Widaplik

Widaplik (telmisartan, amlodipine, and indapamide) is a single tablet combination medication used to treat high blood pressure (hypertension) to reduce the risk of cardiovascular events, including strokes and myocardial infarctions. Widaplik contains three active ingredients:

• Telmisartan – an angiotensin II receptor blocker (ARB)
• Amlodipine – a calcium channel blocker (CCB)
• Indapamide – a thiazide-like diuretic

Widaplik may be prescribed as initial therapy for patients expected to need multiple medications to reach their target blood pressure.

Widaplik tablets are taken once daily with or without food. Tablets should be swallowed whole; do not cut, crush, or chew.

Widaplik contains 3 active ingredients that work through different mechanisms of action to help reduce blood pressure

Telmisartan works by blocking the action of angiotensin II, a chemical in the body that causes blood vessels to constrict. By blocking its effects, telmisartan helps relax blood vessels, lowering blood pressure. Telmisartan is also a partial agonist of peroxisome proliferator-activated receptor gamma (PPAR-γ), a central regulator of insulin and glucose metabolism.

Amlodipine is a calcium channel blocker; it inhibits the influx of calcium ions into vascular smooth muscle and cardiac muscle. This dilates blood vessels and improves blood flow, helping to reduce blood pressure.

Indapamide has a diuretic effect, increasing urine production, reducing plasma volume, and decreasing blood pressure. Indapamide also has direct vasodilatory effects independent of its diuretic action.

Widaplik FDA approval was granted on June 5, 2025, after positive results from clinical trials Study 1 (NCT04518306) and Study 2 (NCT04518293). Widaplik FDA approval is for the treatment of hypertension, including as initial treatment, to lower blood pressure.

Widaplik tablets are taken once daily at the same time each day, with or without food

Tablets should be swallowed whole; do not crush or chew.

Take Widaplik tablets exactly as prescribed by your doctor.

Do not use Widaplik if you are pregnant. It can cause injury or death to an unborn baby. Stop taking it and tell your doctor right away if you become pregnant.

Widaplik may cause low blood pressure, especially when first starting the medication or increasing the dose.

Avoid becoming dehydrated. Serious loss of body water can lower blood pressure further and lead to electrolyte imbalances.

Do not take Widalplik if you have a 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 take this medicine if your kidneys are producing no or a small amount of urine.

This medicine should not be taken with aliskiren in patients with diabetes.

Do not use Widaplik if you are pregnant.

Do not use potassium supplements or salt substitutes that contain potassium without talking to your healthcare provider.

Tell your doctor if you have ever had:

• Kidney or liver disease
• Heart issues
• Electrolyte imbalances (e.g., low potassium or sodium)
• Gout
• Diabetes
• Glaucoma, Acute Myopia, and Choroidal Effusion
• Allergic reactions to sulfa drugs or penicillin.

Pregnancy

Do not take this medicine if you are pregnant or plan to become pregnant. Widaplik can cause injury or death to an unborn baby. Stop taking it and tell your doctor right away if you become pregnant.

Breastfeeding

Do not breastfeed during treatment with Widaplik. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you take this medicine.

Common side effects

Common Widaplik side effects may include:

• Dizziness
• Headache
• Fatigue
• Nausea
• Low blood pressure
• Cough
• Low sodium and potassium levels in your blood.

Serious Widaplik side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Widaplik may harm or cause death to your unborn baby.

Call your doctor at once if you have:

• Severe light-headedness or fainting
• Swelling in the ankles, feet, or hands, or unexplained weight gain
• Muscle weakness, cramping, or irregular heartbeat
• Unusual tiredness
• Decreased urine output
• Vision loss or problems, eye pain
• Signs of gout or increased uric acid levels.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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) once daily.

Initial treatment for elderly patients: start with Widaplik (10 mg/ 1.25 mg/0.625 mg)

Titrate dose: Adjust dose based on clinical response at intervals of approximately 2 weeks.

Maximum dose: Widaplik 40 mg/5 mg/2.5 mg orally once daily.

Widaplik is available in three fixed-dose combinations:

• 10 mg telmisartan / 1.25 mg amlodipine / 0.625 mg indapamide
• 20 mg telmisartan / 2.5 mg amlodipine / 1.25 mg indapamide
• 40 mg telmisartan / 5 mg amlodipine / 2.5 mg indapamide

Seek emergency medical attention or call the Poison Help line at 1‑800‑222‑1222. Overdose symptoms may include severe dizziness, fainting, or electrolyte disturbances.

Other drugs may interact with Widaplik. Tell your healthcare providers about prescription and over-the-counter medicines, vitamins, and herbal products. Especially tell your healthcare provider if you take:

• Aliskiren
• Digoxin
• Lithium
• non-steroidal anti-inflammatory drugs (NSAIDs)
• Simvastatin
• cyclosporine or tacrolimus
• norepinephrine

Not all possible drug interactions are listed here

• Store at room temperature 68°F to 77°F (20°C to 25°C) away from moisture and heat.
• Keep tablets out of the light and away from moisture.
• Store tablets in the original container.
• Do not remove Widaplik tablets from the bottle until right before you take them.

Active ingredients: telmisartan, amlodipine besylate and indapamide.

Inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, meglumine, microcrystalline cellulose, polyvinyl pyrrolidone, pregelatinized starch, and sodium hydroxide.

WidaplikTM is a registered trademark of George Medicines Pty Limited

Widaplik Manufactured by: Piramal Pharma Limited, Plot No. 67-70, Sector II, Pithampur, Dist. Dhar, Madhya, Pradesh 454775, India