Aloperidol Hikma

Patient Information Leaflet: Information for the Patient

Aloperidol Hikma 50 mg/mL prolonged-release injectable solution, 100 mg/mL prolonged-release injectable solution

haloperidol
Generic medicine
Please read this leaflet carefully before you start 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, 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, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

The name of the medicine is Aloperidolo Hikma.
Aloperidolo Hikma contains the active substance haloperidol (as haloperidol decanoate). It belongs to a
group of medicines called "antipsychotics".
Aloperidolo Hikma is used in adults whose condition has previously been treated with oral haloperidol. It is used for illnesses that affect the way a person thinks, feels or behaves. These include mental health disorders (such as schizophrenia). These illnesses can:

• Make you feel confused (delirium)
• Cause you to see, hear, feel or smell things that do not exist (hallucinations)
• Cause you to believe things that are not true (delusions)
• Make you feel unusually suspicious (paranoia)
• Make you feel extremely excited, agitated, enthusiastic, impulsive or hyperactive
• Make you feel very aggressive, hostile or violent.

2. What you should know before taking Aloperidolo Hikma

Do not use Aloperidolo Hikma if:

• You are allergic to haloperidol or to any of the other ingredients of this medicine (listed in section 6)
• You are allergic to sesame oil. Aloperidolo Hikma contains sesame oil. See “Aloperidolo Hikma contains” below
• You are less aware of your surroundings or your reactions become unusually slow
• You have Parkinson's disease
• You have a type of dementia called “Dementia with Lewy bodies”
• You are affected by Progressive Supranuclear Palsy (PSP)
• You have a heart condition called “Long QT interval” or any other heart rhythm disorder resulting in an abnormal ECG (electrocardiogram) trace
• You suffer from heart failure or have recently had a heart attack
• Your blood potassium level is low and has not been treated
• You are taking any of the medicines listed in “Other medicines and Aloperidolo Hikma – Do not use Aloperidolo Hikma if you are taking certain medicines”.

This medicine must not be used if any of the above situations apply. If you are unsure, speak with your doctor, pharmacist, or nurse before receiving Aloperidolo Hikma.

Warnings and precautions

Serious side effects
Aloperidolo Hikma may cause heart problems, movement control problems in the body or limbs, and a serious side effect called “neuroleptic malignant syndrome”. It may also cause severe allergic reactions and blood clots. You should be alert to serious side effects while using Aloperidolo Hikma, as urgent medical treatment may be required. See “Be aware of serious side effects” in section 4.

Elderly people and those with dementia
A small increase in deaths and strokes has been reported in elderly patients with dementia who are taking antipsychotic medicines. Speak with your doctor before taking Aloperidolo Hikma if you are elderly, especially if you have dementia.

Speak with your doctor if you have:

• Slow heartbeat, heart disease, or if someone in your family has died suddenly from heart problems
• Low blood pressure or dizziness when sitting or standing up
• Low levels of potassium or magnesium (or other “electrolytes”) in the blood. Your doctor will decide how to manage this
• Ever had a stroke or your doctor has told you that you are at higher risk of stroke than others
• Epilepsy or have ever had seizures (fits)
• Kidney, liver, or thyroid problems
• High levels of the hormone “prolactin” in the blood or a tumour that could be caused by high prolactin levels (such as breast tumour)
• A history of blood clots or if another family member has a history of blood clots
• Depression

You may require closer monitoring and your doctor may need to adjust the dose of Aloperidolo Hikma.

If you are unsure whether any of the above apply to you, speak with your doctor, pharmacist, or nurse before being given Aloperidolo Hikma.

Medical check-ups
Your doctor may want to perform an electrocardiogram (ECG) before or during treatment with Aloperidolo Hikma. The ECG measures the electrical activity of the heart.

Blood tests
Your doctor may want to check your blood levels of potassium or magnesium (or other “electrolytes”) before or during treatment with Aloperidolo Hikma.

Children and adolescents
Aloperidolo Hikma 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 Aloperidolo Hikma
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

Do not use Aloperidolo Hikma 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). Inform your doctor if you are taking bepridil (for chest pain or lowering blood pressure) or methadone (an analgesic or for drug dependence treatment). These medicines may increase the risk of heart problems, so it is recommended to inform your doctor if you are taking any of them and not to use Aloperidolo Hikma (see “Do not use Aloperidolo Hikma if”).

Special monitoring may be needed if you are using lithium together with Aloperidolo Hikma.
Inform your doctor immediately and stop taking both medicines if you experience:

• Unexplained fever or uncontrollable movements
• Confusion, disorientation, headache, balance problems, or drowsiness. These are symptoms of a serious condition.

Some medicines may affect how Aloperidolo Hikma works or increase the risk of heart problems
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 (for treatment of 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). Inform your doctor if you are taking other medicines to lower blood pressure, such as diuretics.

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

Aloperidolo Hikma may affect how the following medicines work
Inform your doctor if you are taking medicines for:

• Calming or helping you sleep (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)
• Blood thinning (phenindione)

Speak with your doctor, pharmacist, or nurse before receiving Aloperidolo Hikma if you are taking any of these medicines.

Aloperidolo Hikma and alcohol
Drinking alcohol while using Aloperidolo Hikma may cause drowsiness and reduced alertness. This means you should be cautious about how much alcohol you drink. Speak with your doctor about alcohol consumption while using Aloperidolo Hikma 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 have a baby, consult your doctor before using this medicine. Your doctor may advise you not to use Aloperidolo Hikma during pregnancy.

In newborns of mothers who have taken Aloperidolo Hikma during the last three months of pregnancy (third trimester), the following problems may occur:

• Muscle tremors, stiff or weak muscles
• Drowsiness or restlessness
• Breathing or feeding difficulties. The exact frequency of these problems is unknown. If you have used Aloperidolo Hikma during pregnancy and your baby develops any of these side effects, contact your doctor.

Breastfeeding
Speak with your doctor if you are breastfeeding or intend to breastfeed. This is because small amounts of the medicine may pass into breast milk and affect the baby. Your doctor will discuss the risks and benefits of breastfeeding while using Aloperidolo Hikma.

Fertility
Aloperidolo Hikma may increase levels of a hormone called “prolactin”, which may affect fertility in both men and women. If you have any questions about this, speak with your doctor.

Driving and using machines
Aloperidolo Hikma may impair your ability to drive or operate tools or machinery. Side effects such as drowsiness may affect alertness, especially at the beginning of treatment or after a higher dose. It is recommended not to drive or operate tools or machinery without first consulting your doctor.

Aloperidolo Hikma contains benzyl alcohol and sesame oil
This medicine contains 12 mg of benzyl alcohol per mL of solution. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you have liver or kidney disease, are pregnant, or are breastfeeding. This is because large amounts of benzyl alcohol may accumulate in the body and cause unwanted effects (called “metabolic acidosis”).

This medicine also contains sesame oil, which may rarely cause severe allergic reactions.

3. How to use Aloperidolo Hikma

How much medicine will be given to you
Your doctor will decide the amount of Aloperidolo Hikma you need and for how long. Your doctor will adjust the
dose according to your needs and may also prescribe an oral form of haloperidol.
The dose of haloperidol decanoate depends on:

• Age
• Whether you have kidney or liver problems
• How you have reacted to haloperidol in the past
• Other medicines you are taking.

Adults

• The usual starting dose is between 25 mg and 150 mg.
• Your doctor may adjust the dose up to 50 mg every 4 weeks to find the most suitable dose (usually between 50 mg and 200 mg every 4 weeks).
• More than 300 mg every 4 weeks will not be administered.

Elderly

• Elderly patients usually start with a lower dose, typically between 12.5 mg and 25 mg every 4 weeks.
• The dose may be adjusted until your doctor finds the most suitable dose (usually between 25 mg and 75 mg every 4 weeks).
• A dose higher than 75 mg will be given every 4 weeks only if your doctor decides it is safe to do so.

How Aloperidolo Hikma is administered
Aloperidolo Hikma will be administered by a doctor. It is for intramuscular use and is given as a deep intramuscular injection. A single dose of Aloperidolo Hikma normally lasts 4 weeks. Aloperidolo Hikma must not be injected intravenously.
If you have been given too much Aloperidolo Hikma
The medicine is administered by a doctor, so it is unlikely that too much will be given. If you are concerned, inform your doctor.
If you miss a dose or stop using Aloperidolo Hikma
Do not stop taking this medicine unless your doctor tells you to, as symptoms may return. If you miss an appointment, contact your doctor immediately to schedule a new one.
For further information on the use of this medicine, please consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Pay attention to serious side effects
Contact your doctor, pharmacist, or nurse immediately if you notice or suspect any of the following conditions. Urgent medical treatment may be required.

Heart problems:

• Irregular heart rhythm: prevents the heart from functioning normally and may cause loss of consciousness
• Abnormally fast heartbeat
• Extra heartbeats.

Heart problems are uncommon in people using Aloperidol Hikma (may affect up to 1 in 100 people). Sudden deaths have occurred in patients taking this medicine, but the exact frequency of such 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. The exact frequency of this side effect in people using Aloperidol Hikma is unknown.

Problems controlling body or limb movements (extrapyramidal disorder), such as:

• Movements of the mouth, tongue, jaw, and sometimes limbs (tardive dyskinesia)
• Feeling restless or unable to sit still, increased body movements
• Slow or reduced body movements, jerky movements, or twisting
• Tremors or muscle stiffness, shuffling gait
• Inability to move
• Lack of normal facial expression, sometimes resembling a mask. These are very common in people using Aloperidol Hikma (may affect more than 1 in 10 people). If any of these effects occur, 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
• Itchy rash (urticaria). The exact frequency of allergic reactions in people using Aloperidol Hikma is unknown.

Blood clots in the veins, usually in the legs (deep vein thrombosis or DVT). These symptoms have been reported in people taking antipsychotic medicines. Signs of DVT in the leg include swelling, pain, and redness of the leg, but the clot may travel to the lungs causing chest pain and breathing difficulties. Blood clots can be very serious, so you must contact your doctor immediately if you notice any of these problems.

Contact your doctor immediately if you experience 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.

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

• Depression
• Difficulty sleeping or feeling drowsy
• Constipation
• Dry mouth or increased salivation
• Problems during sexual intercourse
• Irritation, pain, or collection of pus (abscess) at the injection site
• Weight gain.

Uncommon (may affect up to 1 in 100 people):

• Abnormal muscle tension
• Headache
• Upward eye movements or rapid, uncontrollable eye movements
• Vision problems, such as blurred vision.

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

• Severe mental health problems, such as believing things that are not true (delusions) or seeing, hearing, sensing, or smelling things that do not exist (hallucinations)
• Feeling agitated or confused
• Seizures
• Dizziness, even when standing up or sitting down
• Low blood pressure
• Breathing problems, such as:
  o Swelling around the larynx or brief spasms of the vocal cords affecting speech
  o Narrowed airways in the lungs
  o Shortness of breath
• Nausea, vomiting
• Blood changes, such as:
  o Effects on blood cells: reduced number of all types of blood cells, including a severe decrease in white blood cells and reduced levels of "platelets" (cells that help blood clotting)
  o Increased levels of certain hormones in the blood – "prolactin" and "antidiuretic hormone" (syndrome of inappropriate antidiuretic hormone secretion)
  o Low blood sugar levels
• Changes observed in liver blood tests and other liver problems, such as:
  o Yellowing of the skin or whites of the eyes (jaundice)
  o Inflamed liver
  o Sudden liver failure
• Reduced bile flow in the bile duct
• Skin problems, such as:
  o Rash or itching
  o Increased sensitivity to sunlight
  o Peeling or flaking skin
  o Inflammation of small blood vessels, causing a rash with small red or purple spots
• Excessive sweating
• Breakdown of muscle tissue (rhabdomyolysis)
• Muscle spasms, contractions, or involuntary spasms, including neck spasms causing head turning to one side
• Difficulty or inability to open the mouth
• Stiff muscles and joints
• Inability to urinate or empty the bladder completely
• Persistent and painful erection of the penis
• Difficulty achieving or maintaining an erection (impotence)
• Loss of sexual desire or decreased sexual desire
• Changes in the menstrual cycle (periods), such as absence of periods or long, heavy, and painful periods
• Breast problems, such as:
  o Pain or discomfort
  o Unexpected production of breast milk
  o Enlarged breasts in men
• Swelling due to fluid accumulation in the body
• High or low body temperature
• Walking difficulties
• Weight loss.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at https://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 Hikma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and on the packaging following the word EXP. The expiry date refers to the last day of the month indicated.
Store in the original packaging to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Package contents and other information

What Aloperidol Hikma contains

• The active substance is aloperidol. Solution 50 mg/mL: Each mL of solution contains 70.52 mg of aloperidol decanoate, equivalent to 50 mg of aloperidol base. Solution 100 mg/mL: Each mL of solution contains 141.04 mg of aloperidol decanoate, equivalent to 100 mg of aloperidol base.
• The other excipients are: benzyl alcohol and sesame oil.

Description of the appearance of Aloperidol Hikma and contents of the pack
Solution 50 mg/mL:
Clear glass vial with a bromobutyl rubber stopper and aluminium cap. The vials contain 1 mL or 3 mL, corresponding to the presentations of 50 mg/1 mL and 150 mg/3 mL, respectively.
Each mL of prolonged-release injectable solution contains 70.52 mg of aloperidol decanoate, equivalent to 50 mg of aloperidol base.
1 mL vial: packs of 10 vials.
3 mL vial: packs of 1 vial.

Solution 100 mg/mL:
Clear glass vial with a bromobutyl rubber stopper and aluminium cap.
The vials contain 1 mL for the presentation of 100 mg/1 mL.
Each mL of prolonged-release injectable solution contains 141.04 mg of aloperidol decanoate, equivalent to 100 mg of aloperidol base.
1 mL vial: packs of 1 vial.
Not all pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, 8, 8A e B – Fervença
2705-906 Terrugem SNT
Portugal

This medicinal product is authorised in the EEA Member States under the following names:
Austria: Haloperidol Hikma 50 mg/mL Depot-Injektionslösung
Haloperidol Hikma 100 mg/mL Depot-Injektionslösung
France: HALOPÉRIDOL HIKMA LP 50 mg/mL, solution injectable à libération prolongée
HALOPÉRIDOL HIKMA LP 100 mg/mL, solution injectable à libération prolongée
Italy: Aloperidolo Hikma
Portugal: Haloperidol Hikma
Netherlands: Haloperidol Hikma, 50 mg/mL, Oplossing voor injectie met verlengde afgifte
Haloperidol Hikma, 100 mg/mL, Oplossing voor injectie met verlengde afgifte

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