Medication info
Telmisartan and Amlodipine Tablets 40/10 mg

Telmisartan and Amlodipine Tablets 40/10 mg

Prescription medication경구
Ingredient · strength
Telmisartan Powder 23.9%›167.36mg / 1 tabletAmlodipine Besylate›13.87mg / 1 tablet
Manufacturer / importer
부광약품(주)
Appearance
Biconvex oval double-coated tablet in white and light gray
Packaging
30 tablets (10 tablets/PTP×3)
Approval status
Active

MFDS item code 201605821 · Approved 2016.09.30

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage of this medication is 1 tablet once daily, to be taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). The dosage can be adjusted to 40/5 mg, 80/5 mg, or 40/10 mg based on blood pressure control. For patients with renal impairment, dose adjustment is not necessary in cases of mild to moderate impairment, but for those with severe renal impairment, treatment should start at a lower dose and gradually increase.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years of age, and the use of this medication is not recommended.

Ingredients

Manufacturer
부광약품(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medicine helps control blood pressure in patients with essential hypertension when blood pressure is not adequately controlled with telmisartan or amlodipine monotherapy. It effectively lowers blood pressure and contributes to the prevention of cardiovascular complications. It is used to manage blood pressure safely and maintain a healthy state.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet once daily, to be taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). The dosage can be adjusted to 40/5 mg, 80/5 mg, or 40/10 mg based on blood pressure control. For patients with renal impairment, dose adjustment is not necessary in cases of mild to moderate impairment, but for those with severe renal impairment, treatment should start at a lower dose and gradually increase.

Child dose

Safety and efficacy have not been established for pediatric patients under 18 years of age, and the use of this medication is not recommended.

Precautions

This medication should not be used during pregnancy, especially in the second and third trimesters, as it can cause serious harm to the fetus. If pregnancy is confirmed, the use of this medication should be discontinued as soon as possible, and if necessary, it should be replaced with another safe medication. This medication is contraindicated in patients with certain conditions, such as those with severely impaired liver or heart function, pregnant or nursing women, and patients with specific allergic reactions. Additionally, patients with diabetes or moderate to severe kidney dysfunction should not take this medication in combination with specific drugs. Some patients should be administered this medication with caution, including those with primary aldosteronism, certain heart valve diseases, liver impairment, gastrointestinal diseases, renal artery hypertension, renal failure, and the elderly. Side effects such as dizziness and peripheral edema are common, and in rare cases, fainting or severe allergic reactions can occur, so it is important to consult a healthcare professional if any abnormal symptoms arise. In particular, caution is required for patients who are dehydrated, as hypotensive symptoms may occur if blood pressure drops too low, necessitating appropriate treatment if symptoms are present. There is a risk of elevated potassium levels in the blood, so patients at risk for hyperkalemia should have their potassium levels monitored regularly with blood tests. Patients with decreased kidney function should also periodically monitor renal function when taking this medication. This medication may interact with other antihypertensives, so if you are taking other medications, you must inform your doctor or pharmacist. During treatment with this medication, caution is advised when driving or operating dangerous machinery, as drowsiness or dizziness may occur. In cases of overdose, symptoms such as hypotension, dizziness, and heart dysfunction may present, requiring immediate medical attention. This medication is not recommended for children as its safety and efficacy have not been sufficiently established.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reaction, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucosa, severe skin reactions, difficulty or shortness of breath, asthma attacks, respiratory abnormalities accompanied by coughing and fever, jaundice (yellowing of the skin or eyes), profound tiredness, liver abnormalities (jaundice), sudden and severe headaches,

Mild side effects

  • Dizziness
  • peripheral edema
  • upper respiratory infection
  • urinary tract infection
  • anemia
  • hyperkalemia
  • hypoglycemia
  • hyponatremia
  • hyperglycemia
  • depression
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  • insomnia
  • anxiety
  • confusion
  • drowsiness
  • migraine
  • sensory disturbances
  • visual disturbances
  • lightheadedness
  • tinnitus
  • palpitations
  • bradycardia
  • tachycardia
  • flushing
  • hypotension
  • orthostatic hypotension
  • cough
  • abdominal pain
  • dyspepsia
  • nausea
  • vomiting
  • dry mouth
  • gingival hyperplasia
  • eczema
  • rash
  • itching
  • angioedema
  • toxic skin rash

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to light and should be stored in a container that protects it from light. It is also best stored at room temperature between 1 to 30 degrees Celsius. This will help maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Biconvex oval double-coated tablet in white and light gray

Package unit

30 tablets (10 tablets/PTP×3)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.