- Approval Id
- b1df8468827d8522
- Drug Name
- Histaclear® Film-Coated Tablet 10 mg
- Product Name
- Histaclear® Film-Coated Tablet 10 mg
- Approval Number
- SIN17339P
- Approval Date
- 2025-09-25
- Registrant
- APEX PHARMA MARKETING PTE. LTD.
- Licence Holder
- APEX PHARMA MARKETING PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Pharmacy Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>How to take Histaclear®?</strong></p>
<p><strong>How much to take</strong></p>
<p>Always take Histaclear® exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.</p>
<p>Don’t take more than the recommended dose.</p>
<p>Don’t take Histaclear® for longer than 7 days, without the advice of your doctor or pharmacist.</p>
<p>Contact your doctor if your symptoms worsen or do not improve after 3 days.</p>
<p><strong>Children aged 6 to 12 years:</strong> Half of the tablet twice daily. The tablet can be divided into equal halves.</p>
<p><strong>Adults and children 12 years of age and older:</strong> 1 tablet once daily. Half of the tablet starting dose may be used if this leads to satisfactory control of the symptoms.</p>
<p>Do not take more than one 10 mg tablet in 24 hours. Swallow the tablet whole, with a glass of water. You can divide the tablet into two equal doses.</p>
<p>Histaclear® film-coated tablets are not recommended for children under 6 years, as the formulation does not allow for appropriate dose adaptation.</p>
<p>Do not take more than the recommended dose.</p>
<p><strong>Patients with kidney and liver disease:</strong></p>
<p>Your doctor will decide on the correct dose of Histaclear® film-coated tablets depending on the illness and the results of blood tests carried out before treatment. Patients who have end stage impairment of kidney function must not take Histaclear® film-coated tablets (see “<em>Don’t take Histaclear®</em>”).</p>
<p>If your child suffers from kidney disease, please contact your doctor or pharmacist who may adjust the dose accordingly.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>What Histaclear® is and what it is used for</strong></p>
<p>Histaclear® contains the active ingredient cetirizine dihydrochloride. Cetirizine belongs to a group of anti-allergic medicines called antihistamines. It blocks the effects of a substance called histamine which occurs naturally in the body. Histamine is involved in allergic reactions.</p>
<p>Histaclear® is used to treat symptoms associated with allergic conditions, such as:</p>
<ul>
<li>Runny, itchy nose</li>
<li>Sneezing</li>
<li>Watery, itchy eyes</li>
<li>Itchy skin rash</li>
</ul>
- Contraindications
- <p><strong>Don’t take Histaclear®:</strong></p>
<ul>
<li>If you are allergic (<em>hypersensitive</em>) to cetirizine, hydroxyzine, any piperazine derivatives (closely related active ingredients of other medicines), or to any ingredients of Histaclear® (listed in section <em>What does Histaclear® contain</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>If you have severe kidney disease (severe impairment of kidney function with creatinine clearance less than 10 mL/min).</li>
<li>If you use other antiallergic medicines.</li>
<li>If you are breastfeeding (see <em>Pregnancy and breast-feeding</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>If you have a rare galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.</li>
</ul>
<p>If you think any of these applies to you, <strong>don’t take Histaclear®</strong> until you have checked with your doctor or pharmacist.</p>
