Tuesday, October 18, 2016

Citanest 1%





Citanest 1% solution for injection



prilocaine hydrochloride




Read all of this leaflet carefully before Citanest is given to 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

  • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.




In this leaflet:



  • 1. What Citanest is and what it is used for

  • 2. Before Citanest is given to you

  • 3. How Citanest is given to you

  • 4. Possible side effects

  • 5. How to store Citanest

  • 6. Further information





What Citanest is and what it is used for



Citanest contains a medicine called prilocaine hydrochloride. This belongs to a group of medicines called local anaesthetics.



Citanest is used to numb (anaesthetise) parts of the body. It stops pain happening during medical procedures and surgery (operations).





Before Citanest is given to you




You must not be given Citanest if:



  • You are allergic (hypersensitive) to prilocaine hydrochloride or any of the other ingredients of Citanest (see Section 6: Further information).

  • You are allergic to any other local anaesthetics of the same class (such as lidocaine or bupivacaine).

  • You are anaemic (a blood problem which means you have too few red blood cells).

  • You have a problem with blood pigment levels called ‘methaemoglobinaemia’.

You must not be given Citanest if any of the above apply to you. If you are not sure, talk to your doctor before you are given Citanest.





Take special care with Citanest



Check with your doctor before having Citanest if:



  • You have high blood pressure or heart problems.

  • You have liver or kidney problems.

  • You have difficulty breathing.

  • You have epilepsy.

  • You have an infection or inflammation at the site where the injection is to be given.

  • You have ever been told that you have a rare disease of the blood pigment called ‘porphyria’ or anyone in your family has it.

If you are not sure if any of the above apply to you, talk to your doctor before having Citanest.





Taking other medicines



Please tell your doctor if you are taking, or have recently taken, any other medicines.



This includes medicines that you buy without a prescription and herbal medicines. This is because Citanest can affect the way some medicines work and some medicines can have an effect on Citanest.



In particular, tell your doctor if you are taking any of the following medicines:



  • Other local anaesthetics.

  • Medicines called sulphonamides, such as co-trimoxazole (used to treat infections caused by bacteria).

  • Anti-malarial medicines (used to prevent or treat malaria).

  • Nitrate medicines (used to treat heart problems).

  • Medicines to treat an uneven heart beat (arrhythmia), such as amiodarone.




Pregnancy and breast-feeding



Before you are given Citanest, tell your doctor if you are pregnant, planning to get pregnant, or if you are breast-feeding.



Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.





Driving and using machines



Citanest may make you feel sleepy and affect the speed of your reactions. After you have been given Citanest, you should not drive or use tools or machines until the next day.





Important information about some of the ingredients of Citanest



  • Citanest contains 2.36 mg of sodium per millilitre (ml), equivalent to 118 mg per 50 ml ampoule. Your doctor will take this into account if you are on a sodium controlled diet.

  • Citanest contains methyl parahydroxybenzoate (E218). This may cause an allergic reaction such as a skin rash. This may happen a while after you have been given the medicine. Rarely, you may have a reaction immediately with a skin rash and breathlessness.





How Citanest is given to you



Citanest will be given to you by a doctor. It will be given to you as an injection. The dose that your doctor gives you will depend on the type of pain relief that you need. It will also depend on your body size, age, and physical condition and the part of your body that the medicine is being injected into. You will be given the smallest dose possible to produce the required effect.



Citanest will usually be given near the part of the body to be operated on. It stops the nerves from being able to pass pain messages to the brain. It will stop you feeling pain.



It will start to work a few minutes after being injected and will slowly wear off when the medical procedure is over.



Citanest is not recommended for use in children under 6 months old.




If you have been given too much Citanest



Serious side effects from getting too much Citanest need special treatment and the doctor treating you is trained to deal with these situations. The first signs of being given too much Citanest are usually as follows:



  • Feeling dizzy or light-headed.

  • Numbness of the lips and around the mouth.

  • Numbness of the tongue.

  • Hearing problems.

  • Problems with your sight (vision).

To reduce the risk of serious side effects, 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 your doctor immediately.



More serious side effects from being given too much Citanest include problems with your speech, twitching of your muscles, tremors, trembling, fits (seizures), and loss of consciousness, low blood pressure, erratic heart beat, slowing or stopping of your heart.






Citanest 1% Side Effects



Like all medicines, Citanest may cause side effects although not everybody gets them.




Severe allergic reactions



If you have a severe allergic reaction, tell your doctor immediately. The signs may include sudden onset of:



  • Swelling of your face, lips, tongue or throat. This may make it difficult to swallow.

  • Severe or sudden swelling of your hands, feet and ankles.

  • Difficulty breathing.

  • Severe itching of the skin (with raised lumps).




Other possible side effects:



Very common (affects more than 1 in 10 people)



  • Low blood pressure. This might make you feel dizzy or light-headed.

  • Feeling sick (nausea).

Common (affects less than 1 in 10 people)



  • Being sick (vomiting).

  • Feeling dizzy.

  • Pins and needles.

  • Slow heart beat.

  • High blood pressure.

Uncommon (affects less than 1 in 100 people)



  • Blurred vision.

  • Ringing in the ears (tinnitus) or being sensitive to sound.

  • Numbness of the lips and around the mouth.

  • Numbness of the tongue.

  • Difficulty in speaking.

  • Loss of consciousness.

  • Shakiness.

  • Fits (convulsions).

Rare (affects less than 1 in 1,000 people)



  • Uneven heart beat (arrhythmias).

  • Heart attack.

  • Nerve damage that may cause changes in sensation or muscle weakness (neuropathy). This may include peripheral nerve damage.

  • Methaemoglobinaemia (a problem with blood pigment levels). If this happens, the skin becomes bluish-grey due to a lack of oxygen (this is more likely in infants).



The following side effects have been reported but it is not known how often they occur



  • Double vision.

  • Shallow breathing.

Do not be concerned by this list of possible side effects. You may not get any of them.




If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.





How to store Citanest



  • Keep out of the reach and sight of children.

  • Do not use after the expiry date, which is 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 when it has been opened if it is not used immediately.

    They are also responsible for disposing of any unused Citanest correctly.




Further information




What Citanest 1% contains



The active ingredient is prilocaine hydrochloride. Each millilitre (ml) of solution contains 10 mg of prilocaine hydrochloride (500 mg per 50 ml vial).



The other ingredients are sodium chloride, hydrochloric acid and/or sodium hydroxide, methyl parahydroxybenzoate and water for injections.





What Citanest 1% looks like and contents of the pack



Citanest is a solution for injection. It comes in glass multi-dose vials of 20 ml or 50 ml.



Not all pack sizes may be marketed.





Marketing Authorisation Holder and Manufacturer



The Marketing Authorisation for Citanest 1% is held by




AstraZeneca UK Ltd

600 Capability Green

Luton

LU1 3LU

UK



Citanest 1% is manufactured by




AstraZeneca UK Ltd

Silk Road Business Park

Macclesfield

Cheshire

SK10 2NA

UK




To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:



0800 198 5000 (UK only)



Please be ready to give the following information:



Product name Reference number



Citanest 1% 17901/0118



This is a service provided by the Royal National Institute of Blind People.




Leaflet prepared: January 2010.



© AstraZeneca 2010.



Citanest is a trade mark of the AstraZeneca group of companies.



PAI 09 0068a





P027225







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