Leaflet: information for the user

Haloperidol Esteve 5 mg/ml injectable solution

Haloperidol

Read this leaflet carefully before you start using this medicine,because it contains important information for you.

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

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

2. What you need to know before you start usingHaloperidol Esteve

3. How to use Haloperidol Esteve

4. Possible side effects

5. Storage of Haloperidol Esteve

6. Contents of the pack andadditional information

The name of this medication is Haloperidol Esteve.

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

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

These diseases may cause the patient:

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

Haloperidol Esteve is also used in adults to:

• To help control movements in Huntington's disease
• To prevent or treat nausea and vomiting after surgery.

Haloperidol Esteve may be used alone or in combination with other medications and is sometimes used when other medications or treatments have not been effective, have caused unacceptable side effects, or cannot be taken orally.

Do not use Haloperidol Esteve:

• If you are allergic to haloperidol or any of the other components of this medication (listed in section 6).
• If your perception has decreased or you believe 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 condition 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 levels of potassium 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 use Haloperidol Esteve if you are taking certain medications to treat the following conditions."

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

Warnings and precautions

Severe side effects

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

Patients with advanced age and patients with dementia

A small increase in the number of deaths and strokes has been reported in elderly patients with dementia who took antipsychotic medications. Consult your doctor before starting to use Haloperidol Esteve if you are an elderly person, especially if you have dementia.

Consult your doctor if:

• You have a slow heart rate, have a heart condition, or if a close relative has died suddenly from heart problems.
• You have low blood pressure or feel dizzy when getting up from a seated or standing position for a certain time.
• You have low levels of potassium or magnesium (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 than others to have a stroke.
• You have epilepsy or have ever had seizures (convulsions).
• You have kidney, liver, or thyroid problems.
• You have high levels of the prolactin hormone in your blood or have a cancer that could be caused by high prolactin levels (such as breast cancer).
• You have a personal or family history of blood clots.
• You have depression or have a bipolar disorder and have started feeling depressed.

You may need to be monitored more closely, and it is also possible that you will need to adjust the amount of Haloperidol Esteve you receive.

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

Medical recognitions

Your doctor may ask you to have an electrocardiogram (ECG) before or during treatment with Haloperidol Esteve. The ECG measures the heart's electrical activity.

Blood tests

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

Children and adolescents

Haloperidol Esteve should not be used in children and adolescents under 18 years old, as this medication has not been studied in these age groups.

Other medications and Haloperidol Esteve

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication.

Do not use Haloperidol Esteve if you are taking certain medications to treat the following conditions:

• 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, 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).
• 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 calm pain or to 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 use Haloperidol Esteve (see "Do not use Haloperidol Esteve if").

You may need to be monitored more closely 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.

This is a sign of a serious condition.

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 (for HIV virus).
• Chlorpromazine or promethazine (for nausea and vomiting).
• Verapamil (for high blood pressure or heart problems).

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

Your doctor may need to adjust your Haloperidol Esteve dose 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:

• To be more calm or to help you sleep (tranquilizers).
• Pain (potent analgesics).
• Depression (tricyclic antidepressants).
• To lower blood pressure (such as guanetidine and methyldopa).
• Severe allergic reactions (epinephrine).
• Attention deficit hyperactivity disorder (ADHD) or narcolepsy (known as "stimulants").
• Parkinson's disease (such as levodopa).
• To prevent blood clotting (phenindione).

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

Use of Haloperidol Esteve with alcohol

Haloperidol Esteve should not be used with alcohol, as it may cause drowsiness and decreased alertness. Therefore, you should be careful with alcoholic beverages. Consult your doctor about drinking alcoholic beverages while using 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 use Haloperidol Esteve while pregnant.

Newborn babies of mothers who have used Haloperidol Esteve in the last three months (the last trimester) of pregnancy may experience:

• Tremors, stiffness, or muscle weakness.
• Drowsiness or agitation.
• Respiratory problems or difficulty feeding.

The exact frequency of these problems is unknown. If you use Haloperidol Esteve while pregnant and your newborn baby 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 affect the baby. Your doctor will discuss the risks and benefits of breastfeeding while using Haloperidol Esteve.

Fertility:Haloperidol Esteve may increase 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 operating machinery

Haloperidol Esteve may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may decrease your reaction time, especially at the beginning of treatment or with high doses. These effects, as well as the underlying condition, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention until your doctor assesses your response to this medication.

What is the recommended dose of the medication

Your doctor will tell you how much Haloperidol Esteve to take and for how long. It may take some time before you notice the desired effect of the medication. Generally, your doctor will prescribe a low dose initially and then adjust it according to your response. The dose of Haloperidol Esteve will depend on:

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

Adults

• The starting dose will usually be between 1 and 5 mg.
• They may administer other doses, usually 1 to 4 hours later.
• They will not administer more than a total of 20 mg per day.

Use in elderly patients

• In elderly patients, treatment will usually start with half of the lowest adult dose.
• Then, your doctor will adjust the dose until they consider it to be the best for you.
• They will not administer more than a total of 5 mg per day, unless your doctor decides you need a higher dose.

How to administer Haloperidol Esteve

Haloperidol Esteve should be administered by a doctor or nurse. It is a product for intramuscular use and should be administered by injection into a muscle.

If you forget a dose or use more Haloperidol Esteve than you should

Since this medication should be administered by a doctor or nurse, it is unlikely that you will forget a dose or use more product than you should. If in doubt, consult your doctor or nurse.

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

If you interrupt treatment with Haloperidol Esteve

Unless your doctor decides otherwise, treatment with Haloperidol Esteve should be discontinued gradually. Abruptly stopping treatment 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, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Be aware of severe side effects

Consult your doctor or nurse immediately if you experience or suspect you may experience any of the following side 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 heart rate.
• Extra heartbeats.

Heart problems are rare in patients using Haloperidol Esteve (they 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. Also, cardiac arrests (the heart stops beating) have occurred in patients taking antipsychotic medications.

A serious condition called "neuroleptic malignant syndrome."This causes high fever, intense muscle rigidity, confusion, and loss of consciousness. It is a rare side effect in patients using Haloperidol Esteve (it may affect up to 1 in 1000 people).

Movement problems controlling the body or limbs (extrapyramidal disorder), such as:

• Mouth, tongue, jaw, and sometimes limb movements (tardive dyskinesia).
• Restlessness or difficulty staying seated, increased body movement.
• Slow or reduced body movements, jerks, or torsions.
• Tremors or muscle rigidity, walking with a dragging gait.
• Inability to move.
• Lack of normal facial expression, sometimes appearing as a mask.

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

Severe allergic reactionssuch as:

• Swelling of the face, lips, mouth, tongue, or throat.
• Difficulty swallowing or breathing.
• Hives with itching (urticaria).

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

Deep vein blood clots, usually in the legs(deep vein thrombosis or DVT). They have been reported in patients taking antipsychotic medications. 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 clots can be very serious, so consult your doctor immediately if you notice these problems.

Consult your doctor immediately if you experience any of the severe side effects listed above.

Other side effects

Consult your doctor if you experience or suspect you may experience any of the following side effects.

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

• Restlessness.
• Difficulty sleeping.
• Headache.

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

• Severe 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.
• Dizziness when sitting or standing.
• Drowsiness.
• Eye movements, such as upward eye movements or rapid, uncontrolled eye movements.
• Visual problems, such as blurred vision.
• Low blood pressure.
• Nausea, vomiting.
• Constipation.
• Dry mouth or increased saliva.
• Skin 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.

Rare(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 platelets (cells that help form clots).
• Confusion.
• Loss or decrease of sexual desire.
• Seizures (convulsions).
• Muscle rigidity and joint stiffness.
• Uncontrolled muscle spasms, jerks, or contractions, including spasms in the neck that can cause the head to turn.
• Difficulty walking.
• Difficulty breathing.
• Jaundice (yellowing of the skin or eyes) due to liver inflammation or liver problems.
• Increased skin sensitivity 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.
• 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 difficulty breathing.
• Difficulty or inability to open the mouth.
• Problems with sexual relationships.

The following side 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 spasms of the vocal cords that can cause difficulty speaking or breathing.
• Sudden liver failure.
• Decreased bile secretion through the bile ducts.
• Peeling or exfoliation of the skin.
• Inflammation of small blood vessels that leads to a skin rash with small red or purple bumps.
• Disintegration of muscle tissue (rhabdomyolysis).
• Persistent and painful erection of the penis.
• Enlargement of the breasts in men.
• Decreased body temperature.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist,even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label and on the packaging. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Haloperidol Esteve 5 mg/ml injectable solution

The active ingredient is haloperidol. Each milliliter contains 5 mg of haloperidol.

The other components are: lactic acid and water for injectable preparations

Appearance of the product and contents of the packaging

Haloperidol Esteve 5 mg/ml injectable solution is presented in the form of a clear, colorless, and transparent solution, in containers containing 5 ampoules of 1 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 – Pol. Industrial Colón II

08228 Terrasa - (Barcelona)

Spain

Last review date of this leaflet:May 2020

The detailed information of this medication is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/