clear, colourless to pale yellow solution. Contents of the pack Each pack of apomorphine contains 5 or 10 ampoules of either 2ml or 5ml solution for injection in a cardboard carton.
behaviour). If any of these side effects get serious, or if you notice any side effects not listed in this leaet, please tell your doctor.
P1255A
Apomorphine hydrochloride 10mg/ml solution for injection/ infusion (apomorphine hydrochloride) 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, nurse or pharmacist. - This medicine has been prescribed for you. Do not give it to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects get serious, or if you notice any side effects not listed in this leaet, please tell your doctor. In this leaet: 1. What Apomorphine is and what it is used for 2. Before you use Apomorphine 3. How to use Apomorphine 4. Possible side effects 5. How to store Apomorphine 6. Further information 1. WHAT APOMORPHINE IS AND WHAT IT IS USED FOR Apomorphine belongs to a group of medicines called dopamine agonists. It is used to treat Parkinsons disease in patients who are already being treated with other dopamine agonists and/or levodopa. Apomorphine helps to reduce the amount of time spent in an off state (periods of immobility). Your doctor or nurse will help you to recognise when you need to use this medicine. 2. BEFORE YOU USE APOMORPHINE You MUST NOT use Apomorphine: Pregnancy and breast-feeding Apomorphine should not be used if you are pregnant, planning to become pregnant or breast-feeding. Ask your doctor or pharmacist before taking any medicine. Driving and using machines Apomorphine may make you feel sleepy. If you become drowsy, do not drive or operate machinery because the medicine could make you less alert and put you or others at serious risk of injury. Important information about some of the ingredients of Apomorphine Sodium metabisulphite - may rarely cause severe allergic reactions and breathing Sodium - Apomorphine contains less than 1mmol sodium (23mg) per ml and is essentially sodium-free. Apomorphine should be used with great caution. Please inform your doctor, nurse or pharmacist: 3. HOW TO USE APOMORPHINE Always use Apomorphine exactly as your doctor has told you. You should check with your doctor, pharmacist or nurse if you are not sure. It is essential that you have already taken domperidone to stop you feeling or being sick. The dose is usually 20mg three times a day for at least 2 days, before starting apomorphine therapy. How much Apomorphine to use The amount of Apomorphine you should use and the number of injections you require each day will depend on your personal needs. Your doctor will discuss this with you and tell you how much of your medicine you should inject and how often. The amount that will work best for you will have been determined during your visit to the specialist clinic. 30mg per day, injected 1 to 10 times a day period. you should inject and how often, ask your doctor. 100mg. time, unless advised by your doctor. If your symptoms are not controlled well that you are requiring more than 10 injections per day, you may require a continuous infusion of Apomorphine. Your doctor will decide if you need this form of treatment and which dose is best for you. For continuous infusion hour. awake and stopped before you go to sleep. be used every 12 hours. The choice of which minipump and/or syringe driver to use will be decided by your doctor. You should check with your doctor, nurse or pharmacist if you are unsure. This medicine should not be used in children Where to inject Apomorphine: (subcutaneously) under the skin of your upper arms, thighs or stomach, as directed by your doctor or nurse. too much Apomorphine, contact the doctor or go to your nearest hospital emergency department immediately. Remember to take any remaining medicine, the container and this leaet with you if possible. What you need to inject Apomorphine For an injection you will need: A bin called a sharps bin to dispose safely of the used needles and glass ampoules. These are available from your doctor or nurse. break the ampoules and use the equipment to administer your medicine. Breaking the Ampoules: - Locate the ring(s) on the thinnest part of the neck. This score is the breaking point of the ampoule. - Hold the bottom of the ampoule in one hand. - Grasp the neck of the ampoule just above the ring. - Apply pressure in a backward direction. This will snap off the top of the ampoule. - Carefully dispose of the top of the ampoule in a sharps bin. immediately Injecting Apomorphine Ampoules syringe dose as advised by your doctor or nurse ml solution before use. Your doctor or nurse will have told you if you need to do this and how to do it doctor or nurse into an area under the skin (subcutaneously) ampoules in a sharps bin (available from your doctor or pharmacist) or other suitable container. onto yourself or the carpet as it may stain green. If you use more Apomorphine than you should prescribed dose.
(confusion, hallucinations)
by pathological gambling or by compulsive sexual drive. Please consult your doctor. Check with your doctor or pharmacist before taking your medicine if: to affect the way your heart beats. This includes medicines used for heart rhythm problems (such as quinidine and amiodarone), for depression (including tricyclic antidepressants such as amitriptyline and imipramine) and for bacterial infections (macrolide antibiotics clarithromycin) and domperidone. Speak to your doctor about having regular blood tests if you are already taking levodopa with apomorphine treatment. Caution: Take care not to spill apomorphine on clothing or household surfaces and textiles as spillages may turn green. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. These include other drugs for Parkinsons disease as well as antipsychotic
to apomorphine hydrochloride or any of the other ingredients in the product (see Section 6 and end of Section 2)
serious illnesses that affect the mind)
Parkinsons disease, which affects the brain or spinal cord movements) or dystonia (movement disorder with spasms and muscle contractions) Take special care with Apomorphine Do not take this medicine and tell your doctor if: have an abnormality of electrocardiogram (ECG) called long QT syndrome.
particularly when you stand up due to low blood pressure. An abnormally slow heart beat.
If you forget to use Apomorphine Take it when you next require it. Do not take a double dose to make up for a forgotten dose. If you stop using Apomorphine may get symptoms of muscular rigidity, high fever, changes in mental function (neuroleptic malignant syndrome). If you have any further questions on the use of this product, ask your doctor, nurse or pharamacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Apomorphine can cause side effects, although not everybody gets them. These adverse effects were reverisble when doses were reduced or treatment was stopped. Skin rashes and itching suggest an allergic reaction, in which case you should stop using Apomorphine immediately and seek urgent medical assistance. Very common side effects (affects more than 1 user in 10) which are sore and troublesome. Common side effects (affects 1 to 10 users in 100)
5. HOW TO STORE APOMORPHINE Keep out of the reach and sight of children. Do not use Apomorphine after the expiry date which is stated Exp on the ampoule label and carton. The expiry date refers to the last day of that month. Do not store above 25C. Keep the ampoules in the outer carton, in order to protect from light. Apomorphine should be used immediately after opening. After dilution, chemical and physical in-use stability has been demonstrated for 24 hours diluted with sodium chloride 0.9% solution for injection or Water for Injections in polypropylene syringes. From a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer and dilution has taken place in controlled and validated aseptic conditions. Do not use Apomorphine if:
Marketing Authorisation Holder Archimedes Pharma UK Ltd Green Park Reading RG2 6UG UK Manufacturer Recipharm Ltd. Vale of Bardsley Ashton-under-Lyne Lancashire This medicinal product is authorised in the Member States of the EEA under the following names: Austria Apomorphin Archimedes 10 mg/ml Injektionslsung/Infusionslsung France Apomorphine Archimedes Pharma France 10 mg/ml solution injectable/pour perfusion Germany Apomorphin Archimedes 10 mg/ml Injektionslsung/Infusionslsung Ireland Apomorphine hydrochloride 10mg/ml soluton for injection/infusion Italy iniettabile/per infusione Netherlands voor injectie of infusie Spain
confusion or hallucinations. Uncommon side effects (affects 1 to 10 users in 1000) light-headedness)
particles in it Any unused solution should be discarded. Used syringes, needles and vials should be discarded in a sharps bin or other suitable container. 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. 6. FURTHER INFORMATION
United Kingdom Apomorphine hydrochloride 10mg/ml soluton for injection/infusion This leaet was last approved in December 2009
(when Apomorphine is working and you feel less rigid)
and Apomorphine: anaemia and positive Coombs test results for antibodies. Rare side effects (affects 1 to 10 users in 10,000) The following side effects have also been reported: impulse to gamble despite serious personal or family consequences)
What Apomorphine contains The active substance is apomorphine hydrochloride. Each ml contains 10 mg apomorphine hydrochloride. 2ml contains 20mg apomorphine hydrochloride 5ml contains 50mg apomorphine hydrochloride The other ingredients are: Sodium metabisulphite (E223), Hydrochloric acid (37%) for pH adjustment, Sodium hydroxide (99%) for pH adjustment, Water for Injections What Apomorphine looks like Apomorphine is a solution for injection or infusion. It is a clear, colourless to pale yellow solution. Contents of the pack Each pack of apomorphine contains 5 or 10 ampoules of either 2ml or 5ml solution for injection in a cardboard carton.
behaviour). If any of these side effects get serious, or if you notice any side effects not listed in this leaet, please tell your doctor.
P1255A
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.
