Medication info
AmloTel Tablet 80/5mg

AmloTel Tablet 80/5mg

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

MFDS item code 201606292 · Approved 2016.10.26 · Insurance code 662503580

Summary

Main use
Improvement of blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage of this drug is one 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). Dosage can be adjusted based on blood pressure control with 40/5 mg, 80/5 mg, and 40/10 mg formulations. In cases of kidney impairment, treatment should begin with a lower dose in severe cases, gradually increasing the dosage. For patients with liver impairment,
Child dose
The safety and efficacy in pediatric patients under 18 years of age have not been established; therefore, the use of this medication is not recommended.

Ingredients

Manufacturer
(주)넥스팜코리아

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This medication is used as an adjunct treatment for patients with essential hypertension whose blood pressure is not adequately controlled with amlodipine or telmisartan monotherapy. Essential hypertension may pose difficulties in maintaining blood pressure within a normal range; this drug helps effectively lower blood pressure and reduce the risk of cardiovascular diseases. Therefore, it is appropriately used for patients requiring blood pressure management, contributing to the maintenance of healthy blood pressure.

How to take

Adult dose

The recommended dosage of this drug is one 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). Dosage can be adjusted based on blood pressure control with 40/5 mg, 80/5 mg, and 40/10 mg formulations. In cases of kidney impairment, treatment should begin with a lower dose in severe cases, gradually increasing the dosage. For patients with liver impairment,

Child dose

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

Precautions

This drug should not be used during pregnancy, especially in the second and third trimesters, as it can pose severe risks to the fetus. If pregnancy is confirmed, the administration of this drug should be discontinued as soon as possible, and if necessary, replaced with another safe treatment. This drug should not be administered to patients with certain conditions, such as liver disease, heart disease, hypotension, or severe kidney impairment. Additionally, patients with allergic reactions or those at high risk of interactions with certain drugs should avoid this medication. Although this drug is effective in lowering blood pressure as an antihypertensive agent, it may cause side effects such as hypotension or dizziness, so caution is needed. Patients at risk of hyperkalemia may need to undergo regular blood tests due to the potential increase in serum potassium levels. Patients with impaired liver or kidney function should be closely monitored while taking this medication. Drowsiness or dizziness may occur during treatment, so caution should be exercised when driving or operating dangerous machinery. Furthermore, interactions with other medications may occur, so it is essential to inform healthcare professionals of any other medications being taken. This drug is not suitable for patients with hereditary fructose intolerance. In case of overdose, severe hypotension or cardiac abnormalities may occur, so the dosage must be strictly adhered to, and any unusual symptoms should be immediately reported to healthcare professionals. The safety and efficacy in children or adolescents under 18 years of age have not been adequately established; therefore, its use is not recommended. In elderly patients, a more sensitive response to this medication may be observed, thus necessitating careful dose adjustments and monitoring. This drug should be kept out of reach of children and should be taken immediately after opening the packaging.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in oral/eye mucosa, difficulty in breathing or shortness of breath, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, significantly decreased urine output, and general malaise.

Mild side effects

  • Dizziness
  • peripheral edema
  • upper respiratory tract infection
  • urinary tract infection
  • anemia
  • hyperkalemia
  • hypoglycemia
  • hyponatremia
  • hyperglycemia
  • depression
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  • insomnia
  • anxiety
  • confusion
  • drowsiness
  • migraines
  • headaches
  • sensory abnormalities
  • visual disturbances
  • vertigo
  • tinnitus
  • palpitations
  • bradycardia
  • tachycardia
  • flushing
  • hypotension
  • orthostatic hypotension
  • cough
  • abdominal pain
  • dyspepsia
  • nausea
  • vomiting
  • dry mouth
  • itching
  • sweating
  • rash
  • hair loss
  • purpura
  • skin discoloration
  • and perspiration.

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

Storage

This drug should be stored in a container that protects it from light and air, at a temperature between 1 and 30 degrees Celsius. This ensures that the ingredients of the medication remain stable and can be used safely.

Appearance and packaging

Appearance

White or off-white rectangular tablets

Package unit

30 tablets/box [(10 tablets/Alu-Alu x 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.