MODITEN depot amp. 25 mg. Ml. 5 ampules
MODITEN depot amp. 25 mg. / Ml. 5 ampules
WHAT MODITEN DEPO AND WHAT IT IS USED FOR?
1 ml solution for injection (1 ampoule) contains 25 mg fluphenazine decanoate (flufenazin decanoate).
Folding box with 5 ampules of 1 ml solution for injection.
What Moditen depo?
Moditen depo belongs to a class of antipsychotic drugs (also known as neuroleptics). These drugs affect nerve pathways and specific areas of the brain and help to eliminate some of the distortions of the chemical balance in the brain that cause the symptoms you.
What used Moditen depo?
Moditen depo is intended for maintenance treatment and prevention of mental disorders, which are characterized by hearing, seeing or sensing things imaginary, impaired thinking, unusual suspiciousness, and the inadequacy of the environment.
It is intended for maintenance therapy in the treatment of mania and hyperactivity, agitation, aggression, and other behavioral disorders, as with all medical conditions characterized by high emotional tension, anxiety, irritability and anxiety.
YOU listed MODITEN DEPO
Tell your doctor if you have a chronic disease, metabolic diseases, if you are allergic or if you take other medicines.
Who should not use ModiteN depo?
You should not use this medicine if you are allergic to fluphenazine or any of the excipients of the drug and / or to other phenothiazines, if you are suffering or suspected subcortical brain damage, severe disturbances of consciousness, severe cerebral arteriosclerosis, tumor of the adrenal gland, severe renal , liver or heart failure.
You should not receive this medicine in case of acute intoxication with agents that inhibit central nervous system (alcohol, antidepressants, antipsychotics, sedatives, anxiolytics, hypnotics and drugs).
It should not be used in children under 12 years of age.
Precautions and warnings
Before you get Moditen depo, you should tell your doctor if you have cardiovascular disease, kidney or liver disease, lung disease, epilepsy, thyroid disease (hyperthyroidism), parkinsonism, blood disorders, narrow-angle glaucoma (increased eye pressure), myasthenia gravis, prostate problems, or if you are exposed to high temperatures or are in contact with organophosphorus insecticides. If you are scheduled for surgery, you should tell your doctor that you are taking Moditen depo, because it enhances the action of general anesthetics and methods that inhibit neuromuscular transmission.
If you receive antiparkinsonian medications during treatment with Moditen depo, in case of a sudden stop must continue with prescribed antiparkinsonian medication for several days.
Moditen depo is not effective for the treatment of behavioral disorders in patients with mental retardatio
Sow Ask your doctor or pharmacist before taking any medicine.
Tell your doctor if you are pregnant, suspect you are pregnant or want to become pregnant. If you are pregnant, you should not receive the drug unless the potential benefit outweighs the risk to the fetus.
Fluphenazine is excreted in breast milk and therefore you should not breast-feed during treatment.
Effects on ability to drive and use machines
Moditen depo can cause drowsiness, especially in early treatment. If you feel dizzy and sleepy when you start treatment with this medicine, do not drive or operate machinery until these effects wear off. The doctor will assess your ability to individually drive the grounds of the underlying disease and the effects of treatment.
What other drugs could interact with Moditen depo?
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Coadministration of Moditen depo and other drugs may slightly modify the activity of these drugs, and some drugs can change its operation.
These are drugs that help with allergies (antihistamines), antidepressants, hypnotics and sedatives, drugs, drugs for birth control and other medications containing these medicinal ingredients: carbamazepine, griseofulvin, phenylbutazone, rifampicin, paracetamol, chloramphenicol or disulfiram .
If you have diabetes or epilepsy, parkinsonism after beginning treatment with Moditen depo may need to make some adjustments in the dose of medicines to treat these diseases.
If you are taking medicines to prevent blood clotting, Moditen depo may enhance their action. Therefore, your doctor will examine more often your blood.
In very low blood pressure can only be applied noradrenaline intravenously. Epinephrine should not be administered concomitantly with phenothiazines as in combination with them he raises and lowers blood pressure. This should be considered especially in surgery and anesthesia.
You should not get Moditen depo together with other medicines to treat abnormal heart rhythms (antiarrhythmics) can take them only under the supervision of a physician.
The concomitant use of alcohol.
The only drugs that you can take while Moditen depo, are the ones that your doctor has approved.
Special warnings about excipients
The use of benzyl alcohol in infants and children up to 3 years of age is contraindicated.
HOW TO USE MODITEN DEPO?
Dosage and method of administration
Your doctor will determine the appropriate dose and frequency of administration. The drug is released slowly and therefore fairly constant amount of it goes into your blood between the two injections. The drug is administered as a deep intramuscular injection.
The usual starting dose is 12.5 to 25 mg Moditen depo. Subsequent doses and dosing intervals are individual. The interval between injections is usually 15 to 35 days. If required doses higher than 50 mg, it increased gradually with 12.5 mg. A single dose should not exceed 100 mg.
If you have not previously treated with phenothiazines should initially be treated with injectable solutions or short-acting oral phenothiazines. When it is found that better tolerate Phenothiazines may go to Moditen depo.
Apply a dose of 12.5 mg Moditen depo intramuscularly. In the absence of severe adverse reactions, 5 to 10 days later may be given an additional dose of 25 mg. Then individually adjusted.
In older patients usually require lower doses, 1/3 to 1/4 of the dose for younger adults.
Upon the occurrence of extrapyramidal reactions (abnormal muscle movements or stiffness, tremors and restlessness, fast or circular eye movements, increased muscle reflexes) your doctor will prescribe antiparkinsonian drugs.
If your doctor finds that Moditen depo dose is too low, treatment may be supplemented with oral phenothiazines. In patients with kidney disease have shown lower doses Patients with liver disease should not take fluphenazine.
Your doctor will decide when to stop treatment. If you do stop too early, symptoms will reappear.
Injection should not be mixed with other injectables. If you feel that the effect of the drug is too strong or too weak, talk to your doctor or pharmacist.
If you receive more than Moditen depo necessary
Acute overdosage can cause severe extrapyramidal reactions (abnormal muscle movements or stiffness, tremors and restlessness, fast or circular eye movements, increased muscle reflexes), severe decrease in blood pressure, constricted pupils, decreased body temperature, urinary retention, functional disorders of the heart and drowsiness, which can result in loss of consciousness with absence of reflexes and coma. Treatment is symptomatic, as no specific antidote. Your doctor will monitor you closely. In functional disorders of the heart are effective sodium bicarbonate and magnesium sulphate. Extrapyramidal disorder treated with antiparkinsonian drugs. In severe hypotension may only be applied noradrenaline. Adrenalin further decrease blood pressure.
If a dose is missed Moditen depo
If a dose is missed violations, why you started taking this medicine may recur or worsen. So you should get the missed dose as soon as possible and then the dosing regimen should be changed accordingly.
POSSIBLE SIDE EFFECTS
Like all medicines, Moditen depo can also have side effects. Moditen depo can cause the following side effects: abnormal muscle movements or stiffness, tremors and restlessness, fast or circular eye movements, increased muscle reflexes. These symptoms are usually reversible and disappear after dose reduction or discontinuation. They can be prevented or reduced by the use of antiparkinsonian drugs. Moditen depo rarely causes involuntary rhythmic movements of the tongue, face, mouth, lips, trunk, and extremities. This could be signs of a rare condition known as tardive dyskinesia. In such cases, you should immediately discontinue use of Moditen depo.
Very rarely, medicines of this type can cause fever, rapid breathing, sweating, muscle stiffness and drowsiness. This could be signs of a condition known as neuroleptic malignant syndrome. In this case, you should stop using Moditen depo and stay in hospital. Sometimes you may experience the following side effects: drowsiness, agitation, abnormal dreams, depression, suicidal intentions, nausea, loss of appetite, salivation, dry ESTAT, a feeling of nasal congestion, urinary abnormalities (need more frequent urination and / or uncontrolled urination), constipation, headache, sweating, weak high or low blood pressure, labile blood pressure, rapid or irregular heartbeat, blurred vision, increased intraocular pressure, clouding of the lens and cornea, skin pigmentation and allergic reactions .
In some patients who are using these drugs to secrete milk from the breast, and sometimes menstruation has stopped or became irregular. In some patients occurred libido disorders, and problems with ejaculation and erection. If you experience such problems, tell your doctor.
Rarely, Moditen depo can cause liver disease (jaundice) or blood disorders, therefore your doctor will monitor your blood counts regularly.
If you notice any side effects, even those not mentioned in this leaflet, please tell your doctor or pharmacist.
STORAGE MODITEN DEPO
Do not use after the expiry date stated on the packaging.
Protect from light and stored at a temperature of 8 ° C to 25 ° C.
Keep out of reach of children.
Only on prescription. The medicine can only be used in public health facilities or by authorized medical personnel.
INSTRUCTIONS FOR MEDICAL PERSONNEL
Moditen depo injection is incompatible with other injectables.