Medication info

Telmisartan and Rosuvastatin Tablets 80/10 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Telmisartan›80mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
동화약품(주)
Appearance
Bright blue oval film-coated tablets
Packaging
30 tablets/box [(10 tablets/PTP*3)]
Approval status
Approval withdrawn

MFDS item code 202001855 · Approved 2020.03.17

This product's status changed to Approval withdrawn on 2024.04.09. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
(hypertension, cardiovascular disease risk) reduction and (hypercholesterolemia) improvement effects
Who takes it
Adults
Adult dose
Telmisartan: For essential hypertension in adults: an oral dose of 40 mg once daily is recommended, with 20 mg once daily also being effective for some patients. If necessary, it can be increased up to 80 mg once daily. To reduce cardiovascular risk: an oral dose of 80 mg once daily is recommended. For patients with liver impairment: patients with mild to moderate liver impairment should not exceed 40 mg once daily. Rosuvastatin Calcium: Primary high

Ingredients

Manufacturer
동화약품(주)

Efficacy & effects

(hypertension, cardiovascular disease risk) reduction and (hypercholesterolemia) improvement effects

  • Essential hypertension
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined hyperlipidemia
  • homozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • elevated 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 who require the simultaneous administration of telmisartan and rosuvastatin. Telmisartan is primarily used to treat essential hypertension and reduce the risk of cardiovascular diseases. It is particularly effective at reducing the risk of myocardial infarction, stroke, and death due to cardiovascular diseases in high-risk patients. Rosuvastatin is used to treat hypercholesterolemia and dyslipidemia that are not controlled by diet, reducing LDL cholesterol and delaying the progression of atherosclerosis. It also helps reduce the risk of cardiovascular diseases and strokes, including myocardial infarction. Therefore, this medication is used to effectively reduce cardiovascular disease risk in patients with concomitant hypertension and dyslipidemia.

How to take

Adult dose

Telmisartan: For essential hypertension in adults: an oral dose of 40 mg once daily is recommended, with 20 mg once daily also being effective for some patients. If necessary, it can be increased up to 80 mg once daily. To reduce cardiovascular risk: an oral dose of 80 mg once daily is recommended. For patients with liver impairment: patients with mild to moderate liver impairment should not exceed 40 mg once daily. Rosuvastatin Calcium: Primary high

Precautions

This medication can cause severe harm, especially to the fetus and newborn during pregnancy; therefore, it should be discontinued immediately upon confirmation of pregnancy. It should not be used in patients with hypersensitivity to this medication, pregnant or breastfeeding women, or women of childbearing age who are not utilizing appropriate contraception. This medication is not suitable for patients with severe liver dysfunction or problems with bile excretion. Patients with a history of myopathy or hereditary angioedema should also avoid using this medication. It is prohibited for patients with severe renal impairment or those taking certain immunosuppressants. This medication contains lactose and should not be given to patients with lactose intolerance. Elderly patients, those with hyperkalemia, and patients with mild liver dysfunction should use this medication with caution and undergo regular tests of liver enzymes and kidney function. If symptoms such as muscle pain, weakness, or cramps occur, consult a physician immediately, and blood tests may be required to check for muscle damage if necessary. The risk of side effects may increase when this medication is combined with other antihypertensives or certain lipid-lowering agents, hence it should be taken according to the physician's instructions. Abnormal symptoms such as liver dysfunction, allergic reactions, hypotension, and worsening kidney function may occur, so patients should inform their healthcare provider immediately if any symptoms arise. This medication may cause dizziness or drowsiness while driving or operating machinery, so caution is advised. Keep out of reach of children and do not transfer to another container for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough + fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Headache
  • orthostatic dizziness
  • sleepiness
  • increased blood pressure
  • decreased diastolic blood pressure
  • hypotension
  • urinary pain
  • rhinitis
  • pharyngeal discomfort
  • pulmonary diseases
Show 23 more
  • unspecified gastrointestinal diseases
  • benign gastrointestinal neoplasms
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory loss
  • movement disorders
  • atherosclerosis
  • frequent urination
  • tinnitus
  • hearing loss
  • bad breath
  • fatty liver
  • depression
  • insomnia
  • anxiety
  • fainting
  • visual disturbances
  • dizziness
  • bradycardia
  • tachycardia
  • hypotension
  • orthostatic hypotension

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture ingress, and it is recommended to keep it at room temperature between 1°C and 30°C. Storing it this way will help maintain the medication's efficacy for a longer period.

Appearance and packaging

Appearance

Bright blue oval film-coated tablets

Package unit

30 tablets/box [(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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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.