On 5 June 2025, the US Food and Drug Administration (FDA) approved WIDAPLIK™ (telmisartan, amlodipine and indapamide) tablets, for oral use, for the treatment of hypertension in adult patients, including as initial treatment, to lower blood pressure. WIDAPLIK is expected to be available to patients in the US later in the year. Please reference the FDA-approved Prescribing Information and Information for Patients.

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IMPORTANT SAFETY INFORMATION

WARNING: WIDAPLIK™ can cause fetal harm when administered to a pregnant woman. When pregnancy is detected, discontinue WIDAPLIK as soon as possible. Drugs that act directly on the renin-angiotensin-aldosterone system can cause injury and death to the developing fetus. Talk with your doctor about other ways to lower blood pressure if you plan to become pregnant.

INDICATIONS

WIDAPLIK™ 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.

  • Before taking WIDAPLIK, tell your doctor if you are breastfeeding or plan to breastfeed. Discuss with your doctor other ways to lower your blood pressure. Breastfeeding while taking WIDAPLIK is not recommended.
 
  • Do not take WIDAPLIK if you make less urine because of kidney problems (anuria).
 
  • Do not take aliskiren-containing products with WIDAPLIK if you have diabetes.
 
  • Tell your doctor about all your medical conditions, including if you have heart problems, have gout, or have liver or kidney problems. Kidney problems may become worse in people that already have kidney disease. If you have kidney problems, you may need blood tests, and your doctor may need to lower your dose or may need to stop treatment with WIDAPLIK. During treatment with WIDAPLIK, certain people who have severe heart failure, narrowing of the artery to the kidney, or who lose too much body fluid such as with nausea, vomiting, bleeding, or trauma, may develop sudden kidney failure.
 
  • Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other medicines to treat your high blood pressure or heart problem; water pills (diuretics); lithium; or digoxin.
 
  • WIDAPLIK may cause serious side effects, including low blood pressure (hypotension) which may cause you to feel faint or dizzy. Vomiting and diarrhea, a low salt diet, sweating a lot, dialysis treatments, or not drinking enough fluid can also lead to low blood pressure.
 
  • If you feel faint or dizzy, lie down and call your doctor right away. If you pass out (faint), have someone call your doctor or get medical help. Stop taking WIDAPLIK.
 
  • If you have fluid and body salt (electrolyte) problems, tell your doctor if you experience any of the following symptoms: dry mouth, confusion, thirst, lack of energy (lethargic), weakness, drowsiness, passing very little urine or passing large amounts of urine, seizures, muscle pain/cramps, restlessness, muscle tiredness (fatigue), fast or abnormal heartbeat, nausea and vomiting, or constipation.
 
  • People who have increased levels of uric acid in the blood may develop gout. If you already have gout, tell your doctor about worsening of your gout symptoms.
 
  • In clinical studies, the most common side effects seen with WIDAPLIK were dizziness from low blood pressure (5.9%), low blood sodium (7.3%), or low blood potassium (6.8%).
 

The Important Safety Information does not include all the information needed to use WIDAPLIK safely and effectively.

For further information, please see accompanying complete Prescribing Information for WIDAPLIK.

To report SUSPECTED ADVERSE REACTIONS contact either:

INDICATIONS

WIDAPLIK™ is a prescription medicine used to treat high blood pressure (hypertension) in adults. WIDAPLIK may be used as the first medicine to lower your high blood pressure if your healthcare provider decides you are likely to need more than one medicine. Medicines that lower your blood pressure may lower your chances of having a stroke or heart attack.

IMPORTANT SAFETY INFORMATION

WARNING: WIDAPLIK™ can cause fetal harm when administered to a pregnant woman. When pregnancy is detected, discontinue WIDAPLIK as soon as possible. Drugs that act directly on the renin-angiotensin-aldosterone system can cause injury and death to the developing fetus. Talk with your doctor about other ways to lower blood pressure if you plan to become pregnant.

  • Before taking WIDAPLIK, tell your doctor if you are breastfeeding or plan to breastfeed. Discuss with your doctor other ways to lower your blood pressure. Breastfeeding while taking WIDAPLIK is not recommended.
 
  • Do not take WIDAPLIK if you make less urine because of kidney problems (anuria).
 
  • Do not take aliskiren-containing products with WIDAPLIK if you have diabetes.
 
  • Tell your doctor about all your medical conditions, including if you have heart problems, have gout, or have liver or kidney problems. Kidney problems may become worse in people that already have kidney disease. If you have kidney problems, you may need blood tests, and your doctor may need to lower your dose or may need to stop treatment with WIDAPLIK. During treatment with WIDAPLIK, certain people who have severe heart failure, narrowing of the artery to the kidney, or who lose too much body fluid such as with nausea, vomiting, bleeding, or trauma, may develop sudden kidney failure.
 
  • Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other medicines to treat your high blood pressure or heart problem; water pills (diuretics); lithium; or digoxin.
 
  • WIDAPLIK may cause serious side effects, including low blood pressure (hypotension) which may cause you to feel faint or dizzy. Vomiting and diarrhea, a low salt diet, sweating a lot, dialysis treatments, or not drinking enough fluid can also lead to low blood pressure.
 
  • If you feel faint or dizzy, lie down and call your doctor right away. If you pass out (faint), have someone call your doctor or get medical help. Stop taking WIDAPLIK.
 
  • If you have fluid and body salt (electrolyte) problems, tell your doctor if you experience any of the following symptoms: dry mouth, confusion, thirst, lack of energy (lethargic), weakness, drowsiness, passing very little urine or passing large amounts of urine, seizures, muscle pain/cramps, restlessness, muscle tiredness (fatigue), fast or abnormal heartbeat, nausea and vomiting, or constipation.
 
  • People who have increased levels of uric acid in the blood may develop gout. If you already have gout, tell your doctor about worsening of your gout symptoms.
 
  • In clinical studies, the most common side effects seen with WIDAPLIK were dizziness from low blood pressure (5.9%), low blood sodium (7.3%), or low blood potassium (6.8%).
 

The Important Safety Information does not include all the information needed to use WIDAPLIK safely and effectively.

For further information, please see accompanying complete Prescribing Information for WIDAPLIK.

To report SUSPECTED ADVERSE REACTIONS contact either:

For Medical Information contact: Medical_Information@george-medicines.com