SKUDEXA FILM-COATED TABLET 75 MG/25 MG [SIN15394P]

Product Info

SKUDEXA FILM-COATED TABLET 75 MG/25 MG

[SIN15394P]

4.1. Therapeutic indications
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.

4.2. Posology and method of administration

Posology

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).
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.

Undesirable effects may be minimised by using the lowest number of doses for the shortest duration necessary to control symptoms (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Elderly:
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.
Limited data are available in patients over 75 years, therefore SKUDEXA should be used with caution in these patients (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment:
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.

SKUDEXA should not be used in patients with severe hepatic impairment (see section 4.3).

Renal impairment:
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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

SKUDEXA should not be used in patients with moderate to severe renal impairment (creatinine clearance ≤59 ml / min) (see section 4.3).

Paediatric population:
The safety and efficacy of SKUDEXA in children and adolescents have not been established. No data are available.
Therefore SKUDEXA should not be used in children and adolescents.

Method of administration

Oral use.
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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), for a faster effect the tablets may be taken at least 30 minutes before meals.

4.3. Contraindications

The contraindications reported for dexketoprofen and tramadol as single agents should be taken into account.

Dexketoprofen must not be administered in the following cases:

• hypersensitivity to dexketoprofen, to any other NSAID, or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information;

• 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;

• known photoallergic or phototoxic reactions during treatment with ketoprofen or fibrates;

• patients with active peptic ulcer/gastrointestinal haemorrhage or any history of gastrointestinal bleeding ulceration or perforation;

• patients with history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy;

• patients with chronic dyspepsia;

• patients who have other active bleedings or bleeding disorders;

• patients with Crohn’s disease or ulcerative colitis;

• patients with severe heart failure;

• patients with moderate to severe renal impairment (creatinine clearance ≤59 ml/min);

• patients with severely impaired hepatic function (Child-Pugh C);

• patients with haemorrhagic diathesis and other coagulation disorders;

• patients with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).

Tramadol must not be administered in the following cases:

• hypersensitivity to tramadol or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information;

• in acute intoxication with alcohol, hypnotics, analgesics, opioids or psychotropic medicinal products;

• in patients receiving MAO inhibitors, or who have taken them within the last 14 days (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information);

• in patients with epilepsy not adequately controlled by treatment (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information);

• Severe respiratory depression.

SKUDEXA is contraindicated during pregnancy and lactation (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).