Haloperidol unia

Package leaflet: Information for the user

Haloperidol UNIA
2 mg/ml, oral drops, solution
Haloperidolum
Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.

• Keep this leaflet so that you can read it again if needed.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Haloperidol UNIA is and what it is used for
2. What you need to know 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 Haloperidol UNIA is and what it is 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 disorders affecting the way a person thinks, feels, and behaves. These include psychiatric disorders (such as schizophrenia, bipolar affective disorder) and behavioural disorders.
These disorders may cause the patient to:

• feel confused (delirium)
• see, hear, or smell things that are not there (hallucinations)
• believe things that are not true (delusions)
• feel unusually suspicious (paranoia)
• feel overexcited, agitated, enthusiastic, impulsive, or overly active
• become aggressive, hostile, or prone to violence.

Haloperidol UNIA is used in adolescents and children for the treatment of schizophrenia in patients aged 13 to 17 years, and for the treatment of behavioural 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, for the treatment of uncontrolled movements and sounds (tics), for example in severe forms of Gilles de la Tourette syndrome.
• in adults, for the treatment of other uncontrolled movements in Huntington's disease.

Haloperidol UNIA is sometimes used when other medicines or treatments do not work or cause side effects that the patient cannot tolerate.

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 things around them, or their reactions become abnormally 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 as abnormal ECG (electrocardiogram).
• If the patient has heart failure or has recently had a heart attack.
• If the patient has untreated low blood potassium levels.
• If the patient is taking any of the medicines listed in section "Haloperidol UNIA with other medicines", subsection: "Do not use Haloperidol UNIA...". If any of the above points apply to the patient, this medicine must not be taken. If in doubt, consult a doctor or pharmacist before taking Haloperidol UNIA.

Warnings and precautions
Serious adverse effects
Haloperidol UNIA may cause heart problems, difficulties in controlling body or limb movements, and a serious adverse effect called neuroleptic malignant syndrome. It may also cause severe allergic reactions and blood clots. The patient should be aware of the possibility of serious adverse effects during treatment with Haloperidol UNIA, as they may require immediate medical attention. See "Warning about serious adverse effects" in section 4.
Elderly patients and patients with dementia
In elderly patients with dementia treated with antipsychotic medicines, a slight increase in the frequency of deaths and strokes has been observed. If the patient is elderly, especially with dementia, they should consult a doctor before receiving Haloperidol UNIA.
Consult a doctor or pharmacist if the patient has:

• Slow heartbeat, heart disease, or if someone in their family died suddenly from heart problems.
• Low blood pressure or if the patient experiences dizziness upon changing position from lying to sitting or from sitting to standing.
• Low levels of potassium or magnesium (or other electrolyte) in the blood. The treating doctor will decide on appropriate treatment.
• A history of stroke or, according to the doctor, a higher risk of stroke than other patients.
• Epilepsy or a history of seizures.
• Kidney, liver, or thyroid problems. This medicine should be used with caution in such patients, also due to its alcohol (ethanol) content.
• High levels of the hormone prolactin in the blood or a tumor that may be caused by high prolactin levels (e.g. breast cancer).
• A history of blood clots or blood clots ever diagnosed in a family member.
• Depression or entering a depressive phase in a patient with bipolar affective disorder. Closer monitoring of the patient's condition and possible dose adjustment of Haloperidol UNIA may be necessary. If the patient is unsure whether any of the above points apply, they should consult a doctor or pharmacist before taking Haloperidol UNIA.

Monitoring tests
The treating doctor may decide to perform an ECG before or during treatment with Haloperidol UNIA. An ECG measures heart function.
Blood tests
The treating doctor may decide to measure blood levels of potassium and magnesium (or other electrolyte) before 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 adequate studies have not been conducted in this patient group.
Haloperidol UNIA and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not use Haloperidol UNIA if the patient is 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, pimozide, prochlorperazine, promethazine, sertindole, thioridazine, trifluoperazine, trifluopromazine, 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 the doctor about taking bepridil (a medicine for chest pain or low blood pressure) or methadone (a painkiller also used in drug addiction treatment). These medicines may increase the risk of heart disorders; therefore, consult a doctor and do not use Haloperidol UNIA if the patient is taking any of the listed medicines (see section "When not to use Haloperidol UNIA"). Concurrent use of lithium and Haloperidol UNIA may require closer monitoring of the patient's condition. Immediately inform the doctor and discontinue both medicines if the patient experiences:
• Unexplained fever or uncontrolled body movements
• Confusion, disorientation, headache, balance problems, drowsiness. These are symptoms of a condition seriously threatening health.

Some medicines may affect the way Haloperidol UNIA works or may worsen heart disorders.
Tell the doctor if the patient is taking medicines such as:

• Alprazolam or buspirone (anti-anxiety medicines)
• Duloxetine, fluoxetine, fluvoxamine, nefazodone, paroxetine, sertraline, St. John's wort (Hypericum perforatum) or venlafaxine (antidepressants)
• Bupropion (used in depression or smoking cessation)
• Carbamazepine, phenobarbital or phenytoin (antiepileptic medicines)
• Rifampicin (used in bacterial infections)
• Itraconazole, posaconazole or voriconazole (used in fungal infections)
• Ketoconazole tablets (used in Cushing's syndrome)
• Indinavir, ritonavir or saquinavir (used in human immunodeficiency virus - HIV infection)
• Chlorpromazine or promethazine (used for nausea and vomiting)
• Verapamil (used in hypertension or heart diseases). The patient should also inform the doctor if they are taking any other medicines to lower blood pressure, such as diuretics. The doctor may consider it necessary to adjust the dose of Haloperidol UNIA if the patient is taking any of these medicines.

Haloperidol UNIA may affect the way the following types of medicines work.
Tell the doctor if the patient is taking:

• Sedatives and sleep aids (sedatives)
• Medicines used for pain relief (strong painkillers)
• Medicines used for depression (tricyclic antidepressants)
• Medicines lowering blood pressure (such as guanethidine or methyldopa)
• Medicines used in severe allergic reactions (adrenaline)
• Medicines used in ADHD (attention deficit hyperactivity disorder) or narcolepsy (so-called stimulants)
• Medicines used in Parkinson's disease (such as levodopa)
• Blood thinners (phenindione). If the patient is taking any of these medicines, they should inform the doctor before taking Haloperidol UNIA.

Haloperidol UNIA and alcohol
Consuming alcohol during treatment with Haloperidol UNIA may cause drowsiness and difficulty concentrating. Therefore, alcohol intake should be carefully monitored. Inform the doctor about alcohol consumption during treatment with Haloperidol UNIA and how much alcohol the patient consumes.
Pregnancy, breastfeeding and fertility
Pregnancy - If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor. The doctor may advise not to use Haloperidol UNIA during pregnancy.
Newborns of mothers who used Haloperidol UNIA during the last three months of pregnancy (third trimester) may experience the following problems:

• Muscle tremors, stiffness or weakness
• Excessive drowsiness or agitation
• Breathing difficulties or feeding problems. The frequency of these disorders is not precisely known. If the patient used Haloperidol UNIA during pregnancy and the baby shows any of these symptoms, contact a doctor.

Breastfeeding - Inform the doctor if the patient is breastfeeding or planning to start breastfeeding. Small amounts of the medicine may pass into breast milk and then into the baby's body. The treating doctor will discuss the risks and benefits of breastfeeding during treatment with Haloperidol UNIA.
Effect on fertility - Haloperidol UNIA may increase levels of a hormone called prolactin, which may affect fertility in both men and women. Consult a doctor if the patient has any doubts.
Driving and operating machinery
Haloperidol UNIA may affect the ability to drive, use tools or operate machinery. Adverse effects such as drowsiness may impair alertness, especially at the beginning of treatment or after taking a high dose. Do not drive, use tools or operate machinery without first discussing this with the treating doctor.
Haloperidol UNIA contains alcohol (ethanol)
This medicine contains 150 mg of alcohol (ethanol) in 1 ml of medicine (1500 mg of alcohol (ethanol) in 10 ml of medicine). The amount of alcohol in 1.5 ml of this medicine is equivalent to 5.7 ml of beer or 2.25 ml of wine. The amount of alcohol in 2.5 ml of this medicine is equivalent to 9.5 ml of beer or 3.75 ml of wine. The amount of alcohol in 10 ml of this medicine is equivalent to 38 ml of beer or 15 ml of wine.
The amount of alcohol in this medicine is unlikely to affect adults and adolescents, and its effect in children is probably not noticeable.
Alcohol in this medicine may alter the effects of other medicines. If the patient is taking other medicines, they should consult a doctor or pharmacist.
If the patient is pregnant or breastfeeding, she should consult a doctor or pharmacist before using this medicine.
If the patient is alcohol-dependent, they should consult a doctor or pharmacist before using this medicine.

3. How to take Haloperidol UNIA

This medicine should always be taken exactly as directed by the doctor. If in doubt, consult your doctor or pharmacist.
The medicine should be taken orally during meals.

What dose should be taken
Your doctor will inform you how much Haloperidol UNIA to take and for how long.
Your doctor will also tell you whether Haloperidol UNIA should be taken once or several times a day.
It may take some time before you feel the full effect of the medicine.
Usually, at the beginning of treatment, your doctor will prescribe a low dose and then adjust it according to your individual needs. It is very important to take the correct dose.

The haloperidol dose you receive depends on:

• your age;
• the condition being treated;
• any kidney or liver problems you may have;
• other medicines you are taking.

Adults

• The usual starting dose ranges from 0.5 mg to 10 mg per day.
• Your doctor may adjust the dose to determine the most appropriate amount for you.
• The maximum dose for adults depends on the condition being treated and ranges from 5 mg to 20 mg per day.

Elderly patients

• Elderly patients usually start treatment with a dose of 0.5 mg per day or half the lowest recommended adult dose.
• The amount of Haloperidol UNIA will then be gradually increased until the doctor determines the most suitable dose.
• The maximum, non-exceedable dose for elderly patients is 5 mg per day, unless the doctor decides that a higher dose is necessary.

Children and adolescents aged 6 to 17 years

• The usual dose ranges from 0.5 mg to 3 mg per day.
• Adolescents up to 17 years of age being treated for schizophrenia or behavioural disorders may receive a higher dose – up to 5 mg per day.

How to take Haloperidol UNIA

• Haloperidol UNIA is intended for oral administration.
• Haloperidol UNIA may be mixed with a small amount of water before administration, but must not be mixed with any other liquids.

10 ml bottle with dropper:

• Unscrew the cap on the bottle by turning it counterclockwise.
• Hold the bottle over a spoon and tilt it.
• Count the required number of falling drops.
• Drink the measured amount of solution.
• After use, close the bottle by screwing the cap back on.

100 ml bottle with oral dosing syringe:

• Draw up the solution using the dosing syringe provided.
• Place the bottle on a flat surface.
• Unscrew the cap by turning it counterclockwise.
• The syringe has a plunger on one end. Insert the other end into the bottle containing the solution.
• While holding the syringe steady, pull the plunger upwards until the desired volume (ml) of solution is drawn into the syringe.
• Remove the syringe from the bottle.
• Transfer the contents of the syringe to a spoon or cup by pushing the plunger down while holding the lower part of the syringe still. The contents may also be administered directly into the patient's mouth.
• Drink the measured amount of solution.
• After use, close the bottle by replacing and tightening the cap, then rinse the syringe with water.

If you take more Haloperidol UNIA than you should
If you take more Haloperidol UNIA than recommended, or if anyone else takes this medicine, seek immediate medical advice from your doctor or go to the nearest hospital emergency department.

If you forget to take Haloperidol UNIA

• If you miss a dose, take the next dose at your usual time. Then continue taking the medicine as directed by your doctor.
• Do not take a double dose.

Stopping Haloperidol UNIA

Haloperidol UNIA should be discontinued gradually, unless your doctor decides otherwise. Abruptly stopping treatment may cause symptoms such as:

• nausea and vomiting
• difficulty sleeping.

Always follow your doctor's instructions carefully. If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Warning about serious adverse reactions.
If any of the symptoms listed below occur or are suspected, a doctor must be contacted immediately.
The patient may require urgent medical intervention.

• Heart problems:
  • irregular heartbeat – the heart does not work properly, which may lead to loss of consciousness
  • abnormally fast heartbeat
  • extra heartbeats. Heart disturbances occur not very frequently in people taking Haloperidol UNIA (may occur in no more than 1 in 100 people). Cases of sudden death have been reported in people taking this medicine, although the exact frequency is unknown. In people taking antipsychotic medicines, cardiac arrest (cessation of heartbeat) has also occurred.
• A serious condition called "neuroleptic malignant syndrome". Symptoms include high fever, severe muscle rigidity, confusion, and loss of consciousness. This condition occurs rarely in people taking Haloperidol UNIA (may occur in no more than 1 in 1,000 people).
• Uncontrolled movements of the body or limbs (extrapyramidal symptoms), such as:
  • movements of the mouth, tongue, jaw, and sometimes limbs (tardive dyskinesia)
  • feeling of restlessness or difficulty sitting still, increased body movements
  • slowed or limited body movements, jerky movements, or twisting
  • muscle tremors or stiffness, shuffling gait
  • inability to perform movements
  • lack of normal facial expression, sometimes appearing mask-like. These disorders occur very frequently in people taking Haloperidol UNIA (may occur in more than 1 in 10 people). If any of these symptoms occur, the patient may be given additional medicines.
• Severe allergic reaction, which may include:
  • swelling of the face, lips, mouth, tongue, or throat
  • difficulty swallowing or breathing
  • itchy rash.

Allergic reaction occurs not very frequently in people taking Haloperidol UNIA (may occur in no more than 1 in 100 people).

• Blood clots in blood vessels, usually in the legs (deep vein thrombosis). These have been reported in people taking antipsychotic medicines. Symptoms of deep vein thrombosis in the leg include swelling, pain, and redness of the leg, but the clot may travel to the lungs, causing chest pain and difficulty breathing. Blood clots can be very serious, so if any of these symptoms occur, a doctor must be contacted immediately. If any of the serious adverse reactions listed above occur, a doctor must be contacted immediately.

Other adverse reactions
A doctor should be contacted if any of the following adverse reactions are suspected or occur.

Very common (may occur in more than 1 in 10 people):

• Feeling of restlessness
• Difficulty falling asleep
• Headache

Common (may occur in no more than 1 in 10 people):

• Severe mental disorders, such as belief in things that are not true (delusions) or seeing, feeling, or hearing things that are not present (hallucinations)
• Depression
• Abnormal muscle tension
• Dizziness, including dizziness felt when changing position from lying down to sitting or from sitting to standing
• Drowsiness
• Eye rolling upwards or rapid, uncontrolled eye movements
• Vision problems, such as blurred vision
• Low blood pressure
• Nausea, vomiting
• Constipation
• Dry mouth or increased salivation
• Skin rash
• Inability to urinate or incomplete bladder emptying
• Erectile dysfunction (impotence)
• Increase or decrease in body weight
• Changes in liver function test results

Uncommon (may occur in no more than 1 in 100 people):

• Effect on blood cells – reduced number of all types of blood cells, including a marked decrease in white blood cells and low platelet count (cells that help blood to clot)
• Confusion
• Loss or reduced sexual drive
• Seizures
• Muscle and joint stiffness
• Muscle spasms, tremors, or uncontrolled contractions, including neck spasms causing head tilting to one side
• Difficulty walking
• Shortness of breath
• Hepatitis or liver disorders causing 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 periods, prolonged, heavy, or painful periods
• Unexpected milk secretion from the breasts
• Breast pain or tenderness
• High body temperature
• Swelling due to fluid accumulation in the body

Rare (may occur in no more than 1 in 1,000 people):

• High levels of prolactin hormone in the blood
• Narrowing of the airways in the lungs, causing breathing difficulties
• Difficulty or inability to open the mouth
• Sexual disorders

The following adverse reactions have also been reported, but their exact frequency is unknown:

• High levels of antidiuretic hormone in the blood (syndrome of inappropriate antidiuretic hormone secretion)
• Low blood sugar levels
• Swelling around the larynx or brief spasm of the vocal cords, which may cause difficulty speaking and breathing
• Sudden liver failure
• Reduced 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)
• Persistent and painful erection
• Breast enlargement in males
• Low body temperature

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Haloperidol UNIA

Keep this medicine out of the sight and reach of children.
Store below 25 °C.
Keep in the original packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Haloperidol UNIA may be used for up to 3 months after the date of first opening of the medicine, provided this does not exceed the expiry date printed on the packaging.
The date of first opening should be entered in this box:
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package 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 components are: ethanol 96% (v/v), lactic acid, purified water.

What Haloperidol UNIA looks like and contents of the pack
Haloperidol UNIA is a clear liquid with a characteristic odour.
Packaging consists of:

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

Marketing Authorisation 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 package leaflet for Haloperidol UNIA is available in the Audio Leaflet system via a nationwide
free telephone number: 800 706 848.
Information intended exclusively for healthcare professionals:
Haloperidol UNIA, 2 mg/ml, oral drops, solution in bottle with dropper is intended for administration
in single doses up to 2 mg of haloperidol (corresponding to 20 drops).
The table below shows the number of drops required to achieve the desired single dose of
Haloperidol UNIA, 2 mg/ml, oral drops, solution.
Dosage conversion table for Haloperidol UNIA, 2 mg/ml, oral drops, solution

Haloperidol UNIA, 2 mg/ml, oral drops, solution in a bottle with a dispenser in the form of a syringe,
is intended for use to achieve single doses of 0.5 mg haloperidol and higher (corresponding to 0.25 ml and more).
The table below provides 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