Blokatens HCT 5/160/12.5 mg - 28 F.C. Tablet

Angiotensin II receptor blocker and calcium channel blocker combination therapy used in the treatment of hypertension.

-Administer with or without food.

-Side effects due to valsartan: Dizziness, increased blood urea nitrogen, hypotension, orthostatic hypotension, syncope, hyperkalemia, abdominal pain, diarrhea, nausea, upper abdominal pain, neutropenia, viral infection, fatigue, headache, orthostatic dizziness, vertigo, arthralgia, back pain, blurred vision, increased serum creatinine, renal insufficiency and dry cough. -Side effects due to Amlodipine: Peripheral edema, Flushing, palpitations, pruritus , skin rash, abdominal pain, nausea, dizziness, drowsiness, fatigue, male sexual disorder, asthenia, muscle cramps, dyspnea, peripheral ischemia, sinus tachycardia, syncope, vasculitis, diaphoresis, erythema multiforme, hot flash, hyperglycemia, weight gain, weight loss, anorexia, constipation, dysphagia, flatulence, gingival hyperplasia, pancreatitis, vomiting, xerostomia, difficulty in micturition, nocturia, urinary frequency, leukopenia, purpuric disease, thrombocytopenia, angioedema, hypersensitivity reaction, abnormal dreams, anxiety, depersonalization, depression, female sexual disorder, hypoesthesia, insomnia, malaise, pain, paresthesia, peripheral neuropathy, rigors, vertigo, arthralgia, back pain, myalgia, osteoarthritis, tremor, conjunctivitis, diplopia, eye pain, tinnitus and epistaxis.

-Use with caution in patients with hepatic impairment. -Avoid salt substitutes which contain potassium. -Should not be used by patients suffering from hypersensitivity to amlodipine, valsartan. -Valsartan may cause hyperkalemia. -Symptomatic hypotension may occur upon initiation in patients who are salt- or volume-depleted. -The most common side effect of amlodipine is peripheral edema; occurs within 2-3 weeks of starting therapy. -Valsartan may be associated with deterioration of renal function and/or increases in serum creatinine, particularly in patients with low renal blood flow (eg, renal artery stenosis, heart failure). -Use amlodipine with extreme caution in patients with severe aortic stenosis. -Use amlodipine with caution in patients with hypertrophic cardiomyopathy (HCM). -Use valsartan with caution in patients with unstented unilateral/bilateral renal artery stenosis. -Consider the use of a lower initial dose of amlodipine in elderly patients. -In case of over dose be ready to tell or show what was taken, how much and when it happened, and seek immediate medical attention. For additional information call us on 16676. Always tell your physician your detailed medical history.

Store at room temperature.

Interactions due to valsartan: -Antipsychotic Agents: blood pressure lowering agents may enhance the hypotensive effect of antipsychotic agents. -Dapoxetine: May enhance the orthostatic hypotensive effect of Angiotensin II Receptor Blockers. -Duloxetine: blood pressure lowering agents may enhance the hypotensive effect of Duloxetine. -Levodopa-containing products: blood pressure lowering agents may enhance the hypotensive effect of levodopa-containing products. -Lithium: Angiotensin II Receptor Blockers may increase the serum concentration of Lithium. -Nicorandil: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. -Nonsteroidal anti-inflammatory agents: Angiotensin II Receptor Blockers may enhance the adverse/toxic effect of nonsteroidal anti-inflammatory agents. -Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of blood pressure lowering agents. -Trimethoprim: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Interactions due to amlodipine: -Alfuzosin: May enhance the hypotensive effect of blood pressure lowering agents. -Calcium Salts: May diminish the therapeutic effect of calcium channel blockers. -Carbamazepine: amlodipine may increase the serum concentration of carbamazepine. -Clopidogrel: Calcium channel blockers may diminish the therapeutic effect of Clopidogrel. -Dabigatran Etexilate: Amlodipine may diminish the therapeutic effect of Dabigatran Etexilate. -Dantrolene: May enhance the hyperkalemic effect of calcium channel blockers. -Lovastatin: Amlodipine may increase the serum concentration of Lovastatin. -Magnesium Sulfate: May enhance the adverse/toxic effect of calcium channel blockers. -Melatonin: May diminish the antihypertensive effect of calcium channel blockers. -Red Yeast Rice: Amlodipine may increase the serum concentration of red yeast rice. -Simvastatin: Amlodipine may increase the serum concentration of Simvastatin.

-Drugs that act on the renin-angiotensin system can cause injury to the developing fetus. -Amlodipine is present in breast milk; excretion of valsartan is unknown. Because of the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended during the treatment. -Ask your physician before taking any medications during pregnancy or lactation.

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