Trazodone CINFA 100 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

trazodone cinfa 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 you should not give it to other people, even if they have the same symptoms as you, because it may 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 cinfa is and what it is used for
2. What you need to know before taking trazodone cinfa
3. How to take trazodone cinfa
4. Possible adverse effects
5. How to store trazodone cinfa
6. Contents of the pack and other information

1. What trazodone cinfa is and what it is used for

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

Trazodone 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 starting to take trazodone cinfa

Do not take trazodone cinfa

• if you are allergic to trazodone or to any of the other components 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 sleep 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 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.

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

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 may shift into a manic phase in bipolar disorder. 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 trazodone may result in a false positive for amphetamines.

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 using other techniques (mass spectrometry or liquid chromatography-tandem mass spectrometry) that do not present this interference.

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 remaining still, mental agitation, seeing things that are not real (hallucinations), dilated pupils, dry mouth, dry and hot skin, thirst, waves of involuntary muscle contractions in the walls of the digestive tract (peristalsis), elevated body temperature, rapid heartbeat (tachycardia), and 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

Trazodone must not be used in children and adolescents under 18 years of age. You should also be aware that patients under 18 years of age have an increased 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 suffer from an anxiety disorder, you may occasionally experience thoughts of self-harm or suicide. These thoughts may increase when you first start taking antidepressants, as all these medications require time to begin working, usually around two weeks, although in some cases it may take longer.

You may be more likely to have these types of thoughts:

• If you have previously had thoughts of self-harm or suicide.
• If 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 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 may ask them whether they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your behavior.

Taking trazodone cinfa with other medicines

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

Trazodone may affect how some other medicines work. In addition, some medicines may affect how trazodone 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 sleep medications).
• Medications for epilepsy, such as carbamazepine and phenytoin.
• Medications for high blood pressure, for example, clonidine.
• Digoxin (used to treat heart problems).
• Medications for fungal infections, such as ketoconazole and itraconazole.
• Certain medications 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 herbal remedy used to treat insomnia, mild depression, etc.).
• Warfarin and other oral anticoagulants (used to thin the blood).

Anesthesia:

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

Taking trazodone cinfa with food, drinks, and alcohol

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, 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. Make sure your midwife and/or doctor know that you are taking trazodone. When taken during pregnancy, particularly during the last 3 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 turn blue. These symptoms usually begin 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 while breastfeeding 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 machinery until you know how trazodone affects you.

Trazodone cinfa contains sodium

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

3. How to take trazodone cinfa

Trazodone is a sedative antidepressant and causes drowsiness, especially at the beginning of treatment. Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. 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 may be gradually increased up to a maximum of 400 mg per day. The dose should be administered either divided into several 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 should be administered divided into several doses.
• If you need to take your daily dose in divided doses, the larger portion of the divided dose should be taken before going to sleep.
• Generally, the dose is increased by 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, you should maintain it for at least four weeks.
• Afterwards, the dose will be gradually reduced depending on the therapeutic response.
• Then, treatment will be continued until you have been well for a period of four to six months.
• After that, 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 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, single doses exceeding 100 mg should be avoided. The daily dose should not exceed 300 mg.

Use in children and adolescents:

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

Dosage for 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 cinfa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. You may also go to the nearest hospital emergency department. Bring the container 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 type of serious 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 cinfa

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

If you forget 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 cinfa

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 can cause adverse effects, although not everyone experiences them.

Stop taking trazodone and see your doctor or go to the hospital immediately if:

• your hands, feet, ankles, face, lips or throat swell, causing difficulty swallowing or breathing, skin itching or hives. This could be an allergic reaction to trazodone,
• you experience a painful erection of the penis unrelated to sexual activity that does not go away (priapism),
• yellowing of the skin or eyes appears. This could be a liver problem (for example, jaundice),
• you suffer infections more frequently. This could be due to a blood disorder (agranulocytosis),
• you bruise more easily than usual. This could be due to a blood disorder (thrombocytopenia),
• you have abdominal pain and swelling, vomiting and constipation. These may be signs that the intestine is not working properly (paralytic ileus).

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

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

Other adverse effects:

• Drowsiness or sleepiness, tiredness.
• Feeling less active than normal.
• 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 (shaking).
• Blurred vision.
• Loss of appetite and weight loss.
• Dizziness or feeling faint when standing up or sitting down quickly (postural hypotension), fainting (syncope).
• Feeling restless and 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), belief in things that are not true (delusions), memory disturbances.
• Nightmares.
• Decreased sex drive.
• Dizziness.
• 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), increased liver enzymes, or decreased sodium levels.

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse 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 cinfa

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.

This medicine does not require any special storage temperature conditions.

Store in the original packaging to protect it from light.

Medicines must not be disposed of via wastewater or household waste. Instead, return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of trazodone Cinfa 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, sodium carboxymethyl starch type A (from potato), pregelatinized corn starch, colloidal anhydrous silica, and magnesium stearate.

Appearance of the product and contents of the container

The tablets are round, biconvex, white to off-white in colour, marked with “IT” and “II” on either side of the score on one side, and smooth on the other side.

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

Only some pack 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

Or

Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain

Date of the most recent review of this leaflet: October 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. 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