Haldol decanoate 50mg/1ml solution for injection ampoules

Haldol decanoate is used to treat a variety of mental health problems. Haldol decanoate works by blocking the effect of a chemical in the brain which is thought to affect thinking, feelings and behaviour. It can help to treat the symptoms of schizophrenia and other psychoses.

Other information about Haldol decanoate:

Haldol decanoate is usually given to you by a healthcare professional. The person responsible for giving you your medicine will make sure that you get the right dose.

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 or a member of your medical team will advise you when you need to have your injections. It is usually only given once every two to four weeks. It is a good idea to make a note of the date that your next injection is due so that you do not miss any of your appointments.

This medicine will be given to you as an injection. 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.

Having extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems.

In the case of Haldol decanoate, the person who is responsible for giving you your medicine will make sure that you are given the correct dose.

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.

As Haldol decanoate will be given to you as an injection, it will usually be stored by the medical team.

Haldol decanoate 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 a child or for someone who is in a coma.

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

Over time it is possible that Haldol decanoate can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Haldol decanoate 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 Haldol decanoate

• abnormal muscle movements or problems controlling muscle movement
• difficulty sleeping
• extrapyramidal side-effects - seek medical advice if you develop side-effects such as tremors; increased salivation; slowing of physical movements; feeling restless and an inability to sit still; difficulty moving; muscle stiffness or muscle spasms
• feeling agitated
• headaches

Common: More than 1 in 100 people who have Haldol decanoate

• a drop in blood pressure on standing or sitting up
• abnormal laboratory test results
• changes to weight
• constipation
• depression
• dry mouth
• erectile dysfunction
• eye or eyesight problems
• feeling dizzy
• increased muscle tone
• injection site problems such as abscess
• lowered blood pressure
• nausea
• oculogyric crisis
• psychosis or psychotic-like behaviour
• reduced facial expression
• skin rash or rashes
• sleepiness
• tardive dyskinesia - seek immediate medical advice if you develop abnormal movements of the tongue, face, mouth or jaw
• urinary retention
• vomiting

Uncommon: More than 1 in 1000 people who have Haldol decanoate

• abnormal gait
• amenorrhoea
• blood and bone marrow problems
• blurred vision
• breast pain or discomfort
• breathing difficulties
• confusion
• convulsions
• decreased libido
• faster heart rate
• galactorrhoea
• hypersensitivity reactions
• increased body temperature
• increased sweating
• itching
• jaundice
• liver problems
• oedema
• painful menstrual periods
• Parkinson's-like symptoms
• photosensitivity skin reaction
• sedation
• torticollis
• urticaria

Rare: More than 1 in 10,000 people who have Haldol decanoate

• bronchospasm
• ECG changes
• endocrine problems
• heavy or long menstrual periods
• involuntary eye movement
• menstrual problems
• motor problems
• muscle twitching
• neuroleptic malignant syndrome - seek immediate medical advice if you develop: very high temperature, stiff muscles, autonomic dysfunction or changes in awareness
• sexual dysfunction
• spasms of the jaw muscles

The frequency of these side-effects is unknown

• anaphylactic reactions
• biliary problems
• breast enlargement in men
• cardiac arrest - this may be fatal
• certain types of dermatitis
• death
• decreased blood sugar levels
• facial oedema
• heart problems - some of these may be fatal
• hypothermia
• laryngeal oedema
• laryngeal spasm
• pneumonia - this may be fatal
• priapism
• reduced alertness
• seizures
• Stevens-Johnson syndrome
• thromboembolism such as deep vein thrombosis or pulmonary embolism
• toxic epidermal necrolysis
• vasculitis

The following side effects have been reported in people who have had medicines similar to Haldol decanoate. The frequency of these side-effects in people who have Haldol decanoate is not known

• cerebrovascular problems

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 Haldol decanoate:

The following types of medicine may interact with Haldol decanoate:

If you are taking Haldol decanoate 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 Haldol decanoate.

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 Haldol decanoate:

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 Haldol decanoate:

Alcohol can interact with certain medicines.

In the case of Haldol decanoate:

You should seek advice from your prescriber as to whether you may drink alcohol while taking this medicine.

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 Haldol decanoate:

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 Haldol decanoate, 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 Haldol decanoate:

Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. You should only breast-feed your baby while taking this medicine on the advice of your doctor or midwife.

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.

Haldol decanoate 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 Haldol decanoate before, do not have Haldol decanoate. Talk to your prescriber, pharmacist or nurse as soon as possible.