Package Insert:Information for the Patient

Trazodone Sandoz 100 mg Tablets EFG

Trazodone Hydrochloride

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

Do not take Trazodona Sandoz

• if you are allergic to trazodone hydrochloride or any of the other ingredients of this medicine (listed in section 6),
• in case of intoxication with alcohol or hypnotic drugs (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 Trazodona Sandoz.

It is recommended to have regular and thorough medical check-ups if any of the following situations apply to you:

• if you have epilepsy. Avoid sudden changes in dosage,
• if you have kidney or liver disease,
• if you have heart disease (such as cardiovascular insufficiency, angina pectoris, conduction disorders or AV block of several 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 benign prostatic hyperplasia,
• if you have elevated intraocular pressure (glaucoma),
• if you have low blood pressure, or hypotension.

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

If you develop yellowing of the skin or the white of the eyes, discontinue treatment with trazodone and consult your doctor immediately.

The administration of antidepressants in patients with schizophrenia or other psychotic disorders may cause an aggravation of psychotic symptoms. Paranoid thoughts may intensify. During treatment with trazodone, a depressive phase may vary from manic-depressive psychosis to manic phase. In this case, discontinue trazodone administration.

If you have a sore throat, fever, or symptoms similar to the flu 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 may manifest clinically with these symptoms.

It is recommended to exercise caution when taking trazodone with other medications that prolong the QT interval, such as phenothiazines, pimozide, haloperidol, tricyclic antidepressants, antibiotics such as ciprofloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarials such as halofantrine, and certain antihistamines such as astemizole and mizolastine.

It is recommended to exercise caution when taking trazodone with other medications that increase the risk of serotonin syndrome/neuroleptic malignant syndrome, such as other antidepressants (including tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone), triptans, and neuroleptics.

Older patients

Older patients may experience dizziness and drowsiness when standing up or stretching. They may also feel more drowsy or dizzy than usual.

Children and adolescents

Trazodone should not be used in children and adolescents under 18 years of age. Also, 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 St. John's Wort (Hypericum perforatum) at the same time.

If you have liver disease, kidney disease, heart disease, epilepsy, or elevated intraocular pressure (glaucoma), or if you have difficulty urinating or benign prostatic hyperplasia, your doctor may decide to perform regular check-ups while you are taking trazodone.

In the unlikely event of painful and prolonged erection of the penis (priapism), discontinue treatment with trazodone. Inform your doctor, and also see the section on possible adverse 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 taking antidepressants for the first time, as all these medications require a period of time to start working, usually around two weeks, although in some cases it may take longer.

You would be more prone to having these thoughts:

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

If you ever have thoughts of self-harm or suicide, contact your doctor or go to the hospital immediately.

It may be helpful to tell a family member or close friendthat you are depressed or 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 Trazodona Sandoz

Do not take Trazodona Sandoz with:

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

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, 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,
• sedatives, such as sleep aids, other antidepressants, tranquilizers, allergy or cold medications, some painkillers,
• medications called monoamine oxidase inhibitors (MAOIs), such as, for example, moclobemide, phenelzine (sulfate), tranilcipromine, although you have stopped taking them for the last two weeks,
• psychosis medications, called antipsychotics,
• barbiturates, which can be used to make you insensitive during surgery (anesthesia), epilepsy, drowsiness, sedation, sudden severe mental illness in which control of behavior and personal actions are altered (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 contractions, including those 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, used to treat heartburn and stomach pain,
• medications for epilepsy, such as carbamazepine or phenytoin,
• medications for hypertension or heart disease, such as digoxin, lisinopril, atenolol, hydrochlorothiazide,
• a medication called levodopa, used to treat Parkinson's disease,
• any anesthetic or muscle relaxant,
• hypnotics,
• sedatives,
• anxiolytics,
• medications for allergic reactions or hypersensitivity (antihistamines),
• phenothiazines, such as chlorpromazine, fluphenazine, levomepromazine, perphenazine,
• supplements or medicinal plants that containSt. John's Wort,
• warfarin.

Taking Trazodona Sandoz with food, drinks, and alcohol

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:The data on the use of trazodone in pregnant women are limited. As a precaution, 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 condition 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.

Lactation:Do not take trazodone if you are breastfeeding, unless you and your doctor have discussed the risks and benefits.

Driving and operating machinery

This medication may cause drowsiness, numbness, and dizziness. It may also cause blurred vision and confusion.Do not drive or operate machinery or perform any activity that requires mental agility until you know how trazodone affects you.

Trazodona Sandoz contains sodium and lactose.

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

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

Trazodone Sandoz tablets should be taken after taking food.

Trazodone is a sedating 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 must 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 increased gradually 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 increased gradually up to a maximum of 600 mg per day. The dose is administered divided into several doses.
• If you must take your daily dose divided into several doses, the majority of the divided dose should be taken before going to bed.
• Generally, the dose increase is 50 mg per day, every three or four days.
• Your doctor will increase the dose until finding the best effect for you.
• You will not feel better immediately, it takes between two and four weeks to find the suitable dose.
• When you find the suitable dose, you should maintain it for at least four weeks.
• Then the dose will be reduced gradually, according to the therapeutic response.
• Next, the treatment will be maintained until you have been well for a period of four to six months.
• Then, the dose will be reduced gradually until it is low enough to discontinue treatment. Do not stop taking trazodone suddenly; this may cause nausea, headache, and general feeling of discomfort.
• To reduce possible adverse effects, it is recommended to take trazodone after a meal.

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

Patients of advanced age

In patients of advanced age, the recommended initial dose is 100 mg per day, divided into several doses after meals, or as a single dose before bedtime. In general, it is recommended to avoid administering single doses exceeding 100 mg. Do not exceed a daily dose of 300 mg.

Use in children and adolescents

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

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

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

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

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

In this way, the doctor can increase or reduce the dose gradually. 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. If this is not possible, 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 packaging of the medication with you. In this way, the doctor will know what you have taken.

The symptoms of overdose most frequently reported are drowsiness, dizziness, nausea, and vomiting. In more severe cases of overdose, coma, convulsions, hyponatremia (low sodium concentration in the blood), reduced blood pressure (hypotension), rapid heart rate (tachycardia), and respiratory failure have been reported. The cardiac effects of an overdose can be arrhythmias, such as 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 (prolongation of QT).

If you forgot 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 normally.

Do not take a double dose to compensate for the missed doses

If you interrupt the treatment with Trazodone Sandoz

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

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

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

Like all medicines, trazodone can cause side effects, although not everyone will experience them.

Cases of suicidal ideas and suicidal behavior have been reported during treatment with trazodone or shortly after stopping treatment (see “What you need to know before starting to take Trazodona Sandoz”).

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

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

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

Very common: may affect more than 1 in 10 people

• anxiety, dizziness, drowsiness**,
• dry mouth.

Common: may affect up to 1 in 10 people

• expressive language disorder affecting the ability to use and understand words (expressive aphasia),
• disorientation, confusion, agitation (in rare cases, exacerbated to delirium), mental disorder characterized by violent outbursts of excitement (mania), aggressive outbursts, and seeing things that do not exist (hallucinations),
• allergic reactions,
• weight gain, anorexia, increased appetite,
• changes in vision, such as blurred vision, difficulty focusing, sometimes elevated intraocular pressure (glaucoma),
• palpitations, rapid or irregular heart rate (tachycardia or bradycardia),
• dizziness when standing up quickly (orthostatic hypotension), fainting (syncope), high blood pressure,
• alteration of taste, gas (flatulence), indigestion (gastrointestinal discomfort) with symptoms such as feeling full 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,
• skin blemishes or patches and itching,
• feeling weak (asthenia), chest pain, back pain, or pain in the limbs,
• sweating, hot flashes, swelling (edema), flu-like symptoms,
• eye pain or itching (pruritus oculi),
• tinnitus (ringing in the ears), headache, tremor,
• stuffy nose, with pain (nasal congestion/congestion of the nasal sinuses).

Rare: may affect up to 1 in 100 people

• weight loss,
• difficulty breathing (dyspnea),
• reduced libido,
• condition 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, rigidity, and convulsions, especially if taking other antidepressants.

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

• very serious blood disorders (decreased white blood cell count) accompanied by high fever, intense sore throat, and mouth ulcers (agranulocytosis), elevated eosinophil count in the blood (eosinophilia), blood disorder (decreased white blood cell count) accompanied by increased sensitivity to infections (leucopenia), blood disorder (decreased platelet count) accompanied by blue marks and a tendency to bleed (thrombocytopenia), and anemia. Your doctor will know how to detect the presence of these side effects,
• sudden muscle contraction (myoclonus),
• obstruction of bile flow, which can cause jaundice, liver dysfunction, and elevated 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 side effects caused by the use of neuroleptic medications such as trazodone (neuroleptic malignant syndrome), such as, for example: increased sweating and fever, changes in the body's function (rapid heart rate, changes in blood pressure, increased or decreased salivation), reduced levels of consciousness, pale skin, skin rash or peeling, muteness or immobility of the body (stupor), which 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 you from behaving naturally, inhibition, anxiety, suicidal ideas, and suicidal behavior*,
• sleep disturbances (nightmares, inability to sleep),
• excessive release of antidiuretic hormone,
• if you feel tired, weak, or confused and experience pain, stiffness, or muscle discoordination, it could be due to low sodium levels in the blood. Contact your doctor if you experience these symptoms (hyponatremia),
• dizziness, anxiety, reduced alertness, alteration of memory, 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 on an ECG, a tracing of the heart's electrical activity),
• muscle pain, joint pain, or stiffness,
• intestinal perforation, intestinal obstruction caused by paralysis of the intestinal muscles (ileus), intestinal cramps, and hiatal hernia, increased salivation,
• weakness, fatigue, fever,
• difficulty urinating or interruption of urine flow,
• excessive sweating.

* Cases of suicidal ideas and suicidal behavior have been reported during treatment with trazodone or shortly after stopping treatment (see “What you need to know before starting to take Trazodona Sandoz”).

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

Reporting of side effects:

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

Keep this medication out of the 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.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

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), carboxymethyl starch sodium (E468) (from potato) , magnesium stearate (E470b).

Appearance of the product and content of the container

White, oblong tablets with three breaking lines.

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

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

The tablets are packaged in PVC/aluminum blisters.

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

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Farmaceutisch Analytisch Laboratorium B.V

Dijkgraaf 30

6921 RL Duiven

Netherlands

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

Last review date of this leaflet: November 2024

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es /