Aloperidolo PensA

Package leaflet: Information for the patient

Aloperidolo Pensa 2 mg/ml oral drops, solution

haloperidol
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Aloperidolo Pensa is and what it is used for

The name of the medicine is Aloperidolo Pensa.
Aloperidolo Pensa contains the active substance haloperidol. This belongs to a group of
medicines called "antipsychotics".
Aloperidolo Pensa is used in adults, adolescents and children for illnesses affecting the way
you think, feel and behave. These include mental health disorders (such as schizophrenia and bipolar disorder) and behavioural disorders.
These conditions may cause:

• confusion (delusions)
• seeing, hearing or smelling things that are not there (hallucinations)
• believing things that are not true (delusions)
• feeling unusually suspicious (paranoia)
• feeling highly excited, agitated, enthusiastic, impulsive or hyperactive
• feeling very aggressive, hostile or violent.

In adolescents and children, Aloperidolo Pensa is used to treat schizophrenia in patients aged 13 to
17 years and to treat behavioural disorders in patients aged 6 to 17 years.
Aloperidolo Pensa is also used:

• in adults, adolescents and children aged 10 to 17 years, and in adults, for movements or sounds that cannot be controlled (tics), for example in severe Tourette syndrome
• in adults to help control movements in Huntington's disease.

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

2. What you should know before taking Aloperidolo Pensa

Do not take Aloperidolo Pensa:

• if you are allergic to haloperidol or to any of the other ingredients of this medicine (listed in section 6)
• if you are less aware of things around you or your reactions become unusually slow after drinking alcohol or after taking other medicines
• 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 problem with your heart rhythm that shows as an abnormal trace on an ECG (electrocardiogram)
• if you suffer from heart failure or have recently had a heart attack
• if you have untreated low levels of potassium in your blood
• if you are taking any of the medicines listed under “Other medicines and Aloperidolo Pensa – Do not use Aloperidolo Pensa if you are taking certain medicines for”. This medicine must not be used if you have any of the following conditions. If in doubt, consult your doctor or pharmacist before taking Aloperidolo Pensa.

Warnings and precautions
Serious side effects
Aloperidolo Pensa can cause heart problems, problems with body control or limb movements, 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 serious side effects while using Aloperidolo Pensa, as urgent medical treatment may be required. See “Carefully read the serious side effects” in section 4.
Elderly people and those with dementia
A slightly increased risk of death and stroke has been reported in elderly patients with dementia who are taking antipsychotic medicines. Talk to your doctor or pharmacist before using Aloperidolo Pensa if you are elderly, especially if you have dementia.
Talk to your doctor or pharmacist if you:

• have a slow heartbeat, heart disease, or if someone in your family has died suddenly from heart problems
• have low blood pressure, or feel dizzy or confused when standing up or sitting down
• have low levels of potassium or magnesium (or another “electrolyte”) in your blood. Your doctor will decide how to manage this
• have ever had bleeding in the brain, or if your doctor has told you that you are more likely than others to have a stroke
• have epilepsy or have ever had seizures (fits)
• have kidney, liver, or thyroid problems
• have high levels of the hormone “prolactin” in your blood, or have a cancer that may be caused by high prolactin levels (such as breast cancer)
• have a history of blood clots, or if someone else in your family has a history of blood clots
• have depression, or if you have bipolar disorder and start feeling depressed.

You may need closer monitoring, and your dose of Aloperidolo Pensa may need to be adjusted.
If you are unsure whether any of the conditions listed above apply to you, consult your doctor or pharmacist before taking Aloperidolo Pensa.
Medical checks
Your doctor may prescribe an electrocardiogram (ECG) before or during treatment with Aloperidolo Pensa. The ECG measures the electrical activity of the heart.
Blood tests
Your doctor may decide to check levels of potassium or magnesium (or another “electrolyte”) in your blood before or during treatment with Aloperidolo Pensa.
Children under 6 years of age
Aloperidolo Pensa must not be used in children under 6 years of age. This is because it has not been adequately studied in this age group.
Other medicines and Aloperidolo Pensa
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use Aloperidolo Pensa if you are taking certain medicines for

• 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 inform your doctor if you are taking bepridil (for chest pain or to lower blood pressure) or methadone (a painkiller or for treatment of drug addiction). These medicines can increase the risk of heart problems, so inform your doctor if you are taking any of these medicines and do not take Aloperidolo Pensa (see “Do not take Aloperidolo Pensa if”).

Special monitoring may be needed if you are using lithium and Aloperidolo Pensa at the same time.
Tell your doctor immediately and stop taking both medicines if:

• you have unexplained fever or uncontrollable movements
• you are confused, disoriented, have headaches, problems with balance, or drowsiness. These are signs of a serious condition.

Some medicines may affect how Aloperidolo Pensa works or may cause heart or similar problems
Tell 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 (for treatment of Cushing's syndrome)
• indinavir, ritonavir, or saquinavir (for human immunodeficiency virus or HIV)
• chlorpromazine and promethazine (for nausea and vomiting)
• verapamil (for blood pressure or heart problems). Also inform your doctor if you are taking other medicines to lower blood pressure, such as diuretics (medicines to increase urine production).

Your doctor may adjust the dose of Aloperidolo Pensa if you are taking any of these medicines.
Aloperidolo Pensa may affect how the following types of medicines work
Tell your doctor if you are taking medicines for:

• calming or sleeping (tranquillisers)
• pain (strong painkillers)
• depression (tricyclic antidepressants)
• lowering blood pressure (such as guanethidine and methyldopa)
• severe allergic reactions (adrenaline)
• attention deficit hyperactivity disorder (ADHD) or narcolepsy (known as “stimulants”)
• Parkinson’s disease (such as levodopa)
• thinning the blood (phenindione). Inform your doctor before taking Aloperidolo Pensa if you are taking any of these medicines.

Aloperidolo Pensa and alcohol
Drinking alcohol while taking Aloperidolo Pensa may make you feel drowsy and less alert. This means you should be careful about how much alcohol you drink. Discuss alcohol use with your doctor while taking Aloperidolo Pensa and inform your doctor about the amount of alcohol you consume.
Pregnancy, breastfeeding, and fertility
Pregnancy – If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice. Your doctor may advise you not to use Aloperidolo Pensa during pregnancy.
The following problems may occur in newborns whose mothers used Aloperidolo Pensa during the last three months of pregnancy (the third trimester):

• muscle tremors, weakness, or muscle stiffness
• drowsiness or restlessness
• breathing or feeding problems. The exact frequency of these problems is unknown. If Aloperidolo Pensa was used during pregnancy and the baby develops any of these side effects, consult your doctor.
  Breastfeeding – Inform your doctor if you are breastfeeding or planning to breastfeed. This is because small amounts of the medicine may pass into breast milk and reach the baby. Your doctor will discuss the risks and benefits of breastfeeding while taking Aloperidolo Pensa.
  Fertility – Aloperidolo Pensa may increase levels of a hormone called “prolactin”, which may affect fertility in both men and women. Inform your doctor if you have any questions about this.
  Driving and using machines
  Aloperidolo Pensa may affect your ability to drive and use tools or machinery. Side effects such as drowsiness may affect your attention, especially when you first start taking it or after a dose increase. This medicine may impair your ability to drive. Do not drive or operate tools or machinery without first discussing this with your doctor.
  Aloperidolo Pensa contains para-hydroxybenzoates. These may cause allergic reactions (including delayed reactions).

3. How to take Aloperidolo Pensa

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
How much medicine to take
Your doctor will tell you how much aloperidol you should take and for how long. Your doctor will also
tell you whether to take Aloperidolo Pensa once or several times a day. It may take some time before
you feel the full effect of the medicine. Usually, your doctor will start you on a low dose and then
adjust it to find the right dose for you. It is very important to take the correct amount.
Your aloperidol dose will depend on:

• your age
• the condition being treated
• whether you have kidney or liver problems
• other medicines you are taking

Adults

• The usual dose ranges between 0.5 and 10 mg per day.
• Your doctor may adjust it to find the dose that is right for you.
• The maximum dose for adults depends on the condition being treated and varies between 5 and 20 mg per day.

Elderly

• Elderly patients usually start with 0.5 mg per day or half the lowest adult dose.
• The amount of Aloperidolo Pensa to take will be adjusted until your doctor finds the right dose for you.
• The maximum dose for elderly patients is 5 mg per day, unless your doctor decides that a higher dose is necessary.

Children and adolescents aged 6 to 17 years

• The usual dose is normally between 0.5 mg and 3 mg per day.
• Adolescents up to 17 years of age being treated for schizophrenia or behavioural disorders may require a higher dose, up to 5 mg per day. Taking Aloperidolo Pensa
• Aloperidolo Pensa is for oral use.
• You may mix Aloperidolo Pensa drops with a small amount of water before taking them, but do not mix them with other liquids.
• Remove the cap from the bottle.
• Turn the bottle upside down over a spoon.

• Gently squeeze the sides of the bottle and count the number of drops you need to take.

• Take the solution immediately.

• Close the bottle.

If you take more Aloperidolo Pensa than you should
If you take more Aloperidolo Pensa than prescribed, or if someone else has taken Aloperidolo Pensa,
contact your doctor or go to the nearest hospital emergency department.
If you forget to take Aloperidolo Pensa

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

If you stop taking Aloperidolo Pensa
Unless your doctor tells you otherwise, you should stop taking Aloperidolo Pensa gradually.
Stopping treatment suddenly may cause effects such as:

• nausea and vomiting
• sleep disturbances. Always follow your doctor's instructions carefully.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Read carefully about the serious side effects
Tell your doctor if you notice or suspect any of the following serious side effects. You may need urgent medical treatment.
Heart problems

• Abnormal heart rhythm – this stops the heart working normally and may cause loss of consciousness.
• Heartbeat that is too fast
• Extra heartbeats. Heart problems are uncommon in people using Haloperidol Pensa (may affect up to 1 in 100 people). Sudden deaths have occurred in patients taking this medicine, but the exact frequency of these deaths is unknown. Cardiac arrest (the heart stops beating) has also occurred in people taking antipsychotic medicines.

A serious condition called “neuroleptic malignant syndrome”. This causes high fever, severe muscle stiffness, confusion and loss of consciousness. It is rare in people using Haloperidol Pensa (may affect up to 1 in 1,000 people).
Problems controlling body or limb movements (extrapyramidal disorders), such as:

• Movements of the mouth, tongue, jaw and sometimes limbs (tardive dyskinesia)
• Feeling restless or unable to stay still, increased body movements
• Slow or reduced body movements, spasms or twisting movements
• Muscle tremors or stiffness, shuffling gait
• Inability to move
• Lack of normal facial expression, sometimes appearing as a mask-like face. These are very common in people using Haloperidol Pensa (may affect more than 1 in 10 people). If you experience any of these effects, you may be given an additional medicine.

Severe allergic reaction which may include:

• Swelling of the face, lips, mouth, tongue or throat
• Difficulty swallowing or breathing
• Skin rash (urticaria). A severe allergic reaction is uncommon in people using Haloperidol Pensa (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 people taking antipsychotic medicines. Signs of DVT in the leg include swelling, pain and redness in the leg, but the clot may travel to the lungs causing chest pain and difficulty breathing. Blood clots can be very serious, so inform your doctor immediately if you notice any of these problems.
Inform your doctor immediately if you notice any of the serious side effects listed above.
Other side effects
Tell your doctor if you notice or suspect any of the following side effects.
Very common (may affect more than 1 in 10 people)

• Feeling agitated
• 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, hearing or smelling things that are not there (hallucinations)
• Depression
• Abnormal muscle tension
• Dizziness, even when sitting or standing up
• Drowsiness
• Upward movement of the eyes or rapid eye movements that cannot be controlled
• Vision problems, such as blurred vision
• Low blood pressure
• Nausea, vomiting
• Constipation
• Dry mouth or increased salivation
• Skin rash
• Inability to urinate or empty the bladder completely
• Difficulty in achieving and maintaining erection (impotence)
• Weight gain or weight loss
• Changes seen in liver blood tests.

Uncommon (may affect up to 1 in 100 people)

• Effects on blood cells – low number of all types of blood cells, including severe decreases in white blood cells and low number of "platelets" (cells that help blood clotting)
• Feeling confused
• Loss of sexual desire or decreased libido
• Seizures (fits)
• Stiff muscles and joints
• Muscle spasms, spasms or contractions that you cannot control, including neck spasms causing the head to twist to one side
• Walking difficulties
• Shortness of breath
• Inflammation of the liver or liver problems causing yellowing of the skin or eyes (jaundice)
• Increased sensitivity to sunlight
• Itching
• Excessive sweating
• Changes in menstrual cycle (periods), such as no periods, or long, heavy, painful periods
• Unexpected production of milk from the breast
• Breast pain or discomfort
• High body temperature
• Swelling due to fluid retention in the body.

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

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

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

• High level of "antidiuretic hormone" in the blood (syndrome of inappropriate antidiuretic hormone secretion)
• Low blood sugar levels
• Swelling around the larynx, or brief spasm of the vocal cords causing difficulty speaking or breathing
• Sudden liver failure
• Reduced bile flow in the bile duct
• Skin peeling or desquamation
• Inflammation of small blood vessels, leading to a skin rash with small red or purple raised spots
• Breakdown of muscle tissue (rhabdomyolysis)
• Persistent and painful erection of the penis
• Breast enlargement in males
• Low body temperature.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aloperidolo Pensa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton.
The expiry date refers to the last day of that month.
Store below 25°C.
The shelf life of the medicine after first opening the bottle is 12 months. After this period, any
remaining medicine must be disposed of.
Do not dispose of medicines via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Package contents and other information

What Aloperidolo Pensa contains
The active substance is haloperidol. Each ml of solution contains 2 mg of haloperidol.
The other components are lactic acid, methyl parahydroxybenzoate, propyl parahydroxybenzoate,
purified water.

Description of the appearance of Aloperidolo Pensa and contents of the package
Bottle of 15 or 30 ml of solution with dropper device.

Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli 6
20154 Milan - Italy
Kern Pharma S.L.
Poligono Industrial Colom II c/Venus 72
08228 Terrassa (Barcelona)
Spain

The following information is intended for healthcare professionals only.
Package leaflet for 2 mg/ml oral drops, solution – dropper container only.
Aloperidolo Pensa 2 mg/ml oral drops, solution in a dropper container is intended for use in doses up to 2 mg of haloperidol (equivalent to 20 drops).
The number of drops required to achieve a given dose using Aloperidolo Pensa 2 mg/ml oral drops, solution is shown below.

Conversion table for Aloperidolo Pensa 2 mg/ml oral drops, solution