ESPRITAL 30 mg. 30 tablets
Esprital (the active substance is mirtazapine) is an antidepressant used for the treatment of depressive disorders. It is known that better respond symptoms such as lack of mood disorders, movement disorders, sleep disorders (early awakening) and weight loss. Also, symptoms of depression such as lack of interest, suicidal mood changes. The effect of treatment with Esprital occurs 1 to 2 weeks after initiation of therapy.
2. BEFORE YOU TAKE ESPRITAL
Do not take Esprital,
if you are allergic / hypersensitive to the active vishtestva or from any excipients (see section 6).
Take special vnimatelnie:
Patients using Esprital observed suppression of bone marrow function, expressed by a lack of white blood cells. This effect occurs after 4 to 6 weeks of treatment and usually disappears after discontinuation of treatment. Possible symptoms are fever, sore throat, stomatitis or other signs of infection. When these symptoms occur, treatment should be discontinued and do research.
Careful dosing and regular monitoring is necessary in patients with:
- Epilepsy and brain damage, although epileptic seizures are rare during treatment with Esprital;
- Hepatic or renal failure;
- Heart disease, such as abnormal heart rhythms, angina pectoris and recent myocardial infarction, which generally require care and caution during the concomitant use of other drugs;
- Low blood pressure.
Like other antidepressants in patients with the following conditions require special attention:
- Complaints with urination, eg. with enlarged prostate (although miitazapine can only slightly abnormal urination);
- Increased intraocular pressure (although the risk during treatment with mirtazapine is very small);
- Diabetes mellitus.
Treatment should be discontinued if jaundice. Like any other antidepressant should be given the following options:
- During the therapy with antidepressants is observed a deterioration of the symptoms of psychotic disorders (eg. Schizophrenia)
- The treatment of the depressive phase of bipolar affective disorders, it can be transformed into a manic;
- Although antidepressants do not cause addiction, abrupt discontinuation can lead to nausea, headache, depression, anxiety and restlessness;
- Elderly patients are often more susceptible to particular adverse effects of antidepressants.
Thoughts of suicide and worsening of your depression or anxiety disorder.
If you are depressed and / or have anxiety disorders can sometimes have thoughts of harming or killing themselves. These may be increased when first starting antidepressants, since these medicines all take time to start running - usually about two weeks but sometimes longer. You may be more likely to think like this:
If you have previously had suicidal thoughts or
If you are a young person. Data from clinical studies suggest an increased risk of behavior associated with suicide in young people (under 25 years) with psychiatric conditions who were treated with an antidepressant.
If at any time there you have thoughts of harming or killing yourself, contact your doctor or go to hospital. You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or are worried about changes in your behavior.
Use in children and adolescents under 18 years.
Esprital should generally not be used in children and adolescents under 18 years. You also know that when patients under 18 are taking this class of drugs, there is an increased risk of side effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behavior and anger). However, your doctor may prescribe Esprital patients aged under 18 years, as assessed / and that it is best for them. If your Esprital acre prescribed for a patient under 18 and you want to discuss this, please go back to him. If any of the above symptoms develop or worsen when patients under 18 are taking Esprital, you should tell your doctor. In addition, has not yet been established safety, prolonged use of Esprital in this age group, in terms of growth, maturation and development of the cognitive and behavioral.
Patients with rare hereditary problems of galactose intolerance, lack of the enzyme that digests lactose or glucose-galactose malabsorption should not use this product.
Please consult your doctor, even if any of these conditions is true for you in the past.
Taking other medicines
Tell your doctor about all the medicines you use or have used, whether on prescription or are freely marketable.
Mirtazapine should not be administered concomitantly with monoamine oxidase inhibitors (MAO inhibitors - antidepressants) or to be initiated within 14 days after discontinuation of MAO inhibitors.
Mirtazapine may enhance the sedative properties of sedatives, including hypnotics. Caution should be exercised when these medicinal products are prescribed together with mirtazapine.
Mirtazapine may potentiate the depressant effect of alcohol on the central nervous system; therefore, patients should be advised to avoid alcohol during treatment with miratzapin.
So-called serotonin syndrome may occur when miratazin mixed with other medicinal products, release serotonin (such as some antidepressants) It is manifested by high blood pressure, fast heartbeat, redness and others. If the combination is considered therapeutically necessary, dose adjustments should be made with caution and monitor for symptoms of serotonin syndrome early.
No significant clinical effects and changes in the pharmacokinetics of concomitant treatment with mirtazapine and lithium.
Levels of mirtazapine in the blood (and other parts of the body) may be increased by the protease inhibitors (anti-viral agents, e. Indinavnr ritonavir), azole antifungals (e. Ketoconazole), erythromycin like antibiotic, nefazodone (antidepressant) or cimetidine ( anti-ulcer agent). When these drugs are co-administered with mirtazapine may be necessary to reduce the dose of mirtazapine.
Mirtazapine levels in the blood (and other body parts) can be reduced by carbamazepine and phenytoin (anticonvulsant) and rifampicin (antibiotic). When these agents are added to the treatment with mirtazapine may be required dose of mirtazapine to be increased miratzapin caused a prolongation of the prothrombin time in patients treated with warfarin, particularly in a daily dose of 30 mg or more. Patients taking warfarin and similar drugs and mirtazapine should be monitored carefully.
In studies conducted so far miratzapin not affect movement, metabolism and excretion in the body of the following products: risperidone (administered to mental illness) or paroxetine (antidepressant), carbamazepine and phenytoin, amitriptyline (an antidepressant) and cimetidine.
Taking Esprital with food and drink
Effect of Esprital influenced by food intake Esprital can reduce the potential of the central nervous system in combination with an alcohol; so should be avoided alcohol during treatment.
Pregnancy and lactation
Please tell your doctor if you are taking or have recently taken any other medicines, including those sold without a prescription.
Although animal studies have not shown any negative effects on the fetus, the safety of mirtazapine in humans has not been established. Mirtazapine should not be used in humans only if absolutely necessary.
Driving and using machines
Esprital may adversely affect the ability of concentration and alertness. During treatment with antidepressants, patients should avoid any potentially hazardous activities that require attention and high concentration, such as driving or operating machinery .Ne triyabva to perform these activities, except with the express consent of the doctor.
Important information about some of the ingredients
This medicinal product contains lactose. If you have an intolerance to some sugars, please tell your doctor before starting treatment with this product:
3. HOW TO USE ESPRITAL
Always take Esprital exactly as it was prescribed by your doctor. If you are not sure talk to your doctor or pharmacist.
The tablets should be swallowed whole and not chewed, with sufficient liquid.
Adults: The initial dose is 15 mg or 30 mg, taken preferably in the evening. The maintenance dose is usually between 15 mg and 45 mg daily.
Elderly: Dosage as for adults. Changes, especially increase in dosage must be made cautiously and under close observation.
Children and adolescents (under 18 years): The use of mirtazapine is not recommended, as safety and efficacy in these patients has not been studied.
Renal or hepatic impairment: In patients with renal or hepatic insufficiency may be a delay of elimination of mirtazapine. This must be taken into account when mirtazapine is administered to these patients and in assessing clinical response.
Esprital can be taken once daily. The product should be administered as a single dose in the evening before falling asleep. This daily dose may be divided into two separate doses administered in the morning and at night before sleep. Most dose should be taken at night.
The antidepressant action of mirtazapine typically occurs after 1 to 2 weeks. Treatment with an adequate dose should give a positive response within 2 to 4 weeks. When insufficient response the dose can be increased to the maximum. Treatment should continue to b 4 months after reaching makegamlen clinical effect and the symptoms have disappeared completely, then treatment may be discontinued gradually. If no clinical response after 2 to 4 weeks of treatment with the maximum dose, treatment should be discontinued gradually. The gradual reduction of the dose necessary to avoid withdrawal symptoms.
If you take more than necessary Esprital:
In case of overdose or accidental ingestion by children, seek medical advice immediately.
Depression of the central nervous system with disorientation and prolonged sedation may occur, as well as rapid heartbeat and slightly high or low blood pressure.
If you forget to take Esprital:
If you forget to take your normal dose, take it as soon as possible after you remember. If the next scheduled dose is near, skip the previous and proceed to the next under the scheme. Do not double dose! Due to the long time needed for the release of mirtazapine is possible to omit the dose. If you forget to take more than one dose, contact your doctor.
If you stop taking Esprital:
Symptoms of depression, for which he started treatment, may worsen or reappear, especially if treatment is discontinued abruptly.
Although antidepressants do not cause addiction, abrupt discontinuation of treatment after long-term use can cause withdrawal symptoms, including nausea, headache, malaise, depression and anxiety, dizziness, sensory disturbances (incl. Changed perceptions of touch), sleep disturbances (incl. insomnia and nightmares), tremor. The risk of withdrawal symptoms may be dependent on many factors including the duration and dose of therapy and the rate of dose reduction. In most cases these symptoms are mild to moderate, but in some patients they may be heavy. Usually no treatment is needed and they subside within two weeks, although some patients may last longer (2-3 months or more). Therefore, it is recommended that treatment with Esprital be stopped gradually over a period of several weeks or months, according to the needs of the patient.
4. POSSIBLE SIDE EFFECTS
Like any medicine, Esprital can cause side effects that occur in any patient.
Usually this medicinal product is well tolerated, even in some cases be difficult to distinguish between induced Esprital signs from those due to disease. The most common are increased appetite and weight gain, drowsiness, dizziness, headache and swelling. Drowsiness can lead to a decreased ability to concentrate and generally occurs within the first few weeks of treatment. The reduction in dosage does not usually decrease senapiyata, but may result in a risk reduction of anti-depressant activity.
Uncommonly appears nausea.
In rare cases, nightmares (vivid dreams), mania, anxiety, confusion, hallucinations, depression, insomnia, cramps, tremors, muscle twitching, paresthesia (altered perceptions of touch), restless legs, hypotension / fainting when standing, dry mouth, diarrhea, elevated liver enzymes, severe suppression of bone marrow function, rash, muscle or joint pain and fatigue may occur.
Generally with antidepressants may occur anxiety and insomnia (which may be symptoms of depression) or get worse. During treatment with miratzapin very rarely observed occurrence of anxiety and insomnia or worsening them.
If you notice any side effects not listed in this leaflet, please tell your doctor.
If any of the side effects or other unusual reactions, consult your doctor about the further use of this product.
5. How STORED ESPIRITAL
Keep out of reach of children!
Do not use after the expiry date which is stated on the box / blister. The expiry date refers to the last day of that month.
No special requirements for storage.
6. FURTHER INFORMATION
The active substance mirtazapine 15,30 or 40 mg in each tablet.
Excipients: lactose monohydrate, low substituted hyprolose, corn starch, microcrystalline cellulose, soluble starch, silicon daoksid, kolondalen anhydrous magnesium srearat, talc, hypromellose, macrogol 6000, titanium dioxide, yellow ferric oxide (Esprital 15,30), red iron oxide (Esprital 30).