Medication info
Telmisartan/Amlodipine Dual Tablets 40/10 mg

Telmisartan/Amlodipine Dual Tablets 40/10 mg

Prescription medication경구
Ingredient · strength
Telmisartan Powder 23.9%›167.36mg / 1 tabletAmlodipine Besylate›13.87mg / 1 tablet
Manufacturer / importer
(주)라이트팜텍
Appearance
White and light gray, double convex, oval-shaped tablets
Packaging
30 tablets/box [(10 tablets/PTP x 3)]
Approval status
Active

MFDS item code 201903427 · Approved 2019.05.27 · Insurance code 690301190

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
Take one tablet once daily with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). For patients with renal impairment: Mild to moderate renal impairment does not require dosage adjustment, but patients with severe renal impairment should start at a lower dose and gradually increase it. For patients with liver impairment: The daily dose of telmisartan should not exceed 40 mg for patients with mild or moderate liver impairment.
Child dose
Safety and efficacy in pediatric patients under 18 years of age have not been established, so its administration is not recommended.

Ingredients

Manufacturer
(주)라이트팜텍

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is for patients with essential hypertension who have not achieved adequate blood pressure control with either amlodipine or telmisartan alone. In such cases, alternative treatment methods may be necessary for more effective blood pressure management compared to using one of the medications alone. Amlodipine primarily lowers blood pressure by dilating blood vessels, while telmisartan controls blood pressure by blocking the action of hormones that raise blood pressure. For those whose blood pressure remains inadequately controlled with monotherapy, combination therapy or other medication adjustments might be considered. Therefore, it is crucial to consult with healthcare professionals to establish an appropriate treatment plan for effectively managing essential hypertension. These medications are used in the treatment of essential hypertension.

How to take

Adult dose

Take one tablet once daily with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). For patients with renal impairment: Mild to moderate renal impairment does not require dosage adjustment, but patients with severe renal impairment should start at a lower dose and gradually increase it. For patients with liver impairment: The daily dose of telmisartan should not exceed 40 mg for patients with mild or moderate liver impairment.

Child dose

Safety and efficacy in pediatric patients under 18 years of age have not been established, so its administration is not recommended.

Precautions

This medication may cause serious side effects to the fetus, especially during the second and third trimesters of pregnancy, so it should not be taken by women who are pregnant or may become pregnant. Before taking this medication, it is essential to check for allergies to the ingredients or similar class of drugs. Patients with severely impaired liver or kidney function, heart issues, or low blood pressure should avoid taking this medication or exercise caution. Patients with primary aldosteronism, heart valve disease, obstructive hypertrophic cardiomyopathy, gastrointestinal disorders, renovascular hypertension, those undergoing dialysis, elderly patients, and others should be extra cautious when using this medication. Various side effects such as dizziness, peripheral edema, headache, visual disturbances, low blood pressure, orthostatic hypotension, gastrointestinal disturbances, liver function abnormalities, and skin rashes may occur, so if any unusual symptoms arise during treatment, you should consult healthcare professionals immediately. Immediate treatment is required if blood pressure drops too low or severe dizziness or fainting occurs, and periodic blood tests to check kidney function and electrolyte levels are important. This medication may interact with other medications, so inform your healthcare provider of any currently taken medications, and concomitant use with grapefruit juice is not recommended. This medication should not be taken during pregnancy or while breastfeeding, and breastfeeding women are advised to avoid using it. Safety and efficacy in pediatric patients have not been sufficiently established, so it is not recommended for children. For the elderly, it is preferable to start with a low dose and gradually increase the dosage. In the case of overdose, symptoms like low blood pressure, dizziness, and changes in heart rate may occur, and appropriate treatment should be sought immediately from a medical facility. This medication should be stored out of reach of children and should be kept in its original packaging to maintain product quality.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), angioedema of the face, angioedema (with potentially fatal results), Stevens-Johnson syndrome, toxic epidermal necrolysis, severe allergic reactions, severe skin adverse reactions, jaundice, liver abnormalities, hepatitis, renal dysfunction, acute renal failure, serious neurological symptoms, syncope, heart failure, congestive heart failure, cerebral infarction, myocardial infarction, dyspnea, intestinal vascular edema

Mild side effects

  • Dizziness
  • peripheral edema
  • upper respiratory tract infection
  • pharyngitis
  • sinusitis
  • urinary tract infection
  • cystitis
  • anemia
  • thrombocytopenia
  • eosinophilia
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  • hyperkalemia
  • hypoglycemia
  • hyponatremia
  • hyperglycemia
  • depression
  • insomnia
  • anxiety
  • confusion
  • drowsiness
  • migraine
  • headache
  • altered sensation
  • altered taste
  • tremor
  • visual disturbances
  • vertigo
  • tinnitus
  • palpitations
  • bradycardia
  • tachycardia
  • flushing
  • hypotension
  • orthostatic hypotension
  • cough
  • nausea
  • dyspepsia
  • vomiting

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 does not allow light to enter. Furthermore, it is important to keep it at room temperature between 1 and 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

White and light gray, double convex, oval-shaped tablets

Package unit

30 tablets/box [(10 tablets/PTP x 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.