Haloperidol wzf 0,2%

HALOPERIDOL WZF 0.2%, 2 mg/ml, oral drops, solution
Haloperidolum
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents

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

The name of this medicine is Haloperidol WZF 0.2%.
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 disorders affecting thinking, emotions, and behavior. These include psychiatric disorders (such as schizophrenia and bipolar affective disorder) and behavioral disorders.
These disorders may cause the patient to:

• Feel confused (delirium)
• See, hear, or smell things that are not there (hallucinations)
• Believe strongly in 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 0.2% is used to treat schizophrenia in patients aged 13 to 17 years, and 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), for example, in severe forms 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 are ineffective or cause unacceptable adverse effects.

2. Important information before taking Haloperidol WZF 0.2%

When not to use 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 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 which have not yet been treated.
• If the patient is taking any of the medicines listed in section "Haloperidol WZF 0.2% and other medicines", subsection: "Do not use Haloperidol WZF 0.2%".

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 0.2%.

Warnings and precautions
Serious adverse effects
Haloperidol WZF 0.2% may cause heart problems, problems 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 must be aware of the possibility of serious adverse effects during treatment with Haloperidol WZF 0.2%, as they may require immediate medical attention. See "Be aware of 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, and especially if they have dementia, they should consult a doctor before receiving Haloperidol WZF 0.2%.

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 when changing position from lying down to sitting or from sitting to standing.
• Low blood potassium or magnesium (or other electrolyte) levels. The treating doctor will decide what treatment to use.
• A history of stroke or, according to the doctor, a higher risk of stroke than other patients.
• Epilepsy or a history of seizures.
• Problems with kidneys, liver, or thyroid.
• 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 someone from the patient's immediate family.
• Depression or if the patient with bipolar affective disorder has entered a depressive phase.

Closer monitoring of the patient's condition may be necessary, as well as adjustment of the Haloperidol WZF 0.2% dose.
If the patient has any doubts whether any of the above points apply, they should consult a doctor or pharmacist before taking Haloperidol WZF 0.2%.

Follow-up examinations
The treating doctor may decide to perform an ECG before or during treatment with Haloperidol WZF 0.2%. 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 0.2%.

Children under 6 years of age
Haloperidol WZF 0.2% should not be used in children under 6 years of age, as adequate studies have not been conducted in this patient group.

Haloperidol WZF 0.2% 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 use Haloperidol WZF 0.2% 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, 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)
• Cancers (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 drug addiction treatment). These medicines may increase the risk of heart-related disorders, so consult a doctor and do not use Haloperidol WZF 0.2% if the patient is taking any of these medicines (see section "When not to use Haloperidol WZF 0.2%").

When taking lithium together with Haloperidol WZF 0.2%, 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 condition seriously threatening health.

Some medicines may affect the way Haloperidol WZF 0.2% works or may worsen heart-related 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 for bacterial infections)
• Itraconazole, posaconazole, or voriconazole (used for 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 disease). 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 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.
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 these medicines, they must inform the doctor before taking Haloperidol WZF 0.2%.

Haloperidol WZF 0.2% and alcohol
Drinking alcohol during treatment with Haloperidol WZF 0.2% may cause drowsiness and difficulty concentrating. This means alcohol intake should be carefully monitored. Inform the doctor about alcohol consumption during treatment with Haloperidol WZF 0.2% 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 have a child, she should consult a doctor. The doctor may advise not to use Haloperidol WZF 0.2% if the patient is pregnant.

Newborns of mothers who took Haloperidol WZF 0.2% 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 0.2% during pregnancy and the child shows any of these effects, contact a doctor immediately.

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 0.2%.

Effect on fertility - Haloperidol WZF 0.2% 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 WZF 0.2% 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 0.2% contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216)
The medicine may cause allergic reactions (including delayed-type reactions).

3. How to take Haloperidol WZF 0.2%

Haloperidol WZF 0.2% should always be taken exactly as directed by your doctor.
If in doubt, consult your doctor or pharmacist.

What dose should be taken
Your doctor will inform you how much Haloperidol WZF 0.2% to take and for how long.
Your doctor will also tell you whether Haloperidol WZF 0.2% 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 the dose according to your needs.
It is very important to take the correct amount of medicine.
The dose of haloperidol you will 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 of the lowest recommended adult dose.
• The amount of Haloperidol WZF 0.2% will then be gradually increased until your doctor determines the most suitable dose.
• The maximum daily dose for elderly patients is 5 mg, unless your 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 behavioral disorders may receive a higher dose – up to 5 mg per day.

How to take Haloperidol WZF 0.2%

• Haloperidol WZF 0.2% is for oral use.
• Haloperidol WZF 0.2% may be mixed with a small amount of water before taking, but must not be mixed with any other liquids.
• Unscrew the cap on the bottle by turning it counterclockwise.
• Turn the bottle upside down and place it over a spoon.
• Count the number of drops prescribed.
• Swallow the measured amount of solution.
• After use, close the bottle by screwing the cap back on.

If you take more Haloperidol WZF 0.2% than prescribed
If you take more Haloperidol WZF 0.2% than prescribed, or if anyone else takes this medicine, contact your doctor immediately or go to the nearest hospital emergency department.

If you miss a dose of Haloperidol WZF 0.2%

• 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 WZF 0.2%
Haloperidol WZF 0.2% should be discontinued gradually, unless your doctor decides otherwise.
Stopping treatment suddenly may cause effects such as:

• nausea and vomiting
• difficulty sleeping.
  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 following symptoms 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 rapid heartbeat
• extra heartbeats. Heart disturbances occur uncommonly in people taking Haloperidol WZF 0.2% (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 condition called "neuroleptic malignant syndrome". Symptoms include high fever, severe muscle stiffness, confusion, and loss of consciousness. This condition occurs rarely in people taking Haloperidol WZF 0.2% (may occur in no more than 1 in 1,000 people).
Uncontrolled body or limb movements (extrapyramidal symptoms), such as:

• movements of the mouth, tongue, jaw, and sometimes limbs (tardive dyskinesia)
• restlessness or difficulty remaining still, increased body movements
• slowed or limited body movements, jerky movements or twisting
• muscle tremors or stiffness, shuffling gait
• inability to move
• lack of normal facial expression, sometimes appearing mask-like. These disorders occur very commonly in people taking Haloperidol WZF 0.2% (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 0.2% (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 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
Contact a doctor 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 sleeping
• Headache.

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

• Severe mental disturbances, such as believing 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 completely empty the bladder
• 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 sex drive
• Seizures
• Muscle and joint stiffness
• Muscle spasms, tremors or uncontrolled contractions, including neck spasms causing the head to tilt to one side
• Walking difficulties
• Shortness of breath
• Inflammation of the liver, 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 production 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 voice box or brief spasms 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)
• Prolonged and painful erection
• Breast enlargement in men
• 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 Drug Reactions of the 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 to provide more information on the safety of the medicine.

5. How to store Haloperidol WZF 0.2%

Keep out of the reach and sight 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 specified month.
The marking on the package following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot indicates the batch number.
The shelf life of the medicine after first opening the bottle is 3 months.
Medicines should 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 0.2% contains

• The active substance 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 colourless, clear solution.
The pack contains a 10 ml amber glass bottle with a polyethylene dropper, closed with a polyethylene cap, and placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
POLPHARMA Pharmaceuticals S.A.
Pelplińska Street 19, 83-200 Starogard Gdanski
tel. +48 22 364 61 01
Manufacturer
POLPHARMA Pharmaceuticals S.A.
Medana Branch in Sieradz
Wladyslawa Lokietka Street 10, 98-200 Sieradz

Information intended exclusively for healthcare professionals:

Haloperidol WZF 0.2% in a bottle with dropper is intended for use to deliver 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 the product Haloperidol WZF 0.2%, 2 mg/ml, oral drops, solution.
Conversion table for the product Haloperidol WZF 0.2%, 2 mg/ml, oral drops, solution