EXPAREL liposomal 133 mg/10 mL prolonged-release dispersion for injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What EXPAREL liposomal is and what it is used for
2. What you need to know before you are given EXPAREL liposomal
3. How you will be given EXPAREL liposomal
4. Possible side effects
5. How to store EXPAREL liposomal
6. Contents of the pack and other information

EXPAREL liposomal should not be used in large abdominal, blood vessel and chest surgeries.

Talk to your doctor or nurse before being given EXPAREL liposomal:

• if you have a heart problem;
• if you have liver or kidney problems.

EXPAREL liposomal use may cause temporary loss of sensation or movement. You may notice a difference in your ability to feel things or move normally for up to 5 days after being given the medicine.

The following conditions have sometimes been reported with use of other local anaesthetics:

• Allergic reactions
  Allergic reactions may rarely occur after being given any local anaesthetic. Signs of allergic reactions to look out for include: hives or skin rash, swelling around the eyes, face, lips, mouth or throat, shortness of breath or difficulty breathing, feeling dizzy or fainting, or fever. Seek urgent medical attention if you notice any of these symptoms after being given EXPAREL liposomal as in rare cases these reactions can become life-threatening (see also section 4 of this leaflet).
• Neurological conditions
  Toxicity of the central nervous system can also sometimes occur. Early signs of this can include: restlessness, anxiety, difficulty speaking, lightheadedness, feeling sick (nausea) or being sick (vomiting), numbness and tingling of the mouth and lips, metallic taste, tinnitus (i.e. ringing in the ears), dizziness, blurred vision, tremors or twitching, depression, drowsiness. Seek urgent medical attention if you notice any of these symptoms after being given EXPAREL liposomal. More serious side effects from being given too much bupivacaine include fits (convulsions), loss of consciousness and heart attack (see also section 4 of this leaflet).
• Cardiovascular conditions
  Cardiovascular conditions can also sometimes occur after use of local anaesthetics. Signs to look out for include: abnormal/irregular heartbeat, low blood pressure, fainting, dizziness or lightheadedness, fatigue (tiredness), shortness of breath, or chest pain. Heart attack can also sometimes occur. Seek urgent medical attention if you notice any of these symptoms after being given EXPAREL liposomal (see also section 4 of this leaflet).
• Methaemoglobinamia
  Methaemoglobinamia is a blood disorder affecting the red blood cells. This condition can occur immediately or a few hours after use of local anaesthetics. Signs and symptoms to look out for include: pale or grey/blue skin, shortness of breath, feeling lightheaded or fainting, confusion, palpitations, or chest pain. Seek urgent medical attention if you notice any of these symptoms after being given EXPAREL liposomal. Sometimes methaemoglobinamia can cause more serious symptoms such as irregular heartbeat, seizures, coma and even death (see also section 4 of this leaflet).
• Chondrolysis
  Chondrolysis (breakdown of cartilage in bone joints) has been noticed in patients receiving intra-articular infusion of local anaesthetics. Exparel liposomal must not be used for intra-articular infusion.

EXPAREL liposomal is not for use in children under 6 years of age to reduce pain in small- to medium-sized wounds following surgery. This medicine has not been studied in this age group. EXPAREL liposomal is not for use in children and adolescents under 18 years of age to reduce pain in a specific part of the body following surgery (such as knee or shoulder joint surgery) . This medicine has not been studied in this age group.

Tell your doctor if you are taking or have recently taken any other medicines.

Taking some medicines together can be harmful. In particular, tell your doctor if you are taking any of the following:

• Nitrates/Nitrites - nitroglycerin, nitroprusside, nitric oxide, nitrous oxide;
• Local anaesthetics - benzocaine, lidocaine, bupivacaine, mepivacaine, tetracaine, prilocaine, procaine, articaine, ropivacaine;
• Anti-arrhythmic - medicines used to treat an uneven heart beat (arrhythmia), such as lidocaine and mexiletine;
• Anti-cancer medicines - cyclophosphamide, flutamide, rasburicase, isofamide, hydroxyurea;
• Antibiotics - dapsone, sulfonamides, nitrofurantoin, para-aminosalicylic acid;
• Antimalarials - chloroquine, primaquine, quinine;
• Anticonvulsants - phenytoin, sodium valproate, phenobarbital;
• Other medicines – acetaminophen (paracetamol), metoclopramide (for stomach problems and anti-sickness), sulfasalazine (for inflammatory conditions), povidone iodine (topical antiseptic).

If you are in doubt about any of these medicines, ask your doctor.

EXPAREL liposomal is NOT recommended for pregnant women and women of childbearing-age who are not using contraception. If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor or nurse before being given this medicine.

EXPAREL liposomal passes into breast milk at very low levels and could cause serious adverse reactions in your baby. Ask your doctor for advice before breastfeeding your baby. They will decide if you should stop breastfeeding your baby or if you should not be given this medicine.

EXPAREL liposomal may affect your ability to feel things or move normally for up to 5 days after being given the medicine. You should not drive or use tools or machines if you have any of these side effects.

This medicine contains 21 mg sodium (main component of cooking/table salt) in each 10 mL vial, and 42 mg in each 20 mL vial. This is equivalent to 1.1% and 2.1%, respectively, of the recommended maximum daily dietary intake of sodium for an adult.

EXPAREL liposomal is intended for use by trained doctors that will check your blood pressure, heart rate, breathing rate, state of consciousness and monitor for any signs that indicate that you have received too much bupivacaine after giving EXPAREL liposomal.

Seek urgent medical attention if you notice any of the below side effects after being given EXPAREL liposomal (see also section 4 of this leaflet). These are signs of having received too much bupivacaine.

• fits (convulsions);
• loss of consciousness;
• feeling restless or anxious;
• difficulty speaking;
• feeling dizzy or lightheaded;
• feeling or being sick;
• numbness and tingling of the mouth and lips;
• changes in vision, hearing, or taste;
• tremors or twitching;
• feeling drowsy, confused or not fully alert;
• increased or decreased blood pressure;
• increased or decreased heart rate.

It is unlikely you will miss a dose. EXPAREL liposomal will be given to you by your doctor only once (during your surgery).

Common (may affect up to 1 in 10 people):

• distortion of the sense of taste;
• constipation;
• feeling sick or being sick;
• oral loss of sensation.

Uncommon (may affect up to 1 in 100 people):

• feeling hot;
• general bruising or falls;
• abnormal blood test results;
• pain in the joints;
• decreased mobility or involuntary/uncontrolled body movements;
• injury, pain, spasms, twitching or weakness in the muscles;
• burning sensation;
• headache;
• loss of sensation;
• itchy skin or skin irritation.

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

• abdominal discomfort, bloating or indigestion;
• diarrhoea;
• dry mouth, difficulty or pain with swallowing;
• itching inside the mouth;
• excess saliva in the mouth;
• chills;
• pain (in the abdomen, wound site, muscles, groin, hands or feet);
• swelling in ankles, feet, legs or joints;
• stiffness in the joints;
• abnormal ECG;
• fresh blood passing from anus, usually with stools;
• feeling tired;
• partial paralysis;
• difficulty breathing;
• reddenning of the skin or around the wound site;
• complications (e.g., redness, swelling, pain) with the wound site;
• excessive sweating;
• nail discolouration.

Not known (frequency cannot be estimated from the available data):

• inability to urinate (i.e. completely or partially empty the bladder);
• Exparel liposomal does not work.

Some of the above side effects may be seen more frequently in children and adolescents aged 6 years or older.

Very common (may affect more than 1 in 10 people)

• anaemia

Common (may affect up to 1 in 10 people):

• tingling sensation (‘pins and needles’);
• hearing loss;
• rapid breathing;
• delayed recovery from anaesthesia.

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

The active substance is bupivacaine. Each mL contains liposomal 13.3 mg of bupivacaine in a prolonged-release dispersion for injection.

Each vial of 10 mL prolonged-release dispersion for injection contains 133 mg bupivacaine free base.

Each vial of 20 mL prolonged-release dispersion for injection contains 266 mg bupivacaine free base.

The other ingredients are dierucoylphosphatidylcholine (DEPC), dipalmitoylphosphatidylglycerol (DPPG), cholesterol for parenteral use, tricaprylin, sodium chloride, phosphoric acid and water for injection.

EXPAREL liposomal is a white to off-white, prolonged-release dispersion for injection.

It is available in 10 mL or 20 mL, single-use glass vials with an ethylenetetrafluoroethylene-faced grey butyl rubber stopper, and an aluminium/polypropylene flip-tear-up seal.

Each pack contains 4 or 10 vials.

Not all pack sizes may be marketed.

For any information about this medicine, please contact the Marketing Authorisation Holder.