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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 / LIDOCAINE HYDROCHLORIDE / PHENYLEPHRINE HYDROCHLORIDE / LIDOCAINE HYDROCHLORIDE / PHENYLEPHRINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

D03259

Lidocaine Hydrochloride 5 % w/v and Phenylephrine
Hydrochloride 0.5 % w/v Topical Solution
Read all of this leaflet carefully before you are given 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, pharmacist
or nurse.
• If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet:
1. What Lidocaine and Phenylephrine topical solution is and what it
is used for
2. What you need to know before you are given Lidocaine and
Phenylephrine topical solution
3. How you will be given Lidocaine and Phenylephrine topical solution
4. Possible side-effects
5. How to store Lidocaine and Phenylephrine topical solution
6. Contents of the pack and other information.

Driving and using machines:
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 you will be given Lidocaine and
Phenylephrine topical solution
Your doctor or nurse will administer this medicine 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.
Children below 12 years of age: Not recommended.

4. Possible side-effects

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.

Like all medicines Lidocaine and Phenylephine topical solution can
cause side effects, although not everybody gets them.
Serious Side effects
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. If used on damaged or inflamed
skin Lidocaine and Phenylephrine topical solution may cause the
following effects: 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.

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.

If any of the above happens, tell your doctor immediately or go to the
casualty department at your nearest hospital as you may need urgent
medical attention.

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

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.

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

2. What you need to know before you are given
Lidocaine and Phenylephrine Topical Solution

PACKAGE LEAFLET: INFORMATION FOR THE USER

These serious side effects are rare.
Other side effects
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist 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.

5. How to store Lidocaine and Phenylephrine
Topical Solution
You should not be given this medicine 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 medicine does not show signs of deterioration.
Do not store this medicine above 25°C.
Keep this medicine out of the sight and reach of children. Keep in the
original container.
Do not throw away any medicines via wastewater. Ask your
pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and other 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 and Phenylephrine Hydrochloride. Each
bottle contains 2.5ml of topical solution containing 50mg/ml of
lidocaine hydrochloride and 5mg/ml of phenylephrine hydrochloride
in Water for Injections, 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
and 12.5mg of Phenylephrine Hydrochloride respectively.
Marketing Authorisation Holder:
Aurum Pharmaceuticals Ltd, Bampton Road, Romford, RM3 8UG,
United Kingdom.
Manufacturers:
Burton Hospitals NHS Foundation Trust, Pharmacy Manufacturing
Unit, Queens Hospital, Belvedere Road, Burton-on-Trent,
Staffordshire, DE13 0RB, United Kingdom.
Martindale Pharmaceuticals Ltd, Bampton Road, Romford, RM3
8UG, England, United Kingdom.
Product Licence No.: PL 12064/0027
The leaflet was last revised in: April 2017

D03259

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

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.

User Guide

Bottle

You may need medical attention.

D03259

Do not use Lidocaine and Phenylephrine topical solution if:
• you are allergic to Lidocaine, local anaesthetics similar to
lidocaine, Phenylephrine or any of the ingredients of this
medicine (listed in section 6)
• you are pregnant or breastfeeding.
• you have a low amount of blood in your body (hypovolaemia);
• you suffer from high blood pressure;
• you suffer from a type of heart disease known as acute ischaemic
heart disease;
• you have some problems with electrical signals in your heart e.g.
you need a pacemaker (a device that regulates heart beats);
• you suffer from problems with your thyroid gland
(thyrotoxicosis);
• you suffer from glaucoma (increased pressure in the eyeball);
• you have difficulty passing urine.
• you are taking a type of medicine known as sympathomimetics,
this can include medicines used to treat asthma, colds, flu,
glaucoma, heart problems, blood pressure and premature
labour;
• you are taking monoamine oxidase inhibitors, (drugs used to
treat depression) or have taken them within the last two weeks.
Warnings and precautions
Talk to your doctor or pharmacist before you are given Lidocaine and
Phenylephrine topical solution if:
• you have any condition affecting the heart or blood vessels
(cardiovascular disease);
• you suffer from diabetes;
• you suffer from high blood pressure
• you have an overactive thyroid gland;
• 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 affects
some enzymes in the blood and liver);
• you have any cut or sore area in your nose or throat;
• you suffer from fits;
• you suffer from heart conditions which includes a slow heart rate;
• you have liver problems;
• you are suffering from severe shock (sweating, feel unwell,
feeling your heartbeat, fainting);
• you suffer from angina.
Other medicines and Lidocaine and Phenylephrine topical solution:
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 irregular heart beat (heart arrhythmias),
such as lidocaine, digoxin or tocainide.
Tell your doctor or nurse if you are taking, have recently taken or
might take any other medicines including:
• 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).
If you have any doubts about whether this medicine should be
administered to you, discuss this more fully with your doctor or nurse.
Pregnancy, breast feeding and fertility:
You should not be given Lidocaine and Phenylephrine Topical
solution when pregnant or breast-feeding.

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.

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 and 0.65mg of Phenylephrine Hydrochloride.
Always hold the bottle upright to ensure dip-tube is immersed in
the solution at its tip.
This product is sterile until opened, and contains no preservative.
Use once for one patient only and discard the bottle and any
remaining topical solution in an appropriate manner.
Do not use if packaging is damaged.
Keep out of the sight and reach of children.
This product also contains Water for Injections, with Sodium
Hydroxide and /or Hydrochloric Acid to adjust pH.
MA Number/Holder
PL 12064/0027
Aurum Pharmaceuticals Ltd, Bampton Road, Romford, RM3 8UG,
England, United Kingdom.
For further information contact:
Aurum Pharmaceuticals Ltd, Bampton Road, Romford, RM3 8UG,
England, United Kingdom.
D03259

100mm Measurement Verification Bar

DEVELOPMENT ARTWORK
D03259
PIL LIDOCAINE/PHENYLEPHRINE

450 x 88 mm

06/04/16

BM

07/04/16

BM

03/03/17

SM

05/04/17

NF

24/04/17

NF

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.

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