Trazodone Neuraxpharm

Leaflet attached to the packaging: patient information

Trazodone Neuraxpharm, 50 mg, tablets

Trazodone Neuraxpharm, 100 mg, tablets

Trazodone Neuraxpharm, 150 mg, tablets

Trazodone hydrochloride

You should carefully read the contents of the leaflet before using 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 to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• 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 Trazodone Neuraxpharm and what is it used for
• 2. Important information before taking Trazodone Neuraxpharm
• 3. How to take Trazodone Neuraxpharm
• 4. Possible side effects
• 5. How to store Trazodone Neuraxpharm
• 6. Contents of the packaging and other information

1. What is Trazodone Neuraxpharm and what is it used for

Trazodone Neuraxpharm contains the active substance trazodone hydrochloride. It belongs to the group of antidepressant medicines. Trazodone Neuraxpharm is used to treat symptoms of depression (episode of severe depression) in adults.

2. Important information before taking Trazodone Neuraxpharm

When not to take Trazodone Neuraxpharm:

• if the patient is allergic to trazodone hydrochloride or any of the other ingredients of this medicine (listed in section 6). The symptoms of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue;
• if the patient has recently had a heart attack (acute myocardial infarction);
• if the patient is under the influence of alcohol or has taken sleeping pills (alcohol or sleeping pill poisoning).

Warnings and precautions

Suicidal thoughts and worsening of depression

If the patient has depression, they may sometimes experience thoughts of self-harm or suicidal thoughts. These thoughts may intensify after starting to take antidepressant medicines, because these medicines start to work only after some time, usually after about 2 weeks, and sometimes later. A greater tendency to such thoughts may occur:

• if the patient has previously experienced suicidal thoughts or self-harm;
• if the patient is a young adult. Data from clinical trials have shown an increased risk of suicidal behavior in adults under 25 years of age with mental illness who were treated with antidepressant medicines.

If the patient ever experiences thoughts of self-harm or suicidal thoughts, they must immediately
contact their doctor or go to the hospital.
It may be helpful to inform a relative or friendthat the patient has depression and
ask them to read this leaflet. The patient may ask them to monitor them if they notice that their depression or anxiety has worsened or if there are worrying changes in their behavior.
There have been reports of severe liver dysfunction during treatment with Trazodone Neuraxpharm. If any of the following symptoms occur, the patient should immediately contact their doctor:
­ weakness (asthenia)
­ loss of appetite (anorexia)
­ nausea, vomiting
­ abdominal pain
­ yellowing of the skin and (or) eyes (jaundice)
Elderly patients
Elderly patients taking Trazodone Neuraxpharm may experience dizziness and dizziness when standing up or stretching. They may also feel more sleepy than usual.
Increased caution is necessary, especially if the patient has other conditions and is taking medicines for them, as well as Trazodone Neuraxpharm.

Before starting to take this medicine, the patient should discuss it with their doctor or pharmacist if:

• the patient has or has ever had seizures or epileptic seizures;
• the patient has liver or kidney disease, especially severe;
• the patient has heart disease [such as: heart failure and circulatory disorders, angina pectoris, conduction disorders or various degrees of atrioventricular block, arrhythmias, recently suffered myocardial infarction, prolonged QT interval or decreased heart rate (bradycardia)];
• the patient has a decreased potassium level in the blood (hypokalemia), which can lead to weakness and muscle cramps, abnormal heart rhythm;
• the patient has a decreased magnesium level in the blood (hypomagnesemia);
• the patient has an increased thyroid function (hyperthyroidism);
• the patient has difficulty urinating or feels a frequent need to urinate;
• the patient has an enlarged prostate (prostate hypertrophy);
• the patient has narrow-angle glaucoma (eye disorder);
• the patient has low blood pressure (hypotension);
• the patient has schizophrenia or other mental illness;
• the patient is elderly, as they may be more prone to side effects, such as: decreased blood pressure when standing up quickly from a sitting or lying position (orthostatic hypotension), sometimes with dizziness and difficulty standing still, mental agitation, hallucinations or hyponatremia (low sodium level in the blood, which can cause fatigue, weakness, disorientation and pain, stiffness and lack of muscle coordination).

If the patient has liver, kidney, heart, epilepsy, increased pressure in the eye (glaucoma), difficulty urinating or prostate disorders, the doctor will periodically monitor the patient's health during treatment with Trazodone Neuraxpharm.
During treatment with trazodone, severe liver dysfunction resulting in death has been reported.
The patient should stop taking Trazodone Neuraxpharm and immediately contact their doctor if they experience yellowing of the skin or the white part of the eye (jaundice), or if they experience symptoms such as weakness (asthenia), loss of appetite, nausea, vomiting, abdominal pain. See section 4. Possible side effects.
If the patient has schizophrenia or other mental disorder, the use of antidepressant medicines may worsen mental symptoms. Paranoid thoughts may worsen. During treatment with Trazodone Neuraxpharm, a depressive episode of manic-depressive psychosis may turn into a manic episode. In such a situation, the use of Trazodone Neuraxpharm should be absolutelystopped.
If the patient experiences a sore throat, fever or flu-like symptoms while taking Trazodone Neuraxpharm, they should immediatelycontact their doctor. In such a situation, it is recommended to perform a blood test, as these may be clinical symptoms of agranulocytosis, a blood disorder.
Caution is recommended if trazodone is used concomitantly with other medicines known to have a QT-prolonging effect or with medicines known to increase the risk of serotonin syndrome or malignant neuroleptic syndrome (see section Trazodone Neuraxpharm and other medicines and section 4. Possible side effects).
Children and adolescents
Trazodone Neuraxpharm should not be used in children and adolescents under 18 years of age.
If the patient is not sure if any of the above situations apply to them, they should contact their doctor or pharmacist before taking Trazodone Neuraxpharm.

Trazodone Neuraxpharm 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.
This includes medicines bought without a prescription, including herbal medicines. Trazodone Neuraxpharm may affect the action of other medicines. Some medicines may also affect the action of Trazodone Neuraxpharm.

The patient should tell their doctor if they are taking any of the following medicines:

• monoamine oxidase inhibitors (MAOIs) such as: tranylcypromine, phenelzine and isocarboxazid (used in depression) or selegiline (used in the treatment of Parkinson's disease), also if the patient has taken them in the last two weeks;
• other antidepressant medicines (such as amitriptyline, nefazodone or fluoxetine);
• tryptophan (an amino acid needed to create proteins);
• triptans (medicines used to treat migraines);
• medicines with a sedative effect (such as: sedatives or sleeping pills);
• medicines used to treat epilepsy, such as: carbamazepine and phenytoin;
• medicines with a known QT-prolonging effect, such as: anti-arrhythmic medicines of class IA and III (a group of medicines used to treat heart rhythm disorders);
• medicines used to treat allergies (hypersensitivity), such as: antihistamines;
• contraceptives (oral contraceptives);
• muscle relaxants (a group of medicines that cause relaxation and reduce muscle tension);
• certain antipsychotic medicines (such as: phenothiazine derivatives, e.g. chlorpromazine, fluphenazine, levomepromazine and perphenazine);
• medicines used to treat high blood pressure, such as: clonidine;
• digoxin (used in the treatment of heart diseases);
• medicines used to treat fungal infections, such as: ketoconazole and itraconazole;
• certain medicines used to treat HIV, such as: ritonavir and indinavir;
• erythromycin, an antibiotic used to treat infections;
• levodopa (used in the treatment of Parkinson's disease);
• St. John's wort (Hypericum perforatum) (herbal preparation);
• warfarin (used to prevent blood clots);
• buprenorphine. This medicine may interact with Trazodone Neuraxpharm and may cause the patient to experience symptoms such as: involuntary, rhythmic muscle contractions, including those that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle stiffness or abnormal muscle function. If the patient experiences such symptoms, they should contact their doctor.

Anesthetics (anesthetic medicines)

If the patient is scheduled to receive an anesthetic medicine (e.g. during surgery), they should inform their doctor or dentist that they are taking Trazodone Neuraxpharm.

Trazodone Neuraxpharm with food, drinks and alcohol

The patient should not consume alcohol while taking Trazodone Neuraxpharm.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. If Trazodone Neuraxpharm was used in the last months of pregnancy, the newborn may experience withdrawal symptoms.

Driving and using machines

The patient may experience drowsiness or dizziness. They may also experience blurred vision and disorientation. If these symptoms occur, the patient should not drive or operate tools or machines.

3. How to take Trazodone Neuraxpharm

This medicine should always be taken according to the doctor's instructions. If the patient has any doubts, they should consult their doctor or pharmacist.

What dose of Trazodone Neuraxpharm to take

Adults:

• The initial dose in adults is usually 150 mg per day, taken as a single dose or in divided doses.
• Depending on the patient's condition, the doctor may gradually increase the dose, e.g. by 50 mg every 3-4 days, up to a maximum dose of 300 mg per day.
• In hospitalized adults, the dose may be 600 mg per day.

Elderly patients

• In elderly or debilitated patients, the initial dose is usually 100 mg per day.

Children and adolescents

Trazodone Neuraxpharm should not be used in children and adolescents under 18 years of age.

How to take this medicine

• Trazodone Neuraxpharm is taken orally. The tablet should be swallowed with water.
• The medicine should be taken after a meal. This may reduce the risk of side effects.

50 mg tablets: The score line on the tablet is not intended for breaking the tablet.
100 mg tablets: The tablet can be divided into equal doses. Each half of the tablet contains 50 mg of trazodone hydrochloride.
150 mg tablets: The tablet can be divided into equal doses. Each half of the tablet contains 75 mg of trazodone hydrochloride.

Duration of treatment

Improvement usually occurs after two to four weeks.
After establishing an effective dose, the patient should take it for at least four weeks.
The doctor will periodically assess the effectiveness of the taken dose and, depending on the patient's condition, decide whether further treatment is necessary.
Usually, the use of antidepressant medicines should be continued until the patient feels well for a period of four to six months.

Taking a higher dose of Trazodone Neuraxpharm than recommended

If the patient has taken a higher dose of Trazodone Neuraxpharm than recommended, they should immediately contact their doctor or go to the hospital emergency department. They should take the medicine packaging with them, so that the doctor knows what medicine was taken.
The following symptoms may occur: nausea or vomiting, drowsiness, dizziness or fainting, seizures (epileptic seizures), disorientation, breathing difficulties or heart disorders.

Missing a dose of Trazodone Neuraxpharm

If the patient misses a dose, they should take it as soon as possible. However, if it is almost time for the next dose, they should skip the missed dose.
The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Trazodone Neuraxpharm

Treatment with Trazodone Neuraxpharm should be continued until the doctor recommends stopping it. The patient should not stop taking Trazodone Neuraxpharm just because they feel better. If the doctor decides to stop the treatment, they will recommend that the patient gradually reduce the dose to minimize the risk of withdrawal symptoms, such as: agitation, difficulty sleeping, nausea, headache and malaise.
If the patient has any further doubts about taking this medicine, they should contact their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The patient should stop taking the medicine and immediately go to the doctor or hospital if:

• they experience swelling of the hands, feet, ankles, face, lips or throat (which may cause difficulty swallowing or breathing), itching of the skin and hives. This may indicate that the patient has experienced symptoms of an allergic reaction.
• they experience a painful erection unrelated to sexual activity that does not subside (priapism).
• they experience loss of appetite, nausea or vomiting, disorientation, abdominal pain, fever, yellowing of the white parts of the eyes and skin (jaundice). These may be symptoms of severe liver disease (hepatitis).
• they are more prone to infections than usual. This may be due to a blood disorder (agranulocytosis).
• they experience bruising more easily than usual. This may be due to a blood disorder (thrombocytopenia).
• they experience severe abdominal pain and bloating, vomiting and constipation. These may be symptoms of abnormal bowel function (paralytic ileus).

The patient should immediately contact their doctor if they experience the following side effects:

• feeling tired, fainting, dizziness, pale skin. These may be symptoms of anemia.
• seizures and (or) epileptic seizures
• abnormal sensations on the skin, such as: numbness, tingling, prickling, burning, chills (paresthesia)
• feeling disoriented, restlessness, sweating, tremors, shivering, hallucinations (strange visions or sounds), sudden involuntary movements (jerks) of muscles or rapid heartbeat, the patient may have experienced serotonin syndrome
• feeling very unwell, with shallow breathing (dyspnea), difficulty moving or walking with a dragging gait, tremors, sudden muscle contractions and high body temperature (above 38°C). This may be a disease known as malignant neuroleptic syndrome.

Below is a list of other reported side effects:

• feeling drowsy and sleepy,
• feeling less alert than usual
• nausea (nausea) or vomiting,
• constipation, diarrhea
• dryness of the mucous membrane of the mouth, altered taste, increased salivation, stuffy nose
• excessive sweating
• dizziness, headache, disorientation (confusion), weakness, tremors
• blurred vision
• weight loss
• rapid or slow heartbeat,
• feeling dizzy or lightheaded when standing up quickly or sitting (orthostatic hypotension),
• feeling restless, difficulty sleeping
• fluid retention, which can lead to swelling of the hands and feet
• skin rash, itching
• chest pain
• limb pain, back pain, muscle pain, joint pain
• involuntary movements (jerks), which cannot be controlled, especially of the hands and feet, uncontrolled muscle movements or cramps
• frequent infections with high fever, severe seizures, sore throat or mouth ulcers. These may be symptoms of a blood disorder known as leukopenia.
• feeling anxious or agitated more than usual, feeling agitated
• excessive activity or racing thoughts (mania), imagining things that do not exist (delusions), memory disorders
• nightmares
• decreased sexual desire
• dizziness, feeling dizzy (vertigo of labyrinthine origin)
• high blood pressure
• high body temperature
• flu-like symptoms
• difficulty speaking
• higher than normal white blood cell count (visible in blood tests)
• higher liver enzyme activity in the blood (visible in blood tests)
• severe liver dysfunction, such as hepatitis
• liver failure resulting in death
• feeling tired, weak and disoriented, feeling pain in the muscles, stiffness or abnormal muscle function. The patient may also experience headache, loss of appetite, nausea or vomiting, seizures. This may be due to low sodium levels in the blood.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
By reporting side effects, it is possible to gather more information on the safety of this medicine.

5. How to store Trazodone Neuraxpharm

The medicine should be stored in a place that is invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the carton after "EXP" or on the blister after the abbreviation "EXP". The expiry date refers to the last day of the month stated.
There are no special storage precautions for this medicine. Store in the original packaging to protect from light.
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 Trazodone Neuraxpharm contains

• The active substance of the medicine is trazodone hydrochloride.
• Trazodone Neuraxpharm, 50 mg, tablets: each tablet contains 50 mg of trazodone hydrochloride.
• Trazodone Neuraxpharm, 100 mg, tablets: each tablet contains 100 mg of trazodone hydrochloride.
• Trazodone Neuraxpharm, 150 mg, tablets: each tablet contains 150 mg of trazodone hydrochloride.

Other ingredients of the tablets are: microcrystalline cellulose, sodium carboxymethyl cellulose (type A), corn starch, colloidal anhydrous silica and magnesium stearate.

What Trazodone Neuraxpharm looks like and what the pack contains

Trazodone Neuraxpharm, 50 mg, are white or almost white, round, biconvex tablets without coating with a score line, 7.14 mm in diameter, with the inscription "IT" and "I" on one side and smooth on the other side.
The score line on the tablet is not intended for breaking the tablet.
Trazodone Neuraxpharm, 100 mg, are white or almost white, round, biconvex tablets with a score line, 9.52 mm in diameter, with the inscription "IT" and "II" on one side and smooth on the other side.
The tablet can be divided into equal doses.
Trazodone Neuraxpharm, 150 mg, are white or almost white, oval, flat tablets without coating with a score line, 16.90 mm long and 8.40 mm wide, with the inscription "IT" and "III" on one side and smooth on the other side.
The tablet can be divided into equal doses.
The tablets are available in Aluminum/Aluminum, PVC/PVDC/Aluminum and PVC/Aluminum blisters.
Available pack sizes:
Trazodone Neuraxpharm, 50 mg: 30 tablets in a carton.
Trazodone Neuraxpharm, 100 mg: 30 tablets in a carton.
Trazodone Neuraxpharm, 150 mg: 30 or 100 tablets in a carton.
Not all pack sizes may be marketed.

Marketing authorization holder

neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert Str. 23
40764 Langenfeld
Germany

Manufacturer/Importer

Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic
Laboratori Fundació Dau
C/ C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona
Spain
neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert Str. 23
40764 Langenfeld
Germany

To obtain more detailed information about this medicine and its names in the Member States of the European Economic Area, the patient should contact the representative of the marketing authorization holder:

Neuraxpharm Polska Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
info-poland@neuraxpharm.com

Date of last revision of the leaflet: 01/2022