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Package Leaflet: Information for the user

Mepivacaine hydrochloride 10 mg/ml solution for injection Mepivacaine hydrochloride 20 mg/ml solution for injection Mepivacaine Hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor, pharmacist or nurse.

-    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any

possible side effects not listed in this leaflet (see section 4). What is in this leaflet:

1.    What Mepivacaine hydrochloride solution for injection is and what it is used for

2.    What you need to know before you use Mepivacaine hydrochloride solution for injection

3.    How to use Mepivacaine hydrochloride solution for injection

4.    Possible side effects

5.    How to store Mepivacaine hydrochloride solution for injection

6.    Contents of the pack and other information

1. What Mepivacaine hydrochloride solution for injectionis and what it is used for

Local anaesthetic.

This medicine is used for the temporary localalised elimination of pain sensation by local infiltration and regional nerve block injection.

2. What you need to know before you are given Mepivacaine hydrochloride solution for injection

Do not use Mepivacaine hydrochloride solution for

injection

•    if you are allergic to active substance(s) or any of the other ingredients of this medicine (listed in section 6),

•    if you suffer from severe heart rhythm disturbances (severe disturbances of the electrical conduction system of the heart),

•    if you have an acute weakness of the heart muscle which cannot be controlled by treatment (acute decompensated heart failure),

•    for anaesthesia of the neck of the womb (cervix) during childbirth (paracervical anaesthesia) In addition, special contraindications for epidural anaesthesia are

•    Increased pressure inside the skull.

•    Acute CNS (brain or spinal) disease including inflammation, tumours, infectious viral or bacterial disease, narrowing of the open spaces within your spine, active spinal disease (such as spondylitis, tuberculosis and tumour) and spinal trauma (such as fracture)

•    Septicaemia (blood poisoning),

•    Infection at the injection site

•    Coagulation disorder or anticoagulant treatment (except low-dose heparin)

•    Heart attack and severe blood and fluid loss.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before using Mepivacaine hydrochloride solution for injection

If you suffer from:

•    kidney or liver diseases,

•    blockage of the blood vessels,

•    calcification of the blood vessels (arteriosclerosis)

•    nerve damage caused by diabetes.

•    porphyria (disorder of the blood-producing system)

Other medicines and Mepivacaine hydrochloride solution for injection

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Please tell your doctor or pharmacist if you are taking one of the following medicines:

•    Some strong medicines used to treat pain (e.g. centrally-acting or opioid analgesics)

•    Medicines used in anaesthesia (e.g. ether)

•    Medicines used for muscle relaxation (e.g. non-depolarising muscle relaxants)

•    Medicines used to treat cardiac arrhythmias (anti-arrhythmics)

•    Other local anaesthetic agents

Pregnancy, breast-feeding and fertility

On the basis of long-standing use, anaesthetics of the mepivacaine type are considered to be reasonably safe for use on pregnant women.

Mepivacaine hydrochloride crosses the placenta, but retrospective studies of pregnant women receiving local anaesthetics for emergency surgery early in pregnancy have not shown that local anaesthetics cause birth defects.

However, no controlled studies have been carried out in pregnant women. Moreover, inadequately investigated animal reproduction studies have been performed with mepivacaine. Therefore, caution should be taken before administering this anaesthetic during early pregnancy.

One possible complication of using Mepivacaine hydrochloride solution for injection in obstetrics is the occurrence of arterial hypotension in the mother.

It is not known whether local anaesthetics are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when mepivacaine is administered to a nursing woman.

It is not known whether local anaesthetics are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when mepivacaine is administered to a nursing woman. Should administration be necessary during lactation, breast-feeding can be resumed approximately 24 hours after the end of treatment.

Driving and using machines

Depending on the dose and route of administration mepivacaine have a transient effect on mobility and coordination.

When Mepivacaine hydrochloride solution for injection is used, the doctor must decide in each individual case whether the patient can drive or use machines.

Mepivacaine hydrochloride solution for injection contains Sodium

Each ml of Mepivacaine 10 mg/ml solution for injection contains 0.14 mmol (3.2 mg) of sodium.

Each 10 ml ampoule of Mepivacaine 10 mg/ml solution for injection contains 1.4 mmol (32 mg) of sodium.

Each 20 ml vial of Mepivacaine 10 mg/ml solution for injection contains 2.8 mmol (64 mg) of sodium.

Each ml of Mepivacaine 20 mg/ml solution for injection contains 0.12 mmol (2.8 mg) of sodium.

Each 2 ml ampoule of Mepivacaine 20 mg/ml solution for injection contains 0.24 mmol (5.6 mg) of sodium.

Each 5 ml ampoule of Mepivacaine 20 mg/ml solution for injection contains 0.60 mmol (14 mg) of sodium.

Each 10 ml ampoule of Mepivacaine 20 mg/ml solution for injection contains 1.2 mmol (28 mg) of sodium.

Each 20 ml vial of Mepivacaine 20 mg/ml solution for injection contains 2.4 mmol (56 mg) of sodium.

To be taken into consideration by patients on a controlled sodium diet.

3. How to take Mepivacaine hydrochloride solution for injection

Mepivacaine hydrochloride solution for injection will be given to you by a doctor. Your doctor will know the correct way to give you this medicine.

The recommended dose that your doctor gives you will depend on the type of pain relief that you need and the part of your body that the medicine will be injected into. It will also depending on type your body weight, age and physical condition.

Mepivacaine hydrochloride solution for injection will be given to you as an injection. The part of the body where you are injected will depend on why you are being given Mepivacaine hydrochloride solution for injection. Your doctor will give you Mepivacaine hydrochloride solution for injection in one of the following places:

•    Into the skin (infiltration)

•    Under the skin near a nerve (regional, plexus or nerve blockade)

•    Around the spinal cord (thoracic or lumbar epidural or caudal anaesthesia).

Mepivacaine hydrochloride solution for injection should be given as a slow injection. The maximum recommended dose for single administration is:

-    ENT region: 200 mg mepivacaine hydrochloride (3 mg/kg body weight),

-    Intercostal blockade: 300 mg mepivacaine hydrochloride (4 mg/kg body weight),

-    Epidural anaesthesia and peripheral blockades: 400 mg mepivacaine hydrochloride (6 mg/kg body weight),

-    Plexus anaesthesia: 500 mg mepivacaine hydrochloride (7 mg/kg body weight).

-    For caudal anaesthesia in children: 5 mg/kg body weight. Individual differences are

possible:

Indications	Dosage (ml)
Fracture repositioning	5-20 ml
Sympathetic nerve blockade	5-10 ml
Skin wheals	0.1-2 ml
Lateral cutaneous nerve of
thigh blockade	10 ml
Femoral nerve blockage	10-20 ml
Median nerve blockage	3-5 ml
Obturator nerve blockage	10-15 ml
Phrenic nerve blockage	10-15 ml
Radial nerve blockage	10-20 ml
Ulnar nerve blockage	5-10 ml
Digital nerve block, each nerve	1-2 ml
Paracervical blockade, each side	■ 6-10 ml
Paravertebral blockade	5-10 ml
Pudendal blockade, each side	7-10 ml
Sacral blockade	10-30 ml
Tonsillectomy, each tonsil	5-10 ml
	.Ste,..................

Instructions for use

The total dose should be administered via slow injection or fractionated at an increasing dose, while closely monitoring the vital functions of the patient with constant verbal contact. When administering an epidural dose a prior test dose is

Wound care    Up to 30 ml

Intravenous regional anaesthesia Up to 40 ml

An age-related adjustment is required for epidural anaesthesia

0.5 ml/segment 0.9 ml/segment

1.3    ml/segment 1.5 ml/segment

1.3    ml/segment 1.0 ml/segment 0.7 ml/segment

If you have given more Mepivacaine hydrochloride solution for injection than you should

You may experience restlessness, dizziness, hearing and visual disturbances, tingling in the region of the tongue and mouth, slurred speech, nausea, vomiting, tremor and muscle twitching as signs of an impending seizure, heart rhythm disturbances, increased heart rate, raised blood pressure and flushing. An extreme overdose can cause loss of consciousness with respiratory and circulatory arrest.

If there are signs of overdose, the administration of Mepivacaine hydrochloride solution for injection must be halted immediately. Your doctor will decide what further therapeutic measures are required, which may include an infusion of a lipid emulsion.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The possible undesirable effects after use of Mepivacaine hydrochloride solution for injection largely correspond to those of other local anaesthetics. Undesirable effects caused by the medicinal products itself are difficult to distinguish from the physiological effects of nerve blockade (e.g. drop in blood pressure, slow heart rate). They are also difficult to distinguish from the consequences of the puncture, either direct (e.g. nerve damage) or indirect (e.g. abscess at the administration site).

Rare (affects less than 1 in 1,000 people)

•    allergic reactions

•    life threatening allergic reactionneuropathy (peripheral nerve disease)

•    peripheral nerve injury

•    arachnoiditis (inflammation of one of the membranes that cover the brain and spinal cord)

•    double vision.

•    heart rate disorders

•    cardiac arrest

•    respiratory failure

•    These side effects occur more commonly after epidural anaesthesia.

Reporting of side effects

If you get any side effects, talk to your doctor or 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, Website: 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 Mepivacaine

hydrochloride solution for injection

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

•    This medicinal product does not require any special storage conditions.

•    Do not freeze.

•    Do not use this medicine after the expiry date, which is stated on the ampoule, vial and carton. The expiry date refers to the last day of that month.

•    Do not use this medicine if you notice the contents are discoloured in any way or if particles are present.

•    Mepivacaine hydrochloride solution for injection is for single use only and should be used immediately after opening. Discard any unused solution.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

Mepivacaine hydrochloride 10 mg/ml solution for injection:

10 ml red band ampoules are supplied in packs of 1 and 5 ampoules

20 ml vials with chlorobutyl rubber stopper and mist grey flip-off seal are supplied in packs of 1, 5 and 10 vials

Mepivacaine hydrochloride 20 mg/ml solution for injection:

2 ml green band ampoules are supplied in packs of 1 and 5 ampoules

5 ml red band ampoules are supplied in packs of 1, 5, 10 and 50 ampoules

10 ml green band ampoules are supplied in packs of 1 and 5 ampoules

20 ml vials with chlorobutyl rubber stopper and lavender flip-off seal are supplied in packs of 1, 5 and 10 vials

The ampoules are available in blister/ tray pack.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Accord Healthcare Limited Sage House

319, Pinner Road, North Harrow Middlesex HA1 4HF United Kingdom

Manufacturer

Accord Healthcare Limited Sage House

319, Pinner Road, North Harrow Middlesex HA1 4HF United Kingdom

Wessling Hungary Kft.

Budapest, Foti ut 56 , 1047,

Hungary

This leaflet was last revised in 05/2016.

In addition, any abnormal absorption characteristics or

disturbances of metabolism in the liver or disturbances in

excretion via the kidneys must be considered as a possible

cause of undesirable effects.

Possible side effects

Common (affects less than 1 in 10 people)

•    pins and needles or numbness

•    dizziness

•    reduction in heart rate

•    low blood pressure*, high blood pressure

•    nausea*, vomiting.

Uncommon (affects less than 1 in 100 people)

•    signs and symptoms of CNS toxicity, e.g. seizures, tingling around the mouth, numbness of the tongue, hearing and vision disturbances, loss of consciousness, tremor, ringing in the ears (tinnitus), speech disturbances, suppression of the functions of the CNS

What Mepivacaine hydrochloride solution for injection contains

The active substance is Mepivacaine hydrochloride. Mepivacaine 10 mg/ml solution for injection:

Each 1 ml of solution contains Mepivacaine hydrochloride 10 mg. Each 10 ml ampoule contains Mepivacaine hydrochloride100 mg. Each 20 ml vial contains Mepivacaine hydrochloride 200 mg.

Mepivacaine 20 mg/ml solution for injection:

Each 1 ml of solution contains Mepivacaine hydrochloride 20 mg. Each 2 ml ampoule contains Mepivacaine hydrochloride 40 mg. Each 5 ml ampoule contains Mepivacaine hydrochloride 100 mg. Each 10 ml ampoule contains Mepivacaine hydrochloride 200 mg.

Each 20 ml vial contains Mepivacaine hydrochloride 400 mg.

The other ingredients are water for injections, sodium chloride and sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment)

What Mepivacaine hydrochloride solution for injection looks like and contents of the pack

Mepivacaine solution for injection is a clear, colourless, sterile solution for injection. It is available in Type I clear glass ampoules and Type I clear glass vials with rubber stopper and flip-off seal.

recommended. Accidental intravascular injection can be recognised by the specific toxicity symptoms. Accidental intrathecal injection is recognised by the signs of spinal blockade. If toxic symptoms occur, the injection must be halted immediately.

Mepivacaine hydrochloride solution for injection is injected into the space around the spinal cord for targeted anaesthesia of individual nerves (epidural nerve block).

To anaesthetise tissue, Mepivacaine hydrochloride solution for injection is injected into a localised area of tissue (infiltration anaesthesia). To anaesthetise individual nerves (peripheral nerve block), for pain therapy and sympathetic nerve blockade, Mepivacaine hydrochloride solution for injection is applied locally following targeted puncture, depending on anatomical considerations.

Mepivacaine hydrochloride solution for injection should be used only by those with the relevant knowledge of successfully conducting the relevant anesthetic procedure.

As a general rule, low concentration solutions are applied in continuous administration (drip).

Repeated use of this medicinal product can result in loss of efficacy due to rapid development of tolerance to the drug (tachyphylaxis).

For small surgical procedures, more short term anaesthesia is desired.

In order to avoid side effects, the following points should be

noted:

•    An intravenous access for an infusion (volume replacement) should be placed in patients who are at risk and when using high doses.

•    In general an agent that causes narrowing of the blood vessels should not be added to the therapy.

•    The patient should be correctly positioned.

•    Blood pressure, pulse/ECG and the size of the pupils must be monitored.

•    General and special contraindications and interactions with other agents should be noted.

•    Ensure that resuscitation equipment (e.g. to keep the airway open and administer oxygen) and emergency medication to treat toxic reactions are immediately available

•    Have a lipidic emulsion available to administer in the event of intoxication with clinical symptoms of neurotoxicity or cardiotoxicity.

Use with caution:

•    In patients receiving the anticoagulant treatment with low molecular weight heparin

•    When injecting into an inflamed (infected) area (increased absorption accompanying reduced efficacy)

•    In retrobulbar and peribulbar injections

•    In epidural anaesthesia (injecting an anesthetic around the spinal canal to achieve anaesthesia), low blood pressure and slow heart rate can occur.

•    In elderly patients (sudden arterial hypotension is one of the possible complications of epidural anaesthesia),

•    In patients in weakened general condition,

•    In patients with partial or complete heart block

•    In patients receiving the certain medicines to treat fever and pain (non-steroidal anti-inflammatories) or agents to increase the blood volume (plasma substitutes).

•    Loss of cartilage tissue was reported in patients who had received continuous infusions of local anesthetics in a joint after surgery. In the majority of cases reported, the shoulder joint was affected.

•    Use in head and neck region is more hazardous, since the risk for central nervous system intoxication symptoms is increased.

Method of administration

The method of administration of Mepivacaine varies according

to the method of infiltration anaesthesia, perineural

anaesthesia and epidural anaesthesia.

Handling Instructions

Only clear solutions practically free from particles should be used.

The solution for injection is intended for single withdrawal and use only and must be used immediately after opening the ampoule and vial. Any unused solution should be discarded. Do not use this medicine after the expiry date, which is stated on the ampoule, vial and carton. The expiry date refers to the last day of that month.

Storage information

Do not freeze.

Use immediately after opening.

Shelf-life

2 years