Europe — EMA
Gopten (Trandolapril)
Gopten (trandolapril) is an EU‑approved ACE inhibitor for hypertension, heart failure, and post‑MI remodeling. Learn uses, side effects, and safety.
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What is Trandolapril?
Gopten is a prescription medication that contains the active ingredient trandolapril, an angiotensin‑converting enzyme (ACE) inhibitor used in oral tablet form. Marketed in the European Union, Gopten belongs to the antihypertensive therapeutic class and is indicated for conditions such as high blood pressure, heart failure, and post‑myocardial infarction ventricular remodeling. The product complies with EU standards and is not sold over the counter.
What is Trandolapril used for?
Gopten is prescribed for several cardiovascular conditions where inhibition of the renin‑angiotensin system is beneficial.
- Hypertension (high blood pressure) - Chronic heart failure - Post‑myocardial infarction ventricular remodeling - Adjunct therapy in patients with reduced left‑ventricular ejection fraction - Prevention of disease progression in certain high‑risk cardiac patients
What are the side effects of Trandolapril?
Side effects reported with trandolapril may vary in frequency and severity.
Common: - Dry cough - Dizziness or light‑headedness - Headache - Fatigue
Serious: - Angioedema (swelling of face, lips, tongue, or throat) - Severe hypotension (marked drop in blood pressure) - Acute renal dysfunction or worsening kidney function
What precautions apply to Trandolapril?
Before starting Gopten, certain health considerations should be reviewed.
- Pregnancy category D: use only if potential benefit justifies the risk - Existing renal impairment may require dose adjustment or monitoring - Hepatic impairment can affect drug metabolism - Hyperkalemia risk, especially when combined with potassium‑sparing agents - History of angioedema or severe allergic reactions to ACE inhibitors - Regular monitoring of blood pressure and renal function during therapy
What does Trandolapril interact with?
Gopten can interact with other medicines, affecting its safety or effectiveness.
Avoid: - Aliskiren in patients with diabetes - Potassium‑sparing diuretics or supplements (e.g., spironolactone, amiloride) - Concurrent use of another ACE inhibitor or an angiotensin‑II receptor blocker (ARB)
Use with caution: - Thiazide or loop diuretics (increased risk of hypotension) - Lithium (potential for lithium toxicity) - Non‑steroidal anti‑inflammatory drugs (NSAIDs) that may impair renal function



