Buy Tofranil Malaysia

TOFRANIL 10 mg coated tablets TOFRANIL 25 mg coated tablets imipramine hydrochloride

Pharmacotherapeutic group

Antidepressant - Non-selective monoamine reuptake inhibitor.

Therapeutic indications adults

Depressive phase of manic-depressive psychosis. Reactive depression. Masked depression. Neurotic depression. Persistent depression of schizophrenic psychosis. Involutionary Depression. Severe depression with neurological diseases or other organic diseases.

Contraindications

Hypersensitivity to the active ingredient or to any of the excipients.

Cross-sensitivity to other tricyclic antidepressants in the dibenzazepine group. Treatment with a monoamine oxidase inhibitor (MAOI) at the same time or in the previous or following two weeks (see "Interactions").

Concomitant treatment with selective and reversible MAO-A inhibitors such as moclobemide. Glaucoma.

Prostate hypertrophy, pyloric stenosis and other stenosing diseases of the gastrointestinal and urogenital systems.

Liver disease.

Heart failure. Rhythm and myocardial conduction disorders. Recovery phase after infarction.

Known or suspected pregnancy. Lactation.

Subjects under the age of 18.

Precautions for use

Use in children and adolescents under 18 years

Tricyclic antidepressants should not be used to treat children and adolescents under the age of 18. Studies conducted in children in this age group for depression have shown no efficacy for this class of drugs. Studies with other antidepressants have shown suicide risk, self-harm, and hostility related to these drugs. This risk can also occur with tricyclic antidepressants.

In addition, tricyclic antidepressants are associated with a risk of cardiovascular side effects in all age groups. It should be noted that long-term safety data for children and adolescents regarding growth, maturation and cognitive and behavioral development are not available.

Suicide design / behavior

Suicide / thoughts of suicide

Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide / related events). This risk remains until a significant remission occurs. Because there may be no improvement in the first or subsequent weeks of treatment, patients should be carefully monitored until improvement has occurred. It is common clinical experience that the risk of suicide may increase in the early stages of improvement.

Other psychiatric disorders for which tofranil is prescribed may also be associated with an increased risk of suicide. In addition, these pathologies can be associated with major depression. Therefore, when treating patients with severe depressive disorders, the same precautions should be taken when treating patients with other psychiatric disorders.

Patients with a history of suicide or suicidal thoughts or with a

A significant amount of suicidal thoughts before starting treatment is at higher risk of suicidal thoughts or attempts and must be carefully monitored during treatment. A meta-analysis of clinical studies performed with antidepressants compared to placebo in the treatment of psychiatric disorders showed an increased risk of suicide in the age group of less than 25 years in patients treated with antidepressants compared to placebo.

Drug therapy with antidepressants should always be associated with close monitoring of patients, especially those at high risk, especially in the early stages of treatment and after dose changes. Patients (or those who care for them) should be warned of the need to immediately monitor and report any worsening of the disease, the onset of behavior or thoughts of suicide or changes in behavior, and to report this to their doctor.

In these patients, the possibility of changing the treatment regimen, including discontinuation of treatment, should be considered, especially if these symptoms are severe, occur suddenly or are not part of the symptoms presented by the patient prior to treatment (see also "Discontinuation of Treatment" in this section).

To reduce the risk of overdose, Tofranil prescriptions must apply to the minimum amount of tablets that are useful for good patient management.

Other psychiatric effects

Publicity Many panic attack patients reported an increase in anxiety at the start of treatment with Tofranil (see "Dose, Method, and Time of Administration"); This paradoxical effect is very evident in the first few days of treatment and then generally disappears within two weeks.

An aggravation of psychotic conditions has occasionally been observed in schizophrenia patients taking tricyclic antidepressants.

Onset of mania or hypomania during the depressive phase has been reported in patients with bipolar mood disorders treated with tricyclic antidepressants. In these cases, it is necessary to reduce the dosage or to discontinue tofranil and to administer antipsychotics. After monitoring these episodes, the low dose treatment with Tofranil can be resumed if necessary.

In predisposed and elderly patients, tricyclic antidepressants, especially at night, can cause drug-induced psychosis (delusions) that will go away within a few days once the drug is stopped.

Heart and vascular diseases

Tofranil treatment should be used with caution in patients with cardiovascular disease, particularly in patients with cardiovascular insufficiency, conduction disorders (e.g. atrioventricular block I to III) or arrhythmias. Monitoring of cardiac function and the electrocardiographic image is recommended in these patients and in the elderly.

With over-therapeutic doses of tofranil, isolated cases of QTc interval prolongation and very rare cases of ventricular tachycardia and sudden death have occurred, mainly in connection with overdose, but also in some cases of concomitant therapy, which may result in prolonged QTc Interval (e.g. thioridazine).

Before starting treatment, it is recommended to check your blood pressure as a drop in blood pressure may occur in patients with postural hypotension or circulatory disorders.

Convulsions

Tricyclic antidepressants can lower the seizure threshold. Therefore, their use in epileptics and in patients with other predisposing factors, such as brain damage of different etiology, simultaneous use of neuroleptics, abstinence from alcohol or drugs with antispasmodic properties (e.g.

Benzodiazepines) are only permitted under medical supervision. The onset of seizures appears to be dose dependent, so the recommended daily doses should not be exceeded.

As with other tricyclic antidepressants, modern electro-seizure therapy should only be carried out by particularly experienced personnel.

Anticholinergics

Due to its anticholinergic properties, tofranil should be used with caution in patients with increased intraocular pressure, narrow-angle glaucoma or urinary retention (e.g. prostate disease).

The decrease in tearing and the accumulation of mucosal secretions due to the anticholinergic properties of tricyclic antidepressants can damage the corneal epithelium in patients with contact lenses.

Special categories of patients

Particular caution should be exercised when administering tricyclic antidepressants to patients with severe hepatic or renal dysfunction and adrenal tumors (pheochromocytoma, neuroblastoma) as this can cause a hypertensive crisis.

Caution should also be exercised in patients with hyperthyroidism or in patients taking thyroid medication, as there is a possibility that cardiac side effects may worsen.

Liver enzyme levels should be checked regularly in patients with hepatic impairment.

Caution should be exercised when Tofranil is administered to patients with chronic constipation. Tricyclic antidepressants can cause paralytic ileus over a long period of time, especially in elderly or bedridden patients.

Long treatments with tricyclic antidepressants can lead to an increased incidence of dental caries. It is therefore recommended to carry out regular checks for longer treatments.

Count white blood cells

Although only a few cases of changes in the number of white blood cells have been detected after treatment with Tofranil, it is advisable to check the blood crust regularly and to monitor the appearance of symptoms such as fever and sore throat, especially in the first months of therapy and during longer treatments .

anesthesia

Before local or general anesthesia, the anesthetist should be informed that the patient is being treated with tofranil (see "Interactions").

Discontinuation of treatment

A sudden stop of treatment due to the possible occurrence of side effects should be avoided. If a decision is made to discontinue treatment, the dose of the drug should be reduced as soon as possible, however, it should be borne in mind that sudden discontinuation may be associated with certain symptoms (for a description of the risks of stopping therapy, see "Undesirable Effects" ). with tofranil).

Interactions

Tell your doctor or pharmacist if you have recently taken other medicines, including those without a prescription.

- Monoamine oxidase inhibitors: Tricyclic antidepressants must not be associated

MAOI drugs for the possibility of serious side effects (hyperthermia, convulsions, hypertensive crisis, myoclonus, restlessness, delirium, coma). The same caution should be exercised if an MAOI is given after previous treatment with Tofranil. In both cases, tofranil or the MAOI drug should first be administered in low doses, which can then be gradually increased by monitoring the effects (see section 4.3).

Some data show that tricyclic antidepressants can only be administered 24 hours after administration of a reversible type A MAO inhibitor such as moclobemide; However, the 2-week washout interval must always be observed if the MAO-A inhibitor is administered after treatment with a tricyclic antidepressant.

- Selective serotonin reuptake inhibitors (SSRIs): Simultaneous use can have additional effects on the serotonergic system. Fluoxetine and fluvoxamine can also cause an increase in imipramine plasma concentrations, leading to undesirable effects.

- CNS depressive substances: Tricyclic antidepressants can increase the effects of alcohol and other CNS depressed medications such as hypnotics, sedatives, anxiolytics and anesthetics.

- Neuroleptics: concomitant administration of neuroleptics and tricyclic antidepressants may increase the plasma concentration of the latter, lower the seizure threshold and the onset of seizures. The simultaneous use of thioridazine can lead to severe cardiac arrhythmias.

- Blockers of adrenergic neurons: Tricyclic antidepressants block the synaptic production of guanethidine and other antihypertensive agents with an analogous mechanism of action and reduce their therapeutic activity. Therefore, it is recommended to administer to patients who need antihypertensive drugs with different mechanisms of action (e.g. diuretics, vasodilators or β-blockers).

- Anticoagulants: Tricyclic antidepressants can increase the anticoagulant effect by inhibiting the liver metabolism of coumarin drugs. We therefore recommend careful monitoring of plasma prothrombin levels.

• Anticholinergics: The use of parasympatholytics (e.g. phenothiazines, medicines to treat Parkinson's disease, antihistamines, atropine, biperids) requires attention, as tricyclic antidepressants can increase the effects on the eye and the central nervous system, intestines and bladder.

• Sympathomimetics: Sympathomimetics (e.g. adrenaline, noradrenaline, isoprenaline, ephedrine, phenylephrine) should generally not be administered during treatment, the effects of which, particularly on the cardiovascular system, can be significantly increased.

The association between imipramine and L-dopa facilitates the occurrence of hypotension and cardiac arrhythmia.

The patient must also avoid the use of decongestants and products for the treatment of asthma and pollinosis, which contain sympathomimetic substances.

• Quinidine: Tricyclic antidepressants should not be used in combination with quinidine-type antiarrhythmics.

• Hepatic enzyme inducers: Medicines that activate the hepatic enzyme system of monooxygenases (e.g. carbamazepine, barbiturates, phenytoin, nicotine, oral contraceptives) can accelerate the metabolism of imipramine and therefore reduce its plasma concentrations, thereby reducing its effectiveness. In addition, the serum concentrations of phenytoin and carbamazepine may increase, leading to side effects. The dosage of these medicines may need to be adjusted, while various phenothiazines, haloperidol and cimetidine can delay their elimination by increasing their blood concentration. The binding of imipramine to plasma proteins can be reduced by competition from phenytoin, phenylbutazone, acetylsalicylic acid, scopolamine and phenothiazines.

• Cimetidine, methylphenidate: Since these medicines increase the plasma concentration of tricyclic antidepressants, their dosage must be reduced in the case of

  simultaneous administration.

• Estrogen: It has been found that concomitant use of estrogen can, in some cases, have a paradoxical effect by reducing its effectiveness while increasing the toxicity of tofranil.

It is recommended not to drink alcoholic beverages during Tofranil therapy.

Special warnings

This medicine contains sucrose and lactose; Patients with intolerance to some sugar should consult their doctor before taking the medicine.

pregnancy

Ask your doctor or pharmacist for advice before taking any medicine. The medicine should not be used in known and suspected pregnancies.

lactation

Because imipramine and its desmethylimipramine metabolite are excreted in human milk in small amounts, tofranil treatment in women who are breastfeeding should be discontinued gradually or patients should be advised to stop breastfeeding.

Impact on the ability to drive and use machines

Tofranil can cause visual disturbances, sleepiness and other disorders of the central nervous system (see "Undesirable effects").

Therefore, Tofranil affects your ability to drive, use machinery, or perform work that requires perfect vigilance.

In addition, the consumption of alcoholic beverages or other drugs can increase these effects (see "Interactions").

Dose, method and time of administration

The posology and the mode of administration must be individually determined and adapted to the patient's condition. Efforts should generally be made to achieve the optimal effect with the minimally effective doses and then gradually and carefully increase them, especially in the elderly or in adolescents, as these two categories of patients generally show a clearer response to tofranil than the middle-aged patients.

The tablets should be swallowed whole without chewing them.

Adults

Depression and depressive syndromes

Adults in the hospital

Start with 25 mg three times a day and gradually increase the dose by 25 mg per day to 200 mg / day. This must be maintained until a clear clinical improvement is noticed. In severe cases, 300 mg / day, divided into 3 administrations, can be administered. The maintenance dose to be determined from time to time for each individual patient is usually 100 mg / day.

Adults in outpatient treatment

Start with 25 mg 1-3 times a day and gradually increase to 150-200 mg / day to achieve this over a week. This dosage should be maintained until significant clinical improvement is noted. The maintenance dose, to be determined on a case-by-case basis by gradually reducing the dose, is usually 50-100 mg per day.

elderly

Administer 10 mg per day at the start of treatment to increase gradually until the optimal dose of 30-50 mg per day is maintained within 10 days until the end of treatment.

Overdose

The signs and symptoms of tofranil overdose are similar to those reported for other tricyclic antidepressants. The most important changes can be found in the heart and in neurology. In children, inadvertent use of Tofranil at any dose should be considered serious and possibly fatal.

Signs and symptoms of advertising

The first symptoms usually appear within 4 hours of taking the medicine and reach their maximum severity after 24 hours. Due to the slow absorption (deterioration of anticholinergic effects due to overdose), the long half-life and the enterohepatic recirculation of the drug, the patient should be classified as at risk for 4-6 days.

The following signs and symptoms can appear:

Cardiovascular system: conduction disorders, heart failure, arrhythmias, tachycardia, hypotension, shock, in very rare cases cardiac arrest.

Central nervous system: drowsiness, stupor, coma, ataxia, restlessness, restlessness; Hyperreflexia, muscle stiffness with choreoathetic movements, cramps.

Other: mydriasis, sweating, vomiting, respiratory depression, cyanosis, fever, oliguria or anuria.

After an overdose, isolated cases of QT interval prolongation, "torsade de pointes" and death have been reported.

treatment

There is no specific antidote, so treatment is essentially symptomatic and supportive. Even suspicion of overdose with tofranil, especially in children, requires immediate hospitalization and at least 72-hour monitoring.

If the patient is conscious, induce vomiting or gastric lavage as soon as possible. If the patient is not conscious, do not induce vomiting and intubate the trachea before proceeding with gastric lavage. These measures should also be taken 12 hours or more after the overdose has occurred, as the anticholinergic properties of the drug can delay gastric emptying. The administration of activated carbon can be useful to reduce absorption of the drug.

Symptoms should be treated with modern intensive care methods, with cardiac function, blood gases and electrolytes continuously monitored. If necessary, emergency measures such as antispasmodic therapy, artificial respiration, installation of a temporary pacemaker, infusion of solutions to increase the plasma volume, intravenous drip infusion of dopamine or dobutamine and resuscitation should be taken. Administration of physostigmine should be avoided since cases of severe bradycardia, asystole and epileptic seizures have been reported. Peritoneal dialysis and hemodialysis are of no benefit since the plasma concentrations of tofranil are low.

If you accidentally take an overdose of Tofranil, tell your doctor immediately or go to the nearest hospital.

unwanted effects

Like all medications, tofranil can cause side effects, although not everyone gets them.

If any of the side effects gets worse or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

The side effects are generally mild and transient, are not always dose-related or plasma-related, and generally resolve by continuing therapy or possibly reducing the dose. It is often difficult to distinguish between side effects and symptoms of depression such as fatigue, sleep disorders, restlessness, anxiety, constipation and dry mouth.

The occurrence of serious neurological or psychological side effects requires stopping treatment.

Elderly patients are particularly sensitive to anticholinergic, neurological, psychological and cardiovascular effects. Indeed, the ability to metabolize and eliminate drugs can be reduced in these patients, with the risk of reaching high plasma concentrations at therapeutic doses.

Side effects are listed by frequency using the following convention: Very common (≥ 1/10); together (≥ 1/100, moins 1/10); unusual (≥ 1/1000, 1/100 minutes); rare (≥ 1 / 10,000, Moins 1/1000); very rare (1 / 10,000 moins), including isolated reports.

Infections and infestation

Very rare: dental caries.

Blood and lymphatic system disorders

Very rare: eosinophilia, bone marrow depression with leukopenia, agranulocytosis, thrombocytopenia and purpura. Adenitis.

Immune system disorders

Very rare: anaphylactic reaction.

Changes in the endocrine system

Very rare: syndrome of inappropriate secretion of the antidiuretic hormone (SIADH).

Changes in metabolism and diet

Very common: weight gain.

Common: anorexia.

Very rare: changes in blood sugar, weight loss.

Psychiatric disorders

Common: euphoria, restlessness, confusion, delirium, hallucinations, anxiety, restlessness, mania, hypomania, changes in libido, sleep disorders, disorientation.

Rare: psychotic disorders, suicidal thoughts / behavior (see "Precautions for Use").

Very rare: aggression.

Nervous system disorders

Very common: tremors.

Common: dizziness, headache, sedation, sleepiness, paraesthesia.

Rare: seizures.

Very rare: myoclonus, extrapyramidal disorders, ataxia, speech disorders, abnormalities in the EEG, stroke.

Eye diseases

Common: blurred vision, changes in visual accommodation, decreased tearing.

Very rare: mydriasis, glaucoma.

Changes in the auditory and vestibular system

Very rare: tinnitus.

Heart changes

Very common: sinus tachycardia, ECG abnormalities (e.g. changes in the ST and T waves). Common: arrhythmias, palpitations, conduction disorders (e.g. enlargement of the QRS complex, bundle branch block, changes in the PQ tract).

Very rare: heart failure, prolongation of the QT interval, ventricular arrhythmia, ventricular tachycardia, ventricular fibrillation, "torsade de pointes", myocardial infarction, heart failure.

Changes in the vascular system

Very common: hot flashes, orthostatic hypotension.

Very rare: purpura, petechiae, vasospasm, high blood pressure.

Changes in the respiratory tract, breast and mediastinum

Very rare: allergic alveolitis (with or without eosinophilia).

Gastrointestinal disorders Very common: dry mouth, constipation. Common: nausea, vomiting, diarrhea.

Very rare: paralytic ileus, stomatitis, abdominal discomfort, tongue ulcers.

Changes in the hepatobiliary system

Common: abnormal liver function test.

Very rare: hepatitis (with or without jaundice).

Skin and subcutaneous tissue disorders

Very common: hyperhidrosis.

Common: allergic dermatitis (rash, urticaria, erythema).

Very rare: itching, photosensitivity reactions, alopecia, skin hyperpigmentation.

Kidney and urinary disorders

Common: urinary disorders.

Very rare: urinary retention.

Reproductive system and breast disorders

Very rare: breast hypertrophy, galactorrhea.

General disorders and changes in the administration site

Common: tiredness.

Very rare: asthenia, edema (localized or generalized), fever, sudden death.

Withdrawal symptoms

The following symptoms commonly appear after abrupt discontinuation or dose reduction: nausea, vomiting, abdominal pain, diarrhea, insomnia, headache, nervousness and anxiety (see "Precautions for use").

Following the directions in the package insert will reduce the risk of side effects.

If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Process and storage

Expiry date: See the expiry date stated on the packaging.

The expiry date refers to the product in intact packaging, stored correctly.

Warning: Do not use the medicine after the expiry date which is stated on the box.

Medicines should not be thrown into wastewater and household waste. Ask your pharmacist how you can get rid of medicines you no longer use. This helps protect the environment.

Keep the medical device out of the reach and sight of children.

Pubblicita'Composizione

One 10 mg coated tablet contains: Active ingredient: 10 mg imipramine hydrochloride. One 25 mg coated tablet contains: Active ingredient: 25 mg imipramine hydrochloride.

Excipients: glycerin; Lactose monohydrate; Magnesium stearate; Cornstarch; Stearic acid; Talc; colloidal anhydrous silica; Sucrose; microcrystalline cellulose; Titanium dioxide; Povidone; macrogoli; Copovidone; red iron oxide; Hypromellose.

Pharmaceutical forms and content

Coated tablets. Box of 60 tablets of 10 mg each; Box of 50 tablets of 25 mg each.