Haloperidol wzf

Patient Information Leaflet

HALOPERIDOL WZF, 1 mg, tablets
HALOPERIDOL WZF, 5 mg, tablets
Haloperidolum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

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

Table of Contents

1. What Haloperidol WZF is and what it is 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. Contents of the pack and other information

1. What Haloperidol WZF is and what it is 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 mental health conditions affecting thinking, emotions, and behaviour. These include psychiatric disorders (such as schizophrenia and bipolar affective disorder) and behavioural disorders.
These conditions 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 excited, agitated, enthusiastic, impulsive, or overly active
• Become aggressive, hostile, or prone to violence.

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

Haloperidol WZF is sometimes used when other medicines or treatments are ineffective or cause side effects that the patient cannot tolerate.

2. Important information before taking Haloperidol WZF

When not to use 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 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 low blood potassium levels that have not been treated.
• If the patient is taking any of the medicines listed in section “Haloperidol WZF and other medicines”, subsection: “Do not take Haloperidol WZF”.

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 WZF.
Warnings and precautions
Serious adverse effects
Haloperidol WZF may cause heart problems, problems with controlling body or limb movements, and a serious condition 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 WZF, as these 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 if they have dementia, they should consult a doctor before receiving Haloperidol WZF.
Consult a doctor or pharmacist if the patient has:

• Slow heartbeat, heart disease, or if someone in their immediate family died suddenly from heart problems.
• Low blood pressure or if the patient experiences dizziness upon changing position from lying down to sitting or from sitting to standing.
• Low blood levels of potassium or magnesium (or other electrolytes). The treating doctor will decide on appropriate treatment.
• A history of stroke or, in the doctor’s opinion, a higher risk of stroke than other patients.
• Epilepsy or a history of seizures.
• Kidney, liver, or thyroid problems.
• High levels of the hormone prolactin in the blood or a tumour that may be caused by high prolactin levels (e.g. breast cancer).
• A history of blood clots or if blood clots have ever occurred in a close family member.
• Depression or if the patient with bipolar affective disorder has entered a depressive phase.

Closer monitoring of the patient’s condition and possibly a change in the dose of Haloperidol WZF 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 WZF.
Follow-up examinations
The treating doctor may decide to perform an ECG before or during treatment with Haloperidol WZF. An ECG measures heart function.
Blood tests
The treating doctor may decide to measure blood levels of potassium and magnesium (or other electrolytes) before 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 adequate studies have not been conducted in this patient group.
Haloperidol WZF 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 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, pimozide, prochlorperazine, promazine, 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). Also inform the doctor if the patient is taking bepridil (a medicine for chest pain or low blood pressure) or methadone (a painkiller also used in the treatment of drug addiction). These medicines may increase the risk of heart-related disorders; therefore, consult a doctor and do not take Haloperidol WZF if the patient is taking any of the listed medicines (see section “When not to use Haloperidol WZF”).

If lithium and Haloperidol WZF are taken together, closer monitoring of the patient may be necessary. Immediately inform the doctor and stop taking both medicines if the patient experiences:

• Unexplained fever or uncontrolled body movements
• Confusion, disorientation, headache, balance problems, or drowsiness. These are symptoms of a potentially life-threatening condition.

Some medicines may affect the way Haloperidol WZF works or may worsen heart-related disorders.
Tell the doctor if the patient is taking:

• 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 for high blood pressure or heart conditions). Also inform the doctor if the patient is taking any other medicines to lower blood pressure, such as diuretics.

The doctor may consider it necessary to adjust the dose of Haloperidol WZF if the patient is taking any of the listed medicines.
Haloperidol WZF 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 (strong painkillers)
• Medicines used for depression (tricyclic antidepressants)
• Medicines that lower 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 the listed medicines, inform the doctor before taking Haloperidol WZF.

Haloperidol WZF and alcohol
Drinking alcohol while taking Haloperidol WZF may cause drowsiness and difficulty concentrating. Therefore, alcohol intake should be limited. Inform the doctor about alcohol consumption during treatment with Haloperidol WZF and how much alcohol the patient drinks.
Pregnancy, breastfeeding, and effects on 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 against using Haloperidol WZF during pregnancy.
Newborns of mothers who took Haloperidol WZF during the last 3 months of pregnancy (third trimester) may experience the following problems:

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

Breastfeeding – Inform the doctor if the patient is breastfeeding or plans 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 WZF.
Effect on fertility – Haloperidol WZF 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 concerns.
Driving and operating machinery
Haloperidol WZF 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 WZF contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult a doctor before taking this medicine.

3. How to take Haloperidol WZF

This medicine should always be taken as directed by the doctor. If in doubt,
contact the doctor.
What dose should be taken
The prescribing doctor will inform the patient how many tablets to take and for how long. The doctor will
also advise whether Haloperidol WZF should be taken 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 prescribe a low dose, and then adjust the dose according to the patient's needs. It is very
important to take the correct amount of medicine.
The haloperidol dose prescribed to the patient depends on:

• the patient's age;
• the condition being treated;
• any kidney or liver problems the patient may have;
• other medicines the patient is taking.

Adults

• The initial dose usually ranges from 0.5 mg to 10 mg per day.
• The prescribing doctor may adjust the dose to determine the most appropriate amount for the patient.
• 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 of the lowest recommended adult dose.
• The number of tablets may then be increased until the doctor determines the most appropriate dose.
• The maximum non-exceedable dose for elderly patients is 5 mg per day, unless the doctor decides 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 WZF

• Haloperidol WZF is intended for oral administration.
• Tablets should be swallowed with water.

Taking more Haloperidol WZF than prescribed
If the patient takes more Haloperidol WZF than prescribed, or if anyone else takes this medicine,
they should immediately contact a doctor or go to the emergency department of the nearest hospital.
Missed dose of Haloperidol WZF

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

Stopping Haloperidol WZF
Haloperidol WZF should be discontinued gradually, unless the doctor decides otherwise. Abruptly
stopping treatment may cause effects such as:

• nausea and vomiting
• difficulty sleeping.
  Always follow the prescribing doctor's instructions carefully.

If there are any further doubts regarding the use of this medicine, consult the 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 are noticed or 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 disorders occur uncommonly in people taking Haloperidol WZF (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. Cardiac arrest (the heart stops beating) has also occurred in people taking antipsychotic medicines.

A serious disorder called "neuroleptic malignant syndrome". Symptoms include high fever, severe muscle rigidity, confusion, and loss of consciousness. This disorder occurs rarely in people taking Haloperidol WZF (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, jerking movements, or twisting
• tremor or muscle stiffness, shuffling gait
• inability to move
• lack of normal facial expression, sometimes resembling a mask.

These disorders occur very commonly in people taking Haloperidol WZF (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 reactions occur uncommonly in people taking Haloperidol WZF (may occur in no more than 1 in 100 people).

Blood clots in blood vessels, usually in the legs (deep vein thrombosis). Cases 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 may travel to the lungs, causing chest pain and breathing difficulties. 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 informed if any of the following adverse reactions are suspected or occur.
Very common (may affect more than 1 in 10 people):

• Feeling of restlessness
• Difficulty falling asleep
• Headache.

Common (may affect up to 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 to sitting or from sitting to standing
• Drowsiness
• Upward rolling of the eyes or rapid, uncontrolled eye movements
• Vision problems, such as blurred vision
• Low blood pressure
• Nausea, vomiting
• Constipation
• Dry mouth or increased salivation
• Skin rash
• Difficulty passing urine or inability to empty the bladder completely
• Erectile dysfunction (impotence)
• Increase or decrease in body weight
• Changes in liver function test results.

Uncommon (may affect up to 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)
• Feeling confused
• Loss or reduced sex drive
• Seizures
• Muscle and joint stiffness
• Muscle spasms, tremor, or uncontrolled spasms, including neck spasm causing the head to tilt to one side
• Problems with walking
• Shortness of breath
• Inflammation of the liver, or liver disorders causing yellowing of the skin and whites of the eyes (jaundice)
• Increased sensitivity of the skin to sunlight
• Itching
• Excessive sweating
• Changes in menstrual cycle, such as absence of menstruation, 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 affect up to 1 in 1,000 people):

• High level 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 level of antidiuretic hormone in the blood (syndrome of inappropriate antidiuretic hormone secretion)
• Low blood sugar level
• 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
• Breakdown of muscle tissue (rhabdomyolysis)
• Persistent and painful erection
• Breast enlargement in males
• Low body temperature.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 this medicine.

5. How to store Haloperidol WZF

Keep this medicine out of sight and reach of children.
Store the medicine 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 stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Haloperidol WZF contains

• The active substance is haloperidol. Each tablet contains 1 mg or 5 mg of haloperidol, respectively.
• Other ingredients: monohydrate lactose, microcrystalline cellulose, colloidal hydrated silica, sodium croscarmellose, magnesium stearate.

What Haloperidol WZF looks like and contents of the packaging
Haloperidol WZF is in the form of white to cream-colored, flat, biconvex tablets.
1 mg tablets:
The packaging contains 40 tablets in 2 aluminum/PVC blisters with 20 tablets each, in a cardboard box.
5 mg tablets:
The packaging contains 30 tablets in 2 aluminum/PVC blisters with 15 tablets each, in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
POLPHARMA S.A. Pharmaceutical Works
Pelplińska Street 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Manufacturer
POLPHARMA S.A. Pharmaceutical Works
Production Plant in Nowa Dęba
Metalowca Street 2, 39-460 Nowa Dęba