Leaflet: Information for the user

Haloperidol Prodes 10 mg tablets

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 suspicious (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 use Haloperidol Prodes

• 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 Prodes - Do not take Haloperidol Prodes if you are taking certain medications to treat the following conditions."

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 Prodes.

Warnings and precautions

Severe side effects

Haloperidol Prodes 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 taking Haloperidol Prodes, 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 or pharmacist before starting to take Haloperidol Prodes if you are an elderly person, especially if you have dementia.

Consult your doctor or pharmacist if:

• You have a slow heart rate, have a 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 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 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 the amount of Haloperidol Prodes 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 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 old

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

Other medications and Haloperidol Prodes

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

Do not take Haloperidol Prodes 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 (for pain relief 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 take Haloperidol Prodes (see "Do not take Haloperidol Prodes if").

You may need to be monitored more closely if you are taking lithium and Haloperidol Prodes 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 Prodes 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/AIDS).
• 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 dose of Haloperidol Prodes if you are taking any of these medications.

Haloperidol Prodes 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 relief (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 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 taking 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 medication. 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 of pregnancy (the last trimester) 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 medication 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 operating machinery

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

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Haloperidol Prodes contains tartrazine

This medication may cause allergic reactions because it contains tartrazine. It may cause asthma, especially in patients allergic to aspirin.

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 many tablets 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 at first 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 usually 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 number of tablets to take until reaching 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 usually 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.
• Swallow the tablets with a little water.

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 department.

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 forgot to take Haloperidol Prodes

• If you forgot 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:

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. Blood clots (heart attacks) have also occurred in patients taking antipsychotic medications.

A severe 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 or difficulties controlling the body or limbs (extrapyramidal disorder), such as:

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:

Allergic reactions are rare in patients taking Haloperidol Prodes (they can affect up to 1 in 100 people).

Deep vein blood clots, usually in the legs(deep vein thrombosis or DVT). These have been reported in patients taking antipsychotic medications. Signs of 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(can affect more than 1 in 10 people):

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

Rare(can affect up to 1 in 100 people):

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

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

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 blister pack or on the box. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Composition of Haloperidol Prodes

The active ingredient is haloperidol. Each tablet contains 10 mg of haloperidol.

The other components are: cornstarch, tartrazine (E-102), indigotin (E-132), anise oil, magnesium stearate (E-470b) and calcium hydrogen phosphate.

Appearance of the product and content of the packaging

Haloperidol Prodes are flat tablets with a central groove on the upper surface, administered orally.

Haloperidol Prodes 10 mg is presented in blister packs containing 30 tablets.

Other presentations

Haloperidol Prodes2 mg/mloral drops in solution: 15 ml and 30 ml bottles.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the last review of this leaflet: September 2017.

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