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Patient Information Leaflet w hameln

Lidocaine Hydrochloride Injection 1%

Lidocaine Hydrochloride

What is in this leaflet

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

2.    What vou need to know before vou use Lidocaine Hvdrochloride Injection 1%

3.    How to use Lidocaine Hydrochloride Injection 1%

4.    Possible side effects

5.    How to store Lidocaine Hydrochloride Injection 1%

6.    Contents ofthe pack and otherinformation

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

Lidocaine Hydrochloride Injection 1% 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 bodv where it is administered.

♦    control fast or abnormal heart beats that vou might experience after a heart attack.

2.    What vou need to know before vou use Lidocaine Hvdrochloride Injection 1%

Do NOT use Lidocaine Hydrochloride

Injection 1%:

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

♦    if vou have certain heart disorders. Tell vour doctor if vou have anv heart problems particular^ where vour heart mav pump blood less efficient^, mav beat irregularlv, or mav beat more slowlv.

♦    if vou suffer from a state of decreased blood volume (hvpovolaemia)

♦    if vou suffer from Porphyria - a disorder of the blood. Tell vour doctor if vou have anv blood disorders.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Lidocaine Hydrochloride Injection 1%:

if vou suffer from a heart or a breathing disorder.

ifvou have kidney or liver disease.

if vou are feeling unwell or run down for any

reason.

ifvou sufferfrom epilepsy or have fits. if vou have myasthenia gravis (a condition causing weakness ofvourmuscles). ifvou are in shock.

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

ifvou have inflammation or infection in the

area to be injected.

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

♦    Cimetidine (forstomach ulcerorheartburn).

♦    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 e g. Verapamil, (forangina and high blood pressure).

♦    Diuretics (watertablets).

♦    Anti-virals - medicines used to treat infections caused bvviruses (e.g. HIV).

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

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

♦    Muscle relaxants, (e.g. Suxamethonium).

♦    Opioids - strong pain relieving medicines^— (e.g. Fentanvl)

♦    Oral contraceptives or oral HRT (Hormone S Replacement Therapv)

Pregnancy and breast-feeding:

If vou are pregnant or breast-feeding, think vou mav be pregnant or are planning to have a babv, ask vour doctor or pharmacist for advice before taking this medicine.

Driving and using machines:

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

You should not drive or use machinery if you

are affected bv the administration of Lidocaine Hydrochloride Injection 1%.

3.    How to use Lidocaine Hydrochloride Injection 1%

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 1% than you should

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

If you think you have been given too much,

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

Lidocaine Hydrochloride Injection 1% is NOT intended for use in the eye.

4.    Possible side effects

Like all medicines, Lidocaine Hvdrochloride Injection 1% can cause side effects, although not evervbodv gets them.

Allergic reactions:

♦    Allergic reactions to lidocaine hvdrochloride are rare, but tell vour doctor immediatety ifvou get anv difficulty with vour breathing, a rash or itchy skin.

Nervous and psychiatric disorders:

♦    Dizziness or lightheadedness, drowsiness, tremor, your tongue going numb - sometimes these svmptoms mav indicate that vou have been given too much lidocaine.

♦    Convulsions (seizures).

Eye disorders:

♦    Blurred or double vision.

Ear disorders:

♦    Tinnitus (aringinginvourears).

♦    Hyperacusis (vou 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 mav find it more difficult to breathe or vour breathing mav stop.

Gastrointestinal disorders:

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

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 1%

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

Your injection will be stored at less than 25⁰C 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 1% contains:

The active substance is lidocaine hydrochloride. In Lidocaine Hydrochloride Injection 1% each ml of solution contains 10 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 1% looks like and contents of the pack:

Lidocaine Hydrochloride Injection 1% 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/ 0002R

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.