Compositoin and forms of issue
Each coated tablet contains: 10 mg of Clomipramine Hydrochloride(Anafranil 10 )
Each coated tablet contains:25 mg of Clomipramine Hydrochloride (Anafranil 25 )

Properties
The active substance is completely absorbed by the oral route. Anafranil has an antidepressive effect of rapid onset, its therapeutic activity being characterized by a high degree of safety and reliability. It exerts a comprehensive action on the depressive syndrome as a whole, including in particular, typical features such as psychomotor retardation, depressed mood, and existential anxiety. Its effect usually sets in within the first week of treatment. The therapeutic activity of Anafranil is believed to be based on its ability to inhibit, the re-uptake of noradrenalin and serotonin into the respective neurons, the re-uptake of serotonin, however, being more strongly inhibited than by other tricyclic antidepressants.

Indications
Depressive states of varying etiology and symptomatology endogenous, reactive, neurotic, masked, organic and involutional forms of depression, depression associated with schizophrenia or personality disorders .Depressive syndromes due to presenility or senility, to chronic painful conditions ,and to chronic somatic diseases. Depressive mood disorders of a reactive, neurotonic ,or psychopathic nature ,including their somatic equivalents in children.

Further indications
Obsessive compulsive syndromes, phobias and panic attacks. Cataplexy accompanying narcolepsy, chronic painful conditions, and nocturnal enuresis( from the age of 5 years onwards, and provided the possibility of organic causes has first been excluded).

Dosage
The dosage and mode of administration should be determined individually and adapted to the patient’s condition. In principle, every effort must be made to achieve an optimum effect with doses as low as possible, particularly when treating elderly patients or adolescent depressives displaying autonomic nervous instability, because these two categories of patients generally show a more marked response to Anafranil than patients belonging to intermediate age groups. The tablets should be swallowed whole. Depressions ,obsessive ,compulsive syndromes , and phobias : Initiate treatment with 1 tablet of 25 mg 2-3 times daily. During the first week of treatment, raise the daily dosage stepwise to 4-6 tablets of 25 mg, in severe cases this dosage can be exceeded. Once a distinct improvement has occurred, adjust the daily dosage to a maintenance level averaging 2-4 tablets of 25 mg.
In cases of cataplexy accompanying narcolepsy: Anafranil should be given orally in a daily dose of 25-75 mg, possibly in combination with methylphenidate (Ritalin) In Chronic painful conditions: The dosage must be individualised (10-150 mg) daily taking account of such concomitant analgesic medications as the patient may be receiving (and of the possibility of reducing the doses of analgesics).
Geriatrics: Initiate treatment with 1 tablet of 10 mg daily. Gradually raise the dosage to an optimum level of 30-50 mg daily, which should be reached after about 10 days and then adhered to, until the end of the treatment.
Pediatrics: Initiate treatment with 1 tablet of 10 mg daily. Over a period of 10 days, increase the daily dosage to 20 mg in children aged 5-7 years, to 20-50 mg in those aged 8-14 years ,and to 50 mg or more in patients aged over 14 years.
Panic attacks :Initially 1 tablet of 10 mg ,possibly in combination with a benzodiazepine . Depending on how the medication is tolerated, raise the dosage until the desired response is obtained, while at the same time gradually withdrawing the benzodiazepine .The daily dosage required varies greatly from patient to patient and lies between 25 and 100 mg ,if necessary, it can be increased to 150 mg .It is recommended that the treatment should be discontinued before 6 months and that during this time the maintenance dose should be slowly reduced.

Restrictions on use
Contra-indications Concomitant treatment with ANAFRANIL and an MAO inhibitor is absolutely contraindicated. Known hypersensitivity to tricyclic antidepressants belonging to the dibenzazepine group.

Precautions
Treatment with Anafranil should be given only under medical supervision. Particular caution is indicated when employing tricyclic antidepressant in the presence of heart failure or circulatory debility, in the acute stage of myocardial infarction, and in patients with disturbances of cardiac conduction, a low convulsion threshold, disorders of micturition due to an impeded flow of urine or glaucoma. Before initiating treatment, it is advisable to check the patient’s blood pressure, because individuals with a low blood pressure or a labile circulation may react to the drug with a fall in blood pressure. This can be controlled be reducing the dosage or administering circulatory stimulants. Occurrences of agranulocytosis have been connected with the use of tricyclic antidepressants. It is therefore also advisable to perform blood counts during treatment with Anafranil, especially if the patient develops fever, an influenzal infection, or sore throat. The patient’s reactions e.g. as a road-user, may be impaired by Anafranil.

Special points to note
The use of Anafranil as antidepressive therapy does not preclude the possibility of additional treatment with neuroleptic agents, hypnotics ,or minor tranquilizers. In the event of an allergic skin reaction Anafranil should be withdrawn. Anafranil should be kept out of the reach of children.

Pregnancy and lacatation
The principle that drugs should whenever possible not employed during the first 3 months of pregnancy also applies to Anafranil. Anafranil may possibly have undesirable pharmacological effects on the foetus and therefore not be administered during the latter months of pregnancy. Since the active substance passes into the breast milk, nursing mothers receiving Anafranil should not breast feed their infants.

Unwanted effects
At the start of treatment, Anafranil - like most other tricyclic antidepressants - may give rise to accompanying anticholinergic reactions such as sweating, dryness of the mouth, a fine tremor, dizziness ,blurring of vision ,and disturbances of micturition, as well as postural hypotension, which generally disappear after a few days either spontaneously or following a decrease in the dosage .Allergic skin reactions may occur.
Very occasionally, usually in response to high dosages, disturbances of cardiac conduction, cardiac arrhythmias, insomnia, transient confusional states, and increased anxiety may be encountered
In rare instances, disorders of hepatic function, hyperpyrexia, and convulsions have been reported.

Interactions
Anafranil may diminish or abolish the antihypertensive effect of adrenergic neuron inhibitors such as guanethidine (if necessary, antihypertensive of different type should be used).
If Anafranil is to be employed following treatment with an MAO inhibitor, this should be done only after an interval of at least 14 days has elapsed, because otherwise severe interactions may occur(e.g. hyper-activity ,hypertensive crisis, hyperpyrexia, spasticity, convulsions, coma).The same caution should be observed when administering an MAO inhibitor after previous treatment with Anafranil.
Anafranil may potentiate the cardiovascular effects of noradrenaline or adrenaline as well as the activity of CNS-depressant drugs and anticholinergic agents. Owing to its mild antagonistic effects on dopamine, Anafranil may increase prolactin secretion.
Since Anafranil, like other pshyco-active drugs, may diminish alcohol tolerance, patients should be advised to abstain from alcohol while under treatment. Since physostigmine increases the risk of seizures occurring, a warning should be uttered against its use. Vital functions (including the ECG) should be monitored for a few days.

Packs
20 Coated tablets of 10 mg (Anafranil 10)
20 Coated tablets of 25 mg (Anafranil 25)