Musalos 15 Mg/30 Mg Capsules

MUSALOS is a medicine used for the management of obesity and is classified as an anorectic medicine. MUSALOS is a short-term adjunct in a medically monitored comprehensive regimen of weight reduction. This is based, for example, on diet (calorie/kilojoule restriction), exercise, and modification of behaviour in obese patients with a body mass index (BMI) of at least 30 kg/m2 or higher and who have not achieved an adequate clinical response to a suitable weight-reducing regimen alone. In patients with a lower BMI with other risk factors, treatment with MUSALOS can be initiated. Before prescribing MUSALOS secondary organic causes of obesity should be excluded.

Adults and Children over 12 years: Take one capsule daily at approximately 7 a.m., swallowed whole. A dose in the evening should be avoided, as MUSALOS may induce insomnia. It is recommended that treatment should be initiated under the care of a medical practitioner experienced in the treatment of obesity. The recommended dose of MUSALOS should not be exceeded, and MUSALOS should not be combined with other appetite suppressants, 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: MUSALOS is not recommended for children under 12 years old.

Method of administration

MUSALOS capsules are for oral use. MUSALOS are to be swallowed whole.

• Hypersensitivity to phentermine and sympathomimetic medicines or to any of the ingredients of MUSALOS
• Pulmonary artery hypertension, arterial hypertension, cerebrovascular disease
• Cardiac disease including dysrhythmias, advanced arteriosclerosis
• 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
• Pregnancy and lactation
• Children under 12 years old.

Concomitant medicine: MUSALOS is only indicated as a short-term (a few weeks) monotherapy for the exogenous obesity management. The safety and efficacy of combination therapy with MUSALOS and any other medicine for weight loss (including prescribed medicine, over-the-counter medicine and herbal products) have not been established. Consequently, co-administration with additional medicines for weight loss is not recommended.

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

Valvular Heart Disease: Serious regurgitant cardiac valvular disease, primarily affecting the aortic, mitral and/or tricuspid valves, has been described in otherwise healthy individuals who took a combination of MUSALOS with fenfluramine or dexfenfluramine for weight loss. The accuracy of the etiology of these valvulopathies has not been established and their course in persons after the medicine use were stopped is not fully known.

Primary Pulmonary Hypertension (PPH): PPH is a rare, frequent fatal lung disease. Cases of primary pulmonary hypertension have been described in patients who have received MUSALOS. The primary symptom of PPH is usually dyspnoea. Other early symptoms include: angina pectoris, syncope, lower extremity oedema or the unexplained start or aggravation of diminished exercise tolerance. Under these circumstances, treatment should be immediately discontinued, and the patient referred to a specialist unit for investigation. PPH has been reported in patients who received a combination of phentermine with fenfluramine or dexfenfluramine.

Hypertension and kidney impairment: In patients with mild hypertension and kidney impairment MUSALOS should be used with caution. It is recommended to determine that there is no loss of blood pressure control in the first days of treatment with MUSALOS.

Epileptic patients: Use MUSALOS with caution in epileptic patients.

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

Inappropriate use: Inappropriate use has been reported with similar medicines and the possibility of this occurrence should be considered with MUSALOS.

Cardiac and cerebrovascular accidents: Infrequent cases of cerebrovascular and cardiac events have been described, often after rapid weight loss. Special care should be taken to ensure gradual and controlled weight loss in obese patients, who are at risk to develop vascular disease. In patients under treatment with anti-hypertensive medicines, MUSALOS should be used with caution since it may cause loss of blood pressure control. This is also true in patients receiving psychotropic medicines, including sedatives and sympathomimetic medicines.

Development of tolerance, discontinuation in case of tolerance: If a tolerance to the anorectant effect develops, the recommended dosage should not be exceeded to increase the effect. It is recommended that the medicine should be discontinued.

Monoamine Oxidase Inhibitors: Monoamine oxidase inhibitors potentiate the effects of MUSALOS (see section 4.3) and may result in a hypertensive crisis and is thus contraindicated during or within 14 days after the administration of monoamine oxidase inhibitors.

Sympathomimetic medicines: MUSALOS should be used with caution in patients receiving sympathomimetic medicines as phentermine is an indirect-acting sympathomimetic which may interact with other medicine.

Adrenergic neurone blocking medicines: MUSALOS antagonises adrenergic neurone blocking medicines such as clonidine, methyldopa and guanethidine and may decrease their hypotensive effect.

Alcohol: Concomitant use of alcohol with phentermine may result in an adverse drug reaction.

Insulin and oral hypoglycemic medication: Requirements may be altered (see section 4.4).

Selective serotonin reuptake inhibitors, ergot-like medicines and clomipramine: Selective serotonin reuptake inhibitors (e.g. fluoxetine, sertraline, fluvoxamine, paroxetine), ergot-like medicines and clomipramine (see section 4.4).

MUSALOS is contradicted in pregnancy and lactation.

Pregnancy: Due to inadequate evidence of safety in human pregnancy, MUSALOS should not be used in pregnant women. Studies in animals have shown evidence of an increased occurrence of foetal damage.

Breastfeeding: There are no data available on the safety of MUSALOS in lactation and as such, its use in lactating women should be avoided.

Fertility: There is no information on the potential for MUSALOS to impair fertility in humans.

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

Summary of the safety profile: Serious adverse reactions including primary pulmonary hypertension (symptoms include, dyspnoea, angina pectoris, syncope, lower extremity oedema, unexplained onset or aggravation of diminished exercise tolerance) require immediate discontinuation of MUSALOS and further investigation under specialist care.

Tabulated list of adverse effects

System Organ Class Frequency Side effects

• Psychiatric disorders Frequency unknown Psychosis
• Nervous system disorders Frequent Less frequent Overstimulation, restlessness, nervousness, insomnia, tremor, dizziness, headache
• Euphoria which may be followed by fatigue and depression, psychotic episodes, hallucinations, dysphoria
• Eye disorders Frequency unknown Blurred vision
• Cardiac disorders Frequent Frequency unknown Tachycardia, palpitations, hypertension, precordial pain
• Myocardial infarction, cardiac failure, cardiac arrest, ischaemic events
• Vascular disorders Frequency unknown Cardiovascular or cerebrovascular accidents, primary pulmonary hypertension (symptoms include, dyspnoea, angina pectoris, syncope, lower extremity oedema, unexplained onset or aggravation of diminished exercise tolerance), facial oedema, regurgitant vulvular heart disease, elevation of blood pressure
• Gastrointestinal disorders Frequency Nausea, vomiting, dry mouth, abdominal cramps, unpleasant taste, diarrhoea, constipation
• Skin and subcutaneous tissue disorders Frequency unknown Rash, urticaria
• Renal and urinary disorders Frequency unknown Micturition disturbances
• Reproductive system and breast disorders Frequency unknown Impotence, changes in libido

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. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

Signs and symptoms: 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.

Management of overdose: Treatment is largely symptomatic. The stomach should be emptied by emesis or stomach tube and washed out with water if the preparation has been ingested within the last three or four hours. Provided renal function is adequate, elimination of phentermine has been shown to be assisted by acidification of the urine. There is insufficient experience to recommend haemodialysis or peritoneal dialysis.