Citanest 1% solution for injection 50ml vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Prilocaine hydrochloride

Available from:

Aspen Pharma Trading Ltd

ATC code:

N01BB04

INN (International Name):

Prilocaine hydrochloride

Dosage:

10mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Perineural; Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 15020100; GTIN: 5000455018082

Patient Information leaflet

Page 1 of 5
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 dif

Summary of Product characteristics

OBJECT 1
CITANEST 1%
Summary of Product Characteristics Updated 07-Jun-2018 | Aspen
1. Name of the medicinal product
Citanest 1% Solution for Injection
2. Qualitative and quantitative composition
Each ml of sterile, clear, aqueous solution contains prilocaine
hydrochloride 10 mg.
Excipient(s) with known effect:
Each millilitre (ml) of Citanest contains 2.36 mg of sodium,
equivalent to 118 mg per 50 ml ampoule.
Citanest contains methyl parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (E216)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
4. Clinical particulars
4.1 Therapeutic indications
Citanest is indicated in adults and children aged above 6 months as a
local anaesthetic for use in
infiltration anaesthesia and nerve blocks.
4.2 Posology and method of administration
Care should be taken to prevent toxic reactions by avoiding
intravascular injection. Careful aspiration
before and during the injection is recommended.
Posology
The dose is adjusted according to the response of the patient and the
site of administration.
The lowest concentration and smallest dose producing the required
effect should be given.
The maximum dose of Citanest for healthy adults should not exceed 400
mg.
_Older People_
Elderly or debilitated patients require smaller doses, commensurate
with age and physical status.
_Paediatric population_
Citanest should not be used in children under 6 months of age and for
use in paracervical (PCB) block
and pudendal block in the obstetric patient. There is an increased
risk of methaemoglobin formation in
children and in the neonate after delivery.
In children above the age of 6 months the dosage can be calculated on
a weight basis up to 5 mg/kg.
There have been post-marketing reports of chondrolysis in patients
receiving post-operative intra-articular
continuous infusion of local anaesthetics. Citanest is not approved
for this indication (see also Section
4.4).
Preservative containing solutions i.e. those supplied in multi-dose
vials should not b