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Home , Glycopyrronium bromide

Package leaflet: information for the user Dosage when used during an operation: Reporting of side effects Adults, adolescents over 12 years old and elderly patients: If you get any side effects, talk to your doctor, pharmacist or Glycopyrronium Bromide 200 micrograms/ml Solution for Injection The recommended single dose of 200 to 400 micrograms (0.2 nurse. This includes any possible side effects not listed in this to 0.4mg) by injection into a vein. Alternatively, they may give leaflet. You can also report side effects directly via the Yellow Glycopyrronium Bromide you a single dose of 4 to 5 micrograms per kilogram of body Card Scheme: www.mhra.gov.uk/yellowcard. By reporting side (referred to as Glycopyrronium Injection in this leaflet) weight (0.004 to 0.005mg per kg), up to a maximum of 400 effects you can help provide more information on the safety of micrograms (0.4mg). This dose may be repeated if necessary. this medicine. Other medicines and Glycopyrronium Injection Read all of this leaflet carefully before you are given this Tell your doctor or nurse if you are taking, have recently taken Children: medicine because it contains important information for or might take any other medicines. you The recommended single dose of 200 micrograms (0.2mg) 5. How to store Glycopyrronium Injection D04150 Medicines which may interact with Glycopyrronium Injection by injection into a vein. • Keep this leaflet. You may need to read it again. include: Keep out of the sight and reach of children. • If you have any further questions, ask your doctor Alternatively they may give them a single dose of 4 to 8 This medicinal product does not require any special storage • drugs for depression known as Tricyclic Antidepressants micrograms per kilogram of body weight (0.004 to 0.008mg or nurse. for example or and Monoamine conditions. Do not use this medicine after the expiry date • If you get any side effects, talk to your doctor, pharmacist per kg) by injection into a vein, up to a maximum of 200 which is stated on the label and carton. The expiry date refers Oxidase Inhibitors (MAOIs) for example phenelzine, micrograms (0.2mg). This dose may be repeated if necessary. or nurse. This includes any possible side effects not listed tranylcypramine); to the last day of that month. in this leaflet. See section 4. • (used to treat schizophrenia); If only part of an ampoule is used the remaining solution • used to treat severe mental problems or If you are given too much Glycopyrronium Injection should be discarded. The injection should not be used if nausea, or vertigo (for example , This medicine will be given to you in hospital so it is unlikely particles are present. Do not use this medicine if you notice What is in this leaflet: fluphenazine, prochlorperazine, trifluoperazine); you will receive too much, however if you are concerned you the ampoule is damaged or if the contents are discoloured. 1. What Glycopyrronium Injection is and what it is used for • antihistamines used to treat allergies (for example may have been given too much you should speak to your 2. What you need to know before you use ); doctor or nurse. If you have any further questions about this Do not throw away any medicines via wastewater or Glycopyrronium Injection. • (used to treat acute and chronic pain); medicine, ask your doctor or nurse. household waste. Ask your pharmacist how to throw away 3. How to use Glycopyrronium Injection. • (used to treat moderate to severe pain); medicines you no longer use. These measures will help protect 4. Possible side effects. the environment. • or (used to treat nausea and Dosage when reversing the effects of non-depolarising 5. How to store Glycopyrronium Injection. vomiting); muscle relaxants: 6. Contents of the pack and other information • ketoconazole (used to treat fungal infections); Adults, adolescents over 12 years old and elderly patients: 6. Contents of the pack and other information • amantadine, levodopa (used to treat Parkinson’s disease); Your doctor will give you 200 micrograms (0.2mg) per 1,000 • memantine (used to treat Alzheimer’s disease); 1. What Glycopyrronium Injection is and what micrograms (1mg) of or the equivalent dose of What Glycopyrronium Injection contains. • parasympathomimetics (these are drugs that affect pyridostigmine, by injection into a vein. Alternatively, they The active substance is Glycopyrronium Bromide. it is used for chemicals in the body which are involved in transmission may give you a dose of 10 to 15 micrograms per kilogram Each 1ml glass ampoule contains 200 micrograms of Glycopyrronium Injection contains the active substance of nerve impulses to a muscle) (for example , of body weight (0.01 to 0.015 mg per kg) into a vein with glycopyrronium bromide. glycopyrronium bromide. neostigmine, physostigmine); 50 micrograms per kg (0.05 mg per kg) of neostigmine or Each 3ml glass ampoule contains 600 micrograms of Glycopyrronium Bromide belongs to a group of medicines • ritodrine (used to prevent uncomplicated premature equivalent dose of pyridostigmine. glycopyrronium bromide. called drugs. labour); Glycopyrronium Injection may be given at the same time and The other ingredients are sodium chloride, hydrochloric acid Glycopyrronium Injection may be used: • corticosteroids used to treat various conditions from the same syringe as the neostigmine or pyridostigmine. (for pH adjustment) and water for injections. • To protect against some of the unwanted effects of drugs including and inflammatory disease (for example such as neostigmine or pyridostigmine, which are used to prednisolone); Children: What Glycopyrronium Injection looks like and contents of reverse the effects of certain types of muscle-relaxing drugs • slow-dissolving digoxin tablets, disopyramide (used to treat Your doctor may give your child 10 micrograms per kg of the pack. (called non-depolarising muscle relaxants). heart problems). body weight (0.01mg per kg) injected into a vein with 50 Glycopyrronium Injection is a clear, colourless solution for • Before an operation, to reduce saliva and other secretions • may increase the when used with a class of drugs micrograms per kg (0.05mg per kg) of neostigmine or the injection. Glycopyrronium Injection is available in glass and to reduce the acidity of the stomach contents. known as sympathomimetics (commonly present in cough equivalent dose of pyridostigmine. Glycopyrronium Injection ampoules containing either 1ml or 3ml of solution. Each • Before or during an operation, to reduce or prevent slowing and cold preparations and weight reducing medicines. may be given at the same time and from the same syringe as carton supplied contains 10 ampoules. of the heartbeat during surgery. the Neostigmine or Pyridostigmine. Glyceryl trinitrate tablets (used to treat angina) may not Marketing Authorisation Holder dissolve under the tongue as well as usual owing to the dry Dosage in patients with impaired kidney function: Martindale Pharmaceuticals Limited, Bampton Road, Harold 2. What you need to know before you use mouth which glycopyrronium bromide causes. If you have impaired kidney function, your doctor will decide Hill, Romford, Essex, RM38UG, UK Glycopyrronium Injection upon a dose that suits your condition. You should not be given Glycopyrronium Injection if: Pregnancy, breast-feeding. Manufacturer • you are allergic to glycopyrronium bromide or to any of the If you are pregnant or breast-feeding, think you may be Macarthy’s Laboratories Ltd. other ingredients in this medicine, (listed in section 6). pregnant or are planning to have a baby, ask your doctor for 4. Possible side effects Trading as Martindale Pharma, Bampton Road, Harold Hill • if you have glaucoma (increased pressure in the eye); advice before being given this medicine. Like all medicines, this medicine can cause side effects, Romford, Essex, UK • if you suffer from myasthenia gravis (a disorder that causes although not everybody gets them. Marketing Authorisation Number: PL 00156/0115 extreme muscle weakness and fatigue); Driving and using machines. Consult a doctor straight away if you notice any of the The leaflet was last revised in February 2018 • if you have an enlarged prostate; After having Glycopyrronium Injection you should not drive following symptoms - you may need urgent medical • if you have stomach or bowel problems. or operate machines because this medicine can cause blurred treatment: • If you suffer from a prolonged QT interval (irregular heart vision, dizziness and other effects that may affect your ability rhythm) should avoid the combination use of neostigmine to do so. Do not drive or use machinery until these effects Swelling mainly of the face, lips or throat which makes it plus glycopyrronium. have gone. difficult to swallow or breathe, itching and rashes. This could be a sign of a severe allergic reaction or angioedema (frequency not known, cannot be estimated from the Warnings and precautions Glycopyrronium Injection contains sodium Take special care with Glycopyrronium Injection. Tell your available data). This injection contains less than 1mmol (23mg) of sodium per Tell your doctor or nurse if you notice any of the following doctor if: 2ml (essentially ‘sodium-free’). • if you have Down’s Syndrome; symptoms: • if you are over 60 years of age; • slow heart rate • if you are a child; 3. How to use Glycopyrronium Injection • confusion may occur in the elderly; • if you have just had a heart attack; • a need to pass water often than usual; • if you have a condition characterised by rapid heartbeat Glycopyrronium Injection is given by injection into a muscle • feeling sick (nausea); (including over-active thyroid, heart failure or heart surgery); (intramuscularly) or into a vein (intravenously). • vomiting; • if you are pregnant or breast-feeding; • giddiness; • if you have a history of high blood pressure, coronary artery Dosage when used before an operation: • flushing and dryness of the skin; disease or irregular heartbeats; Adults, adolescents over 12 years old and elderly patients: • enlarged pupils with loss of focus; • if you are receiving inhalation anaesthesia (to put you You doctor may inject 200 to 400 micrograms (0.2 to 0.4mg) • intolerance to light; asleep before an operation) as it may cause a change in your into a vein or into a muscle before the anaesthetic is given. • ; normal heart rhythm; Alternatively, they may give you a dose of 4 to 5 micrograms • absence of sweating; • if you have gastric reflux (a condition in which the liquid per kilogram of body weight (0.004 to 0.005mg per kg), up to a • reduced bronchial secretions; stomach contents backs up (regurgitates) into the gullet) maximum dose of 400 micrograms (0.4mg). • high pressure in the eye. • if you have diarrhoea; • if you have ulcerative colitis (a chronic inflammation of the Children: Very common side effect (affects more than 1 in 10 people): large intestine (colon) which can cause abdominal pain, The child will be given 4 to 8 micrograms per kilogram of body • dry mouth diarrhoea and bleeding from the back passage); weight (0.004 to 0.008mg per kg) injected into a vein or into • if you have a high temperature (as the drug will inhibit a muscle before the anaesthetic is given, up to a maximum of Common (may affect up to 1 in 10 people) sweating). 200 micrograms (0.2mg). • drowsiness • avoid repeated or large doses if you suffer from renal • visual disturbances impairment (kidney problems), and your doctor may adapt • changes in heart rate (fast/irregular heartbeats) the dose accordingly. • urge to pass water but inability to do so Very rare (may affect up to 1 in 10,000 people) Always tell your doctor or nurse about any of these Continued overleaf conditions before having your injection. • increase pressure in the eye (glaucoma).

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