PACKAGE LEAFLET: INFORMATION FOR THE USER Piritramide [MAH] 7.5 mg/ml solution for injection Piritramide Read all of this leaflet carefully before you start using this medicine because it contains important information for you . - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - If you get any side effects , talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Piritramide [MAH] is and what it is used for 2. What you need to know b efore you use Piritramide [MAH] 3. How to use Piritramide [MAH] 4. Possible side effects 5. How to store Piritramide [MAH] 6. Contents of the pack and other information 1. WHAT PIRITRAMIDE [MAH] IS AND WHAT IT IS USED FOR Piritramide [MAH] contains the active substance piritramide. It belongs to a group of medicines called opioid analgesics (strong painkillers). Piritramide [MAH] is used to relieve severe and strongest pain. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PIRITRAMIDE [MAH] Do not use Piritramide [MAH] : - If you are allergic to piritramide or any of the other ingredients of this medicine (listed in section 6) . - If you suffer from severely impaired consciousness from which you cannot be roused even by external stimuli (comatose states) . - If you have problems with breathing. Warnings and precautions Talk to your doctor or pharmacist before using Piritramide [MAH] - If you have suffer from seizures (such as epileptic fits) - if you suffer from alcoholism - If you have head injuries and/or conditions with increased brain pressure - If you have an enlarged prostate (prostatic hypertrophy) - If you are in shock - you are taking medicines that act on the brain [e.g. alcohol, sleeping tablets (barbiturates, hypnotics), tranquillisers (certain benzodiazepines)] - If you have an under active thyroid (hypothyreosis) - If you have a decreased function of the adrenal cortex (adrenal cortex insufficiency) - If you have an impaired breathing function - If you are elderly - If you have impaired liver function - If your general condition is impaired As with other opioids, take special care when using Piritramide [MAH] – If you have a tumour of the adrenal gland (phaeochromocytoma) – If you have a partial or complete blockade of the bowel and/or inflammatory bowel disease – If you have an impaired function of the gall bladder (biliary impairment) – If you have an inflamed pancreas (pancreatitis) – In children aged under 1 year Blood pressure may fall after administering Piritramide [MAH]. This may exceed the norm if you had insufficient fluid intake or were simultaneously given medicines that have a depressant effect on the central nervous system. As with other opioids, Piritramide [MAH] can cause physical and psychological dependence. The risk of dependence usually increases with the length of use and with increasing doses. Over time, your body may develop a tolerance to the drug so that a higher dose is required to achieve the same pain-relieving effect). Medicine that blocks the effect of Piritramide [MAH] (opioid antagonist) should be available for immediate use. Qualified personnel and adequate facilities should be available for monitoring and ventilation of patients administered high doses of Piritramide [MAH]. Discontinuing the product, substituting a milder opioid or administering a medicine that counteracts the effect of Piritramide [MAH] may trigger withdrawal symptoms such as balance disorders, tremor, anxiety, vomiting, diarrhoea and/or high blood pressure. Other medicines and Piritramide [MAH] Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is especially important with the following medicines: - central nervous system depressants (medicine used to treat anxiety, calm you down or put you to sleep such as barbiturates, benzodiazepines, phenothiazines, inhalational anaesthetics) - medicine prescribed to treat mental depression (monoamine oxidase inhibitors - MAOIs). Administration of MAOIs must be stopped at least 10 days prior to the treatment with piritramide. - painkiller (pentazocine) Piritramide [MAH] with food,drink and alcohol Please tell your doctor if you consumed alcohol before receiving this medicine. Pregnancy and breast-feeding 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 this medicine is administered to you. Piritramide [MAH] must not be administered during pregnancy or lactation, unless the potential benefits outweigh the risks. Repeated administration of this medicine during pregnancy may cause dependence and withdrawal symptoms in a newborn baby. It is recommended that you stop breast-feeding for 24 hours after Piritramide [MAH] has been given to you. Driving and using machines This medicine has major influence on your ability to drive and use machines. Do not drive and do not use any machines or perform any work that requires safe foothold for a minimum of 6 to 8 hours after receiving a single dose of Piritramide [MAH] and for a minimum of 12 to 24 hours after repeated administration. 3. HOW TO USE PIRITRAMIDE [MAH] Piritramide [MAH] is given to you by your doctor or healthcare professional. Use in adults - A usual single dose is 15-30 mg if this medicine is given into a muscle or under the skin. - Single doses of 7.5-22.5 mg will be slowly given into a vein (10 mg per minute) . Use in children - A usual single dose is 0.05-0.2 mg per kg body weight if this medicine is given into a muscle or under the skin. - A usual single dose should be 0.05-0.1 mg per kg body weight if Piritramide [MAH] is given into a vein. Use in special patient groups In elderly patients, patients with impaired liver function and patients with poor general health the dose should be reduced. Single doses can usually be repeated after 6-8 hours to achieve adequate pain relief. Method of administration This medicine can be given as an injection into a muscle (intramuscular), under the skin (subcutaneous) or into a vein (intravenous). For instructions on diluting the medicine before use see Section 5. If you use more Piritramide [MAH] than you should Since Piritramide [MAH] will usually be given to you under carefully controlled conditions, it is unlikely that you will be given too much or that you will miss a dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Piritramide [MAH] can cause side effects, although not everybody gets them. The following side effects have been reported and are listed in order of decreasing frequency : Very common: may affect more than 1 in 10 people - rapid heartbeat - low blood pressure in tests Common: may affect up to 1 in 10 people - dizziness (vertigo) - severe light-headedness (stupor) - drowsiness - nausea - vomiting - retching - pallor Uncommon: may affect up to 1 in 100 people - dependency on the medicine - headache - fall in blood pressure - increased sweating - low respiration rate Not known: frequency cannot be estimated from the available data – severe allergic reactions (anaphylaxis, anaphylactic shock) – withdrawal symptoms after discontinuing the medicine (such as rapid heart rate, vomiting, muscle pain and sweating) – unconsciousness – constriction of the pupils – slow heart beat (bradycardia) – blue discolouration of the skin due to oxygen deficiency (cyanosis) – breathing problems (breathlessness, shallow breathing, respiratory arrest) – allergic skin inflammation – itching – reactions at the injection site – severe asthma attacks (status asthmaticus) – spasms of the bronchial muscles As with other opioids, patients who are on Piritramide [MAH] may experience an absence of bowel movements which can lead to constipation. With other opioids there have also been reports of dry mouth, increased muscle tone in urinary bladder, gall bladder and pancreas and, in rare cases, difficulties in passing water. Reporting of side effects If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE PIRITRAMIDE [MAH] 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 and label after “EXP:”. The expiry date refers to the last day of that month. Do not store above 25°C. Do not freeze. Keep the ampoules in the outer carton in order to protect from light. For information about shelf life after first opening please see section "Preparation guide" for health care professionals. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION What Piritramide [MAH] contains The active substance is piritramide. 1 ampoule of 1 ml solution for injection contains 7.5 mg piritramide. 1 ampoule of 2 ml solution for injection contains 15 mg piritramide. 1 ampoule of 6 ml solution for injection contains 45 mg piritramide. The other ingredients are tartaric acid (Ph. Eur.) and water for injection . What Piritramide [MAH] looks like and the contents of the pack Piritramide [MAH] is a clear and colourless solution for injection. Piritramide [MAH] is available in packs of: 5, 10 or 50 (10x5 or 5x10) ampoules, each filled with 1 ml, 2 ml or 6 ml solution for injection. Not all pack sizes may be marketed. Marketing authorisation holder [to be completed nationally] Manufacturer [to be completed nationally] This leaflet was last approved in {MM/YYYY}.