Prialt 100micrograms/1ml solution for infusion vials

Prialt is used to treat severe pain which has persisted for a long time. It works by stopping pain signals in the spinal cord from reaching the brain.

Prialt is given through a pump as a continuous injection into your spine. The type of pump used may vary. It may be carried outside your body or be implanted in the chest or stomach wall. Your medical team will help you decide which type is most suitable for you.

Long-term treatment with continuous spinal injection may increase your chances of getting a serious infection such as meningitis. If you are having long-term treatment with Prialt your medical team will tell you how to recognise symptoms of infection. You must seek immediate medical advice if you develop any signs of infection while being treated with Prialt.

Other information about Prialt:

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber or someone involved in your medical care.

Your prescriber will advise you when you need to have your injections. Prialt is given continuously through a pump. Your prescriber will advise you how long the supply of Prialt in the pump will last and when it needs to be refilled.

This medicine will be given to you as an infusion via a pump. If you have any concerns about this medicine or how this will be given to you, talk to someone who is involved in your medical care.

Prialt is given continuously through a pump. Your prescriber and pharmacist will make sure that the pump is set to deliver the correct dose of Prialt.

The person in charge of your care will make the decision about when you should stop this medicine. If you experience any problems while having this medicine, talk to someone who is involved in your medical care.

The medical team will often be responsible for looking after this medicine. However, if you are responsible for looking after this medicine make sure that you store it properly and safely. Check the label and Patient Information leaflet for details or ask a member of your medical team.

In the case of Prialt:

Do not use the medicine after the expiry date shown on the packaging. If you have any unused medicine, return it to your pharmacist who will dispose of it safely.

Prialt is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

Furthermore the prescriber may only prescribe this medicine with special care or may not prescribe it at all for someone who is under the age of 18 years.

As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:

Over time it is possible that Prialt can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Prialt has become unsuitable, it is important that the prescriber is contacted immediately.

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

Very common: More than 1 in 10 people who have Prialt:

• abnormal gait
• blurred vision
• confusion - seek medical advice if you experience confusion
• eye or eyesight problems
• feeling dizzy
• headaches
• memory problems - seek medical advice if you develop memory problems
• nausea
• sleepiness
• vomiting
• weakness

Common: More than 1 in 100 people who have Prialt:

• a drop in blood pressure on standing or sitting up
• abnormal laboratory test results
• balance or coordination problems
• breathing difficulties
• burning sensation
• changes to sense of smell
• chest pain
• constipation
• diarrhoea
• difficulty sleeping
• double vision
• dry mouth
• falls
• feeling cold
• feeling jittery
• fever
• hypersensitivity to external stimuli such as light, noise and physical contact
• hypoaesthesia
• increased sweating
• itching
• joint pain
• lethargy
• limb pain
• loss of appetite
• lowered blood pressure
• muscle cramps
• muscle pain or tenderness
• muscle spasm
• muscle weakness
• neurological, psychological or psychiatric problems seek medical advice if you develop any of the following symptoms: hallucinations; feeling paranoid; mania or mania-like behaviour; feelings of hostility; aggressive behaviour; reduced conscious level; psychiatric problems; psychological problems; thinking problems; feelings of disorientation; feeling anxious; feeling agitated; depression; feeling irritable; worsening of depression; feeling nervous; mood changes; worsening of anxiety; speech problems; concentration problems; or lowering of mental acuity
• oedema of the extremities
• over-sensitivity or fear of light
• pain
• painful urination
• paraesthesiae
• reflex problems
• rigors
• sedation
• stomach pain
• swelling of the extremities
• taste changes
• tinnitus
• tiredness
• tremors
• urinary hesitation
• urinary incontinence
• urinary retention
• vertigo
• weight loss
• worsening of nausea
• worsening of pain

Uncommon: More than 1 in 1000 people who have Prialt:

• back pain
• brain or central nervous system problems
• coma
• convulsions
• delirium - seek medical advice if you develop delirium
• difficulty in walking
• ECG changes
• heart problems
• increased body temperature
• indigestion
• kidney problems
• loss of consciousness - seek medical advice if you experience a loss of consciousness
• meningitis or meningitis-like symptoms
• muscle twitching
• myositis
• neck pain
• psychosis or psychotic-like behaviour - seek medical advice if you develop psychosis or psychotic-like behaviour
• respiratory distress
• rhabdomyolysis
• sepsis
• skin rash or rashes
• strange dreams
• stroke
• stupor
• suicide attempt
• thoughts of committing suicide

If you feel unwell or if you have concerns about a side-effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call NHS Direct on 0845 46 47.

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Prialt:

The following types of medicine may interact with Prialt:

If you are taking Prialt and one of the above medicines or types of medicines, make sure your prescriber knows about it.

Medicines can interact with complementary preparations and vitamins. In general, there is not much information available about interactions between medicines and complementary preparations or vitamins.

If you are planning to take or are already taking any complementary preparations and vitamins you should ask your prescriber whether there are any known interactions with Prialt.

Your prescriber can advise whether it is appropriate for you to take combinations that are known to interact. They can also discuss with you the possible effect that the complementary preparations and vitamins may have on your condition.

If you experience any unusual effects while taking this medicine in combination with complementary preparations and vitamins, you should tell your prescriber.

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

In the case of Prialt:

You should see how this medicine affects you before you judge whether you are safe to drive or operate machinery. If you are in any doubt about whether you should drive or operate machinery, talk to your prescriber.

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Prialt:

Alcohol can interact with certain medicines.

In the case of Prialt:

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Prialt:

You need to discuss your specific circumstances with your doctor to weigh up the overall risks and benefits of taking this medicine. You and your doctor can make a decision about whether you are going to take this medicine during pregnancy.

If the decision is that you should not have Prialt, then you should discuss whether there is an alternative medicine that you could take during pregnancy.

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Prialt:

Before you have your baby you should discuss breast-feeding with your doctor or midwife. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast-feed. You should not stop this medicine without taking advice from your doctor.

Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. Some may be used to prolong the life of the medicine.

Prialt contains:

If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Prialt before, do not have Prialt. Talk to your prescriber, pharmacist or nurse as soon as possible.