Medication info
Aetista Tablets 40/5 mg

Aetista Tablets 40/5 mg

Prescription medication경구
Ingredient · strength
Telmisartan›40mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tablet
Manufacturer / importer
(주)휴온스생명과학
Appearance
Biconvex oval double-coated tablet in white and pale blue
Packaging
30 tablets/box (10 tablets/Alu-Alu X3)
Approval status
Active

MFDS item code 201700618 · Approved 2017.02.06 · Insurance code 052701050

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 1 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). If blood pressure is not adequately controlled, the dosage can be adjusted to 40/5 mg, 80/5 mg, or 40/10 mg based on ingredient-specific dosing. For patients with renal impairment, treatment should start at a lower dose in severe cases and be gradually increased.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years of age, thus the use of this medication is not recommended.

Ingredients

Manufacturer
(주)휴온스생명과학

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

Essential hypertension is a common form of hypertension, where additional treatment is needed when blood pressure is not sufficiently controlled by either telmisartan or amlodipine monotherapy. In such cases, the combination of the two medications or consideration of other treatment options is employed to effectively lower blood pressure. This helps reduce the risk of cardiovascular complications and improves the patient's health status.

How to take

Adult dose

The recommended dose of this medication is 1 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). If blood pressure is not adequately controlled, the dosage can be adjusted to 40/5 mg, 80/5 mg, or 40/10 mg based on ingredient-specific dosing. For patients with renal impairment, treatment should start at a lower dose in severe cases and be gradually increased.

Child dose

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

Precautions

This medication can cause severe harm to the fetus if taken during pregnancy, especially in the second and third trimesters, so it should not be used by pregnant women or women who may become pregnant. This medication should not be administered to patients with hypersensitivity to the active ingredients, biliary obstruction diseases, severe liver disease, or significant cardiac disorders. In patients with impaired kidney function, or those with moderate to severe kidney impairment among diabetic patients, the combination of this medication and certain drugs is prohibited. Caution is advised for patients with primary aldosteronism, cardiac valve diseases, liver disorders, gastrointestinal diseases, renal vascular hypertension, those undergoing dialysis for renal failure, and the elderly. Common side effects of this medication may include dizziness, peripheral edema, and others, and serious adverse reactions have been reported rarely, so immediate consultation with a physician is required if unusual symptoms occur. This medication should not be used during pregnancy, and if pregnancy is confirmed, it should be stopped immediately and alternative therapies should be initiated. It is also recommended that lactating women do not use this medication and consult a physician if they are breastfeeding. Patients with fluid or salt depletion should be particularly cautious as symptoms of hypotension may occur due to low blood pressure. Blood potassium levels may increase, so patients at risk for hyperkalemia should have regular blood tests done. Patients with impaired kidney function should undergo regular kidney function tests before and during treatment with this medication. Interactions may occur when this medication is used with other antihypertensive agents or certain drugs, so it is essential to inform the doctor or pharmacist of any other medications being taken. Dizziness or drowsiness may occur while driving or operating machinery, so caution is necessary. In case of overdose, serious hypotension or cardiac issues may occur, thus it is crucial to adhere to the prescribed dose and visit a medical institution immediately if unusual symptoms arise. Keep this medication out of the reach of children, store it in its original packaging, and it is advisable to take it immediately after opening.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), hypersensitivity, anaphylaxis, angioedema, toxic skin rash, Stevens-Johnson syndrome, angioedema, erythema multiforme, exfoliative dermatitis, jaundice, severe skin adverse reactions, dyspnea, abnormal liver function, hepatitis, increased liver enzymes, renal impairment (including acute kidney failure), significantly reduced urine output, severe generalized edema accompanying increased blood pressure, severe edema or urinary disturbances, severe allergic reactions

Mild side effects

  • Dizziness
  • peripheral edema
  • fainting
  • drowsiness
  • headache
  • sensory disturbances
  • taste disorders
  • tremors
  • visual impairment
  • tinnitus
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  • palpitations
  • bradycardia
  • tachycardia
  • flushing
  • hypotension
  • orthostatic hypotension
  • cough
  • abdominal pain
  • dyspepsia
  • nausea
  • vomiting
  • dry mouth
  • itching
  • rash
  • hair loss
  • thrombocytopenia
  • increased blood uric acid
  • muscle cramps
  • joint pain
  • back pain
  • erectile dysfunction
  • weakness
  • fatigue
  • increased liver enzymes
  • elevated blood creatinine
  • weight gain

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 prevents light exposure. Additionally, it is important to store it at room temperature, specifically between 1 to 30 degrees Celsius, to maintain its effectiveness.

Appearance and packaging

Appearance

Biconvex oval double-coated tablet in white and pale blue

Package unit

30 tablets/box (10 tablets/Alu-Alu X3)

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.