Surmontil 25 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Surmontil 25 mg film-coated tablets

trimipramine

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, pharmacist or nurse.
• 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 effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Surmontil is and what it is used for

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

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

• Depressive states of all types.
• Psychosomatic disorders with underlying depression.
• Anxiety states and sleep disturbances.

2. What you need to know before taking Surmontil

Do not take Surmontil

• If you are allergic (hypersensitive) to trimipramine, to other tricyclic antidepressants, or to any of the other ingredients of this medicine (listed in section 6).
• If you are at risk of developing acute angle-closure glaucoma.
• If you are at risk of urinary retention due to urethral or prostate problems.
• If you have recently had a myocardial infarction (heart attack).
• Together with medications that are irreversible inhibitors of Monoamine Oxidase (MAOIs) (e.g. iproniazid) and/or sultopride (see "Use of other medicines").
• If you consume alcohol.
• Together with clonidine, guanethidine, or similar drugs (see "Use of other medicines").

Warnings and precautions

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may occasionally experience thoughts of harming yourself or of suicide. These thoughts may become stronger when you first start taking antidepressants, as these medicines take time to work—usually about two weeks, although sometimes longer.

You may be more likely to have such thoughts:

• If you have previously had thoughts of harming yourself or of suicide.
• If you are a young adult. Clinical trial data have shown a higher risk of suicidal behaviour in psychiatric patients under 25 years of age being treated with an antidepressant.

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

go directly to a hospital.

It may be helpful 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 to tell you if

they think your depression or anxiety is worsening, or if they are concerned about changes

in your behaviour.

Gradual dose reduction is recommended and patients should be closely monitored when stopping treatment, as rare cases of withdrawal syndrome (headache, nausea, vomiting, anxiety, agitation, sweating, malaise, sleep disturbances, etc.) have been reported.

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

Insomnia or restlessness occurring at the beginning of treatment may require a reduction in dosage or temporary symptomatic treatment.

Patients with epilepsy or suspected epilepsy should be clinically and electrically monitored, as the epileptogenic threshold may be lowered. The occurrence of seizures necessitates discontinuation of treatment.

Other warnings

• If you are an elderly patient, as you may be more susceptible to:

  • a drop in blood pressure upon standing after sitting (orthostatic hypotension),

• sedation,

• chronic constipation (risk of paralytic ileus),

• benign prostatic hyperplasia.

• If you have heart disease or are elderly, cardiac function should be regularly monitored, as these types of medicines increase the risk of rapid heartbeat and low blood pressure.

• If you have renal and/or hepatic impairment.

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

Serotonin syndrome may occur when Surmontil is administered together with other serotonergic medicines. This syndrome results from excess of a neurotransmitter called serotonin, can be life-threatening, and includes the following symptoms: neuromuscular excitation, increased body temperature, tachycardia, changes in blood pressure, excessive sweating, tremor, flushing, dilated pupils, anxiety, agitation, confusion, and coma.

Close clinical monitoring is required when serotonergic active substances are combined with trimipramine. If serotonin syndrome occurs, treatment with trimipramine must be discontinued.

This type of medicine may increase the risk of cardiac rhythm disturbances (prolongation of the QT interval). Particular caution is required in patients with known risk factors for QT interval prolongation, bradycardia, hypokalaemia, and hypomagnesaemia.

Children and adolescents

Surmontil must not be used in children and adolescents under 18 years of age.

Other medicines and Surmontil

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, even those obtained without a prescription, especially if they include any of the following:

• Monoamine Oxidase Inhibitors (MAOIs): as their concomitant use may cause serious adverse reactions. Also, treatment with Surmontil must not be started until at least 14 days after stopping treatment with an MAOI.

• Buprenorphine / opioids: these medicines may interact with Surmontil and you may experience symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tone, and body temperature above 38°C. Consult your doctor if you experience such symptoms.

• Other serotonergic active substances, such as: selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), lithium, triptans, tramadol, linezolid, L-tryptophan, and St. John's wort (Hypericum perforatum) preparations. Careful clinical monitoring is necessary when these medicines are combined with trimipramine.

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

• Alpha and beta sympathomimetics (e.g. epinephrine, norepinephrine, dopamine administered parenterally), as paroxysmal hypertension with possible ventricular arrhythmias may occur.

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

• Anticonvulsants; carbamazepine.

• Antidepressants: citalopram, fluoxetine, fluvoxamine, paroxetine, and sertraline.

• Antihypertensives.

• Other central nervous system (CNS) depressants: morphine derivatives (analgesics, antitussives, and substitution therapies), sedating antihistamines, hypnotics (e.g. barbiturates and benzodiazepines), anxiolytics other than benzodiazepines, neuroleptics, centrally-acting antihypertensives, baclofen, thalidomide.

• Baclofen.

• Other medicines that lower the seizure threshold.

• Atropine and other anticholinergic substances such as ipratropium bromide, tiotropium bromide, trospium chloride, butylscopolamine bromide.

Other precautions to consider:

The use of trimipramine should be avoided together with medicines that prolong the QT interval (e.g., Class IA or III antiarrhythmics, antibiotics, antimalarials, antihistamines, neuroleptics), that induce hypokalaemia (e.g. certain diuretics, glucocorticoids), or bradycardia (e.g. beta-blockers, diltiazem, verapamil, clonidine, cardiac glycosides), or that inhibit the hepatic metabolism of trimipramine (e.g. irreversible MAO inhibitors, imidazole antifungals) (see "Take special care with Surmontil").

Trimipramine should be used with caution together with anticonvulsant medicines (e.g. valproic acid), as trimipramine lowers the seizure threshold and may increase the risk of generalized seizures. Your doctor should monitor you clinically and may adjust your dose.

Antipsychotic medicines

Combination therapy with antipsychotics may lead to increased plasma concentrations of trimipramine.

Cimetidine

Cimetidine may increase the plasma concentration of trimipramine.

Taking Surmontil with food and drinks

Alcohol intake increases the sedative effect of this medicine. Reduced alertness may make driving or operating machinery dangerous.

Consumption of alcoholic beverages and other medicines containing alcohol should be avoided during treatment.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, seek advice from your doctor before taking this medicine. Trimipramine tablets are not recommended during pregnancy unless clearly necessary and only after careful risk/benefit assessment.

If you have taken this medicine during the last part of pregnancy, your baby may experience adaptation difficulties and withdrawal symptoms such as irritability, low muscle tone, tremors, seizures, irregular breathing, feeding difficulties, and constipation.

Breastfeeding

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

Driving and using machines

3. How to TAKE Surmontil

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication.

This medicine is administered orally.

The usual dose for mild depression, psychosomatic conditions, anxiety, and sleep disorders is a single dose at night, which may range from 12.5 mg to 50 mg. For severe depression, the dose is 300 to 400 mg daily in 2–3 divided oral doses.

Never change the dose prescribed by your doctor on your own. If you feel that the effect of Surmontil is too strong or too weak, inform your doctor or pharmacist.

Your doctor will determine the duration of your treatment with Surmontil. Do not stop treatment prematurely.

If you take more Surmontil than you should

There is no specific antidote. In cases of acute intoxication, seizures, serious cardiovascular manifestations, and increased anticholinergic effects have been observed, possibly leading to confusion or even coma. Overdose may be fatal.

In case of overdose or accidental ingestion, contact 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 missed doses.

If you stop taking Surmontil

It is recommended to gradually reduce the dose and closely monitor patients when discontinuing treatment, as rare cases of withdrawal syndrome have been reported (headaches, nausea, vomiting, anxiety, agitation, sweating, malaise, sleep disturbances...).

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Nervous system disorders

Frequent: Drowsiness or sedation (antihistaminic effect), which are more common at the beginning of treatment.

Frequency not known: Especially at the start of treatment: tremors (trembling), drowsiness, dizziness, speech disorders, abnormal sensations (mainly in the skin, e.g., tingling), peripheral nerve disorders (peripheral neuropathy), sedation, seizures, and extrapyramidal disorders such as restlessness when sitting, gait disturbances, and motor dysfunction.

Metabolism and nutrition disorders

Frequency not known: Hyperglycaemia: increased risk of developing diabetes mellitus in patients with depression and treated with tricyclic antidepressants (see “Take special care with Surmontil”).

Cardiovascular disorders

Especially at the beginning of treatment: orthostatic hypotension (circulatory regulation disorder with decreased blood pressure), brief loss of consciousness (syncope), and increased heart rate.

Decreased blood pressure. Certain changes in the ECG (prolongation of the QT interval), possibly leading to potentially fatal "torsade de pointes." In such cases, treatment must be discontinued.

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

Vascular disorders

Frequency not known: Dizziness or lightheadedness upon standing (orthostatic hypotension), hot flushes.

Blood and lymphatic system disorders

Frequency not known: Certain changes in blood counts (e.g., leucopenia, agranulocytosis, thrombocytopenia, and eosinophilia). Therefore, periodic laboratory tests with complete blood counts should be performed during treatment with trimipramine.

Psychiatric disorders

Frequency not known: Restlessness, sleep disturbances, mood changes, confusion in elderly patients, disturbances of consciousness (delirium syndromes).

Switching from depression to hypomania or mania.

Cases of suicidal thoughts and suicidal behaviour have been reported during or shortly after the end of treatment (see section 2. “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. In predisposed individuals: signs of an allergic reaction, particularly affecting the skin. Hair loss.

Hepatobiliary disorders

Frequency not known: As manifestations of hypersensitivity: liver and biliary tract reactions, which usually present as a temporary increase in liver enzymes and serum bilirubin, consistent with cytolytic or cholestatic hepatitis (liver inflammation, including biliary stasis).

Periodic laboratory monitoring of liver enzymes should be performed.

Renal and urinary disorders

Frequency not known: Difficulty urinating or possible urinary retention.

Reproductive system and breast disorders

Frequency not known: Breast enlargement, sexual function disorders.

Ear disorders

Frequency not known: Tinnitus.

Endocrine disorders

Frequency not known: SIADH (syndrome of inappropriate antidiuretic hormone secretion), hypoglycaemia.

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

Additional investigations

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

Injury, poisoning and procedural complications

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Surmontil

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

Store below 25 ºC.

Expiry

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers 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 helps protect the environment.

6. Contents of the pack and other information

Composition of Surmontil

• The active substance is trimipramine, in the form of maleate salt. 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. Coating: hypromellose, polyethylene glycol 20,000, purified water, 96º alcohol.

Appearance of the product and contents of the pack

The tablets are round, white, scored on one side, and marked with the inscription:

“SURMONTIL 25”. Each pack contains 50 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69,

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer:

Famar Healthcar Service Madrid, S.A.U.

Avda. de Leganés, 62

28925 Alcorcón (Madrid).

Date of the most recent revision of this leaflet: 06/2022

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/