Package Insert: Information for the Patient

Trazodone Normon 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 should not be given to others who may 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.

Trazodona Normon contains the active ingredienttrazodone, which belongs to a group of medicines called antidepressants.

Trazodone is used to treat:

• Major depressive episodes.
• Mixed states of depression and anxiety, with or without secondary insomnia.

Do not take Trazodona Normon

• If you are allergic to trazodone or any of the other ingredients in 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.
• If you have recently had a heart attack.
• If you are a consumer of alcoholic beverages or are taking sleep medications.

Warnings and precautions

Consult with your doctor or pharmacist before taking this medication:

• If you have or have had seizures or convulsions,
• If you have severe liver or kidney problems,
• If you have a heart condition (such as heart failure, angina, conduction disorders, or AV block of various degrees, arrhythmia, recent myocardial infarction, congenital long QT syndrome, or bradycardia),
• If you have hyperthyroidism,
• If you have difficulty urinating or need to urinate frequently,
• If you have a known eye disorder called narrow-angle glaucoma,
• If you have low blood pressure or hypotension.

If you are unsure about any of these situations, speak with your doctor or pharmacist before taking Trazodona Normon.

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

The administration of antidepressants in patients with schizophrenia or other psychotic disorders may exacerbate 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, trazodone administration should be discontinued.

An increased risk of bone fractures has been observed in patients treated with this type of medication.

If you experience throat pain, 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.

Interference with urine tests:

The analysis of your urine using a specific technique (immunoassay) while taking Deprax may result in a false positive for amphetamine.

This is due to an analytical interference between a trazodone metabolite and an amphetamine derivative (ecstasy). In this case, consult your doctor and request a confirmatory test with other techniques (mass spectrometry or tandem mass spectrometry coupled to liquid chromatography) that do not produce the mentioned interference.

Older patients

Older patients are often more sensitive to antidepressants, particularly orthostatic hypotension when standing up suddenly after sitting or lying down, sometimes accompanied by dizziness, difficulty maintaining balance, mental excitement, seeing things that are not real (hallucinations), dilated pupils, dry mouth, dry and warm skin, thirst, involuntary muscle contractions in the digestive tract walls (peristalsis), elevated temperature, rapid heart rate (tachycardia), reduced blood pressure (anticholinergic effects), or hyponatremia (low sodium concentration in the blood that may cause fatigue, weakness, confusion, pain, stiffness, and muscle discoordination).

Children and adolescents

Depraser should not be used in children and adolescents under 18 years old. Additionally, patients under 18 years old 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.

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may, in some cases, have suicidal thoughts. These thoughts may increase when taking antidepressants for the first time, as all these medications require a 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 had previous suicidal thoughts.
• If you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in young adults (under 25 years) with psychiatric disorders treated with an antidepressant.

If you have any suicidal thoughts, contact your doctor or go directly to a hospital.

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

Taking Trazodona Normon with other medications

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

Trazodona Normon may affect how some other medications work. Additionally, some medications may affect how Trazodona Normon works.

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

• IMAO (monoamine oxidase inhibitors), medications such as tranilcipromina, phenelzine, and isocarboxazide (for depression) or selegiline (for Parkinson's disease). Also inform if you have taken them in the last two weeks.
• Other antidepressants (such as amitriptyline or fluoxetine).
• Sedatives (such as 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 used to treat insomnia, mild depression, etc.).
• Anticoagulants and/or antiplatelet agents (used to make blood more fluid): blood coagulation may be modified with a risk of bleeding.

Anesthesia

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

Taking Trazodona Normon with food, drink, and alcohol

Food: Trazodone should be taken after eating if taken in divided doses, or before bedtime if taken as a single dose.

Alcohol: This medication potentiates drowsiness, reduces alertness, and also produces other effects. 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 recommended to avoid the use of trazodone during pregnancy. Ensure that your midwife and/or doctor know that you are taking trazodone. When taken during pregnancy, particularly in the last 3 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.

Breastfeeding:

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

Driving and operating machinery

During treatment with Trazodona Normon, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how Trazodona Normon affects you.

Trazodona Normon contains yellow orange S (E-110) and sodium

This medication may cause allergic reactions because it contains yellow orange S (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

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

Trazodone is a sedating antidepressant that causes drowsiness, especially at the beginning of treatment.

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

Adults:

• The recommended starting dose is 100-150 mg per day orally, 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 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 bedtime.
• 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, it should be maintained for at least four weeks.
• Subsequently, the dose will be reduced gradually, according to the therapeutic response.
• Then, 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.

Older adults:

In older adults, the recommended starting dose is 50-100 mg per day, divided into several doses after meals, or as a single dose before bedtime. Generally, administration of single doses exceeding 100 mg should be avoided. A daily dose of 300 mg should not be exceeded.

Use in children and adolescents:

Trazodone is not recommended in children under 18 years of age due to the lack of sufficient safety and/or efficacy data.

Patients with kidney problems:

If you have kidney problems, your doctor will decide on the appropriate dose for your condition. In this case, your doctor may monitor your renal function periodically.

Patients with liver problems:

If you have liver problems, your doctor will decide on the appropriate dose for your condition. In this case, your doctor may monitor your liver function periodically, as trazodone may damage your liver.

The tablets are scored to allow for a gradual increase in dose.

If the tablet is split through the central score, two halves of the tablet are obtained. Each half of the tablet contains 50 mg of trazodone.

If you take more Trazodone Normon 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. You can also go to the Emergency Service of the nearest hospital. Bring the packaging so that the doctor knows what you have taken.

The most frequent symptoms of overdose are: drowsiness, dizziness, nausea, and vomiting. In more severe cases, coma, convulsions, hyponatremia (low sodium concentration in the blood), hypotension (reduction of blood pressure), tachycardia (rapid heart rate), and respiratory failure have been reported. Cardiac characteristics may include bradycardia (slow heart rate), QT interval prolongation, and Torsade de Pointes (a type of severe irregular heart rhythm). Symptoms may appear 24 hours or more after an overdose.

Trazodone overdose in combination with other antidepressants may cause serotonin syndrome.

If you forgot to take Trazodone Normon:

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

If you forget to take a dose, take it as soon as you remember, but if it is almost time for the next dose, do not take the missed dose.

If you interrupt treatment with Trazodona Normon:

Do not stop taking trazodone until your doctor tells you to. Your doctor will also help you to leave the treatment gradually.

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

Like all medications, Trazodona Normon may cause side effects, although not everyone will experience them.

Stop taking Trazodona Normon and see your doctor or go to the hospital immediately:

• If your hands, feet, ankles, face, lips, or throat become swollen, which can cause difficulty swallowing or breathing, skin itching, and hives. This could be an allergic reaction to Trazodona Normon.
• If you experience a painful erection of the penis, unrelated to sexual activity, that does not go away (priapism).
• If you notice a yellowish discoloration of the skin or eyes. This could be a liver problem (e.g., jaundice).
• If you experience more frequent infections. This could be due to a blood disorder (agranulocytosis).
• If you notice bruises more easily than usual. This could be due to a blood disorder (thrombocytopenia).
• If you experience abdominal pain, swelling, vomiting, and constipation. These can be signs that the intestine is not functioning properly (paralytic ileus).

Talk to your doctor immediately if you notice the following side effects:

• Self-harming thoughts or suicidal thoughts.
• Feeling tired, weak, dizzy, pale skin: these can be symptoms of anemia.
• Seizures or convulsions.
• Rashes or unusual sensations in the skin such as numbness, prickling, burning, or tingling (paresthesia).
• Feeling confused, restless, sweating, trembling, chills, hallucinations (seeing or hearing things that are not there), muscle spasms, and rapid heartbeat.
• Difficulty breathing (dyspnea), difficulty walking, trembling, and uncontrollable muscle spasms, accompanied by a fever above 38°C.
• Rapid, slow, or irregular heartbeats: different from your usual heart rhythm.

Other side effects:

• Feeling drowsy or sleepy, tired.
• Feeling less active than usual.
• Feeling unwell.
• Nausea, vomiting, or indigestion.
• Constipation, diarrhea.
• Dry mouth, altered taste, increased saliva, blocked nose.
• Sweating more than usual.
• Dizziness, headache, confusion, weakness, trembling (shaking).
• Blurred vision.
• Loss of appetite and weight loss.
• Feeling dizzy or faint when standing up or sitting down quickly (postural hypotension), fainting (syncope).
• Feeling anxious and having trouble sleeping.
• Fluid retention, which can cause swelling of the arms or legs.
• Skin rash, itching.
• Chest pain.
• Pain in the extremities, back pain, muscle pain, joint pain.
• Involuntary muscle movements, especially in the arms and legs.
• Frequent infections with high fever, intense chills, sore throat, or mouth ulcers.
• Feeling anxious or more nervous than usual, agitation.
• Hyperactive behavior or thoughts (mania), delusions (believing things that are not true), memory disorders.
• Nightmares.
• Decreased sex drive.
• Dizziness.
• Increased blood pressure.
• Fever.
• Flu-like symptoms.
• Difficulty speaking.
• Abnormal blood test results that may show a decrease in blood cells (white blood cells, red blood cells, and platelets), an increase in liver enzymes, and a decrease in sodium.
• Urination problems, such as urinary incontinence (loss of urine) or urinary retention (inability to urinate).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 Pharmacovigilance of Medicines for Human Use:https://www.notificaram.esBy reporting side effects, you can contribute to providing more information about 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 packaging after CAD. The expiration date is the last day of the month indicated.

Store below 30°C

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of your pharmacySIGREAsk your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Trazodona Normon tablets.

• The active ingredient is trazodone. Each tablet contains 100 mg of trazodone hydrochloride, equivalent to 91.1 mg of trazodone.
• The other components (excipients) are: microcrystalline cellulose, calcium dihydrogen phosphate, crospovidone, yellow-orange (E-110), povidone, Eudragit E 12.5%, talc, stearate fumarate, and sodium.

Appearance of the product and content of the packaging

The tablets are orange, elongated, and biconvex with a breaking bar on one face.

The tablet can be divided into two equal doses.

This medicine is presented in boxes containing 30, 60, and 500 tablets (clinical packaging), available in blisters.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid,

Spain

Last review of this leaflet: March 2025

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/