POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
Haloperidol Injection BP 5mg/ml
Package leaflet: Information for the patient
Haloperidol 5mg/ml Solution for Injection
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
The product is known by the name above but will be referred to as Haloperidol Injection throughout the rest of this leaflet.
What is in this leaflet
1. What Haloperidol Injection is and what it is used for
2. What you need to know before you are given Haloperidol Injection
3. How you will be given Haloperidol Injection
4. Possible side effects
5. How to store Haloperidol Injection
6. Contents of the pack and other information
1. WHAT HALOPERIDOL INJECTION IS AND WHAT IT IS USED FOR
Haloperidol Injection contains the active substance haloperidol. This belongs to a group of medicines called ‘antipsychotics’.
Haloperidol Injection is used in adults for illnesses affecting the way you think, feel or behave. These include mental health problems (such as schizophrenia and bipolar disorder) and behavioural problems.
These illnesses may make you:
Haloperidol Injection is also used in adults:
Haloperidol Injection may be used on its own or with other medicine, and is sometimes used when other medicines or treatments have not worked, caused unacceptable side effects, or cannot be taken by mouth.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN HALOPERIDOL INJECTION
Do not use Haloperidol Injection if:
This medicine must not be used if any of the above applies to you. If you are not sure, talk to your doctor, pharmacist or nurse before being given haloperidol injection.
Warnings and precautions
Serious side effects
Haloperidol injection can cause problems with the heart, problems controlling body or limb movements and a serious side effect called ‘neuroleptic malignant syndrome’. It can also cause severe allergic reactions and blood clots. You must be aware of serious side effects while you are using Haloperidol injection because you may need urgent medical treatment. See ‘Look out for serious side effects’ in section 4.
Elderly people and people with dementia
A small increase in deaths and strokes has been reported for elderly people with dementia who are taking antipsychotic medicines. Talk to your doctor before being given Haloperidol injection if you are elderly, particularly if you have dementia.
Talk to your doctor if you have:
You may need to be more closely monitored, and the amount of Haloperidol injection you are given may have to be altered.
If you are not sure if any of the above applies to you, talk to your doctor or nurse before you are given Haloperidol injection.
Medical check ups
Your doctor may want to take an electrocardiogram (ECG) before or during your treatment with Haloperidol Injection. The ECG measures the electrical activity of your heart.
Your doctor may want to check the levels of potassium or magnesium (or other electrolytes) in your blood before or during your treatment with Haloperidol injection.
Children and adolescents
Haloperidol Injection should not be used in children and adolescents below 18 years. This is because it has not been studied in these age groups.
Other medicines and Haloperidol Injection
Tell your doctor or nurse if you are taking or have recently taken or might take any other medicines.
Do not use Haloperidol injection if you are taking certain medicines for:
Also tell your doctor if you are taking bepridil (for chest pain or to lower blood pressure) or methadone (a pain killer or to treat drug addiction).
These medicines may make heart problems more likely, so talk to your doctor if you are taking any of these and do not use Haloperidol Injection (see ‘Do not use Haloperidol Injection if’).
Special monitoring may be needed if you are using lithium and Haloperidol injection at the same time.
Tell your doctor straight away and stop taking both medicines if you get:
These are signs of a serious condition.
Certain medicines may affect the way that Haloperidol injection works or may make heart problems more likely
Tell your doctor if you are taking:
Also tell your doctor if you are taking any other medicines to lower blood pressure, such as water tablets (diuretics).
Your doctor may have to change your dose of Haloperidol Injection if you are taking any of these medicines.
Haloperidol injection can affect the way the following types of medicine work
Tell your doctor if you are taking medicines for:
Talk to your doctor or nurse before being given Haloperidol Injection if you are taking any of these medicines.
Haloperidol Injection with alcohol
Drinking alcohol while you are using Haloperidol Injection might make you feel sleepy and less alert. This means you should be careful how much alcohol you drink. Talk to your doctor about drinking alcohol while using Haloperidol Injection, and let your doctor know how much you drink.
Pregnancy, breast-feeding and fertility
Pregnancy – if you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice. Your doctor may advise you not to use Haloperidol Injection while you are pregnant.
The following problems may occur in newborn babies of mothers that use Haloperidol Injection in the last 3 months of their pregnancy (the last trimester):
The exact frequency of these problems is unknown. If you used Haloperidol Injection while pregnant and your baby develops any of these side effects, contact your doctor.
Breast-feeding – talk to your doctor if you are breast-feeding or planning to breast-feed. This is because small amounts of the medicine may pass into the mother’s milk and on to the baby. Your doctor will discuss the risks and benefits of breast-feeding while you are using Haloperidol Injection.
Fertility – Haloperidol Injection may increase your levels of a hormone called ‘prolactin’, which may affect fertility in men and women. Talk to your doctor if you have any questions about this.
Driving and using machines
Haloperidol Injection can affect your ability to drive and use tools or machines. Side effects, such as feeling sleepy, may affect your alertness, particularly when you first start using it or after a high dose. Do not drive or use any tools or machines without discussing this with your doctor first.
Haloperidol Injection contains sodium
This medicine contains less than 1 mmol sodium (23mg) per dose, i.e. is essentially sodium free.
3. HOW TO USE HALOPERIDOL INJECTION
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
How much medicine will be given to you
Your doctor will decide how much Haloperidol Injection you need and for how long. It may be some time before you feel the full effect of the medicine. Your doctor will normally give you a low dose to start, and then adjust the dose to suit you. Your dose of haloperidol will depend on:
How Haloperidol Injection is given
Haloperidol Injection will be given by a doctor or nurse. It is for intramuscular use, and is given as an injection into a muscle.
If you stop using Haloperidol Injection
Unless your doctor decides otherwise, Haloperidol Injection will be stopped gradually. Stopping treatment suddenly may cause effects such as:
Always follow your doctor’s instructions carefully.
If you miss a dose or have too much Haloperidol Injection
A doctor or nurse will give this medicine to you, so it is unlikely that you will miss a dose or be given too much. If you are worried, tell the doctor or nurse.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Look out for serious side effects
Tell your doctor or nurse straight away if you notice or suspect any of the following. You may need urgent medical treatment.
Problems with the heart:
Heart problems are uncommon in people using Haloperidol Injection (may affect up to 1 in 100 people). Sudden deaths have occurred in patients using this medicine, but the exact frequency of these deaths is unknown. Cardiac arrest (the heart stops beating) has also occurred in people taking antipsychotic medicines.
A serious problem called ‘neuroleptic malignant syndrome’.
This causes a high fever, severe muscle stiffness, confusion and loss of consciousness. It is rare in people using Haloperidol Injection (may affect up to 1 in 1,000 people).
Problems controlling movements of the body or limbs (extrapyramidal disorder), such as:
These are very common in people using Haloperidol Injection (may affect more than 1 in 10 people). If you get any of these effects, you may be given an additional medicine.
Severe allergic reaction that may include:
An allergic reaction is uncommon in people using Haloperidol (may affect up to 1 in 100 people).
Blood clots in the veins, usually in the legs (deep vein thrombosis or DVT). These have been reported in people taking antipsychotic medicines. The signs of a DVT in the leg include swelling, pain and redness in the leg, but the clot may move to the lungs causing chest pain and difficulty in breathing. Blood clots can be very serious, so tell your doctor straight away if you notice any of these problems.
Tell your doctor straight away if you notice any of the serious side effects above:
Other side effects
Tell your doctor if you notice or suspect any of the following side effects.
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people):
The following side effects have also been reported, but their exact frequency is unknown:
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE HALOPERIDOL INJECTION
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the ampoule and carton. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package in order to protect from light.
Do not use this medicine if the solution is cloudy, discoloured or if there are any particles present, it should be returned unused to the pharmacist.
If only part used, discard the remaining solution.
This product should be used immediately after opening.
For single use only.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Haloperidol Injection contains
What Haloperidol Injection looks like and contents of the pack
Haloperidol Injection is a clear, colourless sterile solution in 1ml and 2ml clear glass ampoules. Each carton contains 10 ampoules. Not all pack sizes may be marketed.
Marketing Authorisation Holder
This leaflet was last revised in December 2018.
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