Tribatens 20/5/12.5 mg - 30 F.C. Tablet (Old)

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

Administer with or without food.

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. Side effects due to hydrochlorothiazide: Skin photosensitivity, hypokalemia, hypomagnesemia, hypercalcemia, and hyponatremia may occur with hydrochlorothiazide, hyperuricemia, myopia and acute angle-closure glaucoma, hypersensitivity angiitis, hypotension (including orthostatic), alopecia, skin rash, toxic epidermal necrolysis, urticaria, glycosuria, hypomagnesemia, abdominal cramps, anorexia, constipation, diarrhea, gastric irritation, nausea, vomiting, aplastic anemia, thrombocytopenia, anaphylaxis, dizziness, headache, paresthesia, restlessness, vertigo, asthenia, muscle spasm, blurred vision, xanthopsia, acute kidney injury and fever. Side effects due to Olmesartan: Dizziness, headache, hyperglycemia, hypertriglyceridemia, diarrhea, hematuria, back pain, increased creatine phosphokinase, bronchitis, flu-like symptoms, pharyngitis, rhinitis and sinusitis

-Avoid salt substitutes containing potassium. -Should not be given to patients suffering from hypersensitivity to olmesartan, amlodipine, hydrochlorothiazide. -Hyperkalemia may occur with angiotensin II receptor antagonists. -Severe, chronic diarrhea with significant weight loss has been reported with Olmesartan. -Gout can be precipitated by hydrochlorothiazide. -Hypotension may occur upon initiation in patients who are salt- or volume-depleted. -Hydrochlorothiazide may cause acute transient myopia and acute angle-closure glaucoma. -The most common side effect of amlodipine is peripheral edema. -Hydrochlorothiazide may cause photosensitivity. -Olmesartan may be associated with deterioration of renal function and/or increases in serum creatinine, particularly in patients with low renal blood flow. -Use with extreme caution in patients with severe aortic stenosis. -Use hydrochlorothiazide with caution in patients with prediabetes or diabetes mellitus. -Use with caution in patients with severe hepatic impairment. -Thiazide diuretics may decrease renal calcium excretion; consider avoiding use in patients with hypercalcemia. -Use with caution in patients with moderate or high cholesterol concentrations; increased cholesterol and triglyceride levels have been reported with thiazides. -Use amlodipine with caution in patients with hypertrophic cardiomyopathy and left ventricular outflow tract obstruction. -Use olmesartan with caution in patients with unstented unilateral/bilateral renal artery stenosis. -Hydrochlorothiazide can cause SLE exacerbation or activation. -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 amlodipine: -Alfuzosin: May enhance the hypotensive effect of blood pressure lowering agents. -Antipsychotic Agents: blood pressure lowering agents may enhance the hypotensive effect of antipsychotic 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. -Dapoxetine: May enhance the orthostatic hypotensive 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. Interactions due to hydrochlorothiazide: -Alcohol (Ethyl): May enhance the orthostatic hypotensive effect of Thiazide and Thiazide-Like Diuretics. -Allopurinol: Thiazide and Thiazide-Like Diuretics may enhance the potential for allergic or hypersensitivity reactions to Allopurinol. -Antidiabetic Agents: Thiazide and Thiazide-Like Diuretics may diminish the therapeutic effect of Antidiabetic Agents. -Multivitamins/Minerals (containing vitamins ADEK, Folate, Iron): Thiazide and Thiazide-Like Diuretics may enhance the hypercalcemic effect of Multivitamins/Minerals (containing vitamins ADEK, Folate, Iron). -Vitamin D Analogs: Thiazide and Thiazide-Like Diuretics may enhance the hypercalcemic effect of Vitamin D Analogs. Interactions due to Olmesartan: see pregnancy and lactation.

-Drugs that act directly on the renin-angiotensin system can cause injury to the developing fetus. -Amlodipine and hydrochlorothiazide are present in breast milk; it is not known if olmesartan is excreted in breast milk. Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended during the treatment. -Ask your physician before taking any medication during pregnancy or lactation. Interactions due to Olmesartan: -Duloxetine: blood pressure lowering agents may enhance the hypotensive effect of Duloxetine. -Heparin: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. -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. -Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. -Potassium Salts: 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. -Potassium-Sparing Diuretics: Angiotensin II Receptor Blockers may enhance the hyperkalemic effect of Potassium-Sparing Diuretics. -Trimethoprim: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers.

RAMEDA