TRAZODONE CINFA 100 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Trazodona Cinfa100 mg Tablets EFG

Trazodone Hydrochloride

Read this entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Trazodona Cinfa and what is it used for
2. What you need to know before taking Trazodona Cinfa
3. How to take Trazodona Cinfa
4. Possible side effects
5. Storage of Trazodona Cinfa
6. Contents of the pack and additional information

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

Trazodona Cinfa contains the active ingredient trazodone, which belongs to a group of medications called antidepressants.

Trazodona Cinfa 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 taking Trazodona Cinfa

Do not takeTrazodona Cinfa

• if you are allergic to trazodone or any of the other components of this medication (listed in section 6). The signs of an allergic reaction include: skin rash, swallowing or breathing problems, 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 your doctor before starting to take this medication:

• if you 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 problems 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 not sure if you have any of these conditions, talk to your doctor or pharmacist before taking trazodone.

If you develop yellowing of the skin or the whites of your 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 intensify. 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 trazodone 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 mentioned interference does not occur.

Elderly patients

Elderly patients are often more sensitive to antidepressants, particularly 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, which can cause fatigue, weakness, confusion, pain, stiffness, and muscle coordination problems).

Children and adolescents

Trazodone should not be used in children and adolescents under 18 years of age. Additionally, you should be aware 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 suffer from an anxiety disorder, you may, on occasion, have thoughts of self-harm or suicide. These 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 may take longer.

You would be more likely to have these thoughts:

• If you have previously had thoughts of self-harm or suicide.
• If you are a young adult. Clinical trial information has shown an increased risk of suicidal behaviors in young adults (under 25 years of age) with psychiatric illnesses 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 can ask them if they think your depression or anxiety disorder has worsened or if they are concerned about changes in your behavior.

TakingTrazodona Cinfawith other medications

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

Trazodone may affect how some other medications work. Additionally, some medications may affect how trazodone works.

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

• MAOIs (monoamine oxidase inhibitors), such as tranilcipromine, phenelzine, and isocarboxazide (for depression) or selegiline (for Parkinson's disease). Also, inform them 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 for treating epilepsy, such as carbamazepine and phenytoin.
• Medications for treating high blood pressure, such as clonidine.
• Digoxin (used to treat heart problems).
• Medications for treating fungal infections, such as ketoconazole and itraconazole.
• Some medications for treating 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.).
• Warfarin and other oral anticoagulants (used to make blood more fluid).

Anesthesia:

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

TakingTrazodona Cinfawith food, drinks, and alcohol

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

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

Pregnancy, breastfeeding, and fertility

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

Pregnancy:

Data on the use of trazodone in pregnant women are limited. As a precaution, 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 three months, 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 birth. 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 trazodone, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how the treatment with trazodone affects you.

Trazodona Cinfa contains sodium

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

3. How to take Trazodona Cinfa

Trazodone is a sedative antidepressant and causes drowsiness, especially at the beginning of treatment. Follow your doctor's or pharmacist's administration instructions for this medication exactly. If in doubt, consult your doctor or pharmacist again.

Adults:

• The recommended initial 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.
• Once the right dose is found, you should maintain it for at least four weeks.
• Subsequently, 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 general feeling of discomfort.
• To reduce possible side effects, it is recommended that you take trazodone after a meal.

Elderly patients:

In elderly patients, the recommended initial 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.

Dosage for 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 periodically monitor your renal function.

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

If you take moreTrazodona Cinfathan 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 medication 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 takeTrazodona Cinfa

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

If you forget 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 interrupt treatment with Trazodona Cinfa

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

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

4. Possible Adverse Effects

Like all medicines, trazodone can cause adverse effects, although not all people suffer from them.

Stop taking trazodone and 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 trazodone,
• 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 have 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, pinching, burning, or tingling (paresthesia).
• Feeling confused, restless, sweating, trembling, chills, hallucinations (strange visions or sounds), muscle twitches, and rapid heartbeat.
• 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 (shaking).
• 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 or thoughts (mania), believing things that are not true (delusions), memory disorders.
• 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), an increase in liver enzymes, and a decrease in sodium.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Trazodone Cinfa

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.

This medicine does not require any special storage temperature.

Store in the original packaging to protect it from light.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofTrazodone CinfaTablets

• 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, sodium carboxymethyl starch type A (potato), pregelatinized corn starch, anhydrous colloidal silica, and magnesium stearate.

Appearance of the Product and Package Contents

The tablets are round, biconvex, white to off-white, engraved with "IT" and "II" on either side of the score line on one face and smooth on the other face.

The tablets are presented in blisters and are available in boxes containing 30, 60, and 1,000 (clinical packaging) tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Laboratori Fundació DAU

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

08040 Barcelona

Spain

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Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the Last Revision of this Prospectus: October 2018

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

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83568/P_83568.html

QR code to: https://cima.aemps.es/cima/dochtml/p/83568/P_83568.html