Haloperidol Vzf

Package Leaflet: Information for the Patient

HALOPERIDOL WZF, 1 mg, tablets

HALOPERIDOL WZF, 5 mg, tablets

Haloperidol

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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Haloperidol WZF and what is it used for
• 2. Important information before taking Haloperidol WZF
• 3. How to take Haloperidol WZF
• 4. Possible side effects
• 5. How to store Haloperidol WZF
• 6. Package contents and other information

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

The name of this medicine is Haloperidol WZF.
Haloperidol WZF contains the active substance haloperidol. It belongs to a group of medicines called antipsychotics.
Haloperidol WZF is used in adults, adolescents, and children for diseases that affect thinking, feeling, and behavior. 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 excessive suspicion (paranoia)
• Feel excited, agitated, enthusiastic, impulsive, or overly active
• Experience aggression, hostility, or a tendency to violence.

In adolescents and children, Haloperidol WZF 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 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 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

When not to take Haloperidol WZF:

• 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 and other medicines", subsection: "Do not take Haloperidol WZF".

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

Warnings and precautions

Severe side effects

Haloperidol WZF 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, 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 treated with 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.

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, in the doctor's opinion, are at greater 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 if they have bipolar affective disorder and are starting to experience a depressive phase.

The patient's condition may need to be monitored more closely, and the dose of Haloperidol WZF 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.

Check-ups

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

Blood tests

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

Children under 6 years of age

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

Haloperidol WZF 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 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, 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 addiction). These medicines may increase the risk of heart problems, so the patient should consult their doctor and not take Haloperidol WZF if they are taking any of these medicines (see "When not to take Haloperidol WZF").

If the patient is taking lithium and Haloperidol WZF, 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.

Some medicines may affect how Haloperidol WZF 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)
• ketokonazole (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 WZF if the patient is taking any of these medicines.

Haloperidol WZF may affect how the following types of medicines work:

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

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

Haloperidol WZF and alcohol

Drinking alcohol while taking Haloperidol WZF 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 WZF 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 WZF if the patient is pregnant.
In newborns of mothers who took Haloperidol WZF 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 during pregnancy and their child experiences any of these effects, 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 child's body. The treating doctor will discuss the risks and benefits of breastfeeding while taking Haloperidol WZF.
Fertility- Haloperidol WZF 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 doubts.

Driving and using machines

Haloperidol WZF 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 treating doctor.

Haloperidol WZF contains lactose

If the patient has been diagnosed with an intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Haloperidol WZF

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor.

What dose to take

The treating doctor will inform the patient about the dose and how long to take the medicine. The treating doctor will also inform the patient whether to take Haloperidol WZF once or several times a day. It may take some time before the patient feels the full effect of the medicine. Usually, at the beginning 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 of the medicine.
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 between 0.5 mg and 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 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 of the smallest recommended dose for adults.
• The number of tablets will then be increased until the treating doctor finds the most suitable dose.
• The maximum dose for elderly patients is 5 mg per day, unless the treating doctor decides that a higher dose is necessary.

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 treated for schizophrenia or behavioral disorders may receive a higher dose - up to 5 mg per day.

Taking Haloperidol WZF

• Haloperidol WZF is for oral use.
• The tablets should be swallowed with water.

Taking a higher dose of Haloperidol WZF than recommended

If the patient takes a higher dose of Haloperidol WZF 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

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

Stopping treatment with Haloperidol WZF

Haloperidol WZF 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 strictly follow the doctor's instructions.

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

4. Possible side effects

Like all medicines, Haloperidol WZF 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
• abnormally fast heart rate
• extra heartbeats. Heart rhythm disorders occur not very often in patients taking Haloperidol WZF (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 severe condition called "malignant neuroleptic syndrome". Symptoms include high fever, severe muscle stiffness, confusion, and loss of consciousness. This condition occurs rarely in patients taking Haloperidol WZF (may occur in less than 1 in 1,000 people).

Uncontrolled body movements or limb movements (symptoms of extrapyramidal syndrome), such as:

• movements of the mouth, tongue, jaw, and sometimes limbs (late dyskinesia)
• feeling agitated or having difficulty sitting still, increased body movements
• slow or limited body movements, jerky movements or twisting
• tremors or muscle stiffness, shuffling gait
• inability to perform a movement
• lack of normal facial expression, which may look like a mask.

These disorders occur very often in patients taking Haloperidol WZF (may occur in more than 1 in 10 people). If the patient experiences any of these symptoms, they may receive additional medicines.

Severe allergic reaction, which may include:

• swelling of the face, lips, mouth, tongue, or throat
• difficulty swallowing or breathing
• itchy rash. Allergic reactions occur not very often in patients taking Haloperidol WZF (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 a very serious risk, so if the patient experiences any of these symptoms, 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
• Abnormal 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
• Sexual dysfunction (impotence)
• Weight gain or loss
• Changes in liver test results.

Uncommon(may occur in less than 1 in 100 people):

• Effect on 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
• Decreased or lost sex drive
• Seizures
• Muscle stiffness and joint stiffness
• Muscle spasms, tremors, or uncontrolled muscle contractions, including neck muscle contractions 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 dysfunction.

The following side effects 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
• Swelling around the throat or short-term constriction 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 side effects not listed in the leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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

The medicine should be stored out of sight and reach of children.
The medicine should be stored at a temperature not exceeding 25°C. Protect from light.
Do not use this medicine 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/LOT means the batch number.
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. Package contents and other information

What Haloperidol WZF contains

• The active substance of the medicine is haloperidol. One tablet contains 1 mg or 5 mg of haloperidol.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, hydrated colloidal silica, sodium croscarmellose, magnesium stearate.

What Haloperidol WZF looks like and what the package contains

Haloperidol WZF is a white to cream-colored tablet, flat on both sides.
1 mg tablets:
The package contains 40 tablets in 2 Aluminum/PVC blisters of 20 tablets each, in a cardboard box.
5 mg tablets:
The package contains 30 tablets in 2 Aluminum/PVC blisters of 15 tablets each, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba
Date of last revision of the leaflet:December 2024