Medication info
Romethan Tablet 5/40 mg

Romethan Tablet 5/40 mg

Prescription medicationTablet경구
Ingredient · strength
Olmesartan Medoxomil›40mg / 1 tabletAmlodipine Besylate›6.944mg / 1 tablet
Manufacturer / importer
주식회사제뉴원사이언스
Appearance
Pale yellow round film-coated tablets
Packaging
28 tablets/box [14 tablets/PTP×2]
Approval status
Active

MFDS item code 201405131 · Approved 2014.11.03 · Insurance code 671704380

Summary

Main use
Improvement of blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
This medication is administered as one tablet 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: For patients whose blood pressure is not adequately controlled on amlodipine 5 mg or olmesartan medoxomil 20 mg monotherapy. - 10/20 mg: For patients whose blood pressure is not adequately controlled on olmesartan medoxomil 20 mg.
Child dose
The safety and efficacy in pediatric patients under 18 years of age have not been established.

Ingredients

Manufacturer
주식회사제뉴원사이언스

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This medication is used for patients with essential hypertension who have difficulty controlling blood pressure with either amlodipine or olmesartan medoxomil monotherapy. It helps manage hypertension effectively, reducing cardiovascular risk and improving health.

How to take

Adult dose

This medication is administered as one tablet 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: For patients whose blood pressure is not adequately controlled on amlodipine 5 mg or olmesartan medoxomil 20 mg monotherapy. - 10/20 mg: For patients whose blood pressure is not adequately controlled on olmesartan medoxomil 20 mg.

Child dose

The safety and efficacy in pediatric patients under 18 years of age have not been established.

Precautions

This medication may cause serious harm to the fetus and newborn when taken during pregnancy in the second and third trimesters, so it should be discontinued immediately upon confirmation of pregnancy. Patients with hypersensitivity to any component of this medication, pregnant or nursing women, patients with severe liver impairment or aortic stenosis, those with biliary obstruction, patients undergoing kidney dialysis, patients in shock, and specific diabetic patients should not take this medication. Patients with deficiency of water or salt may experience symptoms of low blood pressure at the beginning of treatment with this medication, so their condition should be monitored closely, and appropriate measures should be taken if hypotension occurs. This medication can cause vasodilation, and in rare cases, acute hypotension may occur; hence caution is needed, especially in patients with aortic stenosis. Patients with severe coronary artery obstruction should be cautious, as angina or myocardial infarction may worsen while taking this medication. Patients with heart failure should also be closely monitored while taking this medication, and those with reduced kidney function should be aware of changes in kidney function. Patients with reduced liver function should take this medication with caution. While taking this medication, side effects such as dizziness, headache, hypotension, orthostatic hypotension, edema, dyspepsia, rash, etc., may occur, so any unusual symptoms should be reported to a doctor immediately. Women who are pregnant or planning to become pregnant should be switched to other safe antihypertensive treatments instead of this medication, and it should be discontinued immediately upon confirmation of pregnancy. Nursing mothers should be aware that this medication may pass into breast milk, potentially causing side effects in infants, so breastfeeding or taking this medication should be discontinued. Children under 18 years of age should not take this medication as its safety and efficacy have not been established. Elderly patients should start with a low dose considering reduced liver, kidney, and heart function and other illnesses for safety. In case of overdose, severe hypotension and vascular dilation may occur, and immediate medical treatment is needed; blood pressure raising medications may be required if necessary. This medication should be stored in a tightly closed container to avoid exposure to moisture and heat, out of reach of children.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • chest tightness
  • difficulty breathing
  • yellowing of skin or eyes (jaundice)
  • sudden and severe headache
  • seizures
  • confusion
  • visual disturbances
  • paralysis
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  • significant reduction in urine output
  • angioedema
  • acute renal failure
  • elevated blood creatinine
  • autoimmune hepatitis
  • leukopenia
  • thrombocytopenia
  • toxic epidermal necrolysis
  • intestinal vascular edema
  • rhabdomyolysis
  • worsening of cerebral infarction
  • gum bleeding

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • sensory disturbances
  • decreased perception
  • decreased libido
  • fainting
  • lightheadedness
  • palpitations
  • fast heartbeat
Show 25 more
  • hypotension
  • orthostatic hypotension
  • cough
  • nausea
  • vomiting
  • dyspepsia
  • diarrhea
  • constipation
  • dry mouth
  • upper abdominal pain
  • rash
  • muscle tone
  • limb pain
  • back pain
  • increased urination
  • erectile dysfunction
  • peripheral edema
  • edema
  • pitting edema
  • fatigue
  • weakness
  • facial edema
  • decreased blood potassium
  • increased blood creatinine
  • increased blood uric acid

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

Storage

This medication should be stored in a sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Pale yellow round film-coated tablets

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

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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.