What is Alti-Sir 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 Alti-Sir?

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

What pharmaceutical form is Alti-Sir available in?

Alti-Sir: Syrop 2,17 g/5 ml (doustna)

Is Alti-Sir OTC or prescription only?

Alti-Sir is available over-the-counter (OTC) — no prescription required.

Does Alti-Sir interact with other medications?

Pharmacodynamic interactions. Corticosteroids. Corticosteroids may increase the risk of GI ulceration or bleeding (see SPECIAL WARNINGS AND PRECAUTIONS FOR USE). Antiplatelet agents and SSRIs. Antiplatelet agents and SSRIs increase the risk of GI 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 patients receiving warfarin o

Who manufactures Alti-Sir?

PPH MICROFARM Kacperski i wspólnicy Spółka jawna (Polska)

What ATC class does Alti-Sir belong to?

Alti-Sir: ATC R05CA05. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Alti-Sir

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

Alti-Sir — Description, Dosage, Side Effects | PillsCard

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 amounts to 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 metabolized in the liver by various pathways, including those involving cytochrome P450 isoenzyme CYP 2C9. Therefore, there is a risk of drug interactions when co-administered with medicinal products metabolized by CYP 2C9 (see INTERACTIONS WITH OTHER MEDICINAL PRODUCTS). The principal 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 rate constant for 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 eliminated primarily via the kidneys (approximately 50% of the administered dose). Only 1–3% is excreted unchanged. Hydroxynimesulide — the principal metabolite — is found exclusively as the glucuronide conjugate. Approximately 29% of the administered dose is excreted in the faeces in metabolized 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 principal metabolite in the plasma of patients was no higher than in healthy volunteers. AUC and T½ in patients with renal impairment were 50% higher but always remained 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 carcinogenic potential did not reveal any particular hazard to humans. In repeated-dose toxicity studies, nimesulide showed gastrointestinal, renal, and hepatic toxicity. In reproductive toxicity studies, when females received doses that were not maternally toxic, embryotoxic and teratogenic effects (skeletal malformations, cerebral ventricular dilatation) were observed in rabbits but not in rats. In rats, increased offspring mortality in the early postnatal period and adverse effects on fertility were observed.

⚠️ Warnings

Adverse reactions can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see DOSAGE AND ADMINISTRATION and gastrointestinal and cardiovascular risks below). If treatment proves ineffective, 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 product. During treatment with nimesulide, concomitant use of hepatotoxic drugs should be avoided and alcohol consumption should be abstained from. The use of NSAIDs may mask fever associated with an underlying bacterial infection. Effects on the liver. Serious hepatic reactions associated with the use of nimesulide have been rarely reported, including very rare cases with fatal outcome (see ADVERSE REACTIONS). Patients who develop symptoms suggestive of liver injury during treatment with nimesulide, such as anorexia, nausea, vomiting, abdominal pain, fatigue, or dark urine, or patients whose liver function test results deviate from normal values, should discontinue therapy. Such patients should not be re-prescribed nimesulide. Liver injury, in most cases reversible, has been reported following short-term exposure to the medicinal product. Patients taking nimesulide who develop fever and/or influenza-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 GI events), which may be fatal, have been reported at any time during treatment with all NSAIDs. The risk of GI bleeding, ulceration, or perforation is increased with higher NSAID doses, in patients with a history of ulcer, particularly if complicated by haemorrhage or perforation (see CONTRAINDICATIONS), and in elderly patients. These patients should commence treatment at the lowest possible dose. For these patients, as well as those requiring concomitant low-dose acetylsalicylic acid or other agents that increase the risk of GI 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 GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding), particularly in the initial stages of treatment. GI bleeding, ulceration, or perforation may occur at any time during treatment, with or without warning symptoms or a previous history of GI events. If GI bleeding or ulceration occurs, nimesulide should be discontinued. Nimesulide should be used with caution in patients with GI disorders, including a history of peptic ulcer, GI bleeding, ulcerative colitis, or Crohn's disease (see ADVERSE REACTIONS). Patients receiving concomitant medications 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 to exercise caution. If GI bleeding or ulceration occurs in patients receiving nimesulide, treatment should be discontinued. NSAIDs should be used with caution in patients with a history of GI disease (ulcerative colitis, Crohn's disease), as exacerbation of these conditions is possible (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 GI disorders. Effects on the cardiovascular and cerebrovascular systems. Patients with a history of hypertension and/or mild to moderate congestive heart failure 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 certain NSAIDs, particularly at high doses and with 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 with nimesulide. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should be treated with nimesulide only after careful assessment. Similar assessment should be undertaken before initiating long-term treatment in patients with cardiovascular risk factors, such as hypertension, hyperlipidaemia, diabetes mellitus, or smoking. Since nimesulide may affect platelet function, it should be used with caution in patients with haemorrhagic diathesis (see also CONTRAINDICATIONS). However, Nimesil cannot substitute acetylsalicylic acid for 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, especially GI bleeding and perforation, which may in some cases 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 these reactions early in the course of therapy; in the majority of cases, onset occurs within the first month of treatment. Nimesulide should be discontinued at the first appearance of skin rash, mucosal lesions, or any other signs of hypersensitivity. Cases of fixed drug eruption (FDE) have been reported with nimesulide use. Nimesulide should not be re-prescribed 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 for 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 the 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 increases from less than 1% to approximately 1.5%. The risk is considered 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, an increased incidence of various foetal malformations, including cardiovascular malformations, was reported in animals receiving a prostaglandin synthesis inhibitor during the period of organogenesis. Use of nimesulide from the 20th week of pregnancy onwards may cause oligohydramnios resulting from foetal renal dysfunction. This may occur shortly after initiation of treatment and is usually reversible upon discontinuation. In addition, cases of foetal ductus arteriosus constriction 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 strictly necessary. If nimesulide is used by 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 prescribed. Antenatal monitoring for oligohydramnios and foetal ductus arteriosus constriction should be considered following nimesulide exposure for several days from gestational week 20 onwards. Pregnant women should discontinue nimesulide if oligohydramnios or foetal ductus arteriosus constriction is detected. In the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to: • pneumocardiac toxic effects (premature constriction/closure of the ductus arteriosus and pulmonary hypertension); • renal dysfunction, which may progress to renal failure with the development of oligohydramnios (see above); The mother at the end of pregnancy and the neonate may experience: • prolongation of bleeding time, an antiplatelet effect that 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 for women attempting to conceive (see SPECIAL WARNINGS AND PRECAUTIONS FOR USE). Women who have difficulty conceiving or are undergoing investigation for infertility should consider discontinuing nimesulide. If pregnancy is established during nimesulide use, the physician should be informed. Children. Nimesil is contraindicated in children under 12 years of age. 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.

Alti-Sir

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