Fluanxol

Package Leaflet: Information for the Patient

Fluanxol, 3 mg, Coated Tablets

Flupentixol

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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 taking Fluanxol
• 3. How to take Fluanxol
• 4. Possible side effects
• 5. How to store Fluanxol
• 6. Contents of the pack 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 called antipsychotics (also known as neuroleptics). These medicines work on the nerve pathways in certain areas of the brain and help to balance certain chemical disturbances in the brain that are responsible for the symptoms of the disease.

When Fluanxol is Used

Fluanxol is used to treat schizophrenia.

2. Important information before taking Fluanxol

When Not to Take Fluanxol

• if you are allergic (hypersensitive) to flupentixol or any of the other ingredients of this medicine (listed in section 6);
• if you have a decreased level of consciousness, regardless of the cause (e.g., alcohol, barbiturates, or opioid poisoning), circulatory collapse, coma.

Warnings and Precautions

Before starting treatment with Fluanxol, discuss it with your doctor or pharmacist:

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

Children and Adolescents

Fluanxol is not recommended for this group of patients.

Other Medicines and Fluanxol

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. Inform your doctor about the use of the following medicines:

• tricyclic antidepressants;
• guanethidine and similar medicines (that lower blood pressure);
• barbiturates (medicines that induce sleepiness);
• 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 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Pregnant women or those who suspect they are pregnant should inform their doctor. 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, contact a 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 a doctor for advice.

Driving and Using Machines

There is a risk of drowsiness and dizziness after taking Fluanxol. In such situations, do not drive vehicles, operate machines, or use tools until these symptoms have passed.

Fluanxol Contains Lactose and the Colorant Orange Yellow (E110)

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine. The tablets contain the colorant orange yellow (E110), which may cause allergic reactions. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to Take Fluanxol

Fluanxol should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist. The medicine is used in different doses, the size of which depends on the severity of the disease. The recommended dose is:

Adults

The usual initial dose is 3 mg to 15 mg per day. This dose can be gradually increased to 30 mg per day. In some cases, a significant increase in dose may be required. The maintenance dose usually ranges from 5 mg to 20 mg per day.

Elderly Patients (Over 65 Years)

Elderly 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 and Adolescents

Fluanxol is not recommended for children and adolescents. If you feel that the effect of Fluanxol is too strong or too weak, consult your doctor.

Method of Administration

Tablets should be swallowed with water. Do not chew. In the initial period of treatment, Fluanxol is usually given in divided doses - 2 or 3 times a day. In maintenance treatment, Fluanxol can be given in a single dose, once a day.

Duration of Treatment

As with the use of other antipsychotic medicines, improvement in health is achieved after a few weeks of taking Fluanxol. Treatment should be continued for as long as your doctor recommends. The disease may persist for a long time, and if treatment is stopped too early, symptoms may return. Do not change the dose of the medicine without consulting your doctor.

Taking More than the Recommended Dose of Fluanxol

If you suspect that you have taken too many Fluanxol tablets, contact your doctor or the nearest hospital emergency department immediately, even if you do not feel any discomfort or symptoms of poisoning. Take the Fluanxol packaging with you. 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 slowed heart rhythm, especially when Fluanxol is given in excessive doses in combination with medicines known to affect the heart.

Missing a Dose of Fluanxol

Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping Treatment with Fluanxol

Do not stop taking Fluanxol even if you feel better, unless your doctor recommends it. If you have any doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Fluanxol can cause side effects, although not everybody gets them. If you experience any of the following symptoms, contact your doctor or go to the hospital immediately: Uncommon side effects (may affect up to 1 in 100 people):

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

Very rare side effects (may affect up to 1 in 10,000 people): 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 leg), which can move through the bloodstream to the lungs, causing chest pain and difficulty breathing.

• 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 leg), which can move through the bloodstream to the lungs, causing chest pain and difficulty breathing.

The following side effects are most pronounced at the beginning of treatment and usually disappear as treatment continues: Very common side effects (may affect more than 1 in 10 people):

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

Common side effects (may affect up to 1 in 10 people):

• rapid heart rate (tachycardia), feeling of rapid, strong, or irregular heartbeat (palpitations);
• tremors, twisting or repetitive movements, or abnormal body posture due to continuous muscle contraction (dystonia), dizziness, headache;
• vision disturbances (accommodation disorders), abnormal vision;
• shallow and rapid breathing (dyspnea);
• increased salivation (sialorrhea), constipation, vomiting, gastrointestinal problems, or discomfort in the upper abdomen (dyspepsia), diarrhea;
• urination disorders, urinary retention;
• increased sweating (hyperhidrosis), 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 affect up to 1 in 100 people):

• abnormal movements (dyskinesia), parkinsonism, speech disorders, seizures;
• forced gaze with rotation of the eyeballs;
• abdominal pain, nausea, bloating with gas discharge; 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, erection disorders;
• confusional state.

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

• low platelet count (thrombocytopenia), low neutrophil 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 (prolonged QT interval); irregular heart rhythm (ventricular arrhythmia), which in rare cases can lead to sudden death.

In elderly patients with dementia treated with antipsychotic medicines, a slightly higher number of deaths have been reported compared to those not taking antipsychotic medicines.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to: Department for 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, you can help provide more information on the safety of this medicine.

5. How to Store Fluanxol

Keep the medicine 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 storage precautions are required. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Fluanxol Contains

The active substance of Fluanxol is flupentixol. Each coated tablet contains 3 mg of flupentixol in the form of flupentixol dihydrochloride. The other ingredients of the medicine are: Tablet core: betadex, lactose monohydrate, maize starch, hydroxypropyl cellulose, microcrystalline cellulose, sodium croscarmellose, talc, hydrogenated vegetable oil, magnesium stearate. Tablet coating: tablet coating layer: Opadry II 85F32719 Yellow: polyvinyl alcohol, partially hydrolyzed, macrogol/PEG 3350, yellow iron oxide (E172), talc, titanium dioxide (E171), red iron oxide (E172), FD&C yellow #6/orange yellow (E110) aluminum lake; tablet coating layer: macrogol/PEG6000.

What Fluanxol Looks Like and Contents of the Pack

Fluanxol is available in the form of 3 mg coated tablets. The 3 mg coated tablets are round, biconvex, dark yellow, with the inscription FI. The pack 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.

Marketing Authorization Holder and Manufacturer

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

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

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 Revision of the Leaflet: