Haloperidol wzf

Package leaflet: Information for the patient

HALOPERIDOL WZF, 5 mg/ml, solution for injection
Haloperidolum
Please read carefully the entire leaflet before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Haloperidol WZF is and what it is used for
2. Important information before using Haloperidol WZF
3. How to use 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 for illnesses that affect the way a person thinks, feels, and behaves. 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.

Haloperidol WZF is also used in adults:

• for the treatment of uncontrolled movements in Huntington's disease.
• for the prevention and treatment of postoperative nausea and vomiting. Haloperidol WZF may be used alone or in combination with another medicine. It is sometimes used when other medicines or treatments are ineffective, cause unacceptable side effects, or cannot be administered orally.

2. Important information before using 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 previously 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, pharmacist, or nurse before taking Haloperidol WZF.

Warnings and precautions
Serious adverse effects
Haloperidol WZF 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 should be aware of the possibility of serious adverse effects while taking Haloperidol WZF, 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 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 physician will decide on appropriate treatment.
• A history of stroke or, in the doctor’s opinion, an increased risk of stroke compared to other patients.
• Epilepsy or a history of seizures.
• Kidney, liver, or thyroid problems.
• High blood levels of the hormone prolactin or a tumor that could be caused by high prolactin levels (e.g., breast cancer).
• A history of blood clots or if someone in the patient’s immediate family has had blood clots.
• Depression, or if the patient with bipolar affective disorder has entered a depressive phase.

Closer monitoring of the patient and possible dose adjustment of Haloperidol WZF may be necessary.
If the patient is unsure whether any of the above conditions apply, they should consult a doctor or nurse before taking Haloperidol WZF.
Follow-up examinations
The treating physician may decide to perform an ECG before or during treatment with Haloperidol WZF. An ECG measures heart activity.
Blood tests
The treating physician may decide to measure blood levels of potassium and magnesium (or other electrolytes) before or during treatment with Haloperidol WZF.
Children and adolescents
Haloperidol WZF should not be used in children and adolescents under 18 years of age. The medicine has not been studied in these patient groups.
Haloperidol WZF and other medicines
Tell your doctor, pharmacist, or nurse 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 (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 problems, so 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, difficulty maintaining balance, or drowsiness. These are symptoms of a potentially life-threatening condition.
  Some medicines may affect how Haloperidol WZF works or may worsen heart-related disorders. Inform the doctor if the patient is taking any of the following:
• Alprazolam or buspirone (anti-anxiety medicines)
• Duloxetine, fluoxetine, fluvoxamine, nefazodone, paroxetine, sertraline, St. John's wort (Hypericum perforatum), or venlafaxine (antidepressants)
• Bupropion (used to treat depression or smoking addiction)
• Carbamazepine, phenobarbital, or phenytoin (antiepileptic medicines)
• Rifampicin (used for bacterial infections)
• Itraconazole, posaconazole, or voriconazole (used for fungal infections)
• Ketoconazole tablets (used to treat 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 (water pills). 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. Inform 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 for ADHD (attention deficit hyperactivity disorder) or narcolepsy (so-called stimulants)
• Medicines used for 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.
  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 fertility
Pregnancy – If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her 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 immediately.
  Breastfeeding – Inform the doctor if the patient is breastfeeding or planning 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.
  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 using machines
Haloperidol WZF may affect the ability to drive vehicles, 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 it with the treating doctor.

3. How to use Haloperidol WZF

What dose will be administered
The prescribing doctor will decide how much Haloperidol WZF the patient needs and for how long. It may take some time before the patient experiences the full effect of the medicine. Usually, at the beginning of treatment, the doctor will give the patient a low dose and then adjust it according to the patient's needs.
The dose of haloperidol that the patient receives depends on:

• the patient's age;
• the condition being treated;
• any existing kidney or liver disease;
• other medicines the patient is taking.

Adults

• The initial dose is usually between 1 and 5 mg.
• The patient may receive additional doses, usually at intervals of 1 to 4 hours.
• The patient will not receive more than 20 mg of the medicine per day.

Elderly patients

• Elderly patients usually start treatment with half of the lowest recommended adult dose.
• The dose will then be increased until the doctor determines the most appropriate dose for the patient.
• The patient will not receive a total daily dose greater than 5 mg, unless the doctor decides a higher dose is necessary.

How Haloperidol WZF will be administered
Haloperidol WZF will be administered by a doctor or nurse. This medicine is intended for intramuscular use and is given as an injection into the muscle.

Missed dose or administration of a higher than recommended dose of Haloperidol WZF
This medicine will be administered to the patient by a doctor or nurse, so missing a dose or overdosing is unlikely. If there are any concerns, consult a doctor or nurse.

Discontinuing 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.

Strictly follow the instructions of the treating physician. If you have any further questions regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

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 beat properly, which may lead to loss of consciousness
• unusually fast heartbeat
• extra heartbeats. Heart disturbances occur not commonly 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 condition called "neuroleptic malignant syndrome". Symptoms include high fever,
extreme muscle rigidity, mental confusion, and loss of consciousness. This condition occurs
rarely in people taking Haloperidol WZF (may occur in no more than 1 in 1,000 people).
Uncontrollable 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 initiate movement
• lack of normal facial expression, sometimes appearing mask-like. 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 medication.

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 commonly 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 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 falling asleep
• 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 upon changing position from lying down to sitting or from sitting to standing
• Drowsiness
• Upward eye movements 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 the head to tilt to one side
• Problems with walking
• Shortness of breath
• Hepatitis or liver disorders causing yellowing of the skin and whites of the eyes (jaundice)
• Increased skin sensitivity 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 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 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)
• Persistent and painful erection
• Breast enlargement in males
• Low body temperature.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform a doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Drug Reactions at 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.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Haloperidol WZF

Keep the medicine out of the sight and reach of children.
Store below 25 °C. Do not freeze. Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the label and carton. 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 indicates the batch number.
Medicines must not be disposed of via the sewage system 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 WZF contains

• The active substance is haloperidol. Each ml of solution contains 5 mg of haloperidol.
• The other ingredients are: lactic acid, water for injections.

What Haloperidol WZF looks like and contents of the pack
Haloperidol WZF solution for injection is a clear, colourless liquid.
The pack contains 10 ampoules of 1 ml capacity made of colourless glass, in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Information intended exclusively for healthcare professionals:
Instructions for opening the ampoule
Before opening the ampoule, ensure that the entire solution is in the lower part of the ampoule.
Gently shake the ampoule or tap it with your finger to help the solution flow down.
Each ampoule has a coloured dot (see Figure 1) indicating the score line located beneath it.

• To open the ampoule, hold it vertically in both hands, with the coloured dot facing towards you – see Figure 2. Hold the upper part of the ampoule so that the thumb is positioned above the coloured dot.
• Press in the direction of the arrow shown in Figure 3. The ampoules are intended for single use only and should be opened immediately before use. Any unused portion of the product should be discarded in accordance with applicable regulations.

Figure 1.

Figure 2.

Figure 3.