Haldol Decanoas

PACKAGE LEAFLET

Package leaflet: information for the patient

Haldol Decanoas 50 mg/ml solution for injection for intramuscular use

haloperidol
Please read this leaflet carefully before using 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 others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Haldol Decanoas is and what it is used for

The name of the medicine is Haldol Decanoas.
Haldol Decanoas contains the active substance haloperidol (as haloperidol decanoate). This
belongs to a group of medicines called "antipsychotics".
Haldol Decanoas is used in adults whose condition has previously been treated with oral haloperidol. It is used for illnesses affecting the way a person thinks, feels, and behaves.
These include mental health disorders (such as schizophrenia). These illnesses may cause:

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

2. What you should know before receiving Haldol Decanoas

Do not use Haldol Decanoas:

• 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 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 low levels of potassium in your blood that have not been treated
• if you are taking any of the medicines listed under “Other medicines and Haldol Decanoas – Do not use Haldol Decanoas if you are taking certain medicines”.

This medicine should not be used if you have any of the conditions listed above. If you are unsure,
consult your doctor, pharmacist, or nurse before receiving Haldol Decanoas.
Warnings and precautions
Serious side effects
Haldol Decanoas 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 need to be aware of serious side effects while using Haldol Decanoas because urgent medical treatment may be required.
See “Read carefully about serious side effects” in section 4.
Elderly people and those with dementia
A slight increase in death and stroke events has been reported in elderly patients with dementia who are taking antipsychotic medicines. Talk to your doctor before receiving Haldol Decanoas if you are elderly, especially if you have dementia.
Talk to your doctor if you have:

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

You may need to be monitored more closely, and your doctor may need to adjust the dose of Haldol Decanoas you receive.
If you are not sure whether any of the conditions listed above apply to you, consult your doctor or
nurse before Haldol Decanoas is administered.
Medical checks
Your doctor may prescribe an electrocardiogram (ECG) before or during treatment with Haldol
Decanoas. The ECG measures the electrical activity of the 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 Haldol Decanoas.
Children and adolescents
Haldol Decanoas 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 Haldol Decanoas
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Do not use Haldol Decanoas 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 may increase the risk of heart problems, so inform your doctor if you are taking any of these medicines and do not use Haldol Decanoas (see “Do not use Haldol Decanoas”).

Special monitoring may be needed if you are using lithium and Haldol Decanoas 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, or drowsiness. These are signs of a serious condition.

Some medicines may affect how Haldol Decanoas works or cause heart or similar 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 (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 to increase urination (diuretics). Your doctor may adjust the dose of Haldol Decanoas if you are taking any of these medicines.

Haldol Decanoas may affect how the following types of medicines work:
Inform your doctor if you are taking medicines for:

• calming or sleeping (tranquilisers)
• 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 Haldol Decanoas is administered if you are taking any of these medicines.

Haldol Decanoas and alcohol
Drinking alcohol while using Haldol Decanoas 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 Haldol Decanoas and inform your doctor about the amount of alcohol you consume.
Pregnancy, breastfeeding, and fertility
Pregnancy – If you are pregnant, think you might be pregnant, or are planning to become pregnant, ask your doctor for advice. Your doctor may advise you not to use Haldol Decanoas during pregnancy.
The following problems may occur in newborn babies whose mothers used Haldol Decanoas during the last 3 months of pregnancy (the third trimester):

• muscle tremors, muscle weakness or stiffness
• being drowsy or agitated
• breathing or feeding problems. The exact frequency of these problems is unknown. If Haldol Decanoas was 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 to the baby. Your
doctor will assess the risks and benefits of breastfeeding while you are using Haldol Decanoas.
Fertility – Haldol Decanoas may increase levels of a hormone called "prolactin", which may
affect fertility. Inform your doctor if you have any questions about this.
Driving and using machines
Haldol Decanoas 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 using it or after a higher dose. This medicine may impair your ability to drive.
Do not drive or operate tools or machinery without first discussing this with your doctor.
Haldol Decanoas contains benzyl alcohol and sesame oil
This medicine contains 15 mg of benzyl alcohol per ml of solution. Benzyl alcohol may cause allergic reactions. Ask your doctor or pharmacist for advice if you have liver or kidney disease, or if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and may cause side effects (called "metabolic acidosis").
This medicine also contains sesame oil, which may rarely cause severe allergic reactions.

3. How to use Haldol Decanoas

How much medicine will be administered to you
Your doctor will decide how much Haldol Decanoas you need and for how long. Your doctor will adjust the
dose according to your individual needs and may also prescribe an oral form of haloperidol for you. The dose
of haloperidol decanoate will depend on:

• your age
• whether you have kidney or liver problems
• how you have previously responded to haloperidol
• other medicines you are taking.

Adults

• The initial dose will normally range between 25 mg and 150 mg.
• Your doctor may adjust the dose up to 50 mg every 4 weeks to find the dose suitable for you (usually between 25 mg and 100 mg every 4 weeks).
• You will not be administered more than 300 mg every 4 weeks.

Elderly

• Elderly patients usually start with a lower dose, typically from 12.5 mg to 25 mg every 4 weeks.
• The dose will be adjusted until your doctor finds the appropriate dose for you (usually between 25 mg and 75 mg every 4 weeks).
• A dose higher than 75 mg every 4 weeks will only be administered if your doctor decides it is safe.

How Haldol Decanoas is administered
Haldol Decanoas will be administered by a doctor or nurse. It is for intramuscular use and will be given as a deep intramuscular injection. A single dose of Haldol Decanoas normally lasts 4 weeks. Haldol Decanoas must not be injected intravenously.
If you receive too much Haldol Decanoas
Since the medicine is administered by a doctor or nurse, it is unlikely that you will receive too much. If you are concerned, inform your doctor or nurse.
If you miss a dose or stop using Haldol Decanoate
You must not stop using this medicine unless your doctor tells you to do so, as symptoms may return. If you miss an appointment, contact your doctor immediately to schedule a new one.
If you have any doubts about using 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 may cause loss of consciousness
• excessively fast heartbeat
• extra heartbeats

Heart problems are uncommon in people using Haldol Decanoate (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. The exact frequency of this side effect in
people using Haldol Decanoate is unknown.
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 walk
• inability to move
• lack of normal facial expression, sometimes appearing as a mask

These are very common in people using Haldol Decanoate (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)

The exact frequency of an allergic reaction in people using Haldol Decanoate is unknown.

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 can travel 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.
Common (may affect up to 1 in 10 people)

• Depression
• Difficulty sleeping or drowsiness
• Constipation
• Dry mouth or increased salivation
• Problems with 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 movement of the eyes and rapid eye movements that cannot be controlled
• Vision problems, such as blurred vision

The following side effects have also been reported, but their exact frequency is not known

• Severe mental health problems, such as believing things that are not true (delusions) or seeing, hearing, or smelling things that are not there (hallucinations)
• Feeling agitated or confused
• Seizures (convulsions)
• Feeling dizzy, even when standing up or sitting down
• Low blood pressure
• Breathing problems, such as:
  • swelling around the larynx
  • brief spasm of the vocal cords affecting speech
  • narrowing of the airways in the lungs
  • shortness of breath
• Nausea, vomiting
• Blood changes, such as:
  • 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 clotting)
  • high levels of certain hormones in the blood – "prolactin" and "antidiuretic hormone" (syndrome of inappropriate antidiuretic hormone secretion)
  • low blood sugar levels
• Changes seen in liver blood tests and other liver problems, such as:
  • yellowing of the skin or whites of the eyes (jaundice)
  • liver inflammation
  • sudden liver failure
• Decreased bile flow in the bile duct
• Skin problems, such as:
  • skin rash
  • itching
  • increased sensitivity of the skin to sunlight
  • peeling or flaking of the skin
  • inflammation of small blood vessels, leading to a skin rash with small red or purple raised spots
• Excessive sweating
• Breakdown of muscle tissue (rhabdomyolysis)
• Muscle spasms, spasms or contractions that you cannot control, including neck spasms causing the head to twist 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 menstrual cycle (periods), such as no periods, or long, heavy, painful periods
• Breast problems, such as:
  • pain or discomfort
  • unexpected milk production from the breast
  • breast enlargement in men
• Swelling due to fluid retention in the body
• High or low body temperature
• Walking difficulties
• Weight loss

Reporting of side effects
If you get any side effects, 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
www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Haldol Decanoas

Keep this medicine out of the sight and reach of children.
Haldol Decanoas must not be used after the expiry date which is stated on the label and on the
carton. The expiry date refers to the last day of that month.
Store in the original container to protect from light.

6. Package contents and other information

What Haldol Decanoas contains
50 mg/ml solution
The active substance is haloperidol. Each ml of injection solution contains 70.52 mg of haloperidol decanoate, equivalent to 50 mg of haloperidol base. The other components are benzyl alcohol and sesame oil.

Description of the appearance of Haldol Decanoas and package contents
50 mg/ml solution
Haldol Decanoas is a slightly amber, slightly viscous solution free from visible particles.
It is supplied in amber glass vials containing 1 ml of solution in packs of 1, 3 or 5 vials, or 3 ml of solution in packs of 1, 5 or 50 (10 packs of 5) vials.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

MARKETING AUTHORIZATION HOLDER
Essential Pharma Limited,
Vision Exchange Building
Triq it-Territorjals, Zone 1,
Central Business District,
Birkirkara, CBD 1070,
Malta

MANUFACTURER
Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
GlaxoSmithKline Manufacturing S.p.A. Strada Provinciale Asolana N. 90 (loc. San Polo) 43056 Torrile, Parma, Italy.

This medicinal product is authorized in the European Union Member States under the following names:

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu/