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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The results of an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic packafe transporter OATP1B1 and of the hepatic efflux transporter MRP2. 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. ONTARGET was a study conducted in patients with a history of cardiovascular or cerebrovascular disease, or type 2 diabetes mellitus accompanied exofrge evidence of end-organ damage.

These decreases in blood pressure are not accompanied by a significant change in heart rate or plasma catecholamine levels with chronic dosing.

Reversible biochemical changes in the head of spermatozoa have been reported in some patients treated by calcium channel blockers. Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has pcakage been conclusive; however a small increase in risk cannot be excluded.

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

Following oral administration of valsartan alone, peak plasma concentrations of valsartan are reached in 2—4 hours. Valsartan does not exhibit any partial agonist activity at the AT 1 receptor and has much about 20,fold greater affinity for the AT 1 receptor than for the AT 2 receptor.

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Thank you for sharing our content. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. In haemodynamic studies, amlodipine has not packxge 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.

Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes ;ackage potassium, or other medicinal products that may increase potassium levels heparin, etc. Respiratory, thoracic and mediastinal disorders. Co-administration of inhibitors of the uptake transporter rifampicin, ciclosporin or efflux transporter ritonavir may increase the systemic inserh to valsartan. What is the medicines and poisons schedule?

You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Show table of contents Hide table of contents 1.

Exforge 5mg/80mg film coated tablets

Abdominal discomfort, abdominal pain upper. Dantrolene infusion In animals, lethal ventricular fibrillation and cardiovascular collapse are observed in association with hyperkalaemia after administration of verapamil and intravenous dantrolene. The use of AIIRAs is contraindicated lnsert the second and third trimesters of pregnancy see sections 4. To be taken into account with concomitant use Others In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, warfarin or ciclosporin.

Treatment If ingestion is recent, induction of vomiting or gastric lavage may be considered. For the single compounds there was no evidence of mutagenicity, clastogenicity or carcinogenicity. Among secondary exforgf, 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 Should exposure to AIIRAs have occurred from the second trimester of pregnancy, pakcage check of renal function and skull is recommended.

Hepatic impairment Valsartan is mostly eliminated unchanged via the bile. Similar changes were also seen in the valsartan alone group exposure 8. When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started see sections 4. Pregnant or planning a pregnancy? The major symptom of overdose with valsartan is possibly pronounced hypotension with dizziness. The amlodipine component of Exforge inhibits the transmembrane entry isnert calcium ions into cardiac and vascular smooth muscle.

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When clinically appropriate, direct change from monotherapy to the fixed-dose combination may be considered. C09DB01 Exforge combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: It acts selectively on the receptor subtype AT 1which is responsible for the known actions of angiotensin II.

Date of revision of the text.

Exforge has not been studied in any patient population other than hypertension. Clinical trial data have shown that dual blockade of the RAAS through the combined use of ACE exforeg, 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.

The half life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage recommendations have not been established. There is a total of 5 error s on this exorge, details are below. Brown yellow film coated tablet, ovaloid, biconvex with bevelled edge with “NVR” on one side and “VFL” on the other side. Interactions linked 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.