Trittico Cr

Package Leaflet: Information for the User

Trittico CR

75 mg, prolonged-release tablets

150 mg, prolonged-release tablets

Trazodone hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, tell your doctor or pharmacist. See section 4.

Contents of the pack and other information:

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

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

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

2. Important information before taking Trittico CR

When not to take Trittico CR

If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
If you are under the influence of alcohol or sedatives.
If you have had a recent acute myocardial infarction.

Warnings and precautions

Before starting treatment with Trittico CR, discuss it with your doctor or pharmacist.

• Trittico CR 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 recent myocardial infarction.
• Trazodone does not affect the heart muscle in a way typical of tricyclic antidepressants, but its action 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. Therefore, in patients taking trazodone with other blood pressure-lowering drugs, it may be necessary to reduce their dose. The need to reduce the dose of antihypertensive drugs is decided 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.

and can be more likely to occur 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 you experience suicidal thoughts or thoughts of self-harm, contact your doctor or hospital immediately. It may be helpful to inform your relatives or friends about your depression or anxiety and ask them to read this leaflet. You can ask your relatives or friends for help and ask them to monitor you if they notice that your depression or anxiety has worsened or if you have other disturbing changes in behavior. Close monitoring of the patient is especially required at the beginning of treatment and after changing the dose of the medicine.
• Particular caution should be exercised when using antidepressants in patients with schizophrenia or other psychotic disorders. If the symptoms of the disease worsen, trazodone should be discontinued.
• Particular caution should also be exercised when using trazodone in patients with epilepsy; it is especially important to avoid sudden increases or decreases in dose.
• Additionally, caution should be exercised in patients with hyperthyroidism, urinary retention (e.g., prostate enlargement), acute narrow-angle glaucoma, and increased intraocular pressure.
• 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. Particular attention should be paid to this at the beginning of treatment and during each dose increase of the medicine. These symptoms may worsen due to the concurrent use of psychotropic or antihypertensive drugs, as well as the presence of concomitant disease.
• During treatment with trazodone, hematologic disorders may occasionally occur, such as agranulocytosis (manifested by flu-like symptoms, sore throat, and fever), thrombocytopenia (which may cause bruising and petechiae on the skin), and anemia (manifested by pallor of the skin). Rarely, liver function disorders have been reported, sometimes serious, such as jaundice and liver cell damage. In such cases, trazodone should be discontinued immediately and a doctor should be consulted.
• Very rarely, a prolonged painful erection has occurred, also requiring discontinuation of trazodone and prompt medical intervention.
• The use of other antidepressants together 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 a doctor should be consulted.
• Gradually increasing the daily dose of the medicine to the maximum recommended dose reduces the risk of side effects.
• When discontinuing trazodone treatment, especially long-term treatment, it is recommended to gradually decrease the dose to minimize the occurrence 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 CR in children and adolescents in terms of its impact on growth, maturation, and the development of cognitive and behavioral processes.

Effect on urine test results

In screening urine tests performed by a specific method (immunological tests) in patients taking Trittico CR, false-positive results may appear indicating the presence of amphetamine. This is due to the similarity in structure between trazodone metabolite and amphetamine derivative (ecstasy). In such a case, it is necessary to consult a doctor to perform an additional test by another method (mass spectrometry or liquid chromatography - tandem mass spectrometry).
If any of the above situations apply to the patient (or the patient is unsure), they should consult a doctor or pharmacist before taking Trittico CR.

Trittico CR and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Some medicines may interact with each other or should not be taken together with Trittico CR.
These include:
Antipsychotic, sedative, anxiolytic, and antihistamine drugs (trazodone may enhance their effects; the doctor will recommend appropriate dose adjustments of the taken medicines).
Oral contraceptives, phenytoin, carbamazepine, and barbiturates (they weaken the effect of trazodone).
Cimetidine and some antipsychotic drugs (they enhance or prolong the effect of antidepressant drugs).
Erythromycin, ketoconazole, itraconazole, ritonavir, indinavir, and nefazodone (they enhance the side effects of Trittico CR; if possible, their concurrent use with trazodone should be avoided or the doctor will consider reducing the dose of trazodone).
Carbamazepine (it reduces the plasma concentration of trazodone and the doctor, after careful observation of the patient, may increase its dose).
Tricyclic antidepressants (their concurrent 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) (it is not recommended to take trazodone during MAOI treatment and for two weeks after their discontinuation. It is also not recommended to take MAOIs for a period of one week after discontinuing 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 their concurrent use).
Alcohol (trazodone enhances its sedative effect; avoid consuming alcohol during trazodone treatment).
Levodopa (trazodone may weaken its effect).
Clonidine (trazodone significantly weakens the effect of clonidine in animals. There are no reports in humans regarding the interaction of trazodone with other blood pressure-lowering drugs, but it should be considered that trazodone may affect their action).
Drugs with a known effect of prolonging the QT interval (they increase the risk of heart disorders in the form of dangerous ventricular arrhythmias; caution should be exercised during their concurrent use with trazodone).
St. John's Wort (Hypericum perforatum) preparations may enhance the side effects caused by trazodone.
Anticoagulant and/or antiplatelet drugs (used to reduce blood clotting): blood clotting may change, with a risk of bleeding.
Digoxin, phenytoin (trazodone may increase their serum concentration, enhancing their effect).

Trittico CR with food and drink

The medicine can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Animal studies and data from a limited number of pregnant women (less than 200) do not indicate an adverse effect of trazodone on the course of pregnancy or the health of the fetus and newborn. Currently, there are no other epidemiological data available. If trazodone was used during pregnancy until delivery, the newborn should be monitored for withdrawal symptoms. In breastfeeding women, it should be considered that the drug may pass into breast milk.

• Trittico CR should only be used during pregnancy and breastfeeding in special cases, after careful consideration by the doctor of the benefit-to-risk ratio.

Taking Trittico CR during pregnancy and breastfeeding should be limited to special cases, after careful consideration by the doctor of the benefit-to-risk ratio.

Driving and using machines

Trazodone may slightly or moderately impair the ability to drive and use machines. Do not drive or operate machines if you experience drowsiness, excessive sedation, dizziness, confusion, or blurred vision.

Trittico CR contains sucrose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Trittico CR

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Trittico CR is only used in adult patients.
It is recommended to start treatment with an evening dose. If necessary, the dose of the medicine can be gradually increased according to the doctor's recommendations. The medicine should be taken orally with or without food, and treatment should last at least one month.
The tablets of Trittico CR are divisible into three parts, which facilitates individual dose adjustment of the medicine depending on the severity of the disease, body weight, age, and overall health of the patient.
Recommended dose
Adult patients
The usual dose of the medicine is 75-150 mg per day orally, in one evening dose, before bedtime.
The dose can be gradually increased to 300 mg per day in divided doses.
In hospitalized patients, the dose can be increased to 600 mg per day in divided doses.
Debilitated and elderly patients
Elderly patients should be given lower doses, depending on individual efficacy and tolerance. In these cases, it is recommended to start treatment with the smallest doses of the medicine.
The recommended initial dose is 100 mg per day in divided doses or in one evening dose before bedtime. The dose can then be gradually increased according to the doctor's recommendations, but it is generally recommended to avoid using single doses larger than 100 mg. It is unlikely that a dose increase above 300 mg per day will be necessary.
Patients with liver impairment
Trittico CR is metabolized in the liver and its use may be associated with toxic effects on the liver. Patients with liver impairment, especially severe, should inform their doctor, who will decide whether it is necessary to periodically monitor liver function.
Patients with renal impairment
Usually, there is no need to adjust the dose. However, patients with renal impairment, especially severe, should inform their doctor before starting treatment with the medicine.

Use in children and adolescents

Trittico CR should not be used in children and adolescents under 18 years of age.

Overdose of Trittico CR

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 in combination with other antidepressants may cause serotonin syndrome.
In case of overdose, the patient's stomach should be emptied as soon as possible by inducing vomiting if the patient is conscious, administering activated charcoal, or performing gastric lavage, and electrolyte levels in the blood should be corrected. There is no specific antidote known.
In case of overdose of Trittico CR, consult a doctor or pharmacist immediately, taking the medicine packaging with you.

Missed dose of Trittico CR

If you miss a dose, do not take a double dose to make up for the missed dose, but take it at the time resulting from the recommended dosing schedule.
If you have any further questions about taking the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Trittico CR 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 (frequency cannot be estimated from the available data), and some of them also occur frequently in patients with untreated depression:
Abnormal blood test results, including agranulocytosis (a significant decrease in the number of white blood cells - granulocytes), thrombocytopenia (decrease in the number of platelets), eosinophilia (increase in the number of acidophilic leukocytes), leukopenia (decrease in the number of leukocytes), and anemia (decrease in the number of red blood cells).
Allergic reactions.
Syndrome of inappropriate antidiuretic hormone secretion (leading to fluid retention in the body).
Decreased sodium levels in the blood, decreased body weight, anorexia, increased appetite.
Suicidal thoughts or behaviors, confusion (altered consciousness), insomnia, disorientation, mania, anxiety, nervousness, agitation (rarely 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, clonic muscle seizures (short, sudden muscle contractions), expressive aphasia (inability to pronounce certain words), paresthesia (feeling of pricking, tingling, and numbness of limbs), involuntary body movements, change in taste.
Cardiac arrhythmias (including torsades de pointes, palpitations, premature ventricular contractions, pairs of ventricular excitations, ventricular tachycardia), bradycardia (slow heart rate), tachycardia, abnormal ECG (prolonged QT interval).
Orthostatic hypotension (decrease in blood pressure when standing up, causing dizziness or fainting), hypertension, fainting.
Nasal congestion, shortness of breath.
Nausea, vomiting, dry mouth, constipation, diarrhea, indigestion, abdominal pain, gastrointestinal inflammation, salivation, paralytic ileus (significant decrease or cessation of intestinal peristalsis).
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).
Priapism (painful prolonged erection).
Weakness, edema, flu-like symptoms, fatigue, chest pain, fever.
Increased activity of liver enzymes.

Reporting side effects

If you experience any side effects, tell your doctor or pharmacist. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Aleje 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 CR

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use Trittico CR after the expiry date stated on the carton.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Trittico CR contains

The active substance is trazodone hydrochloride.
Trittico CR 75 mg prolonged-release tablets: Each prolonged-release tablet contains 75 mg of trazodone hydrochloride, equivalent to 68.3 mg of trazodone.
Trittico CR 150 mg prolonged-release tablets: Each prolonged-release tablet contains 150 mg of trazodone hydrochloride, equivalent to 136.6 mg of trazodone.
The other ingredients are: sucrose, povidone, carnauba wax, magnesium stearate.

What Trittico CR looks like and contents of the pack

Trittico CR has the form of prolonged-release tablets with scored lines on both sides, which allow for division into 3 equal doses.
Trittico CR 75 mg: The pack (carton) contains 30 or 90 prolonged-release tablets.
Trittico CR 150 mg: The pack (carton) contains 20, 60, or 90 prolonged-release 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

Istituto de Angeli S.r.L
Loc. Prulli n. 103/c
50066 Reggello (FI), Italy

Representative of the marketing authorization holder:

Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B
02-222 Warsaw
Phone: (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: