Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**6\. How to take Stadeltine Film-Coated Tablet 5mg** **How much to take** - Always take Stadeltine Film-Coated Tablet 5mg exactly as your doctor or pharmacist have told you. You should check with your doctor or pharmacist if you are not sure. - Do not take more than the recommended dose. - Do not take Stadeltine Film-Coated Tablet 5mg for longer than 7 days, without advice of your doctor or pharmacist. - Contact your doctor if your symptoms worsen or do not improve after 3 days. _The usual dose is:_ - **Adults and adolescents 12 years and above**: the daily recommended dose is 5mg (1 film-coated tablet), taken once a day. - **Children aged 6 to 12 years**: the daily recommended dose is 5mg (1 film-coated tablet), taken once a day. _Special dosage instructions for specific populations:_ - If you have impaired kidney function, you may be given a lower dose according to the severity of your kidney disease, and body weight will be taken into consideration in children. The dose will be determined by your doctor. - If you have end-stage kidney disease or are undergoing dialysis you must not take Stadeltine Film-Coated Tablet 5mg. - No dose adjustment is needed if you have liver impairment alone. However, if you have both liver and kidney impairment, please consult your doctor for dose adjustments. - No dose adjustment is needed in the elderly, provided their kidney function is normal. **How to take** Swallow the tablet whole, with some water. Take Stadeltine Film-Coated Tablet 5mg once daily, with or without food. It is best to take Stadeltine Film-Coated Tablet 5mg at bedtime as it can make you feel drowsy. **If you forget to take Stadeltine Film-Coated Tablet 5mg** Do not take an extra dose to make up for a missed dose. Just take your next dose at the usual time. **If you take too much Stadeltine Film-Coated Tablet 5mg** - If you take more Stadeltine Film-Coated Tablet 5mg than you should contact your doctor or pharmacist for advice. - Symptoms of overdose in adults may include drowsiness. Children may initially show agitation and restlessness, followed by drowsiness. **If you stop taking Stadeltine Film-Coated Tablet 5mg** Rarely pruritus (intense itching) may occur if you stop taking Stadeltine Film-Coated Tablet 5mg, even if those symptoms were not present before treatment initiation. The symptoms may resolve spontaneously. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms resolve when the treatment is restarted.
ORAL
Medical Information
**4\. What Stadeltine Film-Coated Tablet 5mg is used for** Stadeltine Film-Coated Tablet 5mg is used to treat symptoms such as sneezing, a runny nose and watery eyes associated with allergic rhinitis (including persistent allergic rhinitis) and to relieve the rashes and itching of chronic urticaria.
**5\. Before you take Stadeltine Film-Coated Tablet 5mg** **Do not take Stadeltine Film-Coated Tablet 5mg** - if you are allergic (hypersensitivity) to levocetirizine, cetirizine, hydroxyzine, any piperazine derivatives (closely related active substances of other medicines) or any other ingredients of Stadeltine Film-Coated Tablet 5mg (listed in Section 2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - if you have severe kidney disease (severe impairment of kidney function with creatinine clearance below 10ml/min). - if you use other antiallergic medicines.
R06AE09
levocetirizine
Manufacturer Information
AUXILTO IMPEX PTE. LTD.
STELLAPHARM J.V. CO., LTD. - BRANCH 1
Active Ingredients
Documents
Patient Information Leaflets
Stadeltine film coated tablet PIL.pdf
Approved: May 4, 2022