HALOPERIDOL ESTEVE 5 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Haloperidol Esteve 5 mg/ml Solution for Injection

Haloperidol

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.Keep this leaflet. You may need to read it again.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Haloperidol Esteve and what is it used for
2. What you need to know before you use Haloperidol Esteve
3. How to use Haloperidol Esteve
4. Possible side effects
5. Storing Haloperidol Esteve
6. Contents of the pack and other information

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

The name of this medicine is Haloperidol Esteve.

Haloperidol Esteve contains the active substance 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 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.

Haloperidol Esteve is also used in adults to:

• Help control movements in Huntington's disease
• Prevent or treat nausea and vomiting after surgery.

Haloperidol Esteve may be used alone or with other medicines and is sometimes used when other medicines or treatments have not worked, have caused unacceptable side effects, or cannot be given orally.

2. What you need to know before you use Haloperidol Esteve

Do not use Haloperidol Esteve:

• If you are allergic to haloperidol or any of the other ingredients of this medicine (listed in section 6).
• If your ability to perceive has decreased or you think 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 shows up 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 medicines listed in the section “Other medicines and Haloperidol Esteve - Do not use Haloperidol Esteve if you are taking certain medicines for the following disorders”.

Do not use this medicine if any of the above points apply to you. If you are not sure, consult your doctor, pharmacist or nurse before starting to use 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 using Haloperidol Esteve, as you may need urgent medical treatment. See the section “Look out for 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 medicines. Consult your doctor before starting to use Haloperidol Esteve if you are an elderly person, especially if you suffer from dementia.

Consult your doctor 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 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 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 you have a cancer that may be caused by high levels of prolactin (such as breast cancer).
• You have a history of blood clots.
• You suffer from depression or you have bipolar disorder and have started to feel depressed.

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

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

Medical checks

Your doctor may ask you to have 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 the levels of potassium or magnesium (or other electrolytes) 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 of age, as this medicine has not been studied in these age groups.

Other medicines and Haloperidol Esteve

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

Do not use Haloperidol Esteve if you are taking certain medicines 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 to treat drug addiction).

These medicines 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 special monitoring if you are using lithium and Haloperidol Esteve at the same time.Consult your doctor immediately and stop taking both medicines if you experience:

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

These are signs of a serious disorder.

Certain medicines may affect how Haloperidol Esteve works 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 you 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 the human immunodeficiency virus or 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 medicine to lower blood pressure, such as water pills (diuretics).

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

Haloperidol Esteve may affect how the following types of medicines work

Consult your doctor if you are taking medicines for:

• To calm you down or help you sleep (tranquilizers).
• Pain (strong painkillers).
• Depression (tricyclic antidepressants).
• To lower 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).
• To prevent blood clotting (phenindione).

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

Using Haloperidol Esteve with alcohol

Haloperidol Esteve should not be used with alcohol, as you may feel drowsy and your alertness may be reduced. Therefore, be very careful with alcoholic beverages. Consult your doctor about drinking alcoholic beverages while using Haloperidol Esteve and tell them how much alcohol you drink.

Pregnancy, breast-feeding and fertility

Pregnancy:if you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Your doctor may advise you not to use Haloperidol Esteve while you are pregnant.

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

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

The exact frequency of these problems is not known. If you use Haloperidol Esteve while you are pregnant and your newborn baby has any of these side effects, contact your doctor.

Breast-feeding:ask your doctor if you are breast-feeding or planning to breast-feed, as small amounts of the medicine may pass into breast milk and therefore to the baby. Your doctor will discuss the risks and benefits of breast-feeding while you are using 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 changes in vision, and may reduce your reaction ability, especially at the start of treatment or if high doses are used. These effects, as well as the disease itself, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines or engage in other activities that require special attention until your doctor has assessed your response to this medicine.

3. How to use Haloperidol Esteve

What is the recommended dose of the medicine

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 medicine. Usually, your doctor will prescribe a low dose at first and then adjust it according to your response. The dose of Haloperidol Esteve will depend on:

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

Adults

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

Use in elderly patients

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

How Haloperidol Esteve is given

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

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

This medicine will be given to you by a doctor or nurse, so it is unlikely that you will miss a dose or use more product than you should. If you have any doubts, talk to your doctor or nurse.

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

If you stop using Haloperidol Esteve

Unless your doctor decides otherwise, treatment with Haloperidol Esteve should be withdrawn gradually. Stopping treatment suddenly 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 medicine, ask your doctor, pharmacist or nurse.

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 or nurse 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 working normally and can cause loss of consciousness.
• Abnormally fast heartbeat.
• Extra heartbeats.

Heart problems are rare in patients using 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 "malignant neuroleptic syndrome".It causes high fever, intense muscle stiffness, confusion, and loss of consciousness. It is a rare adverse effect in patients using 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 medication.

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 using 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 of dizziness when sitting or standing up.
• Drowsiness.
• 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.
• 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 blood clots).
• Feeling of confusion.
• Loss or decrease in sexual desire.
• Seizures (convulsions).
• Muscle and joint stiffness.
• Spasms, jerks, or uncontrolled muscle contractions, including neck spasms that can cause the head to turn to one side.
• 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 the menstrual cycle, such as not having a period or having long, heavy, and painful periods.
• Unexpected milk secretion from the breasts.
• Pain or discomfort in the breasts.
• 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 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 difficulty speaking or breathing.
• Sudden liver failure.
• Decreased bile secretion through the bile ducts.
• Scaling or peeling of the skin.
• Inflammation of the 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 of 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 Pharmacovigilance System for Human Use Medicines: 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 that appears on the label and packaging. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Additional information

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 packaging contents

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Industrial Colón II

08228 Terrasa - (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/