Trittico Xr

Package Leaflet: Information for the User

Trittico XR

150 mg, prolonged-release tablets

300 mg, prolonged-release tablets

Trazodone hydrochloride

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

• Keep this package 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.
• The medicine may harm others, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What Trittico XR is and what it is 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 pack and other information

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

Trittico XR contains trazodone, which has antidepressant and anxiolytic effects. The therapeutic effect occurs after about one week of treatment.
The indications for 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 you are allergic (hypersensitive) to trazodone hydrochloride or any of the other ingredients of the medicine.
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 XR, discuss it with your 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 recent 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 antihypertensive 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 suicidal thoughts, self-harm, or suicidal behavior occur, contact your doctor or hospital immediately. It may be helpful to inform relatives or friends about depression or anxiety disorders and ask them to read this package leaflet. The patient may ask relatives or friends for help and ask them to inform them if they notice that depression or anxiety has worsened or other worrying changes in behavior have occurred. 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, as paranoid thoughts may worsen. 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.
• Caution should also be exercised in patients with hyperthyroidism, urinary retention (e.g., prostatic hyperplasia), acute narrow-angle glaucoma, or increased intraocular pressure.
• Particular caution is recommended when using anticoagulant or antiplatelet agents 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 paid particular attention to at the beginning of treatment and when increasing the dose of the medicine. Concomitant use of psychotropic or antihypertensive drugs, as well as the presence of concomitant disease, may worsen these symptoms.
• During trazodone treatment, hematologic disorders, such as agranulocytosis (manifested by flu-like symptoms, sore throat, and fever), may occur sporadically. 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 medical attention should be sought.
• Prolonged painful erections have also been reported, which also require discontinuation of trazodone and prompt medical attention.
• The use of other antidepressants concomitantly 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. If symptoms such as altered consciousness, muscle tremors, seizures, chills, and fever occur, trazodone should be discontinued immediately and medical attention should be sought.
• Gradually increasing the daily dose of the medicine up to the maximum recommended dose reduces the risk of side effects.
• When discontinuing trazodone treatment, 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 years of age 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 you (or you are not sure), consult your doctor or pharmacist before taking Trittico XR.

Effect on Urine Test Results

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

Trittico XR and Other Medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
Some medicines may interact with each other or should not be taken concomitantly with Trittico XR.
These medicines 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 may reduce the effect of trazodone).
Cimetidine and some antipsychotic drugs (they may enhance or prolong the effect of antidepressant drugs).
Erythromycin, ketoconazole, itraconazole, ritonavir, indinavir, and nefazodone (they may enhance the side effects of Trittico XR; if possible, avoid concomitant use with trazodone or the doctor will 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 antidepressant drugs (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) (it is not recommended to take trazodone during MAOI treatment and for two weeks after discontinuing MAOIs. 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 when concomitantly using them).
Alcohol (trazodone enhances its sedative effect; avoid consuming alcohol during trazodone treatment).
Levodopa (trazodone may reduce its effect).
Clonidine (trazodone significantly reduces the effect of clonidine in animals. There are no reports in humans regarding the interaction between trazodone and other antihypertensive drugs, but it should be considered that trazodone may affect their action).
Drugs with known QT-prolonging effects (they increase the risk of heart rhythm disorders in the form of life-threatening arrhythmias; caution should be exercised when concomitantly using them with trazodone).
St. John's Wort (Hypericum perforatum) preparations may enhance the side effects caused by trazodone.
Anticoagulant and/or antiplatelet agents (used to reduce blood clotting): blood clotting may change, with a risk of bleeding.
Digoxin, phenytoin (trazodone may increase their serum concentration, enhancing their effects).

Trittico XR with Food and Alcohol

Take the tablets on an empty stomach, with a glass of water.
The medicine enhances the sedative effect of alcohol. Do not drink alcohol during Trittico XR treatment.

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.
If trazodone was used during pregnancy until delivery, monitor the newborn for withdrawal symptoms.
In breastfeeding women, consider the possibility of the medicine passing into breast milk.
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 Machines

Trazodone may slightly or moderately impair the ability to drive and operate machines. Do not drive or operate machines if you 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 the medicine is considered "sodium-free".

3. How to Take Trittico XR

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The tablets can be divided, which allows for gradual dose increase.
Adults
The recommended initial dose is 150 mg once daily.
This dose may be increased by 75 mg once daily (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 once daily), 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 once daily (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 than 300 mg, depending on the individual patient's response to treatment.
Children and Adolescents
Do not use Trittico XR in children and adolescents under 18 years of age.
Frail or Elderly Patients
The recommended initial dose in elderly patients or frail patients is 75 mg once daily, taken 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 extensively 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; however, caution should be exercised when using the medicine if the patient has severe renal impairment.
Method of Administration
Take the tablets once daily, in the evening or just before bedtime, on an empty stomach, with a glass of water. To ensure prolonged release of the tablets, do not crush or chew them.

Overdose of Trittico XR

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 antidepressant drugs may cause serotonin syndrome.
After an overdose, the doctor will try to empty the stomach as soon as possible by inducing vomiting, and if the patient is conscious, will administer activated charcoal or gastric lavage. The doctor will also correct electrolyte levels in the blood. There is no specific antidote.
In case of overdose, seek medical attention immediately, taking the medicine packaging with you.

Missed Dose of Trittico XR

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 using this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Trittico XR can cause side effects, although not everybody gets them.
There have been reports of suicidal thoughts and behaviors during trazodone treatment or shortly after 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 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, 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, short, sudden muscle contractions (clonic muscle spasms), inability to pronounce certain words (expressive aphasia), feeling of tingling, numbness, and prickling of limbs (paresthesia), involuntary body movements, change in taste.
Heart rhythm disorders (including torsades de pointes, palpitations, premature ventricular contractions, pairs of ventricular extrasystoles, 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, gastritis, excessive 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).
Prolonged painful erections (priapism).
Weakness, edema, flu-like symptoms, fatigue, chest pain, fever.
Increased activity of liver enzymes.

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration 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 this medicine.

5. How to Store Trittico XR

Keep out of the sight and reach of children.
No special precautions for storage are necessary.
Do not use this medicine 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 XR Contains

The active substance of the medicine is trazodone hydrochloride.
Trittico XR 150 mg prolonged-release tablets: each prolonged-release tablet contains 150 mg of trazodone hydrochloride, which corresponds to 136.6 mg of trazodone.
Additionally, the medicine contains:
Core:contramid granulate (modified starch gel), hypromellose, anhydrous colloidal silica, sodium stearyl fumarate.
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 tablets: each prolonged-release tablet contains 300 mg of trazodone hydrochloride, which corresponds to 273.2 mg of trazodone.
Additionally, the medicine contains:
Core:contramid granulate (modified starch gel), hypromellose, anhydrous colloidal silica, sodium stearyl fumarate.
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: yellowish-beige prolonged-release tablets with a dividing line on both sides, allowing for division into 2 equal doses.
Trittico XR 300 mg: beige-orange prolonged-release tablets with a dividing line on both sides, allowing for division into 2 equal doses.
The immediate packaging of the medicine is a blister pack of PVC/PVDC/Aluminum foil containing 7 or 10 prolonged-release tablets.
The outer packaging (carton) contains: 10, 14, 20, 28, 30 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

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 package leaflet in a format suitable for the blind or visually impaired is available at the representative of the marketing authorization holder.

Date of Last Revision of the Package Leaflet: