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LIDOCAINE HCL 5%W/V AND PHENYLEPHRINE HCL 0.5%W/V TOPICAL SOLUTION

Active substance(s): LIDOCAINE HYDROCHLORIDE / PHENYLEPHRINE HYDROCHLORIDE

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Package leaflet: information for the user

D01546

Lidocaine Hydrochloride 5 % w/v and
Phenylephrine Hydrochloride 0.5 % w/v
Topical Solution
In this leaflet:
1. What Lidocaine and Phenylephrine Topical Solution is and what
it is used for
2. Before Lidocaine and Phenylephrine Topical Solution is used
3. How will Lidocaine and Phenylephrine Topical Solution be used?
4. Possible side-effects
5. Storing Lidocaine and Phenylephrine Topical Solution
6. Further information.

1. What Lidocaine and Phenylephrine Topical
Solution is and what it is used for

Pregnancy and breast feeding:
Lidocaine and Phenylephrine Topical Solution should not be
administered to those who are pregnant or breast-feeding.
Effects on the ability to drive and use machinery:
It is unlikely that after using Lidocaine and Phenylephrine Topical
Solution, your ability to drive and use machines will be affected.
However, if you feel unwell you must speak to your doctor before
driving or operating machinery.

3. How will Lidocaine and Phenylephrine Topical
Solution be used?
Your doctor or nurse will administer the solution onto the area
inside your nose or throat, using the pump spray dispenser
supplied with the product.
Dose:
Adults, and Children over 12 years: Up to a maximum of 8 sprays
in total.

The name of this product is Lidocaine Hydrochloride 5% w/v
and Phenylephrine Hydrochloride 0.5% w/v Topical Solution. The
active ingredients are local anaesthetic (lidocaine) which causes
numbness and a sympathomimetic drug (phenylephrine) that
reduces bleeding.

Children of 12 years and under: Not recommended.

Lidocaine and phenylephrine topical solution is applied to the area
inside your nose and throat to numb the area, and reduce bleeding
prior to performing certain surgical procedures.

The anaesthetic effect induced by lidocaine may cause numbness
of the tongue and mouth and may interfere with swallowing. Do
not eat or drink until the effect has worn off.

It is also used to aid in the removal of foreign bodies from the nose.

If used on damaged or inflamed skin Lidocaine and Phenylephrine
Topical Solution may cause the following effects:

2. Before Lidocaine and Phenylephrine Topical
Solution is used.
Lidocaine and Phenylephrine Topical Solution should not be given
to you if:

Package leaflet: information for the user

D01546

Lidocaine Hydrochloride 5 % w/v and
Phenylephrine Hydrochloride 0.5 % w/v
Topical Solution
User Guide

Like all medicines Lidocaine and Phenylephine Topical Solution can
cause side effects, although not everybody gets them.

Breathing difficulties, fits, coma, heart attack, chest pain,
bradycardia (slow heart rate), cardiac arrhythmias (irregular heart
beat) and low blood pressure (with dizziness, fainting and flushing)
or high blood pressure. These are all very serious side effects and
are very rare.
If any of the above happen, tell your doctor immediately or go to
the casualty department at your nearest hospital as you may need
urgent medical attention.
Tell your doctor or go to the casualty department at your nearest
hospital if you notice any of the following:
Difficulty in passing urine (particularly if you have problems with
your prostate), blurred vision, dizziness, drowsiness, irritability,
extremely high temperature, muscle twitching and shaking. You
may need medical attention. These serious side effects are rare.
Tell your doctor if you notice any of the following:
Excessive saliva, headache, reduced appetite, sweating and
weakness, difficulty in sleeping, feeling sick or being sick,
anxiety, confusion, excitement, fear, nervousness, restlessness,
fits and tinnitus. These are all mild side effects of Lidocaine and
Phenylephrine Topical Solution.
If you experience any side effects or think you may be reacting
badly in any way, inform your doctor, or nurse immediately.

5. Storing Lidocaine and Phenylephrine Topical
Solution
You should not be given the solution if the expiry date on the label
has passed or if it shows signs of deterioration. The doctor or nurse
will check that the expiry date on the label has not passed and that
the solution does not show signs of deterioration.
Do not store the solution above 25°C.
Keep all medicines out of the sight and reach of children. Keep in
the original container.

6. Further information
What Lidocaine and Phenylephrine Topical Solution contains:
The active ingredients in Lidocaine Hydrochloride 5% w/v and
Phenylephrine Hydrochloride 0.5% w/v Topical Solution are
Lidocaine Hydrochloride BP and Phenylephrine Hydrochloride
BP. Each bottle contains 2.5ml of solution containing 50mg/
ml of lidocaine hydrochloride and 5mg/ml of phenylephrine
hydrochloride in Water for Injections BP, with sodium hydroxide
and hydrochloric acid to adjust the pH.
What Lidocaine and Phenylephrine Topical Solution looks like
and contents of the pack:
Lidocaine and phenylephrine topical solution is licensed to be
available in one bottle containing 2.5ml of solution, in a single box.
Each 2.5ml of solution contains 125mg of Lidocaine Hydrochloride
BP and 12.5mg of Phenylephrine Hydrochloride BP respectively.
Marketing Authorisation Holder: Aurum Pharmaceuticals Ltd.,
Bampton Road, Romford, RM3 8UG, United Kingdom.
Manufacturers: Pharmacy Production Unit, Queens Hospital,
Belvedere Road, Burton-on-Trent, Staffordshire, DE13 0RB,
United Kingdom.
Martindale Pharmaceuticals, Bampton Road, Romford, RM3 8UG,
England.
Product Licence No.: PL 12064/0027
Date of Revision: November 2010
If this leaflet is difficult to see or read, please contact the
marketing authorisation holder for help.
D01546

• you are allergic (hypersensitive) to Lidocaine, Phenylephrine or
any of the ingredients of this medicine (listed in section 6)
• you are taking monoamine oxidase inhibitors, (drugs used to
treat depression) or have taken them within the last two weeks.
• you are taking a type of medicine known as sympathomimetics.
This can include medicines used to treat asthma, colds and flu,
glaucoma, heart problems or problems with your blood pressure
and premature labour
• you are sensitive to some local anaesthetics similar to Lidocaine
• you are sensitive to vasoconstrictors; such as phenylephrine
• you have a low amount of blood in your body (hypovolaemia)
• you have some problems with electrical signals in your heart e.g.
you need a pacemaker (a device that regulates heart beats)
• you are pregnant or breast-feeding
• you suffer from high blood pressure
• you suffer from a type of heart disease known as acute ischaemic
heart disease
• you suffer from problems with your thyroid gland (thyrotoxicosis)
• you suffer from glaucoma (increased pressure in the eyeball)
• you have difficulty passing urine.
Take special care with Lidocaine and Phenylephrine Topical
Solution
Tell your doctor if:
• you have any heart disease
• you suffer from diabetes
• you suffer from low blood oxygen level or a high blood carbon
dioxide level (for example you suffer from any lung disease)
• you suffer from porphyria (a hereditary disorder that effects
some enzymes in the blood and liver)
• you have an overactive thyroid gland
• you suffer from fits
• you have liver or kidney problems
• you are suffering from severe shock (sweating, feel unwell,
feeling your heartbeat, fainting)
• you have any cut or sore area in your nose or throat
• you suffer from angina.
Taking other medicines:
Please tell your doctor if you are taking any of the following
medicines.
• beta-blockers (drugs used in the treatment of heart problems or
high blood pressure)
• debrisoquine, reserpine, methyldopa and guanethide (used to
treat high blood pressure)
• quinupristin/dalfopristin (used to treat bacterial infections
resistant to antibiotics)
• diuretics (drugs used to treat difficulty in passing urine and water
retention)
• reboxetine (used to treat depression)
• suxamethonium (a muscle relaxant)
• ergot alkaloids (used to treat migraine)
• doxapram (used to treat severe breathing difficulties)
• oxytocin (used to induce labour)
• anaesthetics such as chloroform, halothane or isoflurane
• phenothiazines (used to treat certain mental disorders)
• drugs used to treat depression known as tricyclic antidepressants.
These include amitriptyline, clomipramine and imipramine
• monoamine oxidase inhibitors (MAOIs) (drugs used to treat
depression). You MUST NOT use Lidocaine and Phenylephrine
Topical Solution if you are taking MAOIs or if you have taken
them within the last two weeks
• drugs for treatment of heart arrhythmias (irregular heart beat),
such as lidocaine, digoxin or tocainide.
If you have any doubts about whether this medicine should be
administered to you, discuss this more fully with your doctor or nurse.

4. Possible side-effects

Instructions For Assembly Of Pump + Actuator To
Bottle.
Priming the Pump.
While holding the bottle upright, the pump should be activated
three times before use to prime it.
Other Information.
The pump dispenser will deliver a dose volume of 130μl in each
spray. Thus, each spray is equivalent to 6.5mg of Lidocaine
Hydrochloride BP and 0.65mg of Phenylephrine Hydrochloride BP.
Always hold the bottle upright to ensure dip-tube is immersed in
the solution at its tip.

Bottle

Pump

Actuator

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.

This product is sterile until opened, and contains no preservative.
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.
Keep out of the reach of children.
This product also contains Water for Injections, with Sodium
Hydroxide and /or Hydrochloric Acid to adjust pH.
MA Number/Holder
12064/0027 Aurum Pharmaceuticals Ltd., Bampton Road, Romford,
RM3 8UG, England.
For further information contact:
Aurum Pharmaceuticals Ltd.
Bampton Road, Romford
RM3 8UG
England.
D01546

100mm Measurement Verification Bar

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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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