Tevagen Dexketoprofen 25 mg, 10 coated tablets

Pain of mild to moderate intensity, such as musculoskeletal pain, dysmenorrhoea, odontalgia.

Adults over 18 years of age.

Oral use:

• Adults: 12.5 mg/4-6 h or 25 mg/8 h, not exceeding 75 mg/day.
• Elderly: it is advisable to start with 50 mg daily, and may be increased to the adult dosage once good tolerability has been established.

• Known hypersensitivity to dexketoprofen or allergy to aine.
• Patients with a history of hypersensitivity to acetylsalicylic acid or other NSAIDs, including patients who have experienced asthma attacks, acute rhinitis, urticaria or angioneurotic oedema after use of acetylsalicylic acid or other NSAIDs.
• Gastrointestinal bleeding, oesophageal bleeding, active peptic ulcer, cerebral haemorrhage.
• Renal insufficiency: patients with moderate to severe renal insufficiency (ClCr < 50 ml/min).
• Hepatic insufficiency: patients with severe hepatic dysfunction (Child-Pugh score 10 - 15).
• During the third trimester of pregnancy or lactation.

• Absorption: Rapidly absorbed through the gastrointestinal tract after oral administration, with peak plasma concentration obtained in 0.5-0.75 h (Tmax). Oral absorption is good. Following im administration in humans, Cmax is reached within 20 min (range 10-45 min). For single doses of 25 and 50 mg, the area under the curve has been shown to be dose proportional after im and iv administration.
• Distribution: As with other drugs with high plasma protein binding (99 %), the volume of distribution averages less than 0.25 l/kg and is selectively distributed in the body. The distribution half-life value was approximately 0.35 hours.
• Metabolism: Glucuronoconjugation.
• Elimination: Excreted via the kidneys (80%) in the form of metabolites conjugated with glucuronic acid. After administration of dexketoprofen trometamol, only the S(+) enantiomer is obtained in urine, demonstrating that no conversion to the R-(-) enantiomer occurs in humans. The elimination half-life is 1-2.7 h.

Elderly: in healthy elderly individuals (65 years and older), exposure was significantly higher than in young volunteers after single and repeated doses administered orally (up to 55%), while there were no significant differences in Cmax and tmax. The elimination half-life was prolonged after single and repeated doses (up to 48%) and the apparent total clearance was reduced.

• Acne
• Agranulocytosis
• Anaphylaxis
• Anaemia
• Aplastic anaemia
• Haemolytic anaemia
• Angioedema
• Anorexia
• Asthenia
• Increased serum creatinine
• Increased urea nitrogen
• Increased transaminases
• Muscle cramps
• Headache
• Ketonuria
• Medullary depression
• Dermatitis
• Diarrhoea
• Dyspnoea
• Dyspepsia
• Pain
• Abdominal pain
• Pain at the injection site
• Edema
• Malleolar oedema
• Skin rashes
• Chills
• Bronchial spasm
• Constipation
• Extrasystole
• Glomerulonephritis
• Heat stroke
• Haematemesis
• Gastrointestinal bleeding
• Hepatitis
• Hyperglycaemia
• Hyperhidrosis
• Hyperkalaemia
• Hypertension
• Hypertriglyceridaemia
• Hypoglycaemia
• Hyponatremia
• Hypotension
• Jaundice
• Insomnia
• Acute renal failure
• Respiratory failure
• Low back pain
• Dizziness
• Aseptic meningitis
• Nausea
• Toxic epidermal necrolysis
• Renal medullary necrosis
• Interstitial nephritis
• Neutropenia
• Pancreatitis
• Paresthesia
• Intestinal perforation
• Polyuria
• Proteinuria
• Pruritus
• Purpura
• Photosensitivity reactions
• Joint stiffness
• Muscle stiffness
• Dry mouth
• Syncope
• stevens-johnson syndrome
• Nephrotic syndrome
• Hot flushes
• Drowsiness
• Tachycardia
• Tinnitus
• Menstrual cycle disorders
• Thrombocytopenia
• Thrombophlebitis
• Duodenal ulcer
• Gastric ulcer
• Urticaria
• Blurred vision
• Vomiting

• Renal insufficiency: It is excreted in urine, so accumulation may occur in case of renal insufficiency. In addition, it may lead to decreased renal blood flow with reversible acute renal failure due to inhibition of vasodilator prostaglandin synthesis, and cases of nephrotic syndrome and acute interstitial nephritis have even been reported with prolonged treatment. Patients with a higher risk of renal failure are those with previous renal failure, the elderly or situations that could reduce renal flow, such as hypovolaemia, dehydration, low sodium diets, heart failure, liver failure, liver cirrhosis or treatment with diuretics, ACE inhibitors or ARBs. In high-risk patients, during prolonged treatment, it is recommended to determine renal function (serum creatinine, CrCl) before starting treatment, and periodically. In case of worsening renal function, a dose reduction may be necessary. In patients with mild renal impairment, it is recommended to start treatment with a lower total daily dose, with careful monitoring of the patient. Use in moderate or severe renal impairment (CLcr < 50 ml/min) is contraindicated.
• Hepatic insufficiency: Due to hepatic metabolism, accumulation may occur in hepatic insufficiency. In patients with mild to moderate hepatic impairment (Child-Pugh class A or B), an initial dose of no more than 50 mg/day is recommended, with careful monitoring of the patient. Use in severe insufficiency (class C or Child-Pugh score 10-15) is contraindicated. On the other hand, the use of aine has sometimes been associated with the development of hepatic symptoms, such as increased transaminases, jaundice and hepatitis, which can be severe and even fatal. Due to the risk of toxicity, patients with liver disease are advised to use this drug at the lowest effective dose, and to regularly check liver function (transaminases, bilirubin) for any signs of liver damage.
• Gastrointestinal toxicity: Treatment with aine has resulted in gastroduodenal ulcers, as well as life-threatening bleeding and perforation. There is an increased risk of ulceration with high-dose or long-term treatment, with a history of peptic ulceration, especially if they have already had gastrointestinal bleeding or perforation from aine, as well as in smoking, chronic alcoholism or elderly or debilitated patients. However, short-term treatment is also not without risk.

• Dexketoprofen trometamol: 36.91 mg dexketoprofen trometamol, equivalent to 25 mg dexketoprofen base.
• Maize starch (excipient)
• Potato carboxymethyl starch (E-468) (excipient).

• The patient should inform the doctor if he/she experiences skin rash, symptoms that could be related to a gastroduodenal ulcer (such as epigastric pain or dark stools), visual disturbances, weight gain, oedema or prolonged headache.
• As a general rule to reduce gastric damage, it is advisable to administer any aine with food. In addition, in risk groups it is advisable to start treatment with the lowest possible dose, and whenever possible to combine it with an anti-ulcer drug (anti-H2 or PPI).

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