pharmacist will explain what this is like, so that you know when you must use Anapen.

Transcription

1 ANAPEN Adrenaline Auto-Injectors Consumer Medicine Information What is in this leaflet? This leaflet answers some common questions about, ANAPEN Adrenaline Auto Injectors, presented as ANAPEN 500, ANAPEN 300 and ANAPEN 150. It does not contain all the available information. It does not take the place of talking to your doctor or All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you receiving ANAPEN against the benefits this medicine is expected to have for you. If you have any concerns about receiving this medicine, talk to your doctor or pharmacist before there is a situation where ANAPEN is needed. Please read this leaflet carefully before an emergency arises. Keep this leaflet safely, with the ANAPEN Auto-Injector. You will probably want to read it again. What ANAPEN is used for pharmacist will explain what this is like, so that you know when you must use Anapen. Anapen is a life-saving treatment in the emergency management of severe allergic reactions. Therefore, it should not be withheld from anyone who is considered to need it. Avoiding known allergens is most important in preventing severe allergic reactions. A severe allergic reaction is overwhelming and lifethreatening. Symptoms vary and are likely to include: Collapse Difficulty in breathing Wheezing Swelling, especially of the face, lips, tongue or throat Skin rash, hives Itching Usually several parts of the body are affected. The patient feels extremely unwell. It is important to act quickly to treat a severe allergic reaction. The adrenaline in ANAPEN treats allergic emergencies. It: shrinks abnormally wide blood vessels and Adrenaline also relaxes the lungs. This eases breathing and lessens wheezing. helps stop swelling, (for example, of the face and lips), skin rash and/or itching. See Side Effects for information regarding allergy to Sodium metabisulfite How much is given The ANAPEN 500 Auto-Injector is intended for use in people who weigh 60 kg or more or for people at high risk of anaphylaxis for whom the 300 microgram dose may not be sufficient The ANAPEN 300 Auto-Injector is intended for use in people who weigh more than 30kg. The ANAPEN 150 Auto-Injector is intended for use in people who weigh between 15kg and 30kg Depending on your clinical needs your doctor may choose to prescribe more or less ANAPEN. ANAPEN: ANAPEN is used for the emergency treatment of severe allergic reactions or anaphylaxis caused by peanuts, other foods, drugs, latex, insect bites or stings or other allergens. Your doctor or makes the heart beat strongly. This helps improve the very low blood pressure and poor circulation that occur in a severe allergic reaction. Anapen CMI Version 7 Page 1 of 6 provides convenient first-aid may be self-administered or administered by a carer has a spring-activated, hidden needle automatically injects one premeasured dose of adrenaline

2 is for single use only. ANAPEN may be prescribed by your doctor or you can purchase it directly from the pharmacist on the advice of the doctor or Ask your doctor or the pharmacist if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason. This medicine is not addictive. Before you use ANAPEN The ANAPEN Auto-Injectors are simple to use. Please read and follow the step-by-step instructions. An ANAPEN Trainer is also available. You should ask your doctor or pharmacist to demonstrate the use of the ANAPEN Trainer if this is the first time you are using ANAPEN. Do not remove the grey safety cap until you need, and are ready to use, ANAPEN. There is no visible needle. This helps overcome fear of injection. The hidden needle is very fine so that the injection does not usually hurt. When you must not use it Do not use ANAPEN after the expiry date on the Auto-Injector and carton. If it is past the expiry date return it to your pharmacist for disposal if the packaging is torn, doesn't look quite right or shows signs of tampering. If the packaging is damaged return it to your pharmacist for disposal. if you have an allergy to any of the ingredients listed at the end of this leaflet, including sodium metabisulfite. If you have cardiac dilation or some types of heart rhythm irregularities If you have an overactive thyroid, called thyrotoxicosis In obstetrics if your blood pressure is more than 130/80 Before you use it ANAPEN auto injectors are effective as emergency treatment of a severe allergic reaction ONLY when used according to the directions in this leaflet. You should tell your doctor or pharmacist if you have any of the following medical conditions: hyperthyroid disease a rare tumour of the adrenal gland which sits near the kidney and causes high blood pressure, (pheochromocytoma) Severe kidney disease low blood calcium levels heart disease high pressure in the eye benign tumour of the prostate diabetes Tell your doctor if you are pregnant or plan to become pregnant. Your doctor can discuss with you the risks and benefits involved. If you are not sure you should be given this medicine, talk to your doctor. If you have not told your doctor about any of the above information, tell him/her before you use ANAPEN. Taking other medicines Tell your doctor or pharmacist if you are taking other medicines, including any medicines that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines may interfere with ANAPEN including: medicines for depression thyroid hormone some beta-blockers digoxin or quinidine medicines for diabetes warfarin These medicines may affect how well the adrenaline in ANAPEN works. You may need different amounts of your medicines or you may need to take different medicines. Your doctor or pharmacist have more information on medicines to be careful with or avoid and can tell you what to do if you are taking any of these medicines. You should discuss any concerns you have with your doctor or How to use ANAPEN It is important to know how to use your ANAPEN Auto injector in an emergency (see Help in using ANAPEN) Carefully follow all directions given to you by your doctor or They may differ from the information contained in this leaflet. If you do not understand the instructions in this leaflet or on the ANAPEN Auto-Injector, ask your doctor or pharmacist for help in using ANAPEN Help in using ANAPEN It is important to know how to use ANAPEN BEFORE a severe allergic reaction causes a medical emergency. Ask your doctor or pharmacist how you can get an "ANAPEN Anapen CMI Version 7 Page 2 of 6

3 Trainer" device for practice or visit for a free ANAPEN trainer An ANAPEN Trainer device is similar to the real ANAPEN. However, the ANAPEN Trainer has NO medicine (adrenaline,) and NO needle Ask your doctor or pharmacist to show you how to practice with the ANAPEN Trainer. If you practice using the ANAPEN Trainer, you will learn how to use the real ANAPEN. When to use it Use ANAPEN immediately if you have signs and symptoms of a severe allergic reaction, as described above and by your doctor or Symptoms do vary. How to use it General Only use the ANAPEN auto injector once. Carefully follow the step-by-step directions to make sure ANAPEN works correctly. See diagrams 1-4 below for instructions on how to use the Anapen auto-injector Do not remove the black needle shield or the grey safety cap until you need to use your Anapen. Do not put thumb, fingers or hand over the end of the device once the black needle shield is removed. Step 1 Grasp the black needle shield and remove by pulling, this may require reasonable force. Do this only when you are ready to use your ANAPEN auto injector. Do not dispose of this cap. It can be used to transport the used ANAPEN auto injector to a pharmacist or doctor or hospital for safe disposal. Step 2 Remove by pulling the grey safety cap from the red firing button. Step 3 Hold needle end firmly against the outer thigh at right angles. Step 4 Press the red firing button so it clicks, and hold for 10 seconds. If necessary, inject through light clothing. This will ensure that the full dose of adrenaline is administered. Gently massage the injection site for about 10 seconds after removal of the ANAPEN auto injector Step 5 Record the time ANAPEN was given. Seek further medical attention for yourself immediately. Although you have received adrenaline from ANAPEN, you should seek medical attention. To avoid injury, follow the used Anapen disposal instructions below (see Disposal). Additional information about treatment of insect sting allergy Use ANAPEN immediately if you have been stung by an insect and experience the signs and symptoms of anaphylaxis as described by your doctor or If the insect's sting is easily accessible, remove the sting with your fingernails. Do not squeeze, pinch or push the sting deeper into the skin. If available, ice packs or sodium Anapen CMI Version 7 Page 3 of 6

4 bicarbonate soaks may then be applied to the stung area. Keep warm, calm, and as still as possible. If you use too much (overdose) Because each ANAPEN contains only one dose, overdosage is unlikely. Overdosage may lead to a rise in blood pressure. This may cause bleeding in the brain or fluid in the lung. Symptoms of overdose may include feeling unwell, flushing or abnormal heart beats, and headaches. If you think you or anyone else may have used too much of this medicine, consult your doctor immediately or telephone the Poisons Information Centre (telephone in Australia or 0800 POISON ( ) in New Zealand) for advice, or go to Accident and Emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning. Urgent medical attention may be required. Ask your doctor or pharmacist if you have any concerns about ANAPEN Things to note about ANAPEN Things you must do Check what the expiry date is on your ANAPEN Mark this expiry date on your calendar or diary. Replace your ANAPEN before this expiry date. The ANAPEN auto-injector can be damaged and made unusable if it is mishandled. ANAPEN auto injectors are NOT toys. Keep it out of reach of children. Things you must not do Do not use ANAPEN to treat any other medical conditions unless your doctor tells you to. Do not touch or place ANAPEN on any person or object while you are removing or have removed the grey safety cap or black needle shield. Do not touch Red button until the needle end is placed against your thigh and ready to use. Do not inject into hands, feet, ears, nose, buttocks, and genital area or into a blood vessel. If this happens accidentally you must immediately seek medical attention. Side effects Like all medicines, ANAPEN can cause some side effects. Side effects not listed in this leaflet may occur in some patients. Tell your doctor or pharmacist if you experience any unpleasant side effects after using ANAPEN even if you do not think the effect is connected with the medicine or is listed in this leaflet. Ask your doctor or pharmacist to answer any questions you may have. Do not be alarmed by the following list of side effects. You may not experience any of them. Adrenaline Tell your doctor or pharmacist if you have any of the following: fear or anxiety fast or noticeable heart beat tremor dizziness breathing difficulty or breathlessness pale skin nausea and vomiting hallucinations restlessness weakness headache cold extremities sweating sleeplessness flushing or redness of face and skin. More severe side effects can occur occasionally. They are caused by adrenaline stimulating the heart and increasing the blood pressure. Rarely, these side effects can cause, for example, a stroke, lung problems or severe irregular heartbeat. Adrenaline may also cause disorientation, impaired memory and psychosis. Sodium metabisulfite ANAPEN contains a very small quantity of sodium metabisulfite as a preservative. In people who are allergic to sodium metabisulfite, this could cause an allergic type reaction. However, the active ingredient, adrenaline, in ANAPEN is expected to overcome any allergic reaction to sodium metabisulfite. In an emergency, the risk of exposure to the very small amount of sodium metabisulfite is generally outweighed by the benefits of ANAPEN. Tell your doctor, nurse or pharmacist if you notice anything that is making you feel unwell. Other side effects not listed above may occur in some people. Storing ANAPEN before use Anapen CMI Version 7 Page 4 of 6

5 Always handle the ANAPEN Auto-Injector carefully, so as not to accidentally activate it or make it "fire". Storage Keep ANAPEN with the person for whom it is intended. Keep ANAPEN in its carton and store in a cool dry place at 15 C to 25 C. Do not refrigerate and protect from light. Do not leave ANAPEN in your car. Extreme temperatures may cause the auto-injector unit to malfunction. Do not store ANAPEN or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines. Keep ANAPEN where children cannot accidentally reach it. After using ANAPEN Transport Take your used ANAPEN to your doctor or emergency healthcare professional. This is for inspection, if required, and also for safe disposal in a rigid sharps container. Disposal Do not touch or bend the exposed needle After the ANAPEN auto-injector has "fired", the needle is exposed and could cause injury. The needle can be forced to retract back into the barrel by placing the black needle shield face up on a flat surface and carefully pushing the used Anapen down into the black cap. After use You CANNOT RE-USE the ANAPEN auto-injector even though some adrenaline is left inside it Continue to handle the ANAPEN auto-injector safely and with care. Do this even if you think the ANAPEN autoinjector has not "triggered", "fired" or worked properly Product description Ingredients ANAPEN holds 1 ml of solution and delivers 0.3mL. ANAPEN 500 Auto-injector provides 500 micrograms of adrenaline. ANAPEN 300 Auto-injector provides 300 micrograms of adrenaline. ANAPEN 150 Auto-injector provides 150 micrograms of adrenaline. The ANAPEN auto-injector also contains small amounts of sodium chloride mg/0.3 ml sodium metabisulfite -510 micro grams/0.3 ml hydrochloric acid to adjust to ph 3.4 Water for injections q.s. to 0.3 ml This is not all the information available on ANAPEN. If you have any more questions or are unsure about anything, ask your doctor or Supplier ANAPEN 500 AUST R ANAPEN 300 AUST R ANAPEN 150 AUST R is distributed in Australia by: Link Medical Products Pty Ltd. 5 Apollo Street, Warriewood NSW 2102 Australia ANAPEN 500, ANAPEN 300 and ANAPEN 150 are distributed in New Zealand by: Link Pharmaceuticals Ltd. Level 31, Vero Centre 48 Shortland Street Auckland 1140 New Zealand This leaflet was prepared in December 2012 Version 7 Anapen CMI Version 7 Page 5 of 6

6 Sign-up for ANAlert.com and receive FREE Expiry Date and Training Alerts! It is important that your Anapen is always in date. If your Anapen has expired, it means that the adrenaline solution has passed its expiry date. Expired adrenaline is not as effective when used for treating allergic reactions. To help keep your Anapen within its Use By date and keep you familiar with Anapen steps, we have created ANAlert! Register to today. It s a simple and free service! ANAlert offers: Online educational resources for you and those around you. FREE Expiry Date Alerts be reminded when your Anapen is nearing its expiry date. FREE Training Alerts be reminded of Anapen s simple instructional steps! FREE Anapen Trainer. ANAlert.com provides general information about anaphylaxis and Anapen adrenaline-autoinjector but does not replace talking to your doctor or Only use Anapen as directed. Your pharmacist's advice is required. The active ingredient in Anapen is adrenaline. DISCLAIMER: While every effort is made by Link Pharmaceuticals to ensure the Expiry Alert (reminder notice) is supplied based on the information you provided via your preferred means of communication, Link Pharmaceuticals cannot be made responsible for any failure of notice. In no event will Link Pharmaceuticals be liable for any damages (including personal injury and/or death), direct, indirect, incidental, special, exemplary, loss of use, data or interruption arising in any way out of the use of this Expiry Alert. Link Pharmaceuticals reserves the right to make changes to its Terms & Conditions (please see ANAlert Terms & Conditions) without prior notice and to terminate any service at any time, at our sole discretion. The information contained in ANAlert.com is for general information and educational purposes only. The information is provided by Link Pharmaceuticals and while we endeavour to keep the information up to date and correct, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability with respect to the website or the information, products, services, or related graphics contained on the website for any purpose. Any reliance you place on such information is therefore strictly at your own risk. In no event will we be liable for any loss or damage including without limitation, indirect or consequential loss or damage, or any loss or damage whatsoever arising from loss of data or profits arising out of, or in connection with, the use of this website. Through ANAlert.com, you are able to link to other websites which are not under the control of Link Pharmaceuticals. We have no control over the nature, content and availability of external sites. The inclusion of any links does not necessarily imply a recommendation or endorse the views expressed within them. Every effort is made to keep the website up and running smoothly. However, Link Pharmaceuticals takes no responsibility for, and will not be liable for, the website being temporarily unavailable due to technical issues beyond our control. Anapen CMI Version 7 Page 6 of 6