Lordyno 10 mg Tablet.

LORDYNO is indicated for the relief of the symptoms associated with perennial and/or seasonal allergic rhinitis, chronic urticaria and other allergic skin disorders.

Posology
Take one tablet once daily.
Method of administration
Oral administration. LORDYNO can be taken with or without food.

• LORDYNO is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to loratadine or to any of the excipients listed in section 6.1.
• Safety of LORDYNO in the elderly has not been established.

Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine, the active ingredient in LORDYNO; an initial dose of 5 mg once daily or 10 mg every second day is recommended. Increase in body mass has been reported with the use of LORDYNO (see section 4.8). LORDYNO contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption, should not take LORDYNO.

When administered concomitantly with alcohol, LORDYNO has no potentiating effects as measured by psychomotor performance studies. Loratadine, as in LORDYNO, is metabolised by cytochrome P450 isoenzymes CYP3A4 and CYP2D6. Concomitant administration of other medicines that inhibit or are metabolised by these hepatic enzymes may result in changes in the plasma concentrations of either medicine and, possibly, may have adverse effects. Cimetidine, erythromycin, ketoconazole, quinidine, fluconazole and fluoxetine are all well known to inhibit one or more of these enzymes. Erythromycin, ketoconazole and cimetidine are all known to inhibit the metabolism of loratadine, as in LORDYNO. Similarly, clarithromycin inhibits the metabolism of loratadine, as in LORDYNO, and its active metabolite descarboethoxyloratadine. LORDYNO should be discontinued approximately 48 hours prior to skin testing procedures since antihistamines may prevent or diminish otherwise positive reactions to dermal reactivity indicators.

The safe use of LORDYNO during pregnancy or lactation has not been established.

LORDYNO lacks significant sedative effects. Patients should however be warned that a small number of individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated tasks. The effect may be compounded by the simultaneous intake of central nervous system depressants.

Summary of the safety profile
The most frequent adverse reactions are somnolence, headache, increased appetite and insomnia.
Tabulated list of adverse reactions
Immune system disorders: Less frequent: Hypersensitivity reactions (including angioedema and anaphylaxis).
Metabolism and nutrition disorders: Frequency unknown: Increased appetite, increased body mass.
Nervous system disorders: Less frequent: Dizziness, convulsions, headache, somnolence, sedation, nervousness.
Cardiac disorders: Less frequent: Tachycardia, palpitations.
Gastrointestinal disorders: Less frequent: Nausea, dry mouth, gastritis.
Hepato-biliary disorders: Less frequent: Abnormal hepatic function.
Skin and subcutaneous tissue disorders: Less frequent: Rash, alopecia.
General disorders and administration site conditions: Less frequent: Fatigue.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of LORDYNO 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 the South African Health Products Regulatory Authority (SAHPRA) via the u201cAdverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

Symptoms
Overdosage with LORDYNO increased the occurrence of anticholinergic symptoms. Somnolence, tachycardia and headache have been reported with overdose.
Treatment:
In the event of overdosage, treatment should be started immediately. Treatment is symptomatic and supportive. Loratadine as in LORDYNO is not removed by haemodialysis and it is not known if it is removed by peritoneal dialysis. Medical monitoring of the patient is to be continued after emergency treatment.