RAZTROL Tablet Ref.[50495] Active ingredients: Rupatadine

Renal and hepatic impairment: As there is no clinical experience reported in patients with impaired kidney or liver functions, the use of RAZTROL is not recommended in these patients.

Paediatric patients: RAZTROL is not recommended for use in children under 12 years as safety is not reported.

The administration with grapefruit juice is not recommended (see section 4.5).

Cardiac : RAZTROL should be used with caution in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, patients with ongoing prodysrhythmic conditions, such as clinically significant bradycardia and acute myocardial ischaemia.

Use in the elderly: RAZTROL should be used with caution in elderly patients (65 years and older). Although no overall differences in effectiveness or safety were reported in clinical trials, higher sensitivity of some older individuals cannot be excluded.

CYP3A4 inhibitors: The combination of rupatadine with potent CYP3A4 inhibitors should be avoided and with moderate CYP3A4 inhibitors should be administered with caution. Dose adjustment of sensitive CYP3A4 substrates (e.g. simvastatin, lovastatin) and CYP3A4 substrates with a narrow therapeutic index (e.g. ciclosporin, tacrolimus, sirolimus, everolimus, cisapride) could be required as rupatadine may increase plasma concentrations of these medicines (see section 4.5).

Due to the presence of lactose monohydrate in RAZTROL tablets, patients with the rare hereditary problems of galactose intolerance, total lactase deficiency, glucose-galactose malabsorption should not take RAZTROL.

Interaction with alcohol: RAZTROL should be used with caution when administered with alcohol.

Interaction with grapefruit: The concomitant administration of grapefruit juice with rupatadine increased the systemic exposure of rupatadine by 3,5 times. It is recommended to avoid intake of grapefruit juice along with rupatadine.

Interaction with CNS depressants: Interactions with other CNS depressants has not been reported. No interactions have been reported with fluoxetine.

Interaction with statins: Asymptomatic creatine phosphokinase (CPK) increases have been reported in clinical trials of rupatadine. The risk of interactions with statins, some of which are also metabolised by the cytochrome P450 CYPA4 isoenzyme, is unknown. Rupatadine should be used with caution when co-administered with statins.

CYP3A4 inhibitors: The concomitant administration of RAZTROL and ketoconazole or erythromycin increases the systemic exposure to rupatadine 10 times and 2-3 times respectively. Co-administration with potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazole, posaconazole, HIV protease inhibitors, clarithromycin, nefazodone) should be avoided and co-medication with moderate CYP3A4 inhibitors (erythromycin, fluconazole, diltiazem) should be used with caution (see section 4.4).

Pregnancy

RAZTROL is contraindicated in pregnancy.

Lactation

Rupatadine is excreted in animal milk. Due to potential harmful effects in neonates, the use of rupatadine should be avoided during breastfeeding.

Fertility

There are no reported clinical data on fertility. A significant reduction of fertility in animals have been reported at exposure levels higher than those reported in humans at the maximum therapeutic dose.

At the recommended dosage, RAZTROL is not expected to influence the ability to drive or use machinery. Nevertheless, care should be taken before driving or using machinery until the patient’s individual reaction to RAZTROL has been reported.

^* tachycardia and palpitations and hypersensitivity reactions (including anaphylactic reactions, angioedema and urticarial) have been reported in post-marketing experience with rupatadine 10 mg tablets.

Additional, rare adverse events, spontaneously reported with use of rupatadine include nasal dryness, genital erythema, erythema, conjunctival hyperaemia, blepharitis and blister, disorientation, abnormal gait, increased sweating, tremor and headache.

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 “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8

Not applicable.