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: Kejind Dousar
Country: Saint Lucia
Language: English (Spanish)
Genre: Business
Published (Last): 16 July 2015
Pages: 441
PDF File Size: 15.99 Mb
ePub File Size: 12.25 Mb
ISBN: 316-9-29497-469-1
Downloads: 23931
Price: Free* [*Free Regsitration Required]
Uploader: Vizshura

Exposure to AIIRA therapy during the second inser third trimesters is known to induce human foetotoxicity decreased renal function, oligohydramnios, skull ossification retardation and neonatal toxicity renal failure, hypotension, hyperkalaemia see section 5.

Thank you for sharing our content. When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative packae should be started. This system is called ‘scheduling’. A total of 33, hypertensive patients aged 55 or older were randomised and followed for a mean of 4.

Commonly used antihypertensive agents e.

Hepatic impairment Valsartan is mostly eliminated unchanged via the bile. Exforge is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.

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

Pregnant or planning a pregnancy? If a medicinal product that affects potassium levels is to be prescribed in combination with valsartan, monitoring of potassium plasma levels is advised.


Exfrge acts selectively on the receptor packagd AT 1which is responsible for the known actions of angiotensin II. They can help you balance the risks and the benefits of this medicine during pregnancy. Administration of activated charcoal to healthy volunteers immediately or up to two hours after ingestion of amlodipine has been shown to significantly decrease amlodipine absorption. Amlodipine does not change sinoatrial nodal function or atrioventricular conduction in intact animals or humans.

For the single compounds there was no evidence of mutagenicity, clastogenicity or carcinogenicity. The pharmacokinetics of amlodipine are not significantly influenced by renal impairment. Plasma concentrations correlate with effect in both young and elderly patients.


Active ingredient valsartan amlodipine besilate. Not all pack packaage may be marketed. Amlodipine bioavailability is unaffected by food ingestion.

In elderly patients, amlodipine clearance tends to decline, causing increases in the area under the curve AUC and elimination half-life. Each film-coated tablet contains 5 mg of amlodipine as amlodipine besylate and 80 mg of valsartan.

The mean incidence of peripheral oedema evenly weighted across all doses was 5. Particular caution should be exfodge when administering Exforge to patients with mild to moderate hepatic impairment or biliary obstructive disorders.

At higher exposures, there were ulceration and erosion of the stomach mucosa in both females and males. Marketing authorisation ineert 8. In a long-term, placebo-controlled study PRAISE-2 of amlodipine in patients with NYHA New York Heart Exflrge Classification III and IV heart failure of non-ischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo.


Following administration of therapeutic doses to patients with hypertension, amlodipine produces vasodilation, resulting in a reduction of supine and standing blood pressures. The safety and efficacy of amlodipine in hypertensive crisis have not been established.

Please enter your name Please enter your email Your email is invalid. When switching eligible elderly hypertensive patients see section 4.

Experimental data suggest that amlodipine binds to both dihydropyridine and non-dihydropyridine binding sites. Common Somnolence, dizziness, palpitations, abdominal pain, nausea, ankle swelling. Similar outcomes have been reported with valsartan. No information is available regarding the use of Exforge 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.

The major symptom of overdose with valsartan is possibly pronounced hypotension with dizziness. Amlodipine elimination from plasma is biphasic, with a terminal elimination half-life of approximately 30 to 50 hours.