FLUANXOL 20 mg /Ml Solution

Contents of the leaflet

1. Leaflet attached to the packaging: Information for the user
2. Fluanxol Depot, 20 mg/ml, solution for injection
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
3. What is Fluanxol Depot and what is it used for
4. Important information before using Fluanxol Depot
   1. When not to use Fluanxol Depot
   2. Warnings and precautions
   3. Fluanxol Depot with other medicines
   4. Fluanxol Depot with food, drink, and alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Pregnancy
   7. Breastfeeding
   8. Fertility
   9. Driving and using machines
5. How to use Fluanxol Depot
   1. Duration of treatment
   2. Using a higher dose of Fluanxol Depot than recommended
6. Possible side effects
   1. Reporting side effects
7. How to store Fluanxol Depot
8. Contents of the packaging and other information
   1. What Fluanxol Depot contains
   2. What Fluanxol Depot looks like and what the pack contains
   3. Marketing authorization holder and manufacturer
   4. Lundbeck Poland Sp. z o. o.

Leaflet attached to the packaging: Information for the user

Fluanxol Depot, 20 mg/ml, solution for injection

Flupentixol decanoate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

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

Table of contents of the leaflet:

• 1. What is Fluanxol Depot and what is it used for
• 2. Important information before using Fluanxol Depot
• 3. How to use Fluanxol Depot
• 4. Possible side effects
• 5. How to store Fluanxol Depot
• 6. Contents of the packaging and other information

1. What is Fluanxol Depot and what is it used for

Fluanxol Depot contains the active substance flupentixol decanoate. Fluanxol Depot belongs to a group of
antipsychotic medicines (also called neuroleptics).
These medicines work on the nerve pathways in certain areas of the brain and help to balance some of the chemical disturbances in the brain that cause the symptoms of the disease.
Fluanxol Depot is used to treat schizophrenia and other related psychoses.

2. Important information before using Fluanxol Depot

When not to use Fluanxol Depot

• if the patient is allergic (hypersensitive) to flupentixol or any of the other ingredients of this medicine (listed in section 6). If an allergy is suspected, a doctor should be consulted;
• if the patient has a reduced level of consciousness, regardless of the cause of this condition (e.g. alcohol, barbiturate or opioid poisoning), circulatory collapse, coma.

Warnings and precautions

Before starting treatment with Fluanxol Depot, the patient should discuss it with their doctor or pharmacist:

• if the patient has liver function disorders;
• if the patient has had seizures in the past;
• if the patient has diabetes (a change in antidiabetic treatment may be required);
• if the patient has an organic brain syndrome (a disease that can develop as a result of alcohol or organic solvent poisoning);
• if the patient has risk factors that may predispose to stroke (e.g. smoking, hypertension);
• if the patient has hypokalemia or hypomagnesemia (too little potassium or magnesium in the blood) or genetic predispositions to such disorders;
• if the patient has had cardiovascular disorders;
• if the patient is taking other antipsychotic medicines;
• if the patient is more agitated or shows increased activity, as the medicine may exacerbate these effects;
• if the patient or someone in their family has had venous thrombosis, as the use of medicines like this is associated with the formation of blood clots.

Fluanxol Depot with other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should tell their doctor about the use of the following medicines:

• tricyclic antidepressants;
• guanethidine and similar medicines (that lower blood pressure);
• barbiturates (medicines that cause drowsiness);
• medicines used to treat epilepsy;
• levodopa and similar medicines (used to treat Parkinson's disease);
• metoclopramide (a medicine used to treat gastrointestinal disorders);
• piperazine (an antiparasitic medicine that acts on pinworms and human roundworms);
• medicines that disrupt water and mineral metabolism (too little potassium or magnesium in the blood);
• medicines known to increase the concentration of Fluanxol Depot in the blood.

The following medicines should not be taken at the same time as Fluanxol Depot:

• medicines that change heart action (quinidine, amiodarone, sotalol, dofetilide, erythromycin, terfenadine, astemizole, gatifloxacin, moxifloxacin, cisapride, lithium);
• other antipsychotic medicines;
• medicines used to treat cancer.

Fluanxol Depot with food, drink, and alcohol

Fluanxol Depot may enhance the sedative effect of alcohol, causing drowsiness. It is not recommended to drink alcoholic beverages while using Fluanxol Depot.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Pregnancy

Pregnant women or those who suspect they are pregnant should inform their doctor.
Fluanxol Depot should not be used in pregnant women unless it is absolutely necessary.
In newborns of mothers who used Fluanxol in the third trimester of pregnancy (the last three months of pregnancy), the following symptoms may occur: tremors, stiffness and/or muscle weakness, drowsiness, agitation, breathing problems, feeding difficulties. If such symptoms occur in a newborn, a doctor should be consulted.

Breastfeeding

Breastfeeding women should consult their doctor. Fluanxol Depot should not be used by breastfeeding women, as small amounts of the medicine may be excreted in breast milk.

Fertility

Studies in animals have shown that flupentixol affects fertility. The patient should consult their doctor for advice.

Driving and using machines

There is a risk of drowsiness and dizziness after using Fluanxol Depot. In such situations, the patient should not drive vehicles, operate machines, or use tools until these symptoms have subsided.

3. How to use Fluanxol Depot

This medicine should always be taken according to the doctor's or pharmacist's recommendations. If in doubt, the patient should consult their doctor or pharmacist.
A small volume of Fluanxol Depot is drawn into a syringe, and then injected into the buttock muscle.
The doctor decides on the dose and frequency of injections. The medicine, injected into the buttock, has a slow release form, which means that a constant amount of the medicine is released into the blood throughout the time between injections.
The recommended dose is:
Adults
Fluanxol Depot 20 mg/ml
The usual dose of the medicine is 1-2 ml, and the time interval between injections is 1 to 4 weeks.
Doses exceeding 2 ml are usually given in two injections, in two different places.
In the case of previous treatment with Fluanxol tablets and switching to Fluanxol Depot treatment, the doctor may recommend continuing to take the tablets for a few days after the first injection.
In the case of changing treatment from oral flupentixol to maintenance treatment with flupentixol decanoate, the following recommendations should be followed:
x mg of Fluanxol tablets, i.e. flupentixol taken orally per day, corresponds to 4x mg of Fluanxol Depot, i.e. flupentixol injected every two weeks
(for example, 1 mg of Fluanxol tablets taken orally per day corresponds to 4 mg of Fluanxol Depot every two weeks).
x mg of Fluanxol tablets, i.e. flupentixol taken orally per day, corresponds to 8x mg of Fluanxol Depot, i.e. flupentixol decanoate every four weeks
(for example, 1 mg of Fluanxol tablets, i.e. flupentixol hydrochloride taken orally per day, corresponds to 8 mg of Fluanxol Depot, i.e. flupentixol decanoate every four weeks).
For one week after the first injection, the patient should continue to take oral flupentixol, but in reduced doses.
Patients who have previously been given other long-acting (depot) medicines should receive doses calculated according to the following scheme:
40 mg of flupentixol decanoate corresponds to 25 mg of flufenazine decanoate or 200 mg of zuclopentixol decanoate or 50 mg of haloperidol decanoate.
From time to time, the doctor may decide to change the dosage or the time interval between injections.
Patient over 65 years old
Older patients are usually given doses at the lower end of the dosage range.
Special patient groups:
Patients with liver disease are usually given doses at the lower end of the dosage range.
Use in children
Fluanxol Depot is not recommended for use in children.
If the patient feels that the effect of Fluanxol Depot is too strong or too weak, they should consult their doctor.

Duration of treatment

Treatment should be continued at regular intervals, even if the patient's condition improves. The disease can persist for a long time, and if treatment is stopped too early, the symptoms may return.
The duration of treatment is determined by the doctor.

Using a higher dose of Fluanxol Depot than recommended

The medicine will be administered by a doctor or nurse. In the unlikely event of an overdose, the patient may experience symptoms of overdose.
Symptoms of overdose may include:

• drowsiness;
• loss of consciousness;
• movement disorders or muscle stiffness;
• seizures;
• low blood pressure, weak pulse, rapid heart rate, pallor, anxiety;
• increased or decreased body temperature;
• changes in heart rate, including irregularity or slowing of the heart rate, when Fluanxol Depot is administered in excessive doses in combination with medicines known to affect the heart.

The doctor or nurse will initiate symptomatic and supportive treatment.

4. Possible side effects

Like all medicines, Fluanxol Depot can cause side effects, although not everybody gets them.
If the patient experiences any of the following symptoms, they should contact their doctor or go to the hospital immediately:
Uncommon side effects (may affect up to 1 in 100 patients):

• involuntary rhythmic movements of the lips and tongue; this may be a sign of a condition called tardive dyskinesia.

Rare side effects (may affect up to 1 in 10,000 patients):

• high fever, unusual muscle stiffness, and impaired consciousness, especially with accompanying sweating and rapid heart rate; these may be symptoms of a rare condition called malignant neuroleptic syndrome, which has been reported in association with the use of various antipsychotic medicines;
• yellowing of the skin and whites of the eyes (jaundice), which may indicate liver damage;
• blood clots in the veins, especially in the veins of the legs (symptoms include swelling, pain, and redness of the skin of the legs), which can move through the bloodstream to the lungs, causing chest pain and breathing difficulties.

The following side effects are most pronounced at the beginning of therapy and most of them subside as treatment continues:
Very common side effects (may affect more than 1 in 10 patients):

• drowsiness, inability to sit or stand for a long time without moving (akathisia), excessive motor activity (hyperkinesia), slowed or impaired movements (hypokinesia);
• dry mouth.

Common side effects (may affect up to 1 in 100 patients):

• rapid heartbeat (tachycardia), feeling of rapid, strong, or irregular heartbeat (palpitations);
• tremors, twisting or repetitive movements or abnormal posture due to continuous muscle contraction (dystonia), dizziness, headache;
• blurred vision of objects close to the eyes (accommodation disorders), impaired vision;
• breathing difficulties or painful breathing (dyspnea);
• increased saliva production (hypersalivation), constipation, vomiting, digestive problems or discomfort in the upper abdomen (dyspepsia), diarrhea;
• urination disorders, urinary retention;
• increased sweating, itching (pruritus);
• muscle pain;
• increased appetite, weight gain;
• fatigue, feeling of weakness (asthenia);
• insomnia, depression, nervousness, agitation, decreased sexual desire (decreased libido);

Uncommon side effects (may affect up to 1 in 1,000 patients):

• abnormal movements (dyskinesia), parkinsonism, speech disorders, seizures;
• forced gaze with eye rotation;
• abdominal pain, nausea, bloating with gas;
• rash, skin reactions related to hypersensitivity to light (phototoxicity), eczema or skin inflammation;
• muscle stiffness;
• decreased appetite;
• decreased blood pressure (hypotension), hot flashes;
• redness or pain at the injection site of Fluanxol Depot;
• abnormal liver function test results;
• sexual disorders (delayed ejaculation, erection problems);
• confusion;

Rare side effects (may affect up to 1 in 10,000 patients):

• low platelet count (thrombocytopenia), low white blood cell count (neutropenia, leukopenia), toxic bone marrow damage (agranulocytosis);
• increased prolactin levels in the blood (hyperprolactinemia);
• increased blood sugar levels (hyperglycemia), impaired glucose tolerance;
• hypersensitivity (allergy), acute systemic and severe allergic reaction (anaphylaxis);
• breast development in men (gynecomastia), excessive milk production (galactorrhea), absence of menstruation;
• slow heart rate and changes in the ECG recording (QT interval prolongation);
• irregular heart rate (ventricular arrhythmias, torsade de pointes);
• irregular heart rate (arrhythmia) ending in sudden death.

In a group of elderly patients with dementia, taking antipsychotic medicines, a slightly higher number of deaths was found compared to patients not taking antipsychotic medicines.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected].
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Fluanxol Depot

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the month.
There are no special recommendations for the storage temperature of the medicinal product.
Ampoules should be stored in the outer packaging to protect them from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Fluanxol Depot contains

The active substance is cis(Z)-flupentixol decanoate.
Each milliliter (ml) of Fluanxol Depot contains 20 mg of cis(Z)-flupentixol decanoate.
The other ingredient of the medicine is a rare vegetable oil (medium-chain triglycerides).

What Fluanxol Depot looks like and what the pack contains

Fluanxol Depot is available as a solution for injection in a dose of 20 mg/ml.
Fluanxol Depot is a clear, pale yellow liquid.
Fluanxol Depot is available in ampoules made of colorless glass containing 1 ml (20 mg) or 2 ml (40 mg) of the medicine.
The ampoules are packaged in cardboard boxes containing 1 ampoule of 1 ml, 10 ampoules of 1 ml, 1 ampoule of 2 ml, or 10 ampoules of 2 ml.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

• H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby Denmark

For more detailed information, the patient should contact the representative of the marketing authorization holder.
Poland

Lundbeck Poland Sp. z o. o.

Marszałkowska Street 142
00-061 Warsaw
Phone: +48 22 626 93 00
Fax: +48 22 626 93 01
Date of last revision of the leaflet: