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CITANEST WITH OCTAPRESSIN DENTAL

Active substance(s): FELYPRESSIN / PRILOCAINE HYDROCHLORIDE

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07 563 86 UT

PATIENT INFORMATION LEAFLET FOR THE
USER
Citanest® with Octapressin DENTAL
Solution for Injection
Prilocaine Hydrochloride 3% w/v
Felypressin 0.54 micrograms/ml
WHAT YOU SHOULD KNOW ABOUT YOUR
MEDICINE
Please read all of this leaflet before you are
given this medicine.
• The full name of your medicine is Citanest®
with Octapressin DENTAL but will be referred
to as Citanest Dental from now on in this
leaflet.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
dentist or doctor.
• This medicine has been prescribed for you.
Do not pass it onto others. It may harm them,
even if their symptoms are the same as
yours.
• Normally a dentist or dental hygienist will
use this product on you in the dental surgery.
It is unlikely that you will be permitted to
take this medicine home.
• If any of the side effects become serious,
or if you notice any side effects not listed
in this leaflet, please tell your dentist or
doctor.
In this leaflet:
1. What Citanest Dental is and what it is used for
2. Before being given Citanest Dental
3. How Citanest Dental will be given
4. Possible side effects
5. How to store Citanest Dental
6. Further information
1. What Citanest Dental is and what it is used
for
The name of your medicine is Citanest Dental
and it is a solution for injection. It contains
prilocaine hydrochloride and Octapressin (which
contains felypressin).
Prilocaine hydrochloride is a type of medicine
called a local anaesthetic. These are medicines
which numb an area of the body. Octapressin
is a type of medicine called a vasoconstrictor.
These are medicines which make the blood
vessels at the site of injection narrower which
means that you will bleed less and the effects
of the medicine will last longer.
What this medicine is used for
It is used to stop the pain during dental procedures.
2. Before being given Citanest Dental
Do not use Citanest Dental
• if you are allergic (hypersensitive) to any
of the ingredients of Citanest Dental (see
Section 6, Further information)

• If your doctor has told you that you have congenital or acquired methaemoglobinanemia
(a condition where too much haemoglobin
has changed into methaemoglobin in your
blood. If too much methaemoglobin is formed,
it becomes more difficult for the blood to
provide the tissues with oxygen)
• If your doctor has told you that you have
anaemia
• if you have ever had an allergic reaction to
another local anaesthetic
• This product contains less than 1 mmol
sodium (23 mg) per 1 ml, i.e. essentially
‘sodium free’. This should be taken into
consideration in patients who are following
a reduced-salt diet.
• as an injection directly into the vein.
Tell your dentist or doctor if you:
• are pregnant, think you might be pregnant,
or considering becoming pregnant
• are breast feeding
• have had high blood pressure or any heart
problems
• have any liver or kidney problems
• have any breathing difficulties
• have any other blood disorders including
anaemia
• have epilepsy
• have an infection at the site where the
injection is to be given
• have received any other local anaesthetics
very recently
Using other medicines
Make sure your dentist or doctor knows if you
are taking any of the medicines listed here:
• sulfonamides, e.g. co-trimoxazole, which are
antibiotics used to treat bacterial infections
• any other anaesthetics
Tell your dentist or doctor if you are taking or
have recently taken any other medicines,
including medicines obtained without a
prescription.
Pregnancy and breast-feeding
If you are pregnant, think you might be
pregnant, are considering becoming pregnant
or are breastfeeding, ask your dentist or
doctor for advice before being given Citanest
Dental.
Driving and using machines
Citanest Dental has no known effect that
should affect your ability to drive or use
machines.
3. How Citanest Dental will be given
This medicine will be given to you as an injection
by your dentist.
You may have this injection inside your mouth
before having your dental treatment. Your
dentist will wait a few minutes for the area
to go numb before starting the treatment, so
that you will feel less pain. The numbness
will last until the treatment is finished and
for a while afterwards.
• Your dentist will decide what dose is right
for you.
Section 3 continued overleaf

Section 3 continued
• The maximum dose should not exceed
5 cartridges or 10 ml.
Adults
• The usual dose is between 1 and 5 ml (half
to two and a half cartridges) for adults and
Children under 10 years of age
• The usual dose is between 1 and 2 ml (half
to one cartridge) for children under 10.
The elderly and unwell patients
• A smaller dose should be given depending
on age or how unwell they are
• In all cases, the smallest dose that is needed
should be used
Please note
• After the injection, your mouth may feel numb
for some time. Take care not to accidentally
bite your tongue or cheek. Also, avoid drinking
very hot drinks and eating very hot food until
the feeling fully returns. The numbness will slowly
go away.
If you feel that you have been given too much
or too little Citanest Dental, talk to your dentist
or doctor immediately.

• Methaemoglobinaemia, which can cause
headache, breathlessness and blue-tinged
skin (more commonly in infants). (Methaemoglobinaemia is a condition where too much
haemoglobin has changed into methaemoglobin in your blood. If too much methaemoglobin is formed, it becomes more difficult
for the blood to provide the tissue with
oxygen.)
If any of these side effects become serious,
or if you get any side effects not listed in this
leaflet, tell your dentist or dental hygienist while
still in the dental surgery or tell your doctor if
you have already returned home when these
occur.
5. How to store Citanest Dental
You will not normally be asked to store your
medicine as it will be given to you by a
healthcare professional.
Keep Citanest Dental out of the reach and sight
of children.
Do not use Citanest Dental after the expiry date
which is printed on the container after Exp.
The expiry date refers to the last day of the
month.
Do not store above 25°C.
Do not use if there is any appearance of
cloudiness or color.
6. Further information

4. Possible side effects of Citanest Dental
Like all medicines, Citanest Dental may
sometimes cause side effects as well as the
effects that are needed. These side effects are
rare and usually only occur with high doses.
If you have any of the following rare side
effects while taking your medicine, tell your
dentist or doctor immediately, or go straight
to the emergency department of your nearest
hospital if you have left the dental surgery
when these occur.
Severe allergic reactions may include:
• a red and lumpy skin rash
• difficulty in breathing
• lowered blood pressure
• swelling of the face, mouth, lips, or eyelids
Rare side effects (affecting fewer than 1 in
1,000 people)
• Feelings of nervousness, dizziness, blurred
vision, shakiness, sounds/ringing in the ears,
and occasionally drowsiness and loss of
consciousness
• Fits
• Lowered blood pressure
• Nausea, headache, or a faster heartbeat
• A slow heart beat or cardiac arrest (heart
attack)
• Slow breathing or respiratory arrest (when
breathing stops completely)

What Citanest Dental contains
Each ml contains Prilocaine Hydrochloride 30
mg (54 mg/1.8 ml cartridge; 66 mg/2.2 ml
cartridge) and Felypressin corresponding to
0.54 micrograms (0.97 micrograms/1.8 ml
cartridge; 1.19 micrograms/2.2 ml cartridge).
The other ingredients are: hydrochloric acid,
sodium chloride, sodium hydroxide and water
for injection.
What Citanest Dental looks like and contents
of the pack
A clear, colourless, sterile solution.
Solution for injection for dental use.
Each glass cartridge contains 1.8 or 2.2 ml of
Citanest Dental.
Each pack contains 100 cartridges.
Marketing Authorisation Holder
DENTSPLY Limited, Building 3, The Heights,
Weybridge, Surrey, KT13 0NY,
United Kingdom
Manufacturer
Pierrel S.p.A., Strada Statale, Appia 46/48
81043, Capua (CE), Italy
This leaflet was last revised in 10/2015.

00756382-03

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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.

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