EXFORGE PACKAGE INSERT PDF

EXFORGE PACKAGE INSERT PDF

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June 4, 2020

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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Others In monotherapy with valsartan, no interactions of clinical significance have been found with the exfroge substances: Valsartan has been studied in patients with post myocardial infarction and heart failure. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: By packqge to browse the site you are agreeing to our policy on the use of cookies. Administration of valsartan to patients with hypertension results in a drop in blood pressure without affecting pulse rate.

On average, in patients with mild to moderate chronic liver disease exposure measured by AUC values to valsartan is twice that found in healthy volunteers matched by age, sex and weight.

Liver function test abnormal, including blood bilirubin increase. All changes were considered to be caused by the pharmacological action of valsartan which produces prolonged hypotension, particularly in marmosets. How to take it You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.

Hypertrophy of the renal juxtaglomerular cells was also seen in both species. This information is intended for use by health professionals. Elderly age 65 years or over In elderly patients, caution is required when increasing the dosage.

Paediatric population The safety and efficacy of Exforge in children aged below 18 years have not been established. In haemodynamic studies, amlodipine has not been associated with a negative inotropic effect when administered in the therapeutic dose range to intact animals and humans, even when co-administered with beta blockers to humans. To bookmark exfforge medicine you must sign up and log in.

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Exforge HCT 10//25 | healthdirect

No information is available regarding the use of Efxorge during breast-feeding, therefore Exforge is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.

Renal impairment There are no available clinical data in severely renally impaired patients. Overdose with amlodipine may result in excessive peripheral vasodilation and, possibly, reflex tachycardia. Primary hyperaldosteronism Patients with primary hyperaldosteronism should not be treated with the angiotensin II antagonist valsartan as their renin-angiotensin system is affected by the primary disease. Last updated on eMC: Detailed information on this medicinal product is available on the website of the European Medicines Agency http: Administration of activated charcoal to healthy volunteers immediately or up to two hours after ingestion of amlodipine has been shown to significantly inswrt amlodipine absorption.

In clinical studies in which amlodipine was administered in combination with beta blockers to patients with either hypertension or angina, no adverse effects on electrocardiographic parameters were observed. These decreases in blood pressure are not accompanied by a significant change in heart rate or packwge catecholamine levels with chronic dosing.

You can report side effects packagd your doctor, or directly at www. Valsartan is an orally active, potent and specific angiotensin II receptor antagonist.

EXFORGE &amp EXFORGE HCT

The primary endpoint was a composite of fatal coronary heart disease or non-fatal myocardial infarction. Arrhythmias including bradycardia, ventricular tachycardia, and atrial fibrillation.

Oackage with all other vasodilators, special caution is indicated in patients suffering from mitral stenosis or significant aortic stenosis that is not high grade. Caution should be exercised in patients with liver disease see section 4. ONTARGET was a study conducted in patients with a history of cardiovascular or cerebrovascular disease, or type 2 inserh mellitus accompanied by evidence of end-organ damage.

Monitoring of potassium levels and creatinine is advised in moderate renal impairment. Co-administration of inhibitors of the uptake transporter rifampicin, ciclosporin or efflux transporter ritonavir may increase the systemic exposure to valsartan.

Exforge 5mg/80mg film coated tablets

Healthdirect 24hr 7 days a week hotline 24 hour health advice you can count on The safety and efficacy of amlodipine in hypertensive crisis have not been established. For the full list of excipients, see section 6. Exforge HCT is indicated ONLY as 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 as three single component formulations or as dual-component formulation with a single component formulation, all components at the same dose level.

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However, there was no significant difference in all-cause mortality between amlodipine-based therapy and chlorthalidone-based therapy RR 0. When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started see sections 4.

The major symptom of overdose with valsartan is exforte pronounced hypotension with dizziness. The combination of these substances has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.

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

Fertility There are no clinical studies on fertility with Exforge. Patients with primary hyperaldosteronism should not be treated with the angiotensin II antagonist valsartan as their renin-angiotensin system is affected by the primary disease.

Valsartan Valsartan is an orally active, potent and specific angiotensin II receptor antagonist. In one rat study, adverse effects were found on male fertility see section 5. Individual dose titration with the components i.

If hypotension occurs with Exforge, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. Interactions common to the combination No drug-drug interaction studies have been performed with Exforge and other medicinal products.

Please check and try again Agree to Terms required. The no-observed-effect-level for developmental effects was observed at 3- valsartan and 4- amlodipine fold the clinical exposure based on AUC.