Medication info
Mizartan Plus Tablets 40/12.5 mg (Telmisartan, Hydrochlorothiazide)

Mizartan Plus Tablets 40/12.5 mg (Telmisartan, Hydrochlorothiazide)

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›40mg / 1 tabletHydrochlorothiazide›12.5mg / 1 tablet
Manufacturer / importer
이연제약(주)
Appearance
White or whitish oval tablets
Packaging
30 tablets (10 tablets/Alu-Alu * 3)
Approval status
Active

MFDS item code 201903560 · Approved 2019.05.29 · Insurance code 658604650

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
For patients not adequately controlled with telmisartan alone, take this medication once daily with water, regardless of meals. It is recommended to adjust the doses of each component separately before switching to this medication, as the doses of its components are fixed. When clinically appropriate, direct switching from monotherapy to this medication may also be considered. - Telmisartan/Hydrochlorothiazide Combination 40/12.5 mg may be given to patients whose blood pressure is not adequately controlled with 40 mg of telmisartan. - Telmisartan/Hydrochlorothiazide Combination 80/12.5 mg may be given to patients whose blood pressure is not adequately controlled with 80 mg of telmisartan. - Telmisartan/Hydrochlorothiazide Combination 80/25 mg may be given to patients whose blood pressure is not adequately controlled with either 80 mg of telmisartan or 12.5 mg of hydrochlorothiazide alone or in combination. Sodium or volume depletion should be corrected before starting this medication. Renal impairment: For patients with mild to moderate renal impairment, dose adjustments are not necessary. This medication should not be given to patients with severe renal impairment (creatinine clearance <30 mL/min). Periodic monitoring of renal function is recommended. Liver impairment: Patients with mild to moderate liver impairment should use this medication with caution. The dosage should not exceed 40/12.5 mg per day. This medication should not be given to patients with severe liver impairment (see Precautions 2). Thiazide diuretics should be used with caution in patients with liver impairment. Elderly patients: Dose adjustments are not necessary. Pediatric patients: The safety and efficacy of this medication have not been established for patients under 18 years of age.
Child dose
The safety and efficacy of this medication have not been established for children under 18 years of age.

Ingredients

Manufacturer
이연제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is used in the treatment of essential hypertension, and is particularly helpful for effectively managing blood pressure when telmisartan alone does not adequately control blood pressure.

How to take

Adult dose

For patients not adequately controlled with telmisartan alone, take this medication once daily with water, regardless of meals. It is recommended to adjust the doses of each component separately before switching to this medication, as the doses of its components are fixed. When clinically appropriate, direct switching from monotherapy to this medication may also be considered. - Telmisartan/Hydrochlorothiazide Combination 40/12.5 mg may be given to patients whose blood pressure is not adequately controlled with 40 mg of telmisartan. - Telmisartan/Hydrochlorothiazide Combination 80/12.5 mg may be given to patients whose blood pressure is not adequately controlled with 80 mg of telmisartan. - Telmisartan/Hydrochlorothiazide Combination 80/25 mg may be given to patients whose blood pressure is not adequately controlled with either 80 mg of telmisartan or 12.5 mg of hydrochlorothiazide alone or in combination. Sodium or volume depletion should be corrected before starting this medication. Renal impairment: For patients with mild to moderate renal impairment, dose adjustments are not necessary. This medication should not be given to patients with severe renal impairment (creatinine clearance <30 mL/min). Periodic monitoring of renal function is recommended. Liver impairment: Patients with mild to moderate liver impairment should use this medication with caution. The dosage should not exceed 40/12.5 mg per day. This medication should not be given to patients with severe liver impairment (see Precautions 2). Thiazide diuretics should be used with caution in patients with liver impairment. Elderly patients: Dose adjustments are not necessary. Pediatric patients: The safety and efficacy of this medication have not been established for patients under 18 years of age.

Child dose

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

Precautions

This medication can pose serious risks to the fetus during pregnancy, especially in the second and third trimesters, so discontinuation should be immediate upon confirmation of pregnancy. Patients who are allergic to the ingredients in this medication or have specific liver or kidney diseases should not use it. Elderly patients or those with certain heart, liver, or kidney conditions should use this medication with caution and be careful not to let blood pressure drop too low. Hydrochlorothiazide may increase sensitivity of the skin to sunlight, so exposure to ultraviolet radiation should be minimized during treatment, and any skin changes should be promptly discussed with a physician. Various side effects such as dizziness, headache, indigestion, and rash may occur during treatment; report any unusual symptoms to healthcare professionals immediately. Interactions may occur when used with other antihypertensive medications, certain diuretics, lithium, potassium supplements, etc., so notify your doctor of any other medications you are taking. Women who are pregnant or breastfeeding should not use this medication, and it should be avoided during breastfeeding due to the potential transfer into breast milk. In cases of overdose, symptoms such as hypotension, electrolyte imbalance, and dehydration may arise, thus seek medical attention immediately for appropriate treatment according to symptoms. This medication has not been established as safe and effective for children under 18 years of age, hence is not recommended. During use, keep out of reach of children, and store in a sealed condition until just prior to administration to maintain quality.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema (including fatal results)
  • chest tightness
  • difficulty breathing
  • angioedema (including fatal results)
  • angioedema
  • sweating
  • angioedema (fatal outcome)
  • angioedema (fatal results included)
  • angioedema
Show 14 more
  • angioedema
  • angioedema
  • angioedema
  • angioedema
  • angioedema
  • angioedema
  • angioedema
  • hives
  • angioedema (fatal results included)
  • angioedema
  • angioedema
  • angioedema
  • hives
  • blood

Mild side effects

Dizziness, diarrhea, cough, pharyngitis, sinusitis, hypokalemia, hyperuricemia, hyponatremia, anxiety, depression, insomnia, sleep disorders, paresthesia, visual impairment, blurred vision, vertigo, tachycardia, arrhythmia, hypotension, orthostatic hypotension, lung inflammation, gastrointestinal disorders (dry mouth, bloating, abdominal pain, constipation, indigestion, vomiting, gastritis), sweating, rash, hives, back pain, muscle cramps, myalgia, arthralgia,

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage will help safely preserve the medication's effectiveness.

Appearance and packaging

Appearance

White or whitish oval tablets

Package unit

30 tablets (10 tablets/Alu-Alu * 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.