Deprax 100 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Deprax 100 mg film-coated 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 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.

Leaflet contents

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

1. What Deprax is and what it is used for

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

Deprax 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 Deprax

Do not take Deprax

• if you are allergic to trazodone or 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 medications for sleep.

Warnings and precautions

Talk to your doctor before starting to take Deprax:

• 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 Deprax.

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 of bipolar disorder may shift into a manic phase. In such cases, trazodone 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 method (immunoassay) while taking Deprax may result in a false positive for amphetamines.

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

Children and adolescents

Deprax must 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 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 have thoughts of self-harm or suicide. These thoughts may increase when first starting antidepressants, as all these medicines require time to begin working—usually about two weeks, although in some cases it may take longer.

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

Taking Deprax with other medicines

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

Deprax may affect how some other medicines work. In addition, some medicines may affect how Deprax 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 if you have taken them within 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 herbal remedy used for insomnia, mild depression, etc.).
• Anticoagulant and/or antiplatelet agents (used to make blood less likely to clot): blood coagulation may be altered, increasing the risk of bleeding.

Anaesthesia

If you are due to undergo anaesthesia (for surgery), inform your doctor or dentist that you are taking Deprax.

Taking Deprax 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, breast-feeding and fertility

If you are pregnant, breast-feeding, 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 precautionary measure, it is preferable to avoid using trazodone during pregnancy. Make sure your midwife and/or doctor know that you are taking Deprax. Medicines like Deprax, when taken during pregnancy—particularly during the last 3 months—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 bluish. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

Breast-feeding:

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 Deprax, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how Deprax affects you.

Deprax contains sunset yellow FCF (E-110), carmine red A (Ponceau 4R) (E-124) and sodium

This medicine can cause allergic reactions because it contains sunset yellow FCF (E-110) and carmine red A (Ponceau 4R) (E-124). It may 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 Deprax

Trazodone is a sedative antidepressant and causes drowsiness, especially at the beginning of treatment. Always follow exactly the instructions for use of 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 orally per day, 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 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, administered in divided doses.
• If your daily dose must be divided into several doses, the largest portion of the divided dose should be taken at bedtime.
• Dose increases are generally made 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 to find the appropriate dose.
• Once the appropriate dose is found, it should be maintained for at least four weeks.
• Afterwards, the dose will be gradually reduced, depending on your therapeutic response.
• Then, treatment will 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, as 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 higher than 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 Deprax 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 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 (fast heart rate), and respiratory failure have been reported. Cardiac effects 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 Deprax

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 Deprax

Do not stop treatment with Deprax unless 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, Deprax may cause adverse effects, although not everyone experiences them.

Stop taking Deprax and see your doctor or go to 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 Deprax,
• you experience a painful erection of the penis unrelated to sexual activity that does not go away (priapism),
• you develop yellowing of the skin or eyes. This could indicate a liver problem (e.g. 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 functioning properly (paralytic ileus).

Contact your doctor immediately if you notice the following adverse effects:

• Thoughts of self-harm or suicide.
• Feeling tired, weak, dizzy, or having pale skin: these may be symptoms of anaemia.
• Seizures or fits.
• Skin rashes or unusual skin sensations such as numbness, prickling, burning, or tingling (paraesthesia).
• Confusion, restlessness, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle twitching, and rapid heartbeat.
• Difficulty breathing (dyspnoea), difficulty walking, tremors and uncontrollable muscle spasms, accompanied by fever above 38°C.
• Fast, slow or irregular heartbeats: different from your usual pattern.

Other adverse effects:

• Drowsiness or sleepiness, tiredness.
• Feeling less active than usual.
• Feeling unwell.
• Nausea, vomiting or indigestion.
• Constipation, diarrhoea.
• 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.
• Feeling dizzy or faint 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 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 behaviour or thoughts (mania), belief in things that are not true (delusions), memory disturbances.
• Nightmares.
• Decreased sexual desire.
• 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.
• Problems urinating, such as urinary incontinence (involuntary loss of urine) or urinary retention (inability to urinate).

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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. Deprax Storage Instructions

Keep this medicine out of sight and reach of children.

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly discard medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Deprax

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:

• Core: calcium hydrogen phosphate dihydrate, povidone, microcrystalline cellulose (Avicel pH 101 and Avicel pH 102), magnesium stearate, carmine red A (Ponceau 4R) (E-124), sodium croscarmellose, orange yellow S (E-110).
• Coating: Eudragit E 12.5%, micronized talc.

Appearance of the product and pack contents

Deprax tablets are elongated, pink-orange in colour and scored on both sides.

The tablets are presented in aluminium blisters with polyvinyl chloride (PVC) film, and are available in boxes containing 30, 60 and 1,000 tablets (clinical pack) film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

ANGELINI PHARMA ESPAÑA, S.L.

C/ Antonio Machado, 78-80

3rd floor, module A - Edificio Australia

08840 Viladecans, Barcelona (Spain)

Telephone: 932 534 500

Manufacturer

Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Spain)

Date of latest revision of the leaflet: November 2023

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