Package Insert: Information for the User

Trazodone Stada 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 for you only, and you should not give it to others, even if they have the same symptoms as you, 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.

The name of this medication is Trazodona Stada. This medication contains an active ingredient called hydrochloride of trazodone that belongs to a group of medications called antidepressants.

Trazodone may be used to treat symptoms of depression (major depressive episodes).

Do not take Trazodona Stada and consult your doctor if:

• You are allergic to hydrochloride trazodone or any of the other components of this medication (listed in section 6). Signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• You have recently had a heart attack.
• You have had a recent alcohol or sleep medication overdose.

Do not take this medication if you are in any of the above circumstances. If you are unsure, consult your doctor or pharmacist before starting to take trazodona.

Warnings and precautions

Consult your doctor or pharmacist before starting to take trazodona.

Be extra careful with Trazodona Stada

Thoughts of suicide and worsening of your depression

If you are depressed, you may sometimes have thoughts of self-harm or suicide. These thoughts may increase at the beginning of treatment with antidepressants, as these medications usually take two weeks to act, and sometimes even longer.

You may be more prone to thinking this way:

• If you have previously had thoughts of self-harm or suicide.
• If you are a young adult. Clinical trials have shown a higher risk of suicidal behavior in adults under 25 years of age with psychiatric disorders treated with an antidepressant.

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

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

Severe liver disorders have been reported with the use of trazodone. If you experience any of the following symptoms, you must inform your doctor immediately:

• Weakness (asthenia)
• Loss of appetite (anorexia)
• Nausea, vomiting
• Abdominal pain
• Yellowing of the skin and/or eyes (jaundice)

Children and adolescents

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

Older adults

Patients over 65 years of age who take trazodone may experience mild dizziness and drowsiness when standing up or lying down. They may also feel more drowsy than usual.

Care should be taken, especially if the patient has other health problems and is taking medication to treat them, in addition to trazodona.

Speak to your doctor or pharmacist before taking Trazodona Stada if you:

• Have or have had seizures (epilepsy).
• Have severe kidney or liver problems.
• Have a heart disease (such as heart failure, angina, conduction disorders or AV block of different degrees, arrhythmias, recent myocardial infarction, congenital long QT syndrome or bradycardia).
• Have low levels of potassium in the blood (hypokalemia) that can cause muscle weakness, muscle cramps, abnormal heart rhythm.
• Have low levels of magnesium in the blood (hypomagnesemia).
• Have an enlarged prostate.
• Have low blood pressure (hypotension).
• Have an overactive thyroid gland (hyperthyroidism).
• Have difficulty urinating or need to urinate frequently.
• Have narrow-angle glaucoma (a type of eye disorder).
• Have schizophrenia or other mental disorders.
• You are an older adult, as you may be more prone to side effects.
• You are taking buprenorphine, naloxone (a potent analgesic). The use of buprenorphine and naloxone with trazodone may cause serotonin syndrome, which can put your life at risk (see "Other medications and Trazodona Stada").
• You are pregnant, trying to become pregnant, or breastfeeding.

If you have liver, kidney, or heart problems, or suffer from epilepsy, have high eye pressure (glaucoma), difficulty urinating or prostate problems, your doctor may want to examine you regularly while taking trazodona.

Severe liver disorders with a potentially fatal outcome have been reported with the use of trazodone.

Stop taking trazodone and talk to your doctor immediately if you experience yellowing of the skin or the white part of the eyes (jaundice) or symptoms such as weakness, loss of appetite, nausea, vomiting, abdominal pain (see Section 4. "Possible side effects").

If you have schizophrenia or other psychotic disorders, the administration of antidepressants may cause a possible worsening of symptoms. Paranoid thoughts may intensify.

During trazodone therapy, a depressive phase may change from a manic-depressive psychosis to a manic phase. In this case, trazodona should be discontinued.

If you have a sore throat, fever, or symptoms similar to the flu while taking trazodone, talk to your doctor immediately. In these cases, a blood test is recommended as agranulocytosis, a blood disorder, may manifest clinically with these symptoms.

Caution should be exercised when trazodone is used with other medications known to prolong the QT interval or that are known to increase the risk of serotonin syndrome/neuroleptic malignant syndrome (see "Other medications and Trazodona Stada" and Section 4. "Possible side effects").

If you are unsure about anything mentioned above, talk to your doctor or pharmacist before taking trazodone.

Other medications and Trazodona Stada

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

This includes medications that you can buy without a prescription, including herbal medications. This is because trazodone may affect how other medications work. Additionally, some medications may affect how trazodone works.

Inform your doctor if you are taking any of the following medications:

• IMAOs (monoamine oxidase inhibitors), such as tranilcipromina, phenelzine, and isocarboxazide (for depression) or selegiline (for Parkinson's disease), or have taken them in the past two weeks.or
• Other antidepressants.
• Fenothiazines: antipsychotic medications used to treat schizophrenia and other mental disorders.
• Buprenorphine and naloxone: used to treat pain. These medications 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.
• Sedatives (tranquilizers or sleep medications).
• Medications used to treat epilepsy, such as carbamazepine and phenytoin.
• Medications used to treat high blood pressure, such as clonidine.
• Digoxin: used to treat heart problems.
• Medications used to treat fungal infections, such as ketoconazole and itraconazole.
• Some medications used to treat HIV, such as ritonavir and indinavir.
• Erythromycin: an antibiotic used to treat infections.
• Levodopa (used to treat Parkinson's disease).
• St. John's Wort (a medicinal plant).
• Warfarin: used to prevent blood clots.
• Tryptophan.
• Triptans (medications used to treat migraines).
• Medications known to prolong the QT interval in the ECG, such as class IA and III antiarrhythmics (a group of medications used to suppress abnormal heart rhythms).
• Medications used to treat allergies, such as antihistamines.
• The birth control pill (oral contraceptives).
• Muscle relaxants (a group of medications that have the ability to relax or reduce muscle tension).

Anesthetics

If you are to undergo anesthesia (for surgery), inform your doctor or dentist that you are taking trazodone.

Taking Trazodona Stada with alcohol

You should avoid drinking alcohol while taking trazodone.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

You should only take trazodone during pregnancy if your doctor tells you to.

Taking trazodone during pregnancy may cause your baby to experience withdrawal symptoms when born. In this case, your doctor should monitor the newborn.

If you are breastfeeding or plan to breastfeed, consult with your doctor or pharmacist before taking any medication.

Driving and operating machinery

Trazodone may cause drowsiness or dizziness.It may also cause blurred vision and confusion.If this happens, do not drive or operate tools or machinery.

Trazodona Stada contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is

Adults:

• Adults generally start taking 150 mg per day in one or several doses.
• Your doctor may increase the dose every 3-4 days in increments of 50 mg, up to a maximum of 300 mg per day, depending on your condition.
• For hospitalized adults, the dose may be increased up to 600 mg per day.

Geriatric patients:

Older adults or those who are frail generally receive an initial dose of 100 mg per day.

Use in children and adolescents

Children and adolescents under 18 years old should not take trazodone.

Administration form

•Administer the medication orally.

•Swallow the tablet whole with a glass of water.

•Take during or after a meal. This may help reduce the likelihood of experiencing adverse effects.

•If you have been instructed to take trazodone only once a day, then take it before bedtime.

•If you feel that the effect of your medication is too weak or too strong, do not change the dose yourself, consult your doctor.

The tablet can be divided into equal doses. Each half of the tablet contains 50 mg of trazodone hydrochloride.

Treatment duration

It usually takes two to four weeks to start feeling better.

When you find the correct dose, you should continue for at least four weeks. Your doctor will periodically re-evaluate your dose depending on your condition and determine if it is necessary to continue with a maintenance treatment.

Generally, treatment with an antidepressant should continue until you have felt well for four to six months.

If you take more Trazodona Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to the nearest hospital emergency department, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Bring the medication packaging with you so that the doctor knows what you have taken.

The symptoms that may appear are: general discomfort, sleepiness, dizziness or fainting, seizures, confusion, respiratory or cardiac alterations.

If you forgot to take Trazodona Stada

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 compensate for the missed doses.

If you interrupt the treatment with Trazodona Stada

Do not stop taking trazodone until your doctor tells you to. Do not stop taking trazodone because you feel better. When your doctor tells you to stop taking these tablets, they will help you stop the treatment gradually.

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

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

Cases of suicidal thoughts and suicidal behavior have been reported during treatment with trazodone or shortly after discontinuation of treatment (see section 2. "What you need to know before starting to take Trazodona Stada")

Stop taking this medicine and contact your doctor immediately if you experience any of the following side effects:

• Allergic reaction, itching, skin with lumps and irritated, skin rash, swelling of hands, face or throat (edema), chest tightness or difficulty breathing.
• Prolonged and painful erection of the penis (priapism).
• Skin rash.
• Unexplained fever, sore throat or flu-like symptoms.
• Yellow discoloration of the eyes (jaundice) or skin, dark urine, back pain.

You should consult your doctor or pharmacist if you experience any of the following side effects, especially if they are prolonged or worsen:

Very common: may affect more than 1 in 10 people
• Nervousness, 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 (occasionally worsening to delirium), mental disorder characterized by violent outbursts of excitement (mania), aggressive outbursts, and the experience of seeing things that are not really there (hallucinations)
• Allergic reactions
• Weight gain, anorexia, and increased appetite
• Changes in vision, such as blurred vision, difficulty focusing, sometimes high pressure in the eye (glaucoma)
• Palpitations, irregular or rapid heart rhythm (bradycardia or tachycardia)
• Dizziness when standing up suddenly (orthostatic hypotension), fainting (syncope), high blood pressure
• Changes in taste, gas (flatulence), indigestion (gastrointestinal discomfort) with symptoms such as feeling full in the upper part of the stomach, belching, feeling unwell or nausea, and acid indigestion (dyspepsia), inflammation of the stomach or small intestine (gastroenteritis), constipation or diarrhea, stomach pain
• Blisters or spots on the skin and itching
• Feeling weak (asthenia), chest pain, back pain, or pain in the limbs
• Sweating, hot flashes, swelling (edema), flu-like symptoms
• Itching and eye pain (pruritus oculi)
• Tinnitus (ringing in the ears), headache, tremor
• Nasal congestion, blocked and painful (nasal congestion/sinusitis)

Uncommon: may affect up to 1 in 100 people
• Weight loss
• Difficulty breathing (dyspnea)
• Decreased libido
• Condition similar to serotonin syndrome, characterized by (extreme) restlessness, confusion, excitability, seeing things that are not really there (hallucinations), chills, sweating, increased reflexes, and sudden muscle contractions, high fever, rigidity, and convulsions - especially if you are taking other antidepressant medications

Rare: may affect up to 1 in 1,000 people
• Very serious blood disorders (agranulocytosis) accompanied by high fever, sore throat, and severe mouth ulcers, increased eosinophils in the blood, blood disorder (leucopenia) accompanied by increased sensitivity to infections, blood disorder (thrombocytopenia) accompanied by blue spots and a tendency to bleed, and anemia. Your doctor will be able to assess this.
• Sudden muscle contractions (myoclonus)
• Obstruction of bile flow, which can cause jaundice, liver dysfunction, elevated liver enzymes

Very rare: may affect up to 1 in 10,000 people
• Prolonged and painful erection of the penis (priapism).
• A group of side effects due to the use of neuroleptic medications such as trazodone (neuroleptic malignant syndrome), including: increased sweating and fever, changes in body function (rapid heartbeats, changes in blood pressure, increased/decreased salivation), decreased level of consciousness, pale skin, skin rash/detachment over the entire body, mutism, immobility of the body (stupor), which may occur during treatment with trazodone

Frequency not known: the frequency cannot be estimated from the available data
• Worsening of delirium, feeling of fear or shame that prevents you from behaving naturally, inhibition, anxiety, suicidal thoughts, and suicidal behavior *
• Sleep disturbances (nightmares, inability to sleep)
• Excessive release of antidiuretic hormone
• If you feel tired, weak, or confused and have muscle pain, stiffness, or lack of coordination, this may be due to low sodium levels in the blood. Contact your doctor if you have these symptoms (hyponatremia).
• Dizziness, restlessness, decreased alertness, memory alteration, tingling or numbness (paresthesia), abnormal and uncontrollable body movement (dystonia)
• Rapid and irregular heartbeats, fainting that may be a symptom of a potentially life-threatening condition known as Torsades de Pointes.
• Alteration of heart rhythm (called "prolongation of the QT interval", which is seen on the ECG, heart electrical activity)
• Muscle pain, joint stiffness, or pain
• Intestinal perforation, intestinal obstruction caused by paralysis of the intestinal muscles (ileus), abdominal cramps, and passage of the stomach through the abdominal muscles and formation of a lump on the skin (hiatal hernia), increased salivation
• Weakness, fatigue, fever
• Difficulty or interruption of urination
• Excessive sweating

* Cases of suicidal thoughts and suicidal behavior have been reported during treatment with trazodone or shortly after discontinuation of treatment (see section 2. "What you need to know before starting to take Trazodona Stada")
**Drowsiness. This usually occurs when starting treatment. It usually disappears when you continue taking your medicine.

Reporting of side effects

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

Keep this medication out of the sight and reach of children.

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

This medication does not require special storage conditions.Store in the original packaging to protect it from light.

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

Composition of Trazodona Stada

• The active principle is trazodone hydrochloride.
• Trazodona Stada 100 mg tablets: each tablet contains 100 mg of trazodone hydrochloride.

The other components are microcrystalline cellulose, sodium starch glycolate (Type A) (from potato), pregelatinized starch (from maize), colloidal anhydrous silica, and magnesium stearate.

Appearance of the product and contents of the package

Trazodona Stada 100 mg: white to off-white, round, biconvex, uncoated tablets, 9.52 mm in diameter, engraved with “IT” and “II” on one side and smooth on the other side.

The tablets are available in OPA-Aluminum-PVC/Aluminum, PVC-PVdC/Aluminum, and PVC/Aluminum blisters.

Package sizes:

100 mg: 20, 30, 50, 56, 60, or 100 tablets in a blister. Also available in a pre-cut single-dose blister of 56 x 1.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

Laboratori Fundació DAU

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

08040 Barcelona,

Spain

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice,

Poland

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Spain:Trazodona Stada 100 mg tablets EFG

Ireland:Trazodone hydrochloride 50/100/150 mg tablets

Netherlands:Trazodone hydrochloride Accord 50/100/150 mg, tablets

United Kingdom

(Northern Ireland):Trazodone hydrochloride 50/100/150 mg tablets

Last review date of this leaflet:July 2023.

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