Package Insert: Information for the Patient

Trazodone Hydrochloride 100 mg Film-Coated Tablets

Trazodone Hydrochloride

Read this entire package insert carefully before taking 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 you should not give it to others who have the same symptoms, as it may harm them.
• If you experienceadverse effects, consult your doctor or pharmacist,even if they are not listed in this package insert.Seesection4.

Trazodone cinfacontains trazodone as its active ingredient, which belongs to a group of medications called antidepressants.

Trazodone cinfais used for thetreatment of:

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

Do not taketrazodone cinfa

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

Warnings and precautions

Consult your doctor before starting to take this medicine:

• if you have or have had seizures or convulsions,
• if you have severe liver or kidney problems,
• if you have a heart disease (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, talk to your doctor or pharmacist before taking trazodone.

If you develop yellowing of the skin or the white of the eyes, you should stop taking trazodone and consult your doctor immediately.

The administration of antidepressants in patients with schizophrenia or other psychotic disorders may cause an exacerbation of 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.

A higher risk of bone fractures has been observed in patients treated with this type of medication.

If you have a sore throat, 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 trazodone may result in a false positive for amphetamine.

This is due to an analytical interference between a metabolite of trazodone and a derivative of amphetamine (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 to 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 walls of the digestive tract (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

Trazodone should not be used in children and adolescents under 18 years old. Also, be aware that 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 an anxiety disorder, you may, on occasion, have thoughts of self-harm or suicide. These 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 previously had thoughts of self-harm or suicide.
• if you are a young adult. Clinical trial information has shown an increase in suicidal behavior in young adults (under 25 years) with psychiatric disorders treated with an antidepressant.

If you ever 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.

Takingtrazodone cinfawith other medicines

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

Trazodone may affect the way some other medicines work. In addition, some medicines may affect the way trazodone works.

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

• MAOIs (monoamine oxidase inhibitors), 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 sleeping medications).
• Medicines for epilepsy, such as carbamazepine and phenytoin.
• Medicines for high blood pressure, for example, clonidine.
• Digoxin (used to treat heart problems).
• Medicines for fungal infections, such as ketoconazole and itraconazole.
• Some medicines for 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.).
• Warfarin and other oral anticoagulants (used to make the blood more fluid).

Anesthesia:

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

Takingtrazodone 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 medicine potentiates drowsiness, reduces alertness, and also produces other effects. Do not drink alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy:

The 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 of pregnancy, medicines 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 baby, unless you and your doctor have discussed the risks and benefits.

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 trazodone affects you.

Trazodone cinfa contains sodium

This medicine 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 initial dose is 100-150 mg per daybyoralroute,dividedintoseveraldosagesafter meals,oras a single dose before sleep.
• The dose can be increased gradually up to a maximum of 400 mg per day. The dose is administered divided into several dosages, or as a single dose before sleep.
• If hospitalized, the dose can be increased gradually up to a maximum of 600 mg per day. The dose is administered divided into several dosages.
• If you take your daily dose divided into several dosages, the majority of the divided dose should be taken before going to sleep
• 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, you should maintain it 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 patients:

In older patients, the recommended initial dose is 50-100 mg per day, divided into several dosages after meals, or as a single dose before sleep. In general, it is recommended to avoid administering single doses exceeding 100 mg. A daily dose of more than 300 mg should not be exceeded.

Use in children and adolescents:

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

Dosage for patients with kidney problems:

If you have kidney problems, your doctor will decide on the suitable 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 suitable 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 moretrazodone cinfathan 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.Also, you can 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 (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 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 forget to taketrazodone cinfa

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

If you interrupt the treatment with trazodone cinfa

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, trazodone may cause side effects, although not everyone will experience 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. This could be an allergic reaction to trazodone,
• 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 (for example, jaundice),
• If you experience 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 attacks.
• Rashes or unusual sensations in the skin such as numbness, pinching, burning, or tingling (paresthesia).
• Feeling confused, restless, sweating, trembling, chills, hallucinations (strange visions or sounds), muscle spasms, and rapid heartbeat.
• Difficulty breathing (dyspnea), difficulty walking, trembling, and uncontrollable muscle spasms, accompanied by a fever above 38°C.
• Irregular heartbeats, different from the usual ones.

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, memory disorders.
• Nightmares.
• Decreased libido.
• 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 side effects:

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

By 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.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from light.

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

Composition of Trazodone cinfa 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, carboxymethylcellulose sodium type A (potato), pregelatinized maize starch, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the packaging

The tablets are round, biconvex, white to off-white in color, engraved with “IT” and “II” on each side of the groove 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 packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Responsible manufacturer

Laboratori Fundació DAU

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

08040 Barcelona

Spain

O

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Last review date of this leaflet: October 2018

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

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet 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