Decaldol

Package leaflet: Information for the patient

DECALDOL, 50 mg/ml, injection solution
Haloperidoli decanoas
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Decaldol is and what it is used for
2. Important information before using Decaldol
3. How to use Decaldol
4. Possible adverse effects
5. How to store Decaldol
6. Contents of the package and other information

1. What Decaldol is and what it is used for

The name of this medicine is Decaldol.
Decaldol contains the active substance haloperidol (in the form of haloperidol decanoate).
It belongs to a group of medicines called antipsychotics.
Decaldol is used in adults who have previously been treated with oral haloperidol. It is used in illnesses that affect the patient's way of thinking, feeling, and behaving. These include psychiatric disorders (such as schizophrenia).
These illnesses may cause the patient to:

• feel confused (delirium)
• see, hear, or smell things that are not there (hallucinations)
• believe things that are not true (delusions)
• feel unusually suspicious (paranoia)
• feel excited, agitated, enthusiastic, impulsive, or overly active
• become aggressive, hostile, or prone to violence.

2. Information before using Decaldol

When not to use Decaldol

• If the patient is allergic to haloperidol decanoate, arachis oil, or any of the other ingredients of this medicine (listed in section 6).
• If the patient is less aware of things around them or their reactions become abnormally slow.
• If the patient has Parkinson's disease.
• If the patient has a type of dementia called dementia with Lewy bodies.
• If the patient has progressive supranuclear palsy (PSP).
• If the patient has a condition called QTc prolongation, or any other heart rhythm disorders visible as abnormal ECG (electrocardiogram).
• If the patient has heart failure or has recently had a heart attack.
• If the patient has low blood potassium levels that have not yet been treated.
• If the patient is taking any of the medicines listed in section “Decaldol with other medicines”, subsection “Do not use Decaldol”. If any of the above points apply to the patient, this medicine must not be used. If in doubt, consult a doctor, pharmacist, or nurse before receiving Decaldol.

Warnings and precautions
Serious side effects
Decaldol may cause heart problems, difficulties controlling body or limb movements, and a serious side effect called neuroleptic malignant syndrome. It may also cause severe allergic reactions and blood clots. The patient should be aware of the possibility of serious side effects during treatment with Decaldol, as these may require immediate medical attention. See “Warning: serious side effects” in section 4.
Elderly patients and patients with dementia
In elderly patients with dementia treated with antipsychotic medicines, a slight increase in the frequency of deaths and strokes has been observed. If the patient is elderly, especially if they have dementia, they should consult their doctor before receiving Decaldol.
Consult a doctor if the patient has:

• Slow heartbeat, heart disease, or if someone in their immediate family died suddenly from heart problems.
• Low blood pressure or if they experience dizziness upon changing position from lying down to sitting or from sitting to standing.
• Low levels of potassium or magnesium (or other electrolytes) in the blood. The treating doctor will decide on appropriate treatment.
• A history of stroke, or if the doctor believes they are at higher risk of stroke than other patients.
• Epilepsy or a history of seizures.
• Kidney, liver, or thyroid problems.
• High levels of prolactin hormone in the blood or a tumour that may be caused by high prolactin levels (e.g. breast cancer).
• A history of blood clots, or if blood clots have occurred in any of their close family members.
• Depression.

Closer monitoring of the patient’s condition and possible dose adjustment of Decaldol may be necessary.
If the patient is unsure whether any of the above points apply to them, they should consult their doctor or nurse before receiving Decaldol.
Follow-up examinations
The treating doctor may decide to perform an ECG before or during treatment with Decaldol. An ECG measures the electrical activity of the heart.
Blood tests
The treating doctor may decide to measure blood levels of potassium and magnesium (or other electrolytes) before or during treatment with Decaldol.
Children and adolescents
Decaldol must not be used in children and adolescents under 18 years of age. Studies with this medicine have not been conducted in these age groups.
Decaldol with other medicines
Tell the doctor, pharmacist, or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
Do not use Decaldol if the patient is taking certain types of medicines used to treat:

• Heart rhythm disorders (e.g. amiodarone, dofetilide, disopyramide, dronedarone, ibutilide, quinidine, sotalol)
• Depression (e.g. citalopram, escitalopram)
• Psychoses (e.g. fluphenazine, levomepromazine, perphenazine, pimozide, prochlorperazine, promethazine, sertindole, thioridazine, trifluoperazine, trifluopromazine, ziprasidone)
• Bacterial infections (e.g. azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, telithromycin)
• Fungal infections (e.g. pentamidine)
• Malaria (e.g. halofantrine)
• Nausea and vomiting (e.g. dolasetron)
• Cancers (e.g. toremifene, vandetanib).

Also inform the treating doctor if the patient is taking bepridil (a medicine for chest pain or low blood pressure) or methadone (a painkiller also used in drug addiction treatment).
These medicines may increase the risk of heart problems, so consult a doctor and do not use Decaldol if the patient is taking any of the above medicines (see section “When not to use Decaldol”).
When using lithium together with Decaldol, closer monitoring of the patient may be necessary. Immediately inform the doctor and stop taking both medicines if the patient experiences:

• Unexplained fever or uncontrolled body movements
• Confusion, disorientation, headache, difficulty maintaining balance, drowsiness. These are symptoms of a condition that seriously threatens health.

Some medicines may affect how Decaldol works or may worsen heart disorders.
Tell the doctor if the patient is taking any of the following medicines:

• Alprazolam or buspirone (anti-anxiety medicines)
• Duloxetine, fluoxetine, fluvoxamine, nefazodone, paroxetine, sertraline, St John’s wort (Hypericum perforatum), or venlafaxine (antidepressants)
• Bupropion (used in depression or smoking cessation)
• Carbamazepine, phenobarbital, or phenytoin (antiepileptic medicines)
• Rifampicin (used in bacterial infections)
• Itraconazole, posaconazole, or voriconazole (used in fungal infections)
• Ketoconazole tablets (used in Cushing's syndrome)
• Indinavir, ritonavir, or saquinavir (used in human immunodeficiency virus - HIV infection)
• Chlorpromazine or promethazine (used for nausea and vomiting)
• Verapamil (used in high blood pressure or heart disease)
  Also inform the doctor if the patient is taking any other medicines to lower blood pressure, such as diuretics.

The doctor may need to adjust the dose of Decaldol if the patient is taking any of these medicines.
Decaldol may affect how the following types of medicines work.
Tell the doctor if the patient is taking:

• Sedatives and sleep aids (sedatives)
• Medicines used for pain relief (strong painkillers)
• Medicines used for depression (tricyclic antidepressants)
• Medicines that lower blood pressure (such as guanethidine or methyldopa)
• Medicines used in severe allergic reactions (adrenaline)
• Medicines used for ADHD (attention deficit hyperactivity disorder) or narcolepsy (so-called stimulants)
• Medicines used in Parkinson’s disease (such as levodopa)
• Blood thinners (phenindione).
  If the patient is taking any of these medicines, they should inform their doctor or nurse before receiving Decaldol.

Decaldol and alcohol
Drinking alcohol while taking Decaldol may cause drowsiness and difficulty concentrating. Therefore, alcohol intake should be carefully monitored. Inform the doctor about alcohol consumption during treatment with Decaldol and how much alcohol the patient drinks.
Pregnancy, breastfeeding, and fertility
Pregnancy – If the patient is pregnant, suspects she may be pregnant, or is planning to have a child, she should consult her doctor. The doctor may advise against using Decaldol if the patient is pregnant.
Newborns of mothers who took Decaldol during the last three months of pregnancy (third trimester) may experience the following problems:

• Muscle tremors, stiffness, or muscle weakness
• Excessive drowsiness or agitation
• Breathing difficulties or feeding problems.
  The frequency of these disorders is not precisely known. If the patient took Decaldol during pregnancy and the baby experiences any of these side effects, contact a doctor.
  Breastfeeding – Inform the doctor if the patient is breastfeeding or plans to breastfeed. Small amounts of the medicine may pass into breast milk and then into the baby’s body. The treating doctor will discuss the risks and benefits of breastfeeding while taking Decaldol.

Effect on fertility – Decaldol may increase levels of a hormone called prolactin, which may affect fertility in both men and women. Consult a doctor if the patient has any doubts.
Driving and using machines
Decaldol may affect the ability to drive, use tools, or operate machinery. Side effects such as drowsiness may impair alertness, especially at the beginning of treatment or after a high dose. Do not drive, use tools, or operate machinery without first discussing it with the treating doctor.
Decaldol contains arachis oil and benzyl alcohol
This medicine contains arachis oil (from peanuts). Do not use if hypersensitivity to peanuts or soya has been diagnosed.
Decaldol contains 15 mg of benzyl alcohol per ml of solution.
Benzyl alcohol may cause allergic reactions.
Pregnant or breastfeeding women and patients with liver or kidney disease should consult their doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause side effects (so-called metabolic acidosis).

3. How to use Decaldol

What dose will be administered
Your doctor will decide how much Decaldol you need and for how long. The doctor will adjust the
dose according to your individual needs and may also prescribe oral haloperidol. The dose of
haloperidol decanoate you will receive depends on:

• your age;
• any existing kidney or liver function disorders;
• your previous response to haloperidol;
• other medications you are taking.

Adults

• The initial dose is usually between 25 mg and 150 mg.
• Your doctor may adjust the dose, increasing it by no more than 50 mg every 4 weeks, to determine the most appropriate dose for you (usually between 50 mg and 200 mg every 4 weeks).
• You will not receive a dose higher than 300 mg once every 4 weeks.

Elderly patients

• Elderly patients usually start treatment with a lower dose, typically between 12.5 mg and 25 mg once every 4 weeks.
• The dose may be adjusted until the doctor determines the most appropriate dose for the patient (usually between 25 mg and 75 mg every 4 weeks).
• You may receive a dose higher than 75 mg every 4 weeks if your doctor considers it safe.

How Decaldol will be administered
Decaldol will be administered by a doctor or nurse. The medicine is intended for intramuscular use and must be injected deeply into the muscle. A single dose usually provides therapeutic effect for 4 weeks.

Overdose of Decaldol
Since Decaldol is administered by a doctor or nurse, it is unlikely that you will receive too high a dose. If you have any concerns, consult your doctor or nurse.

Missed dose or interruption of Decaldol treatment
Do not stop using this medicine unless your doctor advises 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 further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Warning about serious adverse effects
If any of the symptoms listed below occur or are suspected, a doctor or nurse must be contacted immediately.
The patient may require urgent medical intervention.

Heart problems:

• irregular heartbeat – the heart does not work properly, which may lead to loss of consciousness
• abnormally rapid heartbeat
• extra heartbeats

Heart rhythm disturbances occur uncommonly in people taking Decaldol (may occur in up to 1 in 100 people). Cases of sudden death have been reported in people taking Decaldol, although the exact frequency is unknown. Cardiac arrest (the heart stops beating) has also occurred in people taking antipsychotic medicines.

A serious condition called neuroleptic malignant syndrome.
Symptoms include high fever, severe muscle stiffness, confusion, and loss of consciousness. The exact frequency of this adverse effect in people taking Decaldol is unknown.

Uncontrolled body or limb movements (extrapyramidal symptoms), such as:

• movements of the mouth, tongue, jaw, and sometimes limbs (tardive dyskinesia)
• restlessness or difficulty sitting still, increased body movements
• slowed or restricted body movements, jerky movements, or twisting
• tremor or muscle stiffness, shuffling gait
• inability to move
• lack of normal facial expression, sometimes appearing mask-like

These disturbances occur very frequently in people taking Decaldol (may occur in up to 1 in 10 people). If any of these symptoms occur, the patient may be given additional medicines.

Severe allergic reaction, which may include:

• swelling of the face, lips, mouth, tongue, or throat
• difficulty swallowing or breathing
• itchy rash

The exact frequency of allergic reactions in people taking Decaldol is unknown.

Blood clots in blood vessels, usually in the legs (deep vein thrombosis).
These disorders have been reported in people taking antipsychotic medicines. Symptoms of deep vein thrombosis in the leg include swelling, pain, and redness of the leg. A clot may travel to the lungs, causing chest pain and difficulty breathing. Blood clots can be very serious, so if any of these symptoms occur, a doctor must be contacted immediately.

If any of the above serious adverse effects occur, a doctor must be contacted immediately.

Other adverse effects
A doctor should be informed if any of the following adverse effects are suspected or occur.

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

• Depression
• Difficulty falling asleep or feeling sleepy
• Constipation
• Dry mouth or increased salivation
• Sexual dysfunction
• Irritation, pain, or abscess at the injection site
• Weight gain

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

• Abnormal muscle tension
• Headache
• Upward eye movements or rapid, uncontrolled eye movements
• Vision problems, e.g., blurred vision

The following adverse effects have also been reported, with unknown frequency:

• Serious mental disturbances, e.g., belief in things that are not true (delusions) or seeing, feeling, hearing things that are not present (hallucinations)
• Feeling agitated or confused
• Seizures
• Dizziness, including dizziness upon changing position from lying down to sitting or from sitting to standing
• Low blood pressure
• Breathing problems, e.g.:
  • swelling of the larynx or brief spasms of the vocal cords making speech difficult
  • narrowing of the airways in the lungs
  • shortness of breath
• Nausea, vomiting
• Changes in blood tests, e.g.:
  • reduced numbers of all types of blood cells, including a marked decrease in white blood cells and low platelet count (cells that help blood to clot)
• High levels of certain hormones in the blood – prolactin and antidiuretic hormone (syndrome of inappropriate antidiuretic hormone secretion)
• Low blood sugar levels
• Changes visible in liver function tests, and other liver disorders, e.g.:
  • yellowing of the skin and whites of the eyes (jaundice)
  • hepatitis
  • sudden liver failure
• Reduced bile flow in the bile ducts
• Skin problems, e.g.:
  • rash or itching
  • increased sensitivity to sunlight
  • peeling skin
  • inflammation of small blood vessels causing a rash of small red or purple spots
• Excessive sweating
• Breakdown of muscle tissue (rhabdomyolysis)
• Muscle spasms, tremor, or uncontrolled contractions, including neck spasms causing the head to tilt to one side
• Difficulty or inability to open the mouth
• Muscle and joint stiffness
• Difficulty or inability to urinate or completely empty the bladder
• Persistent and painful erection
• Erectile dysfunction (impotence)
• Loss or reduced sex drive
• Changes in menstrual cycle, e.g., absence of menstruation or prolonged, heavy, or painful periods
• Breast disorders, e.g.:
  • pain or tenderness
  • unexpected milk production
  • breast enlargement in men
• Swelling due to fluid retention in the body
• High or low body temperature
• Walking difficulties
• Weight loss

Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Decaldol

Store the ampoules in the outer packaging to protect them from light, at a temperature below 25°C. Do not freeze.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label. The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Decaldol contains

• The active substance is haloperidol in the form of haloperidol decanoate. Each ml of solution contains 50 mg of haloperidol in the form of haloperidol decanoate.
• The other ingredients are: benzyl alcohol, purified arachis oil.

What Decaldol looks like and contents of the pack
Decaldol is a transparent, oily liquid, yellow or brown, with varying intensity of colour.
The pack contains 5 ampoules of 1 ml capacity made of amber glass, in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Information intended exclusively for healthcare professionals:

Instructions for opening the ampoule
Before opening the ampoule, ensure that the entire solution is located in the lower part of the ampoule.
Gently shake the ampoule or tap it with your finger to help the solution flow downward.
Each ampoule has a coloured dot (see Figure 1) indicating the score line located beneath it.

• To open the ampoule, hold it vertically in both hands, with the coloured dot facing towards you – see Figure 2. Grasp the upper part of the ampoule so that your thumb is positioned above the coloured dot.
• Press in the direction of the arrow shown in Figure 3.

Ampoules are intended for single use only and should be opened immediately before use. Any unused portion of the product must be discarded according to applicable regulations.

Figure 1.

Figure 2.

Figure 3.