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COCAINE HYDROCHLORIDE SOLUTION 10% W/V

Active substance(s): COCAINE HYDROCHLORIDE

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Other Information
The pump dispenser will deliver a dose volume of 130?l in each spray.
Thus, each spray is equivalent to 13mg of Cocaine Hydrochloride Ph
Eur.

COCAINE HYDROCHLORIDE SOLUTION 10% W/V
USER GUIDE
Instructions for assembly of Pump + Actuator to Bottle

Always hold the bottle upright to ensure diptube is immersed in the
solution at its tip.
Bottle

Pump

This product is sterile until opened, and contains no preservative.

Actuator

Use once for one patient only and discard the bottle and any
remaining solution in an appropriate manner. Do not use if packaging
is damaged.

1. Immediately before use, remove the screw
cap and rubber stopper from the bottle.
2. Screw the pump onto the bottle.
3. Push the actuator onto the top of the
pump.
4. Press down on the pump-actuator 3 times
to prime the pump before use.
5. The pump spray is now ready for use.
Refer to the Patient Information Leaflet or
Summary of Product Characteristics for
dosing instructions.
Priming the Pump
While holding the bottle upright, the pump should be
activated three times before use to prime it.

Keep out of the sight and reach of children.
This product also contains Water for Injections, with Dilute
Hydrochloric Acid to adjust pH.
Do not store above 25°C. Protect from light.
MA Number: 12064/0016
For further information contact
Aurum Pharmaceuticals Ltd.
Bampton Road, Harold Hill, Romford, Essex RM3 8UG

Continued overleaf

PACKAGE LEAFLET: INFORMATION FOR THE USER

D02808

Cocaine Hydrochloride Solution 10%w/v
Cocaine Hydrochloride
(Referred to as Cocaine Solution this leaflet)

Read all of this leaflet carefully before you are given Cocaine
Solution
• Keep this leaflet. You may need to read it again
• If you have any further questions, please ask your doctor or nurse
• 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

The medicine can affect your ability to drive as it may make you sleepy
or dizzy.
• Do not drive while taking this medicine until you know how it affects
you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
• The medicine has been prescribed to treat a medical or dental
problem and
• You have taken it according to the instructions given by the
prescriber or in the information provided with the medicine and
• It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it
is safe for you to drive while taking this medicine.

In this leaflet:

3. How Cocaine Solution is given

1. What Cocaine Solution is and what it is used for
2. Before Cocaine Solution is given
3. How Cocaine Solution is given
4. Possible side effects
5. How to store Cocaine Solution
6. Further information

This medicine is a solution which will be given to you by a doctor using
a pump dispenser. The solution will be sprayed directly on to the inside
of the area to be numbed.
Adults:
The usual dose is a maximum of 1.5mg per kilogram of body weight.
The elderly and children:
This medicine is not suitable for the elderly and children.
If you think you have been given too much Cocaine Solution
This medicine will be given to you by your doctor so it is unlikely that
you will be given too much. If you are concerned about your treatment,
please talk to your doctor.
4. Possible side effects
Like all medicines, Cocaine Solution can cause side effects, although not
everybody gets them.

This leaflet contains a summary of the information available for this
medicine. You should ask your doctor or nurse if you are unsure
about any aspect of this medicine.

1. What Cocaine Solution is and what it is used for
Cocaine Hydrochloride is a local anaesthetic.
Cocaine Solution is used to numb an area of the ear, nose or throat
ready for surgery. It may also be used to reduce bleeding in the area
during surgery.

2. Before Cocaine Solution is given

Possible side effects include:
• restlessness, excitement, a feeling of intense happiness
• excessive talking or rambling
• involuntary or jerky movements
• confusion, paranoia
• seeing or hearing things that are not real, mental disturbances
• changes in your sensation of touch
• a rise in body temperature
• fast breathing
• a migraine-like headache
• high blood pressure
• enlarged pupils
• sweating, shaking, fits
• rumbling stomach
• a lack of blood in the fingers, toes, spinal cord, kidneys, spleen, and
intestines
• problems sleeping
• loss of appetite.

You should not be given Cocaine Solution if:
• you are allergic (hypersensitive) to Cocaine Hydrochloride or other
local anaesthetics, or to any of the other ingredients of the solution
listed in section 6 of this leaflet
• you suffer from glaucoma (raised pressure in the eye)
• you suffer from a disease that causes muscle weakness, known as
myasthenia gravis
• you or any of your close relatives suffer from a blood enzyme
(pseudocholinesterase) deficiency
• you suffer from epilepsy (fits)
• you have porphyria (a blood disorder).
Cocaine Solution is not suitable for children and the elderly.
Take special care with Cocaine Solution
Tell your doctor if:
• you have open wounds in the area to be numbed
• you have high blood pressure or heart problems
• you have thyroid problems
• you have diabetes.

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

If any of the above applies to you, please tell your doctor or nurse.
Taking other medicines
Please tell your doctor or nurse if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.

5. How to store Cocaine Solution
Keep out of the reach and sight of children.

This product will be stored by your doctor below 25°C and protected
from light in the original carton

6. Further Information
What Cocaine Solution contains:
The active substance is Cocaine Hydrochloride Ph Eur 10%w/v
The other ingredients are dilute hydrochloric acid and water for
injections.
What Cocaine Solution looks like and contents of the pack:
Cocaine Solution is supplied in clear glass bottles. Each bottle contains
2.5ml of solution.
Marketing Authorisation Holder: Manufacturer:
Aurum Pharmaceuticals Ltd
Burton Hospital NHS Trust,
Bampton Road, Harold Hill
Belvedere Road,
Romford, Essex,
Burton on Trent,
RM3 8UG, UK
DE13 0RB, UK
Product Licence Number: PL 12064/0016
Date of last Revision: February 2014
If you would like any more information, or would like the leaflet in
a different format, please contact Medical Information at the above
address.

D02808

Tell your doctor if you are taking any of the following:
• ecothiopate eye drops (a medicine used to treat glaucoma)
• neostigmine (a medicine used to treat myasthenia gravis)
• medicines that affect the nervous system e.g. adrenaline, ephedrine
or amphetamines
• monoamine oxidase inhibitors (MAOIs) a group of medicines used to
treat severe depression
• medicines used to treat high blood pressure e.g. guanethidine
sulphate and reserpine
• medicines used to treat depression (tricyclic anti-depressants) e.g.
imipramine and amitriptyline
• CNS depressants (medicines that act on the brain and can cause
drowsiness or sleepiness e.g. opiates and barbiturates).
You are advised not to drink alcohol whilst being treated with
Cocaine Solution.
Pregnancy & breast-feeding
You should not be given this medicine if you are pregnant, trying for a
baby or breast-feeding.
Driving and using machines
You should not drive or use machinery after being given Cocaine
Solution until your doctor advises that you are safe to do so.
Continued overleaf

You should not be given this medicine if it has passed the expiry date
printed on the bottle. The expiry date refers to the last day of that
month. The doctor or nurse will check that the product has not passed
this date.

100mm Measurement Verification Bar

DEVELOPMENT ARTWORK
Component Code: D02808
Paper size: 90 x 361mm
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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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