Medication info

Telapine 40/10 mg

Prescription medication경구Expired
Ingredient · strength
Telmisartan›40mg / 1 tabletAmlodipine Besylate›13.87mg / 1 tablet
Manufacturer / importer
오스틴제약(주)
Appearance
White and light blue biconvex oval double-coated tablet
Packaging
30 tablets/box [10 tablets/PTP × 3]
Approval status
Expired

MFDS item code 202000464 · Approved 2020.01.29

This product's status changed to Expired on 2025.01.29. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of blood pressure control in 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 recommended to take it at the same time each day (e.g. in the morning). It can be administered in 40/5 mg, 80/5 mg, or 40/10 mg doses depending on the patient's blood pressure control status. For patients with renal impairment, it is advised to start at a lower dose for severe cases and gradually increase the dosage. For liver impairment patients, the daily dosage should not exceed
Child dose
Safety and efficacy in pediatric patients under 18 years of age have not been established, and thus, administration of this medication is not recommended.

Ingredients

Manufacturer
오스틴제약(주)

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This medication is used for patients with essential hypertension who have difficulty controlling blood pressure with monotherapy of telmisartan or amlodipine. Essential hypertension is a condition where high blood pressure imposes burden on the heart and blood vessels. This medicine effectively lowers the blood pressure, protects the cardiovascular system, and reduces the risk of complications. Therefore, it is prescribed to aid in the control of hypertension, leading to stable improvements in blood pressure.

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 recommended to take it at the same time each day (e.g. in the morning). It can be administered in 40/5 mg, 80/5 mg, or 40/10 mg doses depending on the patient's blood pressure control status. For patients with renal impairment, it is advised to start at a lower dose for severe cases and gradually increase the dosage. For liver impairment patients, the daily dosage should not exceed

Child dose

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

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters, and therefore should not be taken by pregnant women or women who may become pregnant. Additionally, it should not be administered to patients who are allergic to any of its components, those with severe liver or heart dysfunction, hypotensive patients, patients in cardiogenic shock, or those with unstable heart failure following acute myocardial infarction. Particular caution is required for patients with compromised liver function, obstructive biliary disease, cardiac valve diseases, gastrointestinal disorders, or renal vascular diseases when using this medication. Common side effects such as dizziness or peripheral edema may occur when taking this medication, and in severe cases, fainting may occur, so consult a healthcare professional immediately if symptoms are severe. The use of this medication should be avoided during pregnancy, and once pregnancy is confirmed, discontinuation should occur as soon as possible and replaced with safer treatment options. Given that this medication lowers blood pressure, hypotensive patients should consult a physician before taking it, and blood pressure changes should be monitored closely during treatment. The medication may increase blood potassium levels; therefore, patients at risk of hyperkalemia should undergo regular blood tests. Patients with compromised renal function may experience worsened kidney function due to this medication, necessitating periodic kidney function tests. This medication can interact with other drugs, so if currently taking other medications, be sure to inform your physician or pharmacist, especially when used in conjunction with diuretics, lithium, warfarin, or grapefruit juice. Breastfeeding women are advised not to take this medication, and caution should be exercised when driving or operating machinery as dizziness or drowsiness may occur. In case of overdose, severe hypotension, dizziness, or acute kidney failure may occur, necessitating immediate medical attention and appropriate emergency treatment. This medication has not been sufficiently confirmed for safety and efficacy in children, and therefore, its use is not recommended. Lastly, this medication should be stored out of reach of children, in its original packaging, and opened just before use.

Side effects and when to seek care immediately

Serious side effects

  • Angioedema, urticaria, severe swelling (edema), cold sweat, pallor, severe allergic reactions
  • Severe rash with fever, blisters, skin peeling, pain in oral/eye mucosa, severe skin reaction
  • Difficulty breathing, respiratory distress, asthma attacks, cough with accompanying fever
  • Liver dysfunction, yellowing of skin or eyes (jaundice), profound lethargy
  • Sudden and very severe headache, thunderclap headache, seizures, altered consciousness

Mild side effects

  • Dizziness
  • peripheral edema
  • upper respiratory infection
  • urinary tract infection
  • anemia
  • hyperkalemia
  • hypoglycemia
  • hyponatremia
  • hyperglycemia
  • depression
Show 28 more
  • insomnia
  • anxiety
  • confusion
  • drowsiness
  • headache
  • migraine
  • sensory disturbances
  • fainting
  • peripheral neuropathy
  • taste disturbances
  • tremors
  • visual impairment
  • vertigo
  • tinnitus
  • palpitations
  • bradycardia
  • tachycardia
  • flushing
  • hypotension
  • orthostatic hypotension
  • cough
  • abdominal pain
  • dyspepsia
  • nausea
  • vomiting
  • dry mouth
  • gum hypertrophy
  • itching

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

Storage

This medication may be sensitive to light and should be stored in a container that blocks light. Additionally, to maintain the effectiveness of the medicine, it is important to store it at room temperature, between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White and light blue biconvex oval double-coated tablet

Package unit

30 tablets/box [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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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.