Lipiclear 5/10 mg - 14 F.C. Tablet

Antilipidemic agent (HMG-CoA Reductase Inhibitor) and calcium channel blocker combination therapy used in the treatment of hypertension with dyslipidemia and in primary or secondary prevention of cardiovascular diseases.

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 Atorvastatin: -Statins are associated with increased serum transaminases and hepatotoxicity. -Statins are associated with several muscle-related effects, including: Myalgia, myopathy and rhabdomyolysis. -Diarrhea, arthralgia, nasopharyngitis, hemorrhagic stroke, diabetes mellitus, dyspepsia, nausea, urinary tract infection, increased serum transaminases, insomnia, limb pain, muscle spasm, musculoskeletal pain, myalgia and pharyngolaryngeal pain.

-Should not be given to patients suffering from hypersensitivity to amlodipine or atorvastatin. -May cause an increase in HbA1c and fasting blood glucose. -Persistent elevations in serum transaminases have been reported; upon dose reduction, drug interruption, or discontinuation, transaminase levels return to or near pretreatment levels. -The most common side effect of amlodipine is peripheral edema. -Use amlodipine with extreme caution in patients with severe aortic stenosis. -Use atorvastatin with caution in patients who consume large amounts of ethanol or have a history of liver disease; use is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases. -Use amlodipine with caution in patients with hypertrophic cardiomyopathy with left ventricular outflow tract obstruction. -May rarely worsen or precipitate myasthenia gravis. -Use atorvastatin with caution in patients with renal impairment. -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. -Dapoxetine: May enhance the orthostatic hypotensive effect of Calcium Channel Blockers. -Lovastatin: Amlodipine may increase the serum concentration of Lovastatin. -Melatonin: May diminish the antihypertensive effect of Calcium Channel Blockers. -Simvastatin: Amlodipine may increase the serum concentration of Simvastatin. Interactions due to atorvastatin: -Amiodarone: May increase the serum concentration of Atorvastatin. -Azithromycin (Systemic): May enhance the myopathic (rhabdomyolysis) effect of Atorvastatin. -Clarithromycin: May increase the serum concentration of Atorvastatin. -Colchicine: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). -Digoxin: Atorvastatin may increase the serum concentration of Digoxin. -Fenofibrate and Derivatives: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). -Gemfibrozil: May enhance the myopathic (rhabdomyolysis) effect of Atorvastatin. -Grapefruit Juice: May increase the serum concentration of Atorvastatin. -Itraconazole: May increase the serum concentration of Atorvastatin. -Rifampin: May increase the serum concentration of Atorvastatin. -Spironolactone: Atorvastatin may enhance the adverse/toxic effect of Spironolactone. -St John's Wort: May decrease serum concentrations of the active metabolite(s) of HMG-CoA Reductase Inhibitors (Statins). -Ticagrelor: May increase the serum concentration of Atorvastatin. -Verapamil: Atorvastatin may increase the serum concentration of Verapamil.

-Use is contraindicated in pregnancy. -Amlodipine is present in breast milk; it is not known if atorvastatin is present in breast milk. Use is contraindicated in breastfeeding women. -Ask your physician before taking any medication during pregnancy or lactation.

CHEMIPHARM