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

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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 (antipsychotics) such as • Children 12 years and under will usually • patients taking benzodiazepine medicines Midazolam 2mg/ml Injection chlorpromazine, haloperidol 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 premedication (to cause relaxation, calm those taking other sedatives (including Read all of this leaflet carefully before you are given Midazolam Injection. and drowsiness before an anaesthetic) alcohol). 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 kidney disease are and opioids (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), coma 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 (ataxia) and this medicine. used for Please tell your doctor about all opioid reflexes. 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 (nystagmus). 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. (hypotension). 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 benzodiazepines. 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 sedation (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 sedative 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 Pregnancy 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 (hypotonia), 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 (insomnia) 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: infants and babies under 6 months this affects your ability to drive. • Anaphylactic shock (a life-threatening will include monitoring 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.
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