Trittico Xr

Leaflet accompanying the packaging: information for the user

Trittico XR

150 mg, prolonged-release coated tablets

300 mg, prolonged-release coated tablets

Trazodone hydrochloride

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Trittico XR and what is it used for
• 2. Important information before taking Trittico XR
• 3. How to take Trittico XR
• 4. Possible side effects
• 5. How to store Trittico XR
• 6. Contents of the packaging and other information

1. What is Trittico XR and what is it used for

Trittico XR contains trazodone, which has antidepressant and anti-anxiety effects. The therapeutic effect occurs after about a week of use.
The indications for use of Trittico XR are depressive disorders of various origins, including depression with anxiety.

2. Important information before taking Trittico XR

When not to take Trittico XR

If the patient is allergic (hypersensitive) to trazodone hydrochloride or any of the other ingredients of the medicine.
If the patient is under the influence of alcohol or sedatives.
If the patient has had a recent acute myocardial infarction.

Warnings and precautions

Before starting treatment with Trittico XR, the patient should discuss it with their doctor or pharmacist.

• Trittico XR should be used with caution and under close medical supervision in patients with liver, kidney, or heart disease, especially with conduction disorders, prolonged QT interval on the ECG, atrioventricular block of any degree, and recently after a myocardial infarction.
• Trazodone may slow down heart rate and cause a drop in blood pressure, especially when changing body position to upright, which may be accompanied by a reflex increase in heart rate. For this reason, in patients taking trazodone with blood pressure-lowering drugs, it may be necessary to reduce their dose. The decision to reduce the dose of antihypertensive drugs is made by the doctor.
• Patients with depression may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressants, as these drugs usually start working after 2 weeks, sometimes later.

If the patient experiences suicidal thoughts or thoughts of self-harm, they should immediately contact their doctor or go to the hospital. It may be helpful to inform relatives or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask their relatives or friends for help and ask them to inform them if they notice that the depression or anxiety has worsened or if there are other worrying changes in behavior. Close monitoring of the patient is especially required at the beginning of treatment and after changing the dose of the medicine.

• The occurrence of suicidal thoughts, thoughts of self-harm, or suicide is more likely if: the patient has had suicidal thoughts or self-harm in the past; the patient is a young adult, as clinical trial data indicate an increased risk of suicidal behavior in people under 25 with mental disorders who have been treated with antidepressants.
• If the patient experiences suicidal thoughts or thoughts of self-harm, they should immediately contact their doctor or go to the hospital. It may be helpful to inform relatives or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask their relatives or friends for help and ask them to inform them if they notice that the depression or anxiety has worsened or if there are other worrying changes in behavior. Close monitoring of the patient is especially required at the beginning of treatment and after changing the dose of the medicine.
• Special caution should be exercised when using antidepressants in patients with schizophrenia or other psychotic disorders. Paranoid thoughts may worsen. If the symptoms of the disease worsen, trazodone should be discontinued.
• Special caution should also be exercised when using trazodone in patients with epilepsy; it is especially important to avoid sudden increases or decreases in dose.
• Caution should also be exercised in patients with hyperthyroidism, urinary retention disorders (e.g., prostate enlargement), narrow-angle glaucoma, and increased intraocular pressure.
• Special caution is recommended when using anticoagulant and/or antiplatelet drugs and in patients with a known tendency to bleed.
• In elderly patients, the use of trazodone may more often cause a drop in blood pressure (especially when changing body position to upright) or drowsiness. Such symptoms should be closely monitored at the beginning of treatment and after each dose increase. Concomitant use of psychotropic or antihypertensive drugs, as well as the presence of concomitant disease, may worsen these symptoms.
• During treatment with trazodone, hematological disorders may occasionally occur, such as agranulocytosis (manifested by flu-like symptoms, sore throat, and fever). Rare cases of liver function disorders, sometimes severe, such as jaundice and liver cell damage, have been reported. In such cases, trazodone should be discontinued immediately and the patient should contact their doctor.
• Very rarely, a prolonged painful erection has been reported, which also requires discontinuation of trazodone and prompt medical intervention.
• The concomitant use of other antidepressants with neuroleptic drugs (drugs used in schizophrenia) may cause very serious and life-threatening side effects in the form of serotonin syndrome and malignant neuroleptic syndrome. Therefore, if symptoms such as altered consciousness, muscle tremors, seizures, chills, and fever occur, trazodone should be discontinued immediately and the patient should contact their doctor.
• Gradually increasing the daily dose of the medicine up to the maximum recommended dose reduces the risk of side effects.
• When stopping treatment with trazodone, especially long-term treatment, it is recommended to gradually reduce the dose to minimize the risk of withdrawal symptoms such as nausea, headache, and malaise.
• The medicine should not be used in children and adolescents under 18 years of age. The use of drugs from this group in patients under 18 may increase the risk of side effects such as suicidal thoughts and hostility (aggression, rebellion, manifestations of anger). Additionally, there is a lack of data confirming the safety of long-term use of Trittico XR in children and adolescents in terms of its impact on growth, maturation, and the development of cognitive and behavioral processes.
• The doctor will decide on the lowest effective dose of the medicine. Treatment with Trittico XR requires regular visits to the doctor, who will decide on the continuation of this treatment each time.

If any of the above situations apply to the patient (or the patient is unsure), they should consult their doctor or pharmacist before taking Trittico XR.

Effect on urine test results

In screening urine tests performed using a specific method (immunological tests), false-positive results indicating the presence of amphetamine may appear in patients taking Trittico XR. This is due to the similarity in structure between the trazodone metabolite and the amphetamine derivative (ecstasy). In such cases, the patient should consult their doctor to perform an additional test using a different method (mass spectrometry or liquid chromatography-tandem mass spectrometry).

Trittico XR and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may interact with each other or should not be taken at the same time with Trittico XR.
These medicines include:
Antipsychotic, sedative, anxiolytic, and antihistamine drugs (trazodone may enhance their effects; the doctor will recommend appropriate dose adjustments).
Oral contraceptives, phenytoin, carbamazepine, and barbiturates (they may reduce the effect of trazodone).
Cimetidine and some antipsychotic drugs (they may enhance or prolong the effect of antidepressants).
Erythromycin, ketoconazole, itraconazole, ritonavir, indinavir, and nefazodone (they may enhance the side effects of Trittico XR; if possible, their concomitant use with trazodone should be avoided or the doctor may consider reducing the dose of trazodone).
Carbamazepine (it may reduce the plasma concentration of trazodone, and the doctor, after careful observation of the patient, may increase the dose).
Tricyclic antidepressants (their concomitant use with trazodone should be avoided due to the risk of serotonin syndrome and cardiovascular side effects).
Fluoxetine (it may increase the risk of serotonin syndrome).
Monoamine oxidase inhibitors (MAOIs) (trazodone should not be used during MAOI treatment and for 2 weeks after its discontinuation. MAOIs should also not be administered for a period of 1 week after discontinuation of trazodone).
Phenothiazine derivatives, such as chlorpromazine, fluphenazine, levomepromazine, or perphenazine (they may cause severe orthostatic hypotension).
Muscle relaxants and anesthetic gases (trazodone may enhance their effects; caution should be exercised during concomitant use).
Alcohol (trazodone may enhance its sedative effect; alcohol should be avoided during treatment with trazodone).
Levodopa (trazodone may reduce its effect).
Clonidine (trazodone may significantly reduce the effect of clonidine in animals. There are no reports in humans regarding the interaction between trazodone and other blood pressure-lowering drugs, but the potential effect of trazodone on their action should be considered).
Drugs with known QT-prolonging effects (they may increase the risk of cardiac arrhythmias in the form of dangerous ventricular arrhythmias; caution should be exercised during their concomitant use with trazodone).
St. John's wort (Hypericum perforatum) preparations may enhance the side effects caused by trazodone.
Anticoagulant and/or antiplatelet drugs (they may alter blood coagulation, with a risk of bleeding).

Trittico XR with food and alcohol

Tablets should be taken on an empty stomach, with a glass of water.
The medicine may enhance the sedative effect of alcohol. The patient should not drink alcohol during treatment with Trittico XR.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or is planning to have a child, they should consult their doctor or pharmacist before taking this medicine.
If trazodone was used during pregnancy until delivery, the newborn should be monitored for withdrawal symptoms.
In breastfeeding women, the possibility of the medicine passing into breast milk should be considered.
The use of Trittico XR during pregnancy and breastfeeding should be limited to special cases, after careful consideration by the doctor of the benefit-to-risk ratio.

Driving and operating machinery

Trazodone may slightly or moderately impair the ability to drive and operate machinery. The patient should not drive or operate machinery if they experience drowsiness, excessive sedation, dizziness, confusion, or blurred vision.

Trittico XR contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Trittico XR

This medicine should always be taken according to the doctor's or pharmacist's recommendations. If the patient has any doubts, they should consult their doctor or pharmacist.
Tablets with a dividing line can be divided, which allows for gradual dose increase.
Adults
The recommended initial dose is 150 mg per day.
This dose may be increased by 75 mg per day (half a 150 mg tablet) at 3-day intervals (which means, for example, that on the fourth day of treatment, the dose is 225 mg per day), up to a maximum daily dose of 300 mg.
Sometimes the doctor may recommend reducing the initial daily dose to 75 mg (half a 150 mg tablet), and then gradually increasing the dose at 3-day intervals by 75 mg per day (half a 150 mg tablet), up to a maximum daily dose of 300 mg.
The doctor may decide to use a lower dose of trazodone, depending on the individual patient's response to treatment.
Children and adolescents
Trittico XR should not be used in children and adolescents under 18 years of age.
Frail patients and elderly patients
The recommended initial dose for elderly or frail patients is 75 mg per day, given as a single dose in the evening before bedtime. The doctor may then gradually increase the dose, depending on individual tolerance and efficacy.
Patients with liver impairment
Trazodone is intensively metabolized in the liver and may have toxic effects on this organ. Therefore, caution should be exercised when using Trittico XR in patients with liver impairment, especially in cases of severe impairment. The doctor may recommend periodic monitoring of liver function.
Patients with renal impairment
Usually, there is no need to adjust the dose, but caution should be exercised when using the medicine in patients with severe renal impairment.
Method of administration
Tablets should always be taken once a day, in the evening or just before bedtime, on an empty stomach, with a glass of water. To ensure prolonged release of the tablets, they should not be crushed or chewed.

Taking a higher dose of Trittico XR than recommended

The most common symptoms of trazodone overdose are drowsiness, dizziness, nausea, and vomiting.
In more severe cases, coma, tachycardia (rapid heart rate), hypotension, decreased sodium levels in the blood, seizures, respiratory disorders, and changes in the ECG have been observed. Symptoms may occur within 24 hours of overdose or later.
Overdose of trazodone with other antidepressants may cause serotonin syndrome.
After an overdose, the doctor will try to empty the patient's stomach as soon as possible by inducing vomiting, and if the patient is conscious, they will be given activated charcoal or their stomach will be lavaged. The doctor will also correct the electrolyte levels in the blood. There is no specific antidote.
In case of taking a higher dose of Trittico XR than recommended, the patient should immediately consult their doctor or pharmacist, taking the medicine packaging with them.

Missing a dose of Trittico XR

If a dose of the medicine is missed, the patient should not take a double dose to make up for the missed dose, but should take it at the time specified in the recommended dosing schedule.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
There have been reports of suicidal thoughts and behaviors during treatment with trazodone or shortly after its discontinuation.
In patients treated with trazodone, the following side effects have been observed, with an unknown frequency of occurrence (the frequency cannot be determined based on available data), and some of them also occur frequently in patients with untreated depression:
Abnormal blood test results, including significant decreases in white blood cell count - granulocytes (agranulocytosis), decreased platelet count (thrombocytopenia), increased eosinophil count (eosinophilia), decreased leukocyte count (leukopenia), and anemia (decreased red blood cell count).
Allergic reactions.
Syndrome of inappropriate antidiuretic hormone secretion (leading to fluid retention in the body).
Decreased sodium levels in the blood, decreased body weight, loss of appetite, increased appetite.
Suicidal thoughts or behaviors, confusion (altered consciousness), insomnia, disorientation, mania, anxiety, nervousness, agitation (sometimes progressing to delirium), delusions, aggressive behavior, hallucinations, nightmares, decreased libido, withdrawal syndrome.
Serotonin syndrome, seizures, malignant neuroleptic syndrome, dizziness, balance disorders, headache, drowsiness, restlessness (mainly motor), decreased alertness, tremors, blurred vision, memory disorders, brief, violent muscle contractions (clonic muscle seizures), inability to pronounce certain words (expressive aphasia), feeling of tingling, numbness, and tingling of limbs (paresthesia), involuntary body movements, changes in taste.
Cardiac arrhythmias (including torsades de pointes, palpitations, premature ventricular contractions, pairs of ventricular contractions, ventricular tachycardia), slowed heart rate, tachycardia (rapid heart rate), abnormal ECG (prolonged QT interval).
Drop in blood pressure when standing up, causing dizziness or fainting (orthostatic hypotension), hypertension, fainting.
Feeling of a blocked nose, shortness of breath.
Nausea, vomiting, dry mouth, constipation, diarrhea, indigestion, abdominal pain, inflammation of the stomach and intestines, salivation, significantly decreased or stopped intestinal peristalsis (paralytic ileus).
Abnormal liver function (including jaundice and liver cell damage), intrahepatic cholestasis.
Skin rash, itching, excessive sweating.
Pain in limbs, back, muscles, joints.
Urinary disorders, urinary incontinence (loss of urine), urinary retention (inability to urinate).
Painful prolonged erection (priapism).
Weakness, swelling, flu-like symptoms, fatigue, chest pain, fever.
Increased activity of liver enzymes.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel. +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Trittico XR

Store in a place out of sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Trittico XR contains

The active substance of the medicine is trazodone hydrochloride.
Trittico XR 150 mg prolonged-release coated tablets: each prolonged-release coated tablet contains 150 mg of trazodone hydrochloride, which corresponds to 136.6 mg of trazodone.
In addition, the medicine contains:
Tablet core:contramid granulate (modified starch), hypromellose, colloidal anhydrous silica, sodium stearylfumarate.
Coating:Yellow Opadry II (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide, red iron oxide).
Trittico XR 300 mg prolonged-release coated tablets: each prolonged-release coated tablet contains 300 mg of trazodone hydrochloride, which corresponds to 273.2 mg of trazodone.
In addition, the medicine contains:
Tablet core:contramid granulate (modified starch), hypromellose, colloidal anhydrous silica, sodium stearylfumarate.
Coating:Pink Opadry II (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide, red iron oxide).

What Trittico XR looks like and contents of the pack

Trittico XR 150 mg: has the form of yellowish-beige prolonged-release coated tablets with a dividing line on both sides, which facilitates division into 2 equal doses.
Trittico XR 300 mg: has the form of beige-orange prolonged-release coated tablets with a dividing line on both sides, which facilitates division into 2 equal doses.
The immediate packaging of the medicine is a blister pack containing 7 or 10 prolonged-release coated tablets.
The outer packaging (carton) contains: 10, 14, 20, 28, 30 prolonged-release coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
Viale Amelia 70
00181 Rome, Italy

Manufacturer:

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
Via Vecchia del Pinocchio

• 22 - 60131 Ancona, Italy

Representative of the marketing authorization holder:

Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B
02-222 Warsaw
tel.: (22) 70 28 200
e-mail: [email protected]
A leaflet in a format suitable for the blind or visually impaired is available at the representative's office of the marketing authorization holder.

Date of last revision of the leaflet: