TRAZODONE NORMON 100 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Trazodona Normon 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 symptoms are the same as yours.
• If you experience 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 Trazodona Normon and what is it used for
2. What you need to know before you take Trazodona Normon
3. How to take Trazodona Normon
4. Possible side effects
5. Storing Trazodona Normon
6. Contents of the pack and further information

1. What is Trazodona Normon and what is it used for

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

Trazodone is used for the treatment of:

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

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

Do not take Trazodona Normon

• If you are allergic to trazodone or any of the other ingredients of this medicine (listed in section 6). The 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 sleeping pills.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• if you have had seizures or convulsions,
• if you have severe liver or kidney problems,
• if you have a 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 hyperthyroidism,
• if you have problems urinating or need to urinate frequently,
• if you have a eye disorder known as narrow-angle glaucoma,
• if you have low blood pressure or hypotension.

If you are not sure if you have any of these conditions, talk to your doctor or pharmacist before taking Trazodona Normon.

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 be intensified. 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.

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

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.

Interference with urine tests:

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 confirmation test with other techniques (mass spectrometry or tandem mass spectrometry coupled to liquid chromatography) with which the aforementioned interference does not occur.

Elderly patients

Elderly patients are often more sensitive to antidepressants, in particular to a drop in blood pressure when standing up suddenly after sitting or lying down (orthostatic hypotension), sometimes accompanied by dizziness, difficulty staying still, mental excitement, seeing things that are not real (hallucinations), dilated pupils, dry mouth, hot and dry skin, thirst, waves of involuntary muscle contractions in the digestive tract (peristalsis), elevated temperature, rapid heart rate (tachycardia), decreased blood pressure (anticholinergic effects) or hyponatremia (low sodium concentration in the blood that can cause fatigue, weakness, confusion, pain, stiffness and muscle coordination problems).

Children and adolescents

Depraser 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 aggressiveness, oppositional behavior and anger) when taking this type of medication.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may, on some occasions, have thoughts of self-harm or suicide. These thoughts can increase when 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 could be 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. Information from clinical trials has shown an increased risk of suicidal behaviors in young adults (under 25 years of age) with psychiatric disorders who were treated with an antidepressant.

If at any time you have thoughts of self-harm or suicide, 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. You could ask them 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 medicines

Tell your doctor or pharmacist that you are taking, have recently taken or might take any other medicines.

Trazodona Normon may affect the way some other medicines work. Also, some medicines may affect the way Trazodona Normon works.

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

• MAOIs (monoamine oxidase inhibitors), such as tranylcypromine, phenelzine and isocarboxazid (for depression) or selegiline (for Parkinson's disease). Also, tell them if you have taken them in the last two weeks.
• Other antidepressants (such as amitriptyline or fluoxetine).
• Sedatives (such as tranquilizers or sleeping pills).
• 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).
• Medicines used to treat fungal infections, such as ketoconazole and itraconazole.
• Some medicines 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 herbal remedy used to treat insomnia, mild depression, etc.).
• Anticoagulant and/or antiplatelet agents (used to make blood more fluid): blood coagulation may be altered with a risk of bleeding.

Anesthesia

If you are going to have an anesthesia (for an operation), tell 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 it is taken in divided doses, or at bedtime if it is taken as a single dose.

Alcohol: this medicine increases drowsiness, reduces alertness and also produces other effects. Do not drink alcohol while taking this medicine.

Pregnancy and breastfeeding

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

Pregnancy:

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 3 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.

Breastfeeding:

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

Driving and using machines

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

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

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

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

3. How to take Trazodona Normon

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

Follow exactly the administration instructions of this medicine 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 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, it should be maintained for at least four weeks.
• Then, 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 possible side effects, it is recommended that you take trazodone after a meal.

Elderly patients:

In elderly patients, the recommended starting dose is 50-100 mg per day, divided into several doses after meals, or as a single dose before bedtime. In general, the administration of single doses greater than 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 under 18 years of age due to insufficient safety and/or efficacy data.

Patients with kidney problems:

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

Patients with liver problems:

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

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

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

If you take more Trazodona Normon 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 medicine and the amount ingested. You can also go to the emergency department of the nearest hospital. Bring the package 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 (reduced blood pressure), tachycardia (rapid heart rate) and respiratory failure have been reported. Cardiac characteristics may include bradycardia (slow heart rate), prolonged QT interval and Torsade de Pointes (a type of severe irregular heartbeat). Symptoms may appear 24 hours or more after an overdose.

Overdose of trazodone in combination with other antidepressants can cause serotonin syndrome.

If you forget to take Trazodona Normon

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

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 forgotten dose.

If you stop taking Trazodona Normon

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

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

4. Possible Adverse Effects

Like all medicines, Trazodona Normon can cause adverse effects, although not all people will experience them.

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

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

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

• Suicidal or self-harming thoughts.
• Feeling tired, weak, dizzy, pale skin: these can be symptoms of anemia.
• Seizures or attacks.
• Rashes or strange sensations on the skin, such as numbness, tingling, burning, or prickling (paresthesia).
• Feeling confused, restless, sweating, trembling, chills, hallucinations (strange visions or sounds), muscle twitches, and rapid heartbeats.
• Difficulty breathing (dyspnea), difficulty walking, tremors, and uncontrollable muscle spasms, accompanied by fever above 38°C.
• Rapid, slow, or irregular heartbeats: different from usual.

Other Adverse 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, stuffy nose.
• Sweating more than usual.
• Dizziness, headache, confusion, weakness, tremors (shakes).
• Blurred vision.
• Lack of appetite and weight loss.
• Feeling dizzy or faint when standing up or sitting down quickly (postural hypotension), fainting (syncope).
• Feeling restless and having trouble sleeping.
• Fluid retention, which can cause swelling of the arms or legs.
• Skin rash, itching.
• Chest pain.
• Pain in the limbs, 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 (mania), believing things that are not true (delusions), memory disorders.
• Nightmares.
• Decreased sexual desire.
• Vertigo.
• Increased blood pressure.
• Fever.
• Flu-like symptoms.
• Difficulty speaking.
• Abnormal blood test results, which 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's (AEMPS) website: https://www.notificaram.es By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Trazodona Normon

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

Do not use this medicine after the expiration date stated 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 via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGREcollection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

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 ingredients (excipients) are: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, crospovidone, orange yellow (E-110), povidone, Eudragit E 12.5%, talc, stearic acid fumarate, and sodium.

Appearance of the Product and Package Contents

The tablets are orange, elongated, and biconvex with a break line on one face.

The tablet can be divided into two equal doses.

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

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Spain

Last Revision of this Leaflet: March 2025

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