SKUDEXA Film-coated tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
Skudexa 75 mg/25 mg film-coated tablets.
2. Qualitative and quantitative composition
<u>Each tablet contains:</u> 75 mg of tramadol hydrochloride and 25 mg of dexketoprofen. <u>Excipients with known effects:</u> each tablet contains 33.07 mg croscarmellose sodium and 1.83 mg sodium stearyl ...
3. Pharmaceutical form
Film-coated tablet. Skudexa: almost white to slightly yellow, oblong, film-coated tablets with a break-mark on one side and a debossed M on the other side. The dimension of the film-coated tablet is ca. ...
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 ...
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, ...
4.4. Special warnings and precautions for use
The special warnings and precautions reported for dexketoprofen and tramadol as single agents should be taken into account. Dexketoprofen Administer with caution in patients with a history of allergic ...
4.5. Interaction with other medicinal products and other forms of interaction
No clinical studies have been performed to evaluate the potential impact of drug-drug interactions on safety profile of Skudexa. However, those reported for dexketoprofen and tramadol as single agents ...
4.6. Fertility, pregnancy and lactation
Pregnancy No cases of pregnancy occurred during the Skudexa clinical development. The safety profile of Skudexa during pregnancy has not been established in the clinical studies included in this section. ...
4.7. Effects on ability to drive and use machines
The effects known for the single components of Skudexa apply to the fixed combination. Dexketoprofen Dexketoprofen has minor or moderate influence on the ability to drive and use machines, due to possible ...
4.8. Undesirable effects
The adverse events at least possibly related reported in the clinical trials performed with Skudexa and the adverse reactions reported in dexketoprofen and tramadol oral formulations SmPCs are tabulated ...
4.9. Overdose
No cases of overdose have been reported in the clinical studies. Data reported for dexketoprofen and tramadol as single agents should be taken into account. Symptoms Dexketoprofen The symptomatology following ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Opioids in combination with non-opioid analgesics <b>ATC code:</b> N02AJ14 Mechanism of action Dexketoprofen is the tromethamine salt of S-(+)-2 - (3-benzoylphenyl)propionic ...
5.2. Pharmacokinetic properties
Concomitant administration of dexketoprofen and tramadol had no effects on the pharmacokinetic parameters of either component in healthy subjects. In normal healthy adults, peak plasma concentrations of ...
5.3. Preclinical safety data
Tramadol hydrochloride-dexketoprofen combination Preclinical data with the combination revealed no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity. ...
6.1. List of excipients
<u>Tablet Core:</u> Microcrystalline cellulose Maize starch, pregelatinised Croscarmellose sodium Sodium stearyl fumarate Silica colloidal, anhydrous <u>Film-coating:</u> Opadry II white 85F18422 composed ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 Years.
6.4. Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light.
6.5. Nature and contents of container
Film-coated tablets are provided in blister packs, in three alternative materials: PA/Aluminium/PVC //Aluminium blister; PVC/PE/PVDC//Aluminium blister; PVC/PVDC//Aluminium blister Skudexa: 2, 4, 10, 15, ...
6.6. Special precautions for disposal and other handling
No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg
8. Marketing authorization number(s)
PL 16239/0041
9. Date of first authorization / renewal of the authorization
02/02/2016
10. Date of revision of the text
December 2022
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