Medication info
Entitelmi Plus Tablet 40/12.5 milligrams

Entitelmi Plus Tablet 40/12.5 milligrams

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›40mg / 1 tabletHydrochlorothiazide›12.5mg / 1 tablet
Manufacturer / importer
한국신텍스제약(주)
Appearance
White or whitish, oval-shaped tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201906944 · Approved 2019.09.30 · Insurance code 623005960

Summary

Main use
Treatment for blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
In patients whose blood pressure cannot be adequately controlled with telmisartan alone, this medication should be taken once daily with water, regardless of meals. Before switching to this medication, it is recommended to individually adjust the dosage of each component with fixed doses. When clinically appropriate, switching directly from monotherapy to this medication can also be considered. - The combination of telmisartan/hydrochlorothiazide 40/12.5mg can be administered to patients whose blood pressure is not adequately controlled with 40mg of telmisartan. - The combination of telmisartan/hydrochlorothiazide 80/12.5mg can be administered to patients whose blood pressure is not adequately controlled with 80mg of telmisartan. - The combination of telmisartan/hydrochlorothiazide 80/25mg can be given to patients whose blood pressure is not adequately controlled with either 80mg of telmisartan and 12.5mg of hydrochlorothiazide alone or in combination. Sodium or volume depletion should be corrected before starting this medication. In patients with kidney impairment No dosage adjustment is necessary for patients with mild to moderate kidney impairment. This medication should not be administered to patients with severe kidney impairment (creatinine clearance <30 mL/min). Periodic monitoring of kidney function is recommended. In patients with liver impairment In patients with mild to moderate liver impairment, this medication should be administered with caution and should not exceed 40/12.5mg once daily. This medication should not be administered to patients with severe liver impairment (refer to precautionary information 2). Thiazide diuretics should be used cautiously in patients with liver dysfunction. In the elderly No dosage changes are necessary. In children The safety and efficacy of this medication have not been established in children under 18 years of age.
Child dose
The safety and efficacy of this medication have not been established in children under 18 years of age.

Ingredients

Manufacturer
한국신텍스제약(주)

Efficacy & effects

Treatment for blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

In patients with essential hypertension whose blood pressure cannot be adequately controlled with telmisartan alone, adding this medication can effectively manage blood pressure. This medication improves hypertension treatment and helps prevent cardiovascular complications.

How to take

Adult dose

In patients whose blood pressure cannot be adequately controlled with telmisartan alone, this medication should be taken once daily with water, regardless of meals. Before switching to this medication, it is recommended to individually adjust the dosage of each component with fixed doses. When clinically appropriate, switching directly from monotherapy to this medication can also be considered. - The combination of telmisartan/hydrochlorothiazide 40/12.5mg can be administered to patients whose blood pressure is not adequately controlled with 40mg of telmisartan. - The combination of telmisartan/hydrochlorothiazide 80/12.5mg can be administered to patients whose blood pressure is not adequately controlled with 80mg of telmisartan. - The combination of telmisartan/hydrochlorothiazide 80/25mg can be given to patients whose blood pressure is not adequately controlled with either 80mg of telmisartan and 12.5mg of hydrochlorothiazide alone or in combination. Sodium or volume depletion should be corrected before starting this medication. In patients with kidney impairment No dosage adjustment is necessary for patients with mild to moderate kidney impairment. This medication should not be administered to patients with severe kidney impairment (creatinine clearance <30 mL/min). Periodic monitoring of kidney function is recommended. In patients with liver impairment In patients with mild to moderate liver impairment, this medication should be administered with caution and should not exceed 40/12.5mg once daily. This medication should not be administered to patients with severe liver impairment (refer to precautionary information 2). Thiazide diuretics should be used cautiously in patients with liver dysfunction. In the elderly No dosage changes are necessary. In children The safety and efficacy of this medication have not been established in children under 18 years of age.

Child dose

The safety and efficacy of this medication have not been established in children under 18 years of age.

Precautions

This medication can pose serious risks to the fetus during pregnancy, particularly in the second and third trimesters, so it should be discontinued immediately if pregnancy is confirmed. This medication should not be used in individuals with allergies to the active ingredients or excipients, hypersensitivity to sulfonamide drugs, pregnant or breastfeeding women, those with biliary obstruction or cholestatic disorders, severe liver or kidney impairment, acute glomerulonephritis or anuria, certain electrolyte imbalances, or those combining it with specific drugs in diabetic or moderate to severe kidney impairment patients. Elderly patients, those with hyperkalemia, liver impairment, valvular heart disease, ischemic heart disease, or cerebrovascular disorders should use this medication with caution, and due to increased risk of skin cancer, sun exposure should be limited while regularly reviewing skin conditions. This medication can cause various side effects including hypotension, dizziness, orthostatic hypotension, electrolyte imbalances, liver function abnormalities, skin rash, myalgia, dyspnea, among others, so immediate consultation with a healthcare provider is necessary if abnormal symptoms occur. Particularly, this medication may affect fluid and electrolyte balance, requiring regular blood tests and kidney function tests; interactions with other drugs necessitate caution during co-administration. It should not be used during pregnancy and should be avoided while breastfeeding. In case of overdose, symptoms such as hypotension, electrolyte imbalances, and dehydration may occur, requiring immediate medical treatment. Safety and efficacy have not been established in children under 18 years of age, and usage in elderly patients should be cautious to avoid excessive blood pressure reduction. This medication should be kept out of reach of children, and transferring it to another container is not recommended.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • angioedema (including fatal outcomes)
  • chest tightness
  • difficulty breathing
  • vascular edema
  • fever
  • severe rash with high fever
  • blisters
  • skin peeling
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  • pain in oral/eye mucous membranes
  • angioedema
  • angioedema
  • angioedema
  • angioedema
  • angioedema
  • angioedema
  • angioedema
  • angioedema
  • angioedema
  • angioedema
  • angioedema
  • angioedema
  • angioedema
  • angioedema
  • angioedema
  • angioedema
  • angioedema

Mild side effects

  • Dizziness
  • diarrhea
  • cough
  • pharyngitis
  • sinusitis
  • hyperuricemia
  • hyponatremia
  • anxiety
  • depression
  • insomnia
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  • sleep disturbances
  • blurred vision
  • lightheadedness
  • tachycardia
  • arrhythmia
  • hypotension
  • orthostatic hypotension
  • pulmonary inflammation
  • abdominal pain
  • vomiting
  • gastritis
  • pruritus
  • rash
  • sweating
  • muscle cramps
  • myalgia
  • arthralgia
  • erectile dysfunction
  • chest pain
  • increased blood uric acid
  • increased blood creatinine
  • increased liver enzymes
  • dry mouth
  • altered taste

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

Storage

This medication should be stored in a sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature to preserve its effectiveness and safety over time.

Appearance and packaging

Appearance

White or whitish, oval-shaped tablets

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

No questions yet.

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.