Europe — EMA
Gopten (Trandolapril)
Gopten trandolapril is an oral ACE inhibitor used in the EU for hypertension, heart failure, and post‑MI remodeling. Learn indications, side effects, and precautions.
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What is Trandolapril?
Gopten is a prescription medication that contains the active ingredient trandolapril, an ACE inhibitor, supplied in oral tablet form. While specific strength information is not disclosed, the product is marketed within the European Union and is classified under the ATC code C09AA06. Trandolapril works by inhibiting the angiotensin‑converting enzyme, which helps lower blood pressure and supports cardiovascular health in patients with hypertension or related cardiac conditions.
What is Trandolapril used for?
Gopten (trandolapril) is indicated for several cardiovascular conditions where inhibition of the renin‑angiotensin system is beneficial.
- Management of essential hypertension to achieve target blood pressure levels. - Treatment of chronic heart failure to improve symptoms and reduce hospitalization risk. - Adjunct therapy after myocardial infarction to limit adverse cardiac remodeling. - Use in patients with left ventricular dysfunction to support cardiac function. - May be considered in combination with other antihypertensive agents when monotherapy is insufficient.
What are the side effects of Trandolapril?
Side effects of Gopten vary in frequency; some are relatively common while others are rare but potentially serious.
Common: - Cough. - Dizziness or light‑headedness, especially after the first dose. - Headache. - Fatigue. - Elevated blood potassium levels. - Mild rash or itching.
Serious: - Angioedema affecting the face, lips, tongue, or airway. - Severe hypotension leading to fainting. - Acute kidney injury indicated by sudden rise in creatinine. - Liver function abnormalities such as hepatitis.
What precautions apply to Trandolapril?
Before prescribing Gopten, clinicians should evaluate several safety considerations to minimize risk.
- Avoid use in pregnancy; trandolapril is classified as category D and may cause fetal harm. - Assess renal function; dose adjustment may be required in patients with impaired kidneys. - Monitor serum potassium and electrolytes, especially when combined with potassium‑sparing diuretics or supplements. - Caution in patients with a history of angioedema or hereditary angioedema. - Evaluate for hypotension, particularly in volume‑depleted individuals or those on diuretics. - Use carefully in elderly patients due to increased sensitivity to blood‑pressure lowering effects.
What does Trandolapril interact with?
Gopten can interact with other medicines; some combinations should be avoided while others require close monitoring.
Avoid: - Concurrent use with other ACE inhibitors, ARBs, or direct renin inhibitors due to additive risk of hyperkalaemia and renal impairment. - Co‑administration with aliskiren in patients with diabetes or renal dysfunction. - Use with potassium supplements or potassium‑sparing diuretics without monitoring serum potassium.
Use with caution: - Non‑steroidal anti‑inflammatory drugs (NSAIDs) which may reduce antihypertensive efficacy and affect kidney function. - Diuretics, especially loop or thiazide types, which can increase the risk of hypotension. - Lithium, as trandolapril may raise lithium concentrations and precipitate toxicity. - Certain antidiabetic agents, where blood‑glucose control may be altered.



