Package Insert: Information for the Patient

Tofranil 25 mg Coated Tablets

Imipramine Hydrochloride

Read this package insert carefully before taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for 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 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), 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 appropriate.

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

Do not take Tofranil

• if you are allergic (hypersensitive) to imipramine or to 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 mainly affects the nervous system and skin and can cause abdominal pain)
• liver diseases
• confirmation or suspicion of pregnancy.
• breastfeeding.
• patients under 18 years of age

Warnings and precautions

Consult your doctor before starting to take Tofranil if:

• if you have suicidal thoughts
• if you have seizures (convulsions)
• if you have heart rhythm disorders

• if you have schizophrenia (a chronic, severe, and incapacitating mental disorder)

• if you have glaucoma (a condition that causes damage to the optic nerve of the eye and worsens over time)if you have liver or kidney disease
• if you have any blood disorder
• if you have difficulty urinating (e.g. due to prostate disease).
• if you have hyperthyroidism
• if you have consumed a lot of alcohol
• if you have frequent constipation
• if you have dry eyes
• if 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 period of 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 increase in the 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.

It may be helpful for you to tell a family member or close friend that you are depressed or have an anxiety disorder and ask them to read this 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 depressed relative/patient shows signs of behavioral changes such as anxiety, restlessness, sleep disorders, irritability, aggression, hyperexcitability, or other unusual changes in 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 monitors your treatment to allow for the adjustment of the dose that helps reduce adverse reactions, through the performance of blood tests and 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, 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 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.

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. If there is a 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. In addition, Tofranil is associated with a risk of heart disease.

Taking Tofranil with other medications

Inform your doctor or pharmacist if you are taking, have recently takenor 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 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
• medications to prevent blood clots (anticoagulants)
• medications for asthma or allergies
• medications for Parkinson's disease
• thyroid medications
• cimetidine (medication used to treat 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 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 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 with you the potential risk of taking Tofranil during pregnancy.

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

Driving and operating machinery

During treatment with Tofranil, you may feel drowsy, dizzy, numb, or have blurred vision. Do not drive or operate tools or machinery 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 them before taking this medication.

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

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 per day. 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 per day. After a few days, the dose will be gradually increased to between 75 mg and 150 mg per day. 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 per day.

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 the5 yearsof age), 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.

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

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, loss of muscle coordination and muscle rigidity, respiratory difficulty, sweating, convulsions, vomiting, and fever.

If you forgot 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 the 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 overall 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, 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,anxiety, 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, blurred vision,dry eyes, 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 (eye condition that causes damage to the optic nerve and worsens over time),decreased tear production, heart 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 relaxations occur rapidly and repeatedly, 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 exam), pupil dilation, increased intraocular pressure, ear noises, heart failure (heart's inability to pump enough blood), heart rhythm disorder, red or blue spots on the skin, blood vessel constriction, increased blood pressure, dry cough and breathing difficulty, intestinal obstruction, injuries inside or around the mouth, abdominal disorders, tongue ulcers, 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, altered taste.

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.

Keep out of sight and reach of children.

Store below 25°C.

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 disposed of through drains or in the trash. Deposit 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 25 mg coated tablets

• The active ingredient is imipramine. Each tablet contains 25 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 25 mg coated tablets are presented in the form of coated tablets. Each package contains 50 tablets.

Holder of the marketing authorization:

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

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, UK

Last review date of this prospectus:February 2025

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/