Fastway 120 mg/180 mg Tablets

FASTWAY 120 is indicated for the relief of symptoms associated with seasonal allergic rhinitis (SAR).

FASTWAY 180 is indicated for the relief of symptoms associated with chronic idiopathic urticaria (CIU).

Adults and children aged 12 years and over

• Chronic idiopathic urticaria (CIU): One 180 mg tablet daily.
• Seasonal allergic rhinitis (SAR): One 120 mg tablet daily.

Children under 12 years of age

The efficacy and safety of FASTWAY has not been studied in children below 12 years of age.

Special risk groups (See u201cWARNINGS AND SPECIAL PRECAUTIONSu201d)

Based on increases of bioavailability and half-life, a dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function.

Patients with known hypersensitivity to fexofenadine hydrochloride or to any of the ingredients of FASTWAY.

Safety in pregnancy and lactation has not been established. (See u201cPREGNANCY AND LACTATIONu201d).

The safety and efficacy of FASTWAY has not been studied in children under the age of 12 years.

Exacerbation of psoriasis has been reported with the use of FASTWAY.

Patients with a history of, or ongoing cardiovascular disease should be warned that antihistamines, as a class of medicines, have been associated with adverse reactions such as tachycardia and palpitations.

There is only limited data for the use in elderly and renally or hepatically impaired patients. FASTWAY should be administered with care in these special risk groups.

FASTWAY does not undergo hepatic biotransformation. Co-administration of FASTWAY with erythromycin or ketoconazole has been found to result in a 2 - 3 times increase in the level of FASTWAY in plasma. The changes were not accompanied by any effects on the QT- interval and were not associated with any increase in adverse events compared to the medicines given individually. The increase in plasma levels of FASTWAY observed after co-administration of erythromycin or ketoconazole, appears to be due to an increase in gastrointestinal absorption and either a decrease in biliary excretion or gastrointestinal secretion, respectively.

No interaction between FASTWAY and omeprazole was observed. However, the administration of an antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to FASTWAY, causes a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of FASTWAY and aluminium and magnesium hydroxide containing antacids.

PREGNANCY

There is no experience with FASTWAY in pregnant women.

LACTATION

FASTWAY has been detected in breast milk. Mothers on FASTWAY should not breastfeed. FASTWAY should not be taken during pregnancy or lactation.

FASTWAY may affect the ability to drive or operate machinery. FASTWAY lacks 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 simultaneous intake of alcohol or other central nervous system depressants. (See u201cINTERACTIONSu201d).

Infections and infestations

• Frequent: Viral infections such as cold or flu

Immune system disorders

• Less frequent: Hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis

Psychiatric disorders

• Less frequent: Paranoia

Nervous system disorders

• Frequent: Fatigue, headache, drowsiness, dizziness
• Less frequent: Insomnia, nervousness, sleep disorders

Respiratory, thoracic and mediastinal disorders

• Frequent: Sinusitis

Gastrointestinal disorders

• Frequent: Nausea, dyspepsia

Skin and subcutaneous tissue disorders

• Less frequent: Rash, urticaria, pruritus

Reproductive system and breast disorders

• Frequent: Dysmenorrhoea

In overdose side effects will be exacerbated and exaggerated (see SIDE EFEFCTS). Dizziness, drowsiness and dry mouth have been reported. Standard measures should be considered to remove any unabsorbed fexofenadine. Haemodialysis does not effectively remove FASTWAY from blood. Treatment is symptomatic and supportive.