Medication info
Telmisartan and Amlodipine Tablets 80/5 mg

Telmisartan and Amlodipine Tablets 80/5 mg

Prescription medication경구
Ingredient · strength
Telmisartan Powder 23.9%›334.72mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
A white and light gray, double convex, oval-shaped tablet.
Packaging
30 tablets (10 tablets/PTP X 3)
Approval status
Active

MFDS item code 201605777 · Approved 2016.09.30 · Insurance code 693902380

Summary

Main use
Improvement in the control of 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 irrespective of meals. It is advisable to take it at the same time each day (e.g., in the morning). In patients with renal impairment, mild to moderate renal impairment does not require dosage adjustment, but in those with severe renal impairment, treatment should begin at a lower dosage and gradually increase. In patients with liver impairment, the daily dose of Telmisartan should not exceed 40 milligrams.
Child dose
The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established; therefore, its use is not recommended.

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

Improvement in the control of essential hypertension.

  • Essential hypertension
View approved original text

This medication is used for patients with essential hypertension whose blood pressure is not sufficiently controlled with monotherapy of Amlodipine or Telmisartan. It effectively lowers blood pressure, aiding in hypertension management. Essential hypertension refers to a persistent high blood pressure state, and appropriate treatment is crucial. This medication stabilizes blood pressure by dilating blood vessels or improving blood pressure control mechanisms, thus reducing the patient's cardiovascular risk and contributing to maintaining healthy blood pressure. It assists in the prevention of complications by improving hypertension management.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet once daily, to be taken with water irrespective of meals. It is advisable to take it at the same time each day (e.g., in the morning). In patients with renal impairment, mild to moderate renal impairment does not require dosage adjustment, but in those with severe renal impairment, treatment should begin at a lower dosage and gradually increase. In patients with liver impairment, the daily dose of Telmisartan should not exceed 40 milligrams.

Child dose

The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established; therefore, its use is not recommended.

Precautions

This medication should not be used during pregnancy, especially in the second and third trimesters, as it can pose serious risks to the fetus. If pregnancy is confirmed, the use of this medication should be discontinued immediately, and a doctor should be consulted. Additionally, patients with known allergies to any of the components of this medication, or those with certain heart conditions, or severely impaired liver or kidney function, should not take it. It is also unsafe for breastfeeding women. This medication is not suitable for patients with excessively low blood pressure or in a state of shock. Special caution is required when using this medication in patients with certain heart valve diseases or liver diseases. Patients with gastrointestinal diseases or vascular kidney issues should strictly follow their doctor's instructions when taking this medication. Elderly patients may be more sensitive to this medication, so caution is advised during use. Dizziness and peripheral edema may occur while taking this medication, so any unusual symptoms should be reported to a doctor. There may be interactions with other medications, so all prescribed medications should be disclosed to the doctor. Caution is needed as this medication may lead to kidney function impairment or excessive blood pressure reduction when used in combination with certain drugs. Caution is also warranted when driving or operating machinery due to potential drowsiness or dizziness. In case of overdose, symptoms such as hypotension, dizziness, or heart problems may occur, necessitating immediate medical attention. The safety and efficacy of this medication have not been sufficiently established for children and adolescents.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, severe skin reactions, asthma attacks, respiratory distress accompanied by cough and fever, shortness of breath or difficulty breathing, jaundice (yellowing of the skin or eyes), extreme fatigue, liver abnormalities, sudden and severe headaches, thunderclap headache, seizures,

Mild side effects

  • Dizziness
  • peripheral edema
  • upper respiratory infection
  • urinary tract infection
  • anemia
  • hyperkalemia
  • hypoglycemia
  • hyponatremia
  • depression
  • insomnia
Show 29 more
  • drowsiness
  • headache
  • paresthesia
  • fainting
  • taste alterations
  • tremors
  • visual disturbances
  • vertigo
  • tinnitus
  • palpitations
  • bradycardia
  • tachycardia
  • flushing
  • hypotension
  • orthostatic hypotension
  • cough
  • abdominal pain
  • dyspepsia
  • nausea
  • vomiting
  • dry mouth
  • pruritus
  • hyperhidrosis
  • rash
  • hair loss
  • purpura
  • skin discoloration
  • eczema
  • erythema

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

Storage

This medication is sensitive to light, so it should be stored in a container that blocks light. It is advisable to store the medication at room temperature between 1 to 30 degrees Celsius. Proper storage maintains the effectiveness and stability of the medication.

Appearance and packaging

Appearance

A white and light gray, double convex, oval-shaped tablet.

Package unit

30 tablets (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.