Package Insert: Information for the User

Surmontil 25 mg Film-Coated Tablets

trimipramina

Read this package insert carefully before starting to take this medication because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1. What is Surmontil and for what it is used

2. What you need to know before starting to take Surmontil

3. How to take Surmontil

4. Possible adverse effects

5. Storage of Surmontil

6. Contents of the package and additional information

Surmontil is a tricyclic antidepressant derived from dibenzazepine. It is used as an antidepressant and anxiolytic.

Under the prescription of your doctor, this medication is indicated for the treatment of:

• All types of depressive states.
• Underlying psychosomatic disorders with depressive components.
• Anxiety states and sleep alterations.

Do not take Surmontil

• If you are allergic (hypersensitive) to trimipramine, other tricyclic antidepressants, or any of the other components of this medication (listed in section 6).
• If you are at risk of developing acute angle glaucoma.
• If you are at risk of urinary retention due to urethral or prostate problems.
• If you have recently had a myocardial infarction.
• With irreversible Monoamine Oxidase (MAO) inhibitors (iproniazid) and/or sultoprida (see "Use of other medications").
• If you consume alcohol.
• With clonidina, guanetidina, and similar medications (see "Use of other medications").

Warnings and precautions

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may have thoughts of harming yourself or committing suicide. These thoughts may be stronger when you start taking antidepressants, as these medications take time to work, usually around two weeks, but sometimes the period is longer.

You may think:

• If you have had thoughts of harming yourself or committing suicide before.
• If you are a young adult. Clinical trial information has shown a higher risk of suicidal behavior in adults under 25 years old with psychiatric disorders being treated with an antidepressant.

If you have thoughts of harming yourself or committing suicide at any time, contact your doctor, or go directly to a hospital.

Telling a family member or close friend that you are depressed or have an anxiety disorder, and asking them to read this leaflet, may be helpful. You can ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

It is recommended to gradually reduce the dose and closely monitor patients when discontinuing treatment, as there have been some exceptional cases of withdrawal syndrome (headaches, nausea, vomiting, anxiety, agitation, sweating, discomfort, sleep problems...).

In the case of a manic episode, treatment with Surmontil should be discontinued, and your doctor will usually prescribe appropriate treatment.

The insomnia or nervousness that may occur at the beginning of treatment may justify a reduction in dosage or temporary symptomatic treatment.

Clinical and electroencephalographic monitoring is recommended for patients with epilepsy or suspected epilepsy, as the epileptogenic threshold may decrease. The appearance of seizures requires discontinuation of treatment.

Other warnings

- If you are an elderly patient, as you are more susceptible to:

• A fall in blood pressure when standing up after sitting (orthostatic hypotension),
• Sedation,
• Chronic constipation (risk of paralytic ileus),
• Prostatic hyperplasia,

• If you have heart disease and are an elderly patient, cardiac function should be regularly monitored, as this class of medications increases the risk of rapid heartbeats and low blood pressure.

• If you have renal or hepatic insufficiency.

• If you are diabetic or have risk factors for developing diabetes, your doctor should monitor your blood glucose levels.

Serotonin syndrome may appear when Surmontil is administered with other serotoninergic medications. This syndrome is caused by an excess of a neurotransmitter called serotonin, can be fatal, and includes the following symptoms: neuromuscular excitement, increased body temperature, tachycardia, changes in blood pressure, excessive sweating, tremors, flushing, dilated pupils, anxiety, agitation, confusion, and coma.

Exhaustive clinical monitoring is required when serotoninergic active substances are combined with trimipramine. If serotonin syndrome appears, treatment with trimipramine should be discontinued.

This type of medication may potentiate the appearance of cardiac rhythm disturbances (prolongation of the QT interval). Special caution should be exercised in patients with known risk factors for QT interval prolongation, bradycardia, hypokalemia, and hypomagnesemia.

Children and adolescents

Surmontil should not be used in children and adolescents under 18 years old.

Other medications and Surmontil

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take other medications, even those purchased without a prescription, and especially if you are taking any of the following:

• MAO inhibitors: as their simultaneous administration may produce severe adverse reactions, as well as starting treatment with Surmontil before completing 14 days of treatment with an MAO inhibitor.

Buprenorphine / opioids: these medications may interact with Surmontil, and you may experience symptoms such as involuntary and rhythmic muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, high body temperature. Consult your doctor when you experience such symptoms.

• Other serotoninergic active substances such as: selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, lithium, triptans, tramadol, linezolid, L-tryptophan, and St. John's Wort preparations. Careful clinical monitoring is required when these medications are combined with trimipramine.

• Guanetidina, guanfacina, and clonidina, as trimipramine reduces their anti-hypertensive effect.

• Alpha and beta sympathomimetics (epinephrine, norepinephrine, dopamine by parenteral route) as it may produce paroxysmal hypertension with a risk of ventricular arrhythmias.

• If you are being treated with the following medications or types of medications:

• Anticonvulsants; carbamazepine.
• Antidepressants: citalopram, fluoxetine, fluvoxamine, paroxetine, and sertraline.
• Anti-hypertensives.
• Other central nervous system depressants: morphine derivatives (analgesics, antitussives, and substitution therapies), sedating antihistamines, hypnotics (e.g. barbiturates and benzodiazepines), different anxiolytics, neuroleptics, central anti-hypertensives, baclofen, talidomide.
• Baclofen.
• Other medications that lower the seizure threshold
• Atropine and other atropinic substances such as ipratropium bromide, tiotropium bromide, tropicamide, butylscopolamine.

Other precautions to be taken into account:

Trimipramine should be avoided with medications that prolong the QT interval (e.g., antiarrhythmic class IA or III, antibiotics, antimalarials, antihistamines, neuroleptics), that induce hypokalemia (e.g., certain diuretics, glucocorticoids), or bradycardia (e.g., beta blockers, diltiazem, verapamil, clonidina, digitals) or inhibit the hepatic metabolism of trimipramine (e.g., irreversible MAO inhibitors, imidazole antimycotics) (see be careful with Surmontil).

Trimipramine should be used with caution with anticonvulsants (e.g. valproic acid) as the use of Trimipramide decreases the seizure threshold, thus there is a risk of generalized convulsive seizures. Your doctor should monitor you clinically and may adjust your dose.

Antipsychotics

Combination therapy with antipsychotics may lead to an increase in the plasma concentration of trimipramine.

Cimetidine

May increase the plasma concentration of trimipramine.

Taking Surmontil with food and drinks

Consuming alcohol increases the sedative effect of this medication. The decrease in alertness may make driving and using machines hazardous.

Avoid consuming alcoholic beverages and other medications containing alcohol while taking this treatment.

Pregnancy and lactation

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

Pregnancy

Animal experimental studies have not demonstrated teratogenic effects. There are no specific studies on the teratogenic effects in humans. Prospective epidemiological studies have not shown teratogenic effects of trimipramine.

If you are pregnant or breastfeeding, or think you may be pregnant, ask your doctor for advice before taking this medication. It is not recommended to take trimipramine tablets during pregnancy unless it is clearly necessary and only after careful consideration of the risk/benefit ratio.

If you have taken this medication during the last part of your pregnancy, your baby may experience withdrawal symptoms such as irritability, low muscle tone, tremors, convulsions, irregular breathing, difficulty with lactation, and constipation.

Lactation

Your doctor will advise you whether to initiate, continue, or discontinue breastfeeding or discontinue this medication, taking into account the benefits of breastfeeding for your child and the benefits of treatment for you.

Driving and using machines

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

Remember to take your medication.

This medication is administered orally.

The normal dose is, for mild depressions, psychosomatic states, anxiety, and sleep disorders, a single dose, taken at night, which can be 12.5 mg to 50 mg. For severe depressions, 300 to 400 mg per day in 2-3 oral doses.

Never change the dose that your doctor has prescribed for you. If you estimate that the action of Surmontil is too strong or too weak, inform your doctor or pharmacist.

Your doctor will indicate the duration of your treatment with Surmontil. Do not stop your treatment before.

If you take more Surmontil than you should

There is no specific antidote. In case of acute poisoning, seizures, severe cardiovascular manifestations, as well as a reinforcement of anticholinergic effects, have been observed, occasionally a state of confusion and even coma. In case of overdose, the outcome can be fatal.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to take Surmontil

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

If you interrupt the treatment with Surmontil

It is recommended to gradually reduce the dose and closely monitor patients when interrupting treatment, as some exceptional cases of withdrawal syndrome (headaches, nausea, vomiting, anxiety, agitation, sweating, discomfort, sleep problems...) have been reported.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Nervous system disorders

Frequent: drowsiness or sedation (antihistamine effect) that are more frequent at the beginning of treatment.

Frequency not known: especially at the beginning of treatment: tremors (tremors), drowsiness, dizziness. Speech disorders, sensations (mainly on the skin, for example, tingling), peripheral nerve diseases (polyneuropathy), sedation, convulsions, and extrapyramidal disorders such as restlessness when sitting, gait disorders, motor dysfunction.

Metabolism and nutrition disorders

Frequency not known: hyperglycemia: increased risk of developing diabetes mellitus in patients with depression and treated with tricyclic antidepressants (see "Be especially careful with Surmontil").

Cardiovascular disorders

Especially at the beginning of treatment: orthostatic hypotension (alteration of circulation regulation with a decrease in blood pressure), brief loss of consciousness (syncope), acceleration of heartbeats.

Decrease in blood pressure. Certain changes in the ECG (prolongation of the QT interval), possibly "torsade de pointes" potentially fatal. In these cases, treatment should be interrupted.

Heart rhythm and conduction disorders (especially in cases of overdose or existing cardiovascular diseases).

Vascular disorders

Frequency not known: dizziness or fainting when standing up (orthostatic hypotension), hot flashes.

Blood and lymphatic system disorders

Frequency not known: certain changes in blood count (for example, leukopenia, agranulocytosis, thrombocytopenia, and eosinophilia). Therefore, periodic laboratory tests with hemograms should be performed during treatment with trimipramine.

Psychiatric disorders

Frequency not known: restlessness, sleep disorders, mood changes, confusion in elderly patients, alterations of consciousness (delirium syndromes).

Change of depression to hypomania or mania.

Cases of suicidal thoughts and suicidal behavior have been reported during or shortly after the end of treatment (see section 2 in "Warnings and precautions").

Eye disorders

Frequency not known: especially at the beginning of treatment, blurred vision.

.

Gastrointestinal disorders

Frequency not known: especially at the beginning of treatment, dry mouth, constipation, indigestion, and nausea.

Skin and subcutaneous tissue disorders

Frequency not known: excessive sweating, allergic reactions, skin redness. With adequate predisposition: signs of an allergic event, especially of the skin. Hair loss.

Hepatobiliary disorders

Frequency not known: as an expression of hypersensitivity: liver and bile duct reactions, which are usually manifested as a temporary increase in liver enzymes and bilirubin in serum in the sense of hepatitis cytolytic or cholestatic (inflammation of the liver, including bile stasis).

Periodic laboratory tests with liver enzyme determinations should be performed.

Renal and urinary disorders

Frequency not known: problems urinating or possible urinary retention.

Reproductive and mammary disorders

Frequency not known: breast enlargement, sexual function disorders.

Auditory disorders

Frequency not known: tinnitus

Endocrine disorders

Frequency not known: SIADH (syndrome of inadequate ADH secretion), hypoglycemia.

Like with other tricyclic antidepressants: an increase in the level of prolactin and/or galactorrhea.

Complementary examinations

Frequency not known: especially at the beginning of treatment, fatigue, weight gain, sweating.

Traumatic injuries, intoxications, and complications of therapeutic procedures

Frequency not known: An increased risk of bone fractures has been observed in patients taking this type of medication.

If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of 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 Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store below 25 °C.

Expiration Date

Do not use Surmontil after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and the

medicaments that you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicaments that you no longer need. By doing so, you will help protect the environment.

Composition of Surmontil

• The active principle is trimipramine in the form of maleate as the active base. Each tablet contains 35 mg of maleate of trimipramine (equivalent to 25 mg of trimipramine).

• The other components are: wheat starch (contains gluten), levilite, magnesium stearate. Coating: hydroxypropylmethylcellulose, polyethylene glycol 20,000, purified water, 96° alcohol.

Appearance of the product and contents of the packaging

The tablets are round, white, scored on one face, and have the text:

“SURMONTIL 25”, engraved. Each package contains 50 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69,

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing:

Famar Healthcar Service Madrid, S.A.U.

Avda. de Leganés, 62

28925 Alcorcón (Madrid).

Date of the last review of this leaflet:06/2022

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