Medication info

Twin Beta-Al Tablet 40/5/5 mg (Telmisartan, Amlodipine, Rosuvastatin)

Prescription medicationApproval withdrawn
Ingredient · strength
Telmisartan›Strength being verifiedAmlodipine Besylate›Strength being verifiedRosuvastatin Calcium›Strength being verified
Manufacturer / importer
대웅바이오(주)
Appearance
Pink oval film-coated tablet
Packaging
30 tablets (10 tablets x 3) / PTP
Approval status
Approval withdrawn

MFDS item code 201803887 · Approved 2018.10.02

This product's status changed to Approval withdrawn on 2023.04.25. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
(Hypertension, Hyperlipidemia) Blood pressure control and cholesterol improvement, reduction of cardiovascular disease risk
Who uses it
Adults
Adult dosage
Take one tablet once a day with water, regardless of meals. It is recommended to take it at the same time each day (e.g., morning) if possible. Dosage adjustments for the telmisartan/amlodipine combination should be individualized based on the patient's blood pressure control. - 40/5 mg: Administer to patients whose blood pressure is not adequately controlled with 5 mg of amlodipine or 40 mg of telmisartan. - 80/5 mg

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

(Hypertension, Hyperlipidemia) Blood pressure control and cholesterol improvement, reduction of cardiovascular disease risk

  • Essential hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined 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 hypertension who do not have adequate blood pressure control with telmisartan and amlodipine combination therapy, while rosuvastatin acts as an adjunct to diet and exercise therapy for patients with hypercholesterolemia and hyperlipidemia. It also assists in treating familial hypercholesterolemia and dysbetalipoproteinemia, lowers total cholesterol and LDL cholesterol levels, and delays the progression of atherosclerosis. For patients over middle age at high risk for cardiovascular events, it is expected to reduce the risk of myocardial infarction, stroke, and arterial revascularization. Therefore, this medication is used to improve symptoms in patients requiring simultaneous management of blood pressure and lipids.

Dosage and Administration

Adult dosage

Take one tablet once a day with water, regardless of meals. It is recommended to take it at the same time each day (e.g., morning) if possible. Dosage adjustments for the telmisartan/amlodipine combination should be individualized based on the patient's blood pressure control. - 40/5 mg: Administer to patients whose blood pressure is not adequately controlled with 5 mg of amlodipine or 40 mg of telmisartan. - 80/5 mg

Precautions

This medication can cause serious harm to the fetus and newborn during pregnancy, so if pregnancy is confirmed, it should be immediately discontinued. Patients with hypersensitivity to any of the active ingredients or components of this medication, those with a history of certain angioedema, severe hepatic or renal impairment, or severe heart diseases should not take this medication. Elderly patients, those with hypotension, patients with mild hepatic dysfunction, and those at risk for muscle disorders should exercise special caution when taking this medication. This medication may cause musculoskeletal adverse reactions such as myalgia or muscle weakness, so if such symptoms occur during treatment, consult a doctor immediately. Since this medication may affect liver function, regular monitoring of liver enzyme levels before and during treatment is recommended. Additionally, this medication can affect serum potassium levels, posing a risk of hyperkalemia, so testing of serum electrolytes may also be necessary. Given the potential for drug interactions, patients should inform their physician or pharmacist of all medications they are taking. It is advisable to avoid the use of this medication during breastfeeding, and if it must be used, breastfeeding should be discontinued. Overdose may lead to symptoms such as hypotension, dizziness, and heart-related abnormal symptoms, which require immediate medical attention. This medication is not recommended for children or adolescents under 18, as safety and efficacy have not been established. Patients should be cautious when driving or operating machinery as dizziness or drowsiness may occur during treatment. Keep this medication out of reach of children and do not transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, peeling skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory difficulties accompanied by cough and fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Headache
  • dizziness
  • orthostatic hypotension
  • back pain
  • viral upper respiratory infection
  • rectal bleeding
  • dyspepsia
  • atopic dermatitis
  • peripheral edema
  • nausea
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  • fatigue
  • pain
  • palpitations
  • leg edema
  • abnormal ECG
  • insomnia
  • drowsiness
  • paresthesia
  • involuntary muscle contractions
  • sensory reduction
  • flatulence
  • constipation
  • gastritis
  • vomiting
  • dry mouth
  • hemorrhoids
  • gastroenteritis
  • enteritis
  • gastroesophageal reflux
  • dental pain
  • nonspecific gastrointestinal disorders
  • gout
  • hypercholesterolemia
  • diabetes

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

Storage

Store this medication in a sealed container that protects from light and air. It is best to maintain the storage temperature between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

30 tablets (10 tablets x 3) / PTP

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.