Fluanxol

Leaflet accompanying the packaging: patient information

Fluanxol, 0.5 mg, coated tablets

Flupentixol

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

• Please keep this leaflet, so you can read it again if you need to.
• If you have 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 their symptoms are the same as yours.
• 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 and what is it used for
• 2. Important information before using Fluanxol
• 3. How to use Fluanxol
• 4. Possible side effects
• 5. How to store Fluanxol
• 6. Contents of the packaging and other information

1. What is Fluanxol and what is it used for

How Fluanxol works

Fluanxol contains the active substance flupentixol. Fluanxol belongs to a group of medicines that relieve symptoms of depression.

When Fluanxol is used

Fluanxol is used in psychotic disorders without depressive disorders. Fluanxol is also used in depressive disorders, other than those occurring in psychosis.

2. Important information before using Fluanxol

When not to use Fluanxol

Warnings and precautions

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

Children and adolescents

Fluanxol is not recommended for this group of patients.

Suicidal thoughts and worsening of depression or anxiety disorder

People with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually start working after about 2 weeks, sometimes later.

• patients who have had thoughts of self-harm or suicide in the past;
• young adult patients. Data from clinical trials show an increased risk of suicidal behavior in people under 25 years of age with mental disorders who were treated with antidepressant medicines. If the patient experiences thoughts of self-harm or suicide, they should contact their doctor or go to the hospital immediately.

It may be helpful to inform relatives or friends about depression or anxiety disorders and ask them to read this leaflet. The patient may ask to be informed if they notice that their depression or anxiety has worsened or if there are any worrying changes in their behavior.

Other medicines and Fluanxol

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.

• tricyclic antidepressant medicines;
• guanethidine and similar medicines (which 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 balance (too little potassium or magnesium in the blood);
• medicines known to increase the level of Fluanxol in the blood.

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

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

Fluanxol with food, drink, and alcohol

Fluanxol can be taken with or without food. Fluanxol may enhance the sedative effect of alcohol, causing drowsiness. It is not recommended to drink alcoholic beverages while taking Fluanxol.

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

In pregnancy and during breastfeeding, or if there is a suspicion that the woman is pregnant, or if she plans to become pregnant, the patient should consult their doctor before using this medicine. Fluanxol 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 the newborn, the patient should contact their doctor.

Breastfeeding

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

Fertility

Studies in animals have shown that Fluanxol 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. In such situations, the patient should not drive vehicles, operate machines, or use tools until these symptoms have resolved.

Fluanxol contains lactose.

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to use Fluanxol

Fluanxol should always be used as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist. The recommended dose is:

Adults

The usual initial dose is 1 mg per day. After one week, the dose may be increased by the doctor to 2 mg per day. The maximum dose is 3 mg per day.

Elderly patients (over 65 years)

The usual initial dose is 0.5 mg per day. After one week, the dose may be increased by the doctor to 1 mg per day. The maximum dose is 1.5 mg per day.

Use in children and adolescents

Fluanxol is not recommended for children and adolescents. If the patient feels that the effect of Fluanxol is too strong or too weak, they should consult their doctor.

Method of administration

The tablets should be swallowed with water. Do not chew. Fluanxol is usually given in the morning in a single daily dose. Doses above 2 mg per day in adults (1 mg in elderly patients) should be given in two divided doses, in the morning and in the afternoon.

Duration of treatment

The response to treatment with Fluanxol is usually rapid. If there is no improvement after using the maximum dose of Fluanxol for about one week, the doctor may decide to discontinue this treatment. The duration of treatment is determined by the doctor. Treatment should be continued for as long as the doctor recommends. The patient should not change the dose of the medicine without consulting their doctor.

Using a higher dose of Fluanxol than recommended

If the patient suspects that they have taken too many Fluanxol tablets, they should contact their doctor or the nearest hospital emergency department immediately, even if they do not feel any discomfort or symptoms of poisoning. The patient should take the packaging of Fluanxol with them. The following symptoms of overdose may occur:

• 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 rhythm, including irregular or slow heart rhythm, which may occur when Fluanxol is given in excessive doses in combination with medicines known to affect the heart.

Missing a dose of Fluanxol

The patient should take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Fluanxol

The patient should not stop using Fluanxol, even if they feel better, unless their doctor recommends it. If the patient has any doubts about using the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Fluanxol 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 occur in less than 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 occur in less than 1 in 10,000 patients):

• high fever, unusual muscle stiffness, and impaired consciousness, with 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 treatment and usually resolve as treatment continues:

Very common side effects (may occur in more than 1 in 10 patients):

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

Common side effects (may occur in less than 1 in 10 patients):

• rapid heart rate (tachycardia), feeling of rapid, strong, or irregular heartbeat (palpitations);
• tremors, twisting or repetitive movements, or abnormal posture of the body due to continuous muscle contraction (dystonia), dizziness, headache;
• vision disturbances (accommodation disorders), abnormal vision;
• shallow and rapid breathing (dyspnea);
• increased salivation, constipation, vomiting, gastrointestinal problems, or discomfort in the upper abdomen (indigestion), 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 (libido).

Uncommon side effects (may occur in less than 1 in 100 patients):

• abnormal movements (dyskinesia), parkinsonism, speech disorders, seizures;
• episode of forced gaze with rotation of the eyeballs;
• abdominal pain, nausea, bloating with gas, rash, skin reactions related to hypersensitivity to light (phototoxicity), skin inflammation;
• muscle stiffness;
• decreased appetite;
• low blood pressure (hypotension), hot flashes;
• abnormal liver function test results;
• ejaculation disorders, erectile dysfunction;
• confusional state.

Rare side effects (may occur in less than 1 in 1,000 patients):

• low platelet count (thrombocytopenia), low granulocyte count (neutropenia), decreased white blood cell count (leukopenia), absence of granulocytes in the blood (agranulocytosis);
• increased prolactin levels in the blood (hyperprolactinemia);
• increased glucose levels in the blood (hyperglycemia), impaired glucose tolerance;
• hypersensitivity (allergy), acute systemic and severe allergic reaction (anaphylaxis);
• development of breast tissue in men (gynecomastia), excessive milk production (galactorrhea);
• absence of menstruation;
• changes in the ECG recording (QT interval prolongation);
• irregular heart rhythm (ventricular arrhythmia), which in rare cases can lead to sudden death. In elderly patients with dementia, an increased number of deaths has been observed in patients taking antipsychotic medicines compared to those not taking antipsychotic medicines.

If any of the side effects worsen or if the patient experiences any side effects not listed in this leaflet, they should inform their doctor or pharmacist.

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:

Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Fluanxol

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. No special precautions for storage are required. 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 contains

The active substance of the medicine is flupentixol. Each coated tablet contains 0.5 mg of flupentixol in the form of flupentixol dihydrochloride. The other ingredients of the medicine are:

Tablet core: betadex, lactose monohydrate, cornstarch, hydroxypropylcellulose, microcrystalline cellulose, sodium croscarmellose, talc, hydrogenated vegetable oil, magnesium stearate.

Tablet coating: coating layer:Opadry II 85F38027 Yellow: polyvinyl alcohol, partially hydrolyzed, macrogol/PEG 3350, talc, titanium dioxide (E171), yellow iron oxide (E172); protective layer:macrogol/PEG6000.

What Fluanxol looks like and contents of the packaging

Fluanxol is available in the form of 0.5 mg coated tablets. The 0.5 mg coated tablets are round, biconvex, yellow, with the marking FD. The packaging contains 50 or 100 coated tablets in blisters or in a high-density polyethylene (HDPE) container, in a cardboard box. Not all pack sizes may be marketed.

Responsible entity and manufacturer

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

For more detailed information, the patient should contact the representative of the responsible entity.

Lundbeck Poland Sp. z o.o.

Marszałkowska 142, 00-061 Warsaw, Tel.: +48 22 626 93 00, Fax: +48 22 626 93 01

Date of last update of the leaflet: