CITANEST 1%

Active substance: PRILOCAINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

5. How to store Citanest

P027465

Citanest 1% solution for injection
®

• 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.

prilocaine hydrochloride

6. 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 (E218), propyl parahydroxybenzoate (E216) 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.

Edge code area

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.

Area for text

Leaflet updated: February 2010.
© AstraZeneca 2010.
Citanest ® is a trade mark of the AstraZeneca group of companies.
PAI 10 0001a
4

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
1. 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).
2. 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.
1

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.

Technical Info

Profile

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) and propyl
parahydroxybenzoate (E216). These 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.
3. 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).

2

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.
4. Possible 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.

3

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)