FLUANXOL 0.5 mg. 100 tablets

WHAT FLUANXOL AND WHAT IT IS USED
How does Fluanxol
Fluanxol belongs to a group of drugs that act as relieve symptoms of depressed mood.

What is Fluanxol
Fluanxol be used for the treatment of depression in patients who may also occur, and may or may not exhibit signs of anxiety.
However, your doctor may prescribe Fluanxol and other purposes. Ask your doctor if you have any additional questions about why you have been prescribed Fluanxol.

2. BEFORE YOU TAKE FLUANXOL
Do not take Fluanxol
If you are allergic (hypersensitive) to flupentixol or any of the other ingredients of Fluanxol (see What Fluanxol). Consult your doctor if you think you might be;
If you have consciousness.
Fluanxol tablets are not suitable if you suffer from severe depression, for example if you need hospital treatment or electroconvulsive therapy (ECT).

Take special care with Fluanxol
if you have liver problems;
if you have data on seizures or fits;
if you have diabetes (you may need adjustment of antidiabetic treatment);
if you have an organic brain syndrome (which may result from toxicity of alcohol or organic solvents);
if you have a risk of stroke (eg smoking, high blood pressure);
if hypokalemia or hopomagneziya (too little potassium or magnesium in your blood or hereditary predisposition to one);
if you ever in history of cardiovascular disease;
if you use other antipsychotic;
if you feel agitated / and overactive or / and than usual, as this drug may aggravate these feelings you.
Please consult your doctor if you have had any of these conditions in your life.

Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and / or suffer from anxiety disorders can sometimes come to your thoughts of harming or killing themselves. These may be more common when first starting antidepressants, since to act any of these drugs usually takes about two weeks and sometimes more.

More likely to have similar thoughts:
If you have previously had thoughts of harming or killing;
If you are an adult at a young age.
Information from clinical trials has shown an increased risk of suicidal behavior in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant. If at any time you have thoughts of harming or killing immediately contact your doctor or go to hospital.

You may find it helpful to tell a relative or close friend that you are suffering from depression or anxiety disorder, and ask them to read this leaflet. You can also ask them if they think your depression or anxiety is getting worse, or if any changes in your behavior disturbed.

Taking other medicines
Some medicines may affect the way others and this can sometimes lead to serious side effects.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Tell your doctor if you are taking any of the following medications:
Tricyclic antidepressants;
Guanethidine and similar medicines (used to lower blood pressure);
Barbiturates (drugs that cause drowsiness);
Drugs that are used to treat epilepsy;
Levodopa and related drugs (used to treat Parkinson's disease);
Metoclopramide (used to treat gastrointestinal disorders);
Piperazine (used for the treatment of tapeworms);
Drugs that cause the disturbed water or salt balance (too little potassium or magnesium in your blood);
Drugs which are known to increase the concentration of Fluanxol in your blood.
The following drugs should not be administered simultaneously with Fluanxol:
Drugs that alter the rhythm of the heartbeat (quinidine, amiodarone, sotalol, dofetilide, erythromycin, terfenadine, astemizole, gatifloxacin, moxifloxacin, cisapride, lithium);
Other antipsychotic drugs.
Taking Fluanxol with food and drink
Fluanxol can be taken with or without food.
Fluanxol may increase the sedative effects of alcohol making you more drowsy. It is recommended not to drink alcohol during treatment with Fluanxol.

pregnancy
Ask your doctor or pharmacist before taking any medicine.
If you are pregnant or think you might be pregnant, tell your doctor. Fluanxol should not be used but pregnancy, unless clearly necessary.
The general condition of your newborn baby may be affected by this medicine.
The following symptoms may occur in newborn babies of mothers who used sertindole in the last quarter (last three months of pregnancy): shaking, muscle stiffness and / or weakness, sleepiness, agitation, breathing problems, and difficulty eating. If your baby develops any of these symptoms you may need to contact your doctor.

breastfeeding
Ask your doctor or pharmacist before taking any medicine.
If you are breastfeeding, talk to your doctor. While breastfeeding, you should not take Fluanxol, as small amounts of the medicine can pass into breast milk.

Driving and using machines
There is a risk of feeling drowsy and dizzy when using Fluanxol. If this happens do not drive or use any tools or machines until these effects wear off.

Important information about some of the ingredients of Fluanxol coated tablets
This product contains lactose and sucrose. If your doctor has informed that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE FLUANXOL
How much to take
Always take Fluanxol exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.

adults
The usual starting dose is 1 mg daily. After a week, the dose may be increased to 2 mg daily. The maximum dose is 3 mg per day.

Elderly (over 65 years)
The usual starting dose is 0.5 mg. After a week, the dose may be increased to 1 mg per day. The maximum dose is 1.5 mg daily.

children
Fluanxol not recommended for children

If you have the impression that the effect of Fluanxol is too strong or too weak, talk to your doctor or pharmacist.

How and when to take Fluanxol
Fluanxol can be taken with or without food.
Take the tablets with water. Do not chew.
Fluanxol usually taken as a single daily dose in the morning. Doses greater than 2 mg per day for adults (and 1 mg in the elderly) should be divided into morning and afternoon dose.

Duration of treatment
Patients often respond very quickly to treatment with Fluanxol, but if you have taken Fluanxol in maximum doses for a week and still not feel improvement, your doctor may decide to stop treatment.
Your doctor determines the duration of treatment. Continue to take the tablets for as long as you recommended. Never change the dose of the drug before you have talked to your doctor first.

If you take more dose Fluanxol
If you think you or anyone else may have taken too many tablets Fluanxol, contact your doctor or the nearest emergency department. Do this even if there are no signs of discomfort or poisoning. Take the container with you Fluanxol to show the doctor or hospital.

Symptoms of overdose may include:
drowsiness;
unconsciousness;
Muscle movements or stiffness;
seizures;
Low blood pressure, weak pulse, rapid heartbeat, pallor, restlessness;
High or low body temperature;
Changes in heart rhythm including irregular heart beat or slow heart rate were observed when Fluanxol overdose was concomitantly with other drugs known to affect the heart.
If you forget to take Fluanxol
If you forget to take appropriate dose, take the next one at the usual time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Fluanxol
Do not stop taking Fluanxol, even if you begin to feel better, unless your doctor has told you.

If you have any further questions on the use of this product, ask 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 these symptoms should immediately contact your doctor or go to hospital:
Uncommon (more than 1 in 1000, but at least 1 in 100 patients):
Abnormal movements of the mouth and tongue; this can be an early sign of a condition known as tardive dyskinesia.
Very rare (less than 1 in 10,000 patients):
High temperature, unusual muscle stiffness and disorder of consciousness, especially if occurring with sweating and rapid heart beat; these symptoms may be signs of a rare condition called neuroleptic malignant syndrome has been reported with the use of different antipsychotics;
Yellowing of the skin and whites of the eyes, which may mean that your liver is affected and is a sign of a condition known as jaundice.
The following side effects are most prominent at the initiation of treatment and most of them are usually resolved during continued treatment:
Very common (in 1 or more of 10 patients):
Drowsiness (somnolence), inability to sit peacefully sitting or standing still (akathisia), involuntary movements (hyperkinesia), slow or limited movement (hypokinesia);
Dry mouth.
Common (more than 1 in 100 patients but less than 1 in 10 patients):
Palpitations (tachycardia), feeling fast, strong or irregular heart beat (palpitations);
Tremor, distorted or repetitive movements or abnormal postures due to sustained muscle contractions (dystonia), dizziness, headache;
Difficulty to focus on subjects close to the eyes (abnormal accommodation), disturbances of vision;
Difficulty breathing or painful breathing (dyspnea);
Increased salivation (increased salivation), constipation, vomiting, digestive problems or discomfort in the upper abdomen (dyspepsia), diarrhea;
Urinary disorders (voiding dysfunction), inability to urinate (urinary retention);
Increased sweating (hyperhidrosis), itching (pruritus);
Muscle pain (myalgia);
Increased appetite, weight gain;
Fatigue, weakness (asthenia);
Drowsiness (insomnia), depression, nervousness, agitation, decreased sex drive (decreased libido).
Uncommon (more than 1 in 1000, but less than 1 in 100 patients):
Irregular movements (dyskinesia), parkinsonism, speech disorder, convulsions;
Rotational movement of the eye (oculogyric crises);
Abdominal pain, nausea, flatulence;
Rash, correcting skin due to sensitivity to light (photosensitivity reaction), eczema or skin inflammation (dermatitis);
Muscle stiffness;
Decreased appetite;
Low blood pressure (hypotension), hot flashes;
Abnormal liver function tests;
Sexual disturbances (delayed ejaculation, erection problems;
Confusional state.
Rare (more than 1 in 10 000, but less than 1 in 1000 patients):
Reduced number of platelets in the blood (thrombocytopenia), decreased neutrophil leukocytes (neutropenia), reduced leukocyte count (leukopenia), poisoning of the bone marrow (agranulocytosis);
Increased levels of prolactin in the blood (hyperprolactinemia);
High blood sugar (hyperglycemia), impaired glucose tolerance;
Hypersensitivity (hypersensitivity), acute systemic and severe allergic reaction (anaphylactic reaction);
Development of breasts in men (gynecomastia), excessive milk production (galactorrhoea), absence of menstrual periods (amenorrhea).
As with other drugs that work in a similar way to flupentixol (the active ingredient of Fluanxol) have been reported rarely following side effects:
Prolongation of the QT-interval (slow heart rate and changes in ECG);
Irregular heartbeat (ventricular arrhythmias, ventricular fibrillation, ventricular tachycardia);
Torsades de Pointes (a specific type of irregular heart rhythm).
In rare cases irregular heart beats (arrhythmias) may lead to sudden death.
Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which can travel through the blood vessels of the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately.
A slight increase in the number of deaths in elderly people with dementia taking antipsychotics compared with those not taking antipsychotics.

If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE FLUANXOL
Keep out of the reach of children.
Fluanxol not use after the expiry date stated on the label. The expiry date refers to the last day of that month.
Do not store above 25 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Fluanxol
The active substance is flupentixol (as dihydrochloride).
Each tablet contains 0.5 mg Fluanxol flupentixol as the hydrochloride salt.

The other ingredients are betadex, lactose monohydrate, starch, gelatin, hydroxypropyl cellulose, microcrystalline cellulose, croscarmellose sodium, talc, hydrogenated vegetable oil, magnesium stearate.

Coating and coloring: macrogol 6000, polylines alcohol, macrogol, iron oxide (E172), talc, titanium dioxide (E171).

Fluanxol looks like and contents of the pack
Fluanxol is supplied as 0.5 tablets.

Description Fluanxol tablets
Fluanxol 0.5 mg tablets are round, biconvex, ocher yellow tablets.
Fluanxol tablets are available in blister packs:
0.5 mg: 100 in blisters.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Lundbeck Export A / S, Denmark.