HALOPERIDOL ESTEVE 2 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Haloperidol Esteve 2 mg/ml Oral Solution

Haloperidol

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Haloperidol Esteve and what is it used for
2. What you need to know before taking Haloperidol Esteve
3. How to take Haloperidol Esteve
4. Possible side effects
5. Storage of Haloperidol Esteve
6. Package Contents and Additional Information

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

The name of this medication is Haloperidol Esteve.

Haloperidol Esteve contains the active ingredient haloperidol, which belongs to a group of medications called "antipsychotics".

Haloperidol Esteve is used in adult, adolescent, and child patients to treat diseases that affect thinking, feeling, or behavior. These include mental health problems (such as schizophrenia and bipolar disorder) and behavioral problems.

These diseases can cause the patient to:

• Feel confused (confusional syndrome).
• See, hear, feel, or smell things that are not real (hallucinations).
• Believe things that are not true (delusions).
• Become extremely distrustful (paranoia).
• Feel very excited, agitated, emotional, impulsive, or hyperactive.
• Become very aggressive, hostile, or violent.

In adolescents and children, Haloperidol Esteve is used to treat schizophrenia in patients aged 13 to 17 years and to treat behavioral problems in patients aged 6 to 17 years.

Haloperidol Esteve is also used:

• In adolescents and children aged 10 to 17 years, and in adults under 65 years to treat movements or sounds that the patient cannot control (tics), such as in severe Tourette's syndrome.
• In adults to help control movements in Huntington's disease.

Haloperidol Esteve is sometimes used when other medications or treatments have not worked or have caused unacceptable side effects.

2. What you need to know before taking Haloperidol Esteve

Do not take Haloperidol Esteve:

• If you are allergic to haloperidol or any of the other ingredients of this medication (listed in section 6).
• If your perception has decreased or you feel that you or your reactions have become particularly slow.
• If you have Parkinson's disease.
• If you suffer from a type of dementia called "dementia with Lewy bodies".
• If you have progressive supranuclear palsy (PSP).
• If you have a heart disorder called "prolonged QT interval" or any other heart rhythm problem that appears as an abnormal tracing on an electrocardiogram (ECG).
• If you have heart failure or have recently had a heart attack.
• If you have low potassium levels in your blood that have not been treated.
• If you are taking any of the medications listed in the section "Other medications and Haloperidol Esteve - Do not take Haloperidol Esteve if you are taking certain medications for the following disorders".

Do not take this medication if any of the above points apply to you. If you are unsure, consult your doctor or pharmacist before starting to take Haloperidol Esteve.

Warnings and Precautions

Serious Side Effects

Haloperidol Esteve may cause heart problems, problems controlling body movements or limbs, and a serious side effect called "neuroleptic malignant syndrome". It may also cause severe allergic reactions and blood clots. You should be aware of the possible side effects while taking Haloperidol Esteve, as you may need urgent medical treatment. See the section "Be aware of serious side effects" in section 4.

Elderly Patients and Patients with Dementia

A small increase in the number of deaths and strokes has been reported in elderly patients with dementia taking antipsychotic medications. Consult your doctor or pharmacist before starting to take Haloperidol Esteve if you are an elderly person, especially if you suffer from dementia.

Consult your doctor or pharmacist if:

• You have a slow heart rate, suffer from heart disease, or if a close relative has died suddenly from heart problems.
• You have low blood pressure or feel dizzy when getting up from a sitting or standing position.
• You have low potassium or magnesium levels (or other electrolytes) in your blood. Your doctor will decide how to treat this problem.
• You have ever had a brain hemorrhage or your doctor has told you that you are more likely to have a stroke than other people.
• You have epilepsy or have ever had seizures (convulsions).
• You have kidney, liver, or thyroid problems.
• You have high levels of the hormone prolactin in your blood or suffer from a cancer that may be caused by high prolactin levels (such as breast cancer).
• You have a personal or family history of blood clots.
• You suffer from depression or have bipolar disorder and have started to feel depressed.

You may need to be monitored more closely, and it is possible that the amount of Haloperidol Esteve you take may need to be adjusted.

If you are unsure whether any of the above points apply to you, consult your doctor or pharmacist before starting to take Haloperidol Esteve.

Medical Examinations

Your doctor may request an electrocardiogram (ECG) before or during treatment with Haloperidol Esteve. The ECG measures the electrical activity of the heart.

Blood Tests

Your doctor may want to check your potassium or magnesium levels (or other electrolytes) in your blood before or during treatment with Haloperidol Esteve.

Children under 6 years

Haloperidol Esteve should not be used in children under 6 years, as this medication has not been adequately studied in this age group.

Other medications and Haloperidol Esteve

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.

Do not take Haloperidol Esteve if you are taking certain medications for the following disorders:

• Heart rhythm problems (such as amiodarone, dofetilide, disopyramide, dronedarone, ibutilide, quinidine, and sotalol).
• Depression (such as citalopram and escitalopram).
• Psychosis (such as fluphenazine, levomepromazine, perphenazine, pimozide, 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).

Also, consult your doctor if you are taking bepridil (for chest pain or to lower blood pressure) or methadone (to relieve pain or treat drug addiction).

These medications may cause heart problems more frequently, so consult your doctor if you are taking any of them and do not take Haloperidol Esteve (see "Do not take Haloperidol Esteve if").

You may need special monitoring if you are taking lithium and Haloperidol Esteve at the same time.Consult your doctor immediately and stop taking both medications if you experience:

• Unexplained fever or uncontrollable movements
• Confusion, disorientation, headache, balance problems, and drowsiness.

These are signs of a serious disorder.

Certain medications may affect the functioning of Haloperidol Esteve or may cause heart problems more frequently

Consult your doctor if you are taking:

• Alprazolam or buspirone (for anxiety).
• Duloxetine, fluoxetine, fluvoxamine, nefazodone, paroxetine, sertraline, St. John's Wort (Hypericum perforatum), or venlafaxine (for depression).
• Bupropion (for depression or to help quit smoking).
• Carbamazepine, phenobarbital, or phenytoin (for epilepsy).
• Rifampicin (for bacterial infections).
• Itraconazole, posaconazole, or voriconazole (for fungal infections).
• Ketoconazole tablets (to treat Cushing's syndrome).
• Indinavir, ritonavir, or saquinavir (against HIV).
• Chlorpromazine or promethazine (for nausea and vomiting).
• Verapamil (for blood pressure or heart problems).

Also, consult your doctor if you are taking any other medication to lower blood pressure, such as diuretic tablets.

Your doctor may need to change the dose of Haloperidol Esteve if you are taking any of these medications.

Haloperidol Esteve may affect the functioning of the following types of medications

Consult your doctor if you are taking medications for:

• Sedation or to help you sleep (tranquilizers).
• Pain (strong painkillers).
• Depression (tricyclic antidepressants).
• Lowering blood pressure (such as guanethidine and methyldopa).
• Severe allergic reactions (epinephrine).
• Attention deficit hyperactivity disorder (ADHD) or narcolepsy (known as "stimulants").
• Parkinson's disease (such as levodopa).
• Preventing blood clotting (phenindione).

If you are taking any of these medications, consult your doctor before starting to take Haloperidol Esteve.

Using Haloperidol Esteve with alcohol

Haloperidol Esteve should not be taken with alcohol, as it may cause drowsiness and reduce your alertness. Therefore, be careful with alcoholic beverages. Consult your doctor about taking alcoholic beverages while taking Haloperidol Esteve and tell them how much alcohol you drink.

Pregnancy, breastfeeding, and fertility

Pregnancy:if you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. Your doctor may advise you not to take Haloperidol Esteve while you are pregnant.

Newborns of mothers who have taken Haloperidol Esteve in the last three months (the last trimester) of pregnancy may experience:

• Tremors, stiffness, or weakness in the muscles.
• Drowsiness or agitation.
• Breathing problems or difficulty feeding.

The exact frequency of these problems is unknown. If you take Haloperidol Esteve while you are pregnant and the newborn experiences any of these side effects, contact your doctor.

Breastfeeding:consult your doctor if you are breastfeeding or plan to breastfeed, as small amounts of the medication may pass into breast milk and, therefore, to the infant. Your doctor will discuss the risks and benefits of breastfeeding while taking Haloperidol Esteve.

Fertility:Haloperidol Esteve may increase the levels of a hormone called "prolactin", which may affect fertility in both men and women. Consult your doctor if you have any questions about this.

Driving and using machines

Haloperidol Esteve may cause symptoms such as drowsiness, dizziness, or vision changes, and may reduce your reaction time, especially at the start of treatment or if you take high doses. These effects, as well as the underlying disease, may impair your ability to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medication.

Haloperidol Esteve contains methyl parahydroxybenzoate

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218).

3. How to take Haloperidol Esteve

Follow the instructions for taking this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

How much to take

Your doctor will tell you how much Haloperidol Esteve to take and for how long. Your doctor will also tell you if you should take Haloperidol Esteve once or several times a day. It may take some time before you notice the desired effect of the medication. Usually, your doctor will prescribe a low dose at first and then adjust it according to your response. It is very important to take the correct amount.

The dose of Haloperidol Esteve will depend on:

• Your age.
• The disease being treated.
• If you have kidney or liver problems.
• What other medications you are taking.

Adults

• The dose will normally be between 0.5 mg and 10 mg per day.
• Your doctor may adjust the dose until they find the one that works best for you.
• The maximum dose that adults should take depends on the disease being treated and ranges from 5 mg to 20 mg per day.

Use in elderly patients

• In elderly patients, treatment will usually start with 0.5 mg per day or half the lowest adult dose.
• Then, your doctor will adjust the amount of Haloperidol Esteve you need to take until they find the dose that works best for you.
• The maximum dose in elderly patients is 5 mg per day, unless your doctor decides that you need a higher dose.

Children and adolescents from 6 to 17 years old

• The dose will normally be between 0.5 mg and 3 mg per day.
• Adolescents up to 17 years old who are being treated for schizophrenia or behavioral problems may take a higher dose, up to 5 mg.

Taking Haloperidol Esteve

• Haloperidol Esteve is an oral medication.
• You can mix Haloperidol Esteve oral solution with a little water before taking it, but do not mix it with any other liquid.

If you take more Haloperidol Esteve than you should

If you take more Haloperidol Esteve than you should or if someone else has taken some Haloperidol Esteve, talk to your doctor or go to the emergency department of the nearest hospital immediately.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Haloperidol Esteve

• If you forget to take a dose, take the next dose as usual. Then, continue taking the medication as your doctor has indicated.
• Do not take a double dose to make up for the missed dose.

If you stop taking Haloperidol Esteve

Unless your doctor tells you to, you should gradually reduce the amount of Haloperidol Esteve you take. Stopping treatment abruptly may cause effects such as:

• Nausea and vomiting.
• Difficulty sleeping.

Always follow your doctor's instructions exactly.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Pay attention to serious adverse effects

Consult your doctor immediately if you suffer or suspect you may suffer from any of the following effects. You may need urgent medical attention.

Heart problems:

• Abnormal heart rhythm; this prevents the heart from functioning normally and can cause loss of consciousness.
• Abnormally fast heartbeat.
• Extra heartbeats.

Heart problems are rare in patients taking Haloperidol Esteve (may affect up to 1 in 100 people). Sudden deaths have occurred in patients treated with this medicine, but the exact frequency of these deaths is unknown. Cardiac arrests (the heart stops beating) have also occurred in patients taking antipsychotic medications.

A serious problem called "neuroleptic malignant syndrome".It causes high fever, intense muscle stiffness, confusion, and loss of consciousness. It is a rare adverse effect in patients taking Haloperidol Esteve (may affect up to 1 in 1000 people).

Problems controlling body or limb movements (extrapyramidal disorder), such as:

• Movements of the mouth, tongue, jaw, and sometimes limbs (tardive dyskinesia).
• Feeling of restlessness or difficulty staying still, increased body movements.
• Slow or reduced body movements, jerks, or twists.
• Tremors or muscle stiffness, shuffling gait.
• Inability to move.
• Lack of normal facial expression, which sometimes appears as a mask.

These are very common adverse effects in patients using Haloperidol Esteve (may affect more than 1 in 10 people). If you experience any of these problems, you may be given an additional medicine.

Severe allergic reactionssuch as:

• Swelling of the face, lips, mouth, tongue, or throat.
• Difficulty swallowing or breathing.
• Itchy rash (urticaria).

Allergic reactions are rare in patients taking Haloperidol Esteve (may affect up to 1 in 100 people).

Blood clots in the veins, usually in the legs(deep vein thrombosis or DVT). These have been reported in patients taking antipsychotic medications. The signs of a DVT in the legs are swelling, pain, and redness of the legs, but the clot can move and reach the lungs, causing chest pain and difficulty breathing. Having blood clots can be very serious, so consult your doctor immediately if you notice these problems.

Consult your doctor immediately if you suffer from any of the serious adverse effects mentioned above.

Other adverse effects

Consult your doctor if you suffer or suspect you may suffer from any of the following adverse effects.

Very common(may affect more than 1 in 10 people):

• Agitation.
• Difficulty sleeping.
• Headache.

Common(may affect up to 1 in 10 people):

• Serious mental health problems, such as believing things that are not true (delusions) or seeing, feeling, hearing, or smelling things that are not real (hallucinations).
• Depression.
• Abnormal muscle tension.
• Feeling dizzy when sitting or standing up.
• Drowsiness.
• Eye movements or rapid, uncontrolled eye movements.
• Visual problems such as blurred vision.
• Low blood pressure.
• Nausea, vomiting.
• Constipation.
• Dry mouth or increased saliva.
• Rash.
• Inability to urinate or empty the bladder completely.
• Difficulty achieving or maintaining an erection (impotence).
• Weight gain or loss.
• Changes in blood parameters that measure liver function.

Uncommon(may affect up to 1 in 100 people):

• Effects on blood cells, such as low numbers of all types of blood cells, including significant decreases in white blood cells and reduction in platelet count (cells that help form clots).
• Feeling of confusion.
• Loss or decreased sexual desire.
• Seizures (convulsions).
• Muscle and joint stiffness.
• Spasms, jerks, or uncontrolled muscle contractions, including neck spasms that can cause the head to turn.
• Difficulty walking.
• Breathing difficulties.
• Liver inflammation or liver problems that cause the skin or eyes to turn yellow (jaundice).
• Increased sensitivity of the skin to sunlight.
• Itching.
• Excessive sweating.
• Changes in menstrual cycle, such as not having a period or having long, heavy, and painful periods.
• Unexpected milk secretion from the breasts.
• Breast pain or discomfort.
• Increased body temperature.
• Swelling caused by fluid accumulation in the body.

Rare(may affect up to 1 in 1000 people):

• High levels of the hormone "prolactin" in the blood.
• Narrowing of the airways that causes breathing difficulties.
• Difficulty or inability to open the mouth.
• Problems maintaining sexual relationships.

The following adverse effects have also been reported, although their exact frequency is unknown:

• High levels of "antidiuretic hormone" in the blood (syndrome of inappropriate antidiuretic hormone secretion).
• Low blood sugar levels.
• Swelling of the larynx or brief spasm of the vocal cords that can cause difficulties speaking or breathing.
• Sudden liver failure.
• Decreased bile secretion through the bile ducts.
• Scaling or peeling of the skin.
• Inflammation of small blood vessels that leads to a skin rash with small red or purple bumps.
• Breakdown of muscle tissue (rhabdomyolysis).
• Persistent and painful erection of the penis.
• Increased breast size in men.
• Decreased body temperature.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's pharmacovigilance system: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Haloperidol Esteve

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the label or carton. The expiration date is the last day of the month indicated.

Store in the original packaging to protect from light

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Additional Information

Composition of Haloperidol Esteve 2 mg/ml oral solution

The active ingredient is haloperidol. Each milliliter contains 2 mg of haloperidol. The other ingredients are lactic acid, methyl parahydroxybenzoate (E-218), and purified water

Appearance and packaging of the product

Haloperidol Esteve 2 mg/ml oral solution is presented as a clear and colorless solution, in a dropper bottle containing 15 or 30 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Manufacturer

TOWA Pharmaceutical Europe, S.L.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Date of the last revision of this leaflet:May 2020

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

Haloperidol Esteve 2 mg/ml oral solution in a dropper bottle is intended to obtain single doses of up to 2 mg of haloperidol (equivalent to 20 drops).

The number of drops needed to achieve a certain dose with Haloperidol Esteve 2 mg/ml oral solution is indicated below.

Conversion table for Haloperidol Esteve 2 mg/ml oral solution