Medication info
Romethan Tablet 10/40 mg

Romethan Tablet 10/40 mg

Prescription medicationTablet경구
Ingredient · strength
Olmesartan Medoxomil›40mg / 1 tabletAmlodipine Besylate›13.888mg / 1 tablet
Manufacturer / importer
주식회사제뉴원사이언스
Appearance
Brownish-red round film-coated tablet
Packaging
28 tablets/box [14 tablets/PTP×2]
Approval status
Active

MFDS item code 201405130 · Approved 2014.11.03 · Insurance code 671704360

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
This medication is administered once daily as one tablet 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: Used for patients whose blood pressure is not adequately controlled with Amlodipine 5 mg or Olmesartan medoxomil 20 mg monotherapy. - 10/20 mg: Used for patients whose blood pressure is not adequately controlled with Olmesartan medoxomil 20 mg.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years of age.

Ingredients

Manufacturer
주식회사제뉴원사이언스

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

Amlodipine or olmesartan medoxomil is used when blood pressure is not adequately controlled with monotherapy in patients with essential hypertension. These medications effectively control blood pressure by dilating blood vessels or lowering blood pressure, thus helping to prevent cardiovascular diseases. They are drugs that contribute to maintaining health through proper blood pressure management.

How to take

Adult dose

This medication is administered once daily as one tablet 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: Used for patients whose blood pressure is not adequately controlled with Amlodipine 5 mg or Olmesartan medoxomil 20 mg monotherapy. - 10/20 mg: Used for patients whose blood pressure is not adequately controlled with Olmesartan medoxomil 20 mg.

Child dose

Safety and efficacy have not been established for pediatric patients under 18 years of age.

Precautions

This medication can cause serious harm or death to the fetus and newborn if taken during the second and third trimesters of pregnancy, so it should be discontinued immediately if pregnancy is confirmed. It should not be administered to individuals with an allergy to the active ingredients or similar substances, pregnant or breastfeeding women, individuals with severe liver disease, aortic stenosis, biliary obstruction, those undergoing kidney dialysis, individuals in shock, or specific diabetic patients. Patients with hypotension due to a deficit in fluid or salt or extreme vasodilation, patients with severe coronary artery disease, congestive heart failure, decreased kidney function, or liver dysfunction should use this medication cautiously. If symptoms of hypotension occur, immediate treatment and observation are necessary. Various side effects such as dizziness, headache, blood pressure drops, digestive disorders, skin rashes, and swelling may appear while taking this medication, so consult a healthcare professional if symptoms are severe or persistent. Abrupt discontinuation of beta-blockers can be dangerous; therefore, although this medication is not a beta-blocker, the dosage should be reduced gradually when discontinuing beta-blockers. This medication may interact with other blood pressure medications, diuretics, antibiotics, grapefruit juice, etc., so it is essential to inform your healthcare provider of any other medications being taken, especially avoiding grapefruit juice. Pregnant women should not use this medication, and those planning to become pregnant or who are pregnant should switch to safer alternatives. During breastfeeding, because this medication can be transferred into breast milk, it is advisable to either stop breastfeeding or discontinue the medication. Safety and efficacy have not been established in pediatric patients under 18 years of age, so it is not recommended. Elderly patients may have decreased kidney and liver function, so treatment should start at lower doses and their conditions should be monitored closely. In cases of overdose, hypotension and abnormal heart rate may occur, requiring immediate medical attention and appropriate treatment, which may include medications to raise blood pressure. This medication should be stored out of the reach of children, avoiding moisture, heat, and direct sunlight.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), difficulty breathing, respiratory distress, severe skin reactions, liver abnormalities (jaundice), sudden and severe headache, seizures, confusion, visual disturbances, paralysis, significantly reduced urination, severe swelling throughout the body with increased blood pressure, angioedema, acute renal failure, increased serum creatinine levels, angioedema, vascular edema, autoimmune hepatitis, toxic epidermal necrolysis.

Mild side effects

  • Dizziness
  • headache
  • orthostatic hypotension
  • drowsiness
  • sensory abnormalities
  • decreased sensation
  • lightheadedness
  • palpitations
  • rapid pulse
  • hypotension
Show 25 more
  • postural hypotension
  • cough
  • nausea
  • vomiting
  • dyspepsia
  • diarrhea
  • constipation
  • dry mouth
  • upper abdominal pain
  • rash
  • hives
  • muscle tension
  • limb pain
  • low back pain
  • frequency of urination
  • erectile dysfunction
  • peripheral edema
  • swelling
  • pitting edema
  • fatigue
  • weakness
  • facial swelling
  • decreased serum potassium
  • increased serum creatinine
  • and blood urea nitrogen.

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. To maintain the drug's efficacy, it is recommended to keep it at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Brownish-red round film-coated tablet

Package unit

28 tablets/box [14 tablets/PTP×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.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.