Obihist 180 Mg Film-Coated Tablets

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

Posology

Adults and children aged 12 years and over : OBIHIST 180 mg: One 180 mg tablet daily.

Paediatric population: Children under 12 years of age : The efficacy and safety of OBIHIST 180 mg has not been studied in children under the age of 12.

Special risk groups: See sections 4.4 and 5.2.

Method of administration: OBIHIST 180 mg should be taken orally. The tablets should be swallowed with liquid and should not be chewed. OBIHIST 180 mg should not be broken because the coating is intended to ensure a prolonged release.

• OBIHIST 180 mg is contraindicated in patients with known hypersensitivity to fexofenadine hydrochloride or any of the excipients of OBIHIST 180 mg listed in section 6.1.
• There is no experience with OBIHIST 180 mg in pregnant women. OBIHIST 180 mg should not be taken during pregnancy or by mothers breastfeeding their babies.

There is only limited data for the use of fexofenadine in elderly and renally or hepatically impaired patients. OBIHIST 180 mg should be administered with care in these special risk groups.

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

Paediatric population

The safety and efficacy of fexofenadine, as in OBIHIST 180 mg, has not been studied in children under the age of 12 years.

OBIHIST 180 mg contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take OBIHIST 180 mg.

Fexofenadine, as in OBIHIST 180 mg does not undergo hepatic biotransformation. 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 OBIHIST 180 mg with P-gp inhibitors erythromycin or ketoconazole has been found to result in 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 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 fexofenadine, as in OBIHIST 180 mg and omeprazole was observed. However, the administration of antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to fexofenadine hydrochloride, as in OBIHIST 180 mg caused a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of OBIHIST 180 mg and aluminium and magnesium hydroxide containing antacids.

Pregnancy

There is no experience with fexofenadine, as in OBIHIST 180 mg, in pregnant women. OBIHIST 180 mg should not be taken during pregnancy (see section 4.3). Limited animal studies do not indicate direct or indirect harmful effects with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development.

Breastfeeding

There are no data on the content of human milk after administering fexofenadine hydrochloride. However, when terfenadine was administered to nursing mothers fexofenadine was found to cross into human breast milk. OBIHIST 180 mg should not be taken by mothers breastfeeding their babies (see section 4.3).

Fertility

No human data on the effect of fexofenadine hydrochloride on fertility are available. In mice, there was no effect on fertility with fexofenadine hydrochloride treatment (see section 5.3).

Fexofenadine as in OBIHIST 180 mg 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 simultaneous intake of alcohol or other central nervous system depressants.

System Organ Class Adverse reaction Frequency

• Immune system disorders Hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis Less frequent
• Psychiatric disorders Insomnia, nervousness and sleep disorders or nightmares/excessive dreaming (paroniria). Less frequent
• Nervous system disorders Headache, drowsiness, dizziness Frequent
• Eye disorders Blurred vision Frequency unknown
• Cardiac disorders Tachycardia, palpitations Frequency unknown
• Gastrointestinal disorders Nausea Frequent
• Diarrhoea Frequency unknown
• Skin and subcutaneous tissue disorder Rash, urticaria, pruritus Less frequent
• General disorders and administrative site conditions Fatigue Less frequent

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. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Medicine Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.

Symptoms: Most reports of fexofenadine hydrochloride 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 fexofenadine hydrochloride from blood.