TRITTICO XR 150 mg. 30 tablets

WHAT TRITTICOXR 150 mg prolonged-release AND WHAT IT IS USED
TRITTICO XR is a medicine to be administered for the treatment of depressive disorders with or without anxiety. These medications are called antidepressants.

2. BEFORE YOU TAKE TRITTICO XR 150 mg prolonged release
Do not take TRITTICO XR 150 mg prolonged-release at:
Known hypersensitivity to the drug or any of its ingredients;
Alcohol intoxication and poisoning with hypnotic drugs;
Severe myocardial infarction.
Take special care with TRITTICOXR 150 mg prolonged release
Use in children and adolescents under 18 years of age
Tritikali should not be used by children and young people under 18 years of age. However, it is necessary to say that, when used in patients under 18 years, this group of drugs may increase the risk of side effects such as attempted suicide, planning suicide and hostility (predominantly aggression of oppositional behavior and anger). Furthermore, data on the safety of long-term use in children and adolescents concerning growth, maturation and cognitive and behavioral development.

Suicide / suicidal thoughts or clinical worsening
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (events related to suicide). The risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be monitored closely to his appearance. Clinical experience has shown that the risk of suicide may increase in the early stages of recovery.
It is known that patients with a history of events associated with suicide or exhibiting a significant degree of suicidal thoughts before starting treatment are at greater risk of suicidal thoughts or suicide attempts, and should be monitored closely during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behavior in patients under 25 years of age treated with antidepressants compared to placebo.
Medication must be accompanied by close monitoring of patients and in particular those at increased risk, especially at the beginning of treatment and after dose adjustments. Patients (and those who care for them) should be alerted about the need to monitor for any clinical worsening, suicidal behavior or thoughts and unusual changes in behavior and immediately seek medical attention if these symptoms are occur.

Consult your doctor before you start taking TRITTICO XR in the following cases:
Epilepsy, in particular to avoid a sudden increase or decrease in the dose;
Patients with hepatic or renal insufficiency, particularly severe;
Patients with cardiac disease such as angina pectoris, abnormal conduction; or varying degree AV block, recent myocardial infarction;
hyperthyroidism;
Abnormal urination, such as prostatic hypertrophy, although problems are not anticipated, as the anticholinergic effect of trazodone is negligible;
Acute angle-closure glaucoma, increased intra ocular pressure, although significant changes are not expected because of the negligible anticholinergic effect of trazodone.
If jaundice treatment with trazodone should be discontinued.
Antidepressants by patients with schizophrenia or other psychotic disorders may cause deterioration of psychotic symptoms. Paranoid thoughts can be intensified. During treatment with trazodone depressive phase can change from manic-depressive to manic. In this case, the intake of trazodone should be discontinued.
Interactions are described in terms of serotonin syndrome / neuroleptic malignant syndrome in case of concomitant use of other substances with serotonergic action, other antidepressants (eg. Tricyclic antidepressants, SSRI, SNRI and MAO - inhibitors) and neuroleptics. Reports of neuroleptic malignant syndrome with fatal coadministration with neuroleptics for which this syndrome is proven adverse reaction. See "Taking / using other medicines" and "Possible Side Effects" for additional information.
Since the agranulocytosis can manifest clinically with flu-like symptoms, sore throat and fever, in these cases it is recommended to study hematology.
Reported hypotension, including orthostatic hypotension, and seizures in patients receiving trazodone. Concomitant administration of drugs to lower blood pressure and trazodone may require dose reduction of antihypertensive drug.
In elderly patients often can occur orthostatic hypotension, drowsiness and other anticholinergic effects of trazodone. Special attention should be paid to the possibility of additive effects when used concomitantly, such as with other psychotropic or anti-hypertensive agents, or in the presence of risk factors such as underlying disease that may worsen these effects. It is recommended that the patient / caregiver is informed of the possibility of such reactions and carefully monitored for such effects at the start of treatment, before and after the upward titration.
After treatment with trazodone, especially if prolonged, it is recommended to gradually reduce the dosage to minimize withdrawal symptoms characterized by nausea, headache and malaise.
There were no reports of addiction trazodone hydrochloride.
As with other antidepressants, there are cases of prolongation of the QT - interval, although very rare. Caution is advised when prescribing trazodone with medicinal products that prolong the QT - interval. Trazodone should be used with caution in patients with known cardiovascular disease including those associated with prolongation of the QT - interval.
Potent inhibitors of CYP3A4 may result in increased serum levels of trazodone. See "Taking / using other medicines" for additional information.
Like other drugs with alpha-adrenolytic action trazodone rarely leads to priapism. It is treated with intracavernosal injection of alpha-andrenergic agent such as e. adrenaline or metaraminol. Reportedly, however, trazodone induced priapism which imposed the surgery or has led to permanent sexual dysfunction. Patients who develop this side effect, it should immediately stop taking trazodone.

Taking / using other medicines
Tell your doctor or pharmacist if you have recently taken medicines, including medicines obtained without a prescription.

General: The sedative effects of antipsychotics, sleeping pills, sedatives, anxiolytics and antihistamine medications can be strengthened; in such cases dose reduction.
Metabolism of antidepressants is accelerated due to hepatic effects of oral contraceptives, phenytoin, carbamazepine and barbiturates. Metabolism of antidepressants is hampered by cimetidine and some other antipsychotic drugs.

Tell your doctor if you are taking any of the following medications:
Inhibitors of CYP3A4: These include erythromycin, ketoconazole, itraconazole, ritonavir, indinavir and nefazodone. These drugs enhance the side effects of TRITTICO XR. Therefore, concomitant use should be avoided where possible, or at least reduce the dose of trazodone;
Carbamazepine: Concomitant carbamazepine lead to reduced plasma concentrations of TRITTICO XR. Patients should be monitored closely to see if he needed a higher dose TRITTICO XR;
Tritsiklinchni antidepressants: Concomitant use should be avoided due to the risk of interaction. Monitor for serotonin syndrome and cardiovascular side effects;
Fluoxetine: Rare cases of elevated plasma levels of trazodone and adverse effects of trazodone in combination with fluoxetine. It is not excluded pharmacodynamic interaction (serotonin syndrome);
Monoamine oxidase inhibitors (MAOG): Possible interactions with monoamine oxidase inhibitors. While some doctors combine two drugs, concomitant use of trazodone with a MAOI, or within two weeks of discontinuation of such agents is not recommended. Not recommended intake of MAOI one week after discontinuation of trazodone;
Phenothiazines: concomitant use with chlorpromazine, fluphenazine, levomepromazine, perphenazine can lead to severe orthostatic hypotension;
Anesthetic / muscle relaxants: TRITTICO XR may enhance the effects of muscle relaxants and volatile anesthetics, therefore, the concomitant use is necessary precautionary approach;
Alcohol: Trazodone increases the sedative effect of alcohol. During treatment with trazodone alcohol should be avoided;
Levodopa: Antidepressants may increase the metabolism of levodopa;
Other: Concomitant use of triticale XR with drugs which have been shown to prolong the QT-interval may increase the risk of ventricular arrhythmias, including torsade de pointes. In such cases, caution is needed regarding the concomitant use of these drugs trazodone.
Trazodone may inhibit most of the acute effects of clonidine.
Since trazodone is very weak inhibitor of the reuptake of noradrenaline and does not modify the blood pressure response to tyramine, is not expected to affect the hypotensive action of guanetidinovite compounds. Studies on laboratory animals, however, suggest that tradozon can prevent most of the acute effects of clonidine. In terms of other medications to treat high blood pressure must take account of the possibility of potentiation, though no reported clinical interactions.
Side effects may be more frequent when trazodone is taken together with preparations containing St. John's wort.
Concomitant use of trazodone and warfarin may result in changes in prothrombin time.
Concomitant use of trazodone may cause increased serum levels of digoxin or phenytoin.

Pregnancy and lactation
Contact your doctor or pharmacist before taking any medicine. Data on a limited number (less than 200) pregnant women trazodone showed no adverse effects of trazodone on pregnancy or health of the fetus / newborn. So far, no other epidemiological data.
When trazodone is taken to delivery, newborns should be monitored for symptoms of withdrawal.
The ability to separate the product into the milk should be given to lactating mothers.
Therefore the use of TRITTICO XR during pregnancy and breastfeeding should be limited to isolated cases and only after careful evaluation of the benefit / risk ratio.

Driving and using machines
Trazodone has minor or moderate influence on the ability to drive and use machines. Patients should be cautioned when driving or operating machinery until they are sure they do not experience drowsiness, sediranost, dizziness, confusion or blurred vision.

3. HOW TO TAKE TRITTICO XR 150 mg tablets c prolonged release
The drug is taken only by adults.
TRITTICO XR tablets 150 mg are divisible into 2 parts, which allows gradually increasing the dose, depending on the severity of the disease, weight, age and general condition of the patient with a prescription.
The recommended starting dose is 150 mg once daily. The dose may be increased by 75 mg / day (half a tablet of 150 mg) every three days (reaching up to 225 mg / day, the fourth day of treatment) to a maximum of 300 mg / day. In some cases, the initial dose may be reduced to 75 mg / day (half a tablet of 150 mg) with a gradual increase of 75 mg / day (half a tablet of 150 mg) every three days, up to 300 mg / day.
The tablets should be taken on an empty stomach with a glass of water once daily in the evening or at bedtime. The tablets should not be crushed or chewed in order to provide prolonged release of the drug.
In elderly and debilitated patients, the recommended initial dose is reduced to 75 mg daily in divided doses or as a single dose in the evening. The dose can be gradually increased, as described in adults under surveillance according to tolerability and efficacy.

Children: not recommended the use of trazodone in children under 18 years of age due to insufficient data on safety.

Hepatic impairment: trazodone undergoes extensive metabolism in the liver and is also associated with hepatotoxicity, see "Take special care with triticale XR" and "Possible side effects". Patients with liver problems, particularly with severe hepatic impairment should inform their doctor who will decide whether they need periodic monitoring of liver function.

Kidney disorders usually do not need dose adjustment. However, patients with renal impairment, especially in cases of severe renal insufficiency should inform their doctor before starting treatment with TRITTICO XR (see also "Take special care with triticale XR").

If you take more than the amount TRITTICO XR 150 mg prolonged release
The most commonly reported adverse reactions following overdose are dizziness, drowsiness, nausea and vomiting.
In more serious cases were reported coma, tachycardia, hypotension, hyponatraemia, convulsions and difficulty breathing. Cardiac disorders may include bradycardia, QT prolongation and Torsade de Pointes. Symptoms can occur within 24 hours or more after the overdose.
Overdose of trazodone in combination with other antidepressants can cause serotonin syndrome.
In case of accidental ingestion of large doses TRITTICO XR contact your doctor immediately or go to the nearest hospital. Take with you and this leaflet.
In case of overdose should be used charcoal or gastric lavage and blood electrolytes should be adjusted. There is no specific antidote to trazodone.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines TRITTICO XR can cause side effects, although not everybody gets them.
Cases of suicidal ideation and suicidal behavior during treatment with trazodone or shortly after discontinuation.

The following symptoms, some of which are often seen in cases of untreated depression also been reported in patients receiving therapy with trazodone:
Blood dyscrasias (including agranulocytosis, thrombocytopenia, leukopenia and anemia);
Allergic reactions;
Syndrome of inappropriate antidiuretic hormone;
Reducing sodium levels in the blood, weight loss, anorexia, increased appetite;
Suicidal thoughts or suicidal behavior, states of confusion, insomnia, disorientation, mania, anxiety, nervousness, irritability (very rare worsening delirium), delusion, aggressive reactions, hallucinations, nightmares, decreased libido, withdrawal syndrome;
Serotonin syndrome, seizures, neuroleptic malignant syndrome, dizziness, dizziness, headache, drowsiness, restlessness, decreased alertness, tremors, blurred vision, memory impairment, myoclonus, expressed aphasia, paraesthesia, dystonia, taste alteration;
Cardiac arrhythmia (including Torsade de Poites, palpation, premature ventricular contractions, ventricular couplets, ventricular tachycardia, bradycardia, tachycardia, ECG abnormalities (prolongation of QT);
Orthostatic hypotension, hypertension, seizures;
Nasal congestion, difficulty breathing;
Nausea, vomiting, dry mouth, constipation, diarrhea, dyspepsia, abdominal pain, gastroenteritis, increased salivation, paralytic ileus;
Liver dysfunction (including jaundice and hepatocellular damage), intrahepatic cholestasis;
Skin rash, pruritus, hyperhidrosis;
Pain in extremity, back pain, myalgia, arthralgia;
Disturbances in urination;
priapism;
Weakness, swelling, flu-like symptoms, fatigue, chest pain, fever;
Elevations of liver enzymes.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE TRITTICO XR150 mg prolonged-release tablets
The medicinal product does not require any special storage conditions.
Do not use TRITTICO XR 150 mg prolonged release after the expiry date stated on the packaging.
Keep out of reach of children.