Tofranil 50 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Trofanil 50 mg coated tablets

imipramine hydrochloride

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 or pharmacist.

• This medicine has been prescribed for you and should not be given 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, even if these adverse effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Tofranil is and what it is used for

Tofranil contains the active substance 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), panic attacks (sudden feelings of intense anxiety and fear or terror that peak within minutes), chronic pain (pain that persists or progresses over a long period of time), and in children over 5 years of age who experience bedwetting when alternative therapies are not considered appropriate.

2. What you need to know before taking Tofranil

It is important that you inform your doctor if you have other medical conditions or are taking other medications.

Do not take Tofranil

• if you are allergic (hypersensitive) to imipramine or to any of the other ingredients of

• this medicine (listed in section 6).

• if you are currently taking or have recently taken a type of antidepressants called monoamine oxidase inhibitors (MAOIs).

• if you have recently suffered a heart attack or if you have a serious heart condition

• glaucoma (a condition causing damage to the optic nerve of the eye and which worsens over time)

• benign 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 affecting mainly the nervous system and skin, which can cause abdominal pain)

• liver disease

• confirmed or suspected pregnancy

• breastfeeding

• patients under 18 years of age

Warnings and precautions

Talk to your doctor before starting 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 causing damage to the optic nerve of the eye and which worsens over time)

• you have liver or kidney disease

• you have any blood disorders

• you have difficulty urinating (e.g., due to prostate conditions)

• you have hyperthyroidism

• you have consumed large amounts of alcohol

• you have frequent constipation

• you have dry eye

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

Concomitant use of this medicine with other antidepressants and with other products containing buprenorphine may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines 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 first starting antidepressants, as all such medicines require time to begin working—usually about two weeks, although in some cases it may take longer.

You are more likely to have these types of thoughts:

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

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

It may help to inform a close relative or friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may ask them whether they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your behavior.

Information for family members and caregivers

Monitor whether the depressed relative/patient shows signs of behavioral changes such as anxiety, restlessness, sleep disturbances, irritability, aggressiveness, hyperexcitability, or other unusual changes in behavior, worsening of depression, or suicidal thoughts. You should immediately inform the patient’s doctor, especially if these symptoms are severe, appear suddenly, or were not part of the patient’s previous symptoms. You should assess for the emergence of these symptoms daily, particularly at the beginning of treatment and when the dose is increased or decreased, as these changes may occur abruptly.

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

Additional safety measures

It is very important that your doctor regularly monitors your treatment to allow dose adjustments that help reduce adverse reactions, including performing blood tests and measuring 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 progress to coma, it is important to seek immediate medical attention at a hospital.

Tofranil causes dry mouth, which may increase the risk of dental caries. This means that regular dental check-ups should be carried out during long-term treatment.

Patients who wear 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 make your skin more sensitive to sunlight. Avoid direct sun exposure and protect yourself with clothing and sunglasses.

Children and adolescents

Tofranil should not be used to treat children or adolescents under 18 years of age. Tofranil may be associated with an increased risk of suicide, self-harm, and hostility. If clinical need arises and a decision is made to treat a child or adolescent with imipramine, the patient must be closely monitored to ensure early detection of any emergence of suicidal symptoms. In addition, Tofranil is associated with a risk of heart disorders.

Taking Tofranil with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, especially:

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

Taking Tofranil with food, drinks, and alcohol

Tablets should be taken whole with liquid.

Alcohol and other substances may increase drowsiness.

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 medicine.

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

Since the active ingredient in Tofranil passes into breast milk, breastfeeding is not recommended during treatment with Tofranil.

Driving and using machines

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

Tofranil contains sucrose and lactose

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

3. How to take Tofranil

Follow exactly the instructions for using this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Your doctor will decide the most appropriate dose for your particular case.

The recommended starting dose in adults for the treatment of depression is 50 mg to 100 mg daily. During the first week of treatment, the dose will be gradually increased to 150–200 mg per day and maintained until 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 slowly increased to between 75 mg and 150 mg daily. However, the required daily dose may vary widely from patient to patient.

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

Depression and chronic anxiety may require prolonged treatment with this medicine.

Use in children and adolescents

The recommended starting dose in children for the treatment of nocturnal enuresis (bedwetting) (from the age of 5 years) is

It is not recommended to use this medicine for the treatment of depression, anxiety attacks, or chronic pain in children and adolescents.

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

If you take more Tofranil than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms of overdose usually appear within a few hours and include: severe dizziness, poor concentration, slow, fast, or irregular pulse, restlessness and agitation, loss of muscle coordination and muscle stiffness, breathing difficulties, sweating, seizures, vomiting, and fever.

If you forget to take Tofranil

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

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

If you stop taking Tofranil

Your doctor may wish to gradually reduce your dose before stopping the medication completely. This is to prevent a worsening of your general condition and to reduce the risk of withdrawal symptoms such as headaches, nausea, and general discomfort.

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

4. Possible adverse effects

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

Very common adverse effects (may affect more than 1 in 10 patients): weight gain, tremor, palpitations, changes in electrocardiogram (heart test), hot flushes, low blood pressure, dry mouth, constipation, excessive sweating.

Common adverse effects (may affect up to 1 in 10 patients): loss of appetite, restlessness, nervousness, euphoria, confusion, disturbances in thought, perception of something (a vision, a sound, an odour) that is not physically present, distress, extreme excitement, mood disturbances, disturbances in sexual desire, sleep disorders, disorientation, sensation of instability, dizziness, sedation, somnolence, headache, need to sleep, tingling sensation, dry eyes, blurred vision, visual fatigue, accommodation disorder (the eye's ability to automatically change focus from far to near vision), mydriasis (excessive dilation of the eye's pupil), glaucoma (a condition causing damage to the optic nerve of the eye and worsening over time), decreased tear production, cardiac rhythm disturbances, nausea, vomiting, liver dysfunction, skin redness and swelling, urinary problems, and extreme fatigue.

Uncommon adverse effects (may affect up to 1 in 1,000 patients): behavioural abnormalities and seizures (the body's muscles contract and relax rapidly and repeatedly, causing uncontrollable body tremors).

Rare adverse effects (may affect up to 1 in 10,000 patients): dental caries, changes in the number of different types of blood cells (increased or decreased white blood cells, decreased platelets, increased eosinophils), severe and sudden allergic reaction affecting the skin and respiratory, digestive, and cardiovascular systems, decreased urine production, increased or decreased blood sugar, weight loss, aggressive behaviours, movement disorders, unpleasant sensation of restlessness and inability to remain still, clumsiness, disturbance of voluntary movements, changes in electroencephalogram (test for brain examination), pupil dilation, increased intraocular pressure, tinnitus (ringing in the ears), heart failure (inability of the heart to pump sufficient blood), cardiac rhythm disturbances, red or blue spots on the skin, constriction of blood vessels, increased blood pressure, dry cough and breathing difficulty, intestinal obstruction, lesions inside or around the mouth, abdominal disorders, tongue ulcers, hepatitis (liver inflammation), skin redness and swelling, photosensitivity (increased sensitivity to sunlight), hair loss, skin darkening, urinary retention, enlargement of breast glands in men, spontaneous milk secretion through the nipples, fatigue, localised or generalised swelling, fever, sudden death.

Adverse effects of unknown frequency (cannot be estimated from available data): suicidal behaviour and thoughts, taste disturbances.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tofranil

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use Tofranil after the expiry date shown on the packaging after the abbreviation "EXP". The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Tofranil 50 mg film-coated tablets

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

Appearance of the product and contents of the pack

Tofranil 50 mg film-coated tablets are supplied as film-coated tablets. Each pack contains 30 tablets.

Marketing Authorization Holder:

Amdipharm Limited

Unit 17, Northwood House

Northwood Crescent

Northwood, Dublin 9

D09 V504, Ireland

Manufacturer responsible for production:

AMDIPHARM UK LIMITED

Capital House 85 King Williams Street, London, United Kingdom

or

ROTTENDORF PHARMA GMBH

Ostenfelder Straße 51-61,

Ennigerloh – Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Advanz Pharma Spain S.L.U.

Paseo de la Castellana 135, 7th floor

28046 Madrid (Spain)

Tel. +34 900 834 889

Date of the most recent review of this leaflet: February 2025

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.es/