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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Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels If a medicinal product that affects potassium levels is to be prescribed in combination with valsartan, monitoring of potassium plasma levels is advised.

Among secondary endpoints, the incidence of heart failure component of a composite combined cardiovascular endpoint was significantly higher in the amlodipine group as compared to the chlorthalidone group In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan. The antihypertensive effect persists over 24 hours after administration. Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary.

Marketing authorisation number s 9. Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other medicinal products that may increase potassium levels heparin, etc. You should seek advice from your doctor or pharmacist about taking this medicine. A vasoconstrictor may be helpful in restoring vascular tone and blood pressure, provided that there is no contraindication to its use.

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The safety of amlodipine in human pregnancy has not been established.

Exforge HCT 10//25 | healthdirect

At higher exposures, there were ulceration and erosion of the stomach mucosa in both females and males. In elderly packaage, caution is required when increasing the dosage. Correction of this condition prior to administration of Exforge or close medical supervision at the start of treatment is recommended. After oral administration of therapeutic doses of amlodipine alone, peak plasma concentrations of amlodipine are reached in 6—12 hours.

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

No dosage adjustment is required for patients with mild to moderate renal impairment. Plasma concentrations correlate with effect in both young and elderly patients. In most patients, after administration of a single oral dose, onset of antihypertensive activity occurs within 2 hours, and the peak drop in blood pressure is achieved within 4—6 hours. Active ingredient valsartan amlodipine besilate. By continuing to browse the site you are agreeing to our policy on the use of cookies.

Active-controlled trials in patients who were non-responders to monotherapy. Clinical data are insufficient regarding the potential effect of amlodipine on fertility. The way to take this medicine: Co-administration of inhibitors of the uptake transporter rifampicin, ciclosporin or efflux transporter ritonavir may increase the systemic exposure to valsartan.

The safety and efficacy of amlodipine in hypertensive crisis have not been established. Symptoms There is no experience of overdose with Exforge. In one rat study, adverse effects were found on male fertility see section 5.

Somnolence, dizziness, palpitations, abdominal pain, nausea, ankle swelling. Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic insfrt, toxicity to reproduction and development. Over 1, hypertensive patients received Exforge once daily in two placebo-controlled trials.

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Liver function test abnormal, including blood bilirubin increase. Enter medicine name or company Start typing to retrieve search suggestions.

Following oral administration of valsartan alone, peak plasma concentrations of valsartan are reached in 2—4 hours. In two long-term follow-up studies the effect of Exforge was maintained for over one year. CYP3A4 inducers anticonvulsant agents [e.

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Exforge has not been studied in any patient population other than hypertension. Since inserf is no effect on ACE and no potentiation of bradykinin or substance P, angiotensin II antagonists are unlikely to be associated with coughing.

Exforge HCT is indicated ONLY exfrge substitution therapy for the treatment of hypertension in patients whose blood pressure is already adequately controlled on the triple combination of amlodipine, valsartan and hydrochlorothiazide taken either isnert three single component formulations or as dual-component formulation with a single component formulation, all components at the same dose level. Read more on myDr — Consumer Medicine Information website. Insomnia, mood changes including anxietydepression, tremor, dysgeusia, syncope, hypoesthesia, visual disturbance including diplopiatinnitus, hypotension, dyspnoea, rhinitis, vomiting, dyspepsia, alopecia, purpura, skin discolouration, hyperhidrosis, pruritus, exanthema, myalgia, muscle cramps, pain, micturition disorder, increased urinary frequency, impotence, gynaecomastia, chest pain, malaise, weight increase, weight decrease.