TRAZODONE SANDOZ 100 mg TABLETS

Introduction

Package Leaflet:information for the patient

Trazodone Sandoz 100 mg tablets EFG

trazodone hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 signs of illness 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 pack

1. What is Trazodone Sandoz and what is it used for
2. What you need to know before you take Trazodone Sandoz
3. How to take Trazodone Sandoz
4. Possible side effects
5. Storing Trazodone Sandoz
6. Contents of the pack and other information

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

Trazodone belongs to a group of medicines known as antidepressants. It is used to treat depressive disorders (major depressive episodes).

2. What you need to know before you take Trazodone Sandoz

Do not take Trazodone Sandoz

• if you are allergic to trazodone hydrochloride or any of the other ingredients of this medicine (listed in section 6),
• in case of alcohol or hypnotic drug intoxication (if you are drunk or under the influence of hypnotic drugs),
• if you have recently had a heart attack.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Trazodone Sandoz.

It is recommended to perform regular and thorough medical checks in case any of the following situations apply to you:

• if you have epilepsy. A sudden increase or decrease in dosage should be avoided,
• if you have kidney or liver disease,
• if you have heart disease (such as cardiovascular insufficiency, angina pectoris, conduction disorders or AV block of various degrees, arrhythmia, recent myocardial infarction, congenital long QT syndrome or bradycardia),
• if you have hypokalemia, i.e., low potassium levels in the blood that can cause muscle weakness, spasms, abnormal heart rhythm,
• if you have hypomagnesemia, i.e., low magnesium levels in the blood,
• if you have hyperthyroidism,
• if you have difficulty urinating,
• if you have prostate hyperplasia,
• if you have elevated eye pressure (glaucoma),
• if you have low blood pressure, or hypotension.

Consult your doctor about these conditions before starting to take trazodone, if you have not previously informed them.

If you develop yellowing of the skin or the whites of the eyes, you should stop treatment with trazodone and consult your doctor immediately.

The administration of antidepressants in patients with schizophrenia or other psychotic disorders may worsen psychotic symptoms. Paranoid thoughts can intensify. During treatment with trazodone, a depressive phase may change from manic-depressive psychosis to a manic phase. In that case, the administration of trazodone should be discontinued.

If you have a sore throat, fever, or flu-like symptoms while taking trazodone, consult your doctor immediately. In these cases, it is recommended to perform a blood test to detect the presence of agranulocytosis, a blood disorder that can manifest clinically with these symptoms.

Care should be taken when taking trazodone with other medications that prolong the QT interval, such as phenothiazines, pimozide, haloperidol, tricyclic antidepressants, antibiotics such as sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarials such as halofantrine, and certain antihistamines such as astemizole and mizolastine.

Care should be taken when taking trazodone with other medications that increase the risk of serotonergic syndrome/neuroleptic malignant syndrome, such as other antidepressants (including tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone), triptans, and neuroleptics.

Elderly patients

Elderly patients may experience dizziness and lightheadedness when standing up or stretching. They may also feel dizziness or more sleepy than usual.

Children and adolescents

Under normal conditions, trazodone should not be used in children and adolescents under 18 years of age. Also, you should know that patients under 18 years of age have a higher risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behavior, and anger) when taking this type of medication.

St. John's Wort

Adverse effects may occur more frequently if you take trazodone and herbal medicines containing St. John's Wort (Hypericum perforatum) at the same time.

If you have liver, kidney, or heart disease, if you have epilepsy, or if you have elevated eye pressure (glaucoma), problems urinating, or prostate problems, your doctor may decide to perform regular checks while you are taking trazodone.

In the unlikely event of painful and prolonged erection of the penis (priapism), treatment with trazodone should be discontinued. Inform your doctor, and see also the section on possible side effects.

Suicidal thoughts and worsening of your depression

If you are depressed, you may occasionally have thoughts of self-harm or suicide. These may increase when you start taking antidepressants for the first time, as all these medications require time to start taking effect, usually around two weeks, although in some cases it may be longer.

You would be more likely to have these types of thoughts:

• if you have previously had thoughts of self-harm or suicide,
• if you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in young adults under 25 years of age with psychiatric disorders who were being treated with some antidepressant.

If at any time you have thoughts of self-harm or suicide, contact your doctor or go immediately to a hospital.

It may be helpful for you to tell a relative or close friendthat you are depressed or that you have an anxiety disorder and ask them to read this leaflet. You can ask them if they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your behavior.

Other medicines and Trazodone Sandoz

Do not take Trazodone Sandoz with:

• CYP3A4 inhibitors, such as erythromycin, ketoconazole, itraconazole, ritonavir, indinavir, and nefazodone,
• MAO inhibitors (certain medications for treating depression or Parkinson's disease),
• tricyclic antidepressants, certain medications for treating depression (such as nortriptyline, clomipramine, desipramine),
• fluoxetine, another medication for treating depression.

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medications, such as:

• antidepressants, such as nefazodone, fluoxetine, and tricyclic antidepressants,
• antiviral medications, such as indinavir or ritonavir,
• antibiotics, such as erythromycin,
• antifungals, such as ketoconazole, itraconazole, or fluconazole,
• sedative medications, such as sleeping pills, other antidepressants, tranquilizers, medications for allergy or cold, some pain relievers,
• medications called monoamine oxidase inhibitors (MAOIs), such as moclobemide, phenelzine (sulfate), tranylcypromine, even if you have stopped taking them in the last two weeks,
• medications for psychosis, called antipsychotics,
• barbiturates, which can be used to anesthetize during surgery (anesthesia), epilepsy, sleepiness, sedation, severe mental illness with altered behavior and personal actions (acute psychosis). Examples of barbiturates include phenobarbital and primidone,

• oral contraceptives (the pill),
• buprenorphine: used for pain treatment. This medication may interact with trazodone, and you may experience symptoms such as involuntary and rhythmic muscle contraction, including the muscles that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor if you experience any of these symptoms,
• cimetidine, which is used to treat stomach symptoms such as heartburn and pain,
• medications for treating epilepsy, such as carbamazepine or phenytoin,
• medications for treating high blood pressure or heart disease, such as digoxin, lisinopril, atenolol, hydrochlorothiazide,
• a medication called levodopa, which is used to treat Parkinson's disease,
• any anesthetic or muscle relaxant,
• hypnotics,
• sedatives,
• anxiolytics,
• medications for treating allergic reactions or hypersensitivity (antihistamines),
• phenothiazines, such as chlorpromazine, fluphenazine, levomepromazine, perphenazine,
• supplements or herbal medicines containing St. John's Wort,
• warfarin.

Taking Trazodone Sandoz with food, drinks, and alcohol

Food:you may have a lower risk of side effects if you take this medication after eating.

Alcohol:this medication increases drowsiness, reduced alertness, and other effects of alcohol. Do not drink alcohol while taking this medication.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:the data on the use of trazodone in pregnant women are limited. As a precautionary measure, it is preferable to avoid the use of trazodone during pregnancy.

Make sure your midwife and/or doctor know that you are taking trazodone. When taken during pregnancy, particularly in the last three months of pregnancy, medications like trazodone may increase the risk of a serious disease in newborns called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start within the first 24 hours after the baby is born. If this happens to your baby, contact your midwife and/or doctor immediately.

Breast-feeding:do not take trazodone if you are breast-feeding your child unless you and your doctor have discussed the risks and benefits involved.

Driving and using machines

This medication may cause drowsiness, numbness, and dizziness. It may also cause blurred vision and confusion. Do not drive or use machines or perform any other activity that requires mental skill until you know how the treatment with trazodone affects you.

Trazodone Sandoz contains sodium and lactose.

This medication contains less than 1 mmol mg of sodium (23 mg) per tablet; this is, essentially "sodium-free".

If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medication.

3. How to take Trazodone Sandoz

Trazodone Sandoz tablets should be taken after eating.

Trazodone is a sedative antidepressant and causes drowsiness, especially at the beginning of treatment.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. The best dose for you will be identified individually.

• The recommended initial dose is 150 mg per day, divided into several doses after meals, or as a single dose before bedtime.
• The dose can be gradually increased up to a maximum of 400 mg per day. The dose is administered divided into several doses, or as a single dose before bedtime.
• If you are hospitalized, the dose can be gradually increased up to a maximum of 600 mg per day. The dose is administered divided into several doses.
• If you need to take your daily dose divided into several doses, the largest part of the divided dose should be taken before bedtime.
• Generally, the dose increase is 50 mg per day, every three or four days.
• Your doctor will increase the dose until the best effect for you is found.
• You will not feel better immediately, it takes between two and four weeks before finding the right dose.
• When the right dose is found, you should maintain it for at least four weeks.
• Then, the dose will be gradually reduced, depending on the therapeutic response.
• Next, the treatment will be maintained until you have been feeling well for a period of four to six months.
• Then, the dose will be gradually reduced until it is low enough to stop treatment. Do not stop taking trazodone suddenly; this can cause nausea, headache, and a feeling of general discomfort.
• To reduce the possible side effects, it is recommended that you take trazodone after a meal.

When treatment with trazodone needs to be discontinued, the dose you are taking will be gradually reduced.

Elderly patients

In elderly patients, the recommended initial dose is 100 mg per day, divided into several doses after meals, or as a single dose before bedtime. In general, the administration of single doses above 100 mg should be avoided. The dose should not exceed 300 mg per day.

Use in children and adolescents

Trazodone is not recommended in children and adolescents under 18 years of age, as there is not enough information on safety and efficacy.

Each tablet contains 100 mg of trazodone. The tablets have three scoring lines separated by the same distance. The division of the tablets allows for different doses to be administered.

If the tablet is broken at the central scoring line, two halves of the tablet are obtained. Each half of the tablet contains 50 mg of trazodone.

If the tablet is broken at one of the lateral scoring lines, a quarter of the tablet is obtained that contains 25 mg of trazodone, and three-quarters of the tablet that contain 75 mg of trazodone.

If the tablet is broken at the three scoring lines, four quarters of the tablet are obtained. Each quarter of the tablet contains 25 mg of trazodone.

In this way, the doctor can gradually increase or decrease the dose. Follow exactly the instructions indicated by your doctor. If you do not understand them or forget them, ask your doctor or pharmacist.

If you take more Trazodone Sandoz than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. If this is not possible, you should ask someone else to take you to the emergency department of the nearest hospital. Do not try to drive yourself; your ability to drive may be affected. Do not forget to bring the medication packaging with you. This way, the doctor will know what you have taken.

The most frequently reported symptoms of overdose are drowsiness, dizziness, nausea, and vomiting. In more severe cases of overdose, coma, convulsions, hyponatremia (low sodium levels in the blood), decreased blood pressure (hypotension), rapid heart rate (tachycardia), and respiratory failure have been reported. The cardiac effects of an overdose can be arrhythmias, such as slow heart rate (bradycardia), a type of severe irregular heart rhythm (Torsade de Pointes), a change in the electrical signal produced by the heart by which the QT interval in the ECG (electrocardiogram) is prolonged (QT prolongation).

If you forget to take Trazodone Sandoz

If you forget to take a dose, take it as soon as you remember. If it is close to the time of your next dose, do not take the missed dose and take the next dose at the usual time.

Do not take a double dose to make up for missed doses.

If you stop taking Trazodone Sandoz

Do not stop taking this medication suddenly, even if you feel better. You should first consult your doctor.

To avoid the risk of withdrawal symptoms, such as general discomfort, headache, or nausea, the dose should be gradually reduced. Your doctor will tell you how to do it. You should follow their instructions carefully.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, trazodone can cause adverse effects, although not all people suffer from them.

There have been reports of suicidal thoughts and suicidal behavior during treatment with trazodone or early after stopping treatment (see "What you need to know before taking Trazodona Sandoz").

You should stop treatment and contact your doctor immediately if you suffer from any of the following effects:

• allergic reaction, itching, irritated skin with hives, skin rash, swelling of hands, face or throat (edema), chest tightness or breathing difficulties,
• painful and prolonged erection of the penis (priapism),
• skin rash,
• fever or sore throat, or flu-like symptoms without explanation,
• yellowing of the eyes (jaundice) or skin, dark urine, back pain.

Consult your doctor or pharmacist if you experience any of the following effects, especially if they persist over time or worsen:

Very common: may affect more than 1 in 10 people

• nervousness, dizziness, somnolence**,
• dry mouth.

Common: may affect up to 1 in 10 people

• expressive disorder of the central nervous system that affects the ability to use and understand words (expressive aphasia),
• disorientation, confusion, agitation (in very isolated cases, worsened to delirium), mental disorder characterized by large outbursts of violent excitement (mania), aggressive outbursts and the experience of seeing something that does not really exist (hallucinations),
• allergic reactions,
• weight gain, anorexia, increased appetite,
• changes in vision, such as blurred vision, difficulty focusing, sometimes elevated ocular tension (glaucoma),
• palpitations, rapid or irregular heartbeat (tachycardia or bradycardia),
• dizziness when standing up suddenly (orthostatic hypotension), fainting (syncope), high blood pressure,
• alteration of taste, gas (flatulence), indigestion (digestive discomfort) with symptoms such as a feeling of fullness in the upper stomach, belching, nausea or vomiting and acid indigestion (dyspepsia), inflammation of the stomach or small intestine (gastroenteritis), constipation or diarrhea, stomach pain,
• bumps or spots on the skin and itching,
• feeling of weakness (asthenia), chest pain, back pain or in the limbs,
• sweating, hot flashes, swelling (edema), flu-like symptoms,
• eye pain and itching (ocular pruritus),
• tinnitus (ringing in the ears), headache, tremor,
• stuffy nose, with pain (nasal congestion/sinusitis).

Uncommon: may affect up to 1 in 100 people

• weight loss,
• difficulty breathing (dyspnea),
• reduced sexual desire,
• disorder similar to serotonin syndrome, characterized by restlessness (extreme), confusion, excitability, seeing things that do not exist (hallucinations), chills, sweating, increased reflexes and sudden muscle contractions, high fever, stiffness and convulsions, especially if taking other antidepressants.

Rare: may affect up to 1 in 1,000 people

• very serious blood disorders (decrease in the number of white blood cells) accompanied by sudden high fever, severe sore throat and ulcers in the mouth (agranulocytosis), elevation of a type of white blood cells in the blood (eosinophilia), blood disorder (decrease in the number of white blood cells) accompanied by increased sensitivity to infections (leukopenia), blood disorder (decrease in the number of platelets) accompanied by blue marks and tendency to bleeding (thrombocytopenia) and anemia. Your doctor will know how to detect the presence of these adverse effects,
• sudden muscle contraction (myoclonus),
• obstruction of the bile flow, which can cause jaundice, alteration of liver function and elevation of liver enzymes.

Very rare: may affect up to 1 in 10,000 people

• painful and prolonged erection of the penis (priapism). See also the section "Warnings and precautions",
• a group of adverse effects caused by the use of neuroleptic medications such as trazodone (neuroleptic malignant syndrome), such as increased sweating and fever, changes in body function (rapid heartbeat, changes in blood pressure, increased/decreased salivation), reduced levels of consciousness, pale skin, eruptions/desquamation of the skin all over the body, mutism or immobility of the body (stupor), can occur during treatment with trazodone.

Frequency not known (cannot be estimated from available data)

• worsening of delirium, feeling of fear or shame that prevents natural behavior, inhibition, anxiety, suicidal thoughts and suicidal behavior*,
• sleep disturbances (nightmares, inability to sleep),
• excessive release of antidiuretic hormone,
• vertigo, nervousness, reduced alertness, memory alteration, tingling or numbness (paresthesia), abnormal and uncontrolled body movement (dystonia),
• rapid and irregular heartbeat or a fainting spell that could be a symptom of a potentially life-threatening condition known as Torsades de Pointes,
• alteration of heart rhythm (or "prolongation of the QT interval", observed in the ECG, a tracing of the heart's electrical activity),
• muscle pain, pain or stiffness in the joints,
• intestinal perforation, intestinal obstruction caused by paralysis of the intestinal muscles (paralytic ileus), intestinal cramps and hiatal hernia, increased salivation,
• weakness, fatigue, fever,
• difficulty urinating or interruption of urine flow,
• excessive sweating.

• There have been reports of suicidal thoughts and suicidal behavior during treatment with trazodone or early after stopping treatment (see "What you need to know before taking Trazodona Sandoz").

** Somnolence. It usually appears at the beginning of treatment and disappears as you continue taking the medication.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for human use medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Trazodona Sandoz

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

Store below 25°C. Store in the original packaging to protect it from moisture.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Trazodona Sandoz

• The active ingredient is trazodone hydrochloride. Each tablet contains 100 mg of trazodone hydrochloride.
• The other components are cornstarch, lactose monohydrate, povidone K30 (E1201), calcium hydrogen phosphate (E341), microcrystalline cellulose (E460i), sodium carboxymethylcellulose (E468) (from potato), magnesium stearate (E470b).

Appearance of the product and package contents

White oblong tablets with three score lines.

The tablets are approximately 18.5 mm long and 6.7 mm wide.

The tablet can be divided into equal doses if broken along the central score line, into a three-quarter and one-quarter tablet if broken along one of the end score lines, or into equal quarters if broken along all three lines.

The tablets are packaged in PVC/aluminum blisters.

Package sizes: 10, 20, 30, 60, 90, 100, 120, 180, 500, 1,000 tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Farmaceutisch Analytisch Laboratorium B.V

Dijkgraaf 30

6921 RL Duiven

Netherlands

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

Date of last revision of this prospectus: November 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es