Medication info

Sebical 10/40 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Olmesartan Medoxomil›40mg / 1 tabletAmlodipine Besylate›13.888mg / 1 tablet
Manufacturer / importer
한국신텍스제약(주)
Appearance
Red-brown round film-coated tablet
Packaging
28/PTP[(14 tablets/PTP x 2)]
Approval status
Expired

MFDS item code 201907787 · Approved 2019.11.07

This product's status changed to Expired on 2024.11.07. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
This medication is taken once daily with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). The recommended dosages are as follows: - 5/20 mg: Administered to patients whose blood pressure is not adequately controlled by monotherapy with amlodipine 5 mg or olmesartan medoxomil 20 mg. - 10/20 mg: Administered to patients with olmesartan medoxomil 20 mg.
Child dose
Safety and efficacy have not been established in pediatric patients under the age of 18.

Ingredients

Manufacturer
한국신텍스제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is used for patients with essential hypertension whose blood pressure is not adequately controlled by monotherapy with amlodipine or olmesartan medoxomil. Essential hypertension refers to a condition where blood pressure is consistently high, and it is important to reduce the risk of cardiovascular complications through appropriate treatment. This medication effectively lowers blood pressure and helps protect the heart and blood vessels. Therefore, it is used in the treatment of essential hypertension.

How to take

Adult dose

This medication is taken once daily with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). The recommended dosages are as follows: - 5/20 mg: Administered to patients whose blood pressure is not adequately controlled by monotherapy with amlodipine 5 mg or olmesartan medoxomil 20 mg. - 10/20 mg: Administered to patients with olmesartan medoxomil 20 mg.

Child dose

Safety and efficacy have not been established in pediatric patients under the age of 18.

Precautions

This medication can cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, so it must be discontinued immediately upon confirmation of pregnancy. It should not be used by individuals with allergies to the active ingredients or similar components, pregnant or nursing women, patients with severe liver impairment, aortic stenosis, bile duct obstruction, patients undergoing dialysis, patients in shock, or certain diabetic patients. Patients with low blood pressure due to a lack of fluid or salt may experience symptoms of hypotension, so careful monitoring is required when starting the medication. Significant vasodilation may lead to hypotension, so patients with heart or vascular issues should be cautious. Caution is required for patients with heart failure, and those with impaired kidney function should be closely monitored for changes in kidney function while on this medication. This medication may cause side effects such as dizziness, headache, hypotension, orthostatic hypotension, drowsiness, nausea, edema, and rash. Particularly, potassium levels may increase, so regular monitoring of potassium levels is necessary. Patients on beta-blockers should avoid sudden discontinuation and taper off doses gradually; this medication is not a beta-blocker. When used in conjunction with other antihypertensives, the blood pressure-lowering effects may be increased, so it should be taken as directed by a physician. Taking this medication with grapefruit juice may enhance the blood pressure-lowering effects, so it is advisable to avoid it. It should not be used during pregnancy; if planning pregnancy or if pregnancy is confirmed, consultation with a physician is mandatory. Nursing women are advised to stop breastfeeding or discontinue the medication, as it may pass into breast milk. Safety and efficacy have not been established in pediatric patients under 18 years old, so its use is not recommended. Elderly patients should start with a low dose, considering potential kidney and liver function decline, and should be cautious while taking it. In cases of overdose, symptoms such as hypotension and cardiac arrhythmias may occur, and immediate medical assistance should be sought; blood pressure and cardiac function should be monitored regularly. This medication should be stored in a tightly sealed container away from moisture, heat, and direct sunlight, out of the reach of children.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, urination

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • sensory disturbances
  • sensory decline
  • decreased libido
  • reduced serum potassium
  • increased serum creatinine
  • increased serum uric acid
  • elevated gamma-glutamyl transferase
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  • decreased hemoglobin and hematocrit
  • palpitations
  • rapid pulse
  • hypotension
  • orthostatic hypotension
  • cough
  • nausea
  • vomiting
  • dyspepsia
  • diarrhea
  • constipation
  • dry mouth
  • upper abdominal pain
  • rash
  • muscle tension
  • limb pain
  • back pain
  • frequent urination
  • erectile dysfunction
  • peripheral edema

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

Storage

This medication should be kept in a tightly sealed container to avoid exposure to air or moisture. The recommended storage temperature is between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Red-brown round film-coated tablet

Package unit

28/PTP[(14 tablets/PTP x 2)]

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.

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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.