Medication info
Telmidipin Al Tablet 40/5/10 mg (Telmisartan, Amlodipine, Rosuvastatin)

Telmidipin Al Tablet 40/5/10 mg (Telmisartan, Amlodipine, Rosuvastatin)

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›40mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
하나제약(주)
Appearance
Pink oval film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201803759 · Approved 2018.09.18 · Insurance code 657806290

Summary

Main use
Treatment of essential hypertension and hypercholesterolemia (risk reduction of atherosclerosis)
Who takes it
Adults
Adult dose
Take 1 tablet daily with water at any time, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). For Telmisartan/Amlodipine combination therapy, the available dosages are 40/5 mg, 80/5 mg, 40/10 mg, and 80/10 mg based on blood pressure control status. For patients with renal impairment, mild to moderate cases do not require dose adjustment, however, severe cases should begin treatment with a lower dose.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

Treatment of essential hypertension and hypercholesterolemia (risk reduction of atherosclerosis)

  • Essential hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol levels
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is used for patients with essential hypertension who have difficulty controlling blood pressure even with the monotherapy of Telmisartan and Amlodipine combination. Additionally, Rosuvastatin acts as an adjunct to dietary therapy for patients with hypercholesterolemia and mixed hyperlipidemia, lowering blood cholesterol levels and delaying the progression of atherosclerosis. It helps reduce the risks of stroke, myocardial infarction, and arterial revascularization, especially for high-risk patients with elevated high-sensitivity C-reactive protein levels. By managing both blood pressure and cholesterol, it effectively improves the risk of cardiovascular diseases.

How to take

Adult dose

Take 1 tablet daily with water at any time, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). For Telmisartan/Amlodipine combination therapy, the available dosages are 40/5 mg, 80/5 mg, 40/10 mg, and 80/10 mg based on blood pressure control status. For patients with renal impairment, mild to moderate cases do not require dose adjustment, however, severe cases should begin treatment with a lower dose.

Precautions

This medication can cause serious harm to the fetus and newborn during pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. It should not be used in patients with allergies to this medication or similar drugs or those with certain diseases. Patients with severe liver or kidney impairment, certain heart diseases, and muscle-related diseases should take this medication carefully and undergo regular check-ups as directed by their physician. If muscle pain, muscle weakness, or any other muscle-related symptoms occur during treatment with this drug, consult a doctor immediately and blood tests should be performed as necessary to check for muscle damage. Patients with excessively low blood pressure, hyperkalemia, elderly patients, gastrointestinal diseases, etc., should use caution when taking this medication, and dosage adjustments or additional tests may be necessary depending on symptoms. This medication may interact with other drugs, so if you are taking other medications, be sure to inform your doctor or pharmacist, particularly when used in conjunction with specific antibiotics, immunosuppressants, anticoagulants, etc. Women who may become pregnant should use appropriate contraception and it is recommended not to use this medication while breastfeeding. Use in children or adolescents under the age of 18 is not recommended as safety and efficacy have not been sufficiently established. In case of overdose, symptoms such as hypotension, dizziness, and renal dysfunction may occur, so immediate medical attention is necessary, and since there is no specific antidote, treatment will be supportive based on the symptoms. Store in a place out of reach of children and do not transfer to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urine changes

Mild side effects

  • Headache
  • dizziness
  • cough
  • nausea
  • fatigue
  • weakness
  • edema
  • back pain
  • constipation
  • diarrhea
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  • abdominal pain
  • itching
  • rash
  • fever
  • malaise
  • pain
  • angioedema
  • thrombocytopenia
  • dermatitis
  • facial edema
  • limb edema
  • vasculitis
  • dry mouth
  • insomnia
  • drowsiness
  • sensory loss
  • paresthesia
  • myalgia
  • muscle spasm
  • myopathy
  • weakness
  • loss of appetite
  • weight gain
  • weight loss
  • blood abnormalities
  • thrombocytopenia
  • leukopenia

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

Storage

This medication is sensitive to light, so it should be stored in a tightly sealed container that blocks light. It is best to store it at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

30 tablets/bottle

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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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.