Medication info
Selfrovel Plus Tablet 150/12.5 mg

Selfrovel Plus Tablet 150/12.5 mg

Prescription medicationTablet
Ingredient · strength
Irbesartan›150mg / 1 tabletHydrochlorothiazide›12.5mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
Pink, double convex, rectangular film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201707500 · Approved 2017.10.18 · Insurance code 693902730

Summary

Main use
Control and treatment effect of essential hypertension
Who uses it
Adults · Children
Adult dosage
This medication is administered once daily regardless of meals. 1. For patients whose blood pressure is not sufficiently controlled with monotherapy: - Administer 1 tablet of Irbesartan 150 mg/Hydrochlorothiazide 12.5 mg once daily. - If blood pressure is not controlled, administer 1 tablet of Irbesartan 300 mg/Hydrochlorothiazide 12.5 mg once daily. - If further blood pressure control is necessary, administer Irbesartan 300 mg/Hydrochlorothiazide 25 mg once daily.
Children's dosage
The safety and efficacy of this medication have not been established for children and adolescents under 18 years of age.

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

Control and treatment effect of essential hypertension

  • Essential hypertension
  • moderate hypertension
  • severe hypertension
View approved original text

This medication helps patients with essential hypertension control their blood pressure. It is used as an additional treatment when blood pressure does not sufficiently lower as a monotherapy, and for moderate to severe hypertension patients, a combination therapy is designed to reach the target blood pressure from the beginning. Therefore, this drug effectively lowers blood pressure and is used in the management of hypertension.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. 1. For patients whose blood pressure is not sufficiently controlled with monotherapy: - Administer 1 tablet of Irbesartan 150 mg/Hydrochlorothiazide 12.5 mg once daily. - If blood pressure is not controlled, administer 1 tablet of Irbesartan 300 mg/Hydrochlorothiazide 12.5 mg once daily. - If further blood pressure control is necessary, administer Irbesartan 300 mg/Hydrochlorothiazide 25 mg once daily.

Children's dosage

The safety and efficacy of this medication have not been established for children and adolescents under 18 years of age.

Precautions

This medication can cause serious harm to the fetus and newborn especially during pregnancy; therefore, it should be discontinued immediately if pregnancy is confirmed. Women who are pregnant or may become pregnant, nursing mothers, and patients with an allergy to this medication or its components should not use it. Patients with severely impaired kidney function or anuria should also refrain from taking this medication. Patients with a history of specific liver diseases or angioedema need to be cautious. Patients with specific diseases such as hypotension, kidney disease, liver dysfunction, valvular heart disease, acute glaucoma should use this medication carefully. Due to the hydrochlorothiazide component, there may be an increased risk of skin cancer; thus, it is advisable to avoid sun exposure and regularly check for skin changes. Common side effects include dizziness, fatigue, nausea, abnormal urination, and less frequently, symptoms such as blood pressure drops, swelling, and liver function abnormalities may occur. Regular blood tests are needed to monitor kidney function or electrolyte levels, as changes may occur. This medication does not significantly affect driving or machine operation, but caution is advised if dizziness or fatigue occurs. Since there is a risk of hypotension, any loss of body fluids due to dietary salt restriction, excessive use of diuretics, diarrhea, or vomiting should be corrected before taking this medication. Patients with renal artery stenosis may experience a significant risk of hypotension and renal failure, so caution is necessary. Patients with liver disease or valvular heart disease need to be particularly careful when taking this medication. Diabetic patients may have difficulty controlling blood sugar levels, thus requiring blood sugar monitoring and treatment adjustments. There is a risk of electrolyte imbalance, especially hypokalemia or hyperkalemia, so periodic checks of serum electrolyte levels are recommended. If acute angle-closure glaucoma symptoms occur, discontinue use immediately and seek treatment. This medication may interact with lithium, certain antidiabetic medications, potassium supplements, etc., so consulting regarding other medications being taken is essential. It should not be used during pregnancy or lactation as it may pose risks to the fetus and newborn. Safety in pediatric or adolescent patients has not been established, so its use is not recommended. Elderly patients may be more sensitive to this medication, hence caution is advised during use. In cases of overdose, symptoms may include hypotension, electrolyte disturbances, and dehydration, necessitating immediate consultation with a healthcare professional. This medication should be stored out of reach of children and kept in its original container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, anaphylactic shock, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, jaundice, hepatic congestion jaundice, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significantly decreased urine output, extreme swelling of the whole body with elevated blood pressure, acute angle-closure glaucoma, toxicity

Mild side effects

  • Dizziness
  • fatigue
  • nausea/vomiting
  • abnormal urination
  • headache
  • orthostatic dizziness
  • fainting
  • hypotension
  • tachycardia
  • flushing
Show 23 more
  • cough
  • diarrhea
  • dyspepsia
  • taste disturbance
  • hepatitis
  • abnormal liver function
  • sexual dysfunction
  • changes in libido
  • limb swelling
  • joint pain
  • muscle pain
  • tinnitus
  • thrombocytopenia
  • hypoglycemia
  • depression
  • sleep disorders
  • orthostatic hypotension
  • arrhythmia
  • aplastic anemia
  • bone marrow suppression
  • neutropenia
  • agranulocytosis
  • hemolytic anemia

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air and moisture, and it is recommended to store it at room temperature between 1 degree to 30 degrees. Storing it this way will help maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Pink, double convex, rectangular film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle

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.