Lidocaine Hc l 1 %/2 %

LIDOCAINE HC l 1 % AND 2 % (VIALS) FRESENIUS is a local anaesthetic. It numbs the area of the body where it is administered.

LIDOCAINE HC l 1 % AND 2 % (VIALS) FRESENIUS should not be administered to you

Do not receive LIDOCAINE HC l 1 % AND 2 % (VIALS) FRESENIUS:

• if you are hypertensive (allergic) to lidocaine (lignocaine) or any of the other ingredients of LIDOCAINE HC l 1 % AND 2 % (VIALS) FRESENIUS (see section 6)
• if you are dehydrated or suffer from heart disorders (such as heart block or conduction disorders)
• if you suffer from a state of decreased volume of circulating blood (hypovolaemia)
• if you suffer from myasthenia gravis (loss of muscle function and weakness)
• if you suffer from porphyria (a disorder of the blood. Tell your doctor if you have any blood disorders).

Warnings and precautions

Special care should be taken with LIDOCAINE HC l 1 % AND 2 % (VIALS) FRESENIUS:

• if you are using heart medication or have heart, lung or breathing problems
• if you have kidney or liver disease
• if you are using a diuretic
• if you suffer from epilepsy or have fits
• if you are in severe 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 HC l 1 % AND 2 % (VIALS) FRESENIUS

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Tell your doctor, if you are taking any of the following medicines before receiving LIDOCAINE HC l 1 % AND 2 % (VIALS) FRESENIUS:

• amiodarone, mexiletine (used to regulate the rhythm of your heart)
• some medicines that relax the skeletal muscles, e.g., suxamethonium
• propranolol (for high blood pressure or other heart problems)
• cimetidine (for stomach ulcer or heart burn)
• anti-viral medicines that used to treat infections caused by viruses (e.g., HIV), such as amprenavir, atazanavir, darunavir, lopinavir
• medicines used to treat certain psychiatric conditions (e.g., pimozide, sertindole, olanzapine, quetiapine, zotepine)
• dolasetron, tropisetrol (used to prevent or treat nausea and vomiting)
• verapamil (used for angina (chest pain) and high blood pressure)
• timolol (used to treat glaucoma)
• quinupristinm, dalfopristin and erythromycin (antibiotics)
• acetazolamide (used to reduce pressure within the eye)
• diuretics (water tablets)
• fluvoxamine (used to treat depression)
• medicines to control fits or epilepsy, e.g., phenytoin
• opioids – strong pain-relieving medicines (e.g., fentanyl)
• oral contraceptives or oral HRT (hormone replacement therapy)

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before receiving LIDOCAINE HC l 1 % AND 2 % (VIALS) FRESENIUS.

You will not be expected to give yourself LIDOCAINE HC l 1 % AND 2 % (VIALS) FRESENIUS. It will be administered by a person who is qualified to do so.

Dosage: Your doctor will decide what the correct dose is and for how long you will be receiving LIDOCAINE HC l 1 % AND 2 % (VIALS) FRESENIUS.

Method of administration: LIDOCAINE HC l 1 % AND 2 % (VIALS) FRESENIUS may be administered by injection into a muscle (intra muscularly).

If you have received more LIDOCAINE HC l 1 % AND 2 % (VIALS) FRESENIUS than you should: Since a healthcare professional will administer LIDOCAINE HC l 1 % AND 2 % (VIALS) FRESENIUS, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

Missed LIDOCAINE HC l 1 % AND 2 % (VIALS) doses: Since a health care provider will administer LIDOCAINE HC l 1 % AND 2 % (VIALS), it is unlikely that the dose will be missed.

LIDOCAINE HC l 1 % AND 2 % (VIALS) FRESENIUS can have side effects. Not all side effects reported for LIDOCAINE HC l 1 % AND 2 % (VIALS) FRESENIUS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving LIDOCAINE HC l 1 % AND 2 % (VIALS) FRESENIUS, please consult your doctor, pharmacist, or other health care provider for advice.

If any of the following happens, stop receiving LIDOCAINE HC l 1 % AND 2 % (VIALS) FRESENIUS and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to LIDOCAINE HC l 1 % AND 2 % (VIALS) FRESENIUS. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Pale, grey or blue coloured skin
• Fits or convulsions
• Collapse
• Unconsciousness
• Difficulty breathing
• Yellowing of your skin and eyes (also called jaundice).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Dizziness or light-headedness, drowsiness, shaking or tremors, numbness of the tongue and mouth area
• Yawning and restlessness
• Excitement and nervousness
• Pain or numbness in the back or lower legs
• Difficulty in walking
• Problems with controlling your bladder or bowels
• Pins and needles
• Blurred or double vision
• Ringing of the ears
• You are more sensitive to everyday sounds
• Sweating
• Low blood pressure. This might make you feel dizzy or light-headed
• Irregular heartbeats and heart failure
• Nausea (feeling sick) and vomiting (being sick)
• Listlessness (lassitude) and loss of memory

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of reach of children. LIDOCAINE HC l 1 % AND 2 % (VIALS) FRESENIUS will be stored in the pharmacy or in the hospital wards. Store at or below 30 ºC. Unused portions of the injection should be discarded.