Leaflet: Information for the User

Haloperidol Prodes 2 mg/ml oral drops in solution

Read this leaflet carefully before you start taking 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 you must not give it 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 or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Haloperidol Prodes

3. How to take Haloperidol Prodes

4. Possible side effects

5. Storage of Haloperidol Prodes

6. Contents of the pack and additional information

The name of this medication is Haloperidol Prodes.

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

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

These diseases may cause the patient to:

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

In adolescents and children, Haloperidol Prodes is used for the treatment of schizophrenia in patients aged 13 to 17 years, and for treating behavioral problems in patients aged 6 to 17 years.

Haloperidol Prodes is also used:

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

Haloperidol Prodes is used sometimes when other medications or treatments have not been effective or have caused unacceptable side effects.

Do not take Haloperidol Prodes

• If you are allergic to haloperidol or any of the other ingredients in this medicine (listed in section 6).
• If your perception 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 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 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 conditions".

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

Warnings and precautions

Severe side effects

Haloperidol Prodes may cause heart problems, movement control problems, and a severe side effect called "neuroleptic malignant syndrome". It may also cause severe allergic reactions and blood clots. Be aware of the possible side effects while taking Haloperidol Prodes, as you may need urgent medical treatment. See the section "Be aware of severe side effects" in section 4.

Older patients and patients with dementia

A small increase in the number of deaths and strokes has been reported in older patients with dementia who took antipsychotic medicines. Consult your doctor or pharmacist before starting to take Haloperidol Prodes if you are an older patient, especially if you have dementia.

Consult your doctor or pharmacist if:

• You have a slow heart rate, 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 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 prolactin hormone in your blood or have a cancer that could be caused by high prolactin levels (such as breast cancer).
• You have a history of blood clots.
• You have depression or have a bipolar disorder and have started to feel depressed.

You may need to have closer monitoring and it may be necessary to adjust the amount of Haloperidol Prodes you take.

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

Medical recognitions

Your doctor may ask you to have an electrocardiogram (ECG) before or during treatment with Haloperidol Prodes. 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 Prodes.

Children under 6 years

Haloperidol Prodes should not be used in children under 6 years old, 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 taken recently, or may need to take any other medicine.

Do not take Haloperidol Prodes if you are taking certain medicines 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 (for pain relief 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 take Haloperidol Prodes (see "Do not take Haloperidol Prodes if").

You may need to have special monitoring if you are taking lithium and Haloperidol Prodes 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.

This is a sign of a serious condition.

Certain medicines may affect the way Haloperidol Prodes 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 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 medicine to lower blood pressure, such as diuretics.

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

Haloperidol Prodes may affect the way the following types of medicines work

Consult your doctor if you are taking medicines for:

• To be more calm or to help you sleep (tranquilizers).
• Pain relief (potent analgesics).
• 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 before starting to take Haloperidol Prodes.

Use of Haloperidol Prodes with alcohol

Haloperidol Prodes should not be taken 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 taking Haloperidol Prodes 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 medicine. Your doctor may advise you not to take Haloperidol Prodes while pregnant.

Newborn babies of mothers who have taken Haloperidol Prodes 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 take Haloperidol Prodes 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 medicine may pass into breast milk and affect the baby. Your doctor will discuss the risks and benefits of breastfeeding while taking Haloperidol Prodes with you.

Fertility:Haloperidol Prodes 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 using machines

Haloperidol Prodes may affect your ability to drive and use machines. Some side effects, such as drowsiness, may affect your reaction time, especially at the beginning of treatment or with high doses. Avoid driving or using tools or machines without consulting your doctor first.

Haloperidol Prodes contains parahydroxybenzoic acid methyl ester (E-218) and parahydroxybenzoic acid propyl ester (E-216)

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much to take

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

The dose of Haloperidol Prodes 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 dose will normally be between 0.5 mg and 10 mg per day.
• The doctor may adjust the dose to find the one that is best for you.
• The maximum dose that adults should take depends on the disease being treated, and varies between 5 mg and 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.
• The doctor will then adjust the amount of Haloperidol Prodes you need to take until you reach the dose that is best for you.
• The maximum dose in elderly patients is 5 mg per day, unless your doctor decides you need a higher dose.

Children and adolescents aged 6 to 17 years

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

Haloperidol Prodes intake

• Haloperidol Prodes is an oral medication.
• You can mix Haloperidol Prodes oral drops in 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 some Haloperidol Prodes, speak immediately with your doctor or go to the nearest hospital emergency service.

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 forget to take Haloperidol Prodes

• 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 compensate for the missed dose.

If you interrupt treatment with Haloperidol Prodes

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

• Nausea and vomiting.
• Difficulty sleeping.

Always follow the doctor's instructions exactly.

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

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

Be aware of severe side effects

Consult your doctor 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 taking Haloperidol Prodes (they can 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, deep vein thrombosis (blood clots in the veins, usually in the legs) has been reported in patients taking antipsychotic medications. Signs of deep vein thrombosis in the legs include 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.

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 taking Haloperidol Prodes (it can 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).
• Sensation of restlessness or difficulty staying seated, increased body movement.
• Slow or reduced body movements, jerks, or torsions.
• Tremors or muscle stiffness, walking with dragging feet.
• Inability to move.
• Lack of normal facial expression, which sometimes appears as a mask.

These are very common side effects in patients using Haloperidol Prodes (they can 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 taking Haloperidol Prodes (they can affect up to 1 in 100 people).

Deep vein thrombosis in the veins, usually in the legs(deep vein thrombosis or DVT). It has been reported in patients taking antipsychotic medications. Signs of DVT in the legs include 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(they can affect more than 1 in 10 people):

• Restlessness.
• Difficulty sleeping.
• Headache.

Common(they can 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.
• Sensation of dizziness when sitting or standing up.
• Drowsiness.
• Eye movements that ascend 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(they can 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).
• Sensation of confusion.
• Loss or decrease of sexual desire.
• Seizures (convulsions).
• Muscle stiffness and joint stiffness.
• Spasms, jerks, or uncontrolled muscle contractions, including spasms in the neck that can cause the head to turn.
• Difficulty walking.
• Difficulty breathing.
• Inflammation of the liver or liver problems that cause the skin or eyes to turn yellow (jaundice).
• Increased sensitivity of the skin to sunlight.
• Hives.
• 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.
• Pain or discomfort in the breasts.
• Increased body temperature.
• Swelling caused by fluid accumulation in the body.

Rare(they can 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 relations.

Other 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.
• Breakdown 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.

Store in the original packaging to protect it from light.

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

Do not use Haloperidol Prodes if you observe visible signs of deterioration.

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

Composition of Haloperidol Prodes

- The active principle is haloperidol. Each ml of solution contains 2 mg of haloperidol.

-The other components are: lactic acid, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216) and purified water.

Appearance of the product and contents of the package

Oral drops in solution. Bottle of 15 ml and 30 ml with dropper.

Other presentations

Haloperidol Prodes 10 mg tablets. Package of 30 tablets

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: September 2017.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

This information is intended solely for healthcare professionals:

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

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

Conversion table for Haloperidol Prodes 2mg/ml oral drops in solution