Medication info
Telmisartan/Amlodipine Tablet 40/5mg

Telmisartan/Amlodipine Tablet 40/5mg

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›40mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tablet
Manufacturer / importer
지엘파마(주)
Appearance
White or off-white oblong tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201903386 · Approved 2019.05.24 · Insurance code 649702210

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage for adults is one tablet once daily, to be taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). In cases of severe renal impairment, treatment should start at a low dose, gradually increasing as needed. Patients with liver impairment should not exceed a total daily dose of 40 milligrams. Elderly patients (75 years and older) should begin treatment at a low dose.
Child dose
Safety and efficacy for pediatric patients under 18 have not been established, thus administration of this medication is not recommended.

Ingredients

Manufacturer
지엘파마(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is used for patients with essential hypertension whose blood pressure is not adequately controlled with monotherapy of amlodipine or telmisartan. It helps to effectively lower blood pressure and reduce the risk of cardiovascular diseases.

How to take

Adult dose

The recommended dosage for adults is one tablet once daily, to be taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). In cases of severe renal impairment, treatment should start at a low dose, gradually increasing as needed. Patients with liver impairment should not exceed a total daily dose of 40 milligrams. Elderly patients (75 years and older) should begin treatment at a low dose.

Child dose

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

Precautions

This medication should not be used during pregnancy, especially in the second and third trimesters, as it may cause serious harm to the fetus. There is an increased risk of fetal kidney dysfunction, decreased amniotic fluid, and cranial formation abnormalities. If pregnancy is confirmed, this medication should be discontinued immediately. This medication is contraindicated for individuals with allergies to the active or similar ingredients, pregnant or potentially pregnant women, nursing mothers, and patients with severe liver or biliary problems. Additionally, it should not be administered to patients with severely impaired heart function, those with very low blood pressure, or patients in an unstable condition after acute myocardial infarction. Caution is required when using this medication in patients with primary aldosteronism, certain valvular heart diseases, liver disorders, gastrointestinal disorders, renal artery stenosis, dialysis patients, and the elderly. In particular, patients with impaired liver function may require dose adjustments. Common side effects while taking this medication include dizziness and peripheral edema, and rarely, serious side effects such as syncope may occur. Hypotension symptoms such as excessively low blood pressure may arise; hence patients with fluid or salt deficiency should correct these deficiencies before taking the medication or adjust the dose under medical supervision. Blood potassium levels may increase; therefore, patients, especially those with renal disease or heart failure, should regularly monitor potassium levels through blood tests. This medication may affect kidney function; therefore, patients with weak kidney function need regular blood and kidney function tests. Patients with heart disease should be careful, as too low blood pressure can worsen myocardial infarction or angina pectoris. Dizziness or drowsiness may occur while driving or operating machinery; caution is advised. There may be drug interactions when taken with other medications, so consult healthcare professionals, particularly when taking digoxin, lithium, warfarin, non-steroidal anti-inflammatory drugs, grapefruit juice, etc. Taking this medication during pregnancy can pose serious risks to the fetus, so individuals planning for pregnancy or who are already pregnant should consult with healthcare professionals, and nursing mothers should also avoid taking this medication. Safety and effectiveness in children under 18 have not been sufficiently established, so use in this population is not recommended. When administered to the elderly, as they may be more sensitive in their bodily reactions, starting with a lower dose and gradually increasing is advisable. In case of overdose, symptoms such as low blood pressure, dizziness, and cardiac function decline may occur, necessitating immediate emergency treatment, as this medication is not removed by hemodialysis. This medication should be kept out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, difficulty breathing, liver abnormalities (jaundice), yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning-like pain

Mild side effects

Dizziness, peripheral edema, syncope, drowsiness, headache, sensory disturbances, taste disturbances, tremors, visual disturbances, vertigo, tinnitus, palpitations, bradycardia, hypotension, orthostatic hypotension, flushing, cough, changes in bowel habits (including diarrhea and constipation), abdominal pain, indigestion, nausea, vomiting, dry mouth, itching, sweating, rash, hair loss, purpura, skin discoloration, eczema, erythema, joint swelling, muscle cramps, arthralgia, myalgia, back pain, erectile dysfunction

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 dark container protected from light. Additionally, it is important to store it at room temperature, specifically between 1 degree and 30 degrees Celsius, to maintain its efficacy.

Appearance and packaging

Appearance

White or off-white oblong tablet

Package unit

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.