Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Razin capsules may be used for a period of up to 3 months of treatment. Razin capsules are indicated only as short-term monotherapy for the management of exogenous obesity. The safety and efficacy of combination therapy with phentermine and other drug products for weight loss have not been established. Therefore, coadministration of drug products for weight loss is not recommended.

Since the selective serotonin reuptake inhibitors (e.g fluoxetine, sertraline, paroxetine), ergot like drugs and clomipramine affect serotonin disposition there remains a theoretical risk that combination of these agents with phentermine may also be associated with cardiac valvular disease and is not recommended. There is no direct scientific evidence to confirm this theory.

Valvular Heart Disease: Serious regurgitate 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 phentermine with fenfluramine or dexfenfluramine for weight loss. The etiology of these valvulopathies has not been established and their course in individuals after the drugs are stopped is not known.

Primary Pulmonary Hypertension (PPH): Cases of severe, sometime fatal primary pulmonary hypertension, have been reported in patients who have received anorectics. In a case-control epidemiological study, the duration of treatment with anorectic agents, not including phentermine, beyond three months significantly increases the risk of PPH. However, patients treated with phentermine require medical review at least every 3 months (Refer to Section 4.2 – Dose and Method of Administration). PPH has been reported in patients receiving phentermine combined with fenfluramine / dexfenfluramine. The possibility of an association between PPH and the use of phentermine alone cannot be ruled out; there have been very rare cases of PPH in patients who reportedly have taken phentermine alone. The initial symptom of PPH is usually dyspnea.
Other early symptoms include: angina pectoris, syncope, lower extremity edema 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:
Razin should be used with caution in patients with mild hypertension. In the first days of treatment, determine that there is no loss of blood pressure control.

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

Inappropriate use has been reported with similar drugs and the possibility of this occurrence should be considered with Razin.

Cardiovascular and cerebrovascular events have rarely been reported, mainly in association with rapid weight loss. Weight loss should be gradual and controlled in obese patients undergoing treatment with Razin. Razin should be used with caution in patients with established coronary artery disease. A single case of exacerbation of angina pectoris in a patient with established coronary artery disease has been reported.

Razin should be used with caution in patients receiving psychotrophic drugs, including sedatives and agents with sympathomimetic activity.

Razin should be used with caution in epileptic patients.

Razin should be used with caution in patients receiving anti-hypertensive agents.
Use in the elderly
Razin is not recommended for the elderly.

Paediatric Use
Razin Capsules (phentermine resin) are not recommended for use in pediatric patients under 16 years of age.
Effects on laboratory tests
There are no reports to-date to suggest that phentermine interferes with laboratory or diagnostic tests.

Excipients
Razin contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Razin contains Sucrose. Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Effects on Driving

4.7   Effects on ability to drive and use machines

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