What is it and how is it used?
Prialt belongs to a group of medicines, called analgesics or ‘painkillers’. Prialt is used for the treatment of long-term pain when your existing treatment is not effective or causes severe side effects.
What do you have to consider before using it?
Do not use Prialt
Take special care with Prialt
case, you should immediately notify your doctor, as he/she may decide to halt your Prialt treatment.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines (for example, baclofen, clonidine, bupivacaine or propofol), including medicines obtained without a prescription. You may feel drowsy if you are given Prialt with certain other medicines used to treat pain.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant, or are breast-feeding ask your doctor for advice before taking any medicine.
Prialt should not be used during pregnancy or breast-feeding unless clearly necessary.
Driving and using machines
The use of Prialt has been reported to cause confusion and drowsiness. Ask your doctor for advice before you drive or operate machinery.
How is it used?
Your treatment with Prialt will be managed by a doctor who has experience of giving medicines into the space around the spinal cord, and in the use of internal and external infusion pumps.
Prialt is given as a very slow continuous injection into the space surrounding the spinal cord. The medicine will be administered continuously from a pump either implanted into your abdominal wall or placed externally in a belt pouch. Your doctor will discuss with you the kind of pump that will be most suitable for you and when you need to have your pump refilled.
The recommended starting dose is no more than 2.4 micrograms per day. Your doctor will adjust the dose of Prialt according to the severity of your pain in dose increments of ≤ 2.4 micrograms/day. The maximum dose is 21.6 micrograms/day. At the start of your treatment your doctor may increase your dose every 1 to 2 days or more. If needed, the dose may be decreased or injection stopped if the side effects are too great.
If you feel that you are still in too much pain while taking Prialt, or that the side effects are too great, talk to your doctor.
Before giving you Prialt, your doctor might decide to slowly stop giving you opiates (other types of medicinal product which are used to treat pain) into your spinal cord and instead replace with alternative pain medicinal products.
If you use more Prialt than you should
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.
What are possible side effects?
Like all medicines, Prialt can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following convention: Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Very common:
Confusion, dizziness, blurred vision, headache, rapid back-and-forth movement of the eyes, loss or impairment of memory (forgetfulness), difficulty walking, vomiting, nausea, general weakness and drowsiness.
Common: 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 pain sensitivity, 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, lightheadedness 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, fever, blood chemistry changes, mental impairment and weight decreased.
Uncommon
Infection of the blood stream, meningitis, delirium (feeling of mental confusion), psychotic disorder (abnormal thinking and perceptions), suicidal thought or attempt, thought disorders, abnormal dreams, incoherence (inability to make sense), loss of consciousness, coma, stupor (unresponsive/difficult to arouse), convulsions (fits), stroke, encephalopathy (brain disorder), abnormal heart rhythm, difficulty breathing, indigestion,rash, muscle breakdown (rhabdomyolysis), muscle inflammation, back pain, muscle twitching, neck pain, acute kidney failure, abnormal heart trace measurements (ECG), raised body temperature.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How should it be stored?
Keep out of the reach and sight of children.
Do not use Prialt after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Store unopened vial in refrigerator (2°C – 8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
Chemical and physical in use stability has been demonstrated for 60 days at 37°C.
From a microbiological point of view, if the product is diluted it should be transferred to the infusion pump immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C – 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
