Lidocaine 10%W.W Local Anaesthetic Spray
WHAT YOU SHOULD KNOW ABOUT LIDOCAINE 10%w/w LOCAL ANAESTHETIC SPRAY
(hereafter referred to as ‘Lidocaine Spray’)
Read nil of this leaflet carefully because it contains important information for you.
A doctor or dentist will usually apply this medicine to you while you are having treatment in the surgery, clinic or hospital. Sometimes, a doctor or dentist will prescribe this medicine for you to use at home or tell you to buy it from a pharmacy. Always follow the instructions of your doctor or dentist.
• Keep this leaflet in a safe place. You may need to read it again.
• Ask your doctor, dentist or pharmacist if you need any more information or advice.
• You must see a doctor or dentist if your symptoms worsen, in this leaflet:
1. What is Lidocaine Spray?
2. What is it used for?
3. Possible Side Effects.
4. Before you use Lidocaine Spray
5. Taking Other Medicines
6. How to use Lidocaine Spray
7. Storing Lidocaine Spray.
1. WHAT IS LIDOCAINE SPRAY?
The name of your medicine is Lidocaine Spray.
• The active ingredient is Lidocaine. Each spray action (squirt) contains 10 mg of lidocaine.
• Other ingredients are ethanol, propylene glycol, banana essence, sodium saccharin and purified water.
• Lidocaine Spray is available in glass bottles of 50ml. Each bottle contains approximately 500 doses of Lidocaine Spray.
Lidocaine Spray is one of a group of medicines known as local anaesthetics. Lidocaine is also known as Ugnocaine. It works by stopping the nerves that sense pain from working properly. As a result, the area that is treated with the spray becomes numb for a short time.
Marketing Authorisation Holder:
Ayrton Saunders Ltd.,
Ayrton House,
Commerce Way,
Parliament Business Park,
Liverpool L8 7BA
Manufacturer:
Pharmaserve (North West) Ltd 9 Arkwright Road Astmoor Industrial Estate Runcorn WA7 1NU
2. WHAT IS IT USED FOR?
Lidocaine Spray can be used to help prevent pain in the following cases:
• During medical examinations and operations involving the nose, throat and sinuses.
• During childbirth and after the birth if stitches are required.
• During dental procedures, for example to numb the gum before injection.
3. POSSIBLE SIDE EFFECTS
Like all medicines Lidocaine Spray can have side effects. If any of the following happen, stop using Lidocaine Spray and tell your doctor or dentist immediately or go to the casualty department at your nearest hospital. You may need urgent medical attention:
• Rash
• Swelling of the hands, feet, ankles, face, lips, mouth or throat.
• Difficulty breathing (may go on to stopping breathing)
• Fainting or losing consciousness.
• Fitting
• Changes in the way your heart beats, for example if you notice it beating slower.
These are all very serious but rare side effects. Sometimes, but not always, some of these side effects occur because of an allergic reaction to lidocaine or to one of the other ingredients in the liquid. Sometimes they occur because more lidocaine than usual has entered the body. Sometimes there is no obvious reason why someone has one or more of these effects. All of these very serious side effects are rare
Other possible side effects are:
• Feeling nervous
• Dizziness
• Drowsiness
• Drop in blood pressure
If you have any side effects not mentioned in this leaflet please inform your doctor, dentist or pharmacist.
4. BEFORE YOU USE LIDOCAINE SPRAY:
Do not use Lidocaine Spray
• If you are allergic to Lidocaine (also known as lignocaine) or any of the other ingredients in Lidocaine Spray.
• If you have ever had an allergic reaction to any other local anaesthetic.
Take special care with Lidocaine Spray
Although lidocaine is sprayed on to a part of your body, some of the lidocaine will enter your body. The amount that enters depends on where the spray is being used and how many squirts are used. In some people, the presence of lidocaine in the body can cause problems. Therefore, special care is needed:
• If you suffer from epilepsy, because lidocaine may increase the risk of having a fit.
■ If you have any problems with your heart, particularly a slow heart beat, or have ever been told that you have a heart rhythm problem, because lidocaine can affect the heart rhythm.
• If you have any problems with your liver. Lidocaine is broken down in the liver so liver problems can cause lidocaine to stay in the body for longer than usual and cause side effects,
• If you are very seriously ill. do not use lidocaine spray unless you have asked your doctor if it is suitable for you.
• If you have any ulcers, sores, cuts or infection in or near the site where the spray is going to be used (for example in your throat,
mouth or nose), because more lidocaine than usual may enter your body with a higher chance of side effects.
Please consult your doctor, dentist or pharmacist, even if these statements were applicable to you in the past.
Using Lidocaine Spray with food or drink
Care should be taken after using Lidocaine Spray in the mouth and throat as chewing and swallowing may be difficult for a while due to numbness/loss of feeling. Choking and biting of gums and tongue are all possible due to local numbness. These problems are particularly likely to happen in children.
Pregnancy
Ask your doctor, dentist or pharmacist for advice before using this medicine.
Breast Feeding
Ask your doctor, dentist or pharmacist for advice before using this medicine.
Driving and Using Machines
Care should be taken when using Lidocaine Spray as very occasionally it may affect your ability to drive or operate machinery. This is because lidocaine in your body may slow down your thinking and interfere with your muscle control for a short time after treatment.
5. TAKING OTHER MEDICINES
Please inform your doctor, dentist or pharmacist if you are taking or have recently taken any other medicines even those not prescribed. Special care is needed if:
• You are taking any medicines used for the treatment of problems with your heart rhythm because lidocaine in your body may affect the heart rhythm
• You are taking medicines for your blood pressure called beta-blockers (such as propranolol and atenolol) because these may increase the amount of time after treatment that lidocaine stays in your body.
• You are taking certain medicines for stomach acidity or ulcers such as cimetidine because it may increase the amount of time after treatment that lidocaine stays in your body.
If you are using Lidocaine Spray near the face it is important not to get Lidocaine Spray in the eyes.
Follow these instructions unless your doctor or dentist tells you otherwise:
1. Remove the cap and attach the spray nozzle onto the top of the bottle.
2. Direct the spray nozzle at the area to be numbed and press the button down {Irmly.
3. Keep the button held down until all the spray has been released.
4. Repeat the above steps, until the number of sprays, advised by your doctor or dentist have been used.
5. Remove the spray nozzle and replace the cap onto the bottle.
6. The spray nozzle can be removed and cleaned by boiling in water for 5 minutes.
If you use more Lidocaine Spray than you should:
if you have used more Lidocaine Spray than you should, or if someone accidentally swallows some of the liquid from the bottle, you must get advice from your doctor or dentist as soon as possible or you should go to the nearest accident and emergency department.
If large amounts of lidocaine enter the body, there may be effects on heart rhythm that can lower blood pressure and even stop the heart beating. Lidocaine also interferes with the normal working of the brain and nerves so fits, dizziness, drowsiness, loss of consciousness and mental problems can occur.
7. STORING LIDOCAINE SPRAY
■ Keep Lidocaine Spray out of the reach and sight of children.
■ Do not use after the expiry date printed on the bottle
• The bottle should be kept at room temperature (not more than 30°C)
Leaflet Last Revised: February 2008
6. HOW TO USE LIDOCAINE SPRAY
Lidocaine Spray will usually be given to you by your doctor or dentist. If you are given Lidocaine Spray to take home, use the dose recommended by your doctor or dentist and apply the spray only to the area as instructed. In all cases you should use as few sprays as possible to produce the desired effect.
Before an injection or other treatment, the usual dose
is between 1 and 20 sprays, depending on the size of the area that
has to be numbed.
• Adults should never use more than 20 sprays before an injection or other treatment.
* The elderly, children and people who are feeling unwell should receive fewer sprays depending on their age and how unwell they feel. Your doctor or dentist will decide how much is needed or wilt tell you how much to use.