Medication info
Telmisartan/Amlodipine Tablets 40/5 mg

Telmisartan/Amlodipine Tablets 40/5 mg

Prescription medication경구
Ingredient · strength
Telmisartan›40mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tablet
Manufacturer / importer
독립바이오제약(주)
Appearance
White and light blue biconvex oval double tablet
Packaging
30 tablets/box [(10 tablets/PTP*3)], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201906142 · Approved 2019.08.29 · Insurance code 057700370

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 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). - 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 patient whose blood pressure is not adequately controlled with 5 mg of amlodipine or this medication at 40/5 mg.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years of age; therefore, this medication is not recommended.

Ingredients

Manufacturer
독립바이오제약(주)

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

Used as an additional treatment option for patients with essential hypertension whose blood pressure is not adequately controlled with monotherapy of telmisartan or amlodipine.

How to take

Adult dose

The recommended dose of this medication 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). - 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 patient whose blood pressure is not adequately controlled with 5 mg of amlodipine or this medication at 40/5 mg.

Child dose

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

Precautions

This medication may cause severe harm to the fetus during pregnancy, especially in the second and third trimesters; hence, it should not be taken by women who are pregnant or may become pregnant. Patients with an allergy to the active ingredient or similar components, severe liver dysfunction or obstructive biliary disease, severe hypotension, patients in cardiogenic shock, and unstable heart failure after acute myocardial infarction should not take this medication. Patients with primary aldosteronism, aortic stenosis, mitral stenosis, obstructive hypertrophic cardiomyopathy, liver dysfunction, gastrointestinal diseases, renal artery hypertension, patients requiring dialysis, and the elderly should use this medication with caution. Dizziness and peripheral edema are common side effects of this medication, and occasionally fainting or cardiac-related adverse reactions can occur, so any abnormal symptoms should be reported to a healthcare professional immediately. During pregnancy, the use of this medication may cause serious side effects such as decreased fetal renal function, delayed skull formation, and hypotension; if pregnancy is confirmed, the medication should be stopped immediately and alternative treatment should be sought. Breastfeeding women should avoid taking this medication as its ingredients may be passed into breast milk. This medication may interact with other antihypertensives or specific medications; therefore, patients should inform their healthcare provider of any concurrent medications and regular blood pressure and blood tests should be performed to monitor their condition. Due to the risk of hypotension, patients with inadequate fluid or salt intake should be particularly cautious, and if hypotensive symptoms develop, they should lie down and rest and may require fluid treatment. While taking this medication, caution is needed when driving or operating hazardous machinery due to potential dizziness or drowsiness. In case of overdose, symptoms such as hypotension, dizziness, and acute renal failure may occur, and immediate medical attention should be sought. This medication is not recommended for children due to insufficiently established safety and efficacy.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rashes accompanied by high fever, blisters, skin peeling, mouth/eye mucosal pain, difficulty breathing or shortness of breath, asthma attacks, respiratory distress accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

Dizziness, peripheral edema, upper respiratory tract infections (including pharyngitis and sinusitis), urinary tract infections (including cystitis), anemia, hyperkalemia, hypoglycemia, hyponatremia, depression, insomnia, anxiety, confusion, drowsiness, migraines, headaches, paresthesia, fainting, peripheral neuropathy, taste disturbances, tremors, visual disturbances (including double vision), dizziness, tinnitus, palpitations, bradycardia, tachycardia, flushing, hypotension, orthostatic hypotension, cough, abdominal pain, dyspepsia,

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 special container that does not allow light to enter. Additionally, it is important to store it at room temperature between 1 degree and 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

White and light blue biconvex oval double tablet

Package unit

30 tablets/box [(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.