Haloperidol Unia

Package Leaflet: Information for the User

Haloperidol UNIA

2 mg/ml, oral drops, solution

Haloperidolum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Haloperidol UNIA and what is it used for
• 2. Important information before taking Haloperidol UNIA
• 3. How to take Haloperidol UNIA
• 4. Possible side effects
• 5. How to store Haloperidol UNIA
• 6. Contents of the pack and other information

1. What is Haloperidol UNIA and what is it used for

The name of this medicine is Haloperidol UNIA.
Haloperidol UNIA contains the active substance haloperidol. It belongs to a group of medicines called antipsychotics.
Haloperidol UNIA is used in adults, adolescents, and children for diseases that affect thinking, feeling, and behavior. These include mental disorders (such as schizophrenia, bipolar affective disorder) and behavioral disorders.
These diseases can cause the patient to:

• feel confused (delirium)
• see, hear, or smell things that are not there (hallucinations)
• be convinced of the truth of things that are not true (delusions)
• feel excessive suspicion (paranoia)
• feel excited, agitated, enthusiastic, impulsive, or overly active
• be aggressive, hostile, or prone to violence. In adolescents and children, Haloperidol UNIA is used to treat schizophrenia in patients aged 13 to 17 years, and to treat behavioral disorders in patients aged 6 to 17 years. Haloperidol UNIA is also used:
• in adolescents and children aged 10 to 17 years and in adults to treat uncontrolled movements and sounds (tics), such as in severe cases of Tourette's syndrome.
• in adults to treat other uncontrolled movements in Huntington's disease.

Haloperidol UNIA is sometimes used when other medicines or treatments do not work, or when they cause side effects that the patient does not accept.

2. Important information before taking Haloperidol UNIA

When not to take Haloperidol UNIA

• If the patient is allergic to haloperidol or any of the other ingredients of this medicine (listed in section 6).
• If the patient is less aware of their surroundings, or their reactions become unnaturally slow.
• If the patient has Parkinson's disease.
• If the patient has a type of dementia called dementia with Lewy bodies.
• If the patient has progressive supranuclear palsy (PSP).
• If the patient has a condition called QTc interval prolongation, or any other heart rhythm disorders visible in an abnormal ECG (electrocardiogram).
• If the patient has heart failure or has recently had a heart attack.
• If the patient has low potassium levels in the blood that have not been treated.
• If the patient is taking any of the medicines listed in the section "Haloperidol UNIA and other medicines", subsection "Do not take Haloperidol UNIA if you are taking...". If any of the above applies to the patient, they should not take this medicine. In case of doubt, the patient should consult their doctor or pharmacist before taking Haloperidol UNIA.

Warnings and precautions

Severe side effects

Haloperidol UNIA may cause heart problems, problems with controlling body movements or limbs, and a severe side effect called malignant neuroleptic syndrome. It may also cause severe allergic reactions and blood clots. The patient must be aware of the possibility of severe side effects when taking Haloperidol UNIA, as they may require immediate medical attention. See "Warning about severe side effects" in section 4.

Elderly patients and patients with dementia

In elderly patients with dementia taking antipsychotic medicines, a slight increase in the frequency of deaths and strokes has been observed. If the patient is elderly, especially if they have dementia, they should consult their doctor before taking Haloperidol UNIA.

The patient should consult their doctor or pharmacist if they:

• have a slow heart rate, heart disease, or if someone in their family has died suddenly from a heart condition.
• have low blood pressure or feel dizzy when changing position from lying down to sitting or from sitting to standing.
• have low levels of potassium or magnesium (or other electrolytes) in the blood. The doctor will decide what treatment to use.
• have had a stroke in the past or are considered to be at higher risk of stroke than other patients.
• have epilepsy or have had seizures in the past.
• have kidney, liver, or thyroid problems. This medicine should also be used with caution in these patients due to its alcohol content (ethanol).
• have high levels of the hormone prolactin in the blood or a tumor that may be caused by high levels of prolactin (e.g., breast cancer).
• have a history of blood clots or blood clots have been found in someone in their family.
• have depression or are entering a depressive phase with bipolar affective disorder. The patient's condition may need to be monitored more closely, and the dose of Haloperidol UNIA may need to be changed. If the patient has any doubts about any of the above, they should consult their doctor or pharmacist before taking Haloperidol UNIA.

Tests

The doctor may decide to perform an ECG before starting or during treatment with Haloperidol UNIA. The ECG measures heart activity.

Blood tests

The doctor may decide to measure the levels of potassium and magnesium (or other electrolytes) in the blood before starting or during treatment with Haloperidol UNIA.

Children under 6 years of age

Haloperidol UNIA should not be used in children under 6 years of age, as there is no experience with the use of this medicine in this age group.

Haloperidol UNIA and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.

Do not take Haloperidol UNIA if you are taking certain types of medicines used to treat:

• heart rhythm disorders (such as amiodarone, dofetilide, disopyramide, dronedarone, ibutilide, quinidine, sotalol)
• depression (such as citalopram and escitalopram)
• psychoses (such as fluphenazine, levomepromazine, perphenazine, pimozyd, prochlorperazine, promazine, sertindol, thioridazine, 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). The patient should also inform their doctor about taking bepridil (a medicine for chest pain or low blood pressure) or methadone (a pain reliever also used to treat drug addiction). These medicines may increase the risk of heart problems, so the patient should consult their doctor and not take Haloperidol UNIA if they are taking any of these medicines (see "When not to take Haloperidol UNIA").

If the patient is taking lithium and Haloperidol UNIA, closer monitoring of their condition may be necessary.

The patient should immediately inform their doctor and stop taking both medicines if they experience:

• fever of unknown origin or uncontrolled body movements
• confusion, disorientation, headache, balance problems, drowsiness. These are symptoms of a serious condition.

Certain medicines may affect the way Haloperidol UNIA works or may increase the risk of heart problems.

The patient should tell their doctor if they are taking medicines such as:

• alprazolam or buspirone (anxiolytics)
• duloxetine, fluoxetine, fluvoxamine, nefazodone, paroxetine, sertraline, St. John's wort (Hypericum perforatum), or venlafaxine (antidepressants)
• bupropion (for depression or smoking cessation)
• carbamazepine, phenobarbital, or phenytoin (antiepileptics)
• rifampicin (an antibiotic)
• itraconazole, posaconazole, or voriconazole (antifungals)
• ketoconazole (in tablet form, for Cushing's syndrome)
• indinavir, ritonavir, or saquinavir (for HIV infection)
• chlorpromazine or promethazine (for nausea and vomiting)
• verapamil (for high blood pressure or heart disease). The patient should also inform their doctor if they are taking any other medicines to lower blood pressure, such as diuretics. The doctor may need to adjust the dose of Haloperidol UNIA if the patient is taking any of these medicines.

Haloperidol UNIA may affect the way certain types of medicines work.

The patient should tell their doctor if they are taking medicines such as:

• sedatives or sleep aids
• strong pain relievers
• tricyclic antidepressants
• medicines to lower blood pressure (such as guanethidine or methyldopa)
• adrenaline (for severe allergic reactions)
• stimulants (for ADHD or narcolepsy)
• medicines for Parkinson's disease (such as levodopa)
• blood thinners (such as phenindione). If the patient is taking any of these medicines, they should inform their doctor before taking Haloperidol UNIA.

Haloperidol UNIA and alcohol

Drinking alcohol while taking Haloperidol UNIA may cause drowsiness and difficulty concentrating. This means that the patient should be careful with the amount of alcohol they drink. The patient should tell their doctor about drinking alcohol while taking Haloperidol UNIA and how much alcohol they drink.

Pregnancy, breastfeeding, and fertility

Pregnancy- If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their doctor. The doctor may advise not to take Haloperidol UNIA if the patient is pregnant.
In newborns of mothers who took Haloperidol UNIA during the last 3 months of pregnancy (the last trimester), the following problems may occur:

• muscle tremors, stiffness, or weakness
• excessive sleepiness or agitation
• breathing or feeding problems. The frequency of these disorders is not precisely known. If the patient took Haloperidol UNIA during pregnancy and any of these effects occur in the baby, they should contact their doctor.

Breastfeeding- The patient should tell their doctor if they are breastfeeding or plan to breastfeed. Small amounts of the medicine may pass into breast milk and then into the baby's body. The doctor will discuss the risks and benefits of breastfeeding while taking Haloperidol UNIA.
Fertility- Haloperidol UNIA may increase the levels of a hormone called prolactin, which can affect fertility in men and women. The patient should consult their doctor if they have any concerns.

Driving and using machines

Haloperidol UNIA may affect the patient's ability to drive or use tools and machines. Side effects such as drowsiness may impair alertness, especially when starting treatment or increasing the dose. The patient should not drive, use tools, or operate machines without first discussing it with their doctor.

Haloperidol UNIA contains alcohol

This medicine contains 150 mg of alcohol (ethanol) per 1 ml of solution (1500 mg of alcohol (ethanol) per 10 ml of solution). The amount of alcohol in 1.5 ml of this solution is equivalent to 5.7 ml of beer or 2.25 ml of wine. The amount of alcohol in 2.5 ml of this solution is equivalent to 9.5 ml of beer or 3.75 ml of wine. The amount of alcohol in 10 ml of this solution is equivalent to 38 ml of beer or 15 ml of wine.
The amount of alcohol in this solution is unlikely to have an effect on adults and adolescents, and its effect on children is unlikely to be noticeable.
The alcohol in this solution may alter the effects of other medicines. If the patient is taking other medicines, they should consult their doctor or pharmacist.
If the patient is pregnant or breastfeeding, they should consult their doctor or pharmacist before taking this solution.
If the patient is addicted to alcohol, they should consult their doctor or pharmacist before taking this solution.

3. How to take Haloperidol UNIA

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
The medicine should be taken orally with food.

What dose to take

The doctor will inform the patient about the dose of Haloperidol UNIA to take and how long to take it.
The doctor will also inform the patient whether to take Haloperidol UNIA once or several times a day. It may take some time before the patient feels the full effect of the medicine.
Usually, at the start of treatment, the doctor will give the patient a small dose of the medicine, and then adjust the dose according to the patient's needs. It is very important to take the correct dose.

• The dose of haloperidol the patient receives depends on:
• the patient's age;
• the disease being treated;
• any kidney or liver disease the patient has;
• other medicines the patient is taking.

Adults

• The initial dose is usually between 0.5 mg and 10 mg per day.
• The doctor may adjust the dose to find the most suitable dose for the patient.
• The maximum dose for adults depends on the disease being treated and is between 5 mg and 20 mg per day.

Elderly patients

• Elderly patients usually start treatment with a dose of 0.5 mg per day or half the smallest recommended dose for adults.
• The amount of Haloperidol UNIA given will then be increased until the doctor finds the most suitable dose.
• The maximum dose for elderly patients is 5 mg per day, unless the doctor decides a higher dose is needed.

Children and adolescents aged 6 to 17 years

• The dose is usually between 0.5 mg and 3 mg per day.
• Adolescents up to 17 years old being treated for schizophrenia or behavioral disorders may receive a higher dose - up to 5 mg per day.

Taking Haloperidol UNIA

• Haloperidol UNIA is for oral use.
• Haloperidol UNIA can be mixed with a small amount of water before taking, but it should not be mixed with other liquids. 10 ml bottle with dropper:
• Remove the cap from the bottle by turning it counterclockwise.
• Place the bottle over a spoon and tilt it.
• Count the prescribed number of drops.
• Drink the measured amount of solution.
• After use, close the bottle by turning the cap clockwise. 100 ml bottle with oral syringe:
• Place the bottle on a flat surface.
• Remove the cap from the bottle by turning it counterclockwise.
• One end of the syringe has a plunger. Insert the other end into the bottle with the solution.
• Holding the syringe, pull the plunger up. Pull the plunger until the desired volume (ml) of solution is drawn into the syringe.
• Remove the syringe from the bottle.
• Empty the syringe into a spoon or cup. This can be done by pushing the plunger down while holding the lower part of the syringe still. The contents of the syringe can be given directly into the patient's mouth.
• Drink the measured amount of solution.
• After use, close the bottle by turning the cap clockwise, and then rinse the syringe with water.

Taking a higher dose of Haloperidol UNIA than recommended

If the patient takes a higher dose of Haloperidol UNIA than recommended, or if someone else takes Haloperidol UNIA, they should immediately consult their doctor or go to the emergency room at the nearest hospital.

Missing a dose of Haloperidol UNIA

• If the patient misses a dose, they should take the next dose at the usual time. Then, they should continue taking the medicine as directed by their doctor.
• The patient should not take a double dose.

Stopping treatment with Haloperidol UNIA

Haloperidol UNIA should be discontinued gradually, unless the doctor decides otherwise. Stopping treatment suddenly may cause side effects such as:

• nausea and vomiting
• difficulty sleeping. The patient should follow their doctor's instructions closely. If they have any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Haloperidol UNIA can cause side effects, although not everybody gets them.

Warning about severe side effects.

If the patient notices or suspects any of the following, they should immediately inform their doctor. The patient may need urgent medical attention.

• Heart problems:
• abnormal heart rhythm - the heart does not beat properly, which can cause loss of consciousness
• abnormally fast heart rate
• extra heartbeats. Heart rhythm disorders occur uncommonly in people taking Haloperidol UNIA (may occur in less than 1 in 100 people). There have been cases of sudden death in people taking Haloperidol UNIA, but the exact frequency is not known. People taking antipsychotic medicines have also experienced cardiac arrest (the heart stops beating).
• A severe condition called "malignant neuroleptic syndrome". Symptoms include high fever, severe muscle stiffness, confusion, and loss of consciousness. This condition occurs rarely in people taking Haloperidol UNIA (may occur in less than 1 in 1,000 people).
• Uncontrolled body movements or limb movements (extrapyramidal symptoms), such as:
• mouth, tongue, jaw, and sometimes limb movements (tardive dyskinesia)
• feeling agitated or having difficulty sitting still, increased body movements
• slow or limited body movements, jerky movements or turning
• tremors or muscle stiffness, shuffling gait
• inability to make a movement
• lack of normal facial expression, which can look like a mask. These disorders occur very commonly in people taking Haloperidol UNIA (may occur in more than 1 in 10 people). If any of these symptoms occur, the patient may receive additional medicines.
• Severe allergic reaction, which can include:
• swelling of the face, lips, tongue, or throat
• difficulty swallowing or breathing
• itchy rash.

An allergic reaction occurs uncommonly in people taking Haloperidol UNIA (may occur in less than 1 in 100 people).

• Blood clots in the veins, usually in the legs (deep vein thrombosis).These have been reported in people taking antipsychotic medicines. Symptoms of deep vein thrombosis in the legs include swelling, pain, and redness of the leg, but the clot can move to the lungs, causing chest pain and difficulty breathing. Blood clots can be life-threatening, so if the patient experiences any of these symptoms, they should immediately inform their doctor. If the patient experiences any of these severe side effects, they should immediately inform their doctor.

Other side effects

The patient should inform their doctor if they notice or suspect any of the following side effects.
Very common(may occur in more than 1 in 10 people):

• Agitation
• Difficulty sleeping
• Headache. Common(may occur in less than 1 in 10 people):
• Severe mental disorders, such as delusions or hallucinations
• Depression
• Unusual muscle tension
• Dizziness, including dizziness when changing position from lying down to sitting or from sitting to standing
• Drowsiness
• Eye movements upward or rapid, uncontrolled eye movements
• Vision problems, such as blurred vision
• Low blood pressure
• Nausea, vomiting
• Constipation
• Dry mouth or increased saliva production
• Skin rash
• Difficulty urinating or emptying the bladder completely
• Erectile dysfunction (impotence)
• Weight gain or loss
• Changes in liver test results. Uncommon(may occur in less than 1 in 100 people):
• Affecting blood cells - decreased numbers of all types of blood cells, including a significant decrease in white blood cells and a low platelet count (cells that help blood clot)
• Confusion
• Loss of or decreased sex drive
• Seizures
• Muscle stiffness and joint stiffness
• Muscle spasms, tremors, or uncontrolled muscle contractions, including neck spasms that cause the head to tilt to one side
• Walking problems
• Shortness of breath
• Liver inflammation or liver problems that cause yellowing of the skin and whites of the eyes (jaundice)
• Skin sensitivity to sunlight
• Itching
• Excessive sweating
• Changes in menstrual cycle, such as absence of menstruation, prolonged, heavy, or painful menstruation
• Unexpected milk production from the breasts
• Breast pain or tenderness
• High body temperature
• Swelling caused by fluid accumulation in the body. Rare(may occur in less than 1 in 1,000 people):
• High levels of the hormone prolactin in the blood
• Narrowing of the airways in the lungs, causing breathing difficulties
• Difficulty or inability to open the mouth
• Sexual disorders.

The following side effects have also been reported, but their exact frequency is not known:

• High levels of antidiuretic hormone in the blood (syndrome of inappropriate antidiuretic hormone secretion)
• Low blood sugar
• Swelling around the throat or short-term spasms of the vocal cords, which can cause difficulty speaking and breathing
• Sudden liver failure
• Decreased bile flow in the bile ducts
• Peeling skin
• Inflammation of small blood vessels, causing a rash of small red or purple spots
• Muscle tissue breakdown (rhabdomyolysis)
• Prolonged and painful erections
• Breast enlargement in men
• Low body temperature.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products), Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of this medicine.

5. How to store Haloperidol UNIA

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C. Store in the original package.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the month.
Haloperidol UNIA can be used for 3 months after the first opening of the medicine, without exceeding the expiry date stated on the package.
In this window, the patient should write the date of the first opening of the medicine:

6. Contents of the pack and other information

What Haloperidol UNIA contains

• The active substance is haloperidol. 1 ml of solution (20 drops) contains 2 mg of haloperidol.
• The other ingredients are ethanol 96% (v/v), lactic acid, purified water.

What Haloperidol UNIA looks like and contents of the pack

The medicine is a clear liquid with a characteristic odor.
The pack sizes are:

• a 10 ml bottle with a polyethylene dropper and cap, in a cardboard box, with a leaflet, 1 bottle of 10 ml;
• a 100 ml bottle with a polyethylene cap and oral syringe, in a cardboard box, with a leaflet, 1 bottle of 100 ml.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne "UNIA" Spółdzielnia Pracy, ul. Chłodna 56/60, 00-872 Warsaw, tel.: 22 620 90 81 ext. 190, fax: 22 654 92 40, e-mail: [email protected]. The leaflet for Haloperidol UNIA is available in the Audio Leaflet system at the toll-free national phone number: 800 706 848.

Date of last revision of the leaflet:

Information intended for healthcare professionals only:
Haloperidol UNIA, 2 mg/ml, oral drops, solution in a bottle with a dropper is intended for single doses of up to 2 mg of haloperidol (corresponding to 20 drops).
The following table shows the number of drops required to achieve the desired single dose of Haloperidol UNIA, 2 mg/ml, oral drops, solution.

Conversion table for Haloperidol UNIA, 2 mg/ml, oral drops, solution

Haloperidol UNIA, 2 mg/ml, oral drops, solution in a bottle with an oral syringe is intended for single doses of 0.5 mg of haloperidol and above (corresponding to 0.25 ml and above).
The following table shows the volume (ml) required to achieve the desired single dose of Haloperidol UNIA, 2 mg/ml, oral drops, solution.

Conversion table for Haloperidol UNIA, 2 mg/ml, oral drops, solution