Forgenap 10/160/12.5 mg - 10 F.C. Tablets

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 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 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.

-Avoid salt substitutes which contain potassium. -Should not be given to patients suffering from hypersensitivity to amlodipine, hydrochlorothiazide or valsartan. -Hyperkalemia may occur with angiotensin II receptor antagonists. -gout can be precipitated by hydrochlorothiazide. -Hypersensitivity reactions may occur with hydrochlorothiazide. -Symptomatic 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. -Use amlodipine with extreme caution in patients with severe aortic stenosis. -Use hydrochlorothiazide with caution in patients with prediabetes or diabetes mellitus. -Avoid use in patients with severe hepatic impairment. -Thiazide diuretics may decrease renal calcium excretion. -Use with caution with preexisting renal insufficiency. Avoid use in severe renal impairment (CrCl <30 mL/minute). -Systemic lupus erythematosus (SLE): Hydrochlorothiazide can cause SLE exacerbation or activation. -Incase 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 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. -Angiotensin-Converting Enzyme Inhibitors: Thiazide and Thiazide-Like Diuretics may enhance the hypotensive effect of Angiotensin-Converting Enzyme Inhibitors. -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). -Nonsteroidal Anti-Inflammatory Agents: Thiazide and Thiazide-Like Diuretics may enhance the nephrotoxic effect of Nonsteroidal Anti-Inflammatory Agents. -Vitamin D Analogs: Thiazide and Thiazide-Like Diuretics may enhance the hypercalcemic effect of Vitamin D Analogs. Interactions due to valsartan: -Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents. -Dapoxetine: May enhance the orthostatic hypotensive effect of Angiotensin II Receptor Blockers. -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. -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: see pregnancy and lactation.

-Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. -Amlodipine and hydrochlorothiazide are present in breast milk; excretion of valsartan is unknown. Due to the potential for serious adverse reactions in the nursing infant, breastfeeding is not recommended during the treatment. -Ask your physician before taking any medications during pregnancy or lactation. Interactions due to amlodipine: -Alfuzosin: May enhance the hypotensive effect of blood pressure lowering agents. -Antipsychotic Agents (Second Generation [Atypical]): 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.