Medication info
Telmisartan and Amlodipine Tablets 80/5 mg

Telmisartan and Amlodipine Tablets 80/5 mg

Prescription medication경구
Ingredient · strength
Telmisartan›80mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tablet
Manufacturer / importer
(주)휴비스트제약
Appearance
White and light blue, double convex, oval-shaped tablets
Packaging
30 tablets (10 tablets/PTP*3), 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201700620 · Approved 2017.02.06 · Insurance code 628800990

Summary

Main use
Improvement of blood pressure in essential hypertension not controlled by monotherapy with telmisartan or amlodipine
Who takes it
Adults · Children
Adult dose
The recommended dosage of this medication is 1 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). 40/5 mg: Administered to patients whose blood pressure is not adequately controlled with 5 mg of amlodipine or 40 mg of telmisartan. 80/5 mg: Administered to patients whose blood pressure is not adequately controlled with 5 mg of amlodipine or this medication 40/5 mg.
Child dose
The safety and efficacy of this medication have not been established in pediatric patients under the age of 18, and it is not recommended for use in this population.

Ingredients

Manufacturer
(주)휴비스트제약

Efficacy & effects

Improvement of blood pressure in essential hypertension not controlled by monotherapy with telmisartan or amlodipine

  • Essential hypertension
View approved original text

This medication is used for patients with essential hypertension who have difficulty controlling their blood pressure with telmisartan or amlodipine monotherapy. It helps effectively lower blood pressure, reduces the risk of cardiovascular diseases, and maintains healthy blood pressure levels.

How to take

Adult dose

The recommended dosage of this medication is 1 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). 40/5 mg: Administered to patients whose blood pressure is not adequately controlled with 5 mg of amlodipine or 40 mg of telmisartan. 80/5 mg: Administered to patients whose blood pressure is not adequately controlled with 5 mg of amlodipine or this medication 40/5 mg.

Child dose

The safety and efficacy of this medication have not been established in pediatric patients under the age of 18, and it is not recommended for use in this population.

Precautions

This medication can cause serious harm to a fetus if taken during pregnancy, especially in the second and third trimesters; therefore, it should not be used by women who are pregnant or may become pregnant. This medication should not be administered to patients with certain diseases, such as liver impairment, severe hypotension, heart-related diseases, diabetes, or significantly reduced kidney function. Additionally, caution should be exercised when using this medication in certain patients, such as those with primary aldosteronism, valve stenosis, liver impairment, gastrointestinal diseases, renovascular hypertension, dialysis patients, and the elderly. When taking this medication, side effects such as dizziness and peripheral edema may occur, requiring attention; rarely, serious side effects may also arise. It should especially not be used during pregnancy, and if pregnancy is confirmed, the medication should be discontinued as soon as possible, and alternative treatments should be sought. Due to the risk of hypotension, patients who are dehydrated or have low sodium levels must correct these conditions before taking the medication, and if symptoms of hypotension occur while taking it, immediate appropriate treatment should be sought. Monitoring of potassium levels is necessary, as this medication may increase potassium levels in the blood, so patients at risk of hyperkalemia should have regular blood tests. Patients with compromised renal function should carefully monitor their kidney function while taking this medication. This medication may interact with certain drugs, so patients taking other medications must consult with their doctor or pharmacist. It is advisable for breastfeeding women not to take this medication, and it is not recommended for children or adolescents under the age of 18. In the event of an overdose, symptoms such as hypotension, dizziness, and arrhythmias may appear, and immediate contact with a medical institution for appropriate treatment is necessary. This medication should be kept out of reach of children, stored in its original packaging, and opened only immediately prior to use. Drowsiness or dizziness may occur while taking this medication, so caution is advised when driving or operating dangerous machinery.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (angioedema)
  • chest tightness
  • difficulty breathing
  • cold sweat
  • pallor
  • thrombocytopenia
  • anaphylactic reaction
  • fainting
  • myocardial infarction
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  • ventricular tachycardia
  • arrhythmia
  • atrial fibrillation
  • hypotension
  • vasculitis
  • dyspnea
  • liver dysfunction
  • liver impairment
  • hepatitis
  • jaundice
  • severe rash
  • blisters
  • skin peeling
  • oral/ocular mucosal pain
  • toxic skin rash
  • drug rash
  • Stevens-Johnson syndrome
  • phototoxicity
  • exfoliative dermatitis
  • serious

Mild side effects

  • Dizziness
  • peripheral edema
  • upper respiratory tract infection
  • urinary tract infection
  • anemia
  • hyperkalemia
  • hypoglycemia
  • hyponatremia
  • hyperglycemia
  • depression
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  • insomnia
  • mood changes
  • anxiety
  • drowsiness
  • headache
  • sensory disturbance
  • vision impairment
  • vertigo
  • tinnitus
  • palpitations
  • bradycardia
  • tachycardia
  • flushing
  • orthostatic hypotension
  • cough
  • abdominal pain
  • dyspepsia
  • nausea
  • vomiting
  • dry mouth
  • itching
  • sweating
  • rash
  • hair loss
  • purpura
  • skin discoloration
  • eczema
  • erythema
  • joint swelling

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

Storage

This medication should be stored in a container that protects it from light and air, at a temperature between 1 degree and 30 degrees Celsius. Proper storage can help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

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

Package unit

30 tablets (10 tablets/PTP*3), 30 tablets/bottle, 100 tablets/bottle

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.