Haloperidol Advanz Pharma

Haloperidol.

Each ml of haloperidol injection contains 5mg of the active substance, haloperidol.
Excipients/Inactive Ingredients: Haloperidol Injection also contains lactic acid, sodium hydroxide and water for injections.

Haloperidol Injection contains the active ingredient haloperidol, which belongs to a class of drugs called 'antipsychotics'.

Haloperidol Injection is used in adults for illnesses affecting the way of thinking, feeling or behaving. These include mental health problems (such as schizophrenia and bipolar disorder) and behavioural problems.
These illnesses may make the patient: Feel confused (delirium).
See, hear, feel or smell things that are not there (hallucinations).
Believe things that are not true (delusions).
Feel unusually suspicious (paranoia).
Feel very excited, agitated, enthusiastic, impulsive or hyperactive.
Feel very aggressive, hostile or violent.
Haloperidol Injection is also used in adults: To prevent or treat nausea and vomiting (feeling and being sick) after surgery.
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.

Always use this medicine exactly as the doctor has instructed. Check with the doctor or pharmacist if not sure.
How much medicine will be given: The doctor will decide how much Haloperidol Injection is needed and for how long. It may be some time before the full effect of the medicine is felt. The doctor will normally give a low dose to start, and then adjust the dose to suit the situation. The dose of haloperidol will depend on: The patient's age; What condition the patient is being treated for; Problems with kidneys or liver; Other medicines being taken.
Adults: Starting dose will normally be between 1 and 5 mg.
Extra doses may be given, normally 1 to 4 hours apart.
The patient will not be given more than a total of 20 mg each day.
Elderly people: Elderly people will normally start on half the lowest adult dose.
The dose will then be adjusted until the doctor finds the dose that suits the situation.
The patient will not be given more than a total of 5 mg each day unless the doctor decides a higher dose is needed.
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 the patient missed a dose of Haloperidol Injection: A doctor or nurse will give this medicine to the patient, so it is unlikely that the patient will miss a dose or be given too much. If worried, tell the doctor or nurse.
If the patient stops using Haloperidol Injection: Unless the doctor decides otherwise, Haloperidol Injection will be stopped gradually. Stopping treatment suddenly may cause effects such as: Nausea and vomiting; Difficulty sleeping.
Always follow the doctor's instructions carefully.
For any further questions on the use of this medicine, ask the doctor, pharmacist or nurse.

Do not use Haloperidol Injection if: The patient is allergic to haloperidol or any of the other ingredients of Haloperidol Injection (listed in Description).
The patient is less aware of the surroundings or reactions become unusually slow.
The patient has Parkinson's disease.
The patient has a type of dementia called 'Lewy body dementia'.
The patient has progressive supranuclear palsy (PSP).
The patient has a heart condition called 'prolonged QT interval', or any other problem with heart rhythm that shows as an abnormal tracing on an ECG (electrocardiogram).
The patient has heart failure or recently had a heart attack.
The patient has a low level of potassium in the blood, which has not been treated.
The patient takes any of the medicines listed under Interactions.
This medicine must not be used if any of the previously mentioned apply. If not sure, talk to the doctor, pharmacist or nurse before being given haloperidol injection.

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. Be aware of serious side effects while using Haloperidol injection because urgent medical treatment may be needed. See Side Effects.
Medical check ups: The doctor may want to take an electrocardiogram (ECG) before or during the treatment with Haloperidol injection. The ECG measures the electrical activity of the heart.
Blood tests: The doctor may want to check the levels of potassium or magnesium (or other electrolytes) in the blood before or during the treatment with Haloperidol injection.
Haloperidol Injection contains: This medicine contains less than 1 mmol sodium (23mg) per dose, i.e. is essentially sodium free.
Driving and using machines: Haloperidol Injection can affect the ability to drive and use tools or machines. Side effects, such as feeling sleepy, may affect alertness, particularly when it is the first time using it or after a high dose. Do not drive or use any tools or machines without discussing with the doctor first.
Use in Elderly 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 the doctor before giving Haloperidol injection to elderly, particularly if with dementia.
Talk to the doctor if the patient has: A slow heartbeat, heart disease or anyone in the close family has died suddenly of heart problems.
Low blood pressure, or feel dizzy upon sitting up or standing up.
A low level of potassium or magnesium (or other 'electrolyte') in the blood. The doctor will decide how to treat this.
Ever had bleeding in the brain, or with high possibility of having a stroke.
Epilepsy or has ever had fits (convulsions).
Problems with the kidneys, liver or thyroid gland.
A high level of the hormone 'prolactin' in the blood, or cancer that may be caused by high prolactin levels (such as breast cancer).
A history of blood clots, or family history of blood clots.
Depression, or has bipolar disorder and start to feel depressed.
Close monitoring may be needed, and the amount of Haloperidol injection may have to be altered.
If not sure if any of the previously mentioned applies, talk to the doctor or nurse before being given Haloperidol injection.
Use in 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.

Pregnancy: If the patient is pregnant, thinks she may be pregnant or is planning to have a baby, ask the doctor for advice. The doctor may advise not to use Haloperidol Injection while 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): Muscle tremors, stiff or weak muscles.
Being sleepy or agitated.
Problems breathing or feeding.
The exact frequency of these problems is unknown. If Haloperidol Injection is being used while pregnant and the baby develops any of these side effects, contact the doctor.
Breast-feeding: Talk to the doctor if the patient is 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. The doctor will discuss the risks and benefits of breast-feeding while using Haloperidol Injection.
Fertility: Haloperidol Injection may increase the levels of a hormone called 'prolactin', which may affect fertility in men and women. Talk to the doctor for any questions about this.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Look out for serious side effects.
Tell the doctor or nurse straight away if any of the following is noticed or suspected. Urgent medical treatment may be needed.
Problems with the heart: Abnormal heart rhythm: this stops the heart working normally and may cause loss of consciousness.
Abnormally fast heart beat.
Extra heart beats.
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: Movements of the mouth, tongue, jaw and sometimes limbs (tardive dyskinesia).
Feeling restless or difficulty sitting still, increased body movements.
Slow or reduced body movements, jerking or twisting movements.
Muscle tremors or stiffness, a shuffling walk.
Being unable to move.
Lack of normal facial expression that sometimes looks like a mask.
These are very common in people using Haloperidol Injection (may affect more than 1 in 10 people). If the patient gets any of these effects, an additional medicine may be given.
Severe allergic reaction that may include: A swollen face, lips, mouth, tongue or throat.
Difficulty swallowing or breathing.
Itchy rash (hives).
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 the doctor straight away if any of these problems occur.
Tell the doctor straight away if any of the previously mentioned serious side effects occur.
Other side effects: Tell the doctor if any of the following side effects occur.
Very common - (may affect more than 1 in 10 people): Feeling agitated; Difficulty in sleeping; Headache.
Common - (may affect up to 1 in 10 people): Serious mental health problem, such as believing things that are not true (delusions) or seeing, feeling, hearing or smelling things that are not there (hallucinations).
Depression.
Abnormal muscle tension.
Feeling dizzy, including upon sitting up or standing up.
Feeling sleepy.
Upward movement of the eyes or fast eye movements that are uncontrollable.
Problems with vision, such as blurred vision.
Low blood pressure.
Nausea, vomiting.
Constipation.
Dry mouth or increased saliva.
Skin rash.
Being unable to pass urine or empty the bladder completely.
Difficulty getting and keeping an erection (impotence).
Weight gain or loss.
Changes that show up in blood tests of the liver.
Uncommon - (may affect up to 1 in 100 people): Effects on blood cells: low number of all types of blood cells, including severe decrease in white blood cells and low number of 'platelets' (cells that help blood to clot).
Feeling confused.
Loss of sex drive or decreased sex drive.
Fits (seizures).
Stiff muscles and joints.
Muscle spasms, twitching or contractions that cannot be controlled, including a spasm in the neck causing the head to twist to one side.
Problems walking.
Being short of breath.
Inflamed liver, or liver problem that causes yellowing of the skin or eyes (jaundice).
Increased sensitivity of the skin to sunlight.
Itching.
Excessive sweating.
Changes in menstrual cycle (periods), such as no periods, or long, heavy, painful periods.
Unexpected production of breast milk.
Breast pain or discomfort.
High body temperature.
Swelling caused by fluid buildup in the body.
Rare - (may affects up to 1 in 1,000 people): High level of the hormone 'prolactin' in the blood.
Narrowed airways in the lungs, causing difficulty breathing.
Difficulty or being unable to open the mouth.
Problems having sex.
The following side effects have also been reported, but their exact frequency is unknown: High level of 'antidiuretic hormone' in the blood (syndrome of inappropriate antidiuretic hormone secretion).
Low level of sugar in the blood.
Swelling around the voice box or brief spasm of the vocal cords, which may cause difficulty speaking or breathing.
Sudden liver failure.
Decreased bile flow in the bile duct.
Flaking or peeling skin.
Inflamed small blood vessels, leading to a skin rash with small red or purple bumps.
Breakdown of muscle tissue (rhabdomyolysis).
Persistent and painful erection of the penis.
Enlarged breasts in men.
Low body temperature.
Reporting of side effects: If any of the side effects occur, talk to the doctor, pharmacist or nurse. This includes any possible side effects not previously listed.
By reporting side effects, more information on the safety of this medicine can be provided.

Tell the doctor or pharmacist if the patient is taking or has recently or might take any other medicines.
Do not use Haloperidol injection if the patient is taking certain medicines for: Problems with heart beat (such as amiodarone, dofetilide, disopyramide, dronedarone, ibutilide, quinidine and sotalol).
Depression (such as citalopram and escitalopram).
Psychoses (such as fluphenazine, levomepromazine, perphenazine, pimozide, prochlorperazine, promazine, sertindole, thiorizadine, trifluoperazine, triflupromazine and ziprasidone).
Bacterial infections (such as azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin and telithromycin).
Fungal infections (such as pentamidine).
Malaria (such as halofantrine).
Nausea and vomiting (such as dolasetron).
Cancer (such as toremifene and vandetanib).
Also tell the doctor if the patient is 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 the doctor if the patient is taking any of these and do not use Haloperidol Injection (see Contraindications).
Special monitoring may be needed if the patient is using lithium and Haloperidol injection at the same time.
Tell the doctor straight away and stop taking both medicines if the patient gets: Unexplainable fever or uncontrollable movements.
Confused, disoriented, a headache, balance problems and feel sleepy.
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 the doctor if the patient is 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 stop smoking).
Carbamazepine, phenobarbital or phenytoin (for epilepsy).
Rifampicin (for bacterial infections).
Itraconazole, posaconazole or voriconazole (for fungal infections).
Ketoconazole tablets (to treat Cushing's syndrome).
Indinavir, ritonavir or saquinavir (for human immunodeficiency virus or HIV).
Chlorpromazine or promethazine (for nausea and vomiting).
Verapamil (for blood pressure or heart problems).
Also tell the doctor if the patient is taking any other medicines to lower blood pressure, such as water tablets (diuretics). The doctor may have to change the dose of Haloperidol Injection if the patient is taking any of these medicines.
Haloperidol injection can affect the way the following types of medicine work.
Tell the doctor if these medicines are taken for: Calming the patient down or helping the patient to sleep (tranquillisers).
Pain (strong pain killers).
Depression ('tricyclic antidepressants').
Lowering blood pressure (such as guanethidine and methyldopa).
Severe allergic reactions (adrenaline).
Attention deficit hyperactivity disorder (ADHD) or narcolepsy (known as 'stimulants').
Parkinson's disease (such as levodopa).
Thinning the blood (phenindione).
Talk to the doctor or nurse before being given Haloperidol Injection if any of these medicines are being taken.
Haloperidol Injection with alcohol: Drinking alcohol while using Haloperidol Injection might cause the patient to feel sleepy and less alert. Be careful of the amount of alcohol intake. Talk to the doctor about drinking alcohol while using Haloperidol Injection, and let the doctor know how much the patient drinks.

Do not store above 25°C. Store in the original package to protect from light.
If only part of the solution is used, the rest should be discarded.

Antipsychotics

N05AD01 - haloperidol ; Belongs to the class of butyrophenone derivatives antipsychotics.

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