NOUCOR HEALTH S.A. (SPAIN)🇸🇬 Health Sciences Authority
Approval Date
Jan 25, 2012
Approval ID
6d345c767e31d953
Company
NOUCOR HEALTH S.A. (SPAIN)
Type
Therapeutic
Approval Details
Approval Id
6d345c767e31d953
Drug Name
RUPAFIN TABLET 10MG
Product Name
RUPAFIN TABLET 10MG
Approval Number
SIN14087P
Approval Date
2012-01-25
Registrant
HYPHENS PHARMA PTE. LTD.
Licence Holder
HYPHENS PHARMA PTE. LTD.
Drug Type
Therapeutic
Forensic Classification
PRESCRIPTION ONLY MEDICINES
Dosage Form
TABLET
Dosage
<p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Adults and adolescents (12 years of age and above)</u><br>
The recommended dose is 10 mg (one tablet) once a day, with or without food.</p>
<p><u>Elderly</u><br>
Rupatadine should be used with caution in elderly people (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><u>Paediatric patients</u><br>
Rupatadine 10 mg Tablets is not recommended for use in children below age 12 due to a lack of data on safety and efficacy.</p>
<p><u>Patients with renal or hepatic insufficiency</u><br>
As there is no clinical experience in patients with impaired kidney or liver functions, the use of Rupatadine 10 mg Tablets is at present not recommended in these patients.</p>
Route Of Administration
ORAL
Indication Info
<p><strong>4.1 Therapeutic indications</strong></p>
<p>Symptomatic treatment of allergic rhinitis and urticaria in adults and adolescents (12 years of age and above).</p>
Contraindications
<p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to rupatadine or to any of the excipients.</p>
