PACKAGE LEAFLET: INFORMATION FOR THE USER Pethidine Injection must not be used with drugs used to treat TECHNICAL PRESCRIBING INFORMATION Renal impairment may result in accumulation of the potentially severe depression, such as rasagiline or moclobemide, or if you toxic metabolite norpethidine, particularly with repeat dosing. All Pethidine 50mg/ml & 100mg/2ml are within 2 weeks of discontinuing them. Pethidine 50mg/ml & 100mg/2ml of these patient groups may experience increased or prolonged Solution for Injection These drugs are known as Monoamine Oxidase Inhibitors Solution for Injection effects of the product. (MAOI’s), Pethidine should be used with caution in patients with shock, Composition/excipients: Pethidine Hydrochloride Other medicines which may interact with Pethidine Injection hypothyrodism, adreno-corticol insufficiency and a history of Pethidine injection is a sterile aqueous solution of 5% w/v include: convulsive disorders. Read all of this leaflet carefully before you are given this Pethidine Hydrochloride. It also contains Water for Injections and • selegiline, a medicine used to treat Parkinson’s disease Although less spasmogenic than morphine, pethidine may medicine because it contains important information for you. may contain Sodium Hydroxide as a pH adjuster. • Keep this leaflet.You may need to read it again. • ritonavir, a medicine used to treat HIV precipitate spasm of the ureter or Sphincter of Oddi. Subsequently • If you have any further questions, ask your doctor, nurse • cimetidine, a medicine used to treat stomach ulcers Indications: it should be used with caution in patients with prostatic • medicines used to reduce anxiety (anxiolytics) (eg. Relief of moderate to severe pain, as a premedication, obstetric hypertrophy and biliary tract disorders including those with pain D05459 or midwife. • If you get any side effects, talk to your doctor or pharmacist . benzodiazepines such as diazepam) analgesia and enhancement of analgesia. secondary to gallbladder pathology. This includes any possible side effects not listed in this leaflet. • medicines used to help you to sleep (hypnotics) Pethidine should be used with caution in patients with existing See section 4. • CNS depressants (drugs that act on the brain and make you Dose: hypotension as it may reduce the blood pressure further. feel drowsy or faint). These include sleeping pills, Adults. In addition it should be avoided in patients with severe What is in this leaflet anti-histamines (medicines used to treat allergies) that make For moderate or severe pain. inflammatory bowel disease due to its effects on the 1. What Pethidine Injection is and what it is used for you drowsy, medicines used to treat certain mental disorders. Normal single dose (usually not to be repeated more often than 4 gastrointestinal tract where it may precipitate toxic megacolon. 2. Before you are given Pethidine Injection • phenytoin, a medicine used to treat fits hourly) Risk from concomitant use of sedative medicines such as 3. How Pethidine Injection will be given • medicines used to treat serious mental disorders By intramuscular or subcutaneous injection 25 - 100 mg. benzodiazepines or related drugs: 4. Possible side effects (phenothiazines) By slow intravenous injection 25 - 50 mg. Concomitant use of Pethidine and sedative medicines such 5. How to store Pethidine Injection • citalopram, a medicine used to treat depression For obstetric analgesia. as benzodiazepines or related drugs may result in sedation, 6. Contents of the pack and other information • medicines for depression (eg. tricyclic antidepressants such as By intramuscular or subcutaneous respiratory depression, coma and death. Because of these risks, amitriptyline) injection repeated 1 – 3 hours later. 50 - 100 mg. concomitant prescribing with these sedative medicines should 1. What Pethidine Injection is and what it is • sedatives, sleeping tablets or barbiturates (eg. phenobarbitone Maximum of 400mg in 24 hours. be reserved for patients for whom alternative treatment options used for for epilepsy) As a premedication. are not possible. If a decision is made to prescribe Pethidine • domperidone and metoclopramide (used for disorders of the Pethidine is a drug with powerful pain relieving properties. By intramuscular injection one hour prior concomitantly with sedative medicines, the lowest effective dose gastrointestinal tract) to the operation. 50 - 100mg should be used, and the duration of treatment should be as short • pain relievers and other opioid medicines Pethidine Injection is used for the relief of moderate to severe For the enhancement of analgesia. as possible. • ciprofloxacin, an antibiotic used to treat a number of bacterial pain and is used for pain relief during labour. It may also be used By slow intravenous injection. 10 -25mg as required. The patients should be followed closely for signs and symptoms of to stop you from feeling pain before and during an operation and infections Elderly or debilitated patients. respiratory depression and sedation. In this respect, it is strongly to provide continuous pain relief if needed • mexiletine, a medicine used to treat seriously irregular heartbeats Initial doses should not exceed 25mg as this group of patients may recommended to inform patients and their caregivers to be aware be specially sensitive to the central depressant effect of the drug. of these symptoms. 2. Before you are given Pethidine Injection Concomitant use of Pethidine Injection and sedative medicines Children such as benzodiazepines or related drugs increases the risk of You should not be given Pethidine Injection if: For moderate or severe pain. Interactions : drowsiness, difficulties in breathing (respiratory depression), • you are allergic (hypersensitive) to Pethidine Hydrochloride or By intramuscular injection 0.5 - 2 mg per Kg of body weight. Pethidine should not be administered to patients receiving: coma and may be life-threatening. Because of this, concomitant to any of the ingredients of this medicine (listed in section 6) Monoamine Oxidase Inhibitors • you suffer from asthma, shallow breathing or other breathing use should only be considered when other treatment options are As a premedication. The concurrent use of MAOIs (including moclobemide) is contra- difficulties not possible. By intramuscular injection one indicated as they may result in CNS excitation or depression. • you are suffering from severe headaches or have suffered a hour prior to the operation 1 - 2 mg per Kg of body weight. However, if your doctor does prescribe Pethidine together Pethidine should not be administered to patients receiving head injury Method of administration with sedative medicines the dose and duration of concomitant monoamine oxidase inhibitors or moclobemide or within two • you suffer from alcoholism Intramuscular, intravenous or subcutaneous injection. treatment should be limited by your doctor. weeks of their withdrawal. • you suffer from a convulsive disorder (fits) such as epilepsy • you have any liver or kidney problems Please tell your doctor about all sedative medicines you are Contraindications: CNS depressants taking and follow your doctor’s dose recommendation closely. It CNS depressants such as alcohol, hypnotics, anxiolytics and • you are suffering from a condition known as delirium tremens, Hypersensitivity to the active substance or to any of the excipients could be helpful to inform friends or relatives to be aware of the sedatives, barbiturates and tricyclic antidepressants may increase caused by withdrawal from alcohol listed in section 6.1 • your heartbeat is faster than usual signs and symptoms stated above. Contact your doctor when the general depressant effects of pethidine and should therefore experiencing such symptoms. Severe respiratory depression, severe obstructive airways disease be used with caution. • you suffer from a tumour of the adrenal gland known as or acute asthma. phaeochromocytoma Opioid agonists If you are in any doubt please tell your doctor of any medication It should not be administered to patients with severe renal • you suffer from diabetes Additive effects on CNS depression, respiratory depression and you are taking. impairment or severe hepatic impairment. • you are taking or have recently taken any drugs used to treat hypotension can occur with concomitant use of opioid agonist depression known as Monoamine Oxidase Inhibitors (MAOI’s) Pregnancy, breast-feeding and fertility Should be avoided in patients with acute alcoholism, delirium analgesics. (see ‘Taking other medicines) If you are pregnant or breast-feeding, think you may be pregnant tremens, raised intracranial pressure or in those with convulsive MAO-B inhibitors or are planning to have a baby, ask your doctor or pharmacist for states such as status epilepticus. Patients in a coma should not be given this medicine Concomitant use of MAO-B inhibitors such as selegiline or advice before using this medicine. It should not be administered to patients receiving monoamine rasagiline is contraindicated as this may lead to hyperpyrexia Warnings and precautions Pethidine can pass into your baby either through your blood oxidase inhibitors (including moclobemide, and the monoamine and CNS toxicity. Rasagiline should not be given with pethidine Talk to your doctor or pharmacist before being given Pethidine (during pregnancy and labour) or through your breast milk. This B inhibitors selegiline and rasagiline) or within two weeks of their as there is risk of CNS toxicity, its use should