Medication info
Telmisartan 80/5 mg Tablets

Telmisartan 80/5 mg Tablets

Prescription medication경구
Ingredient · strength
Telmisartan Powder 23.9%›334.72mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tablet
Manufacturer / importer
유니메드제약(주)
Appearance
It is a white to light gray, double convex, oval tablet.
Packaging
30 tablets (10 tablets/PTP × 3)
Approval status
Active

MFDS item code 201804338 · Approved 2018.10.31 · Insurance code 649507810

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage for this medicine is 1 tablet once daily, to be taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). For patients with kidney disorders, no dose adjustment is needed for mild or moderate impairment; however, treatment should start at a lower dose for patients with severe impairment, and the dose should be gradually increased. For patients with liver impairment, the dose of telmisartan should not exceed 40 mg per day for mild or moderate liver impairment.
Child dose
The safety and efficacy of this medicine in pediatric patients under 18 years have not been established, and its use is not recommended.

Ingredients

Manufacturer
유니메드제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

Used for essential hypertension that is not adequately controlled by monotherapy with telmisartan or amlodipine.

How to take

Adult dose

The recommended dosage for this medicine is 1 tablet once daily, to be taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). For patients with kidney disorders, no dose adjustment is needed for mild or moderate impairment; however, treatment should start at a lower dose for patients with severe impairment, and the dose should be gradually increased. For patients with liver impairment, the dose of telmisartan should not exceed 40 mg per day for mild or moderate liver impairment.

Child dose

The safety and efficacy of this medicine in pediatric patients under 18 years have not been established, and its use is not recommended.

Precautions

This medicine should not be used during pregnancy, especially during the second and third trimesters, as it can pose serious risks to the fetus. If pregnancy is confirmed, this medicine should be discontinued immediately. This drug is contraindicated for patients with specific diseases such as severe liver or heart dysfunction, hypotension, shock, and those with hypersensitivity to certain medications. Furthermore, women who could become pregnant or are breastfeeding should not take this medicine. Caution is required when administering this drug to patients with impaired liver or kidney function, specific heart valve diseases, active gastrointestinal diseases, or renovascular hypertension which necessitates strict medical observation. Side effects such as dizziness or edema may commonly occur during the course of treatment, so caution is advised. If symptoms of significantly low blood pressure or serious side effects occur, medical consultation should be obtained immediately. Additionally, this medicine may interact with other medications, and it is essential to inform the doctor or pharmacist about other medications being taken. Extra caution is warranted when administering this medicine to the elderly, and dose adjustments may be necessary. Overdose may lead to hypotension, cardiac arrhythmias, and impaired kidney function, requiring immediate medical treatment. Finally, the safety and efficacy of this drug in children have not been sufficiently established, hence its use is not recommended.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions; severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions; shortness of breath or difficulty in breathing, asthma attacks, respiratory difficulties accompanied by cough and fever; yellowing of the skin or eyes (jaundice), extreme malaise, liver dysfunction (jaundice); sudden and severe headache.

Mild side effects

Dizziness, peripheral edema, upper respiratory infections (including pharyngitis and sinusitis), urinary tract infections (including cystitis), anemia, hyperkalemia, hypoglycemia (in diabetic patients), hyponatremia, hyperglycemia, depression, insomnia, mood changes, anxiety, drowsiness, headache, migraine, paresthesia, taste disorders, tremors, visual impairment (including diplopia), vertigo, tinnitus, palpitations, bradycardia, tachycardia, flushing, hypotension, orthostatic hypotension, cough, abdominal pain, dyspepsia.

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

Storage

This medicine may be sensitive to light; therefore, it should be stored in a tightly sealed container that is protected from light. The storage temperature should be maintained between 1 to 30 degrees Celsius. Storing it this way will help maintain the drug's efficacy safely.

Appearance and packaging

Appearance

It is a white to light gray, double convex, oval 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

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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.