Pensavital Efg Dexketoprofen 25 Mg, 10 film-coated tablets

• 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 using 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.

Adverse reactions reported as at least possibly related to the administration of dexketoprofen trometamol in clinical trials are tabulated below, classified by organs and systems and ordered according to frequency:

• Alterations of the blood and lymphatic system: rare (0.1-1%): anaemia; very rare / isolated cases (<0.01%): neutropenia, thrombocytopenia.
• Alterations in metabolism and nutrition: rare (0.01-0.1%): hyperglycaemia, hypoglycaemia, hypertriglyceridaemia.
• Nervous system disorders: (0.1-1%): headache, dizziness, insomnia, somnolence; (0.01-0.1%): paraesthesia.
• Ocular disturbances: (0.1-1%): blurred vision.
• Alterations of the ear and labyrinth: (0.01-0.1%): tinnitus.
• Cardiac disturbances: (0.01-0.1%): extrasystoles, tachycardia.
• Vascular disturbances: rare (0.1-1%): hypotension, hot flushes; (0.01-0.1%): arterial hypertension, malleolar oedema, superficial thrombophlebitis.

• Renal insufficiency: It is eliminated in the urine, so accumulation may occur in case of renal insufficiency. In addition, it could lead to a decrease in renal blood flow with reversible acute renal failure due to inhibition of the synthesis of vasodilator prostaglandins, and cases of nephrotic syndrome and acute interstitial nephritis have even been described 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, clcr) 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 insufficiency (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 insufficiency (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.

Pregnancy, lactation and fertility

Do not take DEXKETOPROFEN PENSAVITAL if you are in the last trimester of pregnancy, as this may harm the foetus or cause problems during childbirth. This medicine may cause kidney and heart problems in the developing baby. It may also affect your and your baby's susceptibility to bleeding and cause labour to be delayed or longer than expected. You should not take DEXKETOPROFEN PENSAVITAL during the first 6 months of pregnancy unless absolutely necessary and recommended by your doctor. If you need treatment during this period or while you are trying to become pregnant, you should use the lowest dose for the shortest possible time. From the 20th week of pregnancy, DEXKETOPROFEN PENSAVITAL may cause kidney problems in the unborn baby if taken for more than a few days, which may lead to low levels of the amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional check-ups.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine, as DEXKETOPROPHEN PENSAVITAL may not be suitable for you.

DEXKETOPROFEN PENSAVITAL should be avoided in women who are planning pregnancy or who are already pregnant. Treatment at any time during pregnancy should be carried out only as directed by a doctor.

The use of DEXKETOPROFEN PENSAVITAL is not recommended during attempts to conceive or during infertility studies.

Active substance: 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 his doctor if he 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 groups at risk, it is advisable to start treatment with the lowest possible dose, and to add an anti-ulcer drug (anti-H2 or PPI) whenever possible.

The price of non-prescription medicines is set by law. However, at farmaciasdirect you can buy pensavital efg dexketoprofen 25 mg, 10 coated tablets at a discount of up to 10%, which is the legal maximum allowed.