Azoneurax

Package Leaflet: Information for the User

Azoneurax 75 mg, prolonged-release tablets

Azoneurax 150 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. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What Azoneurax is and what it is used for

Azoneurax contains the active substance trazodone hydrochloride. Azoneurax belongs to a group of antidepressant medicines with a pronounced anxiolytic effect, reducing feelings of tension, anxiety, sleep disturbances, and sexual dysfunction. The medicine is also suitable for elderly patients.
The prolonged-release formulation allows for a steady level of the active substance in the blood and once-daily dosing. The tablets can be divided into 3 parts, allowing for gradual adjustment of the optimal individual therapeutic dose.
This medicine is indicated for the treatment of adult patients.

2. Important information before taking Azoneurax

When not to take Azoneurax

• if you are allergic to trazodone or any of the other ingredients of this medicine (listed in section 6).
• if you have recently consumed excessive alcohol or sedatives.
• if you have had a recent acute myocardial infarction (heart attack).

Warnings and precautions

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

Children and adolescents under 18 years

Azoneurax should not be used in children and adolescents under 18 years. The use of medicines of this group in patients under 18 years may increase the risk of side effects such as suicidal thoughts and hostility (aggression, rebellion, signs of anger).
Your doctor may, however, prescribe Azoneurax to patients under 18 years if he/she believes that it will benefit the patient. If your doctor has prescribed Azoneurax to a patient under 18 years and you have concerns, you should discuss them with your doctor. If patients under 18 years who are treated with Azoneurax experience any of the above symptoms or worsening of their condition, they should inform their doctor. There is no evidence on the safety of long-term use of Azoneurax in children and adolescents regarding its effect on growth, maturation, and cognitive and behavioral development.

Suicidal thoughts and worsening of depression or anxiety disorders

Patients with depression may sometimes have thoughts of self-harm or suicide. Such symptoms or behaviors may worsen at the beginning of treatment with antidepressant medicines, as these medicines start to work not immediately, usually after 2 weeks, sometimes later.
Suicidal thoughts are more likely to occur if you have had them before, or if you are a young adult. If you experience suicidal thoughts or self-harm, you should immediately contact your doctor or go to the hospital. It may be helpful to tell your relatives or friends about your depression or anxiety disorder and ask them to read this leaflet. You can ask your relatives or friends to help you and ask them to inform you if they notice that your depression or anxiety has worsened or if you experience any other worrying changes in your behavior.

Patients with schizophrenia and other psychotic disorders

If you have schizophrenia or other psychotic disorders, your symptoms may worsen when taking this medicine. Paranoid thoughts (irritability, suspiciousness, delusions) may be stronger. If, during treatment with trazodone, the depressive phase of manic-depressive psychosis changes to a manic phase, you should immediately contact your doctor.
You should consult your doctor if you have any of the following conditions:

• Epilepsy (you should especially avoid sudden increases or decreases in dose).
• Liver or kidney disease (especially if severe). If jaundice occurs, you should consult your doctor and stop treatment with trazodone.
• Heart diseases, such as angina pectoris, conduction disorders after a heart attack (myocardial infarction).
• Hyperthyroidism.
• Urination disorders, e.g., due to prostate enlargement (although you should not expect problems) - you should inform your doctor if they occur.
• Acute angle-closure glaucoma or increased intraocular pressure (although you should not expect problems) - you should inform your doctor if they occur.

If you have any of the above conditions and have not informed your doctor before being prescribed this medicine, you should do so.

Children and adolescents

Azoneurax should not be used in children and adolescents under 18 years.
There is no evidence of addictive effects of trazodone.

Azoneurax and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as about medicines you plan to take, including those without a prescription.
You should tell your doctor if you are taking any of the following medicines:

• Erythromycin (an antibiotic), ketoconazole, itraconazole (for fungal infections), ritonavir, indinavir (for HIV infections), nefazodone, fluoxetine (antidepressants), carbamazepine, phenytoin (antiepileptics), levodopa (for Parkinson's disease), digoxin (for heart rhythm disorders): if concomitant use with trazodone is necessary, your doctor will consider adjusting the dose.
• Tricyclic antidepressants: when used concomitantly, you should consider the possible development of serotonin syndrome (characterized by fever, muscle tremors, confusion, or agitation) and adverse effects on the heart and blood vessels.
• Monoamine oxidase inhibitors (MAOIs) (used in the treatment of depression). It is not recommended to take trazodone at the same time as MAOIs or within 2 weeks after stopping treatment with these medicines.
• Phenothiazines: a significant drop in blood pressure may occur when standing up quickly.
• St. John's Wort (Hypericum perforatum).
• Anesthetics/muscle relaxants: Trazodone may enhance the effects of inhaled anesthetics (anesthetics administered by inhalation) and the effects of muscle relaxants.
• Warfarin (used to reduce blood clotting): changes in blood clotting may occur.
• Antihypertensive medicines (medicines that lower blood pressure).
• Other medicines: concomitant use of trazodone and medicines that prolong the QT interval in the ECG (heart rhythm disorders) may increase the risk of certain heart problems. Medicines that prolong the QT interval should be used with caution with trazodone.

Effect on urine test results

In screening urine tests performed by a specific method (immunological tests) in patients taking Azoneurax, false-positive results may appear indicating the presence of amphetamines. In such a case, you should consult your doctor to perform an additional test by another method (mass spectrometry or liquid chromatography - tandem mass spectrometry).

Azoneurax with food, drink, and alcohol

The medicine can be taken with or without food. You should swallow the tablet with a glass of water.
Trazodone enhances the sedative effect of alcohol. During treatment with trazodone, you should avoid consuming alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Data from a limited number of pregnant women exposed to trazodone show that trazodone does not have a negative effect on pregnancy or on the health of the fetus or newborn. There is currently no sufficient data on the use of the product during pregnancy. If trazodone is used until delivery, the newborn should be monitored. Trazodone passes into breast milk in small amounts.
Administration of the medicine during pregnancy and breastfeeding should be limited to selected cases and only after a careful assessment of the risk-benefit ratio by the doctor.

Driving and using machines

If you experience drowsiness, dizziness, confusion, or blurred vision, you should not drive or operate machinery.

Azoneurax contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Azoneurax

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is usually 75-150 mg per day in a single dose in the evening before bedtime. The dose can be increased to 300 mg per day in two divided doses. The daily dose may be increased in hospitalized patients to 600 mg per day, given in divided doses.
In the case of sexual disorders, 150-200 mg is given daily.
The tablets can be divided into 3 parts, allowing for gradual adjustment of the dose according to the severity of the disease, body weight, age, and overall health of the patient.
It is recommended to start the treatment cycle with an evening dose and gradually increase the daily dose.
Duration of treatment
This medicine should be administered in treatment cycles lasting at least one month.
Stopping treatment
When stopping treatment with trazodone, especially after long-term use, it is recommended to gradually reduce the dose to minimize possible symptoms such as nausea, headache, drowsiness.
Elderly and debilitated patients
The recommended initial dose for elderly patients or debilitated patients is 100 mg per day. The dose can be gradually increased, as described for adults, if it is well tolerated. These patients should not be given single doses exceeding 100 mg.
Use in children and adolescents
Azoneurax should not be given to children or adolescents under 18 years. However, your doctor may prescribe Azoneurax to patients under 18 years if he/she believes that it will benefit the patient.
Patients with liver function disorders
Patients with liver failure, especially severe, should inform their doctor, who will decide whether it is necessary to periodically monitor liver function.
Patients with kidney function disorders
If you have kidney function disorders, dose adjustment during treatment with trazodone is not necessary, but you should inform your doctor about your condition before starting treatment.

Overdose of Azoneurax

In case of overdose, you should immediately contact your doctor or go to the nearest hospital or emergency department. If a child has taken the medicine, you should immediately go to the doctor.
Symptoms of overdose may occur within 24 hours or even later. The most commonly reported symptoms of overdose were drowsiness, dizziness, nausea, and vomiting. In more severe cases, coma (loss of consciousness), rapid heartbeat, low blood pressure, low sodium levels in the blood, muscle spasms, and respiratory failure have been reported.
Overdose of trazodone in combination with other antidepressant medicines may cause serotonin syndrome (characterized by fever, muscle tremors, confusion, or agitation).

Missing a dose of Azoneurax

You should not take a double dose to make up for a forgotten dose.

Stopping treatment with Azoneurax

You should avoid stopping treatment abruptly. When stopping treatment, the dose should be gradually reduced.
If you have any further questions on the use of 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.
During treatment with this medicine or soon after stopping it, cases of suicidal thoughts or behaviors have been reported.
Azoneurax is an antidepressant medicine with a sedative effect. In the first few days of treatment, it may cause drowsiness, which usually disappears during further treatment.
Some of the following side effects of trazodone also occur as symptoms of untreated depression. These will be:

• Blood changes
• Allergic reactions
• Syndrome of inappropriate antidiuretic hormone secretion (disorder of maintaining proper water and sodium levels in the body, manifested mainly by excessive fluid intake with subsequent "water poisoning")
• Low sodium levels in the blood, weight loss, anorexia, increased appetite
• Suicidal thoughts or behaviors, confusion, insomnia, disorientation, mania, anxiety, nervousness, agitation, delusions, aggressive reactions, hallucinations, nightmares, decreased libido, withdrawal symptoms
• Serotonin syndrome, muscle spasms, malignant neuroleptic syndrome (elevated body temperature, muscle stiffness, altered consciousness), drowsiness, dizziness, headache, drowsiness, agitation, decreased concentration, tremors, blurred vision, memory disturbances, myoclonus (involuntary, brief, rapid muscle twitching), expressive aphasia (speech disturbances "searching for words"), paresthesia (tingling, numbness), dystonia (abnormal muscle tension - increased, e.g., spasms, or decreased), altered taste
• Heart rhythm disorders, bradycardia (slow heartbeat), tachycardia (rapid heartbeat)
• Orthostatic hypotension (low blood pressure when standing up quickly), high blood pressure, fainting (brief loss of consciousness due to insufficient oxygen supply to the brain, usually due to decreased blood pressure)
• Stuffy nose, shortness of breath
• Nausea, vomiting, dry mouth, constipation, diarrhea, gastrointestinal disorders, abdominal pain, gastritis (inflammation of the stomach and intestines), increased salivation, paralytic ileus (blockage of the intestines due to "paralysis" of the intestinal muscles)
• Changes in liver function (including jaundice and liver cell damage), cholestasis (disorder of bile flow to the intestines)
• Skin rash, itching, excessive sweating
• Pain in limbs and back, muscle or joint pain
• Priapism (prolonged and painful erection) - treatment with trazodone should be stopped immediately, and medical help should be sought.

Elderly patients
Older people are more likely to experience low blood pressure when standing up quickly, drowsiness, and other anticholinergic effects of trazodone (e.g., dry mouth, blurred vision).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should 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, Al. Jerozolimskie 181C, 02-222 Warsaw,
phone: +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 Azoneurax

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Azoneurax contains

• The active substance is trazodone hydrochloride. Each prolonged-release tablet contains 75 mg or 150 mg of trazodone hydrochloride.
• The other ingredients are: sucrose, carnauba wax, povidone K-29/30, magnesium stearate.

What Azoneurax looks like and contents of the pack

Azoneurax 75 mg: White or yellowish, biconvex, uncoated tablets in capsule shape, 10.5 mm long and 4.0 mm wide, with two lines on each side of the tablet allowing it to be divided into three parts. The tablet can be divided into equal doses.
Azoneurax 150 mg: White or yellowish, biconvex, uncoated tablets in capsule shape, 14.0 mm long and 6.0 mm wide, with two lines on each side of the tablet allowing it to be divided into three parts. The tablet can be divided into equal doses.
PVC/PVDC/Aluminum blisters in a cardboard box.
Package sizes:
20, 30, 50, 60, or 100 tablets (Azoneurax 75 mg)
20, 30, 50, 60, or 100 tablets (Azoneurax 150 mg)
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer/Importer

SVUS Pharma a.s.
Smetanovo nábřeží 1238/20a
500 02 Hradec Králové
Czech Republic
neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert Str. 23
40764 Langenfeld
Germany
To obtain more detailed information, please contact the representative of the marketing authorization holder in Poland:
Neuraxpharm Polska sp. z o.o.
ul. Domaniewska 37
02-672 Warsaw
[email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:
Azoneurax
Poland:
Azoneurax
Slovakia:
Azoneurax 75 mg, Azoneurax 150 mg
Hungary:
Azoneurax 75 mg retard tablet, Azoneurax 150 mg retard tablet
Date of last revision of the leaflet:06/2023