Package Insert: Information for the Patient

Trofanil 50 mg Coated Tablets

Imipramine Hydrochloride

Read this package insert carefully before taking this medication, as it contains important information for you.

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

Tofranil contains the active ingredient imipramine, which belongs to a group of medicines called tricyclic antidepressants, noradrenaline and serotonin reuptake inhibitors (non-selective monoamine reuptake inhibitors).

This medicine is used in adults to treat depression (a persistent feeling of sadness and loss of interest), anxiety attacks (sudden feelings of intense concern and fear or terror that peak within minutes), chronic pain(that persists or progresses over a long period of time)and in children over 5 years old who wet the bed when alternative therapies are not considered suitable.

It is essential to inform your doctor if you have any other medical conditions or if you are taking other medications.

Do not take Tofranil

• if you are allergic (hypersensitive) to imipramine or any of the other components of this medication (listed in section 6).
• if you are already taking or have recently taken a type of antidepressant called monoamine oxidase inhibitors (MAOIs).

• if you have recently had a heart attack or if you have a serious heart disease
• glaucoma (a condition that causes damage to the optic nerve of the eye and worsens over time)

• prostatic hyperplasia (enlargement of the prostate gland), pyloric stenosis (narrowing of the opening from the stomach to the first part of the small intestine)
• porphyria (a rare disorder that primarily affects the nervous system and skin and can cause abdominal pain)
• liver diseases
• pregnancy confirmation or suspicion.
• breastfeeding.
• patients under 18 years of age

Warnings and precautions

Consult your doctor before starting to take Tofranil if:

• you have suicidal thoughts
• you have seizures (convulsions)
• you have arrhythmias (abnormal heart rhythms)
• you have schizophrenia (a chronic, severe, and debilitating mental disorder)

• you have glaucoma (a condition that causes damage to the optic nerve of the eye and worsens over time)

• you have liver or kidney disease
• you have any blood disorder
• you have difficulty urinating (e.g., due to prostate disease)
• you have hyperthyroidism
• you have consumed excessive alcohol
• you have frequent constipation
• you have dry eyes

• you have high fever, involuntary, rapid, and irregular muscle movements, delirium, or coma (a state of acute confusion)

The concomitant use of this medication with other antidepressants and with other products containing buprenorphine may cause a serotonin syndrome, a potentially fatal disease (see "Other medications and Tofranil").

Your doctor will take this into account before and during treatment with Tofranil.

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may occasionally have thoughts of self-harm or suicide. These may increase when taking antidepressants for the first time, as all these medications require a time to start taking effect, usually around two weeks, although in some cases it may take longer.

You would be more prone to having these types of thoughts:

• if you have previously had thoughts of self-harm or suicide
• if you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in young adults (under 25 years) with psychiatric disorders treated with an antidepressant.

If you ever have thoughts of self-harm or suicide, 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 if they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your behavior.

Information for families and caregivers

You should monitor if the depressed relative/patient shows signs of behavioral changes such as anxiety, restlessness, sleep disturbances, irritability, aggression, hyperexcitability, or other unusual behavior, worsening of depression, or suicidal thoughts. You should immediately inform the patient's doctor especially if they are severe, sudden, or were not part of the patient's previous symptoms. You should evaluate the appearance of these symptoms daily, especially at the beginning of treatment and when the dose is increased or decreased, as these changes can be sudden.

Symptoms such as those described may be associated with an increased risk of experiencing suicidal thoughts and behaviors and may indicate the need for strict control and possible changes in medication.

Additional safety measures

It is very important that your doctor regularly controls your treatment to allow for the adjustment of the dose that helps reduce adverse reactions, through the performance of blood tests and the measurement of blood pressure and cardiac function, before and during treatment.

If during treatment you experience high fever, involuntary, rapid, and irregular muscle movements, delirium (a state of acute confusion), or decreased level of consciousness that could lead to coma, it is essential that you go immediately to a hospital.

Tofranil produces dry mouth, which can increase the risk of dental caries, meaning that in long-term treatments, regular dental check-ups should be performed.

Patients using contact lenses and experiencing eye irritation should consult their doctor.

Before undergoing any type of surgery or dental intervention, inform your doctor or dentist that you are taking Tofranil.

Tofranil may cause skin to be more sensitive to the sun. Do not take direct sunlight and protect yourself with clothing and sunglasses with protective lenses.

Children and adolescents

Tofranil should not be used to treat children or adolescents under 18 years of age. Tofranil may be associated with a risk of suicide, self-harm, and hostility. In the event of clinical need, if the decision is made to treat a child or adolescent with imipramine, the patient should be closely monitored to ensure that any symptoms of suicide are detected. Additionally, Tofranil is associated with a risk of heart disease

Taking Tofranil with other medications

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

• daily alcohol consumption
• medications used to treat high blood pressure and heart function
• other antidepressants, sedatives, tranquilizers, barbiturates, antiepileptics, and medications containing buprenorphine
• medications used to treat other mental disorders
• medications for asthma or allergies
• blood thinners (anticoagulants)
• medications for asthma or allergies
• medications for Parkinson's disease
• thyroid medications
• cimetidine (medication for peptic ulcers)
• methyphenidate (stimulant)
• oral contraceptives, estrogens
• terbinafine (medication for fungi)
• medications that prolong the QTc interval (heart cycle) (e.g., thioridazine, cisapride, cotrimoxazole)
• haloperidol, phenothiazines (antipsychotic medications)
• cimetidine (medication for peptic ulcers)
• nasal decongestants and products used to treat asthma

Taking Tofranil with food, drinks, and alcohol

The tablets should be taken whole with liquid.

Alcohol and other substances may potentiate drowsiness

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor before using this medication.

Tofranil should not be used during pregnancy unless prescribed by a doctor. Your doctor will discuss the potential risk of taking Tofranil during pregnancy with you.

Since the active ingredient in Tofranil passes into breast milk, it is not recommended to breastfeed your child during treatment with Tofranil.

Driving and operating machines

During treatment with Tofranil, you may feel drowsy, dizzy, numb, or have blurred vision. Do not drive or operate tools or machines until you know how Tofranil affects you.

Tofranil contains saccharose and lactose

This medication contains lactose and saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

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

Your doctor will decide what dose is most suitable for your particular case.

The recommended starting dose in adults for the treatment of depression is 50 mg to 100 mg daily. In the first week of treatment, the dose will be gradually increased to 150-200 mg per day and will be maintained until a clear improvement is achieved.

The recommended starting dose in adults for the treatment of anxiety attacks is 10 mg daily. After a few days, the dose will be gradually increased to between 75 mg and 150 mg daily. However, the daily dose required may vary greatly from one patient to another.

The recommended starting dose in adults for the treatment of chronic pain varies between 25 mg and 75 mg daily.

Depression and chronic anxiety may require a longer treatment with this medication.

Use in children and adolescents

The recommended starting dose in children for the treatment of nocturnal enuresis (children who wet the bed) (from the age of 5), is

This medication is not recommended for the treatment of depression, anxiety attacks, and chronic pain in children and adolescents.

Do not take more tablets, or more frequently, or for a longer period than indicated by your doctor.

If you take more Tofranil than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

The symptoms of overdose usually appear a few hours later and are: severe dizziness, poor concentration, slow or rapid or irregular pulse, restlessness and agitation, muscle coordination loss and muscle rigidity, breathing difficulty, sweating, convulsions, vomiting, and fever.

If you forget to take Tofranil

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

If you forget a dose, take it as soon as you can, then return to your usual administration schedule. If it almost coincides with the next dose, skip this dose and continue with your normal administration schedule. If you have any doubts, consult your doctor.

If you interrupt treatment with Tofranil

Your doctor may want to reduce your dose before completely stopping the medication. This would be to prevent a worsening of your general condition and reduce the risk of symptoms due to sudden withdrawal of the medication, such as headaches, nausea, and general discomfort.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Very common side effects (may affect more than 1 in 10 patients): weight gain, tremor,palpitations, changes in the Electrocardiogram (heart examination), hot flashes,low blood pressure, dry mouth, constipation,excessive sweating.

Common side effects (may affect up to 1 in 10 patients): loss of appetite, restlessness, nervousness, euphoria, confusion, thought alterations, perception of something (a vision, a sound, a smell) that is not physically present, anxiety, extreme excitement, mood alterations, sexual desire alterations, sleep disorders, disorientation, feeling of instability,dizziness, sedation, drowsiness,headaches, need to sleep, feeling of tingling, dry eyes , blurry vision, visual fatigue,accommodation disorder (eye's ability to automatically change focus from far to near vision), mydriasis (excessive dilation of the eye's pupil), glaucoma (condition that causes damage to the optic nerve and worsens over time),decreased tear production, cardiac rhythm disorder, nausea, vomiting, liver alteration, swelling and redness of the skin, urinary problems and extreme fatigue.

Rare side effects (may affect up to 1 in 1,000 patients): anomalies that may be reflected in behavior and seizures (muscle contractions and rapid relaxation, causing uncontrollable body tremors).

Very rare side effects (may affect up to 1 in 10,000 patients): tooth decay, changes in the number of different types of blood cells (increase or decrease in white blood cells, decrease in platelets, increase in eosinophils), very intense and sudden allergic reaction affecting the skin and respiratory, digestive and cardiovascular systems, decreased urine production, increase or decrease in blood sugar, weight loss, aggressive behavior, movement disorders, unpleasant feeling of restlessness and inability to remain still, clumsiness, alteration of voluntary movements, changes in the electroencephalogram (brain examination), pupil dilation, increased intraocular pressure, ear noises, heart failure (heart's inability to pump enough blood), cardiac rhythm disorder, red or blue spots on the skin, blood vessel contraction, increased blood pressure, dry cough and breathing difficulty, intestinal obstruction, injuries inside or around the mouth, abdominal disorders, ulcers on the tongue, hepatitis (liver inflammation), skin swelling and redness, sun susceptibility, hair loss, skin darkening, urine retention, breast enlargement in men, spontaneous milk secretion through the nipples, fatigue, localized or generalized swelling, fever, sudden death.

Side effects of unknown frequency (cannot be estimated from available data): suicidal behavior and thoughts, taste alteration.

A higher risk of bone fractures has been observed in patients treated with this type of medication.

Reporting of side effects

If you experience any type of side effect, consult your doctor, 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 of 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 medication.

Keep out of the sight and reach of children.

No special storage conditions are required.

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

Do not use Tofranil if you observe that the packaging is damaged or shows signs of manipulation

Medicines should not be thrown down the drain or in the trash. Dispose of the containers and medicines you no longer need at thePharmaceutical Waste Collection Pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Tofranil 50 mg coated tablets

• The active ingredient is imipramine. Each tablet contains 50 mg of imipramine hydrochloride.
• The other components are colloidal silica, glycerol (E422), cornstarch, stearic acid, talc, magnesium stearate, hypromellose, vinylpyrrolidone-vinyl acetate copolymer, titanium dioxide (E171), povidone, polyethylene glycol, microcrystalline cellulose, iron oxide red (E172), sucrose, lactose.

Appearance of the product and contents of the packaging

Tofranil 50 mg coated tablets are presented in the form of coated tablets. Each package contains 30 tablets.

Marketing Authorization Holder:

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4, Ireland

Local Representative

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 - Barcelona

Responsible for Manufacturing

AMDIPHARM UK LIMITED

Capital House 85 King Williams Street. London, United Kingdom

or

ROTTENDORF PHARMA GMBH

Ostenfelder StraBe 51-61,

Ennigerloh - Germany

Last review date of the prospectus:February 2025

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.es/