FLUANXOL DEPOT 40mg. / 2 ml. 10 ampoules

What Fluanxol Depot
The active ingredient is cis (Z) -flupentixol decanoate. Each milliliter (ml) Fluanxol Depot contains 20 mg cis (Z) -flupentixol decanoate.
The other ingredient is thin vegetable oil (triglycerides, medium chain).
 
Marketing Authorisation
Lundbeck
 
1. WHAT FLUANXOL DEPOT AND WHAT IT IS USED
  Looks Fluanxol Depot
Fluanxol Depot 20 mg / ml is available in clear glass ampoules containing 1 ml (20 mg) or 2 ml (40 mg)
 
Description Fluanxol Depot
Fluanxol Depot is a clear, colorless or pale yellow liquid.
 
How does Fluanxol Depot
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 On your disease.
 
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 questions about why you have been prescribed Fluanxol Depot.
 
2. BEFORE YOU ARE GIVEN FLUANXOL DEPOT
You should not apply Fluanxol Depot
■ If you are hypersensitive (allergic) to flupentixol or any of the other ingredients of Fluanxol Depot listed above (see What Fluanxol Depot), consult your doctor if you think you might be.
■ If you have a disturbance of consciousness
■ If you have certain blood abnormalities
■ If you have pheochromocytoma (adrenal disease)
Fluanxol Depot is not suitable for excitable and hyperactive patients.
Particular caution is required with Fluanxol
Please tell your doctor if you have any medical problems and in particular
• Liver problems
• Data convulsions or seizures
• Diabetes (you may need adjustment of antidiabetic treatment)
• organic brain syndrome (which may result from toxicity of alcohol or organic solvents).
Please consult your doctor if you have had any of these conditions in your life.
 
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
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
Are you pregnant, you're trying to get pregnant or breast-feeding you? If so, discuss the risks and benefits with your doctor before you start using Fluanxol Depot.
Treatment during pregnancy should be gradual 14 days to 3 weeks before the expected birth as the general condition of the infant may be ill or have tremors in the newborn or lethargy, or to be more excitable than usual.
Mothers do not breast feed their babies while taking this medicine.
 
Driving and using machines
Fluanxol Depot usually does not cause drowsiness; however, if you feel dizzy or you sleep in the beginning when start using this medicine, do not drive or operate machinery until these effects wear off.
 
Taking other medicines
Some medicines may affect the way other medicines and this can sometimes lead to serious side effects.
Please tell your doctor if you are taking or have recently taken any other medicines - even those you have not been prescribed.
Caution should be exercised when administered Fluanxol Depot with the following medications:
■ Tricyclic antidepressants
■ Lithium (used for the prophylaxis and treatment of manic-depressive illness)
■ Drugs that lower blood pressure
■ Medicines that cause drowsiness * Medicines to treat epilepsy
■ Levodopa (used to treat Parkinson's disease)
■ Metoclopramide (used to treat gastrointestinal diseases)
In the following cases need to be paid attention:
If you use other antipsychotic drugs simultaneously.
If you use drugs that cause disturbed water or salt balance (too little potassium or magnesium in your blood)
If you use drugs that prolong the QT-interval (ECG change).
If you have heart problems or hereditary prolongation of the QT-interval (ECG change).
 
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.
 
adults
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.
risk patients
Patients with liver complaints normally receive doses in the lower end of the dosage interval.
 
children
Fluanxol Depot generally not be used in children.
 
If you have the impression that the effect of Fluanxol Depot is too strong or too weak, talk to your doctor.
 
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 when you will stop your treatment.
If you are given more Fluanxol Depot than you should 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 side effects that are listed below.
Your doctor / nurse will start symptomatic and supportive treatment.
 
POSSIBLE SIDE EFFECTS
As with all medicines, Fluanxol Depot can have side effects and some people may experience side effects (side effects) while taking Fluanxol Depot.
Very rare but serious side effects (in less than 1 in 10,000 patsienta-)
If you experience any of these symptoms should immediately meet with your doctor:
• High fever, unusual stiffness of the muscles and disorder of consciousness, especially if occurring and sweating and rapid heart beat;
These may be signs of a rare condition called neuroleptic malignant syndrome has been reported with the use of different antipsychotics.
• unconsciously repeated movements of the mouth and tongue; this can be an early sign of a condition known as tardive dyskinesia.
• Any yellowing of the skin and whites of the eyes (jaundice); your liver may be affected.
The following side effects are most prominent at the initiation of treatment and most of them usually resolve with continued treatment.
If you are concerned about side effects, contact your lekar.Mnogo common adverse effects (10 or more out of 100 patients) include:
Unusual muscle movements or stiffness, tremors and restlessness as difficulty standing or sitting peacefully.
Common side effects (more than 1 but less than 10 in 100 patients) include: Slurred speech.
Depression, insomnia, agitation. Increased salivation. Low blood pressure. Fatigue, general weakness.
Rare side effects (1 in 1,000 to 1 in 100 patients 1 may include:
Rash, itching.
Dizziness.
Blurred vision.
Loss of appetite, aggressive reactions. Constipation.
Weight gain.
Skin redness or soreness at the injection site.
 
In addition, known are certain undesirable effects which are caused by drugs, which act in a similar manner flupentixol (the active ingredient of Fmanxol). They are:
• Prolongation of the QT-interval (ECG change)
• Ventricular arrhythmias - ventricular fibrillation (MF), ventricular tachycardia (VT) (rare)
• Sudden unexplained death
• Cardiac arrest
• A special type of irregular heart rhythm known as Torsades de Pointes.
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
 
5. STORAGE DEPOT FLUANXOL
Usually your doctor or nurse will store the medicine for you.
If you keep it at home:
Always keep medicines out of the reach and invisible children.
Fluanxol Depot store above 25 ° C
Keep the ampoules Fluanxol Depot in the box so as not to be exposed to light.
Packaging is the expiry date. Do not use after its expiry date.