ALOPERIDOLO 2 mg /Ml Injectable Solution

Зміст інструкції

1. ALOPERIDOLO GALENICA SENESE 2 mg/ml injectable solution
   1. What is ALOPERIDOLO GALENICA SENESE and what it is used for
   2. What you need to know before you receive ALOPERIDOLO GALENICA SENESE
   3. How to use ALOPERIDOLO GALENICA SENESE
   4. Possible side effects
   5. How to store ALOPERIDOLO GALENICA SENESE
   6. Contents of the pack and other information

ALOPERIDOLO GALENICA SENESE 2 mg/ml injectable solution

Aloperidolo

Generic Equivalent Medicine
Read this leaflet carefully before 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What ALOPERIDOLO GALENICA SENESE is and what it is used for
• 2. What you need to know before you use ALOPERIDOLO GALENICA SENESE
• 3. How to use ALOPERIDOLO GALENICA SENESE
• 4. Possible side effects
• 5. How to store ALOPERIDOLO GALENICA SENESE
• 6. Contents of the pack and other information

1. What is ALOPERIDOLO GALENICA SENESE and what it is used for

ALOPERIDOLO GALENICA SENESE contains the active ingredient aloperidol. This belongs to a
group of medicines called “antipsychotics”.
ALOPERIDOLO GALENICA SENESE is used in adults for illnesses that affect the 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 smelling 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. ALOPERIDOLO GALENICA SENESE is also used in adults:
• to help control movements in Huntington's disease
• to prevent or treat nausea and vomiting (feeling sick or being sick) after surgery.

ALOPERIDOLO GALENICA SENESE can be used alone or with other medicines, and is sometimes used
when other medicines or treatments have not worked, have caused unacceptable side effects or cannot
be taken by mouth.

2. What you need to know before you receive ALOPERIDOLO GALENICA SENESE

Do not use ALOPERIDOLO GALENICA SENESE

• 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
• 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 in the section “Other medicines and ALOPERIDOLO GALENICA SENESE - Do not use ALOPERIDOLO GALENICA SENESE if you are taking certain medicines”.

The medicine must not be used if you experience any of the conditions listed above. If you have any doubts,
consult your doctor, pharmacist or nurse before receiving ALOPERIDOLO GALENICA SENESE.

Warnings and precautions
Serious side effects
ALOPERIDOLO GALENICA SENESE can cause problems with the heart, problems with controlling your body or the
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 GALENICA SENESE because urgent medical treatment may be needed. See “Read carefully about serious side effects” in section 4.

Elderly and people with dementia
A slight increase in deaths and strokes has been reported in elderly people with dementia who are taking antipsychotic
medicines. Talk to your doctor before using ALOPERIDOLO GALENICA SENESE if you are elderly,
especially if you suffer from dementia.
Talk to your doctor if you have:

• a slow heartbeat, heart disease or someone in your family has suddenly died of 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
• never had a bleed in the brain, or the 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 you may need to change the amount of ALOPERIDOLO GALENICA SENESE you are given.

If you are not sure whether any of the above conditions apply to you, consult your doctor or nurse
before you are given ALOPERIDOLO GALENICA SENESE.

Medical checks
Your doctor may prescribe an electrocardiogram (ECG) before or during treatment with
ALOPERIDOLO GALENICA SENESE.
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 GALENICA SENESE.

Children and adolescents
ALOPERIDOLO GALENICA SENESE should not be used in children and adolescents under 18
years of age. This is because it has not been studied in these age groups.

Other medicines and ALOPERIDOLO GALENICA SENESE
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines.

Do not use ALOPERIDOLO GALENICA SENESE 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 treating 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 use ALOPERIDOLO GALENICA SENESE (see section “Do not use ALOPERIDOLO GALENICA SENESE if”).

You may need to be monitored closely if you use lithium and ALOPERIDOLO GALENICA
SENESE 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 GALENICA SENESE works
or create 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 (to treat Cushing’s syndrome)
• indinavir, ritonavir or saquinavir (for the human immunodeficiency virus or HIV))
• chlorpromazine or 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 blood pressure, such as diuretics (medicines to help you urinate). The doctor may change the dose of ALOPERIDOLO GALENICA SENESE if you are taking any of these medicines.

ALOPERIDOLO GALENICA SENESE 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 or nurse before you are given ALOPERIDOLO GALENICA SENESE if you are taking any of these medicines.

ALOPERIDOLO GALENICA SENESE and alcohol
Drinking alcohol while taking ALOPERIDOLO GALENICA SENESE 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 alcohol use while taking ALOPERIDOLO GALENICA SENESE and tell your doctor
about the amounts of alcohol you drink.

Pregnancy, breastfeeding and fertility
Pregnancy -If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your
doctor for advice. Your doctor may advise you not to use ALOPERIDOLO GALENICA SENESE during
pregnancy.
The following problems may occur in newborns of mothers who use ALOPERIDOLO GALENICA
SENESE 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 GALENICA SENESE 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. The doctor will assess the risks and benefits of breastfeeding while using ALOPERIDOLO GALENICA SENESE.

Fertility –ALOPERIDOLO GALENICA SENESE can increase the levels of a hormone called
‘prolactin’, which can affect fertility in both men and women. Tell your doctor if you have
any questions about this.

Driving and using machines
ALOPERIDOLO GALENICA SENESE can affect your ability to drive and use tools or
machinery. Side effects, such as drowsiness, can affect your attention, especially when
you use it for the first time or after a high dose. This medicine can impair your ability to drive. Do
not drive or use tools or machinery without discussing this with your doctor first.

3. How to use ALOPERIDOLO GALENICA SENESE

This medicine will be administered to you
The doctor will decide how much ALOPERIDOLO GALENICA SENESE is needed and for how long. It may
take some time before you feel the full effect of the medicine. Usually the doctor will give you
a low dose to start with, and then adjust the dose that is right for you. The dose of aloperidol will depend on:

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

Adults

• The starting dose will normally be between 1 and 5 mg. You may be given extra doses, usually 1 to 4 hours apart.
• You will not be given more than 20 mg in total each day.

Elderly

• Elderly patients will normally start with half the lowest adult dose.
• The dose will be adjusted until the doctor finds the dose that is right for you.
• You will not be given more than 5 mg in total each day, unless the doctor decides that a higher dose is needed.

How ALOPERIDOLO GALENICA SENESE will be administered
ALOPERIDOLO GALENICA SENESE will be administered to you by a doctor or nurse. It is for
intramuscular use and will be given by injection into a muscle.

If you forget a dose or receive too much ALOPERIDOLO GALENICA SENESE
A doctor or nurse will administer the medicine to you, so it is unlikely that you will forget a dose
or receive too much. If you are worried, tell your doctor or nurse.

If you stop using ALOPERIDOLO GALENICA SENESE
Unless the doctor decides otherwise, ALOPERIDOLO GALENICA SENESE will be stopped
gradually. Suddenly stopping treatment can cause effects such as:

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
manifest them.

Read carefully about serious side effects
Tell your doctor or nurse 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 from working normally and can cause loss of consciousness.
• Excessively fast heartbeat.
• Extra heartbeats. Heart problems are not common in people using ALOPERIDOLO GALENICA SENESE (may affect up to 1 in 100 people). Sudden deaths have occurred in patients using this medicine, but the exact frequency of deaths is unknown. Cardiac arrest (the heart stops beating) has also occurred in people taking antipsychotic drugs. 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 GALENICA SENESE (may affect up to 1 in 1000).

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 stiffness, walking with a shuffling gait
• being unable to move
• lack of a normal facial expression that sometimes appears as a mask. These are very common in people using ALOPERIDOLO GALENICA SENESE (may affect more than 1 in 10 people). 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 GALENICA SENESE (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 drugs. Signs of deep vein thrombosis 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.
Tell 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

• Feeling agitated
• Difficulty sleeping
• Headache

Common(may affect up to 1 in 10 people)

• Serious mental health problem, such as believing things that are not true (delusions) 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 and 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 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 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 walking
• Being short of breath
• Inflammation of the liver or 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 breast milk
• Breast pain or discomfort
• High body temperature
• Swelling caused by fluid buildup in the body

Rare(may affect up to 1 in 1000 people)

• 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 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
• Swelling around the larynx, or brief spasm of the vocal cords affecting speech
• 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
• Muscle tissue breakdown (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, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly through
the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store ALOPERIDOLO GALENICA SENESE

Keep this medicine out of the sight and reach of children.
ALOPERIDOLO GALENICA SENESE must not be used after the expiry date which is reported
on the label and the carton.
The expiry date refers to the last day of that month.
Keep this medicine in the original package to protect it from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ALOPERIDOLO GALENICA SENESE 2 mg/ml injectable solution contains

• The active ingredient is aloperidol. Each millilitre of solution contains 2 mg of aloperidol.
• The other ingredients are: lactic acid, water for injections.

Description of the appearance of ALOPERIDOLO GALENICA SENESE and contents of the pack
Pack of 1 vial containing 1 ml of injectable solution.
Pack of 10 vials containing 1 ml of injectable solution.

Marketing Authorisation Holder and manufacturer
Industria Farmaceutica Galenica Senese S.r.l. – Via Cassia Nord 351 – 53014 Monteroni d’Arbia (Siena)