TRAZODONE STADAFARMA 150 mg TABLETS

2. What you need to know before you take Trazodona Stadafarma

Do not take Trazodona Stadafarma if

• you are allergic to trazodone hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• you consume alcoholic beverages or are taking sleeping medicines (alcohol or hypnotic intoxication)
• you have recently had a heart attack

Warnings and precautions

Suicidal thoughts and worsening of your depression

If you are depressed, you may sometimes have thoughts of harming or killing yourself. These may increase when you first start taking antidepressants, since these medicines take time to start working, usually around two weeks, but sometimes longer.

You are more likely to think this way if:

• you have previously had thoughts about harming or killing yourself
• you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in young adults under 25 years with psychiatric disorders who were treated with an antidepressant

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital immediately.

It may be helpful to tell a relative or close friend that you are depressed and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

Liver problems

Serious liver disorders have been reported with the use of trazodone. If you experience any of the following symptoms, you should contact your doctor immediately:

• weakness (asthenia)
• loss of appetite (anorexia)
• nausea, vomiting
• stomach pain
• yellowing of the skin and/or eyes (jaundice)

Consult your doctor or pharmacist before taking trazodone if you:

• have or have had seizures or attacks (epilepsy)
• have severe liver or kidney problems
• have a heart disease (such as cardiovascular insufficiency, angina pectoris, conduction disorders or AV blocks of different degree, arrhythmias, recent myocardial infarction, congenital long QT syndrome or bradycardia)
• have low potassium levels in the blood (hypokalemia) that can cause muscle weakness, contractions, abnormal heart rhythm
• have low magnesium levels in the blood (hypomagnesemia)
• have an overactive thyroid gland (hyperthyroidism)
• have problems urinating or need to urinate frequently
• have an enlarged prostate
• have narrow-angle glaucoma (an eye disorder)
• have low blood pressure (hypotension)
• have schizophrenia or other mental disorder
• are elderly, as you may be more prone to side effects such as low blood pressure when standing up quickly from a sitting or lying position (orthostatic hypotension), sometimes accompanied by dizziness, and inability to remain still, mental excitement, seeing things that are not real (hallucinations) or hyponatremia (low sodium levels in the blood, which can make you feel tired, weak or confused and have painful, stiff or uncoordinated muscles)

Serious liver disorders have been reported with the use of trazodone, with a possible fatal outcome.

Stop taking trazodone and talk to your doctor immediately if you experience yellowing of the skin or the whites of your eyes (jaundice) or signs such as asthenia, anorexia, nausea, vomiting, abdominal pain (see section 4 "Possible side effects").

If you have schizophrenia or other psychotic disorders, the administration of antidepressants may result in a possible worsening of psychotic symptoms. Paranoid thoughts may intensify. During therapy with trazodone, a depressive phase may change from a manic-depressive psychosis to a manic phase. In that case, the use of trazodone should be discontinued.

If you have a sore throat, fever or flu-like symptoms while taking trazodone, you should talk to your doctor immediately. In these cases, it is recommended to check your blood as agranulocytosis, a blood disorder, may be revealed clinically with these symptoms.

Caution is recommended when using trazodone with other medicines known to prolong the QT interval or increase the risk of serotonin syndrome/malignant neuroleptic syndrome (see "Other medicines and Trazodona Stadafarma" and section 4 "Possible side effects").

Elderly patients

If you are elderly, you may experience dizziness and lightheadedness when standing up or stretching. You may also feel more drowsy or sleepy than usual.

Greater caution is advised if you suffer from other diseases and are taking medicines to treat them, along with taking trazodone.

Children and adolescents

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

Other medicines and Trazodona Stadafarma

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription, including herbal medicines. This is because trazodone can affect the way other medicines work and vice versa.

Tell your doctor if you are taking any of the following medicines:

• monoamine oxidase inhibitors (MAOIs) such as tranylcypromine, phenelzine and isocarboxazid (for depression) or selegiline (for Parkinson's disease), or have taken them in the last 2 weeks
• other antidepressants (such as amitriptyline, nefazodone or fluoxetine)
• tryptophan (an amino acid used for protein biosynthesis)
• triptans (medicines used to treat migraine)
• antipsychotic medicines used in the treatment of schizophrenia and other mental disorders (such as phenothiazines, e.g. chlorpromazine, fluphenazine, levomepromazine, perphenazine)
• levodopa - used to treat Parkinson's disease
• buprenorphine - used to treat pain. This medicine may interact with trazodone and cause symptoms such as involuntary muscle contractions, including muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38 °C. Contact your doctor if you experience these symptoms
• sedatives - such as tranquilizers, sleeping pills
• medicines known to prolong the QT interval in the ECG, such as antiarrhythmic drugs of class IA and III (a group of medicines used to suppress abnormal heart rhythms)
• medicines used to treat allergies such as antihistamines
• the contraceptive pill (oral contraceptives)
• muscle relaxants (a group of medicines that have the ability to relax or reduce tension in the muscle)
• medicines used to treat epilepsy, such as carbamazepine and phenytoin
• medicines used to treat high blood pressure, such as clonidine
• digoxin - used to treat heart problems
• warfarin - used to prevent blood clotting
• 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
• St. John's Wort - a herbal remedy

Anesthetics

If you are going to be given an anesthetic (for an operation), tell your doctor or dentist that you are taking trazodone.

Taking Trazodona Stadafarma with alcohol

You should avoid taking alcohol while taking trazodone.

Pregnancy and breastfeeding

Pregnancy

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

Trazodone should not be taken during the first 3 months of pregnancy. Taking trazodone in the later stages of pregnancy may cause your baby to have withdrawal symptoms when born. In that case, your newborn will be monitored by a doctor.

Breastfeeding

If you are breastfeeding or plan to breastfeed, talk to your doctor or pharmacist before taking this medicine.

Driving and using machines

Trazodone may make you feel drowsy or dizzy. This can affect your eyesight and ability to react. If this happens, do not drive or use tools or machines.

Trazodona Stadafarma contains sodium

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

3. How to take Trazodona Stadafarma

Always take trazodone exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults

Depression

• adults usually start with 150 mg per day in a single dose or divided doses
• your doctor may gradually increase the dose, e.g. in intervals of 50 mg every 3-4 days, up to a maximum of 300 mg per day depending on your condition
• for hospitalized adults, the highest dose should be 600 mg per day

Elderly patients

In elderly or fragile patients, the initial dose will usually be 100 mg per day.

Children and adolescents

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

Taking this medicine

• Trazodone is taken orally
• swallow the tablet whole with a glass of water
• take it after a meal. Taking this medicine after a meal can reduce the risk of side effects

Trazodona Stadafarma 50 mg tablets EFG

The score line is not intended for breaking the tablet.

Trazodona Stadafarma 100 mg/ 150 mg tablets EFG

The tablet can be divided into equal doses.

Duration of treatment

It will usually take 2 to 4 weeks before you start to feel better.

Your doctor will regularly reassess your dose depending on your condition and determine the need for continued maintenance treatment.

If you take more Trazodona Stadafarma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested. You can also go to the emergency department of the nearest hospital. Take the package to let the doctor know what you have taken.

The following effects may occur: feeling sick or being sick, feeling drowsy, dizzy or faint, fits (seizures), confusion, breathing or heart problems.

If you forget to take Trazodona Stadafarma

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, do not take the missed dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Trazodona Stadafarma

Continue taking trazodone until your doctor tells you to stop. Do not stop taking trazodone just because you feel better. When your doctor tells you that you can stop taking this medicine, they will help you gradually reduce the dose to avoid the risk of withdrawal symptoms, such as agitation, sleep disturbances, feeling sick, headache and feeling unwell.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking trazodone and contact a doctor or go to a hospital immediately if you experience any of the following side effects:

Frequency not known: cannot be estimated from the available data

• swelling of the hands, feet, ankles, face, lips or throat, which can cause difficulty swallowing or breathing, itching of the skin and hives. This could be an allergic reaction to trazodone
• painful erection of the penis, unrelated to sexual activity, that does not disappear (priapism)
• loss of appetite, feeling sick or being sick, confusion, abdominal pain, fever, yellowing of the eyes or skin (jaundice). These could be symptoms of a serious liver problem such as hepatitis
• getting infections more easily than usual. This could be due to a blood disorder (agranulocytosis)
• bruising more easily than usual. This could be due to a blood disorder (thrombocytopenia)
• swelling and severe abdominal pain, being sick (vomiting) and constipation. These can be signs that the intestine is not working properly (paralytic ileus).

Tell your doctor immediately if you notice any of the following side effects:

Frequency not known: cannot be estimated from the available data

• thoughts of self-harm or suicide
• feeling tired, weak, dizzy, having pale skin. These can be symptoms of anemia.
• fast, slow or irregular heartbeats
• fits/seizures
• unusual sensations in the skin such as numbness, tingling, burning or prickling (paresthesia)
• feeling confused, restless, sweating, trembling, chills, hallucinations (seeing or hearing things that are not there), sudden jerks of the muscles or rapid heartbeats. You may have something called serotonin syndrome.
• feeling very unwell, possibly with difficulty breathing (dyspnea), difficulty walking or walking with an unsteady gait, tremors, uncontrolled muscle contractions and a high temperature (above 38 °C). This could be a rare condition known as malignant neuroleptic syndrome.

Other side effects:

Frequency not known: cannot be estimated from the available data

• feeling drowsy or sleepy
• feeling less alert than usual
• feeling weak
• feeling sick (nausea) or being sick (vomiting)
• constipation
• diarrhea
• dry mouth, altered taste, increased saliva, stuffy nose
• dizziness, headache, confusion, weakness, tremors (shakiness)
• blurred vision
• weight loss
• fast or slow heartbeats
• chest pain
• high blood pressure
• feeling dizzy or faint when standing up or sitting down quickly (postural hypotension), fainting (syncope)
• feeling agitated, restless, anxious or more nervous than usual
• difficulty sleeping, nightmares
• decreased sexual desire
• hyperactive behavior or thoughts (mania), believing things that are not true (delusions), memory disorders
• fluid retention, which can cause swelling of the arms or legs.
• skin rash
• pain in the limbs, muscles or joints, flu-like symptoms
• high temperature
• frequent infections with high fever, intense chills, sore throat or mouth ulcers. These can be signs of a blood problem called leucopenia.
• difficulty speaking
• high white blood cell count (in blood tests)
• increased liver enzyme levels (in blood tests)
• feeling tired, weak, confused, painful muscles. Also headache, loss of appetite, nausea or vomiting. This may be due to low sodium levels in your blood (blood test).

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Trazodona Stadafarma

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 carton and blister after "EXP". The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Keep the medicine in its original packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Trazodona Stadafarma

• The active ingredient is trazodone hydrochloride.

Each Trazodona Stadafarma 50 mg tablet contains 50 mg of trazodone hydrochloride.

Each Trazodona Stadafarma 100 mg tablet contains 100 mg of trazodone hydrochloride.

Each Trazodona Stadafarma 150 mg tablet contains 150 mg of trazodone hydrochloride.

• The other components are:

Microcrystalline cellulose

Sodium carboxymethyl starch (type A)

Pregelatinized corn starch

Anhydrous colloidal silica

Magnesium stearate

Appearance of the Product and Container Content

Trazodona Stadafarma 50 mg tablets are white to off-white, round, biconvex tablets, 7.14 mm in diameter, engraved with "IT" and "I" on either side of the score line and smooth on the other side. The score line should not be used to divide the tablet.

Trazodona Stadafarma 100 mg tablets are white to off-white, round, biconvex tablets, 9.52 mm in diameter, engraved with "IT" and "II" on either side of the score line and smooth on the other side. The tablet can be divided into equal doses.

Trazodona Stadafarma 150 mg tablets are white to off-white, oval, flat tablets with beveled edges, 16.90 mm in length and 8.40 mm in width, engraved with "IT" and "III" on either side of the score line and smooth on the other side. The tablet can be divided into equal doses.

Packaging of 20, 30, 50, 60, 100 tablets and packaging of 20x1, 30x1, 50x1, 60x1, 100x1 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Laboratori Fundació DAU

C/ C, 12-14, Pol. Ind. Zona Franca,

08040 Barcelona,

Spain

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

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

Germany: Trazodon STADA 50 mg Tabletten

Trazodon STADA 100 mg Tabletten

Trazodon STADA 150 mg Tabletten

Spain: Trazodona STADAFARMA 50 mg tablets EFG

Trazodona STADAFARMA 100 mg tablets EFG

Trazodona STADAFARMA 150 mg tablets EFG

Date of the Last Revision of this Leaflet:June 2025

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