Trazodone Normon 100 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Trazodone Normon 100 mg tablets EFG

Trazodone hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Trazodone Normon is and what it is used for
2. What you need to know before taking Trazodone Normon
3. How to take Trazodone Normon
4. Possible side effects
5. How to store Trazodone Normon
6. Contents of the pack and other information

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

Trazodone Normon contains the active substance trazodone and 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 starting Trazodone Normon

Do not take Trazodone Normon

• If you are allergic to trazodone or to any of the other ingredients of this medicine (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 consume alcoholic beverages or are taking sleeping medications.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• 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 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 difficulty urinating or need to urinate frequently,
• if you have a type of eye disorder known as narrow-angle glaucoma,
• if you have low blood pressure or hypotension.

If you are unsure whether you have any of these conditions, speak with your doctor or pharmacist before taking Trazodone Normon.

If you develop yellowing of the skin or whites of the eyes, stop treatment with trazodone immediately and consult your doctor without delay.

Administration of antidepressants in patients with schizophrenia or other psychotic disorders may worsen psychotic symptoms. Paranoid thoughts may intensify. During treatment with trazodone, a depressive phase of bipolar disorder may shift into a manic phase. In such cases, 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 sore throat, fever, or flu-like symptoms while taking trazodone, consult your doctor immediately. In such cases, a blood test is recommended to detect agranulocytosis, a blood disorder that may clinically present with these symptoms.

Interference with urine tests:

Urine testing using a specific technique (immunoassay) while taking Deprax may yield a false positive result for amphetamines.

This is due to an analytical interference between a metabolite of trazodone and a derivative of amphetamine (ecstasy). In such cases, consult your doctor and request a confirmatory test using other methods (mass spectrometry or liquid chromatography-tandem mass spectrometry), which do not exhibit this interference.

Elderly patients

Elderly patients are often more sensitive to antidepressants, particularly to drops in blood pressure when standing up suddenly after sitting or lying down (orthostatic hypotension), sometimes accompanied by dizziness, difficulty remaining still, mental agitation, seeing things that are not real (hallucinations), dilated pupils, dry mouth, dry and hot skin, thirst, involuntary muscle contractions in the walls of the digestive tract (peristalsis), elevated body temperature, rapid heartbeat (tachycardia), reduced blood pressure (anticholinergic effects), or hyponatremia (low sodium concentration in the blood, which may cause fatigue, weakness, confusion, pain, muscle stiffness, and lack of coordination).

Children and adolescents

Depraser must not be used in children and adolescents under 18 years of age. Also, be aware that patients under 18 years of age have a higher risk of adverse effects, such as suicide 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 an anxiety disorder, you may occasionally experience thoughts of self-harm or suicide. These thoughts may increase when starting antidepressants, as all such medications require time to begin working—usually about two weeks, although in some cases it may take longer.

You may be more likely to have such thoughts if:

• You have previously had thoughts of self-harm or suicide.
• You are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in young adults (under 25 years of age) with psychiatric disorders who were treated with an antidepressant.

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

It may help to inform a family member or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may also ask them whether they notice your depression or anxiety disorder worsening, or if they are concerned about changes in your behavior.

Taking Trazodone Normon with other medicines

Inform your doctor or pharmacist about any other medicines you are taking, have recently taken, or might need to take.

Trazodone Normon may affect how some other medicines work. In addition, some medicines may affect how Trazodone 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 inform your doctor if you have taken any of these within the past two weeks.
• Other antidepressants (such as amitriptyline or fluoxetine).
• Sedatives (such as tranquilizers or sleeping medications).
• Medicines used to treat epilepsy, such as carbamazepine and phenytoin.
• Medicines used to treat high blood pressure, for example, clonidine.
• Digoxin (used to treat heart problems).
• 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.
• Levodopa (used to treat Parkinson’s disease).
• St. John’s wort (a herbal remedy used for insomnia, mild depression, etc.).
• Anticoagulant and/or antiplatelet agents (used to make the blood less likely to clot): blood coagulation may be altered, increasing the risk of bleeding.

Anesthesia

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

Taking Trazodone Normon with food, drink, and alcohol

Food: Trazodone should be taken after meals if taken in divided doses, or at bedtime if taken as a single daily dose.

Alcohol: This medicine increases drowsiness, reduces alertness, and may cause 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy:

Data on the use of trazodone in pregnant women are limited. As a precaution, it is preferable to avoid using trazodone during pregnancy. Ensure that your midwife and/or doctor are aware that you are taking trazodone. When taken during pregnancy, particularly during the last three months, medicines like trazodone may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear blue. These symptoms usually begin within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.

Breastfeeding:

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

Driving and using machines

During treatment with Trazodone Normon, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how this medicine affects you.

Trazodone Normon contains Orange Yellow S (E-110) and sodium

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; thus, it is essentially “sodium-free.”

3. How to take Trazodone Normon

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

Always follow exactly the instructions for use of this medicine as prescribed by your doctor or pharmacist. If in 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 may be gradually increased up to a maximum of 400 mg per day. The dose is administered either in divided doses or as a single dose before bedtime.
• If you are hospitalized, the dose may be gradually increased up to a maximum of 600 mg per day. The dose is administered in divided doses.
• If you need to take your daily dose in divided doses, the largest portion 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 optimal effect for you is achieved.
• You will not feel better immediately. It may take two to four weeks before the appropriate dose is found.
• Once the appropriate dose is established, it should be maintained for at least four weeks.
• Afterwards, the dose will be gradually reduced, depending on the therapeutic response.
• Then, treatment should continue until you have been well for a period of four to six months.
• After this, the dose will be gradually reduced until it is low enough to discontinue treatment.
• Do not stop taking trazodone suddenly; this may cause nausea, headache, and general malaise.
• To reduce possible adverse effects, it is recommended to 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, single doses above 100 mg should be avoided. The daily dose must not exceed 300 mg.

Use in children and adolescents:

Trazodone is not recommended for children and adolescents under 18 years of age due to insufficient data on safety and/or efficacy.

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 may damage your liver.

The tablets are scored to allow gradual dose titration.

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

If you take more Trazodone Normon than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested. You may also go to the nearest hospital emergency department. Bring the packaging so the doctor knows what you have taken.

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

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

If you forget to take Trazodone Normon

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

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

If you stop taking Trazodone Normon

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

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

4. Possible adverse effects

Like all medicines, Trazodone Normon may cause adverse effects, although not everyone experiences them.

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

• If your hands, feet, ankles, face, lips, or throat swell, which may cause difficulty swallowing or breathing, skin itching, or hives. This could be an allergic reaction to Trazodone Normon.
• If you experience a painful penile erection unrelated to sexual activity that does not go away (priapism).
• If you develop yellowing of the skin or eyes. This could indicate 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. This could be due to a blood disorder (thrombocytopenia).
• If you have abdominal pain and swelling, vomiting, and constipation. These may be signs that the intestine is not functioning properly (paralytic ileus).

Contact your doctor immediately if you experience any of the following adverse effects:

• Self-harming or suicidal thoughts.
• Feeling tired, weak, dizzy, or having pale skin: these may be symptoms of anemia.
• Seizures or fits.
• Skin rashes or unusual skin sensations such as numbness, tingling, burning, or prickling (paresthesia).
• Feeling confused, restless, sweating, trembling, chills, hallucinations (strange visions or sounds), muscle twitching, and rapid heartbeat.
• Difficulty breathing (dyspnea), difficulty walking, tremors, and uncontrollable muscle spasms, accompanied by a fever above 38°C.
• Fast, slow, or irregular heartbeats different from your usual rhythm.

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, nasal congestion.
• Sweating more than usual.
• Dizziness, headache, confusion, weakness, tremors (shakiness).
• Blurred vision.
• Loss of appetite and weight loss.
• Feeling dizzy or lightheaded when standing up or sitting down quickly (postural hypotension), fainting (syncope).
• Feeling restless and having trouble sleeping.
• Fluid retention, which may 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, severe chills, sore throat, or mouth ulcers.
• Feeling anxious or more nervous than usual, agitation.
• Hyperactive behavior or thoughts (mania), false beliefs (delusions), memory disturbances.
• Nightmares.
• Decreased sexual desire.
• 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), increased liver enzymes, or decreased sodium levels.
• Urination problems, such as urinary incontinence (involuntary leakage of urine) or urinary retention (inability to urinate).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Trazodone Normon

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Trazodone Normon tablets.

• The active substance 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 hydrogen phosphate dihydrate, crospovidone, orange yellow (E-110), povidone, Eudragit E 12.5%, talc, stearic fumarate sodium.

Appearance of the medicine and contents of the pack

The tablets are orange-colored, elongated, biconvex, with a score line on one side.

The tablet can be divided into two equal doses.

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

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Spain

The most recent revision of this leaflet: March 2025

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