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1. What Midazolam Injection Is and What It Is Used for 2. What You Need

1. What Midazolam Injection Is and What It Is Used for 2. What You Need

PACKAGE LEAFLET: INFORMATION FOR THE USER • medicines used to treat serious mental into a vein. • blood clots or pain at the injection site. disorders () such as • Children 12 years and under will usually • patients taking medicines Midazolam 2mg/ml Injection , and clozapine be given Midazolam Injection into a vein. are at risk of falling and breaking bones. Midazolam Hydrochloride If any of the above apply to you, or if you are When Midazolam Injection is used for This risk is increased in the elderly and not sure, talk to your doctor or nurse before (to cause relaxation, calm those taking other (including Read all of this leaflet carefully before you are given Midazolam Injection. and drowsiness before an anaesthetic) ). you are given this medicine because it it may be given into the back passage • tiredness (fatigue). contains important information for you. Concomitant use of Midazolam Injection (rectum). • patients with severe disease are and (strong pain killers, medicines • Keep this leaflet. You may need to read it If you are given more Midazolam Injection more likely to experience side effects. for substitution therapy and some cough again. than you should be Reporting of side effects medicines) increases the risk of drowsiness, • If you have any further questions, ask As this medicine will be given to you whilst If you get any side effects, talk to your difficulties in breathing (respiratory your doctor or nurse. you are in hospital, it is unlikely that you will doctor or nurse. This includes any possible depression), and may be life- • If you get any side effects, talk to your be given too little or too much, however, tell side effects not listed in this leaflet. You threatening. Because of this, concomitant doctor or nurse. This includes any your doctor or pharmacist if you have any can also report side effects directly via the use should only be considered when other possible side effects not listed in this concerns. Yellow Card Scheme website: www.mhra. treatment options are not possible. leaflet. See section 4. gov.uk/yellowcard or search for MHRA However, if your doctor does prescribe If you are accidentally given too much Yellow Card in the Google Play or Apple App Midazolam Injection together with opioids Midazolam you may: Store. By reporting side effects you can help What is in this leaflet: the dose and duration of concomitant • Feel drowsy. provide more information on the safety of 1. What Midazolam Injection is and what it is treatment should be limited by your doctor. • Lose your co-ordination () and this medicine. used for Please tell your doctor about all . 2. What you need to know before you are medicines you are taking, and follow your • Have problems with your speech 5. How to store Midazolam (dysarthria). given Midazolam Injection doctor’s dose recommendation closely. It Injection 3. How Midazolam Injection will be given could be helpful to inform friends or relatives • Have involuntary eye movements 4. Possible side effects to be aware of the signs and symptoms (). Your doctor or pharmacist is responsible for 5. How to store Midazolam Injection stated above. Contact your doctor when • Develop low blood pressure storing Midazolam Injection . They are also 6. Contents of the pack and other experiencing such symptoms. (). responsible for disposing of any unused • Stop breathing (apnoea) and suffer Midazolam Injection correctly. information Operations cardiorespiratory depression (slowed or If you are going to have an inhaled Keep out of the sight and reach of children. 1. What Midazolam Injection is stopped breathing and heart beat) and anaesthetic (one that you breathe in) for You should not be given Midazolam Injection and what it is used for coma. an operation or for dental treatment, it is after the expiry date which is printed on the Midazolam belongs to a group of medicines important to tell your doctor or dentist that Stopping treatment with Midazolam carton and vial label. The doctor, nurse or known as . It is a short- you have been given Midazolam Injection. Injection anaesthetist will check that the expiry date acting medicine that is used to induce If you receive long term treatment with Midazolam Injection with alcohol on the label has not been passed before (a very relaxed state of calm, Midazolam Injection (are given the medicine Do not drink alcohol if you have been administering the injection to you. The expiry drowsiness or sleep) and relieves anxiety and for a long time) you may: given Midazolam Injection. This is because date refers to the last day of that month. muscle tension. • Become tolerant to Midazolam Injection. alcohol can increase the effect Do not store above 25°C. The medicine becomes less effective and This medicine is used for: of Midazolam Injection and may cause Keep the container in the outer carton in does not work as well for you. • Conscious sedation (an awake but very problems with your breathing. order to protect from light. • Become dependent upon this medicine relaxed state of calm or drowsiness during and breast-feeding a medical test or procedure) in adults and and get withdrawal symptoms (see 6. Contents of the pack and other Tell your doctor if you are pregnant, think below). information children. you may be pregnant or are planning to Your doctor will reduce your dose gradually • Sedation of adults and children, in have a baby. Your doctor will decide if this What Midazolam Injection contains to avoid these effects happening to you. intensive care units. medicine is suitable for you. The active substance is Midazolam • Anaesthesia in adults, used alone or with Withdrawal symptoms: Hydrochloride 100mg in 50ml Midazolam Injection may harm your unborn other medicines. Benzodiazepine medicines, like Midazolam The other ingredients are hydrochloric acid, baby when used in early pregnancy. When • Premedication (medicine used to cause Injection, may make you dependent if used sodium chloride, sodium hydroxide and high doses are administered during late relaxation, calm and drowsiness before an for a long time (for instance in intensive water for injections pregnancy, labour or caesarean section, you anaesthetic) in adults and children. care). This means that if you stop treatment might have an inhalation risk and your baby What Midazolam Injection looks like and suddenly, or lower the dose too quickly, might have an irregular heartbeat, state contents of the pack 2. What you need to know before you may get withdrawal symptoms. The of low muscle tone (), feeding Midazolam Injection is a clear, colourless you are given Midazolam symptoms can include: difficulties, a low body temperature and solution supplied in a clear glass vial Injection • headache difficulty in breathing. With prolonged containing 50ml of the solution. You should not be given Midazolam • muscle pain administration during late pregnancy, your Marketing Authorisation Holder Injection if: • feeling very worried (anxious), tense, baby may develop a physical dependence Aurum Pharmaceuticals Ltd. • you are allergic to Midazolam restless, confused or bad-tempered and risk of withdrawal symptoms after birth. Bampton Road, or to medicines like Midazolam (irritable) Harold Hill, Romford, (benzodiazepines), or to any of the other Do not breast-feed for 24 hours after being • problems with sleeping () Essex, RM3 8UG ingredients of this medicine, (listed in given Midazolam Injection. This is because • mood changes section 6). Midazolam Injection may pass into your • hallucinations (seeing and possibly Manufacturer • you suffer from breathing difficulties. breast milk. hearing things that are not there) Panpharma GmbH • fits (convulsions). You must not be given Midazolam Injection Driving and using machines Bnsenstrasse 4, if any of the above apply to you. If you are This medicine can affect your ability to drive If you have any further questions on the use D-22946 Trittau, Germany and operate machinery as it may make you of this medicine, ask your doctor or nurse. not sure, talk to your doctor or nurse before This leaflet was last revised in you are given this medicine. sleepy or dizzy. • Do not drive or use machinery until you are 4. Possible side effects May 2020. Warnings and precautions completely recovered. Your doctor should Like all medicines, Midazolam Injection can Product Licence Number: PL 12064/0077 Children and babies advise you when you can start these again. cause side effects, although not everybody If your child is going to be given this • Midazolam Injection may make you gets them. medicine: feel sleepy, forgetful or affect your The following undesirable effects have been • It is particularly important to tell concentration and co-ordination. This may reported (frequency not known). your doctor or nurse if your child has affect your performance at skilled tasks Stop having Midazolam Injection and see cardiovascular disease (heart problems). such as driving or using machines. a doctor straight away if you notice any Your child will be carefully monitored and • You should always be taken home by a of the following side effects. They can the dose will be adjusted specially. responsible adult after your treatment. be life-threatening and you may need • Children must be carefully monitored. For • It is an offence to drive if this medicine urgent medical treatment: and babies under 6 months this affects your ability to drive. • Anaphylactic shock (a life-threatening will include of breathing and • However, you would not be committing an allergic reaction). Signs may include a oxygen levels. offence if: sudden rash, itching or lumpy rash (hives) Adults • The medicine has been prescribed to and swelling of the face, lips, tongue or Before Midazolam Injection is given, let your treat a medical or dental problem and other parts of the body. You may also have doctor or nurse know if: • You have taken it according to the , wheezing or trouble • You are over 60 years of age. instructions given by the prescriber or breathing. • You have a long term illness (such as in the information provided with • Heart attack (cardiac arrest). Signs may breathing problems or kidney, or the medicine and include tightness of the chest or chest heart problems). • It was not affecting your ability to drive pain which may spread to your neck and • You are debilitated (have an illness that safely shoulders and down your left arm. makes you feel very weak, run down and Talk to your doctor or pharmacist if you are • Breathing problems or complications short of energy). not sure whether it is safe for you to drive (sometimes causing the breathing to • You have myasthenia gravis (a while taking this medicine. stop). neuromuscular disease causing muscle Important information about some of • Choking and sudden blockage of the weakness). the ingredients of Midazolam Injection airway (laryngospasm) • You regularly drink large amounts of This medicine contains 3.33 mg sodium Life-threatening side effects are more likely alcohol or you have had problems (main component of cooking/table salt) in to occur in adults over 60 years of age and with alcohol use in the past. Alcohol each ml. This is equivalent to 0.17% % of those who already have breathing difficulties can increase the effects of Midazolam the recommended maximum daily dietary or heart problems, particularly if the injection Injection, possibly leading to severe intake of sodium for an adult. is given too fast or at a high dose sedation that could result in coma or Other possible side effects . Talk to your pharmacist or doctor if you Not known: frequency cannot be estimated • You regularly take recreational drugs or need Midazolam Injection on a daily basis from the available data you have had problems with drug use in for a prolonged period of time, especially • general allergic reactions (skin reactions, the past. if you have been advised to have a low salt heart and blood system reactions, • You are pregnant or think you may be diet. wheezing). pregnant (see ‘Pregnancy and breast- • restlessness, agitation, . feeding’). 3. How Midazolam Injection will be given • nervousness, anxiety. If any of the above apply to you or your child • hostility, anger or aggression. Midazolam Injection should be given only please tell your doctor before you are given • excitement. by experienced healthcare professionals Midazolam Injection • hyperactivity. (doctor or nurse). It should be given in a • changes in libido. Other medicines and Midazolam Injection place (hospital, clinic or surgery) equipped to • inappropriate behaviour. Tell your doctor or pharmacist if you are monitor and support the patient’s breathing, • muscle spasms and muscle taking, have recently taken or might take heart and circulation (cardiovascular (shaking of your muscles that you cannot any other medicines, including medicines function) and recognise the signs of and control). obtained without a prescription and herbal manage the expected side effects of • confusion, disorientation. medicines. anaesthesia. This is extremely important, as using more • emotional and mood disturbances. than one medicine at the same time can Normal adult dose • involuntary movements. strengthen or weaken the effect of the Your doctor will decide on a suitable dose for • nightmares, abnormal dreams. medicines involved. In particular, tell your you. The dose you are given will depend on • hallucinations (seeing and possibly hearing doctor or nurse if you are taking any of the why you are being treated and the type of things that are not really there). following medicines: sedation needed. Your weight, age, your • psychoses (losing contact with reality). • tranquilisers (for anxiety or to help you state of health, how you respond to • drowsiness and prolonged sedation. sleep) Midazolam Injection and whether other • reduced alertness. • (medicines to make you sleep) medicines are needed at the same time will • headache. • sedatives (to make you feel calm or sleepy) also influence the dose that you are given. • . • (medicines for depression) If you need strong painkillers, you will be • difficulty co-ordinating muscles. • narcotic analgesics (very strong pain killers) given these first and then be given • fits (convulsions) in premature infants and e.g. Midazolam Injection. The dose will be new-born babies. • (used to treat allergies) adjusted specially for you. • temporary memory loss. How long this last depends on how much Midazolam • medicines used to treat fungal infections Midazolam Injection may be given to you Injection you were given. You may (, voriconazole, fluconazole, in one of four different ways: experience this after your treatment. In , posaconazole) • by slow injection into a vein (intravenous isolated cases this has been prolonged • medicines used to treat bacterial infections injection) (lasted for a long time). such as , , • through a tube into one of your veins • drug dependence, abuse. roxithromycin and telithromycin. (intravenous infusion) • low blood pressure. • (used to treat high blood • by injection into a muscle (intramuscular • slow heart rate. pressure) injection) • redness of the face and neck (flushing), • medicines used to treat HIV called protease • into your back passage (rectum). feeling faint. inhibitors (such as saquinavir) You should always be taken home by a • shortness of breath. • medicines for hepatitis C (protease responsible adult after your treatment. inhibitors such as boceprevir and telaprevir) • hiccup. • (used to treat high ) Children and babies • feeling sick or being sick. • (used to treat mycobacterial • In infants and babies under 6 months • constipation. infections such as tuberculosis) of age Midazolam Injection is only • dry mouth. • the herbal medicine St John’s Wort. recommended for sedation in intensive • rash. • medicines used to treat chest pains e.g. care units. The dose will be given gradually • hives (lumpy rash). verapamil • itchiness. Continued overleaf • medicines used to treat (fits) such • redness • swelling of the skin. as and D05277 D05277

100mm Measurement Verification Bar 5277-D

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