Skip to Content

CITANEST 1%

Active substance(s): PRILOCAINE HYDROCHLORIDE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

M120203AB

Package leaflet: Information for the user

Citanest® 1% solution for injection
prilocaine hydrochloride

Read all of this leaflet carefully before you start using this
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
same as 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:
1. What Citanest is and what it is used for
2. What you need to know before you use Citanest
3. How to use Citanest
4. Possible side effects
5. How to store Citanest
6. Contents of the pack and other 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 in adults and children above 6 months in age to
numb (anaesthetise) parts of the body. It stops pain happening during
medical procedures and surgery (operations).
2. What you need to know before you use Citanest
Do not use Citanest:
• if you are allergic to prilocaine hydrochloride or any of the other
ingredients of this medicine (listed in section 6).
• if you are allergic to any other local anaesthetics of the same class
(such as lidocaine or bupivacaine).
• if you are anaemic (a blood problem which means you have too few
red blood cells).
• if 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.
Warnings and precautions
Talk to your doctor or nurse before using 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.
Other medicines and Citanest
Tell your doctor or nurse if you are taking, have recently taken or might
take 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.
1

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, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or nurse for advice before
taking this medicine.
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.
Citanest contains sodium
• 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)
Citanest contains methyl parahydroxybenzoate (E218) and
propyl parahydroxybenzoate (E216). These may cause allergic
reactions (possibly delayed) such as a skin rash, and exceptionally
bronchospasm (breathlessness). This may happen a while after you
have been given the medicine.
3. How to use Citanest
Always use this medicine exactly as your doctor or nurse has told you.
Check with 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 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.
Use in children and adolescents
Citanest is not recommended for use in children under 6 months old.
If you use more Citanest than you should
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.
2

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, this medicine can cause side effects, although not
everybody gets them.
If you have any of these side effects, stop taking the medicine and/or
seek urgent medical advice immediately:
• 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: may affect more than 1 in 10 people
• Low blood pressure. This might make you feel dizzy or
light-headed.
• Feeling sick (nausea).
Common: may affect up to 1 in 10 people
• Being sick (vomiting).
• Feeling dizzy.
• Pins and needles.
• Slow heart beat.
• High blood pressure.
Uncommon: may affect up to 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: may affect up to 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).
Not known: frequency cannot be estimated from the available
data
• 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.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes
any possible side effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
3






Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.

6. Contents of the pack and other information
What Citanest contains
The active substance 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 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
Marketing Authorisation Holder: Aspen Pharma Trading Limited,
3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Tel: +44 (0)1 748 828 391
Manufacturer: Recipharm Monts, Usine de Monts,
18, rue de Montbazon, F-37260, Monts, France

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%
39699/0073
This is a service provided by the Royal National
Institute of Blind People.
This leaflet was last revised in September 2017.
© AstraZeneca 2014.
Citanest® is a trade mark of the AstraZeneca group of companies.

4

PHARMA CODE № 121

5. How to store Citanest

+ Expand Transcript

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