Novaroc Tablet (Amlodipine Besilate)

Adult dose

As amlodipine, 5 mg is taken orally once daily, and may be increased to a maximum of 10 mg per day based on the patient’s response. It should be adjusted appropriately based on age and symptoms.

This medication should not be used in certain patients. For example, it should not be administered to those with allergic reactions to this drug or similar medications, nursing women, patients with severe liver dysfunction, patients with severe aortic stenosis, and those in a state of shock. Additionally, it should be administered cautiously to patients with severe hypotension, those requiring kidney dialysis, the elderly, and women who are pregnant or may become pregnant. This medication primarily lowers blood pressure and dilates blood vessels and is generally well tolerated. However, side effects such as flushing, fatigue, edema, palpitations, dizziness, headaches, drowsiness, abdominal pain, and nausea may commonly occur. Rarely, various adverse reactions such as hypotension, vasculitis, neurological disorders, gastrointestinal problems, skin rashes, and liver function abnormalities have been reported, so if symptoms develop, immediate consultation with healthcare personnel is necessary. Particularly in patients with heart failure or impaired liver function, careful administration is required, and since the drug may remain in the body for a long time, dosage adjustment and monitoring of the condition are necessary. This medication is generally safe to use with other antihypertensives, diuretics, antibiotics, and hypoglycemic agents, but when used in combination with certain drugs, it may increase efficacy or the risk of side effects, so patients must inform healthcare providers of all medications they are taking. Taking grapefruit juice with this medication may excessively enhance its blood pressure-lowering effect, so it is advisable not to consume them together. Women who are pregnant or breastfeeding should avoid this medication as its safety has not been established, and it is recommended to suspend breastfeeding while taking this medication. In children, it can lower blood pressure at certain doses, but safety and efficacy have not been confirmed in children under 6 years of age. In cases of overdose, severe hypotension and heart problems may occur, requiring immediate medical attention, and since this drug continues to act gradually even after discontinuation, careful management is needed. This medication is known not to impair driving or machine operation abilities, but caution should be taken if symptoms such as dizziness occur.

Serious side effects

• Hives, angioedema → severe allergic reaction
• Hepatitis, jaundice → liver abnormalities (jaundice)
• Respiratory distress → respiratory problems

Mild side effects

• Flushing
• fatigue
• edema
• palpitations
• dizziness
• headache
• drowsiness
• abdominal pain
• nausea
• weakness

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is important to maintain a cool room temperature between 1 degrees and 30 degrees Celsius while storing the medication to preserve its effectiveness and safety.

Appearance

White octagonal tablet

Package unit

30 tablets/bottle, 300 tablets/bottle