Cilzec-A 40+5 Tablets_

Widaplik (telmisartan/amlodipine/indapamide) is indicated for the treatment of hypertension in adult patients, to lower blood pressure. Widaplik may be used as initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including angiotensin II receptor blockers, dihydropyridine calcium channel blockers and thiazide-like diuretics. There are no controlled trials demonstrating risk reduction with Widaplik. …

• For initial treatment of hypertension, start with Widaplik (10 mg/ 1.25 mg/0.625 mg) or Widaplik (20 mg/2.5 mg/1.25 mg) orally once daily
• Titrate up to a maximum dose of Widaplik (40 mg/5 mg/2.5 mg) orally once daily
• Dosage may be increased after 2 weeks to a maximum dose of 40 mg/5 mg/2.5 mg orally once daily to achieve more rapid control
• Almost all of the antihypertensive effect is apparent within 2 weeks of initiating treatment
• General Considerations Dose orally once daily
• Dosage must be individualized and may be increased after 2 weeks of treatment
• Almost all the antihypertensive effect is apparent within 2 weeks of initiating treatment
• Swallow tablets whole
• Do not cut, crush, or chew tablets
• Widaplik may be taken with or without food
• Correct imbalances of intravascular volume- or salt-depletion, before initiating therapy with Widaplik [see Warnings and Precautions ]
• Recommended Dosage The recommended starting dosage is with Widaplik (10 mg/1.25 mg/0.625 mg) orally once daily or Widaplik (20 mg/2.5 mg/1.25 mg) orally once daily, based on anticipated need for blood pressure reduction
• Elderly patients consider starting with Widaplik (10 mg/1.25 mg/0.625 mg) orally once daily [see Use in Specific Populations, Geriatric Use ]
• The maximum recommended dose is Widaplik (40 mg/5 mg/2.5 mg) orally once daily

Widaplik tablets are available as follows: 10 mg/1.25 mg/0.625 mg: 10 mg telmisartan/1.25 mg amlodipine/0.625 mg indapamide tablets – white to off-white oval tablet, debossed with “ULD” on one side and plain on the other side. …

• Safety and effectiveness of Widaplik
• Pediatric patients have not been established
• Neonates with a history of in utero exposure to Widaplik If oliguria or hypotension occurs, support blood pressure and renal perfusion
• Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function

Widaplik In subgroup analysis in subjects ≥65 years (n= 176) the antihypertensive effect of Widaplik was not substantially different compared to younger subjects, however the number of elderly patients enrolled in both Widaplik studies was small. Telmisartan Of the total number of patients receiving telmisartan in clinical studies, 551 (18.6%) were 65 to 74 years of age and 130 (4.4%) were 75 years and older. …

• Advise the patient to read the FDA-approved patient labelling (see Patient Information)
• Pregnancy Advise female patients of childbearing age about the consequences of exposure to Widaplik during pregnancy
• Discuss treatment options with women planning to become pregnant
• Tell patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions and Use in Specific Populations ]
• Lactation Advise nursing women not to breastfeed during treatment with Widaplik [see Use in Specific Populations ] . …

• Do not use in patients with anuria, known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan, amlodipine, indapamide, or to other sulfonamide-derived drugs, or to any other component of this product
• Do not co-administer aliskiren with Widaplik in patients with diabetes [see Drug Interactions ] . …

NSAIDs: Increased risk of renal impairment and loss of anti-hypertensive effect ( 7.1 ) If simvastatin is co-administered with Widaplik, do not exceed doses greater than 20 mg daily of simvastatin ( 7.2 ) Do not co-administer aliskiren with Widaplik in patients with diabetes ( 7.1 ) 7.1 Drug Interactions with Telmisartan Aliskiren and other renin-angiotensin-aldosterone system (RAAS) inhibitors: Do not co-administer aliskiren with Widaplik in patients with diabetes. Most patients receiving the combination of two RAAS inhibitors do not obtain any additional benefit compared to monotherapy [see Contraindications ( 4 )] . …

Hypotension: Correct volume depletion prior to initiation ( 5.2 ) Electrolyte and Glucose Imbalances: Monitor serum electrolytes and glucose ( 5.3 ) Impaired Renal Function: Monitor renal function ( 5.4 ) Acute angle closure glaucoma can develop ( 5.5 ) Hyperuricemia may occur ( 5.6 ) 5.1 Fetal Toxicity Use of drugs that act on the renin-angiotensin-aldosterone system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. …

The following is discussed in more detail in other sections of the labeling: • Fetal toxicity [see Warnings and Precautions ( 5.1 )] • Hypotension [see Warnings and Precautions ( 5.2 )] • Electrolyte and Glucose Imbalances [see Warnings and Precautions ( 5.3 )] • Impaired Renal Function [see Warnings and Precautions ( 5.4 )] • Acute Angle-Closure Glaucoma, Acute Myopia, and Choroidal Effusion [see Warnings and Precautions ( 5.5 )] • Hyperuricemia [see Warnings and Precautions ( 5.6 )] The most common adverse reaction is symptomatic hypotension. Low sodium and potassium values were recorded more often with Widaplik compared to placebo ( 6.1 ). …

8.1 Pregnancy Risk Summary Widaplik can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin-aldosterone system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death ( see Clinical Considerations ). …

Telmisartan Limited data are available with regard to overdosage in humans. The most likely manifestations of overdosage would be hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by hemodialysis. Amlodipine Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of amlodipine is limited. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.