SURMONTIL 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Surmontil 25 mg Film-Coated Tablets

trimipramine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What is Surmontil and what is it used for

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

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

• Depressive states of all kinds.
• Psychosomatic disorders with a depressive background.
• States of anxiety and sleep disturbances.

2. What you need to know before you take Surmontil

Do not take Surmontil

• If you are allergic (hypersensitive) to trimipramine, to other tricyclic antidepressants, or to any of the other components of this medication (included in section 6).
• If you have a risk of suffering from acute angle glaucoma.
• If you have a risk of urinary retention due to problems with the urethra or prostate.
• If you have recently suffered a myocardial infarction.
• Together with irreversible Monoamine Oxidase Inhibitors (IMAO) (iproniazid) and/or sultoprida (see "Use of other medications").
• If you consume alcohol
• Together with clonidine, guanethidine, and similar medications (see "Use of other medications").

Warnings and precautions

Suicidal thoughts and worsening of depression or anxiety disorder

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

You may think this way:

If you have thoughts of harming yourself or committing suicide at any time, contact your doctor, or

go directly to a hospital.

It may be helpful to tell a relative or close friendthat you are depressed or that

you have an anxiety disorder, and ask them to read this leaflet. 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 some exceptional cases of withdrawal syndrome (headaches, nausea, vomiting, anxiety, agitation, sweating, discomfort, sleep problems ...) have occurred.

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 could justify a decrease in dosage or temporary symptomatic treatment.

It is recommended to clinically and electrically monitor patients with epilepsy or suspected epilepsy, as the epileptogenic threshold may decrease. The onset of convulsive crises implies the discontinuation of treatment.

Other warnings

• If you are an elderly patient, as you are more susceptible to:
• a drop in blood pressure when standing up after sitting (orthostatic hypotension),

sedation,

• chronic constipation (risk of paralytic ileus),
• prostatic hyperplasia

• If you have heart diseases and in elderly patients, cardiac function should be regularly monitored, as this class of medications increases the risk of accelerated heartbeats and low blood pressure.

• If you have kidney and/or liver failure.

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

Serotonin syndrome may occur when Surmontil is administered with other serotonergic medications. This syndrome is caused by an excess of a neurotransmitter called serotonin and can be fatal. It 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 serotonergic substances are combined with trimipramine. If serotonin syndrome occurs, 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 taken 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 of age.

Other medications and Surmontil

Tell your doctor or pharmacist if you are taking, have recently taken, or may take other medications, including those obtained without a prescription, especially if they are any of the following:

• Monoamine Oxidase Inhibitors (IMAO): as their simultaneous administration can

produce severe adverse reactions, as well as starting treatment with Surmontil before 14 days have passed since stopping treatment with an IMAO.

Buprenorphine/opioids: these medications can interact with Surmontil, and you may experience symptoms such as involuntary and rhythmic muscle contractions, including muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Consult your doctor when you experience such symptoms.

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

• Guanethidine, guanfacine, and clonidine, as trimipramine decreases their antihypertensive effect.

• Sympathomimetic alpha and beta (epinephrine, norepinephrine, dopamine by parenteral route), as paroxysmal hypertension with the possibility of ventricular arrhythmias may occur.

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

• Anticonvulsants; carbamazepine.
• Antidepressants: citalopram, fluoxetine, fluvoxamine, paroxetine, and sertraline.
• Antihypertensives.
• Other medications that depress the Central Nervous System: morphine derivatives (analgesics, antitussives, and substitution therapies), sedating antihistamines, hypnotics (e.g., barbiturates and benzodiazepines), anxiolytics different from benzodiazepines, neuroleptics, central antihypertensives, baclofen, thalidomide.
• Baclofen.
• Other medications that decrease the convulsive threshold
• Atropine and other atropine-like substances such as ipratropium bromide, tiotropium bromide, trospium chloride, butylscopolamine.

Other precautions to consider:

It should be avoided to use trimipramine together with medications that prolong the QT interval (e.g., antiarrhythmics class IA or III, antibiotics, antimalarials, antihistamines, neuroleptics), which induce hypokalemia (e.g., certain diuretics, glucocorticoids), or bradycardia (e.g., beta blockers, diltiazem, verapamil, clonidine, digitalis) or inhibit the hepatic metabolism of trimipramine (e.g., irreversible MAO inhibitors, imidazole antimycotics) (see "Special caution with Surmontil").

Trimipramine should be used with caution together with anticonvulsant medications (e.g., valproic acid), as the use of trimipramine decreases the convulsive threshold, and there is a risk of generalized convulsive crises. Your doctor should perform clinical monitoring and may adjust the dose.

Antipsychotic medications

Combined 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 can make driving vehicles and using machines dangerous.

It is recommended to avoid consuming alcoholic beverages and other medications that contain alcohol while taking this treatment.

Pregnancy and breastfeeding

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

Pregnancy

Experimental studies in animals have not shown a teratogenic effect. 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, think you may be pregnant, or are planning to have a baby, 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.

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

Breastfeeding

Your doctor will indicate whether you should start/continue/stop breastfeeding or stop using this medication, taking into account the benefit of breastfeeding for your child and the benefit of treatment for you.

Driving and using machines

3. How to TAKE Surmontil

Follow exactly the administration instructions of this medication 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, in minor depressions, psychosomatic states, anxiety, and sleep disorders, a single dose, at night, which can be 12.5 mg to 50 mg. In severe depressions, 300 to 400 mg per day in 2-3 doses orally.

Never change the dose that your doctor has prescribed for you. If you think the action of Surmontil is too strong or too weak, tell 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 intoxication, convulsions, severe cardiovascular manifestations, as well as reinforcement of anticholinergic effects, eventually confusional state, and even coma have been observed. In case of overdose, the result can be fatal.

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

If you forget to take Surmontil

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

If you stop treatment with Surmontil

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

If you have any other doubts about the use of this product, 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.

Nervous System Disorders

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

Of unknown frequency: especially at the start of treatment: tremors (tremors), drowsiness, dizziness. Speech disorders, sensations (mainly on the skin, such as tingling), peripheral nerve diseases (polyneuropathy), sedation, convulsions, and extrapyramidal disorders such as restlessness when sitting, gait disorders, motor dysfunctions.

Metabolism and Nutrition Disorders

Of unknown frequency: hyperglycemia: increased risk of developing diabetes mellitus in patients with depression and being treated with tricyclic antidepressants (see "Take special care with Surmontil").

Cardiovascular Disorders

Especially at the start 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 discontinued.

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

Vascular Disorders

Of unknown frequency: dizziness or dizziness when standing up (orthostatic hypotension), hot flashes.

Blood and Lymphatic System Disorders

Of unknown frequency: certain changes in blood count (such as leukopenia, agranulocytosis, thrombocytopenia, and eosinophilia). Therefore, periodic laboratory tests with hemograms should be performed during treatment with trimipramine.

Psychiatric Disorders

Of unknown frequency: restlessness, sleep disorders, mood changes, confusion in elderly patients, alterations of consciousness (delirium syndromes).

Change from depression to hypomania or mania.

There have been reports of suicidal thoughts and suicidal behavior during or shortly after the end of treatment (see section 2 in "Warnings and Precautions").

Ocular Disorders

Of unknown frequency: especially at the beginning of treatment, blurred vision.

.

Gastrointestinal Disorders

Of unknown frequency: especially at the beginning of treatment, dry mouth, constipation, indigestion, and nausea.

Skin and Subcutaneous Tissue Disorders

Of unknown frequency: excessive sweating, allergic reactions, skin redness. With adequate predisposition: signs of an allergic event, especially of the skin. Hair loss.

Hepatobiliary Disorders

Of unknown frequency: as an expression of hypersensitivity: reactions by the liver and biliary tract, which are usually manifested as a temporary increase in liver enzymes and bilirubin in serum in the sense of cytolytic or cholestatic hepatitis (inflammation of the liver, including biliary stasis).

Periodic laboratory tests with liver enzyme determinations should be performed.

Renal and Urinary Disorders

Of unknown frequency: urination problems or possible urinary retention.

Reproductive System and Breast Disorders

Of unknown frequency: increase in breast size, sexual function disorders.

Ear Disorders

Unknown frequency: tinnitus

Endocrine Disorders

Unknown frequency: SIADH (syndrome of inappropriate antidiuretic hormone secretion), hypoglycemia.

As with other tricyclic antidepressants: an increase in prolactin levels and/or galactorrhea.

Complementary Examinations

Of unknown frequency: especially at the beginning of treatment, fatigue, weight gain, sweating.

Traumatic Injuries, Poisoning, and Complications of Therapeutic Procedures

Of unknown frequency: An increased risk of bone fractures has been observed in patients taking this type of medication.

If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of Adverse Effects

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

5. Conservation of Surmontil

Keep this medicine out of sight and reach of children.

Store below 25 ºC.

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 thrown down the drain or into the trash. Deposit the packaging and the 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 Surmontil

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

• The other components are: wheat starch (contains gluten), levilite, magnesium stearate. Varnish: hydroxypropyl methylcellulose, polyethylene glycol 20,000, purified water, 96º alcohol.

Appearance of the Product and Package Contents

The tablets are round, white, scored on one side, and bear the text:

"SURMONTIL 25", engraved. Each package contains 50 tablets.

Marketing Authorization Holder and Manufacturer

Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69,

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer:

Famar Healthcare Service Madrid, S.A.U.

Avda. de Leganés, 62

28925 Alcorcón (Madrid).

Date of the Last Revision of this Prospectus:06/2022

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