Aloperidol Galenica Senese

Patient Information Leaflet: Information for the User

ALOPERIDOL GALENICA SENESE 2 mg/ml injectable solution

Haloperidol
Generic Medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

ALOPERIDOLO GALENICA SENESE contains the active substance haloperidol. This belongs to a
group of medicines called “antipsychotics”.
ALOPERIDOLO GALENICA SENESE is used in adults for illnesses affecting the way a person
thinks, feels, and behaves. These include mental health conditions (such as schizophrenia and bipolar
disorder) and behavioural disorders.
These illnesses may cause:

• confusion (delirium)
• 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 highly 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 may be used alone or in combination with other medicines, and
sometimes it is used when other medicines or treatments have not worked, have caused unacceptable
side effects, or cannot be taken by mouth.

2. What you should know before receiving ALOPERIDOL GALENICA SENESE

Do not use ALOPERIDOL GALENICA SENESE

• 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;
• 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 appears as an abnormal trace on an ECG (electrocardiogram);
• • if you suffer from heart failure or have recently had a heart attack;
• • if you have low potassium levels in your blood that have not been treated;
• • if you are taking any of the medicines listed in the section “Other medicines and ALOPERIDOL GALENICA SENESE - Do not use ALOPERIDOL GALENICA SENESE if you are taking certain medicines”.

You must not use this medicine if you have any of the conditions listed above. If you are unsure,
consult your doctor, pharmacist or nurse before receiving ALOPERIDOL GALENICA SENESE.
Warnings and precautions
Serious side effects
ALOPERIDOL GALENICA SENESE may 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 these serious side effects during treatment with ALOPERIDOL GALENICA SENESE, as urgent medical treatment may be required. See “Carefully read about serious side effects” in section 4.
Elderly people and those with dementia
A slight increase in deaths and stroke events has been reported in elderly patients with dementia who are taking antipsychotic medicines. Please consult your doctor before using ALOPERIDOL GALENICA SENESE if you are elderly, especially if you have dementia.
Contact your doctor 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 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 treat you;
• have ever had bleeding in the brain, or 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 have bipolar disorder and start feeling depressed. You may need to be monitored more closely, and your dose of ALOPERIDOL GALENICA SENESE may need to be adjusted.

If you are not sure whether any of the conditions listed above apply to you, consult your doctor or nurse
before being administered ALOPERIDOL GALENICA SENESE.
Medical checks
Your doctor may prescribe an electrocardiogram (ECG) before or during treatment with
ALOPERIDOL GALENICA SENESE.
The ECG measures the electrical activity of the heart.
Blood tests
Your doctor may decide to check your blood levels of potassium or magnesium (or another “electrolyte”) before or during treatment with ALOPERIDOL GALENICA SENESE.
Children and adolescents
ALOPERIDOL GALENICA SENESE must 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 ALOPERIDOL GALENICA SENESE
Inform your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicine.
Do not use ALOPERIDOL GALENICA SENESE 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 opioid dependence). These medicines may increase the risk of heart problems, so inform your doctor if you are taking any of these medicines and do not use ALOPERIDOL GALENICA SENESE (see section “Do not use ALOPERIDOL GALENICA SENESE if”).

Special monitoring may be needed if you are using lithium and ALOPERIDOL GALENICA SENESE
at the same time.
Inform 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 and drowsiness.
These are signs of a serious condition.
Some medicines may affect how ALOPERIDOL GALENICA SENESE works or may cause heart problems or similar issues
Inform 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 (to treat Cushing's syndrome);
• indinavir, ritonavir or saquinavir (for human immunodeficiency virus or HIV);
• chlorpromazine or 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 medicines that increase urination (diuretics). Your doctor may adjust the dose of ALOPERIDOL GALENICA SENESE if you are taking any of these medicines.

ALOPERIDOL GALENICA SENESE may affect how the following types of medicines work:
Inform 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 or nurse before being administered ALOPERIDOL GALENICA SENESE if you are taking any of these medicines.

ALOPERIDOL GALENICA SENESE and alcohol
Drinking alcohol while taking ALOPERIDOL GALENICA SENESE may make you feel drowsy and less alert. This means you should be cautious about how much alcohol you drink. Discuss alcohol use with your doctor while taking ALOPERIDOL GALENICA SENESE 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, consult your doctor. Your doctor may advise you not to use ALOPERIDOL GALENICA SENESE during pregnancy.
The following problems may occur in newborns whose mothers used ALOPERIDOL GALENICA SENESE during the last 3 months of pregnancy (the third trimester):

• muscle tremors, weakness or stiffness;
• being drowsy or agitated;
• breathing or feeding problems. The exact frequency of these problems is unknown. If ALOPERIDOL GALENICA SENESE has been used during pregnancy and the baby develops any of these side effects, contact 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 assess the risks and benefits of breastfeeding while using ALOPERIDOL GALENICA SENESE.

Fertility – ALOPERIDOL GALENICA SENESE 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
ALOPERIDOL GALENICA SENESE may affect your ability to drive and to use tools or machinery. Side effects such as drowsiness may affect your attention, especially when you first start taking it or after a high dose. This medicine may impair your ability to drive. Do not drive or operate tools or machinery without first discussing this with your doctor.

3. How to use ALOPERIDOLO GALENICA SENESE

This medicine will be administered to you
Your doctor will decide how much ALOPERIDOLO GALENICA SENESE you need and for how long. It may
take some time before you feel the full effect of the medicine. Normally, your doctor will start you on a low dose,
and then adjust the dose to suit your needs. The dose of haloperidol will depend on:

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

Adults

• The initial dose will normally range between 1 and 5 mg. Additional doses may be given, usually at intervals of 1 to 4 hours.
• You will not be given more than 20 mg in total per day.

Elderly

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

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

If you miss a dose or receive too much ALOPERIDOLO GALENICA SENESE
Since a doctor or nurse will administer the medicine, it is unlikely that you will miss a dose or receive too much. If you are concerned, inform your doctor or nurse.

If you stop using ALOPERIDOLO GALENICA SENESE
Unless your doctor decides otherwise, treatment with ALOPERIDOLO GALENICA SENESE will be stopped 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, pharmacist, or nurse.

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 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 working normally and can cause loss of consciousness.
• Heartbeat that is too fast.
• Extra heartbeats. Heart problems are uncommon in people taking ALOPERIDOL GALENICA SENESE (may affect up to 1 in 100 people). Sudden deaths have occurred in patients taking this medicine, but the exact frequency of 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 taking ALOPERIDOL GALENICA SENESE (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. These are very common in people taking ALOPERIDOL GALENICA SENESE (may affect more than 1 in 10 people). If you experience any of these side 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). An allergic reaction is uncommon in people taking ALOPERIDOL GALENICA SENESE (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 a deep vein thrombosis 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

• Feeling restless
• 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 standing up or sitting down
• Drowsiness
• Upward movement of the eyes and rapid, uncontrollable eye movements
• 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 achieving or maintaining an 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 platelet count (cells that help blood to clot)
• Feeling confused
• Loss of sexual desire or decreased libido
• Seizures (convulsions)
• 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 absence of periods, or long, heavy, painful periods
• Unexpected production of breast milk
• 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 difficulty breathing
• Difficulty or inability to open the mouth
• Problems during 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 spasms of the vocal cords affecting speech
• Sudden liver failure
• Reduced bile flow in the bile duct
• Skin exfoliation or peeling
• 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 men
• Low body temperature

Reporting of side effects
If you get any side effect, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via 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 ALOPERIDOL GALENICA SENESE

Keep this medicine out of the sight and reach of children.
ALOPERIDOL GALENICA SENESE must not be used after the expiry date stated
on the label and on the carton.
The expiry date refers to the last day of that month.
Keep this medicine in its original packaging to protect it from light.
Do not dispose of any medicine via wastewater 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 ALOPERIDOL GALENICA SENESE 2 mg/ml injectable solution contains

• The active substance is haloperidol. Each millilitre of solution contains 2 mg of haloperidol.
• The other components are: lactic acid, water for injections.

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