Medication info

Hanmi Felodipine Extended-Release 5 mg

Prescription medicationTabletOral
Ingredient · strength
Felodipine›5mg / 1 tablet
Manufacturer / importer
Hanmi Pharmaceutical Co., Ltd.
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 200301834 · Approved 2003.09.09

Summary

Main use
Treatment of hypertension and stable angina
Who takes it
Adults · Children
Adult dose
Swallow this medicine whole with water. Do not split, chew, or crush it. 1. Hypertension The initial dose of felodipine is 5㎎ once daily, and the maintenance dose is 5-10㎎ daily, administered orally in the morning. Do not exceed the maximum daily dose of 20㎎. This medicine may be administered in combination with a β-blocker or diuretic, and may be administered as monotherapy if other antihypertensive agents are unsuitable. Adjust the dose according to the patient's response to treatment. 2. Stable angina Administer an initial dose of 5㎎ once daily and increase to 10㎎ if necessary. This medicine may be administered in combination when a β-blocker does not provide an adequate effect. Adjust the dose according to the patient's response to treatment. 3. Older adults Administer with caution while monitoring the patient's condition; consider an initial dose of 2.5㎎ once daily. 4. Patients with renal impairment Renal impairment does not affect the plasma concentration of felodipine. Dose adjustment is not necessary, but use with caution in patients with severe renal impairment (GFR<30ml/min). 5. Patients with hepatic impairment Plasma concentrations of felodipine may increase in patients with hepatic impairment, and a response to treatment may occur at lower doses. Therefore, use with caution in patients with hepatic impairment, considering an initial dose of 2.5㎎ once daily; do not administer to patients with severe hepatic impairment.
Child dose
The safety and efficacy in children have not been established.

Ingredients

Manufacturer
Hanmi Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of hypertension and stable angina

  • Hypertension
  • stable angina
View approved original text

This medication is used in the treatment of hypertension and stable angina.

How to take

Adult dose

Swallow this medicine whole with water. Do not split, chew, or crush it. 1. Hypertension The initial dose of felodipine is 5㎎ once daily, and the maintenance dose is 5-10㎎ daily, administered orally in the morning. Do not exceed the maximum daily dose of 20㎎. This medicine may be administered in combination with a β-blocker or diuretic, and may be administered as monotherapy if other antihypertensive agents are unsuitable. Adjust the dose according to the patient's response to treatment. 2. Stable angina Administer an initial dose of 5㎎ once daily and increase to 10㎎ if necessary. This medicine may be administered in combination when a β-blocker does not provide an adequate effect. Adjust the dose according to the patient's response to treatment. 3. Older adults Administer with caution while monitoring the patient's condition; consider an initial dose of 2.5㎎ once daily. 4. Patients with renal impairment Renal impairment does not affect the plasma concentration of felodipine. Dose adjustment is not necessary, but use with caution in patients with severe renal impairment (GFR<30ml/min). 5. Patients with hepatic impairment Plasma concentrations of felodipine may increase in patients with hepatic impairment, and a response to treatment may occur at lower doses. Therefore, use with caution in patients with hepatic impairment, considering an initial dose of 2.5㎎ once daily; do not administer to patients with severe hepatic impairment.

Child dose

The safety and efficacy in children have not been established.

Precautions

This medication should not be administered to women who are pregnant or may become pregnant. It should also not be used in patients with severely impaired cardiac function, acute myocardial infarction, or unstable angina. It is safer not to administer this medication to patients with severely impaired liver or kidney function, and to certain genetically lactose intolerant patients. Caution should be exercised in elderly patients, patients with heart failure, and those with hypotension. When taking this medication for the first time or increasing the dose, symptoms such as flushing, headache, palpitations, dizziness, and fatigue may occur. These symptoms are generally temporary and vary with dosage. Caution should be taken as blood pressure may drop too low or heart rate abnormalities may occur, and there may also be symptoms of ankle swelling. Digestive symptoms such as nausea, constipation, abdominal pain, and loss of appetite have been reported rarely. If there are issues with dental or gum health, the gums may swell after taking the medication, so attention to oral hygiene is necessary. The medication should be discontinued and a doctor consulted if liver function abnormalities are suspected. As this medication has a strong effect in lowering blood pressure, suddenly stopping it can worsen symptoms, so dosage should be reduced gradually. Additionally, if blood pressure drops too low, immediate medical attention should be sought. Caution is needed when driving or operating dangerous machinery due to the possibility of dizziness, and it is advisable to take this medication in the morning on an empty stomach or after a light meal. Drug interactions may occur when taking this medication with others, so it is essential to consult a physician or pharmacist. Particularly, taking this medication with certain antibiotics, antifungals, or grapefruit juice can increase its blood concentration and risk of side effects. It is safest for women who are pregnant or breastfeeding not to take this medication, and if necessary, breastfeeding should be discontinued. The safety for pediatric use has not been established, so it is advisable not to use it. Elderly patients should start with a low dose and be carefully monitored. In case of overdose, there is a risk of severe hypotension, heart rhythm abnormalities, or coma; immediate emergency care is required, and appropriate treatment according to medical personnel's instructions is necessary. Dizziness or fatigue may occur while taking this medication, so caution is needed when driving or operating machinery.

Side effects

Facial flushing, headache, palpitations, dizziness, fatigue, tachycardia, feeling of suffocation, chest tightness, ankle edema, hypotension accompanied by tachycardia causing angina, extrasystole, heaviness in the head, dizziness, staggering, lethargy, drowsiness, anxiety, sensory disturbances, syncope, nausea, constipation, discomfort in the stomach, heartburn, abdominal pain, loss of appetite, diarrhea, thirst, vomiting, gingival hypertrophy symptoms, gingivitis, AST elevation, ALT elevation, ALP elevation, LDH elevation, BUN elevation, creatinine elevation, anemia, rash, itching, exfoliative dermatitis, pruritic erythema, urticaria, photosensitivity reaction, vascular edema, leukocytoclastic vasculitis, myalgia, arthralgia, hyperglycemia, weight gain, peripheral edema, leg cramps, shoulder stiffness, weakness, hand tremor, cough, throat irritation, sweating, tearing, conjunctival injection, paresthesia, CPK elevation, total cholesterol elevation, triglycerides elevation, serum potassium decrease, gynecomastia, erectile dysfunction, sexual dysfunction, increased urination, angioedema, fever, confusion, sleep disorders, hypothermia, nausea

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

Storage

This medication may be sensitive to light, so it should be stored in a tightly sealed container that blocks light. It is important to maintain storage temperatures between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness and safety.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 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

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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.