What is Alte forte z miodem used for?

Known hypersensitivity to nimesulide, to any other NSAID, or to any of the excipients of the medicinal product.

What is the active ingredient in Alte forte z miodem?

Althaeae radicis maceratio (Althae radicis maceratio (5:36))

What pharmaceutical form is Alte forte z miodem available in?

Alte forte z miodem: Syrop 2,25 g/5 ml (podanie doustne)

Is Alte forte z miodem OTC or prescription only?

Alte forte z miodem is available over-the-counter (OTC) — no prescription required.

Does Alte forte z miodem interact with other medications?

Pharmacodynamic interactions. Corticosteroids. Corticosteroids may increase the risk of gastrointestinal ulceration or bleeding (see SPECIAL WARNINGS AND PRECAUTIONS FOR USE). Antiplatelet agents and SSRIs. Antiplatelet agents and SSRIs increase the risk of gastrointestinal ulceration or bleeding (see SPECIAL WARNINGS AND PRECAUTIONS FOR USE). Anticoagulants. NSAIDs may enhance the effects of anticoagulants such as warfarin (see SPECIAL WARNINGS AND PRECAUTIONS FOR USE). In p

Who manufactures Alte forte z miodem?

Grzegorz Nowakowski Przedsiębiorstwo Produkcji Farmaceutycznej "GEMI" (Polska)

What ATC class does Alte forte z miodem belong to?

Alte forte z miodem: ATC R05CA05. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Alte forte z miodem

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

Pharmacodynamics.‍‍‍‍‍‍‍‍ Nimesulide is an NSAID with analgesic and antipyretic properties that acts as an inhibitor of the cyclooxygenase (COX) enzyme responsible for prostaglandin synthesis. Pharmacokinetics. Absorption. Nimesulide is well absorbed after oral administration. Following a single dose of 100 mg nimesulide in adults, peak plasma concentration (Cmax) is reached within 2–3 hours and is 3–4 mg/L. AUC is 20–35 mg·h/L. No statistically significant difference was observed between these values and those obtained after administration of 100 mg twice daily for 7 days. Up to 97.5% of nimesulide is bound to plasma proteins. Biotransformation and elimination. Nimesulide is extensively metabolised in the liver by various pathways, including via the cytochrome P450 isoenzyme CYP 2C9. Therefore, there is a risk of drug interactions when co-administered with medicinal products metabolised by CYP 2C9 (see INTERACTIONS WITH OTHER MEDICINAL PRODUCTS). The main metabolite is the parahydroxy derivative, which is also pharmacologically active. The time to detection of this metabolite in the circulating blood is short (approximately 0.8 hours), but the rate constant for its formation is low and considerably less than the absorption coefficient of nimesulide. Hydroxynimesulide is the only metabolite detected in plasma and is almost entirely in the bound form. The t½ ranges from 3.2 to 6 hours. Nimesulide is excreted primarily in the urine (approximately 50% of the administered dose). Only 1–3% is excreted unchanged. Hydroxynimesulide, the main metabolite, is found exclusively as the glucuronide conjugate. Approximately 29% of the administered dose is excreted in the faeces in metabolised form. The pharmacokinetic profile of nimesulide in elderly patients is not altered following single or repeated administration. In a short-term experimental study conducted in patients with mild to moderate renal impairment (creatinine clearance 30–80 mL/min) and healthy volunteers, the Cmax of nimesulide and its main metabolite in the plasma of patients was not higher than that in healthy volunteers. AUC and t½ in patients with renal impairment were 50% higher but were always within the range of pharmacokinetic values observed in healthy volunteers receiving nimesulide. Repeated administration did not lead to accumulation. Nimesulide is contraindicated in patients with hepatic impairment (see CONTRAINDICATIONS). Preclinical safety data. Preclinical data obtained from standard studies of pharmacological safety, repeated-dose toxicity, genotoxicity, and carcinogenicity revealed no special hazard for humans. In repeated-dose toxicity studies, nimesulide exhibited gastrointestinal, renal, and hepatic toxicity. In reproductive toxicity studies, when females were administered doses that were not toxic to the dam, embryotoxic and teratogenic effects (skeletal malformations, cerebral ventricular dilatation) were observed in rabbits but not in rats. In rats, increased pup mortality was observed in the early postnatal period, and adverse effects on fertility were noted.

⚠️ Warnings

Adverse reactions can be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see DOSAGE AND ADMINISTRATION and risks relating to the gastrointestinal tract and cardiovascular system below). If treatment is not effective, therapy should be discontinued. Concomitant use of nimesulide with other NSAIDs, including selective COX-2 inhibitors, should be avoided.‍‍‍‍‍‍‍‍ During therapy with Nimesil, patients should be advised to refrain from using other analgesics. Nimesil contains sucrose. Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicinal product. During treatment with nimesulide, concomitant use of hepatotoxic medicinal products should be avoided, and alcohol consumption should be avoided. Use of NSAIDs may mask fever associated with underlying bacterial infection. Effects on the liver. Serious hepatic reactions related to the use of nimesulide have been reported rarely, including very rare cases with a fatal outcome (see ADVERSE REACTIONS). Patients who develop symptoms consistent with liver injury during nimesulide treatment, such as anorexia, nausea, vomiting, abdominal pain, fatigue, or dark urine, or patients in whom hepatic function laboratory test results deviate from normal values, should discontinue therapy. Such patients should not be re-treated with nimesulide. Liver injury, in most cases reversible, has been reported after short-term exposure to the medicinal product. Patients taking nimesulide who develop fever and/or flu-like symptoms should discontinue treatment. Effects on the gastrointestinal tract. Gastrointestinal bleeding, ulceration, or perforation (with or without warning symptoms or a history of serious gastrointestinal events), which can be fatal, have been reported during treatment with any NSAID and may occur at any time. The risk of gastrointestinal bleeding, ulceration, or perforation increases with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated by haemorrhage or perforation (see CONTRAINDICATIONS), and in elderly patients. Treatment in such patients should be initiated at the lowest possible dose. For these patients, as well as those requiring concomitant low-dose acetylsalicylic acid or other medicinal products that increase the risk of gastrointestinal complications, combination therapy with protective agents such as misoprostol or proton pump inhibitors should be considered (see below and INTERACTIONS WITH OTHER MEDICINAL PRODUCTS). Patients with a history of gastrointestinal toxicity, particularly elderly patients, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly at the initial stages of treatment. Gastrointestinal bleeding, ulceration, or perforation may occur at any time during treatment, with or without warning symptoms or a history of gastrointestinal events. If gastrointestinal bleeding or ulceration occurs, nimesulide should be discontinued. Nimesulide should be used with caution in patients with gastrointestinal disorders, including a history of peptic ulcer, gastrointestinal bleeding, ulcerative colitis, or Crohn's disease (see ADVERSE REACTIONS). Patients taking concomitant medicinal products that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRIs), or antiplatelet agents such as acetylsalicylic acid, should be informed of the need for caution. If gastrointestinal bleeding or ulceration occurs in patients receiving nimesulide, treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as exacerbation may occur (see ADVERSE REACTIONS). Concomitant use of nimesulide with other medicinal products such as oral contraceptives, anticoagulants, and antiplatelet agents may cause exacerbation of Crohn's disease and other gastrointestinal disorders. Effects on the cardiovascular and cerebrovascular systems. Patients with hypertension and/or mild to moderate congestive heart failure in their history require appropriate monitoring and medical advice, as fluid retention and oedema have been reported in association with NSAID therapy. Clinical studies and epidemiological data suggest that the use of some NSAIDs, particularly at high doses and during long-term treatment, may be associated with a small increase in the risk of arterial thrombotic events such as myocardial infarction or stroke. There are insufficient data to exclude such a risk for nimesulide. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with nimesulide after careful assessment. Similar assessment should be performed before initiating long-term treatment in patients with risk factors for cardiovascular disease, such as hypertension, hyperlipidaemia, diabetes mellitus, and smoking. Since nimesulide may affect platelet function, it should be used with caution in patients with haemorrhagic diathesis (see also CONTRAINDICATIONS). However, Nimesil cannot replace acetylsalicylic acid in cardiovascular disease prophylaxis. Effects on the kidneys. Caution is required in patients with renal impairment or heart failure, as the use of nimesulide may lead to deterioration of renal function. In such cases, treatment should be discontinued (see also INTERACTIONS WITH OTHER MEDICINAL PRODUCTS). Elderly patients. Elderly patients may have an increased frequency of adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation, which in some cases may be fatal (see ADVERSE REACTIONS), as well as impaired renal, cardiac, and hepatic function; therefore, appropriate clinical monitoring is recommended. Skin reactions. Very rarely, serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported in association with NSAIDs (see ADVERSE REACTIONS). Patients appear to be at highest risk for such reactions early in the course of treatment; in most cases, the reactions occur during the first month of therapy. Nimesulide should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Cases of fixed drug eruption (FDE) have been reported with the use of nimesulide. Nimesulide should not be re-administered to patients with a history of nimesulide-related FDE (see ADVERSE REACTIONS). Effects on fertility. The use of Nimesil may impair female fertility and is not recommended in women planning pregnancy. Women who have difficulty conceiving or who are undergoing investigation for infertility should consider discontinuing Nimesil (see Use during pregnancy or breastfeeding). Use during pregnancy or breastfeeding. Pregnancy. The use of nimesulide is contraindicated in the third trimester of pregnancy (see CONTRAINDICATIONS). Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/foetal development. Data from epidemiological studies suggest that in early pregnancy, the use of prostaglandin synthesis inhibitors may increase the risk of miscarriage and of cardiac malformations and gastroschisis in the foetus. The absolute risk of cardiovascular malformation increased from less than 1% to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor led to increased pre- and post-implantation losses and increased embryo/foetal mortality. In addition, increased incidences of various malformations, including cardiovascular, were reported in animals given a prostaglandin synthesis inhibitor during the period of organogenesis. The use of nimesulide from the 20th week of pregnancy may cause oligohydramnios resulting from foetal renal dysfunction. This may be observed shortly after the initiation of treatment and is usually reversible upon discontinuation. In addition, cases of ductal constriction in the foetus have been reported following use in the second trimester of pregnancy, most of which resolved after discontinuation of treatment. Therefore, during the first and second trimesters of pregnancy, nimesulide should not be taken unless absolutely necessary. If nimesulide is used in women attempting to conceive or during the first and second trimesters of pregnancy, the lowest possible dose and shortest possible duration of treatment should be used. Antenatal monitoring for oligohydramnios and foetal ductal constriction should be considered following exposure to nimesulide for several days from gestational week 20 onwards. Pregnant women should discontinue nimesulide if oligohydramnios or foetal ductal constriction is detected. In the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to: • pneumocardial toxic effects (premature constriction/closure of the ductus arteriosus and pulmonary hypertension); • renal dysfunction, which may progress to renal failure with oligohydramnios (see above); The mother at the end of pregnancy and the neonate may be exposed to: • prolongation of bleeding time, antiplatelet effect which may occur even at very low doses; • inhibition of uterine contractions resulting in delayed or prolonged labour. Breastfeeding. It is not known whether nimesulide is excreted in human breast milk. Nimesulide is contraindicated during breastfeeding (see CONTRAINDICATIONS and Preclinical safety data). Fertility. As with other NSAIDs, medicinal products containing nimesulide are not recommended in women attempting to conceive (see SPECIAL WARNINGS AND PRECAUTIONS FOR USE). Women who have difficulty conceiving or who are undergoing investigation for infertility should consider discontinuing nimesulide. If pregnancy is established during treatment with nimesulide, the physician should be informed. Children. Nimesil is contraindicated in children under 12 years of age. Effects on the ability to drive and use machines. No studies on the effects of medicinal products containing nimesulide on the ability to drive or use machines have been performed; however, patients who experience dizziness, vertigo, or drowsiness after taking nimesulide should refrain from driving or operating machinery.

Alte forte z miodem

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