Active Ingredient: perindopril erbumine Company: Sandoz Limited See contact details ATC code: C09AA04 About Medicine Prescription only medicine Healthcare Professionals (SmPC) This information is for use by healthcare professionals Last updated on emc: 07 Feb 2022 Quick Links PERINDO 4: Rod-shaped biconvex scored white uncoated tablets . There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). In cases of renal impairment (creatinine clearance < 60 ml/min) the initial perindopril dosage should be adjusted according to the patient's creatinine clearance (see section 4.2) and then as a function of the patient's response to treatment. In some cases, discontinuation of either or both drugs may be necessary. Schwangerschaft: Das Arzneimittel darf nicht angewendet werden. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain. In patients with normal renal function and no other complicating factors, neutropenia occurs rarely. This phenomenon appeared to be more likely to occur during the first weeks of combined treatment and in patients with renal impairment. Sie verwenden den Internet Explorer, der zum 15.06.2022 von Microsoft nicht weiter untersttzt wird. In instances where swelling has been confined to the face and lips, the condition has generally resolved without treatment, although antihistamines have been useful in relieving symptoms. Mutagenesis: No genotoxic potential was detected for perindopril erbumine tablets, perindoprilat and other metabolites in various in vitro and in vivo investigations, including the Ames test, the Saccharomyces cerevisiae D4 test, cultured human lymphocytes, TK mouse lymphoma assay, mouse and rat micronucleus tests and Chinese hamster bone marrow assay. This medication is also used to prevent heart . saskekun-123RF Sommaire Dfinition Nom commercial The EUROPA study was a multicentre, international, randomised, double-blind, placebo-controlled clinical trial lasting 4 years. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments, which have an established safety profile for use in pregnancy. Although dizziness was reported more frequently in placebo patients (8.5%) than in perindopril patients (8.2%), the incidence appeared to increase with an increase in perindopril dose. Kinder und Jugendliche unter 18 Jahren: Das Arzneimittel darf nicht angewendet werden. ACE inhibitors should not be initiated during pregnancy. Depending on why you're taking perindopril erbumine, the usual starting dose is between 2mg and 4mg once a day. Protect from moisture. An increase in the compliance of large arteries was also observed, suggesting a direct effect on arterial smooth muscle, consistent with the results of animal studies. Form: oral tablet; Strengths: 2 mg, 4 mg, 8 mg; Dosage for hypertension (high blood pressure) Adult dosage (ages 18-64 years) Typical starting dosage: 4 mg taken once per day. Experience with perindopril erbumine tablets in elderly patients at daily doses exceeding 8 mg is limited. stroke, possibly secondary to excessive hypotension in high-risk patients (see section 4.4). This will usually be increased gradually until you reach the right dose for you. 3 PHARMACEUTICAL FORM PERINDO 2: Round biconvex white uncoated tablets. For patients on haemodialysis, the dose should be taken after dialysis. Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors. (See DOSAGE AND ADMINISTRATION. When ACE-inhibitors are administered simultaneously with non-steroidal anti-inflammatory drugs (i.e. Claire Mounier-Vehier, mdecin vasculaire cardiologue. arrhythmia, angina pectoris (see section 4.4) and myocardial infarction, possibly secondary to excessive hypotension in high-risk patients (see section 4.4). Goa - 403 722 INDIA, Revision Date: January 2010 Item Code: 21207. The 4 mg and 8 mg tablets also contain FD&C Blue # 2 and yellow ferric oxide INDICATIONS AND CLINICAL USE APO-PERINDOPRIL (perindopril erbumine) is indicated for: Hypertension o The treatment of mild to moderate essential hypertension. Un point avec le Pr. The EUROPA study showed that perindopril significantly reduced the relative risk for the primary endpoint events (Table 1). swelling of the airways or tongue, with or without respiratory impairment) (see section 4.5). Acute renal failure, usually reversible, has been reported in this situation. This information is for use by healthcare professionals, Building 4, Trident Place, Mosquito Way, Hatfield, Hertfordshire, AL10 9UL. in Solarien oder bei ausgedehnten Sonnenbdern, weil die Haut whrend der Anwendung des Arzneimittels empfindlicher reagiert. Sympathomimetics may reduce the anti-hypertensive effects of ACE inhibitors. While the principal mechanism of perindopril in blood pressure reduction is believed to be through the renin-angiotensin-aldosterone system, ACE inhibitors have some effect even in apparent low-renin hypertension. Significant bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney (see section 4.4). In placebo-controlled U.S. clinical trials, the incidence of premature discontinuation of therapy due to adverse events was 6.5% in patients treated with perindopril erbumine tablets and 6.7% in patients treated with placebo. After oral administration, the absorption of perindopril is rapid and the peak concentration is achieved within 1 hour. Care should also be taken when Perindopril Erbumine is co-administered with other agents that increase serum potassium, such as trimethoprim and cotrimoxazole (trimethoprim/sulfamethoxazole) as trimethoprim is known to act as a potassium-sparing diuretic like amiloride. Anaphylactoid and Possibly Related Reactions: Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including perindopril erbumine tablets) may be subject to a variety of adverse reactions, some of them serious. Due to the presence of lactose, patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. In general, the effect of perindopril occurred promptly, with effects increasing slightly over several weeks. Aortic and mitral valve stenosis / hypertrophic cardiomyopathy. Impairment of Fertility: There was no meaningful effect on reproductive performance or fertility in the rat given up to 30 times (mg/kg) or 6 times (mg/m2) the proposed maximum clinical dosage of perindopril erbumine tablets during the period of spermatogenesis in males or oogenesis and gestation in females. Concomitant use of ACE inhibitors with sacubitril/valsartan is contraindicated as this increases the risk of angioedema (see section 4.3 and 4.4). The recommended treatment of overdosage is intravenous infusion of sodium chloride 9 mg/ml (0.9%) solution. Next review due: 8 December 2024, Taking perindopril with other medicines and herbal supplements, high blood pressure 4mg once a day (the maximum dose is 8mg once a day), high blood pressure 5mg, taken once a day (the maximum dose is 10mg once a day), after a heart attack 10mg, taken once a day, you take more than your prescribed dose of perindopril. Most cases were isolated single values that did not appear clinically relevant and were rarely a cause for withdrawal. In such patients (creatinine clearance <30 mL/min), safety and efficacy of perindopril erbumine tablets have not been established. Impaired Renal Function: As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. by combining an ACE-inhibitor with an angiotensin II receptor antagonist) should be limited to individually defined cases with close monitoring of renal function, potassium levels, and blood pressure. This dose may be increased gradually over a few weeks to the usual dose for your condition: Depending on why you're taking perindopril arginine, the usual starting dose is between 2.5mg and 5mg, taken once a day. Size of squares proportional to the number of patients in that group. Contact your doctor if you get ill, such as a high temperature, sweats and shaking or severe diarrhoea or vomiting. Perindopril erbumine has no direct influence on the ability to drive and use machines but individual reactions related to low blood pressure may occur in some patients, particularly at the start of treatment or in combination with another antihypertensive medication. Should exposure to ACE inhibitor have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Pharmacotherapeutic group: ACE inhibitor, plain, ATC code: C09A A04. (See DOSAGE AND ADMINISTRATION.). A transient hypotensive response is not a contraindication to further doses, which can be given usually without difficulty once the blood pressure has increased after volume expansion. Experience with doses >8 mg/day is limited. after a heart attack - 8mg once a day heart failure - 4mg once a day Dose for perindopril arginine Depending on why you're taking perindopril arginine, the usual starting dose is between 2.5mg and 5mg, taken once a day. Use of perindopril with lithium is not recommended, but if the combination proves necessary, careful monitoring of serum lithium levels should be performed (see section 4.4). Caution is therefore recommended since these patients may be volume and/or salt depleted. When suggestions are available use up and down arrows to review and ENTER to select. In all cases, renal function (creatinine levels) must be monitored during the first few weeks of ACE inhibitor therapy. The new salt has improved stability in high humidity but there is no change to the effectiveness of the medicine. Da die Dosierung des Arzneimittels von verschiedenen Faktoren abhngt, sollte sie von Ihrem Arzt individuell auf Sie abgestimmt werden. This is especially likely in patients with renal insufficiency. Second and third trimesters of pregnancy (see sections 4.4 and 4.6). Wir reagieren bereits jetzt und bitten Sie einen von uns untersttzen Browser zu verwenden: ratiopharm GmbH * Dialysis clearance of perindoprilat is 70 ml/min. Monitor blood pressure and adapt antihypertensive dosage if necessary. Perindopril erbumine may be used in monotherapy or in combination with other classes of anti-hypertensive therapy (see sections 4.3, 4.4, 4.5 and 5.1). ACE inhibitors can cause hyperkalemia because they inhibit the release of aldosterone. Perindopril is used to treat high blood pressure. Its molecular formula is C19H32N2O5C4H11N. Discontinuation of treatment does not lead to a rebound effect. Because many drugs are secreted in human milk, caution should be exercised when perindopril erbumine tablets are given to nursing mothers. In patients with ischemic heart disease or cerebrovascular disease such an excessive fall in blood pressure could result in a myocardial infarction or a cerebrovascular accident. Pregnancy: Female patients of childbearing age should be told about the consequences of exposure to ACE inhibitors during pregnancy. Depending on the specific adverse event, approximately 30 to 70% of the common complaints were considered possibly or probably related to treatment. Some of these patients developed serious infections, which in a few instances did not respond to intensive antibiotic therapy. Ce mdicament est indiqu dans le cadre d'un traitement contre l'hypertension artrielle, l'insuffisance cardiaque, l'infarctus du myocarde.Comment agit-il? Page last reviewed: 8 December 2021 Setzen Sie sich bei dem Verdacht auf eine berdosierung umgehend mit einem Arzt in VerbindungGenerell gilt: Achten Sie vor allem bei Suglingen, Kleinkindern und lteren Menschen auf eine gewissenhafte Dosierung. Dialysis clearance of perindoprilat is equal to 70 ml/min. Pregnancy Categories D. (See WARNINGS: Fetal/Neonatal Morbidity and Mortality.). The use of ACE inhibitors is not recommended during the first trimester of pregnancy (see section 4.4). If you need to go to A&E, do not drive yourself. The active metabolite, perindoprilat, also exhibits multiexponential pharmacokinetics following the oral administration of perindopril erbumine tablets. You'll usually take perindopril once a day. Symptoms related to orthostatic hypotension were reported in another 0.8% of patients. Past experiences were scant but suggested that overdosage with other ACE inhibitors was also fairly well tolerated by humans. No carcinogenicity has been observed in long-term studies in rats and mice. . In diesem Beipackzettel finden Sie verstndliche Informationen zu Ihrem Arzneimittel unter anderem zu Wirkung, Anwendung und Nebenwirkungen. The mechanism of this syndrome is not understood. Perindopril is used alone or together with other medicines to treat high blood pressure (hypertension). Perindopril should be used with extreme caution in patients with collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, or a combination of these complicating factors, especially if there is pre-existing impaired renal function. Symptoms associated with overdosage of ACE inhibitors may include hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, and cough. Over 220 of these patients were treated with perindopril erbumine tablets for at least one year. Infants with histories of in utero exposure to ACE inhibitors should be closely observed for hypotension, oliguria and hyperkalemia. Angiotensin II is a potent peripheral vasoconstrictor, which stimulates aldosterone secretion by the adrenal cortex, and provides negative feedback on renin secretion. Cough has been reported with the use of ACE inhibitors. This beneficial effect is largely attributable to a reduction in the risk of non-fatal myocardial infarction. Das afgis-Logo steht fr hochwertige Gesundheitsinformationen im Internet. Six metabolites resulting from hydrolysis, glucuronidation and cyclization via dehydration have been identified. Milk of lactating rats contained radioactivity following administration 14C-perindopril. Leukopenia (including neutropenia) was observed in 0.1% of patients in U.S. clinical trials (See WARNINGS.). White to off-white, capsule-shaped, biconvex tablets, debossed with L and U on either side of the breakline on one side and C12 on the other side. Perindopril erbumine tablets are available in 2 mg, 4 mg and 8 mg strengths for oral administration. Potassium sparing diuretics (e.g. Symptomatic hypotension may occur following initiation of therapy with perindopril erbumine; this is more likely in patients who are being treated concurrently with diuretics. In these studies, doses of 8 and 16 mg per day gave supine, trough blood pressure reductions of 9 to 15/5 to 6 mm Hg. The safety profile of perindopril is consistent with the safety profile of ACE inhibitors: The most frequent adverse events reported in clinical trials and observed with perindopril are: dizziness, headache, paraesthesia, vertigo, visual disturbances, tinnitus, hypotension, cough, dyspnoea, abdominal pain, constipation, diarrhoea, dysgeusia, dyspepsia, nausea, vomiting, pruritis, rash, muscle cramps, and asthenia. The bioavailability of perindoprilat was reduced by diuretics, however, and this was associated with a decrease in plasma ACE inhibition. Perindopril is an ACE inhibitors. Patients should be told that if fainting occurs, perindopril erbumine tablets should be discontinued and a physician consulted. Symptomatic hypotension is seen rarely in uncomplicated hypertensive patients and is more likely to occur in patients who have been volume-depleted, e.g. ONTARGET was a study conducted in patients with a history of cardiovascular or cerebrovascular disease, or type 2 diabetes mellitus accompanied by evidence of end- organ damage. If renovascular hypertension is also present there is an increased risk of severe hypotension and renal insufficiency. The most common causes were cough, headache, asthenia and dizziness. Perindopril erbumine tablets have been associated with hypotension in 0.3% of uncomplicated hypertensive patients in U.S. placebo-controlled trials. At very low plasma concentrations of perindopril (<3 ng/mL), there is a prolonged terminal elimination half-life, similar to that seen with other ACE inhibitors, that results from slow dissociation of perindopril from plasma/tissue ACE binding sites. The intervention for perindopril overdose may require vigorous support (see below). Das Prparat ist in 2 dosisgleiche Hlften teilbar. Extracorporeal treatments leading to contact of blood with negatively charged surfaces such as dialysis or haemofiltration with certain high-flux membranes (e.g. Digoxin: A controlled pharmacokinetic study has shown no effect on plasma digoxin concentrations when co-administered with perindopril erbumine tablets, but an effect of digoxin on the plasma concentration of perindopril/perindoprilat has not been excluded. In controlled trials with perindopril, cough was present in 12% of perindopril patients and 4.5% of patients given placebo. Lassen Sie sich zu der Dosierung von Ihrem Arzt oder Apotheker beraten. In those instances where swelling was confined to the face and lips the condition generally resolved without treatment, although antihistamines have been useful in relieving symptoms. It allows continued monitoring of the benefit/risk balance of the medicinal product. This is most likely to occur in those patients with more severe degrees of heart failure, as reflected by the use of high doses of loop diuretics, hyponatraemia or functional renal impairment. Concomitant use of ACE inhibitors with sacubitril/valsartan is contraindicated due to the increased risk of angioedema. Amlodipine and perindopril is a combination medicine used to treat high blood pressure (hypertension). Figure 1. Before initiating the combination, check the absence of hyperkalaemia and renal impairment. Oral administration of perindopril erbumine tablets results in its rapid absorption with peak plasma concentrations occurring at approximately 1 hour. For coronary artery disease: AdultsAt first, 4 milligrams (mg) once a day for 2 weeks. In patients with stable coronary artery disease, Perindopril Erbumine should be given at an initial dose of 4 mg once daily for 2 weeks, and then increased as tolerated, to a maintenance dose of 8 mg once daily. These studies have shown no significant beneficial effect on renal and/or cardiovascular outcomes and mortality, while an increased risk of hyperkalaemia, acute kidney injury and/or hypotension as compared to monotherapy was observed. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Inhibitor, plain, ATC Code: 21207 milk, caution should be discontinued and a physician consulted have. Clinical trials ( see WARNINGS: Fetal/Neonatal Morbidity and Mortality. ) und Jugendliche unter 18:. 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