TOFRANIL 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Trofanil 50 mg Coated Tablets

Imipramine Hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

• If you experience side effects, consult your doctor, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Tofranil and what is it used for
2. What you need to know before taking Tofranil
3. How to take Tofranil
4. Possible side effects
5. Storage of Tofranil
6. Package contents and additional information

1. What is Tofranil and what is it used for

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

This medication is used in adults to treat depression (a persistent feeling of sadness and loss of interest), anxiety crises (sudden feelings of intense concern and fear or terror that reach a peak in minutes), chronic pain (which persists or progresses over a long period of time), and in children over 5 years old who wet their beds when alternative therapies are not considered appropriate.

2. What you need to know before taking Tofranil

It is essential that you discuss with your doctor if you have other medical problems 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 suffered a heart attack or if you have a severe heart condition
• 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 affects the nervous system and skin and can cause abdominal pain)
• liver disease
• confirmation or suspicion of pregnancy.
• 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 epileptic seizures (convulsions)
• you have heart rhythm disorders
• you have schizophrenia (a chronic, severe, and disabling brain 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 diseases).
• you have hyperthyroidism
• you have consumed a lot of alcohol
• you have frequent constipation
• you have dry eye

• you have a high fever, involuntary muscle movements, rapid and irregular, 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 your depression or anxiety disorder

If you are depressed and/or suffer from 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 time to start taking effect, usually around two weeks, although in some cases it may take longer.

You would be more likely to have these 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 behaviors in young adults (under 25 years) with psychiatric disorders who were treated with an antidepressant.

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

It may be helpful for you to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this package leaflet. 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 relative/patient with depression shows signs of changes in behavior such as anxiety, restlessness, sleep disturbances, irritability, aggression, hyperexcitability, or other unusual changes in behavior, worsening of depression, or suicidal thoughts. You should inform the patient's doctor immediately, especially if they are severe, appear suddenly, or were not part of the patient's previous symptoms. You should evaluate the appearance of these symptoms day by day, especially at the beginning of treatment and when the dose is increased or decreased, as these changes can be sudden.

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

Additional safety measures

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

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

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

Patients who use contact lenses and experience eye irritation should consult their doctor.

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

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

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 case 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

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

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

Taking Tofranil with food, drinks, and alcohol

The tablets should be taken whole with a liquid.

Alcohol and other substances can potentiate somnolence.

Pregnancy and breastfeeding

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

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

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

Driving and using machines

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

Tofranil contains sucrose and lactose

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

3. How to take Tofranil

Follow exactly the administration instructions of this medication 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 initial 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 maintained until a clear improvement is achieved.

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

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

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

Use in children and adolescents

The recommended initial dose in children for the treatment of nocturnal enuresis (children who wet their beds) (from 5 years of age) is

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

Do not take more tablets, or more frequently, or for longer than your doctor indicates.

If you take more Tofranil than you should

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

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

If you forget to take Tofranil

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

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

If you stop 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 the sudden withdrawal of the medication, such as headaches, nausea, and general discomfort.

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

4. Possible side effects

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

Very common side effects (may affect more than 1 in 10 patients): weight gain, tremors, palpitations, changes in the electrocardiogram (heart exam), 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, changes in thinking, perception of something (a vision, a sound, a smell) that is not physically present, anxiety, extreme excitement, changes in mood, changes in sexual desire, sleep disorders, disorientation, feeling of instability, dizziness, sedation, drowsiness, headaches, need to sleep, feeling of tingling, dry eyes, blurred vision, visual fatigue, accommodation disorder (ability of the eye to automatically change focus from far to near), mydriasis (excessive dilation of the pupil), glaucoma (a condition that causes damage to the optic nerve of the eye and worsens over time), decreased tear production, cardiac arrhythmia, nausea, vomiting, liver alteration, skin swelling and redness, urinary problems, and extreme fatigue.

Rare side effects (may affect up to 1 in 1,000 patients): behavioral anomalies and convulsions (the body's muscles contract and relax rapidly and repeatedly, causing uncontrollable body tremors).

Very rare side effects (may affect up to 1 in 10,000 patients): dental caries, changes in the number of different types of blood cells (increase or decrease in white blood cells, decrease in platelets, increase in eosinophils), severe and sudden allergic reaction that affects the skin and respiratory, digestive, and cardiovascular systems, decreased urine production, increased or decreased 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 exam), pupil dilation, increased intraocular pressure, ear noises, heart failure (inability of the heart to pump enough blood), cardiac arrhythmia, red or blue spots on the skin, blood vessel constriction, increased blood pressure, dry cough, and breathing difficulties, intestinal obstruction, lesions inside or around the mouth, abdominal disorders, tongue ulcers, hepatitis (inflammation of the liver), skin swelling and redness, sun sensitivity, hair loss, skin darkening, urinary 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 thoughts and behaviors, alteration of taste.

An increased risk of bone fractures has been observed in patients treated with this type of medication.

Reporting side effects

If you experience any side effects, consult your doctor, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tofranil

Keep out of sight and reach of children.

No special storage conditions are required.

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

Do not use Tofranil if you notice that the packaging is damaged or shows signs of tampering.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE Pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

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 silicon, glycerol (E422), corn starch, stearic acid, talc, magnesium stearate, hypromellose, vinylpyrrolidone acetate, titanium dioxide (E171), povidone, polyethylene glycol, microcrystalline cellulose, red iron oxide (E172), sucrose, lactose.

Appearance of the product and packaging content

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

Marketing Authorization Holder:

Amdipharm Limited

Unit 17

Northwood House

Northwood Crescent

Northwood

Dublin 9

D09 V504

Ireland

Local Representative

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 - Barcelona

Manufacturer

AMDIPHARM UK LIMITED

Capital House 85 King Williams Street. London, United Kingdom

or

ROTTENDORF PHARMA GMBH

Ostenfelder StraBe 51-61,

Ennigerloh - Germany

Date of the last revision of this prospectus:February 2025

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