Medication info
Telmisartan Plus Tablet 80/12.5 mg

Telmisartan Plus Tablet 80/12.5 mg

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›80mg / 1 tabletHydrochlorothiazide›12.5mg / 1 tablet
Manufacturer / importer
신풍제약(주)
Appearance
An oval tablet that consists of two layers, white and pink, with possible pink specks on the white layer.
Packaging
30 tablets/box (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201101835 · Notified 2011.03.31 · Insurance code 648506860

Summary

Main use
Treatment of hypertension
Who takes it
Adults · Children
Adult dose
For patients whose blood pressure is not adequately controlled with Telmisartan alone, take one dose daily with a drink, regardless of meal timing. It is recommended to adjust the dosage of each component separately before switching to this fixed-dose combination medication. It may be considered to directly switch from monotherapy if clinically appropriate. - Telmisartan/Hydrochlorothiazide combination 40/12.5 mg can be administered to patients whose blood pressure is not adequately controlled with 40 mg of Telmisartan. - Telmisartan/Hydrochlorothiazide combination 80/12.5 mg can be administered to patients whose blood pressure is not adequately controlled with 80 mg of Telmisartan. - Telmisartan/Hydrochlorothiazide combination 80/25 mg can be administered to patients whose blood pressure is not adequately controlled with 80 mg of Telmisartan and 12.5 mg of Hydrochlorothiazide, whether single or combination therapy. Sodium or volume depletion should be corrected before starting this medication. For renal impairment patients: No dose adjustment is necessary for patients with mild-to-moderate renal impairment. This medication should not be administered to patients with severe renal impairment (creatinine clearance <30 mL/min). Regular monitoring of renal function is recommended. For liver impairment patients: Caution is advised for administering this medication to patients with mild-to-moderate liver impairment. It should not be given in doses exceeding 40/12.5 mg per day. This medication should not be administered to patients with severe liver impairment (see Note 2 in the precautions for use). Thiazide diuretics should be used with caution in patients with impaired liver function. For elderly patients: No dose adjustment necessary. For children: Safety and efficacy have not been established for pediatric patients under 18 years of age.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years of age.

Ingredients

Manufacturer
신풍제약(주)

Efficacy & effects

Treatment of hypertension

  • Essential hypertension
View approved original text

This medication is used for patients with essential hypertension for effective blood pressure reduction when blood control is insufficient with Telmisartan alone. This helps manage blood pressure appropriately to reduce the risk of complications.

How to take

Adult dose

For patients whose blood pressure is not adequately controlled with Telmisartan alone, take one dose daily with a drink, regardless of meal timing. It is recommended to adjust the dosage of each component separately before switching to this fixed-dose combination medication. It may be considered to directly switch from monotherapy if clinically appropriate. - Telmisartan/Hydrochlorothiazide combination 40/12.5 mg can be administered to patients whose blood pressure is not adequately controlled with 40 mg of Telmisartan. - Telmisartan/Hydrochlorothiazide combination 80/12.5 mg can be administered to patients whose blood pressure is not adequately controlled with 80 mg of Telmisartan. - Telmisartan/Hydrochlorothiazide combination 80/25 mg can be administered to patients whose blood pressure is not adequately controlled with 80 mg of Telmisartan and 12.5 mg of Hydrochlorothiazide, whether single or combination therapy. Sodium or volume depletion should be corrected before starting this medication. For renal impairment patients: No dose adjustment is necessary for patients with mild-to-moderate renal impairment. This medication should not be administered to patients with severe renal impairment (creatinine clearance <30 mL/min). Regular monitoring of renal function is recommended. For liver impairment patients: Caution is advised for administering this medication to patients with mild-to-moderate liver impairment. It should not be given in doses exceeding 40/12.5 mg per day. This medication should not be administered to patients with severe liver impairment (see Note 2 in the precautions for use). Thiazide diuretics should be used with caution in patients with impaired liver function. For elderly patients: No dose adjustment necessary. For children: Safety and efficacy have not been established for pediatric patients under 18 years of age.

Child dose

Safety and efficacy have not been established for pediatric patients under 18 years of age.

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately upon confirmation of pregnancy. Individuals allergic to any components or additives of this medication, as well as pregnant or breastfeeding women, or individuals with severe liver or kidney disease should not use it. Elderly patients, those with hyperkalemia, liver disease patients, and those with heart valve diseases should use this medication with caution. The Hydrochlorothiazide component can cause electrolyte imbalance in the body, so potassium, sodium levels, and other values should be monitored regularly with blood tests. Adverse reactions such as dizziness, low blood pressure, cardiac abnormalities, skin rashes, etc., may occur during the intake of this medication; if symptoms arise, consult a doctor immediately. When taken with other blood pressure medications, diuretics, lithium, or drugs that affect blood potassium levels, there is a potential for interactions, so follow the advice of a healthcare professional. Women planning or currently pregnant should use alternative treatments that have proven safety instead of this medication, and do not administer it while breastfeeding. Overdose can lead to low blood pressure, electrolyte disturbances, dehydration, etc., so strict adherence to the dosage must be maintained, and if abnormal symptoms occur, visit a medical institution immediately. Safety and efficacy in children have not been established; therefore, it is not recommended. While taking this medication, caution is needed as dizziness or drowsiness may occur when driving or operating machinery. This medication may be sensitive to light; therefore, avoid excessive exposure to sunlight and consult a doctor immediately if any skin abnormalities occur. Store it in a tightly closed container away from air and moisture, and ensure it is kept out of reach of children. It should be taken out of the packaging just before use.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • severe swelling (edema)
  • angioedema
  • chest tightness
  • difficulty breathing
  • angioedema (including fatal outcomes)
  • anaphylactic reactions
  • severe rash with high fever
  • blisters
  • peeling skin
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  • mucosal pain in mouth/eyes
  • liver function abnormalities
  • jaundice (yellowing of the skin or eyes)
  • extreme lethargy
  • dyspnea or difficulty breathing
  • asthma attacks
  • cough+breathe abnormalities with fever
  • acute respiratory distress syndrome.

Mild side effects

Bronchitis, pharyngitis, sinusitis, hypokalemia, hyperuricemia, hyponatremia, anxiety, depression, insomnia, sleep disturbances, dizziness, visual impairment, blurred vision, lightheadedness, tachycardia, arrhythmia, hypotension, orthostatic hypotension, dyspnea, cough, pulmonary inflammation, pulmonary edema, diarrhea, dry mouth, flatulence, abdominal pain, constipation, dyspepsia, vomiting, liver function abnormalities/liver disease, erythema, pruritus, rash, hyperhidrosis, urticaria, etc.

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air or moisture and should be kept at room temperature between 1 degree and 30 degrees Celsius. Proper storage will safely preserve the effectiveness of the medication.

Appearance and packaging

Appearance

An oval tablet that consists of two layers, white and pink, with possible pink specks on the white layer.

Package unit

30 tablets/box (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.