Package leaflet: Information for the user Glycopyrronium Bromide 200 micrograms/ml injection (Glycopyrronium Bromide)

Transcription

1 Package leaflet: Information for the user Glycopyrronium Bromide 200 micrograms/ml injection (Glycopyrronium Bromide) Read all of this leaflet carefully before you start using this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have further questions, please ask your doctor or pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. What is in this leaflet: 1. What Glycopyrronium Bromide 200 micrograms/ml Injection is and what it is used for 2. What you need to know before you use Glycopyrronium Bromide 200 micrograms/ml Injection 3. How to use Glycopyrronium Bromide 200 micrograms/ml Injection 4. Possible side effects 5. How to store Glycopyrronium Bromide 200 micrograms/ml Injection 6. Contents of the pack and other information 1. What Glycopyrronium Bromide 200 micrograms/ml injection is and what it is used for Glycopyrronium bromide belongs to a group of medicines called anti-muscarinic drugs. Glycopyrronium Bromide 200 micrograms/ml Injection may be given: To protect against some of the unwanted effects of drugs such as neostigmine or pyridostigmine, which are given to reverse the effects of certain types of muscle-relaxing drugs (called non-depolarising muscle relaxants). Before an operation to reduce saliva and other secretions and to reduce acidity in the stomach contents. Before or during an operation, to reduce or prevent slowness of the heartbeat during surgery. 2. What you need to know before you use Glycopyrronium Bromide 200 micrograms/ml Injection Before you are given Glycopyrronium Bromide 200 micrograms/ml Injection, please read the following statements: Do not use Glycopyrronium Bromide 200 micrograms/ml Injection: if you are allergic to glycopyrronium bromide or any of the other ingredients of this medicine (listed in section 6). if you have glaucoma. if you suffer from myasthenia gravis (a disorder that causes extreme muscle weakness and fatigue). if you have an enlarged prostate. if you have stomach or bowel problems. Warnings and precautions: Talk to your doctor or pharmacist or nurse before using Glycopyrronium Bromide 200 micrograms/ml Injection

2 if you have Down s Syndrome if you are over 60 years of age if you are a child if you have just had a heart attack if you have a condition characterised by rapid heart beat (including over-active thyroid, heart failure or heart surgery) if you are pregnant or breast-feeding if you have a history of high blood pressure, coronary artery disease or irregular heart beats if you are receiving inhalation anaesthesia (to put you asleep before an operation) as it may cause a change in your normal heart rhythm if you have gastric reflux (a condition in which the liquid stomach contents backs up (regurgitates) into the gullet if you have diarrhoea if you have ulcerative colitis (a chronic inflammation of the large intestine (colon) which can cause abdominal pain, diarrhoea and bleeding from the back passage) if you have a high temperature (as the drug will inhibit sweating). Avoid repeated or large doses if you have kidney disease. Always tell your doctor or nurse about any of these conditions before having your injection. Other medicines and Glycopyrronium Bromide 200 micrograms/ml Injection: Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. Taking some medicines together can be harmful. Remember the doctor at the hospital may not have been informed if you have recently begun a course of treatment for another illness. Use of glycopyrronium bromide along with one or more similar medicines can increase side-effects such as dry mouth, retention of urine and constipation. The elderly may become confused. Please tell the doctor if you are taking, or have recently taken: tricyclic antidepressants (for example amitriptyline or imipramine) or monoamine oxidase inhibitor (MAOIs) antidepressants (for example phenelzine, tranylcypramine) clozapine (used to treat schizophrenia) phenothiazines used to treat severe mental problems or nausea, vomiting or vertigo (for example chlorpromazine, fluphenazine, prochlorperazine, trifluoperazine) antihistamines used to treat allergies (for example promethazine) nefopam (used to treat acute and chronic pain) pethidine (used to treat moderate to severe pain) domperidone or metoclopramide (used to treat nausea and vomiting) ketoconazole (used to treat fungal infections) amantadine, levodopa (used to treat Parkinson s disease) memantine (used to treat Alzheimer s disease) parasympathomimetics (these are drugs that affect chemicals in the body which are involved in transmission of nerve impulses to a muscle) (for example carbachol, neostigmine, physostigmine) ritodrine (used to prevent uncomplicated premature labour) corticosteroids used to treat various conditions including asthma and inflammatory disease (for example prednisolone) slow-dissolving digoxin tablets, disopyramide (used to treat heart problems). Glyceryl trinitrate tablets (used to treat angina) may not dissolve under the tongue as well as usual owing to the dry mouth which glycopyrronium bromide causes.

3 Pregnancy and breast-feeding: Always tell your doctor if you are pregnant, think you might be pregnant or are trying to become pregnant. Glycopyrronium Bromide 200 micrograms/ml Injection should be given during pregnancy only if considered essential by the doctor. You should not breast-feed if you are taking this medicine. Driving and using machines: Do not drive or use machines because this medicine can cause blurred vision, dizziness and other effects that may affect your ability to do so. Do not drive or use machinery until these effects have gone. Glycopyrronium Bromide 200 micrograms/ml Injection contains sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodium free. 3. How to use Glycopyrronium Bromide 200 micrograms/ml injection Glycopyrronium bromide will be given to you as an injection either into a vein (intravenous) or into a muscle (intramuscular) by a doctor or nurse. The following doses may be given: When given before an operation: A single dose of micrograms or 4-5 micrograms per kilogram of bodyweight to a maximum of 400 micrograms given by injection into a vein or muscle. 4-8 micrograms per kilogram of body weight to a maximum of 200 micrograms, preferably given by injection into a vein or alternatively into a muscle. When given during an operation: A single dose of micrograms or 4-5 micrograms per kilogram of body weight to a maximum of 400 micrograms given by injection into a vein. This dose may be repeated if necessary. A single dose of 4-8 micrograms per kilogram of body weight up to a maximum of 200 micrograms. This dose may be repeated if necessary. At the end of an operation (for control of side effects of neostigmine in reversing neuromuscular block): 200 micrograms per 1000 micrograms (1 mg) of neostigmine or the equivalent dose of pyridostigmine given by injection into a vein. Alternatively, micrograms per kilogram of body weight with 50 micrograms per kilogram of body weight of neostigmine or equivalent dose of pyridostigmine. 10 micrograms per kilogram of body weight with 50 micrograms per kilogram of body weight of neostigmine or the equivalent dose of pyridostigmine given by injection into a vein. Glycopyrronium bromide and neostigmine or pyridostigmine may be administered together from the same syringe.

4 If you use more Glycopyrronium Bromide 200 micrograms/ml Injection than you should: Tell your doctor or nurse if you think you have been given too much of Glycopyrronium Bromide 200 micrograms/ml Injection. The effects of overdose can be treated by repeated (5-10 minutes) injections of neostigmine metilsulfate 0.25 mg to a maximum of 2.5 mg. Proportionately smaller doses are used in children. If you forget to use Glycopyrronium Bromide 200 micrograms/ml Injection: A doctor, rather than you, will be responsible for administering your injection. 4. Possible side effects Like all medicines, this medicine can have side effects, although not everyone gets them. The following side effects have been reported but their frequency is not known. If you experience any of the following reactions stop taking this medicine and contact your doctor immediately: rash, itching, difficulty in breathing or swelling of the face, lips, throat or tongue (hypersensitivity/allergic reaction) rapid swelling of the tissues around the neck, face, mouth and/or throat (angioedema) The following side effects can occur: changes in heart rate (fast/irregular heartbeats) confusion may occur in the elderly urge to pass water but inability to do so nausea vomiting giddiness flushing dryness of the skin enlarged pupils with loss of focus intolerance to light constipation dry mouth absence of sweating reduced bronchial secretions glaucoma Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Glycopyrronium Bromide 200 micrograms/ml injection Keep out of the sight and reach of children. Do not use this medicine after the expiry date (EXP) which is stated on the label and carton. The expiry date refers to the last day of that month. Do not store above 25oC. Keep the ampoule in the outer carton in order to protect from light. For single use only. Use immediately after opening. Discard any unused solution. The injection should not be used if particles are present Do not use this medicine if you notice the ampoule is damaged or if the contents are discoloured.

5 Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Glycopyrronium Bromide 200 micrograms/ml Injection contains The active substance is glycopyrronium bromide. Each millilitre (ml) of sterile solution contains 200 micrograms of the active substance glycopyrronium bromide. The other ingredients are sodium chloride, hydrochloric acid and water for injections. What Glycopyrronium Bromide 200 micrograms/ml Injection looks like and contents of the pack Glycopyrronium Bromide 200 micrograms/ml Injection is a clear, colourless, sterile solution for injection. Each 1 ml of sterile solution for injection contains 200 micrograms of glycopyrronium bromide (200 micrograms/ml). Each 3 ml of sterile solution for injection contains 600 micrograms of glycopyrronium bromide (200 micrograms/ml). Pack sizes: 1 ml glass ampoules in packs of 10 and 3 ml glass ampoules in packs of 3 and 10. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom This leaflet was last revised in 09/2016.