Phentolene 15 mg &30 mg Hard capsules

PHENTOLENE is an anorectic medicine used in the management of obesity. PHENTOLENE is indicated as a short-term adjunct in a medically monitored comprehensive regimen of weight reduction based, for example, on exercise, diet (caloric/ kilojoule restriction) and behaviour modification in obese patients with a body mass index (BMI) of 30 kg/m2 or higher who have not achieved an adequate clinical response to an appropriate weight-reducing regimen alone. Treatment with PHENTOLENE can be initiated at a lower BMI in patients with other risk factors. Secondary organic causes of obesity should be excluded by diagnosis before prescribing this medicine.

Posology

Adults and children over 12 years

One capsule daily at approximately 7 a.m., swallowed whole. Evening dosing should be avoided, as this medicine may induce insomnia. It is recommended that treatment should be initiated under the care of medical practitioner experienced in the treatment of obesity. The recommended dose of PHENTOLENE should not be exceeded, and PHENTOLENE should not be combined with other appetite suppressants, in an attempt to increase the effect. Patients require medical review after a defined course of treatment, which ideally should not exceed three months.

Paediatric population

Children under 12 years: PHENTOLENE is not recommended for children under the age of 12 years, as safety and efficacy have not been established.

Method of administration

PHENTOLENE capsules are for once daily oral administration.

• Hypersensitivity to phentermine or to any of the excipients of PHENTOLENE (see section 6.1).
• Pulmonary artery hypertension.
• Moderate to severe arterial hypertension.
• Existing heart valve abnormalities or heart murmurs.
• Cerebrovascular disease.
• Cardiac disease including dysrhythmias.
• Advanced arteriosclerosis.
• Known hypersensitivity to sympathomimetic medicines (see section 4.5).
• Hyperthyroidism.
• Agitated states or a history of psychiatric disorders including anorexia nervosa and depression.
• Glaucoma.
• History of drug/alcohol abuse or dependence.
• Obstructive uropathy.
• Poorly controlled epilepsy.
• Concomitant treatment with Monoamine Oxidase (MAO) Inhibitors or within 14 days following their administration (see section 4.5).
• Pregnancy and breastfeeding.

PHENTOLENE capsules are indicated only as short-term monotherapy for the management of exogenous obesity. The safety and efficacy of combination therapy with phentermine and any other medicines for weight loss have not been established. Therefore, coadministration of medicines for weight loss is not recommended.

Since the selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), ergot-like medicines and clomipramine affect serotonin metabolism, there is a risk that combination of these medicine with phentermine may be associated with cardiac valvular disease.

Valvular Heart Disease

Serious regurgitant cardiac valvular disease, primarily affecting the mitral, aortic and/or tricuspid valves, has been reported in otherwise healthy persons who had taken a combination of fenfluramine or dexfenfluramine with phentermine for weight loss. The aetiology of these valvulopathies has not been established and their course in individuals after the medicines are stopped is not known. There have been no reported cases to date of valvular heart disease occurring with the use of phentermine alone.

Primary Pulmonary Hypertension (PPH)

Cases of severe, sometime fatal primary pulmonary hypertension have been reported in patients who have received phentermine as in PHENTOLENE. The initial symptom of PPH is usually dyspnoea. Other early symptoms include angina pectoris, syncope, lower extremity oedema or the unexplained onset or aggravation of diminished exercise tolerance. Under these circumstances, treatment should be immediately discontinued, and the patient referred to a specialist unit for investigation.

Use with caution in the following circumstances

PHENTOLENE should be used with caution in patients with mild hypertension and kidney impairment. In the first days of treatment, determine that there is no loss of blood pressure control.

In patients receiving PHENTOLENE, response to insulin and oral hypoglycaemic medicines may vary due to alterations in dietary regimes. This should be kept in mind if PHENTOLENE is used in diabetic patients.

Inappropriate use has been reported with similar medicines and the possibility of this occurrence should be considered with PHENTOLENE. Infrequent cases of cardiovascular and cerebrovascular events have been reported, mainly in association with rapid weight loss. Special care should be taken to ensure gradual and controlled weight loss in obese patients undergoing treatment with PHENTOLENE, who are subjects to a risk of vascular disease. PHENTOLENE should be used with caution in patients with established coronary artery disease.

PHENTOLENE should be used with caution in patients under treatment with antihypertensive medicines, since it may cause loss of blood pressure control, and in patients receiving psychotropic medicines, including sedatives and medicines with sympathomimetic activity.

PHENTOLENE should be used with caution in epileptic patients.

Use in the elderly

PHENTOLENE is not recommended for the elderly.

Paediatric population

PHENTOLENE is not recommended for children under the age of 12 years.

Excipient warning

PHENTOLENE contains sucrose. Patients with the rare hereditary condition of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take PHENTOLENE.

PHENTOLENE should be used with caution in patients receiving sympathomimetic medicines. Phentermine as in PHENTOLENE, antagonises adrenergic neurone blocking medicines such as clonidine, methyldopa and guanethidine, and may decrease their hypotensive effect. The effects of phentermine as in PHENTOLENE, are potentiated by monoamine oxidase inhibitors (see section 4.3) and may result in a hypertensive crisis. The concurrent use of thyroid hormones with phentermine, as in PHENTOLENE, may increase the CNS stimulation that can occur with phentermine. Alcohol may increase CNS side effects, such as dizziness, light headedness and confusion, and its concurrent use should be avoided with phentermine, as contained in PHENTOLENE.

Pregnancy

Weight reduction using appetite suppression medicines is not recommended during pregnancy. Studies in animals have shown evidence of an increased occurrence of foetal damage. Due to inadequate evidence of safety in human pregnancy, PHENTOLENE should not be used in pregnant women.

Breastfeeding

There is no data available on the safety of phentermine, as contained in PHENTOLENE, in lactation and as such, its use in lactating women should be avoided.

Fertility

There is no data available on the potential of phentermine to impair fertility in humans.

PHENTOLENE may impair the ability to perform activities requiring mental alertness, such as driving and operating machinery, and patients therefore should be cautioned accordingly.

a. Summary of the safety profile

The most reported adverse reactions during treatment, are palpitations, tachycardia, elevation of blood pressure, precordial pain. See section 4.4 regarding the onset or aggravation of exertional dyspnoea. Cases of cardiovascular or cerebrovascular events have been described with anorectic medicines.

b. Tabulated summary of adverse reactions

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions & Quality Problem Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

Symptoms

Initially irritability, rapid respiration, agitation, euphoria, restlessness, hyperreflexia, disorientation and tremor, aggressiveness, hallucinations, and panic states may occur, followed by cardiac dysrhythmias, convulsions, fatigue, central nervous system depression and coma. Cardiovascular effects include hypertension or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhoea, and abdominal cramps.

Treatment

The treatment is largely symptomatic. The stomach should be emptied by emesis. Provided renal function is adequate, elimination of phentermine as in PHENTOLENE, has been shown to be assisted by acidification of the urine. There is insufficient experience to recommend haemodialysis or peritoneal dialysis.