TRITICUM AC, modified release tablets, 150 mg

NAME OF THE MEDICAL PRODUCT
Triticum AC

Qualitative and quantitative composition
Each modified release tablet contains:

Active substance: Trazodone hydrochloride: 150 mg

Pharmaceutical form and content
Packages containing blisters with 20 and 60 divisible modified release tablets

Pharmacotherapeutic class
Pharmacotherapeutic group: 2.9.3 – Psychopharms - Antidepressants

Market Authorisation Holder
L. Lepori, Lda
Rua João Chagas 53, Piso 3,
1495-764 Cruz Quebrada - Dafundo

Therapeutic indications
Depression of varied nature with or without anxiety.

Contraindications and side effects
Contraindications: Hypersensitivity to the active substance or any of its excipients. Contraindicated in individuals below 18 years.

Side effects: Occasionally in patients treated with trazodone, there was a decrease in leucocytes, normally without any clinical meaning and without the need to interrupt treatment. This procedure should only be adopted if the number of leucocytes is decreased to levels below normal values, in such a way, that there is the need to
count leucocytes and check the formula in patients experiencing fever, sore throat or other signs of infection during treatment. It was also reported cases of agranulocytosis and anaemia.

It was reported cases of insomnia, headaches, asthenia, vertigo, confusion, tremor, hypotension, tachycardia, bradycardia, cardiac arrhythmia, decrease of concentration, convulsions and very rarely, alteration in transaminases levels. It was rarely reported gastric disorders, nauseas, vomits, diarrhoea and loss of appetite.

Like with other drugs which present alfa-adrenolitic effects, trazodone was rarely associated to the occurrence of priapism. In such situation, the patient should discontinue treatment immediately.

Triticum AC is an antidepressant with sedative properties, which can cause drowsiness, normally in the first days of the treatment.

Drug interactions and other forms of interaction
Although no side effects have been reported, trazodone may enhance the effects of muscular relaxants and anaesthetics. Trazodone is well tolerated in depressed schizophrenic patients with standard phenotiazine therapy, as well as in depressed parkinsonic patients treated with levodopa.

Moreover, it can enhance the effect of alcohol, barbiturates and other depressants of the Central Nervous System.

The association with other psycopharms requires the special caution and monitoring of the doctor, in order to avoid the occurrence of undesirable effects resulting from the interaction.

It was occasionally observed situations of possible interaction with monoaminoxidase inhibitors (MAOI).

An eventual concomitant treatment with antihypertensives may require the reduction of the dosage of antihypertensive used.

Studies carried out in laboratory animals suggest that trazodone may considerably inhibit the hypotensive effect of clonidine.

The association of trazodone with digoxin or phenytoin, may increase serum levels of these substances.

Warnings and special precautions for use
Triticum AC should be administered with caution in cardiac patients and in patients recovering from a myocardial infarction.

In the presence of another drug, trazodone should be administered with caution in patients with hepatic or renal dysfunction.

The frequency of the side effects of Triticum AC® , may increase during the concomitant use of naturopathic products or preparations based on vegetable extracts that contain Hypericum perforatum in their composition

The administration of trazodone to epileptic patients should be carefully performed.

Since the tablets contain saccarosis, the treatment of individuals with diabetes or submitted to a hypocaloric diet, should be carefully performed.

The possibility of suicide is inherent to depression and it may persist until the significant remission of the symptoms.
In the beginning of the treatment, a close control should be made to high risk patients.

Effects in pregnant women, breast-feeding women, children, elderly patients and patients with special pathologies
The safety of trazodone was not assessed in pregnant women. Avoid use in the first trimester of pregnancy.

During lactation, the fact that tradozone may be excreted in the milk should be considered.

Its use during pregnancy and breastfeeding should be limited to exceptional cases and only after the assessment of the benefit-risk relation by the doctor.

Effects on the ability to drive and use machines
Since Trazodone is an antidepressant drug with anxiolytic-sedative properties it may influence the capacity of attention and the necessary psychophysic conditions to drive vehicles, execute risk jobs and use complex machines.

List of excipients
Saccarosis, povidone, carnaube wax, magnesium stearate.

Posology and administration mode
Tablets are divisible to allow a progressive posology with fractionated doses, according to the severity of the disease, weight, age and general conditions of the patient.

It is recommended to begin the therapeutic cycle with one administration before going to sleep at night and increasing daily doses.

Indication of the most favourable moment for the administration of the medicine
According to the doctor’s indication. In the mild to moderate forms, administer one single dose before going to sleep at night. In the mean to severe forms, administer 2 times a day.
The medicine should be administered preferably after meals.

Duration of the average treatment when it should be limited
According to the doctor’s indication. Therapeutic cycles of at least 1 month should be performed. .

Instructions about what to do if you forget to take one or more doses
If you forget to take one or more doses, treatment must be continued. Do not take two doses to compensate for the dose you forgot to take.

Indication of how to discontinue the treatment when its discontinuation causes withdrawal effects
The interruption of the treatment should be done according to the doctor’s indication. Normally, no special precautions are necessary to suspend the treatment.

Measures to adopt in case of overdosage and/or intoxication, emergency measures and antidotes
The most frequently observed symptoms are: drowsiness, vertigo and vomits.

There is no specific antidote for trazodone. In case of accidental ingestion of high doses a stomach lavage should be performed as soon as possible. If hypotension or sedation occurs, treatment is symptomatic.

Advice to the patient
If you notice any side effect not mentioned in this leaflet, please inform your doctor or pharmacist.

Check if the product is within the expiry date mentioned in the package.

Keep the medicine out of reach and sight of children.

Special precautions for storage
Do not store above 25ºC.

Date of the revision of the leaflet
November 2005

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