IONAMIN

Oral administration. Adults: 15 mg or 30 mg daily at breakfast time. Evening dosing should be avoided as Ionamin may induce nervousness and insomnia. It is recommended that treatment should be conducted under the care of physicians experienced in the treatment of obesity.

Secondary organic causes of obesity must be excluded by diagnosis before prescribing Ionamin. The recommended dose should not be exceeded in an attempt to increase the anorectic effect, and the drug should be discontinued in non-responsive cases.

The management of obesity should be undertaken using a overall approach which should include dietary, medical and psychotherapeutic methods. The duration of treatment is four to six weeks and should not exceed three months. An intermittent dosage regimen consisting of treatment for up to four weeks, followed by a similar period without medication may be as effective as continuous treatment.

Children (below 12 years) and The Elderly:

Ionamin is not recommended for use.

Pulmonary artery hypertension - An epidemiological study has shown that anorectic intake is a risk factor involved in the development of pulmonary artery hypertension and that the use of anorectics is strongly associated with an increased risk for this adverse drug reaction.

Cases of pulmonary artery hypertension have been reported in patients treated with phentermine. Pulmonary artery hypertension is a severe and often fatal disease. The occurrence or aggravation of exertional dyspnoea is usually the first clinical sign and requires treatment discontinuation and investigation in a specialised unit (see Special Warnings).

CNS effects - the prolonged use of this agent is associated with a risk of pharmacological tolerance, dependence and withdrawal syndrome. - the most common adverse reactions which have been described are: psychotic reactions or psychosis, depression, nervousness, agitation, sleep disorders and vertigo.

- Convulsions, dry mouth and headache have also been reported. Cardio-vascular effects - the most common reported reactions are tachycardia, palpitations, hypertension, precordial pain. - rarely, cases of cardiovascular or cerebro-vascular accidents have been described in patients treated with anorectic agents.

In particular stroke, angina, myocardial infarction, cardiac failure and cardiac arrest have been reported. Other effects - Constipation, nausea, vomiting and rashes have been reported.

Special Warnings Cases of severe, often fatal, pulmonary artery hypertension, have been reported in patients who have received anorectics of the type in this product. An epidemiological study has shown that anorectic intake is a risk factor involved in the development of pulmonary artery hypertension and that the use of anorectics is strongly associated with an increased risk for this adverse drug reaction.

In view of this rare but serious risk, it must be emphasised that: - careful compliance with the indication and the duration of treatment is required, - duration of treatment greater than 3 months and a BMI ≥ 30 kg/m2 increase the risk of pulmonary artery hypertension.

- the onset or aggravation of exertional dyspnoea suggests the possibility of occurrence of pulmonary artery hypertension. Under these circumstances, treatment should be immediately discontinued and the patient referred to a specialist unit for investigation.

Special Precautions for Use - Prolonged treatment may give rise to pharmacological tolerance and drug dependence, and more rarely to severe psychotic disorders in predisposed patients. - Rarely, cases of cardiac and cerebro-vascular accidents have been reported, often following rapid weight loss.

Special care should be taken to ensure gradual and controlled weight loss in obese patients, who are subject to a risk of vascular disease. Ionamin should not be prescribed in patients with current or a past medical history of cardio-vascular or cerebro-vascular disease.

- Ionamin should be used with caution in epileptic patients.

Pulmonary artery hypertension; severe arterial hypertension. Thyrotoxicosis, glaucoma, epilepsy. Hypersensitivity to sympathomimetic amines. Current or past medical history of cardiovascular or cerebro-vascular disease or psychiatric disorders including anorexia nervosa and depression.

Propensity towards drug abuse, known alcoholism. Ionamin should not be administered to children under 12 years of age. Combination drug therapy Concurrent use with any other centrally acting anorectic agent is contra- indicated due to the increased risk of potentially fatal pulmonary artery hypertension.

Concurrent or recent use of monoamine oxidase inhibitors (MAOI's) also contra-indicates the use of Ionamin.