Medication info
Fosnil 150 mg Tablets (Risedronate Sodium Dihydrate)

Fosnil 150 mg Tablets (Risedronate Sodium Dihydrate)

Prescription medicationTabletOral
Ingredient · strength
Risedronate Sodium Monohydrate›158.9mg / 1 tablet
Manufacturer / importer
Jungheon Pharmaceutical Co., Ltd.
Appearance
Bright blue oblong film-coated tablet
Packaging
1 tablet/PTP
Approval status
Active

MFDS item code 201000872 · Notified 2010.01.26 · Insurance code 053300070

Summary

Main use
Treatment and prevention of osteoporosis in postmenopausal women
Who takes it
Adults · Children
Adult dose
Adults: Administer 150 mg of risedronate sodium orally once a month. No dosage adjustment is necessary in elderly patients (over 60 years of age), since the bioavailability and pharmacodynamics of this medicine are similar to those in younger people. No dosage adjustment is necessary in patients with creatinine clearance of 30 mL/min or higher. This medicine is contraindicated in patients with severe renal impairment and creatinine clearance below 30 mL/min. Food interferes with the absorption of this medicine. For adequate absorption, take it at least 30 minutes before the first food or beverage other than water of the day. To allow this medicine to reach the stomach easily and reduce the possibility of esophageal irritation, take it in an upright position with a sufficient amount of plain water (170 ∼ 230 mL). Taking this medicine with other beverages, including mineral water, may reduce its absorption. Do not chew or suck this medicine because of the possibility of oropharyngeal ulceration. Patients should not lie down for at least 30 minutes after taking it. If a patient forgets to take a dose on the scheduled day, follow these instructions. If the next scheduled dose is 7 days or more away, take 1 tablet the next morning after remembering. Resume the next dose on the originally scheduled day. Do not take more than 1 tablet of this medicine within 7 days. If the next scheduled dose is within 7 days, wait until the originally scheduled day and then take 1 tablet of this medicine.
Child dose
The safety and efficacy in children under 18 years of age have not been established.

Ingredients

Manufacturer
Jungheon Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of osteoporosis in postmenopausal women

  • Osteoporosis
View approved original text

This medication is used for the treatment and prevention of osteoporosis that may occur in postmenopausal women.

How to take

Adult dose

Adults: Administer 150 mg of risedronate sodium orally once a month. No dosage adjustment is necessary in elderly patients (over 60 years of age), since the bioavailability and pharmacodynamics of this medicine are similar to those in younger people. No dosage adjustment is necessary in patients with creatinine clearance of 30 mL/min or higher. This medicine is contraindicated in patients with severe renal impairment and creatinine clearance below 30 mL/min. Food interferes with the absorption of this medicine. For adequate absorption, take it at least 30 minutes before the first food or beverage other than water of the day. To allow this medicine to reach the stomach easily and reduce the possibility of esophageal irritation, take it in an upright position with a sufficient amount of plain water (170 ∼ 230 mL). Taking this medicine with other beverages, including mineral water, may reduce its absorption. Do not chew or suck this medicine because of the possibility of oropharyngeal ulceration. Patients should not lie down for at least 30 minutes after taking it. If a patient forgets to take a dose on the scheduled day, follow these instructions. If the next scheduled dose is 7 days or more away, take 1 tablet the next morning after remembering. Resume the next dose on the originally scheduled day. Do not take more than 1 tablet of this medicine within 7 days. If the next scheduled dose is within 7 days, wait until the originally scheduled day and then take 1 tablet of this medicine.

Child dose

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

Precautions

This medication can irritate the gastric and esophageal mucosa, so patients with upper gastrointestinal diseases such as gastritis, esophagitis, or ulcers need to take caution when using it. Always take it with enough water and refrain from lying down for at least 30 minutes after taking it to help reduce esophageal irritation. If you experience difficulty swallowing, chest pain, or heartburn, stop taking the medication immediately and consult a doctor. Patients with esophageal motility disorders, hypocalcemia, women who are pregnant or breastfeeding, and those with severe renal impairment should not take this medication. As a bisphosphonate, long-term use may rarely lead to serious side effects such as osteonecrosis of the jaw and atypical fractures; therefore, regular check-ups and caution are necessary. Taking this medication with foods or drugs that contain calcium, magnesium, iron, or aluminum may interfere with its absorption, so maintain an adequate time interval between dosages. This medication may affect the fetus during pregnancy; therefore, women of childbearing potential should consult a doctor before taking it, and caution is also necessary for breastfeeding women. Safety and efficacy in pediatric patients have not been established, so children under 18 years of age should avoid its use. Elderly individuals show similar safety and efficacy to adults, but caution is advisable based on individual health status. In case of overdose, serum calcium and phosphorus levels may decrease, so immediate medical attention is necessary. This medication should be kept out of reach of children, and transferring it to another container is not advisable for quality and safety maintenance.

Side effects

  • esophagitis
  • esophageal ulcer
  • esophageal erosion
  • esophageal obstruction
  • esophageal perforation
  • bleeding
  • infection
  • back pain
  • accidental injury
  • pain
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  • abdominal pain
  • flu symptoms
  • headache
  • fatigue
  • neck pain
  • chest pain
  • allergic reaction
  • hypertension
  • constipation
  • diarrhea
  • dyspepsia
  • nausea
  • peripheral edema
  • arthralgia
  • arthritis
  • fracture
  • joint abnormalities
  • myalgia
  • bone pain
  • dizziness
  • depression
  • insomnia
  • bronchitis
  • sinusitis
  • rhinitis
  • pharyngitis
  • increased cough
  • rash
  • cataract
  • urinary tract infection
  • loss of appetite
  • chest discomfort
  • palpitations
  • increased sweating
  • facial flushing
  • burning sensation
  • kidney stones
  • belching
  • hematuria
  • fever
  • eye pain
  • mucous membrane syndrome
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • Riel syndrome
  • angioedema
  • blisters
  • skin reactions
  • outer ear bone necrosis
  • iritis
  • uveitis
  • scleritits
  • jawbone necrosis
  • liver dysfunction
  • jaundice
  • lethargic bones
  • joint and muscle pain
  • vomiting
  • upper abdominal pain

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air, and it is important to maintain the storage temperature between 1 degree and 30 degrees Celsius. Proper storage will help preserve the drug's effectiveness over time.

Appearance and packaging

Appearance

Bright blue oblong film-coated tablet

Package unit

1 tablet/PTP

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.