Medication info

Telmisartan and Amlodipine Besylate Tablets 40/10 mg

Prescription medication경구Expired
Ingredient · strength
Telmisartan Powder 23.9%›167.36mg / 1 tabletAmlodipine Besylate›13.87mg / 1 tablet
Manufacturer / importer
제이더블유중외제약(주)
Appearance
The tablet is a white and light gray, biconvex, oval-shaped double tablet.
Packaging
30 tablets/PTP [30 tablets (10 tablets/Alu-Alu × 3)]
Approval status
Expired

MFDS item code 201906172 · Approved 2019.08.29

This product's status changed to Expired on 2024.08.29. 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 for this medication is one tablet once daily, taken with water regardless of meals. It is advised to take it at the same time each day (e.g., in the morning) if possible. For patients with renal impairment, mild to moderate cases do not require dosage adjustments, while severe renal impairment should start at a lower dose and increase gradually. Patients with liver impairment should not exceed a daily dose of 40 mg.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years old, so administration is not recommended.

Ingredients

Manufacturer
제이더블유중외제약(주)

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This medication is used for patients with chronic hypertension whose blood pressure is not adequately controlled by monotherapy with amlodipine or telmisartan. It effectively lowers blood pressure in these patients, helping to reduce the risk of cardiovascular complications.

How to take

Adult dose

The recommended dosage for this medication is one tablet once daily, taken with water regardless of meals. It is advised to take it at the same time each day (e.g., in the morning) if possible. For patients with renal impairment, mild to moderate cases do not require dosage adjustments, while severe renal impairment should start at a lower dose and increase gradually. Patients with liver impairment should not exceed a daily dose of 40 mg.

Child dose

Safety and efficacy have not been established for pediatric patients under 18 years old, so administration is not recommended.

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters, so it should not be taken by women who are pregnant or may become pregnant. This medication should not be administered to individuals who are allergic to the active ingredients or components, patients with severe liver impairment or hypotension, patients with serious heart problems, and those with specific kidney diseases. Patients with impaired liver function or biliary obstruction should use this medication with caution, and dose adjustments may be necessary. Patients with ulcers or inflammation in the stomach are advised to be cautious when taking this medication, as there is a risk of gastrointestinal bleeding and other side effects. Patients with reduced kidney function or issues with kidney blood vessels may experience worsening kidney function while taking this medication, so regular check-ups are necessary. Elderly patients may be more sensitive to this medication, so it is advisable to start with a lower initial dose and gradually increase it. As this medication lowers blood pressure, dizziness or hypotensive symptoms may occur after administration, so caution is advised when driving or operating machinery. There may be interactions with other medications, so it is essential to consult a doctor or pharmacist if the patient is taking diuretics, potassium supplements, heart medications, anticoagulants, or analgesics. In cases of overdose, severe hypotension, dizziness, and abnormal heart rhythms may occur, so it is essential to adhere strictly to the prescribed dosage and seek medical attention immediately if unusual symptoms arise. This medication is not recommended for children as safety and efficacy have not been sufficiently established, nor is it advisable for breastfeeding women.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in the mouth/eyes mucous membranes, severe dermatological reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of the skin or eyes (jaundice), profound lethargy, liver abnormalities (jaundice), sudden and severe headache, lightning-like headache

Mild side effects

  • Dizziness
  • peripheral edema
  • upper respiratory infection
  • urinary tract infection
  • anemia
  • hyperkalemia
  • hypoglycemia
  • hyponatremia
  • hyperglycemia
  • depression
Show 28 more
  • insomnia
  • headache
  • drowsiness
  • paresthesia
  • visual disturbances
  • vertigo
  • tinnitus
  • heart palpitations
  • bradycardia
  • tachycardia
  • flushing
  • hypotension
  • orthostatic hypotension
  • cough
  • abdominal pain
  • dyspepsia
  • nausea
  • vomiting
  • dry mouth
  • liver function abnormalities
  • itching
  • rash
  • hair loss
  • vascular edema
  • vasculitis
  • arthralgia
  • muscle cramps
  • renal function

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

Storage

This medication should be stored in a special container that prevents light from entering, as it is sensitive to light. Additionally, it should be kept at room temperature between 1 and 30 degrees Celsius. This will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

The tablet is a white and light gray, biconvex, oval-shaped double tablet.

Package unit

30 tablets/PTP [30 tablets (10 tablets/Alu-Alu × 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.