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.

Author: Zulkree Meztizahn
Country: Mozambique
Language: English (Spanish)
Genre: History
Published (Last): 24 October 2009
Pages: 296
PDF File Size: 17.19 Mb
ePub File Size: 5.34 Mb
ISBN: 900-8-44900-957-3
Downloads: 30736
Price: Free* [*Free Regsitration Required]
Uploader: Vimi

Inhibitors of the uptake transporter rifampicin, ciclosporin or efflux transporter ritonavir. Treatment can be continued once blood pressure has been stabilised. Similar changes were found in the valsartan alone group exposure 8.

Read more on myDr — Consumer Medicine Information insery. Posology The recommended dose of Exforge is one tablet per day. Qualitative and quantitative composition 3.

Please check and try again Agree to Terms required. Commonly used antihypertensive agents e.

Healthdirect 24hr 7 days a week hotline

Valsartan Valsartan is oackage orally active, potent and specific angiotensin II receptor antagonist. Concomitant use of amlodipine with apckage or moderate CYP3A4 inhibitors protease inhibitors, azole antifungals, macrolides like erythromycin or clarithromycin, verapamil or diltiazem may give rise to significant increase in amlodipine exposure.

Tabulated list of adverse reactions Adverse reactions have been ranked under headings of frequency using the following convention: There are no available clinical data in severely renally impaired patients. There is a total of 5 error s on this form, details are below.

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

In vitro studies with amlodipine have shown that approximately Healthdirect Australia is not responsible for the content and advertising on the external website you are now entering. In two long-term follow-up studies the effect of Exforge was maintained for over one year. Abrupt withdrawal of valsartan has not been associated with rebound hypertension or other adverse clinical events. Furthermore, concomitant use of angiotensin II ppackage and NSAIDs may lead to an increased risk of worsening of renal function and an increase in serum potassium.

  BOSCH LHM 0606 PDF

This reduction in AUC is not, however, accompanied by a clinically significant reduction in the therapeutic effect, and valsartan can therefore be given either with or without food.

Carcinogenesis, mutagenesis Rats and mice treated with amlodipine in the diet for two years, at concentrations calculated to provide daily dosage levels of 0. Treatment If ingestion is recent, induction of vomiting or gastric lavage may be considered. At higher exposures, there were ulceration and erosion of the stomach mucosa in both females and males.

Interactions linked to amlodipine Concomitant use not recommended Grapefruit or grapefruit juice Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients, resulting in increased blood pressure lowering effects.

Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other medicinal products that may inserrt potassium levels heparin, etc. In animals, lethal ventricular fibrillation and cardiovascular collapse are observed in association with hyperkalaemia after administration of verapamil and intravenous dantrolene.

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. Amlodipine is excreted in human milk. Following oral administration of valsartan alone, peak plasma concentrations of valsartan are reached in 2—4 hours. For the single compounds there was no evidence of mutagenicity, clastogenicity or carcinogenicity.

In a long-term, placebo-controlled study PRAISE-2 of amlodipine in patients with NYHA New York Heart Association Classification III and IV heart failure of non-ischaemic aetiology, amlodipine was associated packagr increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo.

  MANUAL DE OBSERVAO PSICOMOTORA VITOR DA FONSECA PDF

Overdose exforve amlodipine may result in excessive peripheral vasodilation and, possibly, reflex tachycardia.

High Blood Pressure Medication | EXFORGE & EXFORGE HCT

Co-administration of inhibitors of the uptake transporter rifampicin, ciclosporin or efflux transporter ritonavir may increase the systemic exposure to valsartan. Amlodipine Reversible biochemical changes packave the head of spermatozoa have been reported in some patients treated by calcium channel blockers.

The safety and efficacy of Exforge in children aged below 18 years have not been established. Administration of valsartan to patients with hypertension results in a drop in blood pressure without affecting pulse rate. Uncommon Insomnia, mood changes including anxietydepression, tremor, dysgeusia, syncope, hypoesthesia, visual disturbance including diplopiatinnitus, inset, dyspnoea, rhinitis, vomiting, dyspepsia, alopecia, purpura, skin discolouration, hyperhidrosis, pruritus, exanthema, myalgia, muscle insret, pain, micturition disorder, increased urinary frequency, impotence, gynaecomastia, chest pain, malaise, weight increase, weight decrease.

Monitoring of potassium levels and creatinine is advised in moderate renal impairment.

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. The antihypertensive effect of a single dose of the combination persisted for 24 hours.

Similar outcomes have been reported with valsartan. Special populations Paediatric population age below 18 years No pharmacokinetic data are available in the paediatric population.