ALOPERIDOLO 2 mg /Ml Oral Drops, Solution

Зміст інструкції

1. Aloperidolo Pensa 2 mg/ml oral drops, solution
   1. What is Aloperidolo Pensa and what is it 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

Aloperidolo Pensa 2 mg/ml oral drops, solution

aloperidolo

Generic medicine

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Aloperidolo Pensa and what is it used for

The name of the medicine is Aloperidolo Pensa.
Aloperidolo Pensa contains the active ingredient aloperidol. This belongs to a group of
medicines called “antipsychotics”.
Aloperidolo Pensa is used in adults, adolescents and children for illnesses that affect its
way of thinking, feeling and behaving. These include mental health problems (such as schizophrenia
and bipolar disorder) and behavioral disorders.
These illnesses can cause:

• feeling confused (delusions)
• seeing, hearing or perceiving smells of things that are not there (hallucinations)
• believing things that are not true (delusions)
• feeling unusually suspicious (paranoia)
• feeling very 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 behavioral 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 you cannot control (tics), for example in severe Tourette's 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 need to know before taking Aloperidolo Pensa

Do not take Aloperidolo Pensa:

• if you are allergic to aloperidol or 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 up as an abnormal tracing on an ECG (electrocardiogram)
• if you suffer from heart failure or have recently had a heart attack
• if you have a low level of potassium in your blood, which has not been treated
• 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”. The medicine must not be used if you experience any of the following conditions. If you have any doubts, ask your doctor or pharmacist before taking Aloperidolo Pensa.

Warnings and precautions
Serious side effects
Aloperidolo Pensa can cause heart problems, problems with controlling your body or movements of your
limbs and a serious side effect called “neuroleptic malignant syndrome”. It can also cause serious
allergic reactions and blood clots. You need to be aware of serious side effects while
using Aloperidolo Pensa because urgent medical treatment may be needed. See
“Read carefully about serious side effects” in section 4.

Elderly people and people with dementia
A slight increase in deaths and strokes has been reported in elderly people with dementia who are taking antipsychotic medicines. Ask your doctor or pharmacist before using Aloperidolo Pensa if you are elderly, especially
if you suffer from dementia.

Talk to your doctor or pharmacist if you have:

• a slow heartbeat, heart disease or someone in your family has died suddenly from heart problems
• low blood pressure, or you feel dizzy when you stand up or sit down
• a low level of potassium or magnesium (or another “electrolyte”) in your blood. The doctor will decide how to treat it
• ever had a bleed in the brain, or your doctor has told you that you are more likely than other people to have a stroke
• epilepsy or have ever had seizures (convulsions)
• problems with your kidneys, liver or thyroid
• a high level of the hormone “prolactin” in your blood, or a cancer that can be caused by high levels of prolactin (such as breast cancer)
• a history of blood clots, or someone else in your family has a history of blood clots
• depression, or if you have bipolar disorder and start to feel depressed. You may need to be monitored more closely, and the amount of Aloperidolo Pensa you take may need to be adjusted.

If you are not sure if any of the above conditions apply to you, ask your doctor or pharmacist
before taking Aloperidolo Pensa.

Medical checks
Your doctor may prescribe you an electrocardiogram (ECG) before or during treatment with Aloperidolo
Pensa. The ECG measures the electrical activity of your heart.

Blood tests
Your doctor may decide to check the 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 should 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

• problems with your heartbeat (such as amiodarone, dofetilide, disopyramide, dronedarone, ibutilide, quinidine and sotalol)
• depression (such as citalopram and escitalopram)
• psychoses (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 tell your doctor if you are taking bepridil (for chest pain or to lower blood pressure) or methadone (a painkiller or for the treatment of drug addiction). These medicines can increase the risk of heart problems, so tell 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 a fever that you cannot explain or movements that you cannot control
• you are confused, disoriented, have a headache, problems with balance and drowsiness. These are signs of a serious condition.

Some medicines can affect how Aloperidolo Pensa works or may have heart problems or similar
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 you stop smoking)
• carbamazepine, phenobarbital or phenytoin (for epilepsy)
• rifampicin (for bacterial infections)
• itraconazole, posaconazole or voriconazole (for fungal infections)
• ketoconazole tablets (for the treatment of Cushing’s syndrome)
• indinavir, ritonavir or saquinavir (for the human immunodeficiency virus or HIV)
• chlorpromazine and promethazine (for nausea and vomiting)
• verapamil (for high blood pressure or heart problems). Also tell your doctor if you are taking other medicines to lower your blood pressure, such as diuretics (water tablets).

Your doctor may need to adjust the dose of Aloperidolo Pensa if you are taking any of these medicines.

Aloperidolo Pensa can affect how the following types of medicines work
Tell your doctor if you are taking medicines for:

• calming down or for 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 your blood (phenindione). Tell 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 sleepy and less alert.
This means you need to be careful about how much alcohol you drink. Discuss with your doctor
about the use of alcohol while taking Aloperidolo Pensa and tell your doctor about the amount of alcohol
you drink.

Pregnancy, breastfeeding and fertility
Pregnancy- if you are pregnant, if you suspect you are pregnant or are planning to become pregnant, ask
for advice from your doctor. Your doctor may advise you not to use Aloperidolo Pensa during
pregnancy.
The following problems can occur in newborns of mothers who use Aloperidolo Pensa in the
last 3 months of pregnancy (the last trimester):

• muscle tremors, weakness or stiffness
• being sleepy or agitated
• breathing or feeding problems. The exact frequency of these problems is unknown. If Aloperidolo Pensa has been used during pregnancy and the baby develops any of these side effects, contact your doctor.

Breastfeeding- tell your doctor if you are breastfeeding or are planning to breastfeed.
This is because small amounts of the medicine can pass into breast milk and to the baby. Your doctor
will explain the risks and benefits of breastfeeding while taking Aloperidolo Pensa.

Fertility- Aloperidolo Pensa can increase the levels of a hormone called “prolactin”, which can
affect fertility, in men and women. Tell your doctor if you have any questions about this.

Driving and using machines
Aloperidolo Pensa can affect your ability to drive and use tools and machines. Side
effects, such as drowsiness, may affect your attention, especially if you are taking it
for the first time or after an increase in the dose. This medicine can alter your ability to drive.
Do not drive or use tools or machines until you have discussed this with your doctor.

Aloperidolo Pensa contains para-hydroxybenzoates.These can 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 to take and for how long. Your doctor will also tell you whether
to take Aloperidolo Pensa one or more times a day. It may take some time before you
feel the full effect of the medicine. Usually your doctor will give you a low dose to start with, and then
adjust the dose that is right for you. It is very important to take the correct amount.
The dose of aloperidol will depend on:

• your age
• what you are being treated for
• if you have kidney or liver problems
• other medicines you are taking

Adults

• The dose will normally be between 0.5 and 10 mg per day.
• Your doctor may change it to find the dose that is right for you.
• The maximum dose that adults should take depends on the condition being treated and varies between 5 and 20 mg per day. Elderly
• Elderly people will normally start with 0.5 mg per day or with half the lowest adult dose.
• The amount of Aloperidolo Pensa to be taken will be adjusted until your doctor finds the dose that is right for you.
• The maximum dose that elderly people should take is 5 mg per day, unless your doctor decides that a higher dose is needed.

Children and adolescents from 6 to 17 years of age

• The dose will normally be between 0.5 mg and 3 mg per day
• Adolescents up to 17 years of age treated for schizophrenia or behavioral disorders may need a higher dose, up to 5 mg per day.

Taking Aloperidolo Pensa

• Aloperidolo Pensa is for oral use.
• Aloperidolo Pensa drops can be mixed with a little water before taking, but do not mix it with other liquids.
• Remove the cap from the bottle.
• Turn the bottle upside down over a spoon.
• Gently press on the sides of the bottle and count the number of drops you need to take.
• Drink the solution immediately.
• Close the bottle.

If you take more Aloperidolo Pensa than you should
If you take more Aloperidolo Pensa than you have been told or if someone else has taken Aloperidolo
Pensa, consult your doctor or go to the emergency room of the nearest hospital.

If you forget to take Aloperidolo Pensa

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

If you stop taking Aloperidolo Pensa
Unless your doctor tells you otherwise, you should stop Aloperidolo Pensa gradually.
Suddenly stopping treatment can cause effects such as:

• nausea and vomiting
• sleep disturbances. Always follow your doctor's instructions carefully. If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Read carefully about serious side effects
Inform your doctor if you notice or suspect any of the following serious side effects. Urgent medical treatment may be needed.

Heart problems

• Abnormal heart rhythm - this stops the heart working normally and can cause loss of consciousness.
• Excessively fast heartbeat
• Extra heartbeats. Heart problems are uncommon in people using Aloperidolo 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 problem called “neuroleptic malignant syndrome”.This causes high fever, severe muscle rigidity, confusion and loss of consciousness. It is rare in people using Aloperidolo Pensa (may affect up to 1 in 1,000).

Problems with controlling body movements or limbs (extrapyramidal disorders), such as:

• movements of the mouth, tongue, jaw and sometimes the limbs (tardive dyskinesia)
• feeling restless or difficulty staying still, increased body movements
• slow or reduced body movements, spasms or twisting movements
• muscle tremors or rigidity, walking with dragging feet
• being unable to move
• a lack of a normal facial expression that sometimes appears as a mask. These are very common in people using Aloperidolo Pensa (may affect more than 1 in 10). If you experience any of these effects, you may be given an additional medicine.

Serious allergic reactionwhich may include:

• swelling of the face, lips, mouth, tongue or throat
• difficulty swallowing or breathing
• skin rashes (urticaria). An allergic reaction is uncommon in people using Aloperidolo Pensa (may affect up to 1 in 100).

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 a DVT in the leg include swelling, pain and redness in the leg, but the clot can move to the lungs causing chest pain and difficulty breathing. Blood clots can be very serious, so tell 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
Inform your doctor if you notice or suspect any of the following side effects.

Very common(may affect more than 1 in 10)

• Feeling agitated
• Difficulty sleeping
• Headache. Common(may affect up to 1 in 10)
• Serious mental health problem, such as believing things that are not true (manias) or seeing, hearing or smelling things that are not there (hallucinations)
• Depression
• Abnormal muscle tension
• Feeling dizzy, even when getting up or sitting down
• Drowsiness
• Upward movement of the eyes or rapid eye movements that you cannot control
• Vision problems, such as blurred vision.
• Low blood pressure
• Nausea, vomiting
• Constipation
• Dry mouth or increased salivation
• Skin rash
• Being unable to urinate or completely empty the bladder
• Difficulty getting and maintaining an erection (impotence)
• Weight gain or loss
• Changes that appear in liver blood tests.

Uncommon(may affect up to 1 in 100)

• Effects on blood cells - low number of all types of blood cells, including serious decreases in white blood cells and low number of “platelets” (cells that help blood clotting)
• Feeling confused
• Loss of sexual desire or decreased sexual desire
• Seizures (convulsions)
• Stiff muscles and joints
• Muscle spasms, spasms or contractions that you cannot control, including a spasm in the neck causing the head to twist to one side
• Problems with walking
• Being short of breath
• Inflammation of the liver or a liver problem causing yellowing of the skin or eyes (jaundice)
• Increased sensitivity to sunlight
• Itching
• Excessive sweating
• Changes in the menstrual cycle (periods), such as no period, or long, heavy, painful periods
• Unexpected production of milk from the breast
• Pain or discomfort in the breast
• High body temperature
• Swelling caused by fluid buildup in the body. Rare(may affect up to 1 in 1,000)
• High level of the hormone “prolactin” in the blood
• Narrowing of the airways in the lungs, causing difficulty breathing
• Difficulty or being unable to open your mouth
• Problems having sexual intercourse.

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

• High level of the “antidiuretic hormone” in the blood (syndrome of inappropriate secretion of

antidiuretic hormone)

• Low blood sugar
• Swelling around the larynx, or brief spasm of the vocal cords that can cause difficulty speaking or breathing
• Sudden liver failure
• Decreased flow of bile into the bile duct
• Peeling or flaking of the skin
• Inflammation of small blood vessels, leading to a 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
• Low body temperature.

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the blister or the carton. The expiry
date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

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

Marketing authorisation holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milano
The following information is intended for healthcare professionals only.
Aloperidolo Pensa 2 mg/ml oral drops, solution in a dropper container is intended to be
used for doses up to 2 mg of aloperidol (equivalent to 20 drops).
The number of drops needed to reach a given dose using Aloperidolo Pensa 2 mg/ml
oral drops, solution is presented below.
Conversion table for Aloperidolo Pensa 2 mg/ml oral drops, solution