Prialt 100 micrograms/mL solution for infusion

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

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

• if you are allergic to ziconotide or any of the other ingredients of this medicine (listed in section 6).
• if you are receiving an anticancer medicine into the space around your spinal cord.
• if you have a history of suicidal attempt or suicidal ideation with ziconotide.

Patients should undergo a neuropsychiatric evaluation before, after starting and during intrathecal ziconotide, and immediately when any depressive signs or symptoms appear.

Caregivers should contact a physician immediately if the patient experiences symptoms of potentially life-threatening adverse event.

Talk to your doctor before you are given Prialt^®

• The effects of long-term treatment of Prialt^® are uncertain at this time and the possibility of toxic effects on the spinal cord have not yet been ruled out. In case of a need for long term treatment, monitoring may be necessary (as decided by your doctor).
• If you are receiving Prialt^® via a pump worn outside your body, it is important you check once daily for any signs of infection at the point where the tube enters your body.
• If you observe any signs of infection around the tube, such as skin redness, swelling, pain or discharge, you must tell your doctor immediately and seek treatment for the infection.
• If you develop any tenderness in the area around the tube without signs of infection, you should seek advice from your doctor as soon as possible as tenderness may be an early sign of infection.
• If you are receiving Prialt^® via a pump worn outside your body and any part of the infusion tubing becomes disconnected, you must contact your doctor or nurse immediately.
• If you have any of the following symptoms: high temperature, headache, stiff neck, tiredness, confusion, feeling sick, vomiting or occasional fits, these may be signs of meningitis. You must tell your doctor immediately if you experience any of the above symptoms.
• If you notice any adverse change in your thinking, mood or memory, please tell your doctor.
• If you are receiving chemotherapy please tell your doctor.
• You may have an increased level of an enzyme called creatine kinase in your blood and although this does not usually cause any symptoms or problems, your doctor is likely to monitor its level. In addition, you may also occasionally experience muscular problems. If such is the case, you should immediately notify your doctor, as he/she may decide to halt your Prialt^® treatment.
• You should tell your doctor immediately if you experience any of the following symptoms after receiving your treatment; sudden wheeziness, difficulty in breathing, pain in the chest, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body). These may be signs of a severe allergic reaction.
• In patients that suffer from severe long term pain, there is a higher likelihood of suicide and attempted suicide than in the general population. Prialt^® may also cause or worsen depression in people that are already susceptible. If you are experiencing depression or have a history of depression please inform your healthcare professional before you are commenced on Prialt^®. If after starting Prialt^® you experience a worsening of your depression or have any other symptoms affecting your mood, please inform your healthcare professional.
• You may experience drowsiness or may not be fully aware of your surroundings whilst receiving treatment. If this happens, you should immediately notify your doctor, as he/she may decide to halt your Prialt^® treatment.

Prialt^® is not recommended for use in children and adolescents.

Tell your doctor if you are taking, have recently taken or might take any other medicines (for example, baclofen used to treat muscle spasticity, clonidine used to treat high blood pressure, bupivacaine used for local anaesthesia, morphine used for pain, propofol used for general anaesthesia or any medicine which is administered by intrathecal injection (injection into the space that surrounds the spinal cord and the brain)). You may feel drowsy if you are given Prialt^® with certain other medicines used to treat pain.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Prialt^® is not recommended during pregnancy and in women of childbearing potential not using contraception.

The use of Prialt^® has been reported to cause confusion and drowsiness. Ask your doctor for advice before you drive or operate machinery.

This medicine contains less than 1 mmol sodium (23 mg) per maximum recommended intrathecal dose (21.6 micrograms per day), that is to say essentially 'sodium-free'.

If you receive more Prialt^® than your doctor intended, you may feel unwell with signs such as confusion, problems with speech, word finding difficulties, excessive shaking, light-headedness, excessive sleepiness, feeling or being sick. If this happens, consult your doctor or hospital immediately.

You must tell your doctor immediately if you notice these serious side effects as you may require urgent medical treatment.

• Meningitis (may affect up to 1 in 100 people) - is inflammation of the coverings of the brain and spinal cord usually caused by an infection. Symptoms of meningitis are headache, stiff neck, dislike of bright lights, fever, vomiting, confusion and drowsiness.
• Convulsions (may affect up to 1 in 100 people) - convulsions (fits) are when a person's body shakes rapidly and uncontrollably. During a convulsion, the person's muscles contract and relax repeatedly and the person may lose consciousness.
• Suicidal thoughts or suicide attempt (may affect up to 1 in 100 people).
• Rhabdomyolysis (may affect up to 1 in 100 people) - is breakdown of muscle fibres that can lead to kidney damage. Symptoms of rhabdomyolysis are abnormal urine colour (brown coloured), reduced urine production, muscle weakness, muscle aching and muscle tenderness.
• Coma (may affect up to 1 in 100 people) - a state of unconsciousness with difficulty responding or waking up.
• Anaphylactic reaction (frequency cannot be estimated from the available data) - is a severe allergic reaction, the signs of which are sudden wheeziness, difficulty in breathing, pain in the chest, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).

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

Confusion, dizziness, blurred vision, headache, rapid back-and-forth movement of the eyes, loss or impairment of memory (forgetfulness), vomiting, nausea, general weakness and drowsiness.

Common (may affect up to 1 in 10 people)

Decreased appetite, anxiety or worsened anxiety, hallucinations, inability to fall or stay asleep, agitation, disorientation, depression or worsened depression, nervousness, mood swings, mental status changes (thinking abnormal, confusion), paranoia, irritability, worsened confusion, difficulty with learning, memory or thinking, reflexes absent or impaired, problems expressing or understanding words, slurred speech, difficulty with speech or loss of ability to speak, sluggishness, balance or coordination impaired, burning sensation, increased abnormal sensation, reduced level of consciousness (unresponsive or almost unconscious), sedation, difficulty in concentrating, problems with the sense of smell, odd or no sense of taste, shaking, pins and needles, double vision, visual disturbance, intolerance to light, tinnitus (ringing in the ears), dizziness or spinning sensation, light-headedness or dizziness when standing, low blood pressure, shortness of breath, dry mouth, abdominal pain, worsened nausea, diarrhoea, constipation, sweating, itching, muscle weakness, muscle spasms, muscle cramp, muscle or joint pain, difficult or painful urination, difficulty starting or controlling urination, feeling jittery, falling, pain or pain exacerbated, fatigue, feeling cold, swelling of the face, legs or feet, chest pain, blood chemistry changes, mental impairment and weight decreased.

Uncommon (may affect up to 1 in 100 people)

Infection of the blood stream, delirium (feeling of mental confusion), psychotic disorder (abnormal thinking and perceptions), thought disorders, abnormal dreams, incoherence (inability to make sense), loss of consciousness, stupor (unresponsive/difficult to arouse), stroke, encephalopathy (brain disorder), aggressiveness, abnormal heart rhythm, difficulty breathing, indigestion, rash, muscle inflammation, back pain, muscle twitching, neck pain, acute kidney failure, abnormal heart trace measurements (ECG), raised body temperature, difficulty walking.

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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 ziconotide.
• One mL solution contains 100 micrograms ziconotide (as acetate).
• Each 1 mL vial contains 100 micrograms; each 2 mL vial contains 200 micrograms; each 5 mL vial contains 500 micrograms.
• The other ingredients (excipients) are methionine, sodium chloride, water for injections, hydrochloric acid and sodium hydroxide.

Prialt^® is a solution for infusion (infusion). The solution is clear and colourless.

Prialt^® is supplied in packs containing a single vial of either 1 mL, 2 mL or 5 mL.

Not all pack sizes may be marketed.