Medication info
Telmisartan and Amlodipine Tablets 80/5mg

Telmisartan and Amlodipine Tablets 80/5mg

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›80mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tablet
Manufacturer / importer
(주)경보제약
Appearance
White or off-white rectangular tablet
Packaging
30 tablets (10 tablets/Alu-Alu * 3), 30 tablets/bottle
Approval status
Active

MFDS item code 201605862 · Approved 2016.09.30 · Insurance code 665002160

Summary

Main use
Improvement of blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication is one tablet once a day, taken with water without regard to food. It is advisable to take it at the same time every 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
Safety and efficacy in pediatric patients under 18 years of age have not been established, hence use of this medication is not recommended.

Ingredients

Manufacturer
(주)경보제약

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

In cases where blood pressure is not adequately controlled due to essential hypertension, treatment can be administered with either amlodipine or telmisartan monotherapy. These two drugs effectively lower blood pressure by either dilating blood vessels or aiding in blood pressure regulation. In particular, these antihypertensive medications play an important role in reducing the risk of cardiovascular disease by improving blood pressure management. If either drug alone is not sufficient for adequate control, combination therapy may be considered. This allows for effective management of hypertension.

How to take

Adult dose

The recommended dose of this medication is one tablet once a day, taken with water without regard to food. It is advisable to take it at the same time every 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

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

Precautions

This medication should be avoided during pregnancy, especially in the second and third trimesters, as it can cause serious harm to the fetus. If pregnancy is confirmed, use should be discontinued as soon as possible, and women planning to conceive are advised to switch to other medications with confirmed safety. This medication should not be administered to patients with specific conditions, such as severe liver impairment, severe hypotension, cardiogenic shock, or unstable heart failure after acute myocardial infarction. Additionally, diabetic patients with severely impaired kidney function or breastfeeding women should not take this medication. Patients with primary hyperaldosteronism, certain heart valve diseases, liver impairment, gastrointestinal disorders, renal artery hypertension, patients undergoing dialysis, and the elderly should use this medication with special caution. Common side effects may include dizziness and peripheral edema, and more serious side effects may occur, so any unusual symptoms should be discussed with a doctor immediately. Hypotensive symptoms may appear if blood pressure drops too low, so patients, especially those who are deficient in fluids or salts, should manage their condition carefully before taking this medication. There is a risk of increased potassium levels in the blood, so patients at risk for hyperkalemia should have regular blood tests. Patients with impaired kidney function should periodically check their renal function and electrolyte levels, and heart failure patients require caution while taking this medication. Moreover, this drug may interact with other medications, so inform your doctor or pharmacist of any other medications taken. Pregnant and breastfeeding women should not use this medication, as it may be transferred through breast milk. Safety and efficacy have not been established in pediatric patients, thus it is not recommended for use in children. The elderly may respond more sensitively to this medication, so it should be used cautiously with dose adjustments. In case of overdose, symptoms such as hypotension, tachycardia, and in severe cases, shock may occur, requiring immediate medical attention. This medication should be kept out of reach of children and should not be transferred to another container to maintain product quality. It should be opened just before use.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • severe allergic reactions
  • angioedema
  • toxic skin rash
  • urticaria
  • Stevens-Johnson syndrome
  • liver dysfunction
  • liver impairment
  • hepatitis
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  • jaundice
  • severe adverse skin reactions
  • angioedema (with fatal outcomes)
  • myocardial infarction
  • ventricular tachycardia
  • arrhythmia
  • atrial fibrillation
  • severe edema or urinary anomalies
  • syncope
  • intestinal vascular edema
  • difficulty breathing
  • sepsis
  • acute kidney failure
  • renal dysfunction
  • hypotension
  • shock
  • cerebral infarction

Mild side effects

  • Dizziness
  • peripheral edema
  • upper respiratory infection
  • urinary tract infection
  • cystitis
  • anemia
  • hyperkalemia
  • hypoglycemia
  • hyponatremia
  • hyperglycemia
Show 29 more
  • depression
  • insomnia
  • anxiety
  • confusion
  • drowsiness
  • migraine
  • sensory disturbances
  • visual impairments
  • vertigo
  • tinnitus
  • palpitations
  • bradycardia
  • tachycardia
  • flushing
  • hypotension
  • orthostatic hypotension
  • cough
  • abdominal pain
  • dyspepsia
  • nausea
  • vomiting
  • dry mouth
  • pruritus
  • hyperhidrosis
  • rash
  • hair loss
  • angioedema
  • eczema
  • flushing

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 protects it from light. Additionally, it is important to maintain a room temperature between 1 to 30 degrees Celsius when storing the medication. This helps to preserve the effectiveness of the drug over time.

Appearance and packaging

Appearance

White or off-white rectangular tablet

Package unit

30 tablets (10 tablets/Alu-Alu * 3), 30 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.