Decaldol

Leaflet accompanying the packaging: patient information

DECALDOL, 50 mg/ml, solution for injection

Haloperidol decanoate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Decaldol and what is it used for
• 2. Important information before using Decaldol
• 3. How to use Decaldol
• 4. Possible side effects
• 5. How to store Decaldol
• 6. Package contents and other information

1. What is Decaldol and what is it 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 haloperidol orally. The medicine is used in diseases that affect the patient's thinking, feeling, and behavior. These include mental disorders (such as schizophrenia).
These diseases can cause the patient to:

• feel confused (delirium)
• see, hear, or smell things that are not there (hallucinations)
• be convinced of the truth of things that are not true (delusions)
• experience excessive suspicion (paranoia)
• experience excitement, agitation, enthusiasm, be impulsive, or overactive
• be aggressive, hostile, or prone to violence.

2. Important 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 their surroundings or their reactions become unnaturally slow.
• If the patient has Parkinson's disease.
• If the patient has a type of dementia called Lewy body dementia.
• If the patient has progressive supranuclear palsy (PSP).
• If the patient has a condition called QTc interval prolongation, or any other heart rhythm disorders visible on an abnormal ECG (electrocardiogram).
• If the patient has heart failure or has recently had a heart attack.
• If the patient has low potassium levels in the blood that have not been treated.
• If the patient is taking any of the medicines listed in the section "Decaldol and other medicines", subsection "Do not use Decaldol". If any of the above points apply to the patient, they should not use this medicine. In case of doubt, before receiving Decaldol, the patient should consult their doctor, pharmacist, or nurse.

Warnings and precautions

Severe side effects

Decaldol may cause heart problems, problems with controlling body movements or limbs, and a severe side effect called malignant neuroleptic syndrome. It may also cause severe allergic reactions and blood clots. The patient must be aware of the possibility of severe side effects when using Decaldol, as they may require immediate medical attention. See "Warning about severe side effects" in section 4.

Elderly patients and patients with dementia

In elderly patients with dementia using 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 experiences:

• Slow heart rate, heart disease, or if someone in their close family has died suddenly from heart problems.
• Low blood pressure or if the patient feels dizzy when 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 what treatment to use.
• A stroke in the past, or if the doctor believes they have a higher risk of stroke than other patients.
• Epilepsy or if the patient has had seizures in the past.
• Kidney, liver, or thyroid problems.
• High levels of the hormone prolactin in the blood or a tumor that may be caused by high prolactin levels (e.g., breast cancer).
• Blood clots in the past or if blood clots have occurred in someone in the patient's close family.
• Depression.

It may be necessary to monitor the patient's condition more closely and adjust the dose of Decaldol.
If the patient has any doubts about whether any of the above points apply to them, they should consult their doctor or nurse before receiving Decaldol.

Control tests

The treating doctor may decide to perform an ECG test before starting or during treatment with Decaldol. The ECG test measures the electrical activity of the heart.

Blood test

The treating doctor may decide to measure the levels of potassium and magnesium (or other electrolytes) in the blood before starting or during treatment with Decaldol.

Children and adolescents

Decaldol should not be used in children and adolescents under 18 years of age. No studies have been conducted in these age groups.

Decaldol and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are currently taking or have 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 and escitalopram)
• psychoses (e.g., fluphenazine, levomepromazine, perphenazine, pimozyd, prochlorperazine, promazine, sertindol, thioridazine, trifluoperazine, triflupromazine, and ziprasidone)
• bacterial infections (e.g., azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, and telithromycin)
• fungal infections (e.g., pentamidine)
• malaria (e.g., halofantrine)
• nausea and vomiting (e.g., dolasetron)
• cancer (e.g., toremifene and vandetanib).

The patient should also inform their doctor about taking bepridil (a medicine for chest pain or low blood pressure) or methadone (a pain reliever also used to treat drug addiction).
These medicines may increase the risk of heart disorders, so the patient should consult their doctor and not use Decaldol if they are taking any of the above medicines (see "When not to use Decaldol").

In case of concurrent use of lithium and Decaldol, closer monitoring of the patient's condition may be necessary.

The patient should immediately inform their doctor and stop taking both medicines if they experience:

• fever of unknown origin or uncontrolled body movements
• confusion, disorientation, headache, balance problems, drowsiness. These are symptoms of a serious condition.

Certain medicines may affect the way Decaldol works or may increase the risk of heart disorders.

The patient should tell their doctor if they are taking medicines such as:

• anxiolytics or sedatives (e.g., alprazolam or buspirone)
• antidepressants (e.g., duloxetine, fluoxetine, fluvoxamine, nefazodone, paroxetine, sertraline, St. John's wort (Hypericum perforatum), or venlafaxine)
• bupropion (for depression or smoking cessation)
• antiepileptics (e.g., carbamazepine, phenobarbital, or phenytoin)
• rifampicin (an antibiotic)
• itraconazole, posaconazole, or voriconazole (antifungals)
• ketoconazole (in tablet form, for Cushing's syndrome)
• indinavir, ritonavir, or saquinavir (for HIV infection)
• chlorpromazine or promethazine (for nausea and vomiting)
• verapamil (for high blood pressure or heart disease) The patient should also inform their doctor if they are 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 the above medicines.

Decaldol may affect the way the following types of medicines work:

The patient should tell their doctor if they are taking medicines such as:

• sedatives or sleep aids
• strong pain relievers
• tricyclic antidepressants
• blood pressure lowering medicines (e.g., guanethidine or methyldopa)
• adrenaline (for severe allergic reactions)
• stimulants (for ADHD or narcolepsy)
• medicines for Parkinson's disease (e.g., levodopa)
• blood thinners (e.g., phenindione). If the patient is taking any of these medicines, they should tell their doctor or nurse before receiving Decaldol.

Decaldol and alcohol

Consuming alcohol while using Decaldol may cause drowsiness and difficulty concentrating. This means the patient should be careful with the amount of alcohol they drink. The patient should tell their doctor about drinking alcohol while using Decaldol and how much alcohol they drink.

Pregnancy, breastfeeding, and fertility

Pregnancy- if the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their doctor. The doctor may advise not to use Decaldol if the patient is pregnant.
In newborns of mothers who used Decaldol in the last 3 months of pregnancy (last trimester), the following problems may occur:

• muscle tremors, stiffness, or weakness
• excessive drowsiness or agitation
• breathing or feeding problems. The frequency of these disorders is not known. If the patient used Decaldol during pregnancy and their child experiences any of these side effects, they should contact their doctor. Breastfeeding- The patient should tell their doctor if they are breastfeeding or plan to breastfeed. Small amounts of the medicine may pass into breast milk and then into the child's body. The treating doctor will discuss the risks and benefits of breastfeeding while using Decaldol.

Fertility- Decaldol may increase the levels of a hormone called prolactin, which can affect fertility in men and women. The patient should consult their doctor if they have any doubts.

Driving and using machines

Decaldol may affect the patient's ability to drive, use tools, and operate machines. Side effects such as drowsiness may impair alertness, especially when starting treatment or using a high dose. The patient should not drive, use tools, or operate machines without first discussing it with their doctor.

Decaldol contains arachis oil and benzyl alcohol

The medicine contains arachis oil (from peanuts). Do not use if the patient has a known hypersensitivity to peanuts or soya.
Decaldol contains 15 mg of benzyl alcohol in each ml of solution.
Benzyl alcohol may cause allergic reactions.
Pregnant women, breastfeeding women, and patients with liver or kidney disease should contact their doctor before using the medicine, as high amounts of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).

3. How to use Decaldol

What dose will be given

The doctor will decide how much Decaldol the patient needs and for how long. The doctor will adjust the dose according to the patient's needs and may also prescribe haloperidol in oral form. The dose of haloperidol decanoate the patient will receive depends on:

• the patient's age;
• any kidney or liver problems the patient has;
• the patient's previous response to haloperidol;
• other medicines the patient is taking.

Adults

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

Elderly patients

• Elderly patients usually start with a lower dose, usually between 12.5 mg and 25 mg every 4 weeks.
• The dose may be adjusted until the doctor finds the most suitable dose for the patient (usually between 25 mg and 75 mg every 4 weeks).
• The patient may receive a higher dose than 75 mg every 4 weeks if the doctor decides it is safe.

How Decaldol will be given

Decaldol will be given to the patient by a doctor or nurse. The medicine is for deep intramuscular injection. A single dose usually lasts for 4 weeks.

Using more Decaldol than prescribed

This medicine will be given to the patient by a doctor or nurse, so it is unlikely that the patient will receive too much medicine. If the patient has any concerns, they should consult their doctor or nurse.

Missing a dose or stopping Decaldol

The patient should not stop using this medicine unless their doctor advises them to, as their symptoms may return. If the patient misses an appointment, they should contact their doctor as soon as possible to schedule a new appointment.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Decaldol can cause side effects, although not everybody gets them.

Warning about severe side effects

If the patient notices or suspects any of the following symptoms, they should immediately inform their doctor or nurse. The patient may need urgent medical attention.

Heart problems:

• abnormal heart rhythm - the heart does not work properly, which can cause loss of consciousness
• unusually fast heart rate
• extra heartbeats. Heart rhythm disorders occur uncommonly in people using Decaldol (may occur in up to 1 in 100 people). There have been cases of sudden deaths in people using this medicine, but the exact frequency is not known. In people using antipsychotic medicines, there have also been cases of cardiac arrest (the heart stops beating). A severe disorder called malignant neuroleptic syndrome.Symptoms include high fever, severe muscle stiffness, confusion, and loss of consciousness. The exact frequency of this side effect in people using Decaldol is not known.

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

• movements of the mouth, tongue, jaw, and sometimes limbs (tardive dyskinesia)
• feeling agitated or having difficulty sitting still, increased body movements
• slow or limited body movements, jerky or twisting movements
• tremors or muscle stiffness, shuffling gait
• inability to make a movement
• lack of normal facial expression, which may look like a mask. These disorders occur very commonly in people using Decaldol (may occur in up to 1 in 10 people). If the patient experiences any of these symptoms, they may receive additional medicines.

A severe allergic reaction, which may cause::

• swelling of the face, lips, tongue, or throat
• difficulty swallowing or breathing
• itchy rash. The exact frequency of allergic reactions in people using Decaldol is not known. Blood clots in the blood vessels, usually in the legs(deep vein thrombosis). Blood clots have been reported in people using antipsychotic medicines. Symptoms of deep vein thrombosis in the legs include swelling, pain, and redness of the leg. However, the clot can move to the lungs, causing chest pain and breathing difficulties. Blood clots can be very serious, so if the patient experiences any of these symptoms, they should immediately inform their doctor.

If the patient experiences any of the above severe side effects, they should immediately inform their doctor.

Other side effects

The patient should inform their doctor if they suspect or experience any of the following side effects.
Common(may occur in up to 1 in 10 people):

• Depression
• Difficulty sleeping or drowsiness
• Constipation
• Dry mouth or increased saliva production
• Sexual disorders
• Irritation, pain, or abscess at the injection site
• Weight gain.

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

• Muscle tension
• Headache
• Eye movements upwards or rapid, uncontrolled eye movements
• Vision problems, such as blurred vision.

The following side effects have also been reported with an unknown frequency:

• Severe mental disorders, such as delusions or hallucinations
• Feeling agitated or confused
• Seizures
• Dizziness, including dizziness when changing position from lying down to sitting or from sitting to standing.
• Low blood pressure
• Breathing problems, such as:
• swelling of the throat or short-term constriction of the vocal cords, making it difficult to speak
• narrowing of the airways in the lungs
• shortness of breath
• Nausea, vomiting
• Changes in blood tests, such as:
• decreased numbers of all types of blood cells, including a significant decrease in white blood cells and a low platelet count (cells that help blood clot)
• high levels of certain hormones in the blood - prolactin and antidiuretic hormone (syndrome of inappropriate antidiuretic hormone secretion)
• low blood sugar
• Changes visible in liver function tests, and other liver disorders, such as:
• yellowing of the skin and whites of the eyes (jaundice)
• liver inflammation
• sudden liver failure
• Decreased bile flow in the bile ducts
• Skin problems, such as:
• rash or itching
• sensitivity to sunlight
• peeling skin
• inflammation of small blood vessels, causing a rash of small red or purple spots
• Excessive sweating
• Muscle breakdown (rhabdomyolysis)
• Muscle spasms, tremors, or uncontrolled muscle contractions, including neck spasms, causing the head to tilt to one side
• Difficulty or inability to open the mouth
• Muscle stiffness and joint stiffness
• Difficulty or inability to urinate or fully empty the bladder
• Prolonged and painful erections
• Erectile dysfunction (impotence)
• Loss of or decreased sexual desire
• Changes in menstrual cycle, such as:
• absence of menstruation or prolonged, heavy, or painful menstruation
• Breast problems, such as:
• pain or tenderness
• unexpected milk production
• breast enlargement in men
• Swelling caused by fluid accumulation in the body
• High or low body temperature
• Walking problems
• Weight loss.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicines Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Decaldol

Store the ampoules in the outer packaging to protect 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 month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Decaldol contains

• The active substance of the medicine 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 of the medicine are: benzyl alcohol, purified arachis oil.

What Decaldol looks like and what the package contains

Decaldol is a clear, oily liquid, yellow or brown, with varying intensity of color.
The package contains 5 ampoules of 1 ml each, made of orange glass, in a cardboard box.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Date of last revision of the leaflet:

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Information intended for healthcare professionals only:

Instructions for opening the ampoule

Before opening the ampoule, make sure the entire solution is in the lower part of the ampoule.
You can gently shake the ampoule or tap it with your finger to help the solution flow down.
Each ampoule has a colored dot (see Figure 1) as a mark indicating the break point below it.

• To open the ampoule, hold it vertically, with both hands, with the colored dot facing you - see Figure 2. Hold the top part of the ampoule in such a way that your thumb is above the colored dot.
• Press in the direction of the arrow shown in Figure 3.

The ampoules are for single use only and should be opened immediately before use. Any remaining contents of the unused product should be disposed of in accordance with the applicable regulations.
Figure 1.

Figure 2.

Figure 3.