Trazodone Neuraxpharm

Package Leaflet: Information for the Patient

Trazodone Neuraxpharm, 50 mg, tablets

Trazodone Neuraxpharm, 100 mg, tablets

Trazodone Neuraxpharm, 150 mg, tablets

Trazodone hydrochloride

Read the package 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, including those not listed in this leaflet, please inform your 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 pack 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:

Warnings and precautions

Suicidal thoughts and worsening of depression

If you have depression, you may sometimes have thoughts of self-harm or suicidal thoughts. These thoughts may worsen when you start taking antidepressant medicines, because these medicines start working only after some time, usually after about 2 weeks, and sometimes later. A greater tendency to such thoughts may occur:

If you ever have thoughts of self-harm or suicidal thoughts, you must immediately
contact your doctor or go to the hospital.
It may be helpful to inform a relative or friendthat you have depression and ask them to read this leaflet. You may ask them to keep an eye on you and inform you if they notice that your depression or anxiety has worsened or if you have made any disturbing changes in your behavior.
There have been reports of severe liver dysfunction during treatment with Trazodone Neuraxpharm. If you experience any of the following symptoms, you must immediately contact your 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.
Caution is required, especially if the patient has other conditions and is taking medicines for them, as well as Trazodone Neuraxpharm.

Before taking this medicine, you should discuss it with your doctor or pharmacist if:

• you have or have had seizures or epilepsy;
• you have liver or kidney disease, especially severe;
• you have heart disease [such as: heart failure and vascular disease, angina pectoris, conduction disorders or various degrees of atrioventricular block, arrhythmias, recently suffered myocardial infarction, prolonged QT interval syndrome or reduced heart rate (bradycardia)];
• you have low potassium levels in the blood (hypokalemia), which can lead to weakness and muscle cramps, abnormal heart rhythm;
• you have low magnesium levels in the blood (hypomagnesemia);
• you have increased thyroid function (hyperthyroidism);
• you have difficulty urinating or feel the need to urinate frequently;
• you have prostate enlargement (prostate hypertrophy);
• you have narrow-angle glaucoma (eye disorder);
• you have low blood pressure (hypotension);
• you have schizophrenia or other mental illness;
• you are elderly, as you 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, agitation, hallucinations, or hyponatremia (low sodium levels in the blood, which can cause fatigue, weakness, disorientation, and pain, stiffness, and lack of muscle coordination).

If you have liver, kidney, heart, epilepsy, increased pressure in the eyeball (glaucoma), difficulty urinating, or prostate disorders, your doctor will periodically monitor your health while taking Trazodone Neuraxpharm.
During treatment with trazodone, severe liver dysfunction resulting in death has been reported.
You must stop taking Trazodone Neuraxpharm and immediately contact your doctor if you experience yellowing of the skin or the white part of the eye (jaundice), or if you experience symptoms such as weakness (asthenia), loss of appetite, nausea, vomiting, abdominal pain. See section 4. Possible side effects.
If you have schizophrenia or other mental disorder, taking 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, taking Trazodone Neuraxpharm must be stopped immediately.
If you experience a sore throat, fever, or flu-like symptoms while taking Trazodone Neuraxpharm, you must immediately contact your doctor. In such a situation, it is recommended to have a blood test, as these may be clinical symptoms of agranulocytosis, a blood disorder.
Caution is required if trazodone is taken with other medicines known to prolong the QT interval 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 taken by children and adolescents under 18 years of age.
If you are not sure if any of the above situations apply to you, you should contact your doctor or pharmacist before taking Trazodone Neuraxpharm.

Trazodone Neuraxpharm and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you 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.

Tell your doctor if you 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), even if you have 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 effect of prolonging the QT interval on the ECG, 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) (a herbal preparation);
• warfarin (used to prevent blood clots);
• buprenorphine. This medicine may interact with Trazodone Neuraxpharm and may cause symptoms such as: involuntary, rhythmic muscle contractions, including those that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle stiffness, or body temperature above 38°C. If you experience such symptoms, you should contact your doctor.

Anesthetics (anesthetic medicines)

If you are scheduled to receive an anesthetic (e.g., during surgery), you should inform your doctor or dentist that you are taking Trazodone Neuraxpharm.

Trazodone Neuraxpharm with food, drink, and alcohol

Do not consume alcohol while taking Trazodone Neuraxpharm.

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 Neuraxpharm was taken in the last months of pregnancy, the newborn may experience withdrawal symptoms.

Driving and using machines

You may experience drowsiness or dizziness. You may also experience blurred vision and disorientation. If these symptoms occur, do not drive or operate tools or machines.

3. How to take Trazodone Neuraxpharm

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

What dose of Trazodone Neuraxpharm to take

Adults:

• The initial dose for 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

• The initial dose for elderly patients or debilitated patients is usually 100 mg per day.

Children and adolescents

Trazodone Neuraxpharm should not be taken by 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 you have taken a higher dose of Trazodone Neuraxpharm than recommended, you should immediately contact your doctor or go to the hospital emergency department. You should take the medicine packaging with you so that the doctor knows what medicine was taken.
The following symptoms may occur: nausea or vomiting, drowsiness, dizziness, or fainting, seizures (epileptic fits), disorientation, breathing difficulties, or heart problems.

Missing a dose of Trazodone Neuraxpharm

If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose.
Do not take a double dose to make up for the missed dose.

Stopping treatment with Trazodone Neuraxpharm

Do not stop taking Trazodone Neuraxpharm unless your doctor tells you to. You should not stop taking Trazodone Neuraxpharm just because you feel better. If your doctor decides to stop treatment, they will advise you to gradually reduce the dose to minimize the risk of withdrawal symptoms, such as: agitation, difficulty sleeping, nausea, headache, and malaise.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking the medicine and immediately go to your doctor or hospital if:

• you 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 you have had an allergic reaction.
• you experience a painful erection unrelated to sexual activity that does not subside (priapism).
• you experience loss of appetite, nausea, or vomiting, disorientation, abdominal pain, fever, or yellowing of the whites of the eyes and skin (jaundice). These may be symptoms of severe liver disease (hepatitis).
• you are more prone to infections than usual. This may be due to a blood disorder (agranulocytosis).
• you experience bruising more easily than usual. This may be due to a blood disorder (thrombocytopenia).
• you experience severe abdominal pain and bloating, vomiting, and constipation. These may be symptoms of abnormal bowel function (paralytic ileus).

Immediately contact your doctor if you experience the following side effects:

• feeling tired, fainting, dizziness, pale skin. These may be symptoms of anemia.
• seizures and (or) epileptic fits
• abnormal sensations on the skin, such as: numbness, tingling, prickling, burning, chill, or paresthesia
• feeling disoriented, restless, sweating, trembling, shivering, hallucinations (strange visions or sounds), sudden involuntary movements (jerks) of muscles or rapid heartbeat, you 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 condition known as malignant neuroleptic syndrome.

Other reported side effects:

• feeling drowsy or sleepy,
• feeling less alert than usual
• nausea (feeling sick) or vomiting,
• constipation, diarrhea
• dryness of the mucous membranes 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 may 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 spasms
• frequent infections with high fever, severe convulsions, 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
• reduced 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. You 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 you experience any side effects, including those not listed in this leaflet, please inform your 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, you can help provide more information on the safety of this medicine.

5. How to store Trazodone Neuraxpharm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP" or on the blister after "EXP". The expiry date refers to the last day of the month stated.
There are no special storage instructions for this medicine. Store in the original package to protect from light.
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 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, carbomer (type A), corn starch, colloidal anhydrous silica, and magnesium stearate.

What Trazodone Neuraxpharm looks like and contents of the pack

Trazodone Neuraxpharm, 50 mg, are white or almost white, round, biconvex tablets without coating with a score line, 7.14 mm in diameter, with "IT" and "I" embossed on one side and smooth on the other.
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 "IT" and "II" embossed on one side and smooth on the other.
The tablet can be divided into equal doses.
Trazodone Neuraxpharm, 150 mg, are white or almost white, oval, flat tablets without coating with beveled edges, 16.90 mm long and 8.40 mm wide, with a score line, with "IT" and "III" embossed on one side and smooth on the other.
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 on this medicine and its names in the Member States of the European Economic Area, please contact the representative of the marketing authorization holder:

Neuraxpharm Polska Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
[email protected]

Date of last revision of the leaflet: 01/2022