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Document: leaflet MAH GENERIC_PL 01502-0021R change

• leaflet MAH GENERIC_PL 01502-0021R
• leaflet MAH GENERIC_PL 02848-0177

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Patient Information Leaflet w hameln

Lidocaine Hydrochloride Injection 2%

Lidocaine Hydrochloride

What is in this leaflet

1.    What Lidocaine Hydrochloride Injection 2% is and what it is used for

2.    What you need to know before you use Lidocaine Hydrochloride Injection 2%

3.    How to use Lidocaine Hydrochloride Injection 2%

4.    Possible side effects

5.    How to store Lidocaine Hydrochloride Injection 2%

6.    Contents of the pack and other information

1.    What Lidocaine Hydrochloride Injection 2% is and what it is used for

Lidocaine Hydrochloride Injection 2% is a local anaesthetic. It is used to:

•    produce local anaesthesia (numb a specific area) and stop pain being felt in the area of the body where it is administered.

•    control fast or abnormal heart beats that you might experience after a heart attack.

2.    What you need to know before you use Lidocaine Hydrochloride Injection 2%

Do NOT use Lidocaine Hydrochloride Injection 2%:

•    if you are sensitive or allergic to Lidocaine Hydrochloride or any of the other ingredients in this injection (listed in section 6). Tell your doctor if you ever had an allergic or bad reaction, for example, skin rash or breathlessness, to any local anaesthetic medicines.

•    if you have certain heart disorders. Tell your doctor if you have any heart problems particularly where your heart may pump blood less efficiently, may beat irregularly, or may beat more slowly.

•    if you suffer from a state of decreased blood volume (hypovolaemia)

•    if you suffer from Porphyria - a disorder of the blood. Tell your doctor if you have any blood disorders.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Lidocaine Hydrochloride Injection 2%:

•    if you suffer from a heart or a breathing disorder.

•    if you have kidney or liver disease.

•    if you are feeling unwell or run down for any reason.

•    if you suffer from epilepsy or have fits.

•    if you have myasthenia gravis (a condition causing weakness of your muscles).

•    if you are in shock.

•    if you have a blood disorder or an imbalance in the constituents of your blood.

•    if you have inflammation or infection in the area to be injected.

Other medicines and Lidocaine Hydrochloride Injection 2%:

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This is especially important with the following medicines as they may interact with your Lidocaine Hydrochloride Injection 2%:

•    Acetazolamide (used to reduce pressure within the eye).

•    Cimetidine (for stomach ulcer or heartburn).

•    Dolasetron (used to prevent / treat nausea and vomiting) .

•    Quinupristin and dalfopristin (antibiotics).

•    Beta-blockers, e.g. propranolol, (for angina, high blood pressure or other heart problems)

•    Calcium Channel Blockers eg. Verapamil, (for angina and high blood pressure).

•    Diuretics (water tablets).

•    Anti-virals - medicines used to treat infections caused by viruses (e.g. HIV).

•    Anti-arrhythmics - medicines used to regulate the rhythm of your heart. (e.g. Amiodarone, mexiletine).

•    Anti-psychotics - medicines used to treat certain psychiatric conditions (e.g. Pimozide, Sertindole).

•    Muscle relaxants (e.g. Suxamethonium).

•    Opioids - strong pain relieving medicines (e.g. Fentanyl)

•    Oral contraceptives or oral HRT (Hormone Replacement Therapy)

Pregnancy and breast-feeding:

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines:

Depending on where and how lidocaine hydrochloride is used, it may affect your ability to drive or operate machinery. Ask your doctor about when it would be safe to drive or operate machines.

You should not drive or use machinery if you are affected by the administration of Lidocaine Hydrochloride Injection 2%.

3.    How to use Lidocaine Hydrochloride Injection 2%

Your nurse or doctor will give you the injection.

Your doctor will decide the correct dosage for you and how and when the injection will be given.

If you use more Lidocaine Hydrochloride Injection 2% than you should

Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much.

If you think you have been given too much,

or you begin to experience lightheadedness, numbness of your tongue or a ringing in your ears you must tell the person giving you the injection immediately

Lidocaine Hydrochloride Injection 2% is NOT intended for use in the eye.

4.    Possible side effects

Like all medicines, Lidocaine Hydrochloride Injection 2% can cause side effects, although not everybody gets them.

Allergic reactions:

•    Allergic reactions to lidocaine hydrochloride are rare, but tell your doctor immediately if you get any difficulty with your breathing, a rash or itchy skin.

Nervous and psychiatric disorders:

•    Dizziness or lightheadedness, drowsiness, tremor, your tongue going numb - sometimes these symptoms may indicate that you have been given too much lidocaine.

•    Convulsions (seizures).

Eye disorders:

•    Blurred or double vision.

Ear disorders:

•    Tinnitus (a ringing in your ears).

•    Hyperacusis (you are more sensitive to everyday sounds).

Heart disorders:

•    Increased or decreased blood pressure.

•    Slowing and stopping of your heart.

•    Changes in the rhythm of your heart.

Breathing disorders:

•    You may find it more difficult to breathe or your breathing may stop.

Gastrointestinal disorders:

•    Nausea (feeling sick) and vomiting (being sick).

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Skin disorders:

•    Rash, itching and swelling of the face.

•    Pain, inflammation or numbness at the site of injection after the effects of the injection should have worn off.

Blood disorders

•    You may experience a blueish discolouration to your skin, a headache, breathlessness and fatigue as a result of abnormal amounts of methaemoglobin (a form of haemoglobin) in your blood

After spinal injection of lidocaine, you should tell your doctor if you experience any of the following side effects:

•    Pain or numbness in the back or lower legs.

•    Difficulty in walking.

•    Problems with controlling your bladder or bowels.

•    Feeling faint or light headed.

•    Slow heart rate or pulse rate.

For patients going home before the numbness or loss of feeling caused by a local anaesthetic wears off:

•    During the time that the injected area feels numb, serious injury can occur without your knowing about it. Be especially careful to avoid injury until the anaesthetic wears off or feeling returns to the area.

If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse or pharmacist.

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 Hydrochloride Injection 2%

Keep this medicine out of the sight and reach of children.

Your injection will be stored at less than 25°C and protected from light.

Do not use this medicine after the expiry date which is stated on the label and carton after “Exp. date”. The expiry date refers to the last day of that month.

6. Contents of the pack and other information

What Lidocaine Hydrochloride Injection 2% contains:

The active substance is lidocaine hydrochloride. In Lidocaine Hydrochloride Injection 2% each ml of solution contains 20 mg of lidocaine hydrochloride in a sterile solution for injection.

The other ingredients are hydrochloric acid, sodium hydroxide and water for injections.

What Lidocaine Hydrochloride Injection 2% looks like and contents of the pack:

Lidocaine Hydrochloride Injection 2% is a clear, colourless, sterile solution in a clear glass ampoule containing 2, 5, 10 or 20 ml. Not all ampoule sizes may be marketed.

The marketing authorisation number of this medicine is: PL 01502/0021R

Marketing Authorisation Holder:

hameln pharmaceuticals ltd

Gloucester

United Kingdom

Manufacturer:

hameln pharmaceuticals gmbh Langes Feld 13 31789 Hameln Germany

hameln rds a.s.

Horna 36 900 01 Modra Slovak Republic

For any information about this medicine, please contact the Marketing Authorisation Holder

This leaflet was last approved April 2015.