5 mg / ml injection solution
haloperidol
1. What Haldol is and what it is used for
The name of your medicine is Haldol.
Haldol contains the active substance haloperidol. It belongs to a group of drugs called “antipsychotic drugs”.
Haldol is used for adults with diseases that affect how they think, feel, and behaves. These include mental health problems (such as schizophrenia and bipolar disorder ) as well as behavioral problems.
These diseases can cause you to:
- feel confused ( delirium )
- see, hear, feel or smell things that do not exist (hallucinations)
- believe things that are not true (delusions)
- feel unusually suspicious ( paranoia )
- feel very playful, excited, enthusiastic, impulsive or hyperactive
- feel very aggressive, threatening or violent
Haldol is also used in adults:
- to help control movements in Huntington’s disease
- to prevent and treat nausea and vomiting after surgery.
Haldol can be used alone or in combination with other medicines and is sometimes used when other medicines or treatments have not worked, given unacceptable side effects, or can not be taken by mouth.
Haloperidol contained in Haldol may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before you receive Haldol
Do not use Haldol:
- if you are allergic to haloperidol or any of the other ingredients of this medicine (listed in section 6).
- if you are less aware of things around you and your reactions become unusually slow
- if you have Parkinson’s disease
- if you have a type of dementia called “Lewy body dementia”
- if you have a condition called progressive supranuclear palsy (PSP)
- if you have a heart condition called a “prolonged QT interval” or any other problem with your heart rhythm that can be seen as an abnormal curve on an ECG ( electrocardiogram )
- if you have heart failure or have recently had a heart attack
- if you have a low level of potassium in your blood and this has not yet been treated
- if you are taking any of the medicines mentioned under “Other medicines and Haldol – Do not use Haldol if you are taking special medicines”.
This medicine should not be used in any of the above apply to you. If you have any further questions, ask your doctor, pharmacist, or nurse before taking Haldol.
Warnings and cautions
Serious side effects are
Haldol can cause problems with the heart, problems with control of body movements or movements in the arms and legs, and a serious side effect called “malignant neuroleptic syndrome”. It can also cause severe allergic reactions and blood clots. You must be aware that serious side effects can occur when you take Haldol, as you may need immediate medical attention. See “Beware of serious side effects” in section 4.
Elderly people and people with dementia
A small increase in deaths and strokes has been reported in elderly people with dementia taking antipsychotic drugs. Talk to your doctor before receiving Haldol if you are older, especially if you have dementia.
Talk to your doctor if you have:
- slow heartbeat, heart disease or if someone in your immediate family has died suddenly due to heart problems.
- low blood pressure or feeling dizzy when you sit up or stand up.
- a low level of potassium or magnesium (or other “electrolyte”) in your blood. Your doctor will decide how to treat this.
- Have you ever had a cerebral haemorrhage or if your doctor has told you that you have a higher risk of having a stroke than other people.
- epilepsy or if you have had seizures (seizures).
- problems with the kidneys, liver or thyroid gland.
- a high level of the hormone a prolactin in the blood or cancer that may have arisen due to high prolactin levels (such as breast cancer).
- had blood clots, or if someone else in your family has had blood clots.
- depression or if you have bipolar disorder and are starting to feel depressed.
You may need to go through thorough checks and the amount of Haldol you may need may change.
If you are not sure if any of the above applies to you, talk to your doctor or nurse before taking Haldol.
Medicinal studies
Your doctor may perform an electrocardiogram ( ECG ) before or during your treatment with Haldol. ECG measures the electrical activity of your heart.
Blood tests
Your doctor may check your potassium or magnesium (or other “electrolyte”) levels in your blood before and during your treatment with Haldol.
Children and young people
Haldol should not be used in children and adolescents under 18 years of age. This is because it has not been studied in these age groups.
Other medicines and Haldol
Tell your doctor, pharmacist, or nurse if you have recently taken, or might take any other medicines.
Do not use Haldol if you are taking special medicines for:
- problems with your heart rhythm (eg amiodarone , dofetilide, disopyramide , dronedarone, ibutilide, quinidine and sotalol)
- depression (eg citalopram and escitalopram)
- psychosis (eg flufenazine, levomepromazine, perfenazine, pimozide, proclorperazine, promazine, sertindole, thiorizadine, trifluoperazine, triflupromazine and ziprasidone)
- bacterial infections (eg azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin and telithromycin)
- fungal infections (eg pentamidine)
- malaria (eg halofantrine)
- nausea and vomiting (eg dolasetron)
- cancer (eg toremifene and vandetanib).
Tell your doctor if you are taking bepridil (for chest pain or to lower your blood pressure ) or methadone (for painkillers or to treat drug addiction).
These medicines may increase the risk of heart problems, so talk to your doctor if you are taking any of these and do not use Haldol (see “Do not use Haldol”).
Special care may be needed if you use lithium and Haldol at the same time.
Tell your doctor immediately and stop taking both medicines if you suffer from:
- fever you can not explain or movements you can not control
- confusion, disorientation, headaches, balance problems and feeling sleepy.
These are signs of a serious illness.
Some medicines may affect the way Haldol works or increase the risk of heart problems.
Tell your doctor if you are taking:
- alprazolam or buspirone (for anxiety)
- duloxetine, fluoxetine , fluvoxamine, nefazodone, paroxetine , sertraline , St. John’s wort ( Hypericum perforatum ) or venlafaxine (for depression)
- bupropion (for depression or to help you quit smoking)
- carbamazepine, phenobarbital or phenytoin (for epilepsy )
- rifampicin (against bacterial infections)
- itraconazole, posaconazole or voriconazole (for fungal infections)
- ketoconazole tablets (for the treatment of Cushing’s syndrome)
- indinavir, ritonavir or saquinavir (against human immunodeficiency virus or HIV )
- chlorpromazine or promethazine (for nausea and vomiting)
- verapamil (for blood pressure or heart problems).
Also tell your doctor if you are taking any other medicines to lower your blood pressure, such as diuretics ( diuretics ).
Your doctor may need to change your dose of Haldol if you are taking any of these medicines.
Haldol may affect the way the following medicines work
Tell your doctor if you are taking the following medicines:
- sedatives, or medications that help you sleep
- strong painkillers
- antidepressants (“tricyclic antidepressants”)
- antihypertensive drugs (eg guanetidine and methyldopa)
- drugs for severe allergic reactions ( adrenaline )
- drugs for ADHD (Attention deficit hyperactivity disorder) or narcolepsy (known as “stimulants”)
- medicines used to treat Parkinson’s disease (eg levodopa )
- blood thinners (phenindione)Talk to your doctor or nurse before receiving Haldol if you are taking any of these medicines.
Haldol and alcohol
If you drink alcohol while using Haldol, you may feel sleepy and less alert. This means that you should be careful about how much alcohol you drink. Talk to your doctor about drinking alcohol while using Haldol, and let your doctor know how much you drink.
Pregnancy, breastfeeding 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 Haldol while you are pregnant.
In newborns whose mothers have used Haldol during the last 3 months of pregnancy (the last trimester), the following problems may occur:
- muscle tremors, stiff or weak muscles
- drowsiness or restlessness
- breathing problems or difficulty eating.
It is unknown how often these problems occur. If you used Haldol when you were pregnant and your baby gets any of these side effects, talk to your doctor.
Breast-feeding – Tell your doctor if you are breastfeeding or planning to breastfeed. The reason for this is that small amounts of the drug can pass into the breast milk and on to the baby. Your doctor will discuss the risks and benefits of breastfeeding when you use Haldol.
Fertility – Haldol can increase your levels of the hormone “prolactin”, which can affect male and female fertility. Talk to your doctor if you have any questions about this.
Driving and using machines
Haldol may affect your ability to drive and use tools or machines. Side effects such as drowsiness can affect your attention, especially at the beginning of drug treatment or after a high dose. Do not drive or use any tools or machines without first discussing this with your doctor.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. How to use Haldol
How much medicine you should get
Your doctor will decide how much Haldol you need and for how long. It may take some time before you feel the full effect of the medicine. Your doctor will usually give a low dose at the beginning and then adjust the dose to suit you. Your dose of haloperidol will depend on:
- your age
- what disease you are being treated for
- if you have kidney or liver problems
- what other medicines you are taking.
Adults
- Your starting dose will usually be between 1 and 5 mg.
- You may receive an extra dose , usually 1 to 4 hours apart.
- You will not receive more than a total of 20 mg daily.
Elderly
- Older people usually start with half the lowest adult dose.
- Dose one will then be adjusted until your doctor finds the dose that suits you best.
- You will not receive more than a total of 5 mg daily unless your doctor decides that a higher dose is needed.
How Haldol is given
You will receive Haldol from a doctor or nurse. It should be used intramuscularly and given as an injection into a muscle.
If you miss a dose or get too much Haldol
A doctor or nurse will give you the medicine so you are not likely to miss a dose or get too much. If you are worried, talk to your doctor or nurse.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you stop using Haldol
Unless your doctor decides otherwise, Haldol treatment will be stopped gradually. If you suddenly stop treatment, you may experience symptoms such as:
- Nausea and vomiting
- Difficulty sleeping.
Always follow your doctor’s instructions carefully.
If you have any further questions on the use of this product, 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 are
Tell a doctor or nurse immediately if you experience any of the following. You may need immediate medical attention.
Heart problems :
- Abnormal heart rhythm – this prevents the heart from functioning normally and can make you unconscious
- abnormally fast heartbeats
- extra heartbeat
Heart problems are less common in people taking Haldol (may affect up to 1 in 100 people). Sudden death has occurred in patients using this medicine, but it is unknown how often these deaths occur. Cardiac arrest (the heart stops beating) has occurred in people taking antipsychotic drugs.
A serious problem called “malignant neuroleptic syndrome” . This causes high fever, severe muscle stiffness, confusion and unconsciousness. It is rare in people who get Haldol (may affect up to 1 in 1,000 people).
Problems with controlling body movements or movements in the arms and legs (extrapyramidal side effects ) , such as:
- movements of the mouth, tongue, jaw and sometimes arms and legs ( tardive dyskinesia )
- restlessness or difficulty sitting still, more body movements
- slow or reduced body movements, jerking or twisting movements
- muscle tremors or stiffness, a lingering gait
- inability to move
- impaired facial expressions, which sometimes look like a maskThese are very common in people who get Haldol (may occur in more than 1 in 10 people). If you get any of these side effects , you may need to get another medicine.
Severe allergic reaction which may include:
- swelling of the face, lips, mouth, tongue or throat
- difficulty swallowing or breathing
- itchy rash, hives.
Allergic reactions are less common in people receiving Haldol (may affect up to 1 in 100 people).
Blood clots in veins, especially in the legs (deep vein thrombosis or DVT). These have been reported in people taking antipsychotic drugs. Signs of DVT in the leg include swelling, pain and redness in the leg, but the blood clot can move to the lungs and cause chest pain and difficulty breathing. Blood clots can be very serious, so tell your doctor immediately if you get any of these problems.
Tell your doctor immediately if you get any of the serious side effects described above.
Other side effects are
Tell your doctor if you have or suspect you may have any of the following side effects .
Very common (may affect more than 1 in 10 people):
- feeling of anxiety
- difficulty sleeping
- headache.
Common (may affect up to 1 in 10 people):
- serious mental health problems, such as believing things that are not true (delusions) or seeing, feeling, hearing, or smelling something that does not exist (hallucinations)
- Depression
- abnormal muscle tension
- dizziness, e.g. when you sit up or stand up
- somnolence
- upward movement of the eyes or rapid eye movements that you cannot control
- visual disturbances, such as blurred vision
- low blood pressure
- nausea, vomiting
- constipation
- dry mouth or more saliva
- rash
- inability to urinate or empty the bladder properly
- difficulty getting and maintaining an erection ( impotence )
- weight gain or weight loss
- changes seen in liver function tests.
Uncommon (may affect up to 1 in 100 people):
- effect on blood cells – low number of all blood cells, including severe decrease in the number of white blood cells and low number of platelets (cells that help the blood to clot)
- feeling of confusion
- lost sex drive or decreased sex drive
- seizures
- stiff muscles and joints
- muscle spasms, twitches or contractions that you can not control, including spasms in the neck that cause the head to turn to one side
- trouble walking
- respiratory distress
- inflammation of the liver or liver problems that cause the skin or eyes to turn yellow (jaundice)
- the skin becomes more sensitive to the sun
- itching
- heavy sweating
- changes in the menstrual cycle, such as missed periods or long, heavy, painful periods
- unexpected production of breast milk
- pain or discomfort in the breasts
- high body temperature
- swelling caused by accumulation of fluid in the body.
Rare (may affect up to 1 in 1,000 people):
- high levels of the hormone et prolactin in the blood
- narrower airways in the lungs and thus breathing difficulties
- difficulty or inability to open the mouth
- problems with having sex.
The following side effects have also been reported but it is unknown how often they occur:
- high level of antidiuretic hormone in your blood (syndrome called “inadequately increased secretion of antidiuretic hormone”)
- low blood sugar levels
- swelling around the speech machine or short-term spasms in the vocal cords, which can make speech and breathing difficult
- sudden liver failure
- decreased flow of bile in the bile duct
- peeling or flaking of the skin
- inflamed, small blood vessels, which give skin rashes with small red or purple nodules
- degradation of muscle tissue ( rhabdomyolysis )
- persistent and painful penile erections
- enlarged breasts in men
- low body temperature.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Haldol
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 label and carton (after EXP). The expiration date is the last day of the specified month.
Store in the original package. Sensitive to light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is haloperidol . One ml of solution for injection contains 5 mg of haloperidol .
The other ingredients are: lactic acid , water for injections.
What the medicine looks like and contents of the pack
Haldol is a clear, colorless solution without visible particles. It is supplied in amber glass ampoules containing 1 ml solution in pack sizes of 1, 5, 30 (3 packs of 10) or 50 (10 packs of 5) ampoules .
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Janssen-Cilag AB
Box 4042
169 04 Solna
Tel: +46 8 626 50 00
Manufacturer
GlaxoSmithKline Manufacturing SpA, Strada Provinciale Asolana N. 90 (loc. San Polo), 43056 Torrile, Parma, Italy.
Janssen Pharmaceutica NV, 30 Turnhoutseweg, 2340 Beerse, Belgium.