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Haloperidol 1mg/ml Oral Solution
Haloperidol 1mg/ml Oral Solution
The name of your medicine is Haloperidol 1mg/ml Oral Solution but it will be referred to as 'Haloperidol' throughout this leaflet.
1. What Haloperidol is and what it is used for
2. What you need to know before you take Haloperidol
3. How to take Haloperidol
4. Possible side effects
5. How to store Haloperidol
6. Contents of the pack and other information
This medicine contains the active substance haloperidol. This belongs to a group of medicines called 'antipsychotics'.
Haloperidol is used in adults, adolescents and children 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:
In adolescents and children, Haloperidol is used to treat schizophrenia in patients aged 13 to 17 years, and to treat behavioural problems in patients aged 6 to 17 years.
Haloperidol is also used:
Haloperidol is sometimes used when other medicines or treatments have not worked or caused unacceptable side effects.
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Haloperidol.
Serious side effects
Haloperidol 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 taking Haloperidol because you may need urgent medical treatment. See 'Look out for serious side effects' in section 4.
A small increase in deaths and strokes has been reported for elderly people with dementia who are taking antipsychotic medicines. Talk to your doctor or pharmacist before taking Haloperidol if you are elderly, particularly if you have dementia.
Talk to your doctor or pharmacist if you have:
You may need to be more closely monitored, and the amount of Haloperidol you take may have to be altered.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Haloperidol.
Your doctor may want to take an electrocardiogram (ECG) before or during your treatment with Haloperidol. The ECG measures the electrical activity of your heart.
Your doctor may want to check the levels of potassium or magnesium (or other 'electrolyte') in your blood before or during your treatment with Haloperidol.
Haloperidol should not be used in children below 6 years of age. This is because it has not been studied adequately in this age group.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Haloperidol 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 take Haloperidol (see 'Do not take Haloperidol if').
Special monitoring may be needed if you are taking lithium and Haloperidol 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 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 if you are taking any of these medicines.
Haloperidol can affect the way the following types of medicine work
Tell your doctor if you are taking medicines for:
Talk to your doctor before taking Haloperidol if you are taking any of these medicines.
Drinking alcohol while you are taking Haloperidol 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 taking Haloperidol and let your doctor know how much you drink.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor may advise you not to take Haloperidol while you are pregnant.
The following problems may occur in newborn babies of mothers that take Haloperidol in the last 3 months of their pregnancy (the last trimester):
The exact frequency of these problems is unknown. If you took Haloperidol while pregnant and your baby develops any of these side effects, contact your doctor.
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 taking Haloperidol.
Haloperidol 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.
Haloperidol 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 taking it or after a high dose. Do not drive or use any tools or machines without discussing this with your doctor first.
Methyl parahydroxybenzoate (E218):
May cause an allergic reaction (possibly delayed).
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will tell you how much Haloperidol to take and for how long. Your doctor will also tell you whether to take Haloperidol one or more times a day. 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. It is very important you take the correct amount.
Your dose of Haloperidol will depend on:
Children and adolescents 6 to 17 years of age
This medicinal product must be taken orally.
Use the measuring syringe provided in the pack to deliver the required dose.
Your doctor, pharmacist or nurse will show you how to administer this medicine. The box containing this medicine will contain a 1ml dosing syringe, a 10ml dosing syringe, and a syringe adaptor.
A 10ml oral syringe is recommended when a dose volume more than 1ml has to be given.
A 1ml oral syringe is recommended when a dose volume of 1ml or less has to be given and when an additional volume of 0.1ml or more is required but less than 1 ml.
Diagram of 1ml syringe
On the 1ml syringe each numbered increment is 0.1ml which is equivalent to 0.1mg of Haloperidol.
Diagram of 10ml syringe
On the 10ml syringe each numbered increment is 1ml which is equivalent to 1mg Haloperidol.
If you are not sure how to use the syringe ask your pharmacist for help.
a) Open the bottle: press the cap and turn it anticlockwise (figure 1). Separate the adaptor from the syringe (figure 2).
b) Insert the adaptor into the bottle neck (figure 3). Ensure it is properly fixed. Take the syringe and put it in the adaptor opening (figure 4).
c) Turn the bottle upside down. Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upwards in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 5C).
d) Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).
e) During administration the oral syringe should be directed towards the cheek on the side of the mouth. Empty the content of the syringe by pushing the piston to the bottom of the syringe (figure 7). The contents of the syringe should be emptied into the side cheek of the patient's mouth to avoid a choking hazard. Close the bottle with the plastic screw cap. Wash the syringe with water (figure 8).
If you are still not sure how to administer the medicine, please ask your pharmacist.
If you take more Haloperidol than you were told to or if someone else has taken any Haloperidol, talk to a doctor or go to the nearest hospital casualty department straight away.
Unless your doctor tells you otherwise, you should stop taking Haloperidol gradually. Stopping treatment suddenly may cause effects such as:
Always follow your doctor's instructions carefully.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor 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 taking Haloperidol (may affect up to 1 in 100 people). Sudden deaths have occurred in patients taking 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 taking Haloperidol (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 taking Haloperidol (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 taking 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.
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:
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: 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 haloperidol.
Each ml of oral solution contains 1mg haloperidol.
The other ingredients are (S)-lactic acid, methyl parahydroxybenzoate (E218) and purified water.
Haloperidol is a clear, colourless oral solution supplied in amber glass bottles with a tamper evident child resistant plastic cap. The pack also contains a 1ml oral syringe with 0.01ml graduation marks and a 10ml oral syringe with 0.5ml graduation marks and a syringe adaptor.
Haloperidol is supplied in bottles containing 100ml and 200ml of oral solution.
Not all pack sizes may be marketed.
If this leaflet is hard to see or read, please call +44 (0) 208 515 3700 for help.
This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Malta:Haloperidol Thame 1mg/ml Oral Solution
United Kingdom (Northern Ireland): Haloperidol 1mg/ml Oral Solution
This leaflet was last revised in 07/2022.