Haloperidol Prodes 2 mg/ml oral solution drops

Patient Information Leaflet

Introduction

Patient Information Leaflet

Haloperidol Prodes 2 mg/ml oral drops solution

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Leaflet contents

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

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

The name of this medicine is Haloperidol Prodes.

Haloperidol Prodes contains the active substance haloperidol, which belongs to a group of medicines called "antipsychotics".

Haloperidol Prodes is used in adult patients, adolescents, and children to treat disorders affecting the way a person thinks, feels, or behaves. These include mental health disorders (such as schizophrenia and bipolar disorder) and behavioral problems.

These disorders may 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 highly excited, agitated, emotional, impulsive, or hyperactive.
• Become highly aggressive, hostile, or violent.

In adolescents and children, Haloperidol Prodes 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 Prodes is also used:

• In children and adolescents aged 10 to 17 years, and in adults, to treat uncontrollable movements or sounds (tics), such as in severe Gilles de la Tourette syndrome.
• In adults, to help control movements in Huntington's disease.

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

2. What you need to know before taking Haloperidol Prodes

Do not take Haloperidol Prodes

• If you are allergic to haloperidol or any of the other ingredients of this medicine (listed in section 6).
• If your perception has decreased or you feel that 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 "long QT interval" or any other heart rhythm disorder that appears as an abnormal tracing on the electrocardiogram (ECG).
• If you have heart failure or have recently had a heart attack.
• If you have untreated low levels of potassium in the blood.
• If you are taking any of the medicines listed in the section "Other medicines and Haloperidol Prodes – Do not take Haloperidol Prodes if you are taking certain medicines to treat the following disorders".

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

Warnings and precautions

Serious adverse effects

Haloperidol Prodes may cause heart problems, difficulties controlling body or limb movements, and a serious adverse effect called "neuroleptic malignant syndrome". It may also cause severe allergic reactions and blood clots. You should be alert to possible adverse effects while taking Haloperidol Prodes, as you might require urgent medical treatment. See the section "Be aware of serious adverse 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 who were taking antipsychotic medicines. Consult your doctor or pharmacist before starting Haloperidol Prodes if you are elderly, especially if you have dementia.

Consult your doctor or pharmacist if:

• You have a slow heart rate, heart disease, or if a close family member has died suddenly due to heart problems.
• You have low blood pressure or feel dizzy when standing up from sitting or after standing for some time.
• You have low levels of potassium or magnesium (or other electrolytes) in your blood. Your doctor will decide how to manage this condition.
• 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 (fits).
• You have kidney, liver, or thyroid problems.
• You have high levels of the hormone prolactin 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 a bipolar disorder and have recently started feeling depressed.

You may require closer monitoring, and it may also be necessary to adjust your dose of Haloperidol Prodes.

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

Medical examinations

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

Blood tests

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

Children under 6 years

Haloperidol Prodes must not be used in children under 6 years of age, as this medicine has not been adequately studied in this age group.

Other medicines and Haloperidol Prodes

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Do not take Haloperidol Prodes if you are taking certain medicines to treat 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 flufenazine, 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 (for pain relief or to treat drug addiction).

These medicines may increase the risk of heart problems, so consult your doctor if you are taking any of them and do not take Haloperidol Prodes (see "Do not take Haloperidol Prodes").

Special monitoring may be required if you are taking lithium and Haloperidol Prodes at the same time. Contact your doctor immediately and stop taking both medicines if you experience:

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

These are signs of a serious disorder.

Certain medicines may affect how Haloperidol Prodes works or may increase the risk of heart problems

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 stop 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 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 retention tablets (diuretics).

Your doctor may need to adjust your dose of Haloperidol Prodes if you are taking any of these medicines.

Haloperidol Prodes may affect how the following types of medicines work

Consult your doctor if you are taking medicines for:

• Calming or helping you sleep (tranquilizers).
• Pain (strong analgesics).
• 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 medicines, consult your doctor before starting Haloperidol Prodes.

Use of Haloperidol Prodes with alcohol

Haloperidol Prodes must not be taken with alcohol, as you may feel drowsy and your alertness may be reduced. Therefore, you should be very careful with alcoholic drinks. Consult your doctor about drinking alcohol while taking Haloperidol Prodes and inform them how much alcohol you consume.

Pregnancy, breastfeeding, and fertility

Pregnancy: If you are pregnant, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Your doctor may advise you not to take Haloperidol Prodes during pregnancy.

Newborn babies of mothers who have taken Haloperidol Prodes during the last three months (the third trimester) of pregnancy may experience:

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

The exact frequency of these problems is unknown. If you take Haloperidol Prodes during pregnancy and the newborn shows any of these adverse effects, contact your doctor.

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

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

Driving and using machines

Haloperidol Prodes may affect your ability to drive and use machinery. Some adverse effects, such as drowsiness, may affect your reaction ability, especially at the beginning of treatment or when taking high doses. Avoid driving or operating tools or machines without first consulting your doctor.

Haloperidol Prodes contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216)

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

3. How to take Haloperidol Prodes

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

What dose should you take

Your doctor will tell you how much Haloperidol Prodes you should take and for how long. Your doctor will also indicate whether you should take Haloperidol Prodes once or several times a day. It may take some time before you notice the desired effect of the medicine. Generally, your doctor will start you on a low dose and then gradually adjust it according to your response. It is very important to take the correct dose.

The dose of Haloperidol Prodes will depend on:

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

Adults

• The usual dose is between 0.5 mg and 10 mg per day.
• Your doctor may adjust the dose until the most appropriate one for you is found.
• The maximum daily dose for adults depends on the condition being treated and ranges from 5 mg to 20 mg per day.

Use in elderly patients

• In elderly patients, treatment usually starts at 0.5 mg per day or half the lowest adult dose.
• Your doctor will then adjust the amount of Haloperidol Prodes you need to take until reaching the most appropriate dose for you.
• The maximum daily dose in elderly patients is 5 mg, unless your doctor decides that you need a higher dose.

Children and adolescents aged 6 to 17 years

• The usual dose is between 0.5 mg and 3 mg per day.
• Adolescents up to 17 years of age being treated for schizophrenia or behavioural problems may take a higher dose, up to 5 mg.

How to take Haloperidol Prodes

• Haloperidol Prodes is a medicine for oral use.
• You may mix Haloperidol Prodes oral drops solution with a little water before taking it, but do not mix it with any other liquid.

If you take more Haloperidol Prodes than you should

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

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

If you forget to take Haloperidol Prodes

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

If you stop taking Haloperidol Prodes

Unless your doctor tells you otherwise, you should gradually reduce your intake of Haloperidol Prodes. Stopping treatment abruptly may cause effects such as:

• Nausea and vomiting.
• Difficulty sleeping.

Always follow your doctor's instructions exactly.

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

4. Possible adverse effects

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

Pay attention to serious adverse effects

Contact your doctor immediately if you experience or suspect you may be experiencing any of the following effects. You may require urgent medical attention.

Heart problems:

• Abnormal heart rhythm; this prevents the heart from functioning properly and may lead to loss of consciousness.
• Abnormally fast heartbeat.
• Extra heartbeats.

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

A serious condition called "neuroleptic malignant syndrome". This causes high fever, severe muscle stiffness, confusion, and loss of consciousness. It is a rare adverse effect in patients taking Haloperidol Prodes (may affect up to 1 in 1,000 people).

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

• Movements of the mouth, tongue, jaw, and sometimes limbs (tardive dyskinesia).
• Feeling restless or unable to sit still, increased body movements.
• Slow or reduced body movements, jerking, or twisting.
• Tremors or muscle stiffness, shuffling gait.
• Inability to move.
• Lack of normal facial expression, sometimes appearing mask-like.

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

Severe allergic reactions such as:

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

Allergic reactions are uncommon in patients taking Haloperidol Prodes (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 medicines. Signs of DVT in the legs include swelling, pain, and redness of the legs, but the clot may travel to the lungs, causing chest pain and difficulty breathing. Blood clots can be very serious; therefore, contact your doctor immediately if you notice these symptoms.

Contact your doctor immediately if you experience any of the serious adverse effects listed above.

Other adverse effects

Contact your doctor if you experience or suspect you may be experiencing 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):

• 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 up.
• 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 saliva.
• Skin rash.
• Difficulty urinating or inability to empty the bladder completely.
• Difficulty achieving or maintaining an erection (impotence).
• Weight gain or weight loss.
• Changes in blood tests measuring 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 reduced platelet count (cells that help form clots).
• Feeling confused.
• Loss or reduced sexual desire.
• Epileptic seizures (convulsions).
• Stiffness in muscles and joints.
• Spasms, jerks, or uncontrolled muscle contractions, including neck spasms that may cause the head to turn to one side.
• Difficulty walking.
• Difficulty breathing.
• Liver inflammation or liver problems causing the skin or eyes to turn yellow (jaundice).
• Increased sensitivity of the skin to sunlight.
• Itching.
• Excessive sweating.
• Changes in menstrual cycle, such as absence of periods or long, heavy, and painful periods.
• Unexpected milk secretion from the breasts.
• Breast pain or discomfort.
• Increased body temperature.
• Swelling due to fluid accumulation in the body.

Rare (may affect up to 1 in 1,000 people):

• High levels of the hormone "prolactin" in the blood.
• Narrowing of the airways causing difficulty breathing.
• Difficulty or inability to open the mouth.
• Problems with sexual intercourse.

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 spasms of the vocal cords that may cause difficulty speaking or breathing.
• Sudden liver failure.
• Reduced bile secretion through the bile ducts.
• Skin peeling or exfoliation.
• Inflammation of small blood vessels leading to a skin rash with small red or purple spots.
• Breakdown of muscle tissue (rhabdomyolysis).
• Persistent and painful erection of the penis.
• Enlargement of the breasts in men.
• Decreased body temperature.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Haloperidol Prodes

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

Store in the original container to protect from light.

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

Do not use Haloperidol Prodes if there are any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Haloperidol Prodes

• The active substance is haloperidol. Each ml of solution contains 2 mg of haloperidol.
• The other components are: lactic acid, methylparaben (E-218), propylparaben (E-216), and purified water.

Appearance of the medicinal product and contents of the container

Oral drops solution. 15 ml and 30 ml bottles with dropper.

Other presentations

Haloperidol Prodes 10 mg tablets. Pack of 30 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.
Venus, 72 - Pol. Ind. Colón II
08228 Terrassa - Barcelona
Spain

Date of the most recent revision of this leaflet: September 2017.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

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

The number of drops required to achieve a specific dose with Haloperidol Prodes 2 mg/ml oral solution is indicated below.

Conversion table for Haloperidol Prodes 2 mg/ml oral solution