Lorfast 10 mg Tablet

LORFAST is indicated for the relief of symptoms associated with seasonal allergic rhinitis and chronic urticaria.

Posology

• Adults: one tablet a day

Use of LORFAST should be limited to 14 days.

Method of administration

• Oral use.

• LORFAST should not be used in patients with known hypersensitivity to loratadine or any of the excipients of LORFAST (listed in section 6.1).
• Cross sensitivity to other antihistamines.
• Porphyria.

The safety of LORFAST in the elderly has not been established. The safety of LORFAST in children under two years has not been established.

LORFAST should be used with caution in patients:

• severe liver impairment, as reduced clearance of loratadine may occur. Dosage adjustment may be needed.
• Renal impairment - A lower starting dose should be used. In patients with chronic renal impairment, (creatinine clearance of 30 ml/minute or less), both oral bioavailability and peak plasma concentrations of loratadine may be increased. However, the elimination half-life of loratadine and its active metabolite appear to be similar to those individuals with normal renal function.
• The use of LORFAST should be discontinued approximately 48 hours prior to skin testing procedures since it may prevent or diminish otherwise positive reactions to dermal reactivity indicators.
• LORFAST shall be used with caution when the following medical conditions exist and/or in patients using other medicines metabolised by the cytochrome P-450 system: Emphysema; prostatic hypertrophy; narrow angle glaucoma; cardiovascular disorder; epilepsy; and during acute attacks of asthma.

Potential interaction may occur with all known inhibitors of CYP3A4 or CYP2D6 resulting in elevated levels of loratadine, which may cause an increase in adverse events. Concomitant use of LORFAST with inhibitors of cytochrome P-450 enzyme system such as cimetidine, ketoconazole, clarithromycin and erythromycin may increase the plasma concentrations of LORFAST.

Pregnancy

Safety and efficacy in pregnancy and lactation have not been established. A large amount of data on pregnant women (more than 1000 exposed outcomes) indicate no malformative nor feto/neonatal toxicity of loratadine. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of loratadine tablet during pregnancy.

Breastfeeding

Loratadine and its metabolites have been detected in breast milk. Small amounts of LORFAST entering breast milk may cause drowsiness or excitement in infants. Therefore, the use of LORFAST is not recommended in breast-feeding women.

Fertility

There are no data available on male and female fertility.

LORFAST 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. This effect may be compounded by the simultaneous intake of alcohol or other central nervous system depressants.

System Order Class

• Frequent
• Less frequent
• Frequency unknown

Immune system disorders

• Anaphylaxis including angioedema

Nervous system disorders

• Headache, somnolence, confusion, nightmares
• Sedation, nervousness
• Dizziness, convulsions

Eye disorders

• Blurred vision

Cardiac disorders

• Tachycardia and palpitation

Gastrointestinal disorders

• Dry mouth, nausea and gastritis

Hepato-biliary disorders

• Abnormal hepatic function

Skin and subcutaneous tissue disorders

• Rash, alopecia

Metabolism and nutrition disorders

• Increased appetite

General disorders and administration site conditions

• Fatigue

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 Reporting Formu201d, found online under SAHPRAu2019s publications: https:// www.sahpra.org.za/

Symptoms of overdose that have been reported are somnolence, tachycardia and headaches. In children, extrapyramidal manifestations and palpitations have been reported.

Treatment of overdose

Treatment is symptomatic and supportive. Administration of activated charcoal after emesis may be useful in preventing absorption of LORFAST. Saline cathartics may be of value to rapidly dilute bowel contents. LORFAST is not cleared by haemodialysis.