Medication info
Distab 40/5mg

Distab 40/5mg

Prescription medication경구
Ingredient · strength
Telmisartan›40mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tablet
Manufacturer / importer
삼남제약(주)
Appearance
White and light blue, bilaterally convex oval dual tablet
Packaging
30 tablets (10 tablets/PTP*3)
Approval status
Active

MFDS item code 201605767 · Approved 2016.09.30 · Insurance code 653702220

Summary

Main use
Improvement in blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dose for this medication is 1 tablet once daily, to be taken with water regardless of meals. It is advisable to take it daily at the same time (e.g., in the morning). In cases of severe renal impairment, treatment should start with a lower dose, which should be gradually increased. In patients with hepatic impairment, the daily dose of telmisartan should not exceed 40 milligrams. In elderly patients (75 years and older), it is preferable to start with a lower dose.
Child dose
Safety and efficacy in pediatric patients under 18 years of age have not been established, and therefore, administration of this medication is not recommended.

Ingredients

Manufacturer
삼남제약(주)

Efficacy & effects

Improvement in blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This medicine is used in patients with essential hypertension who do not achieve adequate blood pressure control with telmisartan or amlodipine monotherapy. It helps lower and control blood pressure effectively in such cases. Hence, this medicine can be used for the stable management of blood pressure in essential hypertension therapy.

How to take

Adult dose

The recommended dose for this medication is 1 tablet once daily, to be taken with water regardless of meals. It is advisable to take it daily at the same time (e.g., in the morning). In cases of severe renal impairment, treatment should start with a lower dose, which should be gradually increased. In patients with hepatic impairment, the daily dose of telmisartan should not exceed 40 milligrams. In elderly patients (75 years and older), it is preferable to start with a lower dose.

Child dose

Safety and efficacy in pediatric patients under 18 years of age have not been established, and therefore, administration of this medication is not recommended.

Precautions

This medicine should not be used during pregnancy, especially in the second and third trimesters, as it may pose serious risks to the fetus. It should not be administered to women who are allergic to the active ingredients, those who are pregnant or breastfeeding, patients with obstructive biliary disease, severe hepatic impairment, or certain heart conditions. Caution should be exercised in patients with primary aldosteronism, impaired liver function, gastrointestinal diseases, renal artery hypertension, elderly patients, and others. Common side effects such as dizziness and peripheral edema may occur when taking this medicine, and serious side effects like fainting or heart-related issues may rarely occur. Avoid the use of this medicine during pregnancy, and if pregnancy is confirmed, stop taking it immediately and switch to another safe medication. Due to the risk of hypotension, patients with insufficient fluids or salt should correct their condition or adjust the dose under medical supervision before taking this medicine. This medicine may increase serum potassium levels, and regular testing of potassium levels and kidney function is necessary. Patients with heart failure or cardiovascular diseases need careful management when taking this medicine, especially those with severe heart failure. This medicine contains sorbitol and is not suitable for patients with fructose intolerance. Diabetic patients should consult with their physician as the risk of coronary artery disease may increase. Dizziness or drowsiness may occur while taking this medication, so caution is needed when driving or operating hazardous machinery. There may be interactions with other antihypertensive medications, so inform your doctor or pharmacist if you are taking other medications. Overdose may result in hypotension, arrhythmia, renal failure, and immediate medical attention is required. This medicine is not recommended for children and adolescents under 18 due to insufficient evidence of safety and efficacy. Elderly patients may be more sensitive to this medicine, so it is advisable to start with a lower dose and gradually increase it. This medicine should be kept out of reach of children and stored in a cool, dry place in the prescribed container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), cold sweat, pallor, severe allergic reaction, severe rash accompanied by high fever, blisters, peeling skin, pain in mucous membranes of mouth/eyes, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, breathing problems, yellowing of skin or eyes (jaundice), extreme lethargy, liver dysfunction (jaundice), sudden and severe headache, seizures

Mild side effects

Dizziness, drowsiness, headache, migraine, abnormal sensations, peripheral edema, palpitations, 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, low back pain, limb pain, urinary disorders, frequent urination, nocturia, erectile dysfunction, asthenia, fatigue, chest pain, malaise

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

Storage

This medicine is sensitive to light, so it should be stored in a container that does not allow light to pass through. Additionally, it is recommended to store the medicine at room temperature, between 1 to 30 degrees Celsius, to ensure safe storage.

Appearance and packaging

Appearance

White and light blue, bilaterally convex oval dual tablet

Package unit

30 tablets (10 tablets/PTP*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

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.