FLUANXOL DEPOT 20 mg. / Ml. 10 ampoules
Н. Lundbeck A/S
Fluanxol Depot belongs to the group of medicines known as antipsychotics (also called neuroleptics).
These medicines act on nerve pathways in specific parts of the brain and help to correct certain chemical imbalances in the brain that cause the symptoms of your illness.
What is Fluanxol Depot
Fluanxol depot is used for the treatment of schizophrenia and other psychoses.
However, your doctor may prescribe Fluanxol Depot and other purposes. Ask your doctor if you have any additional questions about why you have been prescribed Fluanxol Depot.
2. BEFORE YOU USE FLUANXOL DEPOT
Do not use Fluanxol Depot:
If you are allergic (hypersensitive) to flupentixol or any of the other ingredients of Fluanxol Depot (see What Fluanxol Depot). Consult your doctor if you think you might be;
If you have consciousness.
Take special care with Fluanxol Depot
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.
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:
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 depot in your blood.
The following drugs should not be administered simultaneously with Fluanxol Depot:
Drugs that alter the rhythm of the heartbeat (quinidine, amiodarone, sotalol, dofetilide, erythromycin, terfenadine, astemizole, gatifloxacin, moxifloxacin, cisapride, lithium);
Other antipsychotic drugs.
You interact with alcohol Fluanxol Depot
Fluanxol Depot may increase the sedative effects of alcohol making you more drowsy. It is recommended not to drink alcohol during treatment with Fluanxol Depot.
Ask your doctor or pharmacist before taking any medicine. If you are pregnant or think you might be pregnant, tell your doctor.
Fluanxol depot should not be used during 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.
Ask your doctor or pharmacist before taking any medicine.
If you are breastfeeding, talk to your doctor. While breastfeeding, you should not take Fluanxol Depot, 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 Depot. If this happens do not drive or use any tools or machines until these effects wear off.
3. HOW TO USE FLUANXOL DEPOT
How much to receive and when
Small volume Fluanxol Depot with a syringe and administered intramuscularly into the buttocks. Your doctor will determine the exact amount of the drug that should get and how often to give it. The drug is slowly released after injection so that a relatively constant amount of it falls in your blood during the period between the two injections.
Fluanxol Depot 20 mg / ml
Typically, this will be 1-2 ml and the interval between injections will be between 1 and 4 weeks.
If you need more than 2 ml of medicine, it would probably be implemented in two places.
If you have taken Fluanxol tablets and be transferred to Fluanxol Depot may ask you to continue to take the tablets for several days after the first injection.
Occasionally your doctor may adopt a decision to adjust the amount applicable or the interval between injections.
Elderly (over 65 years)
Commonly used doses in the lower recommended limit of the dosing interval.
Patients with liver complaints normally receive doses in the lower end of the dosage interval.
Fluanxol Depot is not recommended for children.
If you have the impression that the effect of Fluanxol Depot is too strong or too weak, talk to your doctor or pharmacist.
Duration of treatment
It is important to continue to receive your medicine at regular intervals even if you feel completely well, because the underlying illness may persist for a long time. If you stop your treatment too soon, your symptoms may reappear. Your doctor will decide what is the duration of your treatment.
If you receive more than the amount Fluanxol Depot
Your medicine will be given to you by your doctor / nurse.
In the unlikely event when you are given too much Fluanxol Depot, you may experience certain symptoms.
Symptoms of overdose may include:
Muscle movements or stiffness;
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 Depot was overdoses concomitantly with other drugs known to affect the heart.
Your doctor / nurse will start symptomatic and supportive treatment.
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);
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;
Violation of urination (micturition disorders), 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, skin reaction due to sensitivity to light (photosensitivity reaction), eczema or skin inflammation (dermatitis);
Low blood pressure (hypotension), hot flashes;
Red or inflamed skin where an injection with Fluanxol Depot;
Abnormal liver function tests;
Sexual disturbances (delayed ejaculation, erection problems);
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 decanoate (the active ingredient of Fluanxol Depot) 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.
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 DEPOT
Usually your doctor or nurse will store the medicine for you.
If you keep it at home:
Keep out of the reach of children.
Do not use Fluanxol Depot 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
Keep the ampoules Fluanxol Depot in the box, so as not to be exposed to light.
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 Depot
The active substance is flupentixol decanoate.
Each milliliter (ml) Fluanxol Depot contains 20 mg flupentixol decanoate.
The other ingredient is thin vegetable oil.
Looks Fluanxol Depot and contents of the pack
Fluanxol depot is provided as a 20 mg / ml, injection solution.
Description Fluanxol Depot
Fluanxol Depot is a clear, colorless or pale yellow liquid.
Fluanxol Depot 20 mg / ml is available in clear glass ampoules containing 1 ml (20 mg). Ampoules of 1 ml are available in boxes of 10 ampoules.
Not all pack sizes may be marketed