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M120203AB

Package leaflet: Information for the user

Citanest® 1% solution forinjection

prilocaine hydrochloride

Readall of this leaflet carefully before you startusingthis ; medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor 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 sameas yours.
• ; If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

| What is in this leaflet:

11. what citanest is and what it is used for

2. What youneedto know before you use Citanest

; 3. How to use Citanest

14. Possible side effects

5. How tostoreCitanest

; 6. Contents of the pack and other information

1. whatcitanestisand what it is used for

Citanestconta­insamedicine called prilocainehydrochlo­ride.This belongs to a group of medicines called local anaesthetics.

Citanest is used in adults and children above 6 months in age to numb(anaesthetise) parts of the body.lt stopspainhappe­ningduring medical procedures and surgery (operations).

2. whatyou needto know before you use citanestdonotusecitanest: if you are allergic to prilocaine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

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14. Possible side effects                                             1

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5. How to store Citanest                                          

• Keep this medicine out of the sight and reachofchildren.
• Do not use this medicine after the expiry date, whichis stated on the container after EXP. The expiry date refers to the last day of that month.
• Store below 25°C.
• Your doctor or the hospital will normally store Citanest and they are responsible for the quality of the product whenithasbeenopened ifitis not used immediately. They are also responsiblefor disposing of any unused Citanest correctly.

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16. Contents of the pack and other informati

WhatCitanest contains

The active substance is prilocaine hydrochloride. Each millilitre (ml) of solutioncontains 10 mg of prilocaine hydrochloride(500 mgper 50 ml vial).

The other ingredients are sodium chloride, hydrochloric acid and/or sodium hydroxide, methyl parahydroxyben­zoate(E218), propyl parahydroxybenzoate (E216) and water for injections.

What Citanest looks like and contents of the pack

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M120203AB

Package leaflet: Information for the user

Citanest® 1% solution forinjection

prilocaine hydrochloride

Readall of this leaflet carefully before you startusingthis ; medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor 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 sameas yours.
• ; If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

| What is in this leaflet:

11. what citanest is and what it is used for

2. What youneedto know before you use Citanest

; 3. How to use Citanest

14. Possible side effects

5. How tostoreCitanest

; 6. Contents of the pack and other information

1. whatcitanes­tisand what it is used for

Citanestconta­insamedicine called prilocainehydrochlo­ride.This belongs to a group of medicines called local anaesthetics.

Citanest is used in adults and children above 6 months in age to numb(anaesthetise) parts of the body.lt stopspainhappe­ningduring medical procedures and surgery (operations).

2. whatyou needto know before you use citanestdonotu­secitanest: if you are allergic to prilocaine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

• if you are allergicto any other local anaestheticsofthe same class (suchaslidoca­ineorbupivaca­ine).
• if you are anaemic (a blood problem which means you have too few red blood cells).
• if you have a problemwith blood pigment levelscalled ‘methaemoglobi­naemia’.

You must not be given Citanest if any of the above applyto you.lfyou are not sure, talkto your doctor before you are given Citanest.

Warnings and precautions

Talktoyourdoctoror nurse before using Citanest if:

• you have highblood pressure or heart problems.
• you have liver or kidney problems.
• youhave difficulty breathing.
• you have epilepsy.
• you have an infection or inflammation at the site where the injection is tobegiven.
• youhaveeverbe­entoldthat you have a rare disease of theblood pigment called ‘porphyria’ or anyone in your family has it.

If youarenot sureifany of the above apply to you, talk to your doctor beforehavingCi­tanest.

Other medicines and Citanest

Tellyourdoctoror nurse if you are taking, have recently taken or might takeany othermedicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Citanest can affect the waysome medicines work and some medicines can have an effectonCitanest.

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In particular, tell your doctor if you are takingany ofthefollowing medicines:

• Other local anaesthetics.
• Medicines called sulphonamides,suchas­co-trimoxazole (used to treat infections caused by bacteria).
• Anti-malarial medicines (used to preventor treat malaria).
• Nitrate medicines (used to treat heart problems).
• Medicines to treat an uneven heart beat (arrhythmia), such as amiodarone.

Pregnancy, breast-feeding and fertility

If youarepregnant or breast-feeding, think you may be pregnant or areplanning to have a baby, ask your doctor or nurse for advice before taking this medicine.

Drivingandusing machines

Citanestmay make you feel sleepy and affect the speed of your reactions. After you have been given Citanest, youshouldnotdriveor use tools or machines until the next day.

Citanestconta­inssodium

• Citanest contains 2.36 mg of sodium permillilitre(ml),e­quivalentto 118 mg per 50 ml ampoule. Your doctor will take thisinto account if youareonasodium controlled diet.

Citanest contains methyl parahydroxyben­zoate(E218)and propyl parahydroxybenzoate (E216)

Citanestconta­insmethylpara­hydroxybenzoa­te (E218) and propyl parahydroxybenzoate (E216). These maycauseallergic reactions (possibly delayed) such as a skin rash,and exceptionally bronchospasm(bre­athlessness). This may happen a while after you have beengiven themedicine.

Always use this medicine exactly as your doctor or nurse has told you. Checkwith your doctor or nurse if you are not sure. Citanest will be given to you by a doctor. It will be given to you as aninjection.The dosethatyourdoc­torgivesyouwi­ll depend on the type of pain relief that you need.Itwillal­sodepend on your body size,age,andphy­sical condition and the part of your body that the medicineisbein­ginjected into. You will be given the smallest dose possible to produce the requiredeffect.

Citanest will usually be given near the part of thebodytobeoperated on.ltstopsthe­nervesfrombein­gable to pass pain messages to thebrain.Itwill stop you feeling pain. It will start to work a few minutes after being injected and will slowly wear offwhenthemedical procedureisover.

Usein children andadolescents

Citanest is not recommended for use in children under6 monthsold.

If youusemore Citanest thanyou should

Serioussideef­fectsfromgettin­gtoo much Citanest need special treatment and the doctor treating you is trained to deal withthese situations.The first signsofbeinggiven too much Citanest are usually asfollows:

• Feeling dizzy or light-headed.
• Numbness of the lips and around the mouth.
• Numbnessofthe­tongue.
• Hearing problems.
• Problems with your sight (vision).

Toreducetheris­kofseriousside­effects, your doctor will stop giving you Citanest as soon as these signs appear. This means that if any of these happen to you, or you think you have received too much Citanest, tell yourdoctorimme­diately.

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