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Home , Codeine, Mexiletine, Pethidine

Package leaflet: Information for the patient Hydrochloride 50mg/ml Solution for Injection Pethidine Hydrochloride READ ALL OF THIS LEAFLET CAREFULLY • you are taking any medicine from the group of BEFORE YOU START USING THIS MEDICINE. medicines known as . Taking Keep this leaflet. You may need to read it again. these medicines with Pethidine may result in If you have any further questions, ask your doctor sedation, difficulties in breathing (respiratory or pharmacist. depression), coma and may be fatal. Even if This medicine has been prescribed for you only. benzodiazepines are prescribed, your doctor Do not pass it on to others. It may harm them, even may need to change the , the duration of if their symptoms are the same as yours. treatment or monitor you regularly. If you get any side effects talk to your doctor or If you are elderly or ill, or your baby or child is pharmacist. This includes any possible side effects being given Pethidine Injection, special care will be not listed in this leaflet. See section 4. taken. The name of your medicine is Pethidine If any of the above apply to you or your child, Hydrochloride 50mg/ml Solution for Injection but please tell your doctor before being given will be referred to as “Pethidine Injection” Pethidine Injection. throughout the remainder of this leaflet. Other medicines and Pethidine injection: What is in this leaflet: Tell your doctor if you are taking or have recently 1. What Pethidine Injection is and what it is used taken any other medicines, including medicines for obtained without a prescription. 2. What you need to know before you are given Pethidine Injection must not be used with Pethidine injection used to treat severe depression, such as 3. How Pethidine Injection is given to you or or if you are within 2 weeks of 4. Possible side effects discontinuing them. 5. How to store Pethidine Injection A large number of drugs can interact with Pethidine 6. Contents of the pack and other information Injection which can significantly alter their effects. These drugs include: 1. WHAT PETHIDINE INJECTION IS AND • medicines for depression (eg. tricyclic WHAT IT IS USED FOR such as ) and Pethidine Injection is a type of medicine called an medicines for anxiety (anxiolytics) (eg. . The word opioid means a benzodiazepines such as ) substance similar to , for instance strong • medicines used to help you to sleep relievers such as or . An (hypnotics) analgesic is a medicine that can be used to relieve • medicines for schizophrenia or other serious pain. mental illness, such as (which Pethidine Injection is used to relieve moderate to may be present in various medicines including severe pain. Including pain associated with some for treating allergic disorders, childbirth, or during an anaesthetic or following an (feeling sick) and (being sick) operation. As well as relieving pain, pethidine has • CNS (drugs that act on the brain other effects including a (calming) effect. and make you feel drowsy or faint). These include sleeping pills, 2. WHAT YOU NEED TO KNOW BEFORE YOU (medicines used to treat allergies) that make ARE GIVEN PETHIDINE INJECTION you drowsy, medicines used to treat certain mental disorders. You should not be given this medicine if: • , sleeping tablets or (eg. • you know that you are allergic (hypersensitive) phenobarbitone for epilepsy) to Pethidine Injection or any of the ingredients • (for heart burn or stomach ulcers) in this medicine (listed in section 6), or to • duloxetin (used to treat depression) other strong pain relievers, such as morphine • and metoclopramide (used for • you have any problems that affect your disorders of the ) breathing including chronic bronchitis or • monoamine oxidase inhibitor A and B (used to asthma, shallow breathing or other breathing treat depression) difficulties • ritanovir (antiviral), a medicine used to treat • you are taking monoamine oxidase inhibitors HIV (MAOIs) or have been taking them within the • pain relievers and other opioid medicines last two weeks. MAOIs (eg. or • drugs (eg. for a tummy or isocarboxazid) are medicines used to treat intestine problem or for a “weak” bladder or depression. (see ‘Taking other medicines) as an inhaler for a breathing problem) • you are suffering from severe headaches or • , a medicine used to treat you have recently suffered a head injury, Parkinson’s disease • you have any conditions associated with • , a medicine used to treat fits raised pressure in the brain or a tumour of the (antiepileptic medicine) adrenal gland (phaeochromocytoma). • isoniazid (used to treat tuberculosis) • you suffer from alcoholism • ciprofloxacin, an used to treat a • you suffer from a convulsive disorder (fits) number of bacterial such as epilepsy • , a medicine used to treat seriously • you are suffering from a condition known as irregular heartbeats delirium tremens, caused by withdrawal from • concomitant use of Pethidine and sedative medicines such as benzodiazepines or related • your heartbeat is faster than usual drugs increases the risk of drowsiness, • you suffer from diabetes. difficulties in breathing (respiratory Patients in a coma should not be given this depression), coma and may be medicine. life-threatening. Because of this, concomitant Speak to your doctor if one of these applies to you use should only be considered when other before you are given this medicine. treatment options are not possible. Warnings and Precautions However, if your doctor does prescribe Pethidine Talk to your doctor or pharmacist before being together with sedative medicines the dose and given Pethidine injection if: duration of concomitant treatment should be • you are in shock, the symptoms of which include limited by your doctor. sweating, a fast pulse and cold, clammy skin Please tell your doctor about all sedative medicines • you have an underactive thyroid gland (which you are taking and follow your doctor’s dose may cause tiredness, intolerance to cold, recommendation closely. It could be helpful to , and puffiness of the face) inform friends or relatives to be aware of the signs • you have underactive adrenal glands and symptoms stated above. Contact your doctor (Addison’s disease) or suffer from problems when experiencing such symptoms. related to your adrenal gland (the organ responsible for stress levels), including If you are already taking one of these medicines, adrenocortical insufficiency (a lack of the speak to your doctor before you receive Pethidine hormones produced by the adrenal gland) Injection. • you have a condition that makes you have fits, Pethidine Injection with food, drink and alcohol: eg. epilepsy You must avoid drinking alcohol whilst being given • you have problems with your heart causing an Pethidine Injection as it may increase the risk of increased heart rate developing breathing problems and low • you have a problem with your bowel, , pressure. kidneys or gall bladder , breast-feeding and fertility: • you are in a collapsed state from loss of blood If you are pregnant or breast-feeding, think you or fluid may be pregnant or are planning to have a baby, • you are feeling weak and run-down ask your doctor or pharmacist for advice before • you are complaining of headache and using this medicine. vomiting • you suffer from sickle cell anaemia As with all drugs Pethidine Injection should only be • you are elderly and in a poor state of health given in pregnancy if absolutely necessary. • you have an enlarged prostate gland causing Pethidine can pass into your baby either through difficulty passing water (men only) your blood (during pregnancy and labour) or • you have low blood pressure through your breast milk. Pethidine Injection may • you have weak muscular movement cause breathing problems in newborns. • you have diseases of the stomach or intestine Driving and using machines: • you have lung problems Pethidine Injection can cause drowsiness and • you have been drinking alcohol within the clouding of consciousness which could interfere previous 24 hours. with your ability to use machines. Do not operate

Package leaflet: Information for the patient

Pethidine Hydrochloride 50mg/ml Solution for Injection Pethidine Hydrochloride machinery whilst you are taking this medicine. • pin-point pupils When your Pethidine Injection treatment has • delay in blinking reflex when things are close stopped, ask your doctor when it will be safe for to your eye you to use machines. • feeling sleepy The medicine can affect your ability to drive as it • weakness, headache, may make you sleepy or dizzy. • fits • Do not drive while taking this medicine until • CNS excitation you know how it affects you. • a feeling of dizziness or spinning • It is an offence to drive if this medicine affects • fainting your ability to drive. • (seeing or hearing things that • However, you would not be committing an are not there) offence if: • addiction o The medicine has been prescribed to • confusion treat a medical or dental problem and • mood changes (symptoms include feeling o You have taken it according to the tense and restless) instructions given by the prescriber or in • flushing of the face, the information provided with the • , rash, wheals (raised, itchy area of skin), medicine and • pain, and redness or itching over site of o It was not affecting your ability to drive injection safely • difficulty in passing and swelling over the body especially on legs Talk to your doctor or pharmacist if you are not • feeling restless or agitated sure whether it is safe for you to drive while taking • trembling, uncoordinated movements this medicine. • dry mouth, constipation, abdominal pain Tolerance and dependence: • spasms in the lower abdomen Pethidine Injection can become less effective with • also in elderly patients there is an increased repeated use. This is called tolerance and it risk of delirium (confusion, slurred speech means that the dose may have to be increased for and hallucinations). Pethidine Injection to remain effective. If Pethidine • irregular heartbeats, fast or slow Injection is used repeatedly, it becomes • palpitations (an irregular heart rhythm or habit-forming. This is called dependence and if missed beats) Pethidine Injection treatment is suddenly stopped, • unpleasant withdrawal symptoms may occur. • feeling sick (nausea), being sick (vomiting), Important information about some of the sweating ingredients of Pethidine Injection: • rapid changes in the blood pressure This medicine contains less than 1mmol sodium • feeling faint on standing up from a seated (23mg) per dose, i.e. is essentially ‘sodium-free’. • slowed breathing • low blood pressure, the symptoms of which 3. HOW PETHIDINE INJECTION WILL BE include feeling dizzy or light-headed, feeling GIVEN TO YOU weak and fainting • high blood pressure Pethidine Injection may be administered by • dilatation of blood vessels (vasodilatation) injection into a muscle (intramuscular), or into the • increased or decreased body temperature tissue just below the skin (subcutaneous) or by • overactive reflexes slow injection into the vein (intravenous). • feeling overly happy () or overly sad Your doctor will choose the most suitable dose () depending on your age and your particular • anxiety, nervousness condition. • reduced sex drive Use in Adults: • difficulty achieving or maintaining an erection A single dose of between 25 - 100mg may be • hypothermia, the symptoms of which include injected into a muscle or into the tissue just shivering, drowsiness and feeling weak beneath the skin. For injection into a vein, a single • muscle twitching. dose of between 25 - 50mg may be given slowly. If any of the side effects gets serious, or if you These single doses should not usually be notice any side effects not listed in this leaflet, repeated more frequently than every 4 hours if please tell your doctor or pharmacist. required. Reporting of side effects Use in Elderly Patients or for Patients in a If you get any side effects, talk to your doctor or Weakened Condition: pharmacist or nurse. This includes any possible The initial dose should not exceed 25mg, because side effects not listed in this leaflet. You can also elderly patients or those in a weakened condition report side effects directly via Yellow Card are more sensitive to the unwanted effects of Scheme. Website: www.mhra.gov.uk/yellowcard or pethidine. search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you Use in Children: can help provide more information on the safety of The usual single dose is 0.5 to 2.0mg per kilogram this medicine. of body weight by injection into a muscle. If necessary, this dose may be repeated, allowing at 5. HOW TO STORE PETHIDINE INJECTION least 4 hours between doses. Keep this medicine out of the sight and reach of To ensure that the correct dose is given, use of a children. special syringe with fine markings is Do not use this medicine after the expiry date recommended for administration in children. which is stated on the carton and ampoule label Alternatively, the solution may be diluted in Water after ‘Exp Date’. The expiry date refers to the last for Injections to make it easier to measure the day of that month. dose accurately. Do not store above 25°C. Keep the ampoules in If you have any further questions on the use of this the outer carton in order to protect from light. product, ask your doctor or pharmacist. The product should not be used after the expiry If you think you have been given more date printed on the ampoule or carton. Pethidine Injection than you should: If only part of the contents of an ampoule is used, The symptoms and signs of taking too much of the remaining solution should be discarded. this medicine include shallow breathing, 6. FURTHER INFORMATION drowsiness, incoordination, coma, , blue skin and lips, eye closure (), shaking, cold, The active substance is pethidine hydrochloride. clammy skin, drop in body temperature, slow The other ingredients are sodium hydroxide or heartbeat and low blood pressure. dilute hydrochloric acid in water for injections BP. This medicine will be given to you in hospital so it What Pethidine Injection looks like and is unlikely you will receive too much. Your doctor contents of pack: has information on how to recognise and treat an Pethidine Injection is a clear, colourless, sterile overdose. solution. Each 1ml of solution contains 50mg of If you feel unwell after being given this medicine, pethidine hydrochloride. or are at all concerned you have been given too The solution is presented in clear glass ampoules much, tell your doctor or nurse immediately. (bottles), containing either 1ml or 2ml. The If you think you have missed a dose, tell your ampoules are then packed in cardboard cartons doctor, nurse immediately. with 10 ampoules per box. If you have any further questions on the use of this Marketing authorisation holder: product, ask your doctor or nurse. Mercury Pharmaceuticals Limited 4. POSSIBLE SIDE EFFECTS Capital House, 85 King William Street, London EC4N 7BL, UK Like all medicines, Pethidine Injection can cause side-effects, although not everyone gets them. Manufacturer: Repeated use of pethidine can result in B. Braun Melsungen AG, Mistelweg 2, 12357 tolerance and addiction Berlin, . These are more common when Pethidine is given This leaflet was last revised in December 2018. into a vein. All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness and tightness of the chest, difficulty in breathing, swelling of the eyelids, face or lips, skin lumps or , skin rash (red spots) or itching (especially affecting your whole body), fever and collapse should be reported to a doctor immediately. The most serious side effects are difficulty breathing and low blood pressure. Other side effects that may occur include: Not known (frequency cannot be estimated from the available data): • disturbances in eyesight LF-116765-01