AMS Component No.: LF-104722-01 Proof Number: 5 Revision Date: 11-Jul-2018 Product Description: Pethidine HCL Do not operate machinery whilst you are taking • high blood pressure 50mg/ml Injection - this medicine. When your Pethidine Injection • dilatation of blood vessels (vasodilatation). 1ml & 2ml - 10 treatment has stopped, ask your doctor when it Other side effects include: Component: Leaflet will be safe for you to use machines. Not known: frequency cannot be estimated Package leaflet: Information for the patient Product Code: 100497, 100498 The medicine can affect your ability to drive as it from the available data Pethidine Hydrochloride 50mg/ml Solution for Injection Country: Ireland may make you sleepy or dizzy. • addiction Vendor Name: B Braun • Do not drive while taking this medicine until • confusion Pethidine Hydrochloride CRF(s): PR 21793 you know how it affects you. • feeling of unease (anxiety) • It is an offence to drive if this medicine affects PR 13921 • nervousness READ ALL OF THIS LEAFLET CAREFULLY depression), coma and may be fatal. Even if your ability to drive. • changes in mood BEFORE YOU START USING THIS MEDICINE. benzodiazepines are prescribed, your doctor Revised by: ADD • However, you would not be committing an • disturbances in eyesight Keep this leaflet. You may need to read it again. may need to change the dose, the duration of offence if: • dry eye If you have any further questions, ask your doctor treatment or monitor you regularly. Dimension: 155 x 447 mm o The medicine has been prescribed to • pin-point pupils or pharmacist. treat a medical or dental problem and This product must be used with caution in Commodity No.: N/A • delay in blinking reflex when things are close This medicine has been prescribed for you only. o You have taken it according to the to your eye newborn and premature babies. Pharma Code: N/A Do not pass it on to others. It may harm them, even If you are elderly or ill, or your baby or child is instructions given by the prescriber or in • sensation of spinning (vertigo) if their symptoms are the same as yours. being given Pethidine Injection, special care will be Core Spec Ref.: N/A the information provided with the • spasms in the lower abdomen If you get any side effects talk to your doctor or taken. Print Colours: Black medicine and • muscle twitching pharmacist. This includes any possible side effects If any of the above apply to you or your child, Non-Print Colours: Cutter o It was not affecting your ability to drive • reduced sex drive not listed in this leaflet. See section 4. please tell your doctor before being given safely • difficulty achieving or maintaining an erection The name of your medicine is Pethidine Pethidine Injection. Min. Font Size: 8 pt Talk to your doctor or pharmacist if you are not • hypothermia, the symptoms of which include sure whether it is safe for you to drive while taking shivering, drowsiness and feeling weak Hydrochloride 50mg/ml Solution for Injection but Other medicines and Pethidine injection: will be referred to as “Pethidine Injection” this medicine. • weakness, Tell your doctor before you are given this medicine • seeing or hearing things that are not there throughout the remainder of this leaflet. Tolerance dependance and withdrawal if you are taking or have recently taken any other (hallucinations) What is in this leaflet: Pethidine Injection can become less effective with medicines, including medicines obtained without a PAGE 1 OF 2 • feeling overly happy (euphoria) or overly sad 1. What Pethidine Injection is and what it is used repeated use. This is called tolerance and it prescription. (dysphoria) for means that the dose may have to be increased for Pethidine Injection must not be used with drugs • irregular heartbeats, fast or slow heartbeats, 2. What you need to know before you are given Pethidine Injection to remain effective. used to treat severe depression, such as rasagiline loss of consciousness, Pethidine injection If Pethidine Injection is used repeatedly, it or moclobemide, or if you are within 2 weeks of • difficulty in passing urine 3. How Pethidine Injection is given to you becomes habit-forming. This is called dependence discontinuing them. These drugs are known as • feeling agitated 4. Possible side effects and if Pethidine Injection treatment is suddenly Monoamine Oxidase Inhibitors (MAOI’s). • inability to empty the bladder completely 5. How to store Pethidine Injection stopped, unpleasant withdrawal symptoms, like A large number of drugs can interact with Pethidine (urinary retention) 6. Contents of the pack and other information nausea, vomiting, loss of appetite and Injection which can significantly alter their effects. • abdominal pain caused by kidney stones restlessness may occur. 1. WHAT PETHIDINE INJECTION IS AND These drugs include: (renal colic) WHAT IT IS USED FOR • medicines to treat depression (e.g. tricyclic Important information about some of the • pain or irritation at the site of injection or local antidepressants such as amitriptyline) ingredients of Pethidine Injection tissue, wheal, redness over the vein (after an Pethidine Injection is a type of medicine called an • selegiline, a medicine used to treat This medicine contains less than 1mmol sodium injection into the vein). opioid analgesic. The word opioid means a Parkinson’s disease (23mg) per dose, i.e. is essentially ‘sodium-free’. If any of the side effects gets serious, or if you substance similar to opium, for instance strong • ritonavir, a medicine used to treat HIV notice any side effects not listed in this leaflet, pain relievers such as morphine or codeine. 3. HOW PETHIDINE INJECTION WILL BE please tell your doctor or pharmacist. • medicines for anxiety (anxiolytics) (e.g. GIVEN TO YOU An analgesic is a medicine that can be used to benzodiazepines such as diazepam) relieve pain. Reporting of side effects • medicines used to help you to sleep Pethidine Injection may be administered by If you get any side effects, talk to your doctor, Pethidine Injection is used to relieve moderate to (hypnotics) injection into a muscle (intramuscular) or into the severe pain, including pain associated with pharmacist or nurse. This includes any possible • medicines to treat schizophrenia or other tissue (subcutaneous) just below the skin or by side effects not listed in this leaflet. You can also childbirth, before an operation and as a medicine serious mental illness, such as phenothiazines slow injection into the vein (intravenous). given before administration of an anaesthetic. report side effects directly via HPRA (which may be present in various medicines You should be lying down when the injection is Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2. WHAT YOU NEED TO KNOW BEFORE YOU including some for treating allergic disorders) given. Your doctor will choose the most suitable 2; Tel: +353 1 6764971; ARE GIVEN PETHIDINE INJECTION • sedatives, sleeping tablets or barbiturates dose depending on your age and your particular Fax: +353 1 6762517. Website: www.hpra.ie; (e.g. phenobarbital for epilepsy) condition. E-mail: [email protected]. By reporting side • domperidone and metoclopramide (used for You should not be given this medicine if: Use in Elderly Patients effects you can help provide more information on disorders of the gastrointestinal tract) • you know that you are allergic (hypersensitive) Elderly patients may require reduced doses. the safety of this medicine. to Pethidine Hydrochloride or any of the other • pain relievers and other opioid medicines. Use in children ingredients in this medicine (listed in Section Other medicines which may interact with Pethidine 5. HOW TO STORE PETHIDINE INJECTION In children the dose is calculated according to the 6) injection are: child’s weight. Keep this medicine out of the sight and reach of • you have any problems that affect your • Cimetidine (for heart burn or stomach ulcer) children. breathing including chronic bronchitis or • anticholinergic drugs (e.g. for a stomach or If you think you have been given more Do not use this medicine after the expiry date asthma, shallow breathing or other breathing intestine problem, for Parkinson’s disease (a Pethidine Injection than you should have which is stated on the carton and ampoule label difficulties condition where you get tremor, stiffness and The symptoms and signs of taking too much of after ‘Exp Date’. The expiry date refers to the last • you are taking monoamine oxidase inhibitors shuffling), for a “weak” bladder, or as an this medicine include shallow breathing, day of that month. (MAOIs) or have been taking them within the inhaler for a breathing problem, for example drowsiness, incoordination, coma, seizures, blue Keep the ampoules in the outer carton in order to last two weeks. MAOIs (e.g. phenelzine or ipratropium bromide, oxybutynin, skin and lips, eye closure (miosis), shaking, cold, protect from light. Do not store above 25°C. isocarboxazid) are medicines used to treat orphenadrine and hyoscine hydrobromide) clammy skin, drop in body temperature, slow For single use only. depression (see ‘Taking other medicines) • Halothane, a gas used in general anesthesia heartbeat and low blood pressure. Once the ampoule has been opened it should be • you are suffering from severe headaches or • medicines for depression (eg. tricyclic This medicine will be given to you in hospital so it used immediately. If only part of the contents of an have suffered a head injury antidepressants such as amitriptyline) is unlikely you will receive too much. Your doctor ampoule is used, the remaining solution should be • you suffer from alcoholism • monoamine oxidase inhibitors (MAOIs) (e.g. has information on how to recognise and treat an discarded. • you suffer from a convulsive disorder (fits) phenelzine or isocarboxazid used to treat overdose. Do not use the solution if the ampoule is damaged such as epilepsy depression) If you feel unwell after being given this medicine, or if the contents are discoloured in any way or • you have any liver or kidney problems • ciprofloxacin, an antibiotic used to treat a or are at all concerned you have been given too contains particles in it. • you are suffering from a condition known as number of bacterial infections much, tell your doctor or nurse immediately. Medicines should not be disposed of via delirium tremens, caused by withdrawal from • mexiletine, a medicine used to treat seriously This is unlikely as your injection will be wastewater or household waste. Ask your alcohol irregular heartbeats administered by a doctor or nurse. If you are pharmacist how to dispose of medicines no longer • your heartbeat is faster than usual • concomitant use of Pethidine and sedative concerned about the dose, discuss this with your required. These measures will help to protect the • you suffer from a tumour of the adrenal gland medicines such as benzodiazepines or related doctor. environment. known as phaeochromocytoma drugs increases the risk of drowsiness, If you think you have missed a dose of • you suffer from diabetes. difficulties in breathing (respiratory Pethidine Injection tell your doctor or nurse 6. FURTHER INFORMATION Patients in a coma should not be given this immediately. depression), coma and may be life- What Pethidine Injection contains medicine. threatening. Because of this, concomitant use If you have any further questions on the use of this product, ask your doctor or pharmacist. The active substance is Pethidine Hydrochloride. Warnings and Precautions should only be considered when other Each 1ml contains 50mg of Pethidine Talk to your doctor before using Pethidine treatment options are not possible. 4. POSSIBLE SIDE EFFECTS Hydrochloride (100mg in 2ml). Injection if : However, if your doctor does prescribe Pethidine Like all medicines, Pethidine Injection can cause The other ingredients are sodium hydroxide or • you are in shock, the symptoms of which together with sedative medicines the dose and side-effects, although not everybody gets them. dilute hydrochloric acid in water for injections. include sweating, a fast pulse and cold, duration of concomitant treatment should be Repeated use of pethidine can result in clammy skin What Pethidine Injection looks like and limited by your doctor. tolerance and addiction • you have an underactive thyroid gland (which contents of pack Please tell your doctor about all sedative medicines All medicines can cause allergic reactions may cause tiredness, intolerance to cold, Pethidine Injection is a clear, colourless, sterile you are taking and follow your doctor’s dose although serious allergic reactions are rare. constipation and puffiness of the face) solution for injection in 1ml or 2ml clear glass recommendation closely. It could be helpful to Any sudden wheeziness, tightness of the • you have underactive adrenal glands or suffer ampoules. inform friends or relatives to be aware of the signs breast and difficulty in breathing, swelling of from problems related to your adrenal gland Pack size: The ampoules are then packed in and symptoms stated above. Contact your doctor the eyelids, face or lips, skin rash (red spots), (the organ responsible for stress levels), cardboard cartons with 10 ampoules per box. when experiencing such symptoms. fever or itching (especially affecting your whole including adrenocortical insufficiency (a lack Not all pack sizes may be marketed. body) and collapse should be reported to a of the hormones produced by the adrenal If you are already taking one of these medicines, doctor immediately. Marketing authorisation holder gland) speak to your doctor before you are given The following side effects have also been Mercury Pharmaceuticals (Ireland) Ltd, • you suffer from fits Pethidine Injection. reported: 4045, Kingswood Road, City West Business Park, • you have problems with your heart causing an Pethidine Injection with food, drink and alcohol Co Dublin, Ireland. Very common (may affect more than 1 in 10 increased heart rate You must avoid drinking alcohol before or after people) Manufacturer • you suffer from any problem with your bowel, being given Pethidine Injection. liver, kidneys or gall bladder • feeling sick (nausea) B Braun Melsungen AG, Mistelweg 2, 12357 • you have any problems that affect your Pregnancy and breast-feeding • being sick (vomiting) Berlin, Germany. If you are pregnant or breast-feeding, think you • dry mouth breathing This leaflet was last revised in July 2018 • you suffer from low blood pressure due to loss may be pregnant or are planning to have a baby, • constipation, of blood or fluid ask your doctor or pharmacist for advice before • lightheadedness, dizziness, sleepiness • you suffer from raised pressure in the brain using this medicine. • slowing of breathing or shallow breathing • you were born with sickle cell anaemia, where As with all drugsPethidine Injection should only be • sweating you have abnormally shaped red blood cells given in pregnancy or when breast-feeding if • flushing of the face • you are elderly and in a poor state of health absolutely necessary. Pethidine can pass into your • itching, rash causing redness of the skin • you have an enlarged prostate gland causing baby either through your blood. • feeling faint on standing up from a seated difficulty in passing water (men only) It can be administered as pain relief during • fits • you have cancer childbirth but it may cause breathing problems in • trembling, uncoordinated muscle movements • you are dependent on alcohol newborns. • headache • you have weak muscular movement Ask your doctor or pharmacist for advice before • CNS excitation • you have lung problems taking any medicine. • fainting • you are taking any medicine from the group of Driving and using machines • low blood pressure, the symptoms of which medicines known as benzodiazepines. Taking Pethidine Injection will cause drowsiness which include feeling dizzy or light-headed, feeling these medicines with Pethidine may result in could interfere with your ability to use machines. weak and fainting

sedation, difficulties in breathing (respiratory

Pharmacode area Pharmacode area Pharmacode

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Pharmacode area Pharmacode area AMS Component No.: LF-104722-01 Proof Number: 5 Revision Date: 11-Jul-2018 Do not operate machinery whilst you are taking • high blood pressure Product Description: Pethidine HCL this medicine. When your Pethidine Injection • dilatation of blood vessels (vasodilatation). 50mg/ml Injection - 1ml & 2ml - 10 treatment has stopped, ask your doctor when it Other side effects include: will be safe for you to use machines. Not known: frequency cannot be estimated Component: Leaflet The medicine can affect your ability to drive as it from the available data Product Code: 100497, 100498 may make you sleepy or dizzy. • addiction Country: Ireland • Do not drive while taking this medicine until • confusion Vendor Name: B Braun you know how it affects you. • feeling of unease (anxiety) CRF(s): PR 21793 • It is an offence to drive if this medicine affects • nervousness PR 13921 READ ALL OF THIS LEAFLET CAREFULLY depression), coma and may be fatal. Even if your ability to drive. • changes in mood BEFORE YOU START USING THIS MEDICINE. benzodiazepines are prescribed, your doctor • However, you would not be committing an • disturbances in eyesight Revised by: ADD Keep this leaflet. You may need to read it again. may need to change the dose, the duration of offence if: • dry eye If you have any further questions, ask your doctor treatment or monitor you regularly. o The medicine has been prescribed to • pin-point pupils Dimension: 155 x 447 mm or pharmacist. treat a medical or dental problem and This product must be used with caution in • delay in blinking reflex when things are close Commodity No.: N/A This medicine has been prescribed for you only. o You have taken it according to the to your eye newborn and premature babies. Pharma Code: N/A Do not pass it on to others. It may harm them, even If you are elderly or ill, or your baby or child is instructions given by the prescriber or in • sensation of spinning (vertigo) if their symptoms are the same as yours. being given Pethidine Injection, special care will be the information provided with the • spasms in the lower abdomen Core Spec Ref.: N/A If you get any side effects talk to your doctor or taken. medicine and • muscle twitching Print Colours: Black pharmacist. This includes any possible side effects If any of the above apply to you or your child, o It was not affecting your ability to drive • reduced sex drive Non-Print Colours: Cutter not listed in this leaflet. See section 4. please tell your doctor before being given safely • difficulty achieving or maintaining an erection The name of your medicine is Pethidine Pethidine Injection. Talk to your doctor or pharmacist if you are not • hypothermia, the symptoms of which include Min. Font Size: 8 pt sure whether it is safe for you to drive while taking shivering, drowsiness and feeling weak Hydrochloride 50mg/ml Solution for Injection but Other medicines and Pethidine injection: will be referred to as “Pethidine Injection” this medicine. • weakness, Tell your doctor before you are given this medicine • seeing or hearing things that are not there throughout the remainder of this leaflet. Tolerance dependance and withdrawal if you are taking or have recently taken any other (hallucinations) What is in this leaflet: Pethidine Injection can become less effective with medicines, including medicines obtained without a • feeling overly happy (euphoria) or overly sad PAGE 2 OF 2 1. What Pethidine Injection is and what it is used repeated use. This is called tolerance and it prescription. (dysphoria) for means that the dose may have to be increased for Pethidine Injection must not be used with drugs • irregular heartbeats, fast or slow heartbeats, 2. What you need to know before you are given Pethidine Injection to remain effective. used to treat severe depression, such as rasagiline loss of consciousness, Pethidine injection If Pethidine Injection is used repeatedly, it or moclobemide, or if you are within 2 weeks of • difficulty in passing urine 3. How Pethidine Injection is given to you becomes habit-forming. This is called dependence discontinuing them. These drugs are known as • feeling agitated 4. Possible side effects and if Pethidine Injection treatment is suddenly Monoamine Oxidase Inhibitors (MAOI’s). • inability to empty the bladder completely 5. How to store Pethidine Injection stopped, unpleasant withdrawal symptoms, like A large number of drugs can interact with Pethidine (urinary retention) 6. Contents of the pack and other information nausea, vomiting, loss of appetite and Injection which can significantly alter their effects. • abdominal pain caused by kidney stones restlessness may occur. 1. WHAT PETHIDINE INJECTION IS AND These drugs include: (renal colic) WHAT IT IS USED FOR • medicines to treat depression (e.g. tricyclic Important information about some of the • pain or irritation at the site of injection or local antidepressants such as amitriptyline) ingredients of Pethidine Injection tissue, wheal, redness over the vein (after an Pethidine Injection is a type of medicine called an • selegiline, a medicine used to treat This medicine contains less than 1mmol sodium injection into the vein). opioid analgesic. The word opioid means a Parkinson’s disease (23mg) per dose, i.e. is essentially ‘sodium-free’. If any of the side effects gets serious, or if you substance similar to opium, for instance strong • ritonavir, a medicine used to treat HIV notice any side effects not listed in this leaflet, pain relievers such as morphine or codeine. 3. HOW PETHIDINE INJECTION WILL BE please tell your doctor or pharmacist. • medicines for anxiety (anxiolytics) (e.g. GIVEN TO YOU An analgesic is a medicine that can be used to benzodiazepines such as diazepam) relieve pain. Reporting of side effects • medicines used to help you to sleep Pethidine Injection may be administered by If you get any side effects, talk to your doctor, Pethidine Injection is used to relieve moderate to (hypnotics) injection into a muscle (intramuscular) or into the severe pain, including pain associated with pharmacist or nurse. This includes any possible • medicines to treat schizophrenia or other tissue (subcutaneous) just below the skin or by side effects not listed in this leaflet. You can also childbirth, before an operation and as a medicine serious mental illness, such as phenothiazines slow injection into the vein (intravenous). given before administration of an anaesthetic. report side effects directly via HPRA (which may be present in various medicines You should be lying down when the injection is Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2. WHAT YOU NEED TO KNOW BEFORE YOU including some for treating allergic disorders) given. Your doctor will choose the most suitable 2; Tel: +353 1 6764971; ARE GIVEN PETHIDINE INJECTION • sedatives, sleeping tablets or barbiturates dose depending on your age and your particular Fax: +353 1 6762517. Website: www.hpra.ie; (e.g. phenobarbital for epilepsy) condition. E-mail: [email protected]. By reporting side • domperidone and metoclopramide (used for You should not be given this medicine if: Use in Elderly Patients effects you can help provide more information on disorders of the gastrointestinal tract) • you know that you are allergic (hypersensitive) Elderly patients may require reduced doses. the safety of this medicine. to Pethidine Hydrochloride or any of the other • pain relievers and other opioid medicines. Use in children ingredients in this medicine (listed in Section Other medicines which may interact with Pethidine 5. HOW TO STORE PETHIDINE INJECTION In children the dose is calculated according to the 6) injection are: child’s weight. Keep this medicine out of the sight and reach of • you have any problems that affect your • Cimetidine (for heart burn or stomach ulcer) children. breathing including chronic bronchitis or • anticholinergic drugs (e.g. for a stomach or If you think you have been given more Do not use this medicine after the expiry date asthma, shallow breathing or other breathing intestine problem, for Parkinson’s disease (a Pethidine Injection than you should have which is stated on the carton and ampoule label difficulties condition where you get tremor, stiffness and The symptoms and signs of taking too much of after ‘Exp Date’. The expiry date refers to the last • you are taking monoamine oxidase inhibitors shuffling), for a “weak” bladder, or as an this medicine include shallow breathing, day of that month. (MAOIs) or have been taking them within the inhaler for a breathing problem, for example drowsiness, incoordination, coma, seizures, blue Keep the ampoules in the outer carton in order to last two weeks. MAOIs (e.g. phenelzine or ipratropium bromide, oxybutynin, skin and lips, eye closure (miosis), shaking, cold, protect from light. Do not store above 25°C. isocarboxazid) are medicines used to treat orphenadrine and hyoscine hydrobromide) clammy skin, drop in body temperature, slow For single use only. depression (see ‘Taking other medicines) • Halothane, a gas used in general anesthesia heartbeat and low blood pressure. Once the ampoule has been opened it should be • you are suffering from severe headaches or • medicines for depression (eg. tricyclic This medicine will be given to you in hospital so it used immediately. If only part of the contents of an have suffered a head injury antidepressants such as amitriptyline) is unlikely you will receive too much. Your doctor ampoule is used, the remaining solution should be • you suffer from alcoholism • monoamine oxidase inhibitors (MAOIs) (e.g. has information on how to recognise and treat an discarded. • you suffer from a convulsive disorder (fits) phenelzine or isocarboxazid used to treat overdose. Do not use the solution if the ampoule is damaged such as epilepsy depression) If you feel unwell after being given this medicine, or if the contents are discoloured in any way or • you have any liver or kidney problems • ciprofloxacin, an antibiotic used to treat a or are at all concerned you have been given too contains particles in it. • you are suffering from a condition known as number of bacterial infections much, tell your doctor or nurse immediately. Medicines should not be disposed of via delirium tremens, caused by withdrawal from • mexiletine, a medicine used to treat seriously This is unlikely as your injection will be wastewater or household waste. Ask your alcohol irregular heartbeats administered by a doctor or nurse. If you are pharmacist how to dispose of medicines no longer • your heartbeat is faster than usual • concomitant use of Pethidine and sedative concerned about the dose, discuss this with your required. These measures will help to protect the • you suffer from a tumour of the adrenal gland medicines such as benzodiazepines or related doctor. environment. known as phaeochromocytoma drugs increases the risk of drowsiness, If you think you have missed a dose of • you suffer from diabetes. difficulties in breathing (respiratory Pethidine Injection tell your doctor or nurse 6. FURTHER INFORMATION Patients in a coma should not be given this immediately. depression), coma and may be life- What Pethidine Injection contains medicine. threatening. Because of this, concomitant use If you have any further questions on the use of this product, ask your doctor or pharmacist. The active substance is Pethidine Hydrochloride. Warnings and Precautions should only be considered when other Each 1ml contains 50mg of Pethidine Talk to your doctor before using Pethidine treatment options are not possible. 4. POSSIBLE SIDE EFFECTS Hydrochloride (100mg in 2ml). Injection if : However, if your doctor does prescribe Pethidine Like all medicines, Pethidine Injection can cause The other ingredients are sodium hydroxide or • you are in shock, the symptoms of which together with sedative medicines the dose and side-effects, although not everybody gets them. dilute hydrochloric acid in water for injections. include sweating, a fast pulse and cold, duration of concomitant treatment should be Repeated use of pethidine can result in clammy skin What Pethidine Injection looks like and limited by your doctor. tolerance and addiction • you have an underactive thyroid gland (which contents of pack Please tell your doctor about all sedative medicines All medicines can cause allergic reactions may cause tiredness, intolerance to cold, Pethidine Injection is a clear, colourless, sterile you are taking and follow your doctor’s dose although serious allergic reactions are rare. constipation and puffiness of the face) solution for injection in 1ml or 2ml clear glass recommendation closely. It could be helpful to Any sudden wheeziness, tightness of the • you have underactive adrenal glands or suffer ampoules. inform friends or relatives to be aware of the signs breast and difficulty in breathing, swelling of from problems related to your adrenal gland Pack size: The ampoules are then packed in and symptoms stated above. Contact your doctor the eyelids, face or lips, skin rash (red spots), (the organ responsible for stress levels), cardboard cartons with 10 ampoules per box. when experiencing such symptoms. fever or itching (especially affecting your whole including adrenocortical insufficiency (a lack Not all pack sizes may be marketed. body) and collapse should be reported to a of the hormones produced by the adrenal If you are already taking one of these medicines, doctor immediately. Marketing authorisation holder gland) speak to your doctor before you are given The following side effects have also been Mercury Pharmaceuticals (Ireland) Ltd, • you suffer from fits Pethidine Injection. reported: 4045, Kingswood Road, City West Business Park, • you have problems with your heart causing an Pethidine Injection with food, drink and alcohol Co Dublin, Ireland. Very common (may affect more than 1 in 10 increased heart rate You must avoid drinking alcohol before or after people) Manufacturer • you suffer from any problem with your bowel, being given Pethidine Injection. liver, kidneys or gall bladder • feeling sick (nausea) B Braun Melsungen AG, Mistelweg 2, 12357 • you have any problems that affect your Pregnancy and breast-feeding • being sick (vomiting) Berlin, Germany. If you are pregnant or breast-feeding, think you • dry mouth breathing This leaflet was last revised in July 2018 • you suffer from low blood pressure due to loss may be pregnant or are planning to have a baby, • constipation, of blood or fluid ask your doctor or pharmacist for advice before • lightheadedness, dizziness, sleepiness • you suffer from raised pressure in the brain using this medicine. • slowing of breathing or shallow breathing • you were born with sickle cell anaemia, where As with all drugsPethidine Injection should only be • sweating you have abnormally shaped red blood cells given in pregnancy or when breast-feeding if • flushing of the face • you are elderly and in a poor state of health absolutely necessary. Pethidine can pass into your • itching, rash causing redness of the skin • you have an enlarged prostate gland causing baby either through your blood. • feeling faint on standing up from a seated difficulty in passing water (men only) It can be administered as pain relief during • fits • you have cancer childbirth but it may cause breathing problems in • trembling, uncoordinated muscle movements • you are dependent on alcohol newborns. • headache • you have weak muscular movement Ask your doctor or pharmacist for advice before • CNS excitation • you have lung problems taking any medicine. • fainting • you are taking any medicine from the group of Driving and using machines • low blood pressure, the symptoms of which medicines known as benzodiazepines. Taking Pethidine Injection will cause drowsiness which include feeling dizzy or light-headed, feeling these medicines with Pethidine may result in could interfere with your ability to use machines. weak and fainting sedation, difficulties in breathing (respiratory LF-104722-01 Druckfrei Druckfrei Druckfrei Druckfrei

magenta = non-printing area