ATTROGY Film-coated tablet Ref.[115596] Active ingredients: Diflunisal

Posology

The recommended dose of diflunisal is one 250 mg tablet taken twice daily. The tablets should preferably be taken with food to reduce risk of gastro-intestinal adverse reactions (see section 4.4).

Special populations

Elderly

Diflunisal should be used with caution in elderly patients who are more prone to adverse reactions. No dose adjustment is required for elderly patients (≥65 years) in the absence of severe renal or hepatic insufficiency (see below and sections 4.3 and 4.4). Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs.

Renal impairment

Since diflunisal and its major metabolites are eliminated primarily by the kidneys, its half-life is extended in patients with reduced renal function. Diflunisal is contra-indicated in patients with renal impairment (GFR ≤30 ml/min) (see sections 4.3 and 4.4). No dose adjustment is required in patients with mild or moderate renal impairment.

Hepatic impairment

No dose adjustment is required for patients with mild or moderate hepatic impairment (Child-Pugh A or B). Diflunisal is contra-indicated in patients with severe hepatic impairment (Child-Pugh C; see section 4.3).

Paediatric population

There is no relevant use of diflunisal in the paediatric population in the hATTR amyloidosis indication.

Method of administration

It is recommended that the tablets are swallowed whole, not crushed or chewed, due to the bitter taste. Patients who are taking antacids should leave a 2-hour interval between taking diflunisal and taking antacid medicines.

The most common signs and symptoms observed with overdosage are drowsiness, dizziness, vomiting, nausea, epigastric pain, gastro-intestinal bleeding, diarrhoea, hyperventilation, tachycardia, sweating, tinnitus, disorientation, stupor, excitation and coma. Diminished urine output and cardiorespiratory arrest have also been reported. The lowest dose of diflunisal alone at which death was reported was 15 g. Death has also been reported from a mixed drug overdose that included 7.5 g diflunisal.

In the event of recent overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage. The patient should be observed carefully and given symptomatic and supportive treatment. To facilitate urinary elimination of the drug, attempt to maintain renal function. Because of the high degree of protein binding, haemodialysis is not recommended. Monitor renal and liver function as well as the patient’s clinical condition. Convulsions should be treated with antiseizure medication.

2 years.

This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light.

HDPE bottle with polypropylene child-resistant tamper-evident screw cap with a liner. Pack size of 100 film-coated tablets.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.