Haloperidol Vzf 0,2%

Patient Information Leaflet: Patient Information

HALOPERIDOL WZF 0.2%, 2 mg/ml, oral drops, solution
Haloperidolum

Read the 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 any not listed in this leaflet, tell your doctor or pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Haloperidol WZF 0.2% and what is it used for
• 2. Important information before taking Haloperidol WZF 0.2%
• 3. How to take Haloperidol WZF 0.2%
• 4. Possible side effects
• 5. How to store Haloperidol WZF 0.2%
• 6. Contents of the pack and other information

1. What is Haloperidol WZF 0.2% and what is it used for

The name of this medicine is Haloperidol WZF 0.2%.
The medicine Haloperidol WZF 0.2% contains the active substance haloperidol. It belongs to a group of medicines
called antipsychotics.
Haloperidol WZF 0.2% is used in adults, adolescents, and children for diseases that affect the way of thinking, feeling, and behaving. These include mental disorders (such as schizophrenia and 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 unusual suspicion (paranoia)
• Feel excitement, agitation, enthusiasm, be impulsive, or overly active
• Feel aggression, hostility, or a tendency to violence.

In adolescents and children, Haloperidol WZF 0.2% 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 WZF 0.2% 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 Gilles de la Tourette syndrome.
• In adults, to treat other uncontrolled movements in Huntington's disease.

Haloperidol WZF 0.2% 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 WZF 0.2%

When not to take Haloperidol WZF 0.2%:

• 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 Lewy body dementia.
• 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 WZF 0.2% and other medicines", subsection: "Do not take Haloperidol WZF 0.2%".

If any of the above points apply to the patient, they should not take this medicine.
In case of doubts, before taking Haloperidol WZF 0.2%, the patient should consult a doctor or pharmacist.

Warnings and precautions

Severe side effects

Haloperidol WZF 0.2% may cause heart problems, problems with controlling body movements or limbs, and a severe condition 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 WZF 0.2%, 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 a doctor before taking Haloperidol WZF 0.2%.

The patient should consult a doctor or pharmacist if they:

• Have a slow heart rate, heart disease, or if someone in their close family has died suddenly from heart problems.
• Have low blood pressure or feel dizzy when changing position from lying down to sitting or from sitting to standing.
• Have low potassium or magnesium (or other electrolyte) levels in the blood. The treating 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.
• Have high levels of the hormone prolactin in the blood or a tumor that may be caused by high prolactin levels (e.g., breast cancer).
• Have a history of blood clots or have had blood clots in the past.
• Have depression or are experiencing a depressive phase of bipolar affective disorder.

The patient's condition may need to be monitored more closely, and the dose of Haloperidol WZF 0.2% may need to be changed.
If the patient has any doubts about whether any of the above points apply to them, they should consult a doctor or pharmacist before taking Haloperidol WZF 0.2%.

Check-ups

The treating doctor may decide to perform an ECG before starting or during treatment with Haloperidol WZF 0.2%. The ECG measures heart activity.

Blood tests

The treating doctor may decide to measure potassium and magnesium (or other electrolyte) levels in the blood before starting or during treatment with Haloperidol WZF 0.2%.

Children under 6 years of age

Haloperidol WZF 0.2% should not be used in children under 6 years of age, as no appropriate studies have been conducted in this patient group.

Haloperidol WZF 0.2% and other medicines

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

Do not take Haloperidol WZF 0.2% if the patient is taking certain types of medicines, including:

• medicines for heart rhythm disorders (such as amiodarone, dofetilide, disopyramide, dronedarone, ibutilide, quinidine, sotalol)
• medicines for depression (such as citalopram and escitalopram)
• medicines for psychosis (such as fluphenazine, levomepromazine, perphenazine, pimozyd, prochlorperazine, promazine, sertindol, thioridazine, trifluoperazine, triflupromazine, and ziprasidone)
• medicines for bacterial infections (such as azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, and telithromycin)
• medicines for fungal infections (such as pentamidine)
• medicines for malaria (such as halofantrine)
• medicines for nausea and vomiting (such as dolasetron)
• medicines for cancer (such as toremifene and vandetanib). The patient should also inform their doctor if they are taking bepridil (a medicine for chest pain or low blood pressure) or methadone (a pain reliever also used to treat addiction). These medicines may increase the risk of heart problems, so the patient should consult a doctor and not take Haloperidol WZF 0.2% if they are taking any of these medicines (see "When not to take Haloperidol WZF 0.2%").

In case of concurrent use of lithium and Haloperidol WZF 0.2%, closer monitoring of the patient's 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, or drowsiness. These are symptoms of a serious condition.

Some medicines may affect the way Haloperidol WZF 0.2% 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 decide to change the dose of Haloperidol WZF 0.2% if the patient is taking any of these medicines.

Haloperidol WZF 0.2% may affect the way the following 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 WZF 0.2%.

Haloperidol WZF 0.2% and alcohol

Consuming alcohol while taking Haloperidol WZF 0.2% may cause drowsiness and difficulty concentrating. This means that the patient should be careful with the amount of alcohol they consume. The patient should tell their doctor about their alcohol consumption while taking Haloperidol WZF 0.2% and how much alcohol they consume.

Pregnancy, breastfeeding, and fertility

Pregnancy- if the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult a doctor. The doctor may advise not to take Haloperidol WZF 0.2% if the patient is pregnant.
In newborns of mothers who took Haloperidol WZF 0.2% during the last 3 months of pregnancy (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 WZF 0.2% during pregnancy and the baby experiences any of these effects, they should contact a 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 treating doctor will discuss the risks and benefits of breastfeeding while taking Haloperidol WZF 0.2%.
Fertility- Haloperidol WZF 0.2% may increase the levels of a hormone called prolactin, which can affect fertility in men and women. The patient should consult a doctor if they have any doubts.

Driving and using machines

Haloperidol WZF 0.2% may affect the patient's ability to drive, use tools, and operate machines. Side effects such as drowsiness may impair alertness, especially when starting treatment or taking a high dose. The patient should not drive, use tools, or operate machines without first discussing it with their doctor.

Haloperidol WZF 0.2% contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216)

The medicine may cause allergic reactions (possible late reactions).

3. How to take Haloperidol WZF 0.2%

Haloperidol WZF 0.2% should always be taken as directed by the doctor. If the patient has any doubts, they should ask their doctor or pharmacist.

What dose to take

The treating doctor will inform the patient about the dose of Haloperidol WZF 0.2% to take and how long to take it.
The treating doctor will also inform the patient whether to take Haloperidol WZF 0.2% 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 that 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 0.5 mg to 10 mg per day.
• The treating 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 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 of the smallest recommended dose for adults.
• The amount of Haloperidol WZF 0.2% 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 that a higher dose is needed.

Children and adolescents aged 6 to 17 years

• The dose is usually 0.5 mg to 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 WZF 0.2%

• Haloperidol WZF 0.2% is for oral use.
• Haloperidol WZF 0.2% can be mixed with a small amount of water before taking, but it should not be mixed with other liquids.
• Open the bottle by turning the cap in the opposite direction to the arrow.
• Turn the bottle upside down and place it over a spoon.
• Count the drops to be taken.
• Drink the measured amount of solution.
• After use, close the bottle by turning the cap in the direction of the arrow.

Taking a higher dose of Haloperidol WZF 0.2% than recommended

If the patient takes a higher dose of Haloperidol WZF 0.2% than recommended, or if someone else takes the medicine, they should immediately consult a doctor or go to the emergency room at the nearest hospital.

Missing a dose of Haloperidol WZF 0.2%

• 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 the doctor.
• The patient should not take a double dose.

Stopping treatment with Haloperidol WZF 0.2%

Haloperidol WZF 0.2% should be stopped gradually, unless the doctor decides otherwise. Stopping treatment suddenly may cause side effects such as:

• Nausea and vomiting
• Difficulty sleeping. The patient should follow the doctor's instructions carefully.

If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Haloperidol WZF 0.2% can cause side effects, although not everybody gets them.

Warning about severe side effects.

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

Heart problems:

• Abnormal heart rhythm - the heart does not work properly, which can cause loss of consciousness
• Unusually fast heart rate
• Extra heartbeats. Heart rhythm disorders occur not very often in people taking Haloperidol WZF 0.2% (may occur in less than 1 in 100 people). There have been cases of sudden deaths in people taking this medicine, but the exact frequency is not known. People taking antipsychotic medicines have also experienced cardiac arrest (the heart stops beating).

A serious condition called "malignant neuroleptic syndrome". Symptoms include high fever, very strong muscle stiffness, confusion, and loss of consciousness. This condition occurs rarely in people taking Haloperidol WZF 0.2% (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 or twisting movements
• 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 often in people taking Haloperidol WZF 0.2% (may occur in more than 1 in 10 people). If the patient experiences any of these symptoms, they may be given additional medicines.

Severe allergic reaction, which can include:

• Swelling of the face, lips, tongue, or throat
• Difficulty swallowing or breathing
• Itchy rash. Allergic reactions occur not very often in people taking Haloperidol WZF 0.2% (may occur in less than 1 in 100 people).

Blood clots in the 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 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 very serious, 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 suspect or experience 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 upwards 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 number of all types of blood cells, including a significant decrease in white blood cells and a low number of platelets (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 disorders 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 frequency is not known:

• High levels of antidiuretic hormone in the blood (syndrome of inappropriate antidiuretic hormone secretion)
• Low blood sugar levels
• 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 any not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 collected on the safety of the medicine.

5. How to store Haloperidol WZF 0.2%

Keep out of the sight and reach of children.
Do not freeze.
Do not use Haloperidol WZF 0.2% after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
The shelf life of the medicine after opening the bottle is 3 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Haloperidol WZF 0.2% contains

• The active substance of the medicine is haloperidol. One ml of solution contains 2 mg of haloperidol.
• The other ingredients are: lactic acid, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), purified water.

What Haloperidol WZF 0.2% looks like and contents of the pack

Haloperidol WZF 0.2% is a colorless, clear solution.
The packaging contains a 10 ml glass bottle with a polyethylene dropper, closed with a polyethylene cap, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz
Date of last revision of the leaflet:December 2024
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Information intended for healthcare professionals only:
Haloperidol WZF 0.2% 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 needed to achieve the desired single dose of Haloperidol WZF 0.2%, 2 mg/ml, oral drops, solution.