- Approval Id
- f2b9827ab9988ede
- Drug Name
- OVIPLA FILM-COATED TABLET 200MG
- Product Name
- OVIPLA FILM-COATED TABLET 200MG
- Approval Number
- SIN17243P
- Approval Date
- 2025-05-27
- Registrant
- GOLDPLUS UNIVERSAL PTE LTD
- Licence Holder
- GOLDPLUS UNIVERSAL PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>4.2 Posology and Method of Administration</strong><br>
<strong>Posology/ Frequency of administration and period:</strong><br>
<u>Adults (including the elderly)</u><br>
The minimum effective dose should be employed. This dose should not exceed 6.5 mg/kg/day (calculated from ideal body weight and not actual body weight) and will be either 200 mg or 400 mg per day.</p>
<p><u>In patients able to receive 400 mg daily:</u><br>
Initially 400 mg daily in divided doses. The dose can be reduced to 200 mg when no further improvement is evident. The maintenance dose should be increased to 400 mg daily if the response lessens.</p>
<p><u>Pediatric Population</u><br>
The minimum effective dose should be employed and should not exceed 6.5 mg/kg/day based on ideal body weight. The 200 mg tablet is therefore not suitable for use in children with an ideal body weight of less than 31 kg.</p>
<p>Hydroxychloroquine is cumulative in action and will require several weeks to exert its beneficial effects, whereas minor side effects may occur relatively early. For rheumatic disease treatment should be discontinued if there is no improvement by 6 months. In light- sensitive diseases, treatment should only be given during periods of maximum exposure to light.</p>
<p><strong>Method of administration:</strong><br>
It is taken orally. It should be taken with meal or glass of milk.</p>
<p><strong>Additional information on special populations:</strong><br>
<strong>Renal/Hepatic impairment</strong><br>
Patients who have hepatic or renal impairment or who use drugs known to affect these organs should be closely monitored and the dose should be reduced when necessary.</p>
<p><strong>Pediatric population</strong><br>
It should not be used in children with an ideal body weight of less than 31 kg.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong><br>
Treatment of rheumatoid arthritis, juvenile chronic arthritis, discoid and systemic lupus erythematosus, dermatological conditions caused or aggravated by sunlight.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul class="dash">
<li>Known hypersensitivity to 4-aminoquinoline compounds or to any of the substances listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</li>
<li>Pre-existing, eye maculopathy</li>
<li>Below 6 years of age (200 mg tablets not adapted for weight <35 kg) or for ideal body weight < 31 kg (see section 4.2)</li>
</ul>
