Document: leaflet MAH GENERIC_PL 12064-0077 change

• leaflet MAH GENERIC_PL 12064-0077
• leaflet MAH GENERIC_PL 20075-0337

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Midazolam Injection BP 2mg/1 ml

_Midazolam

Read all of this leaflet carefully before you are given this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or nurse.

•    If any of the side effects gets serious, or if you notice

any side effects not listed in this leaflet, please tell your doctor or nurse._

In this leaflet:

1.    What Midazolam Injection is and what it is used for

2.    Before you are given Midazolam Injection

3.    How Midazolam Injection will be given

4.    Possible side effects

5.    How to store Midazolam Injection

6.    Further information

1.    What Midazolam Injection is and what it is used for

Midazolam isoneofa group of medicines known as benzodiazepines. Benzodiazepines are sedatives, meaning that they are used relax you and help you to sleep.

Midazolam Injection is used to help you to relax before an operation and is used to relax and calm you during operations where you are awake. It may also be used to help patients in intensive care units to sleep.

2.    Before you are given Midazolam Injection

You should not be given Midazolam Injection if:

•    you knowyou are allergic to Midazolam or to medicines like Midazolam (benzodiazepines), or to any of the other ingredients of this medicine, listed in section 6 of this leaflet.

•    you suffer with a disease that effects the muscles known as myasthenia gravis

•    you suffer from breathing difficulties

•    you are suffering from lung problems

Take special care with Midazolam Injection.Tellyour doctor if:

•    you suffer from liver or kidney problems

•    you have a history ofa type of mental illness known as a personality disorder

•    you suffer from heart disease

•    you suffer from lung disease

If you are elderly or ill, or this medicine is being given to your child, special care will be taken.

Midazolam Injection should not be used for prolonged periods of time.

If any ofthe above apply to you or your child please tell your doctor before you are given Midazolam Injection Taking other medicines

Please tell your doctor or pharmacist ifyou are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Medicines which may interact with Midazolam Injection include:

•    alcohol

•    anaesthetics e.g. ketamine

•    medicines that cause drowsiness (sedatives, barbiturates)

•    painkillers (opioids) e.g.fentanyl

•    medicines used to treat bacterial infections such as erythromycin, clarithromycin, quinupristin/dalfopristin and telithromycin

•    cimetidine, a medicine used to treat stomach ulcers

•    medicines used to treat chest pains e.g. diltiazem and verapamil

•    medicines used to treat fungal infections e.g itraconazole ketoconazole and fluconazole

•    nifedipine, a medicine used to treat a disease of the blood vessels known as Raynauds disease

•    ciclosporin, a medicine used to treat a variety ofdifferent conditions including psoriasis and arthritis

•    medicines used to treat high blood pressure (ace inhibitors, adrenergic neurone blockers, alpha-blockers, angiotension II receptor agonists, betablockers, calcium channel blockers) such as ramipril, reserpine, indoramin, losartan, propranolol, nifedipine, clonidine, diazoxide, methyldopa, moxonidine, hydralazine, minoxidil and sodium nitroprusside

•    medicines used to treat epilepsy (fits) such as phenytoin and carbamazapine

•    medicines used to treat allergies (antihistamines) such as desloratadine and promethazine hydrochloride

•    medicines used to treat serious mental disorders antipsychotics) such as chlorpromazine, haloperidol and clozapine

•    medicines used to treat HIV (the virus that causes AIDS such as amprenavir, atazanavir, efavirenz, indinavir, nelfinavir, ritonavir and saquinavir

•    disulfiram, a medicine used to treat alcoholism

•    medicines that make you pass more urine than usual (diuretics)

•    levodopa, a medicine used to treat Parkinsons disease

•    lofexidine, a medicine used to treat opiate withrawal

•    medicines used to relax the muscles such as baclofen anc tizanidine

•    nabilone, a medicine used to treat feeling or being sick

•    sodium oxybate, a medicine used to treat narcolepsy

•    theophylline, a medicine used to treat lung problems such as asthma and chronic obstructive pulmonary disease (COPD)

Ifyou have any doubts about whether you should be given Midazolam Injection please discuss these with the doctor, anaesthetist or nurse before use.

Pregnancy and breast-feeding Ifyou are pregnant or trying for a baby you should discuss this with your doctor before being given Midazolam Injection. Your doctor will only give you Midazolam Injection if the benefits outweigh the potential risks. Midazolam may pass into breast milk. Ifyou are breastfeeding you should not do so for 24 hours after being given Midazolam Injection.

Driving and using machines

Midazolam Injection will cause drowsiness, do not drive or use machinery until you have checked with your doctor that it is safe to do so.

This medicine can affect your ability to drive and operate machinery as it may make you sleepy or dizzy.

•    Do not drive while taking this medicine until you know how it affects you.

•    It is an offence to drive if this medicine affects your ability to drive.

•    However, you would not be committing an offence if:

•    The medicine has been prescribed to treat a medical or dental problem and

•    You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

•    It was not affecting your ability to drive safely Talk to your doctor or pharmacist ifyou are not sure whether it is safe for you to drive while taking this

medicine.    , ,

Continued overleaf

	3.    How Midazolam Injection will be given four doctor will administer Midazolam Injection to you nto a vein (intravenously) either by injection or by slow nfusion(drip) Adults To help you to sleep: The usual initial dose is 1-2mg given by injection, followed after 2 minutes by 0.5 - Img if necessary until sedation is achieved. f you are to be given an infusion (drip) the usual initial dose s 30-300 micrograms per kilogram of body weight given aver 5 minutes, then 30-200 micrograms per kilogram every hour. The doctor may adjust your dose depending on aow much sedation you need. lo help you to relax before an operation: The usual dose is 200-300 micrograms per kilogram of aodyweight depending on your fitness and general health. The elderly lo help you to relax before an operation: The usual dose is 100-200 micrograms per kilogram of aody weight. Children over 7 years Ra help you to relax before an operation: The usual dose is 150 micrograms per kilogram of body weight Children under 7 years Mot recommended f you are given more Midazolam Injection than you should be As this medicine will be given to you whilst you are in tospital, it is unlikely that you will be given too little or too much, however, tell your doctor or pharmacist if you have any concerns. 4.    Possible side effects _ike all medicines, Midazolam Injection can cause side affects, although not everybody gets them, f any of the following symptoms occur tell your doctor or aurse immediately. These are symptoms of a serious allergic reaction. •    sudden wheeziness and tightness of chest •    swelling of eyelids, face or lips •    skin lumps or hives •    skin rash (red spots), itchiness, fever •    collapse f any of the following symptoms occur tell your doctor or aurse immediately. These are symptoms of a heart attack. •    sudden chest pains •    shortness of breath •    sweating •    anxiety Other possible side effects include: •    slower breathing than usual, difficulty breathing or stopping breathing •    feeling restless or worried •    feeling confused or disoriented •    seeing or hearing things that aren't real (hallucinations). These hallucinations may be sexual •    headache •    hiccups •    temporary loss of memory •    pain at the site ofinjection, or swelling, redness or damage to the skin around the injection site •    blood clots •    increased appetite •    feeling or being sick •    flatulence (passing wind) •    heartburn (acid reflux)		•    constipation •    diarrhoea •    yellowing of the skin (jaundice) - low blood pressure, the symptoms of which include feeling dizzy or lightheaded and fainting •    drowsiness •    feeling'high' •    a feeling ofdizziness or spinning (vertigo) •    involuntary muscle movements •    difficulty speaking •    difficulty passing urine •    involuntary passing ofurine or faeces (incontinence) •    changes in sex drive •    blurred vision or difficulty focusing •    changes in the amount of saliva you produce •    dry skin, flushing, rash or other skin reactions •    feeling excited or aggressive, particularly in children and the elderly •    blood disorders (this can be checked using blood tests) •    muscle weakness •    difficulty catching your breath •    fits, particularly in infants and young children •    an unusually fast, slow or irregular heartbeat f any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor ar nurse. 5.    How to store Midazolam Injection <eepout of the sight and reach of children. fou should not be given Midazolam Injection after the expiry date which is printed on the carton and ampoule abel. The doctor, nurse or anaesthetist will check that the expiry date on the label has not been passed before administering the injection to you. The expiry date refers to the last day of that month. Store below 25°C. <eep in the outer carton and protect from light. 6.    Further Information What Midazolam Injection contains The active substance is Midazolam lOOmg in 50ml The other ingredients are dilute hydrochloric acid, sodium chloride, sodium hydroxide and water for injections What Midazolam Injection looks like and contents of the pack Midazolam Injection is a clear, colourless solution supplied n a clear glass vial containing 50ml of the solution. Marketing Authorisation Manufacturer Holder Rotexmedica GMBH Aurum Pharmaceuticals Ltd. Arzneimittel Werk 3ampton Road, Bunsenstrasse4, Harold Hill, Romford, D-22946Trittau Essex, RM3 8UG Germany This leaflet was last approved in January 2014. 3L 12064/0077
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100mm Measurement Verification Bar