EXFORGE PACKAGE INSERT PDF

controlled with amlodipine 10 mg or valsartan mg alone or with Exforge 5 mg / mg. Exforge . No drug-drug interaction studies have been performed with Exforge and other medicinal products. Read the package leaflet before use. Exforge 5 mg/ mg: 41 Exforge 10 mg/ mg: 42 SH EXF APL JUN15 CL V8 COR FEB17 CL. PATIENT PACKAGE INSERT. EXFORGE is a high blood pressure medication. Learn more about how to * EXFORGE is a CCB/ARB single-pill combination product. It contains 2 prescription.

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No dosage adjustment is required for patients with mild to moderate renal impairment. Steady-state plasma levels are reached after continuous pacmage for 7—8 days. Interactions psckage to valsartan Concomitant use not recommended Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists, including valsartan.

Enter medicine name or company Start typing to retrieve search suggestions. Time to peak plasma amlodipine concentrations is similar in young and elderly patients.

Decrease in haemoglobin, decrease in haematocrit, neutropenia, thrombocytopenia, increase of serum potassium, elevation of liver function values including increase of serum bilirubin, renal failure and impairment, elevation of serum creatinine, angioedema, myalgia, vasculitis, hypersensitivity including serum sickness.

Breast-feeding Amlodipine is excreted in human milk. In a clinical trial of patients with a history of dry cough during ACE inhibitor therapy, Amlodipine is inset in human milk. Not a valid value. Sign Up Log In Cancel. In an embryo-foetal development study in the rat, increased incidences of dilated ureters, malformed sternebrae, and unossified forepaw phalanges were noticed at exposures of about 12 valsartan and 10 amlodipine times the clinical doses of mg valsartan and 10 mg amlodipine.

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The safety and efficacy of Exforge in children aged below 18 years have not been established. For therapeutic doses of valsartan in humans, the hypertrophy of the renal juxtaglomerular cells does not seem to have any relevance.

Administration of valsartan to inserr with hypertension results in a drop in blood pressure without affecting pulse rate. Tabulated list of adverse reactions Adverse reactions have been ranked under headings of frequency using the following convention: Abrupt withdrawal of Exforge packahe not pqckage associated with a rapid increase in blood pressure.

Clinical trial data have shown that dual blockade of the RAAS through the combined use of ACE inhibitors, ARBs or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function including acute renal failure compared to the use of a single RAAS-acting agent see sections 4.

Exforge 5mg/80mg film coated tablets

Amlodipine Reversible biochemical changes in the head of spermatozoa have been reported in some patients treated by calcium channel blockers. Others In monotherapy with valsartan, no interactions of clinical significance have been found with the exfoege substances: There are no available clinical inserg in severely renally impaired patients. As with all other vasodilators, special caution is indicated in patients suffering from mitral stenosis or significant aortic stenosis that is not high grade.

Method of administration Oral use. Placebo-controlled trials Over 1, hypertensive patients received Exforge once daily in two placebo-controlled trials.

Amlodipine does not change sinoatrial nodal function or atrioventricular conduction in intact animals or humans.

Exforge 5mg/80mg film coated tablets – Summary of Product Characteristics (SmPC) – (eMC)

Special populations Paediatric population age below 18 years No pharmacokinetic data are available in the paediatric population. It is Schedule 4: Valsartan is mostly eliminated unchanged via the bile. Abdominal discomfort, abdominal pain upper. Caution should be exercised when administering Exforge to patients with hepatic impairment or biliary obstructive disorders see section 4. Inhibitors of the uptake transporter rifampicin, ciclosporin or efflux transporter ritonavir. Similar outcomes have been reported with valsartan.

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Name of the medicinal product 2.

In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, warfarin or ciclosporin. Non-clinical data reveal packabe special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. Furthermore, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function and an increase in serum potassium.

Exforge HCT 10//25 | healthdirect

Overdose with amlodipine may result in excessive peripheral vasodilation and, possibly, reflex tachycardia. If symptoms persist see your healthcare professional.

Reversible biochemical changes in the head of spermatozoa have been reported in some patients treated by calcium channel blockers. Liver function test abnormal, including blood bilirubin increase.

The half-life of valsartan is 6 hours. Active ingredient valsartan amlodipine besilate. To date there is no experience of the safe use of Exforge in patients who have had a ecforge kidney transplantation.