- Approval Id
- 70d0e53e1e42a756
- Drug Name
- ALERINIT FILM-COATED TABLET 5MG
- Product Name
- ALERINIT FILM-COATED TABLET 5MG
- Approval Number
- SIN16312P
- Approval Date
- 2021-08-31
- Registrant
- GOLDPLUS UNIVERSAL PTE LTD
- Licence Holder
- GOLDPLUS UNIVERSAL PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PHARMACY ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>3. How to take ALERINIT?</strong></p>
<ul>
<li><p><strong>Instructions for appropriate use and dose / administration frequency:</strong></p>
<ul class="bullet">
<li><p>Do not take ALERINIT for longer than 7 days, without advice of your doctor or pharmacist.</p></li>
<li><p>Contact your doctor if your symptoms worsen or do not improve after 3 days.</p></li>
<li><p>Please always take ALERINIT exactly as your doctor has told you. If you are not sure, you should contact your doctor or pharmacist.</p>
<p><em>In children between 6–12 years old: Once a day 5 mg (1 film coated tablet)</em></p>
<p><em>In adults and children aged 12 years and over: Once a day 5 mg (1 film coated tablet)</em></p>
</li>
</ul>
</li>
<li><p><strong>Administration route and method:</strong></p>
<ul class="bullet">
<li><p>ALERINIT is administrated orally.</p></li>
<li><p>Film tablet should be swallowed as a whole with a glass of water. Daily dose is recommended to be administrated in one single dose.</p></li>
<li><p>ALERINIT may be administrated with the following foods or alone.</p></li>
</ul>
</li>
</ul>
<p><strong>Elderly:</strong><br>
In elderly patients with normal renal functions, the usual dose for adults may be taken.</p>
<ul>
<li><p><strong>Specific use:</strong></p>
<p><strong>Renal/Hepatic insufficiency:</strong></p>
<p>Patients with impaired kidney function may be given a lower dose according to the severity of their kidney disease, and in children the dose will also be chosen on the basis of body weight; the dose will be determined by your doctor.</p>
<p>Patients who have severe impairment of kidney function must not take Alerinit.</p>
<p>Patients who only have impaired liver function should take the usual prescribed dose.</p>
<p>Patients who have both impaired liver and kidney function may be given a lower dose depending on the severity of the kidney disease, and in children the dose will also be chosen on the basis of body weight; the dose will be determined by your doctor.</p>
</li>
</ul>
<p><strong>If you take more ALERINIT than you should:</strong><br>
<em>If you take more than the recommended dose of ALERINIT, tell your doctor or pharmacist.</em><br>
Symptoms of overdose in adults may include drowsiness. Children may initially show agitation and restlessness, followed by drowsiness.</p>
<p><strong>If you forget to take ALERINIT</strong><br>
If you forget to take ALERINIT, take the next dose at the usual time.<br>
<em>Do not take a double dose to make up for a forgotten dose.</em></p>
<p><strong>Possible effects after stopping ALERINIT</strong><br>
Stopping treatment should have no negative effects. However, rarely pruritus (intense itching) may occur if you stop taking ALERINIT, 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 should resolve when the treatment is restarted.</p>
<p>If you have any further questions on the use of this medicine, ask your doctor or pharmacist.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>1. What ALERINIT is and what is it used for?</strong></p>
<ul>
<li><p>ALERINIT contains the active substance, levocetirizine. Levocetirizine belongs to a group of antiallergic medicines called antihistamines.</p></li>
<li><p>ALERINIT is indicated for the treatment of symptoms such as sneezing, runny nose and watery eyes associated with; allergic rhinitis (including persistent allergic rhinitis) and to relieve the rashes and itching of chronic urticaria.</p></li>
<li><p>ALERINIT is presented in blister of 10 tablets each. A box contains a leaflet and 20 tablets. Alerinit is a white, one side scored, oval shaped, standard concave film coated tablet. The tablet should be swallowed whole with 1 glass of water. The score-line is non-functional and only for visual purposes. Do not break the tablet.</p></li>
</ul>
- Contraindications
- <p><strong>2. Before you take ALERINIT</strong></p>
<p><strong>Please do not take ALERINIT:</strong><br>
If:</p>
<ul>
<li>You are using other antiallergic medicines,</li>
<li>You are allergic (hypersensitive) to levocetirizine, cetirizine, hydroxyzine, any piperazine derivatives (closely related active substances of other medicines) or any of the other ingredients of ALERINIT,</li>
<li>You have a severe impairment of kidney function (severe renal failure with creatinine clearance below 10 ml/min).</li>
</ul>
- Atc Code
- R06AE09
- Atc Item Name
- levocetirizine
- Pharma Manufacturer Name
- GOLDPLUS UNIVERSAL PTE LTD
