Medication info

Seviol Tablet 10/40 mg

Prescription medicationExpired
Ingredient · strength
Amlodipine Besylate›Strength being verifiedOlmesartan Medoxomil›Strength being verified
Manufacturer / importer
(주)중헌제약
Appearance
Reddish-brown round film-coated tablets
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Expired

MFDS item code 201803057 · Approved 2018.07.24

This product's status changed to Expired on 2023.07.24. 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 uses it
Adults · Children
Adult dosage
This medication should be taken once daily, one tablet, with water regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). The recommended dosing is as follows: - 5/20 mg: administered to patients whose blood pressure is not adequately controlled with monotherapy of amlodipine 5 mg or olmesartan medoxomil 20 mg. - 10/20 mg: administered to patients whose blood pressure is not adequately controlled with olmesartan medoxomil 20 mg monotherapy.
Children's dosage
The safety and efficacy in pediatric patients under 18 years of age have not been established.

Ingredients

Manufacturer
(주)중헌제약

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is used for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled with monotherapy of amlodipine or olmesartan medoxomil. It helps patients with hypertension effectively lower their blood pressure, reducing the risk of cardiovascular disease.

Dosage and Administration

Adult dosage

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

Children's dosage

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

Precautions

This medication can cause serious harm to the fetus and newborn during the second and third trimesters of pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. It should not be used in individuals who are allergic to any of the ingredients, are pregnant or breastfeeding, have severe liver disease, aortic stenosis, biliary obstruction, are undergoing renal dialysis, are in shock, certain diabetic patients, and patients with moderate to severe renal impairment. Blood pressure should be monitored carefully in patients with low blood pressure due to dehydration or electrolyte deficiency, particularly in the early stages of treatment, as their blood pressure may drop too low. If hypotension occurs, appropriate measures should be taken. Due to the risk of rapid vasodilation leading to hypotension, caution should be taken in patients with severe aortic stenosis. Patients with severe obstructive coronary artery disease may have an increased risk of angina or myocardial infarction when taking this medication, warranting extra caution. Use with caution in patients with heart failure, as renal function may deteriorate and lead to renal failure, requiring regular monitoring. Patients with reduced liver function may be affected by the metabolism of this drug, necessitating dosage adjustments and careful supervision. While on this medication, regular checks of blood pressure, renal function, electrolyte levels, etc., are essential, especially due to the risk of hyperkalemia, necessitating careful monitoring of potassium levels. This medication may interact with other antihypertensive agents or specific medications. If you are taking other medications, make sure to inform your healthcare provider. Breastfeeding women are advised to stop either breastfeeding or taking this medication, as it may pass into breast milk and cause side effects in infants. The safety and efficacy in children under 18 years of age have not been established, so use is not recommended. The elderly may experience altered effects and side effects due to decreased renal and liver function and should start with a low dose and be treated with caution. In case of overdose, there may be a drop in blood pressure and cardiac function abnormalities, and immediate medical attention is required, with close observation of blood pressure and cardiac function. This medication should be stored away from direct sunlight and moisture, in a tightly closed container, and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), polyuria, angioedema, liver abnormalities (jaundice and increased liver enzymes), severe skin reactions (hair loss, itching, hives, toxic epidermal necrolysis), severe rash accompanied by high fever, blisters, skin peeling, pain in oral/eye mucosa, difficulty breathing, asthma attacks, sudden severe headache, worsening stroke, seizures, confusion, visual disturbances, severe hypertension.

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • paresthesia
  • palpitations
  • cough
  • nausea
  • vomiting
  • indigestion
  • diarrhea
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  • constipation
  • dry mouth
  • upper abdominal pain
  • rash
  • decreased libido
  • acute hypotension due to vasodilation
  • fatigue
  • erectile dysfunction
  • muscle tension
  • limb pain
  • back pain
  • polyuria
  • weakness
  • facial swelling
  • decreased blood potassium
  • increased serum creatinine
  • increased uric acid
  • elevated gamma-glutamyl transferase
  • decreased hemoglobin and hematocrit.

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

Storage

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

Appearance and packaging

Appearance

Reddish-brown round film-coated tablets

Package unit

30 tablets (10 tablets/PTP x 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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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.