Mepivacaine hydrochloride S.A.L.F.

Patient Information Leaflet

MEPIVACAIN HYDROCHLORIDE S.A.L.F. 10 mg/ml injectable solution, 20 mg/ml injectable solution

mepivacaine hydrochloride
Please read this leaflet carefully before this medicine is administered to you because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What MEPIVACAIN HYDROCHLORIDE S.A.L.F. is and what it is used for
2. What you need to know before you are given MEPIVACAIN HYDROCHLORIDE S.A.L.F.
3. How MEPIVACAIN HYDROCHLORIDE S.A.L.F. will be administered to you
4. Possible side effects
5. How to store MEPIVACAIN HYDROCHLORIDE S.A.L.F.
6. Contents of the pack and other information

1. What MEPIVACAINA CLORIDRATO S.A.L.F. is and what it is used for

MEPIVACAINA CLORIDRATO S.A.L.F. contains mepivacaine hydrochloride, a medicine
belonging to the group of local anaesthetic medicines.
MEPIVACAINA CLORIDRATO S.A.L.F. is used to numb (anaesthetize) parts of the body
(local anaesthesia) in adults and children.
It can be used in all types of local anaesthesia, that is, to eliminate pain in a specific area of
the body without loss of consciousness.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before you are given MEPIVACAINA CLORIDRATO

S.A.L.F.
You will not be given MEPIVACAINA CLORIDRATO S.A.L.F.

• if you are allergic to mepivacaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other local anaesthetics and/or similar substances;
• if you are pregnant or suspect you may be pregnant. (See section Pregnancy and breastfeeding).

Warnings and precautions
Talk to your doctor or nurse before you are given MEPIVACAINA CLORIDRATO S.A.L.F.
Inform your doctor, who will monitor you closely:

• if you have severe liver or kidney disease;
• if you have a heart condition (partial or complete heart block);
• if you are elderly or in a generally poor state of health;
• if you are taking class III antiarrhythmic medicines (e.g. amiodarone) for irregular heartbeat (see Other medicines and MEPIVACAINA CLORIDRATO S.A.L.F.). Your doctor may also perform an ECG (electrocardiogram, a test to assess heart function);
• if you have porphyria, an inherited disorder affecting the production of certain blood cells, red blood cells.

Other medicines and MEPIVACAINA CLORIDRATO S.A.L.F.
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

• other local anaesthetics or similar substances;
• medicines such as mexiletine or class III antiarrhythmics (e.g. amiodarone), used to treat heart rhythm disorders;
• MAO inhibitors (MAOIs) or tricyclic antidepressants, used to treat depression.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before this medicine is administered.
MEPIVACAINA CLORIDRATO S.A.L.F. will not be administered if you are pregnant or suspect you may be pregnant (see section 2. You will not be given MEPIVACAINA CLORIDRATO S.A.L.F.).
MEPIVACAINA CLORIDRATO S.A.L.F. is not recommended during labour and delivery.
Breastfeeding
Like other local anaesthetics, mepivacaine may pass into breast milk.
Driving and using machines
MEPIVACAINA CLORIDRATO S.A.L.F. may impair your ability to drive or operate machinery.
Local anaesthetics may have a very mild effect on mental function and coordination, and may temporarily affect movement ability and level of alertness.
MEPIVACAINA CLORIDRATO S.A.L.F. contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How MEPIVACAINA CLORIDRATO S.A.L.F. will be administered to you

The dose will be determined by the doctor based on your weight and your health status.
MEPIVACAINA CLORIDRATO S.A.L.F. will be administered to you by a physician specialized in the use of this type of medicine, in appropriately equipped facilities, at the site of the body requiring treatment.
If a large area of your body needs to be anesthetized or if you are to receive a high dose of the medicine, your doctor will insert a small tube into a vein (catheter) before administering MEPIVACAINA CLORIDRATO S.A.L.F.
Use in children
Mepivacaine must not be used in newborns.
If you are given more MEPIVACAINA CLORIDRATO S.A.L.F. than you should
It is highly unlikely that you will be given more solution than required, as your doctor will monitor you during treatment.
Accidental injection of local anesthetics into a blood vessel may cause immediate generalized adverse reactions (occurring within seconds to several minutes). In cases of overdose, adverse effects appear later (15–60 minutes after injection) (see section 4 Possible side effects).
If you stop treatment with MEPIVACAINA CLORIDRATO S.A.L.F.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, MEPIVACAINA CLORIDRATO S.A.L.F. can cause side effects,
although not everyone experiences them.
If you experience any of the following serious side effects during administration of MEPIVACAINA CLORIDRATO S.A.L.F., your doctor will IMMEDIATELY STOP
administration at the first sign of warning and will provide appropriate treatment, if possible,
to manage these symptoms:

• low blood pressure (hypotension);
• decreased heart rate (bradycardia);
• heart rhythm disturbances (arrhythmias);
• cardiac arrest;
• uncontrolled body movements (convulsions), unconsciousness;
• cessation of blood circulation and breathing (cardiorespiratory collapse) caused by a severe allergic reaction (anaphylactic shock);
• temporary cessation of breathing (apnea). Immediate availability of equipment and medications necessary for monitoring and emergency resuscitation is essential, as severe allergic reactions have been reported, even in the absence of known allergies.

The possible side effects are listed below according to the following frequency:
Common (may affect up to 1 in 10 people)

• increased blood pressure (hypertension);
• nausea, vomiting [(most frequent adverse effects after spinal anaesthesia (epidural block)];
• numbness (paraesthesia), dizziness.

Uncommon (may affect up to 1 in 100 people)

• numbness around the mouth (circumoral paraesthesia), tongue insensitivity;
• increased sensitivity to sounds (hyperacusis);
• visual disturbances;
• loss of consciousness;
• tremor;
• ringing in the ears (tinnitus);
• difficulty speaking (dysarthria);
• reduced activity of the central nervous system (CNS depression).

Rare (may affect up to 1 in 1,000 people)

• allergic reactions such as various types of skin rash, urticaria, pruritus, temporary narrowing of the bronchi preventing air passage into the lungs (bronchospasm);
• swelling of the larynx, the organ responsible for voice production (laryngeal oedema);
• respiratory depression;
• nerve disease (neuropathy);
• nerve injury;
• inflammation of a meningeal membrane covering the brain (arachnoiditis);
• double vision (diplopia).

Other reported adverse effects include:
Effects affecting the nervous system

• excitation, disorientation;
• pupil dilation (mydriasis);
• increased metabolism and body temperature;
• jaw muscle spasm making mouth opening impossible (trismus);
• sweating;
• increased respiratory rate (tachypnea), increased bronchial diameter facilitating air passage into the lungs (bronchodilation);
• nausea and vomiting;
• sensation of emptiness in the head;
• muscle twitching and tremors;
• lack of oxygen throughout the body (hypoxia);
• increased carbon dioxide levels in the blood (hypercapnia);
• increased acid levels in the blood (acidosis);
• increased potassium levels in the blood (hyperkalaemia);
• decreased calcium levels in the blood (hypocalcaemia).

Effects affecting the heart and circulation

• increased diameter of blood vessels (vasodilation).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor.
You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MEPIVACAINA CLORIDRATO S.A.L.F.

The solutions do not contain preservatives and must be used immediately after opening the
vial. Any unused medicinal product must be discarded.
Re-sterilization of MEPIVACAINA CLORIDRATO S.A.L.F. is not recommended.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What MEPIVACAINA CLORIDRATO S.A.L.F. contains

• The active substance is mepivacaine hydrochloride 10 or 20 mg.
• The other components are sodium chloride, water for injections.

Description of the appearance of MEPIVACAINA CLORIDRATO S.A.L.F. and contents of the
package
MEPIVACAINA CLORIDRATO S.A.L.F. is a clear, colourless injectable solution.
MEPIVACAINA CLORIDRATO S.A.L.F. 10 mg/ml and 20 mg/ml injectable solution is available in
packs of:

• 5 vials of 5 ml
• 5 vials of 10 ml.

Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Manufacturer
S.A.L.F. SPA LABORATORIO FARMACOLOGICO – VIA G. MAZZINI 9 – 24069 CENATE SOTTO (BG)

The following information is intended exclusively for physicians or healthcare professionals:
The physician must have received complete and adequate training in the technique to be used and must
be experienced in the diagnosis and management of adverse reactions, systemic toxicity, and other
complications.
The anesthetic solution must be injected cautiously in small increments, following aspiration every
approximately 10 seconds. Especially when infiltrating highly vascularized areas, it is advisable to wait
approximately two minutes before proceeding with the actual locoregional block.
Any overdose of local anesthetic must be avoided, and two maximum doses must never be administered
without an interval of at least 24 hours.
In any case, the lowest effective doses and concentrations should be used to achieve the desired effect.
Some local anesthetic techniques may be associated with severe adverse reactions, regardless of the
local anesthetic used, such as:

• Central nervous block: may cause cardiovascular depression, particularly in the presence of hypovolemia. Epidural anesthesia must be used with caution in patients with impaired cardiovascular function;
• Retrobulbar injections: may, very rarely, reach the cerebral subarachnoid space, causing temporary blindness, cardiovascular collapse, apnea, seizures, etc. Such reactions must be diagnosed and treated immediately;
• Retro- and peribulbar injections of local anesthetics: carry a low risk of persistent ocular muscle dysfunction. Primary causes include trauma and/or local toxic effects on muscles and/or nerves. The severity of such tissue reactions is related to the extent of trauma, the concentration of local anesthetic, and the duration of tissue exposure to the local anesthetic. As with all local anesthetics, the lowest effective doses and concentrations should therefore be used. Vasoconstrictors may worsen tissue reactions and should only be used when indicated.

Accidental intra-arterial injections in the cranial and cervical regions may cause severe symptoms even at low doses.
Data from lidocaine use suggest that in patients with advanced liver disease (Child class C), clearance may be reduced by approximately 50%.
A clinically relevant reduction in mepivacaine clearance is expected only in patients with severe renal impairment (CrCl <30 mL/min) not undergoing hemodialysis.
Reduced clearance is not expected to influence the occurrence of toxicity episodes caused by high plasma concentrations of mepivacaine after single doses in surgical anesthesia. However, in chronic renal failure, the renal excretion of the metabolite PPX is impaired, and accumulation may occur following repeated administrations.

DOSAGE, METHOD AND TIME OF ADMINISTRATION
The maximum dose in healthy adults (not pre-medicated with sedatives) for a single administration or repeated administrations within less than 90 minutes is 7 mg/kg, without exceeding 550 mg.
The total dose within 24 hours must never exceed 1000 mg; in pediatric patients, do not exceed 5–6 mg/kg.
Recommended doses:
Surgery
Epidural and caudal block: up to 400 mg, achievable with 15–30 mL of a 1% solution or with 10–20 mL of a 2% solution.
Paravertebral block: up to 400 mg with a 1% solution for stellate ganglion block and autonomic blocks, or 1–2% solution for paravertebral somatic nerve blocks.
Cervical, brachial, intercostal, paracervical, pubic, and peripheral nerve terminal blocks: up to 400 mg, achievable with 5–20 mL of a 1% or 2% solution, depending on the area and extent of the block.
Infiltration: up to 400 mg depending on the surgical area, achievable with variable volumes up to 40 mL of a 0.5%–1% solution.
Obstetrics
Paracervical block: up to 200 mg within a 90-minute period, achievable with 10 mL of a 1% solution per side.

Special populations
Hepatic impairment
In patients with impaired liver function, dose reduction is not required for surgical anesthesia.
In patients with liver disease of Child class C, when prolonged blocks are used involving repeated administration, repeated doses of mepivacaine should be reduced by 50%, and the total dose within 24 hours must not exceed 750 mg of mepivacaine.

Renal impairment
In patients with renal dysfunction, dose reduction for surgical anesthesia within 24 hours is not required.
For further information, consult the Summary of Product Characteristics