Tofranil 10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tofranil 10 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 you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, even if they are adverse reactions 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 side 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), anxiety attacks (sudden feelings of intense worry and fear or terror), chronic pain (pain that persists or progresses over a long period of time), and in children over 5 years of age who wet the bed when alternative therapies are not considered appropriate.

2. What you need to know before starting to take Tofranil

It is important that you inform your doctor if you have any other medical conditions or if you are taking any 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 the skin, which may 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 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 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 eyes
• you have high fever, involuntary, rapid, and irregular muscle movements, delirium, or coma (acute state of 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 these factors into account before and during treatment with Tofranil.

Suicidal thoughts and worsening of 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 thoughts may increase when starting antidepressants for the first time, as all such medications require time to begin working—usually about two weeks, although in some cases it may take longer.

You are more likely to have such 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 of age) with psychiatric disorders treated with an antidepressant.

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

It may be helpful for you 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 families and caregivers

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

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 for 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 (acute state of confusion), or decreased level of consciousness that could progress to coma, it is important that you seek immediate medical attention at a hospital.

Tofranil causes dry mouth, which may increase the risk of dental caries. Therefore, regular dental check-ups are recommended during long-term treatment.

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

Before undergoing any type of 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, due to clinical necessity, a decision is made to treat a child or adolescent with imipramine, the patient must be closely monitored to ensure early detection of any suicidal symptoms. In addition, Tofranil is associated with a risk of heart disorders.

Other medicines and Tofranil

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 medications
• 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 (electrical cycle of the heart) (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 are planning 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 your doctor before taking this medicine.

3. How to take Tofranil

Follow exactly the instructions for using this medicine given by your doctor. If in doubt, 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 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 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) (children over 5 years of age) is:

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

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

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 would be 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 thinking, perception of something (a vision, sound, or smell) that is not physically present, distress, extreme excitement, mood disturbances, disturbances in sexual desire, sleep disorders, disorientation, sensation of lack of stability, 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 disorder, nausea, vomiting, liver dysfunction, skin swelling and redness, urinary problems, and extreme fatigue.

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

Very rare adverse 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 affecting the skin and the respiratory, digestive, and cardiovascular systems, decreased urine production, increased or decreased blood sugar levels, weight loss, aggressive behaviors, movement disorders, unpleasant sensation of restlessness and inability to remain still, clumsiness, disturbance of voluntary movements, changes in electroencephalogram (a test for brain examination), pupil dilation, increased intraocular pressure, ringing in the ears, heart failure (the heart's inability to pump sufficient blood), cardiac rhythm disorder, red or bluish spots on the skin, contraction of blood vessels, increased blood pressure, dry cough and breathing difficulty, intestinal obstruction, lesions inside or around the mouth, abdominal disorders, tongue ulcers, hepatitis (inflammation of the liver), skin swelling and redness, photosensitivity, hair loss, skin darkening, urine retention, enlargement of mammary glands in men, spontaneous milk secretion through the nipples, fatigue, localized or generalized swelling, fever, sudden death.

Adverse effects of unknown frequency (cannot be estimated from available data): suicidal behavior 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 this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use Tofranil after the expiry date stated 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 medicines and their packaging at the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Tofranil 10 mg coated tablets

• The active substance is imipramine. Each tablet contains 10 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 container

Tofranil 10 mg coated tablets are presented as coated tablets. Each pack contains 60 tablets.

Marketing Authorization Holder:

Amdipharm Limited

Unit 17, Northwood House

Northwood Crescent

Northwood, Dublin 9

D09 V504, Ireland

Manufacturer responsible:

ROTTENDORF PHARMA GMBH

Ostenfelder StraBe, 51-61 (Ennigerloh) - D-59320 - Germany

or

ROTTENDORF PRODUKTION GMBH

Ostenfelder Strasse, 51-61 (Ennigerloh) - 59320 - Germany

or

AMDIPHARM UK LIMITED

Capital House 85 King Williams Street. London, United Kingdom

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