- Approval Id
- 37aeb90b09163328
- Drug Name
- SKUDEXA FILM-COATED TABLET 75 MG/25 MG
- Product Name
- SKUDEXA FILM-COATED TABLET 75 MG/25 MG
- Approval Number
- SIN15394P
- Approval Date
- 2017-12-13
- Registrant
- ZUELLIG PHARMA PTE. LTD.
- Licence Holder
- A. MENARINI SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>4.2. Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p>The recommended dosage is one film-coated tablet (corresponding to 75 mg of tramadol hydrochloride and 25 mg of dexketoprofen). Additional doses can be taken as needed, with a minimum dosing interval of 8 hours. The total daily dose should not exceed three film-coated tablets per day (corresponding to 225 mg of tramadol hydrochloride and 75 mg of dexketoprofen).<br>
SKUDEXA is intended for short term use only and the treatment must be strictly limited to the symptomatic period and in any case not more than 5 days. Switching to a single agent analgesia should be considered according to pain intensity and response of the patient.</p>
<p>Undesirable effects may be minimised by using the lowest number of doses for the shortest duration necessary to control symptoms (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><em>Elderly:</em><br>
In elderly patients the starting recommended dosage is one film-coated tablet; additional doses can be taken as needed with the minimum dose interval of 8 hours and not exceeding the total daily dose of 2 film-coated tablets (corresponding to 150 mg of tramadol hydrochloride and 50 mg of dexketoprofen). The dosage may be increased to a maximum of 3 daily film-coated tablets as recommended for the general population only after good general tolerance has been ascertained.<br>
Limited data are available in patients over 75 years, therefore SKUDEXA should be used with caution in these patients (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><em>Hepatic impairment:</em><br>
Patients with mild to moderate hepatic impairment should start therapy at reduced number of doses (total daily dose 2 film-coated tablets SKUDEXA) and be closely monitored.</p>
<p>SKUDEXA should not be used in patients with severe hepatic impairment (see section 4.3).</p>
<p><em>Renal impairment:</em><br>
The initial total daily dosage should be reduced to 2 film-coated tablets SKUDEXA in patients with mildly impaired renal function (creatinine clearance 60 – 89 ml / min) (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>SKUDEXA should not be used in patients with moderate to severe renal impairment (creatinine clearance ≤59 ml / min) (see section 4.3).</p>
<p><em>Paediatric population:</em><br>
The safety and efficacy of SKUDEXA in children and adolescents have not been established. No data are available.<br>
Therefore SKUDEXA should not be used in children and adolescents.</p>
<p><u>Method of administration</u></p>
<p>Oral use.<br>
SKUDEXA should be swallowed with a sufficient amount of fluid (e.g. one glass of water). Concomitant administration with food delays the absorption rate of the drug (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>), for a faster effect the tablets may be taken at least 30 minutes before meals.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1. Therapeutic indications</strong><br>
Symptomatic short term treatment of moderate to severe acute pain in adult patients whose pain is considered to require a combination of tramadol and dexketoprofen.</p>
- Contraindications
- <p><strong>4.3. Contraindications</strong></p>
<p>The contraindications reported for dexketoprofen and tramadol as single agents should be taken into account.</p>
<p>Dexketoprofen must not be administered in the following cases:</p>
<ul>
<li>hypersensitivity to dexketoprofen, to any other NSAID, or to any of the excipients 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>patients in whom substances with a similar action (e.g. acetylsalicylic acid, or other NSAIDs) precipitate attacks of asthma, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioneurotic oedema;</li>
<li>known photoallergic or phototoxic reactions during treatment with ketoprofen or fibrates;</li>
<li>patients with active peptic ulcer/gastrointestinal haemorrhage or any history of gastrointestinal bleeding ulceration or perforation;</li>
<li>patients with history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy;</li>
<li>patients with chronic dyspepsia;</li>
<li>patients who have other active bleedings or bleeding disorders;</li>
<li>patients with Crohn’s disease or ulcerative colitis;</li>
<li>patients with severe heart failure;</li>
<li>patients with moderate to severe renal impairment (creatinine clearance ≤59 ml/min);</li>
<li>patients with severely impaired hepatic function (Child-Pugh C);</li>
<li>patients with haemorrhagic diathesis and other coagulation disorders;</li>
<li>patients with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).</li>
</ul>
<p>Tramadol must not be administered in the following cases:</p>
<ul>
<li>hypersensitivity to tramadol or to any of the excipients 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>in acute intoxication with alcohol, hypnotics, analgesics, opioids or psychotropic medicinal products;</li>
<li>in patients receiving MAO inhibitors, or who have taken them within the last 14 days (see section 4.5 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>);</li>
<li>in patients with epilepsy not adequately controlled by treatment (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>);</li>
<li>Severe respiratory depression.</li>
</ul>
<p>SKUDEXA is contraindicated during pregnancy and lactation (see section 4.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- N02AJ14
- Atc Item Name
- tramadol and dexketoprofen
- Pharma Manufacturer Name
- A. MENARINI SINGAPORE PTE. LTD.
