Tellerge 120 mg & 180 mg FC tablets

TELLERGE 120 mg is indicated for:

• the relief of symptoms associated with seasonal allergic rhinitis (SAR).

TELLERGE 180 mg is indicated for:

• the relief of symptoms associated with chronic idiopathic urticaria (CIU).

Posology

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 TELLERGE has not been studied in children under 12 (see section 4.3 and section 4.4).

Special Populations (See section 4.4).

Renal impairment

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.

Paediatric population

The efficacy and safety of TELLERGE in children under twelve has not been established

Method of administration

For oral administration

TELLERGE is contraindicated in:

• Patients with hypersensitivity to fexofenadine hydrochloride or to any excipients in TELLERGE (see section 6.1).
• Children under the age of 12 years.
• Pregnancy and lactation (see section 4.6).

There is only limited data for the use in elderly and renally or hepatically impaired patients. TELLERGE should be administered with care in these special risk groups or special populations (see section 4.2).

Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as a medicine class, such as TELLERGE, have been associated with the adverse reactions, tachycardia and palpitations (see section 4.8).

Fexofenadine is a P-glycoprotein (P-gp) and organic-anion-transporting polypeptide (OATP) substrate. Concomitant use of fexofenadine with P-gp inhibitors or inducers can affect the exposure to fexofenadine. Co-administration of fexofenadine hydrochloride with P-gp inhibitors erythromycin or ketoconazole has been found to result in a 2-3 times increase in the level of fexofenadine in plasma. The changes were not accompanied by any effects on the QT interval and were not associated with any increase in adverse reactions compared to the medicinal products given singly.

TELLERGE 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 section 4.7).

The efficacy and safety of TELLERGE has not been studied in children under the age of 12 years (see section 4.3).

Interaction with other medicines

TELLERGE does not undergo hepatic biotransformation and therefore will not interact with other medicines through hepatic mechanisms (see {section 5.2). Co-administration of TELLERGE with erythromycin or ketoconazole has been found to result in 2 to 3 times increase in the level of TELLERGE 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.

A clinical drug-drug interaction study showed that co-administration of apalutamide (a weak inducer of P-gp) and a single oral dose of 30 mg fexofenadine resulted in a 30 % decrease in AUC of fexofenadine.

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

The safety of TELLERGE in pregnancy and lactation has not been established (see section 4.3).

Pregnancy

There are no adequate data from the use of TELLERGE in pregnant women. TELLERGE should not be used during pregnancy, unless clearly necessary (see section 4.3).

Breastfeeding

TELLERGE is excreted into breastmilk. Mothers breastfeeding their infants should not be treated with TELLERGE (see section 4.3).

Fertility

No data on the effect of TELLERGE on fertility are available.

TELLERGE has a moderate influence on the ability to drive and use machines. Since adverse reactions such as headache, drowsiness and dizziness have been reported in patients receiving TELLERGE, patients should not drive, use machinery or perform any tasks that require concentration, until they are certain that TELLERGE does not adversely affect their ability to do so (see section 4.8).

System organ class

• Frequent
• Less frequent
• Frequency unknown (cannot be estimated from the available data)

Respiratory thoracic and mediastinal disorders

• Sinusitis and viral infections such as cold and flu

Immune system disorders

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

Psychiatric disorders

• Insomnia, nervousness, sleep disorders, nightmares/excessive dreaming (paroniria)

Nervous system disorders

• Headache, drowsiness, dizziness

Cardiac disorders

• Tachycardia, palpitations

Gastrointestinal disorders

• Nausea
• Diarrhoea, dyspepsia

Skin and subcutaneous tissue disorders

• Rash, urticaria, pruritus

Reproductive system and breast disorders

• Dysmenorrhoea

Musculoskeletal, connective tissue and bone disorders

• Fatigue

Eye disorders

• Vision blurred

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/publications/Index/8 May also report to Adcock Ingram Limited using the following email: [email protected]

Symptoms

Most reports of TELLERGE overdose contain limited information. However, dizziness, drowsiness and dry mouth have been reported.

Treatment

Standard measures should be considered to remove any unabsorbed medicine. Haemodialysis does not effectively remove TELLERGE from blood.