TRAZODONE STADA 100 mg TABLETS

2. What you need to know before you take Trazodona Stada

Do not takeTrazodona Stada and consult your doctor if:

• If you are allergic to trazodone hydrochloride or any of the other ingredients of this medicine (listed in section 6). The 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 have had alcohol or drug poisoning.

Do not take this medicine if you are in any of the above situations. If you are not sure, consult your doctor or pharmacist before taking trazodone.

Warnings and precautions

Consult your doctor or pharmacist before taking trazodone.

Be careful with Trazodona Stada

Suicidal thoughts and worsening of your depression

If you are depressed, you may sometimes have thoughts of self-harm or suicide. These thoughts can increase when you start treatment with antidepressants, as these medicines usually take a few weeks to work, sometimes longer.

You may be more likely to think this way:

• If you have previously had thoughts of self-harm or suicide.
• If you are a young adult. Clinical trials have shown a greater risk of suicidal behavior in adults under 25 with psychiatric disorders who were treated with an antidepressant.

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

It may be helpful to tell a relative or close friendthat you are depressed and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

There have been reports of severe liver disorders with the use of trazodone. If you experience any of the following symptoms, you should inform your doctor immediately:

• Weakness (asthenia)
• Loss of appetite (anorexia)
• Nausea, vomiting
• Stomach pain
• Yellowing of the skin and/or eyes (jaundice)

Children and adolescents

Trazodone should not be used in children and adolescents under 18 years of age.

Elderly people

Elderly patients taking trazodone may experience mild dizziness and drowsiness when standing up or lying down. They may also feel more sleepy than usual.

Greater caution is required, especially if the patient has other illnesses and is taking medication to treat them, along with trazodone.

Talk to your doctor or pharmacist before taking Trazodona Stada if you:

• Have or have had seizures or convulsions (epilepsy).
• Have severe kidney or liver problems.
• Have heart disease (such as heart failure, angina, conduction disorders or AV blocks of different degrees, arrhythmias, recent myocardial infarction, congenital long QT syndrome or bradycardia).
• Have low potassium levels in the blood (hypokalemia) that can cause muscle weakness, nervous contractions, abnormal heart rhythm.
• Have low magnesium levels in the blood (hypomagnesemia).
• Have an enlarged prostate.
• Have low blood pressure (hypotension).
• Have an overactive thyroid gland (hyperthyroidism).
• Have problems urinating or need to urinate frequently.
• Have narrow-angle glaucoma (a eye disorder).
• Have schizophrenia or other mental disorders.
• Are an elderly person, as you may be more prone to side effects.
• Are taking buprenorphine, naloxone (a potent analgesic). The use of buprenorphine and naloxone with trazodone can cause serotonin syndrome, which can put your life at risk (see "Other medicines and Trazodona Stada").
• Are pregnant, trying to become pregnant or are breastfeeding.

If you have liver, kidney or heart problems, suffer from epilepsy, have high eye pressure (glaucoma), problems urinating or with the prostate, it is likely that your doctor will want to examine you periodically while you are taking trazodone.

Severe liver disorders with a potentially fatal outcome have been reported with the use of trazodone.

Stop taking trazodone and talk to your doctor immediately if you experience yellowing of the skin or the white of the eyes (jaundice) or signs such as asthenia, anorexia, nausea, vomiting, abdominal pain (see Section 4. "Possible side effects").

If you have schizophrenia or other psychotic disorders, the administration of antidepressants may cause a possible worsening of psychotic symptoms. Paranoid thoughts may intensify.

During therapy with trazodone, a depressive phase may change from a manic-depressive psychosis to a manic phase. In that case, trazodone should be discontinued.

If you have a sore throat, fever or flu-like symptoms while taking trazodone, you should talk to your doctor immediately. In these cases, a blood test is recommended as agranulocytosis, a blood disorder, may manifest clinically with these symptoms.

Cautions are recommended when using trazodone with other medicines known to prolong the QT interval or that are known to increase the risk of serotonin syndrome/neuroleptic malignant syndrome (see "Other medicines and Trazodona Stada" and Section 4. "Possible side effects").

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking trazodone.

Other medicines and Trazodona Stada

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

This includes medicines that you can buy without a prescription, including herbal medicines. This is because trazodone can affect the way other medicines work. Additionally, some medicines can affect the way 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), or have taken them in the last two weeks.
• Other antidepressants.
• Phenothiazines: antipsychotic medicines used in the treatment of schizophrenia and other mental disorders.
• Buprenorphine and naloxone: used for pain treatment. These medicines can interact with trazodone and you may experience symptoms such as involuntary and rhythmic muscle contractions, including the muscles that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor if you experience any of these symptoms.
• Sedatives (tranquilizers or sleeping pills).
• Medicines used to treat epilepsy, such as carbamazepine and phenytoin.
• Medicines used to treat high blood pressure, such as clonidine.
• Digoxin: used to treat heart problems.
• Medicines used to treat fungal infections, such as ketoconazole and itraconazole.
• Some medicines used to treat HIV, such as ritonavir and indinavir.
• Erythromycin: an antibiotic used to treat infections.
• Levodopa (used in the treatment of Parkinson's disease).
• St. John's Wort (a herbal medicine).
• Warfarin (used to prevent blood clots from forming).
• Tryptophan.
• Triptans (medicines used to treat migraines).
• Medicines that are known to prolong the QT interval in the ECG, such as antiarrhythmic drugs of class IA and III (a group of medicines used to suppress abnormal heart rhythms).
• Medicines used to treat allergies such as antihistamines.
• The contraceptive pill (oral contraceptives).
• Muscle relaxants (a group of medicines that have the ability to relax or reduce muscle tension).

Anesthetics

If you are going to have an anesthetic (for an operation), tell your doctor or dentist that you are taking trazodone.

Taking Trazodona Stada with alcohol

You should avoid drinking alcohol while taking trazodone.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

You should only take trazodone during pregnancy if your doctor has told you to.

Taking trazodone during pregnancy may cause your baby to experience withdrawal symptoms when born. In this case, your doctor will monitor the newborn.

If you are breastfeeding or planning to breastfeed, consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Trazodone can make you feel drowsy or dizzy. It can also cause blurred vision and confusion. If this happens, do not drive or use tools or machinery.

Trazodona Stada contains sodium

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

3. How to take Trazodona Stada

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is

Adults:

• Adults usually start taking 150 mg per day in one or several doses.
• Your doctor may increase the dose every 3-4 days in intervals of 50 mg, up to a maximum of 300 mg per day, depending on your condition.
• For hospitalized adults, the dose may be increased up to 600 mg per day.

Elderly patients:

Elderly people or those who are fragile usually receive an initial dose of 100 mg per day.

Use in children and adolescents

Children and adolescents under 18 years of age should not take trazodone.

Method of administration

• Administer the medicine orally.
• Swallow the tablet whole with a glass of water.
• Take during or after a meal. This can help reduce the likelihood of side effects.
• If you have been told to take trazodone only once a day, then take it before bedtime.
• If you feel that the effect of your medicine is too weak or too strong, do not change the dose yourself, consult your doctor.

The tablet can be divided into equal doses. Each half of the tablet contains 50 mg of trazodone hydrochloride.

Duration of treatment

It usually takes two to four weeks to start feeling better.

When the correct dose is found, you should continue for at least four weeks. Your doctor will periodically re-evaluate your dose depending on your condition and determine if it is necessary to continue with maintenance treatment.

In general, treatment with an antidepressant should continue until you have felt well for four to six months.

If you take more Trazodona Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to the emergency department of the nearest hospital or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken. Bring the medicine packaging with you so that the doctor knows what you have taken.

The symptoms that may appear are: general discomfort, sleepiness, dizziness or fainting, convulsions, confusion, respiratory or heart problems.

If you forget to take Trazodona Stada

If you forget to take 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.

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

If you stop taking Trazodona Stada

Do not stop taking trazodone until your doctor tells you to. Do not stop taking trazodone because you feel better. When your doctor tells you to stop taking these tablets, they will help you stop 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, this medicine can cause adverse effects, although not all people suffer from them.

There have been reports of suicidal thoughts and suicidal behavior during treatment with trazodone or shortly after stopping treatment (see section 2. "What you need to know before taking Trazodona Stada")

Stop taking this medicine and contact your doctor immediately if you experience any of the following adverse effects:

• Allergic reaction, itching, skin with bumps and irritation, rash, swelling of hands, face or throat (edema), chest tightness or difficulty breathing.
• Prolonged and painful erection of the penis (priapism).
• Rash.
• Unexplained fever, sore throat or flu-like symptoms.
• Yellowing of the eyes (jaundice) or skin, very dark urine, back pain.

You should consult your doctor or pharmacist if you experience any of the following effects, especially if they are prolonged or worsen:

Very frequent: may affect more than 1 in 10 people • nervousness, dizziness, drowsiness **• dry mouth Frequent: may affect up to 1 in 10 people • expressive disorder of the central nervous system that affects the ability to use and understand words (expressive aphasia) • disorientation, confusion, agitation (very occasionally worsening to delirium), mental disorder characterized by large explosions of violent excitement (mania), aggressive outbursts and the experience of seeming to see something that is not really there (hallucinations) • allergic reactions • weight gain, anorexia and increased appetite • changes in vision, such as blurred vision, difficulty focusing, sometimes high pressure in the eye (glaucoma) • palpitations, irregular or rapid heart rate (bradycardia or tachycardia) • dizziness when standing up suddenly (orthostatic hypotension), fainting (syncope), high blood pressure • changes in taste, gas (flatulence), indigestion (digestive discomfort) with symptoms such as a feeling of fullness in the upper stomach, belching, feeling of discomfort or nausea and acid indigestion (dyspepsia), inflammation of the stomach or small intestine (gastroenteritis), constipation or diarrhea, stomach pain • lumps or spots on the skin and itching • feeling weak (asthenia), chest pain, back pain or limb pain • sweating, hot flashes, swelling (edema), flu-like symptoms • itching and eye pain (ocular pruritus) • tinnitus (ringing in the ears), headache, tremor • blocked, congested and painful nose (nasal/sinus congestion)

Infrequent: may affect up to 1 in 100 people • weight loss • difficulty breathing (dyspnea) • decreased sexual desire • condition similar to serotonin syndrome, characterized by (extreme) restlessness, confusion, excitability, seeing things that do not exist (hallucinations), chills, sweating, increased reflexes and sudden muscle contractions, high fever, stiffness and convulsions - especially if you are taking other antidepressant medications Rare: may affect up to 1 in 1,000 people • very serious blood disorders (lack of white blood cells) accompanied by sudden high fever, sore throat and severe mouth ulcers (agranulocytosis), increase in the amount of a type of white blood cell in the blood (eosinophilia), blood disorder (lack of white blood cells) accompanied by increased sensitivity to infections (leukopenia), blood disorder (lack of platelets) accompanied by blue spots and tendency to bleeding (thrombocytopenia) and anemia. Your doctor will know how to assess this. • sudden muscle contraction (myoclonus) • obstruction of bile flow, which can cause jaundice, alteration of liver function, elevated liver enzymes Very rare: may affect up to 1 in 10,000 people • prolonged and painful erection of the penis (priapism). • a group of side effects due to the use of neuroleptic medications such as trazodone (neuroleptic malignant syndrome), such as: increased sweating and fever, changes in body function (rapid heartbeats, changes in blood pressure, increased/decreased salivation), decreased level of consciousness, paleness of the skin, eruptions on the skin/descaling all over the body, muteness, immobility of the body (stupor), may occur during treatment with trazodone

Frequency not known: the frequency cannot be estimated from the available data • worsening of delirium, feeling of fear or shame that prevents natural behavior, inhibition, anxiety, suicidal thoughts and suicidal behavior * • sleep disturbances (nightmares, inability to sleep) • excessive release of antidiuretic hormone • if you feel tired, weak or confused and have painful, stiff or uncoordinated muscles, this may be due to low sodium levels in the blood. Contact your doctor if you have these symptoms (hyponatremia). • vertigo, restlessness, decreased alertness, altered memory, tingling or numbness (paresthesia), abnormal and uncontrolled body movement (dystonia) • rapid and irregular heartbeats, fainting that could be symptoms of a potentially fatal condition known as Torsades de Pointes. • alteration of heart rhythm (called "prolongation of the QT interval", which is seen in the ECG, electrical activity of the heart) • muscle pain, stiffness in the joints or pain • intestinal perforation, intestinal obstruction caused by paralysis of the intestinal muscles (paralytic ileus), gastrointestinal cramps and passage of the stomach through the abdominal muscles and formation of a lump in the skin (hiatal hernia), increased salivation • weakness, fatigue, fever • difficulty or interruption of urination • excessive sweating * There have been reports of suicidal thoughts and suicidal behavior during treatment with trazodone or shortly after stopping treatment (see section 2. "What you need to know before taking Trazodona Stada”)**Drowsiness. This usually occurs when starting treatment. It usually disappears when you continue taking your medicine.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Trazodona Stada

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging and the blister pack after "CAD". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions. Store in the original packaging to protect it from light.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Trazodona Stada

• The active ingredient is trazodone hydrochloride.
• Trazodona Stada 100 mg tablets: each tablet contains 100 mg of trazodone hydrochloride.

The other components are microcrystalline cellulose, sodium glycolate starch (Type A) (derived from potato), pregelatinized starch (derived from corn), anhydrous colloidal silica and magnesium stearate.

Appearance of the Product and Package Contents

Trazodona Stada 100 mg: white to off-white, round, biconvex tablets, without coating, 9.52 mm in diameter, engraved with "IT" and "II" on either side of the score line on one face and smooth on the other face.

The tablets are available in OPA-Aluminum-PVC/Aluminum, PVC-PVdC/Aluminum and PVC/Aluminum blisters.

Package sizes:

100 mg: 20, 30, 50, 56, 60 or 100 tablets in blister packs. Also available in single-dose precut blister packs of 56 x 1.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

Laboratori Fundació DAU

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

08040 Barcelona,

Spain

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice,

Poland

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Spain: Trazodona Stada 100 mg tablets EFG

Ireland: Trazodone hydrochloride 50/100/150 mg tablets

Netherlands: Trazodone hydrochloride Accord 50/100/150 mg, tablets

United Kingdom

(Northern Ireland): Trazodone hydrochloride 50/100/150 mg tablets

Date of the last revision of this prospectus:July 2023.

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