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Pethidine Hydrochloride 50Mg/Ml Solution for Injection

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Package leaflet: Information for the patient Pethidine 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 benzodiazepines. 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 dose, 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 drugs Pethidine injection used to treat severe depression, such as rasagiline 3. How Pethidine Injection is given to you or moclobemide 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 antidepressants such as amitriptyline) and Pethidine Injection is a type of medicine called an medicines for anxiety (anxiolytics) (eg. opioid analgesic. The word opioid means a benzodiazepines such as diazepam) substance similar to opium, for instance strong • medicines used to help you to sleep pain relievers such as morphine or codeine. An (hypnotics) analgesic is a medicine that can be used to relieve • medicines for schizophrenia or other serious pain. mental illness, such as phenothiazines (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, nausea childbirth, or during an anaesthetic or following an (feeling sick) and vomiting (being sick) operation. As well as relieving pain, pethidine has • CNS depressants (drugs that act on the brain other effects including a sedative (calming) effect. and make you feel drowsy or faint). These include sleeping pills, antihistamines 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: • sedatives, sleeping tablets or barbiturates (eg. • you know that you are allergic (hypersensitive) phenobarbitone for epilepsy) to Pethidine Injection or any of the ingredients • cimetidine (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 • domperidone and metoclopramide (used for • you have any problems that affect your disorders of the gastrointestinal tract) 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. phenelzine or • anticholinergic 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 • selegiline, a medicine used to treat you have recently suffered a head injury, Parkinson’s disease • you have any conditions associated with • phenytoin, 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 antibiotic used to treat a • you suffer from a convulsive disorder (fits) number of bacterial infections such as epilepsy • mexiletine, 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 alcohol 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 constipation, 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 blood • you have a problem with your bowel, liver, pressure. kidneys or gall bladder Pregnancy, 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. • hallucinations (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 • itch, 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 urine 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.
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