BUPIVACAINE AUROVITAS 5 mg/ml INJECTABLE SOLUTION

2. What you need to know before you use Bupivacaine Aurovitas

Do not useBupivacaineAurovitas

• if you are allergic to bupivacaine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to any other local anesthetic of the same class (such as lidocaine or ropivacaine).
• if you have a skin infection near the injection site.
• if you have a condition called cardiogenic shock (a disorder in which the heart cannot supply enough blood to the body).
• if you have a condition called hypovolemic shock (very low blood pressure that leads to fainting).
• if you have blood coagulation problems.
• if you have brain or spinal cord diseases, such as meningitis, poliomyelitis or spondylitis.
• if you have a severe headache caused by bleeding inside the head (intracranial hemorrhage).
• if you have spinal cord problems due to anemia.
• if you have blood poisoning (septicemia).
• if you have recently had trauma, tuberculosis or tumors in the spine.
• if you have a paracervical obstetric block (a type of anesthesia given during childbirth).
• bupivacaine containing adrenaline for special techniques (e.g. penile block, Oberst block) to numb parts of the body in areas with terminal artery involvement.

If any of the above applies to you, you should not be given bupivacaine. If in doubt, consult your doctor before you are given the bupivacaine injection solution.

Warnings and precautions

Consult your doctor before you start using Bupivacaine Aurovitas.

• if you are an elderly person and have a poor general condition.
• if you have heart, liver or kidney problems. In this case, your doctor may need to adjust the dose of bupivacaine.
• if you have a swollen abdomen due to more fluid than normal.
• if you have a stomach tumor.
• if you have been told you have a decrease in blood volume (hypovolemia).
• if you have fluid in the lungs.

Children

In children under 12 years of age, since the use of some doses of bupivacaine for numbing parts of the body during surgical procedures in younger children has not been established. The use of bupivacaine in children under 1 year of age has not been established.

If you are not sure if any of the above applies to you, consult your doctor before you are given bupivacaine.

UsingBupivacaineAurovitas with other medicines

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

Taking some medicines together can be harmful. Remember that the hospital doctor may not be aware that you have recently started treatment for another illness. In particular, tell your doctor if you are taking:

• medicines used to treat heart rhythm (such as lidocaine, mexiletine or amiodarone).
• medicines used to prevent blood clots (anticoagulants).

The doctor should be aware of these medicines in order to calculate the correct dose of bupivacaine for you.

Pregnancy, breastfeeding and fertility

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

Bupivacaine may pass into breast milk. If you are breastfeeding, you should consult your doctor about the options.

Driving and using machines

Bupivacaine may make you feel drowsy and affect your reaction speed. After receiving bupivacaine, you should not drive or use tools or machines until the next day.

BupivacaineAurovitas contains sodium

Patients on low-sodium diets should note that this medicine contains approximately 3.19 mg (or 0.14 mmol) of sodium per ml.

3. How to use Bupivacaine Aurovitas

Bupivacaine will be administered to you by a doctor with the necessary knowledge and experience in epidural anesthesia techniques.

The recommended dose that your doctor will administer to you will depend on the type of pain relief you need and where in the body the injection will be given. It will also depend on your body size, age and physical condition. Usually, a dose of sufficient duration can be administered, but more doses may be administered if the surgical procedure is prolonged.

Bupivacaine will be administered to you in the form of an injection. The part of the body where the injection will be given will depend on the reason why you are being given bupivacaine. The doctor will administer bupivacaine to you in one of the following places:

• Near the part of the body that needs to be numbed.
• In an area away from the part of the body that needs to be numbed. This is the case if you are given an epidural injection (an injection around the spinal cord).

When bupivacaine is injected into the body in one of these places, it prevents nerves from transmitting pain messages to the brain. The effect will wear off gradually once the medical procedure is finished.

Method of administration

The medicine is exclusively for percutaneous infiltration, peripheral nerve block(s) and central nervous block (caudal or epidural).

If you use more Bupivacaine Aurovitas than you should

It is unlikely that serious side effects will occur from using too much bupivacaine. They require special treatment and the doctor treating you has experience in dealing with these situations. The first signs that you are using too much bupivacaine are usually the following:

• Dizziness
• Numbness of the lips and around the mouth
• Numbness of the tongue
• Hearing problems
• Vision problems

To reduce the risk of serious side effects, the doctor will stop administering bupivacaine as soon as these signs appear. This means that if you experience any of these signs or if you think you have received more bupivacaine than you should, you should inform your doctor immediately.

The most serious side effects due to excessive administration of bupivacaine include muscle spasms, convulsions and loss of consciousness.

If you forget to useBupivacaineAurovitas

If you think you have forgotten a dose, inform your doctor or nurse.

Do not use a double dose to make up for forgotten doses.

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

4. Possible side effects

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

Severe allergic reactions (rare, may affect up to 1 in 1,000 people):

Tell your doctor immediately if you have a severe allergic reaction. The signs may include:

• Sudden swelling of the face, lips, tongue or throat, which may make it difficult to swallow.
• Severe or sudden swelling of the hands, feet and ankles.
• Difficulty breathing.
• Severe itching of the skin (with hives).

Other possible side effects:

Very common: may affect more than 1 in 10 people

• Low blood pressure. You may feel dizzy.
• Nausea.

Common: may affect up to 1 in 10 people

• Vomiting.
• Dizziness.
• Numbness.
• High blood pressure (hypertension).
• Slow heart rate.
• Urination problems.

Uncommon: may affect up to 1 in 100 people

• Dizziness.
• Convulsions.
• Numbness of the tongue or around the mouth.
• Noises in the ears or sensitivity to noise.
• Difficulty speaking.
• Blurred vision.
• Loss of consciousness.
• Tremors.
• Muscle spasms.

Rare: may affect up to 1 in 1,000 people

• Double vision.
• Nerve damage that can cause changes in sensitivity or muscle weakness (neuropathy). It can include damage to the peripheral nerves.
• A condition called arachnoiditis (inflammation of the membrane that surrounds the spinal cord). The signs include a burning or stinging sensation in the lumbar area or legs and numbness, tingling or weakness in the legs.
• Weak or paralyzed legs.
• Irregular heartbeat (arrhythmias). This reaction could be potentially life-threatening.
• Slow or interrupted breathing or interrupted heartbeat. This reaction could be potentially life-threatening.

Other possible side effects observed with other local anesthetics that may also be caused by bupivacaine include:

• Liver enzyme problems. This can happen if you follow long-term treatment with this medicine.
• Nerve damage. It rarely causes permanent problems.
• Blindness, which is not permanent, or eye muscle problems, which are long-lasting. This can happen with injections given around the eyes.

Other side effects in children and adolescents

• The side effects of the medicine in children are similar to those observed in adults.

Reporting of side effects

If you experience 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 to the Spanish Medicines Agency: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bupivacaine Aurovitas

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

Do not use this medicine after the expiry date which is stated on the ampoule and carton after EXP. The expiry date is the last day of the month shown.

Do not use this medicine if you notice that the contents have changed color or if there are particles.

Bupivacaine Aurovitas is for single use. Discard the unused solution.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition ofBupivacaineAurovitas

• The active substance is bupivacaine hydrochloride.

Each ml contains 5 mg of bupivacaine hydrochloride.

Each ampoule with 10 ml of solution contains 50 mg of bupivacaine hydrochloride.

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

Appearance of the product and pack contents

Injection solution.

Clear and colorless sterile aqueous solution.

10 ml type I glass ampoules.

Each carton contains 1, 5, 10, 20 and 100 ampoules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

You can request more information about this medicine from the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: November 2016

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended only for healthcare professionals:

The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.

1. Administration

Injection solution.

The medicine is exclusively for percutaneous infiltration, peripheral nerve block(s) and central nervous block (caudal or epidural).

The doctor's experience and knowledge of the patient's physical condition are important for calculating the necessary dose. The minimum dose necessary for adequate anesthesia should be used. The dose limit should not be exceeded. A dose of 400 mg administered in 24 hours is well tolerated by the average adult. In pediatric patients, the minimum dose necessary for adequate anesthesia should be used.

1. Handling instructions

For single use.

Only clear solutions that are practically free of particles should be used. The unused solution should be discarded.

Do not use this medicine after the expiry date which is stated on the ampoule and carton after EXP. The expiry date is the last day of the month shown.

Information on storage

No special storage conditions are required.