Medication info
Telmisartan Plus Tablets 80/12.5mg

Telmisartan Plus Tablets 80/12.5mg

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›80mg / 1 tabletHydrochlorothiazide›12.5mg / 1 tablet
Manufacturer / importer
(주)씨엠지제약
Appearance
White or almost white, biconvex, round tablets
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201404666 · Approved 2014.10.10 · Insurance code 648602810

Summary

Main use
Treatment of essential hypertension for blood pressure control
Who takes it
Adults · Children
Adult dose
For patients whose blood pressure is not adequately controlled with telmisartan alone, take this medication once daily with or without food. It is recommended to adjust individual doses of each component before switching to a fixed-dose combination product. If clinically appropriate, a direct switch from monotherapy to this combination can be considered. - The telmisartan/hydrochlorothiazide combination 40/12.5mg can be administered to patients whose blood pressure is not adequately controlled with 40mg of telmisartan. - The telmisartan/hydrochlorothiazide combination 80/12.5mg can be administered to patients whose blood pressure is not adequately controlled with 80mg of telmisartan. - The telmisartan/hydrochlorothiazide combination 80/25mg can be administered to patients whose blood pressure is not adequately controlled with a combination of 80mg of telmisartan and 12.5mg of hydrochlorothiazide. Before starting treatment with this medication, sodium depletion or hypovolemia should be corrected. Patients with kidney impairment: For patients with mild to moderate kidney impairment, no dose adjustment is required. This drug should not be administered to patients with severe renal impairment (creatinine clearance <30 mL/min). Regular monitoring of kidney function is recommended. Patients with liver impairment: For patients with mild to moderate liver impairment, this drug should be administered with caution. It should not be given at doses exceeding 40/12.5mg per day. This medication should not be given to patients with severe liver impairment (refer to usage precautions 2). Thiazide diuretics should be used cautiously in patients with liver dysfunction. Elderly: No dose adjustment is necessary. Pediatric: The safety and efficacy of this medication have not been established in children under 18 years of age.
Child dose
The safety and efficacy in children under 18 years of age have not been established, so they should not be administered.

Ingredients

Manufacturer
(주)씨엠지제약

Efficacy & effects

Treatment of essential hypertension for blood pressure control

  • Essential hypertension
View approved original text

This medication is used additionally in patients with essential hypertension when blood pressure is not sufficiently controlled with telmisartan alone, allowing for more effective blood pressure control. It helps improve blood pressure management and prevents the occurrence of complications.

How to take

Adult dose

For patients whose blood pressure is not adequately controlled with telmisartan alone, take this medication once daily with or without food. It is recommended to adjust individual doses of each component before switching to a fixed-dose combination product. If clinically appropriate, a direct switch from monotherapy to this combination can be considered. - The telmisartan/hydrochlorothiazide combination 40/12.5mg can be administered to patients whose blood pressure is not adequately controlled with 40mg of telmisartan. - The telmisartan/hydrochlorothiazide combination 80/12.5mg can be administered to patients whose blood pressure is not adequately controlled with 80mg of telmisartan. - The telmisartan/hydrochlorothiazide combination 80/25mg can be administered to patients whose blood pressure is not adequately controlled with a combination of 80mg of telmisartan and 12.5mg of hydrochlorothiazide. Before starting treatment with this medication, sodium depletion or hypovolemia should be corrected. Patients with kidney impairment: For patients with mild to moderate kidney impairment, no dose adjustment is required. This drug should not be administered to patients with severe renal impairment (creatinine clearance <30 mL/min). Regular monitoring of kidney function is recommended. Patients with liver impairment: For patients with mild to moderate liver impairment, this drug should be administered with caution. It should not be given at doses exceeding 40/12.5mg per day. This medication should not be given to patients with severe liver impairment (refer to usage precautions 2). Thiazide diuretics should be used cautiously in patients with liver dysfunction. Elderly: No dose adjustment is necessary. Pediatric: The safety and efficacy of this medication have not been established in children under 18 years of age.

Child dose

The safety and efficacy in children under 18 years of age have not been established, so they should not be administered.

Precautions

This drug may cause serious harm to the fetus during pregnancy, particularly in the second and third trimesters, and should not be used during pregnancy. If pregnancy is confirmed, it should be discontinued as soon as possible and replaced with another safe medication if necessary. This medication should not be given to patients with allergies to the active ingredient or excipients, to pregnant or nursing women, or to patients with serious liver or kidney diseases. Caution is advised when using this drug in the elderly or patients with specific heart diseases, liver impairment, or kidney disorders, as there is a risk of rapid blood pressure drops, and they should be taken carefully. The hydrochlorothiazide component can cause fluid and electrolyte imbalances, so electrolyte levels should be regularly monitored during use. The risk of side effects may increase when this drug is combined with other antihypertensive medications, so it should be taken only after consulting a doctor. Sensitivity to sunlight may increase, so attention should be paid to UV protection during use, and if any skin abnormalities occur, consult a healthcare professional immediately. Dizziness or drowsiness may occur when driving or operating machinery, so these activities should be avoided if such symptoms appear. Overdose may result in symptoms such as hypotension, electrolyte imbalances, dehydration, and the dosage must be strictly adhered to; if unusual symptoms occur, a healthcare facility should be visited immediately. Safety in children has not been established, so it is advisable not to use in individuals under 18 years of age. This drug should be kept out of the reach of children and taken immediately after the sealed package is opened.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, peeling skin, mucosal pain in the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis

Mild side effects

  • Bronchitis
  • pharyngitis
  • sinusitis
  • hypokalemia
  • hyperuricemia
  • hyponatremia
  • anxiety
  • depression
  • insomnia
  • sleep disturbances
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  • dizziness
  • visual disturbances
  • blurred vision
  • vertigo
  • tachycardia
  • arrhythmia
  • hypotension
  • orthostatic hypotension
  • breathing difficulties
  • respiratory distress
  • pulmonary inflammation
  • pulmonary edema
  • diarrhea
  • dry mouth
  • abdominal distention
  • abdominal pain
  • constipation
  • dyspepsia
  • vomiting
  • liver dysfunction/liver disease
  • erythema
  • pruritus
  • rash
  • hyperhidrosis
  • back pain

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

Storage

This medication may be sensitive to air or moisture, so it is important to store it in a tightly closed container. The storage temperature should be kept between 1 and 30 degrees Celsius, avoiding extremely hot or cold conditions.

Appearance and packaging

Appearance

White or almost white, biconvex, round tablets

Package unit

30 tablets (10 tablets/PTP x 3)

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.