Medication info
Riselon Tablet 150mg (Risedronate Sodium Monohydrate)

Riselon Tablet 150mg (Risedronate Sodium Monohydrate)

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

MFDS item code 201600587 · Approved 2016.01.28 · Insurance code 628900630

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. Elderly patients: No dosage adjustment is necessary because the bioavailability and pharmacodynamics of this drug in elderly patients (over 60 years of age) are similar to those in younger people. Patients with renal impairment: No dosage adjustment is necessary in patients with a creatinine clearance of 30 mL/min or higher. This drug is contraindicated in patients with severe renal impairment whose creatinine clearance is less than 30 mL/min. Because food interferes with the absorption of this drug, take it at least 30 minutes before the first food or beverage other than water consumed during the day to ensure adequate absorption. To help this drug 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 drug with other beverages, including mineral water, may reduce its absorption. Do not chew or suck this drug 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 this drug on the scheduled day, take it as follows. If the next scheduled dose is at least 7 days away, take 1 tablet the morning after remembering. Take the next dose on the originally scheduled day. Do not take more than 1 tablet of this drug 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 drug.
Child dose
Pediatrics: The safety and efficacy of this drug in children under 18 years of age have not been established.

Ingredients

Manufacturer
Eden Pharma 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 in postmenopausal women. Osteoporosis refers to a condition in which bones become weak and can easily fracture, and this medication helps to increase bone density and reduce the risk of fractures. Regular use contributes to maintaining bone health and improving quality of life.

How to take

Adult dose

Adults: Administer 150 mg of risedronate sodium orally once a month. Elderly patients: No dosage adjustment is necessary because the bioavailability and pharmacodynamics of this drug in elderly patients (over 60 years of age) are similar to those in younger people. Patients with renal impairment: No dosage adjustment is necessary in patients with a creatinine clearance of 30 mL/min or higher. This drug is contraindicated in patients with severe renal impairment whose creatinine clearance is less than 30 mL/min. Because food interferes with the absorption of this drug, take it at least 30 minutes before the first food or beverage other than water consumed during the day to ensure adequate absorption. To help this drug 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 drug with other beverages, including mineral water, may reduce its absorption. Do not chew or suck this drug 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 this drug on the scheduled day, take it as follows. If the next scheduled dose is at least 7 days away, take 1 tablet the morning after remembering. Take the next dose on the originally scheduled day. Do not take more than 1 tablet of this drug 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 drug.

Child dose

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

Precautions

This medication may cause irritation to the gastrointestinal mucosa, so individuals with esophageal disorders or upper gastrointestinal conditions such as gastritis, duodenitis, or ulcers should be cautious when taking it. It should be taken with a sufficient amount of water, and one should not lie down for at least 30 minutes after taking it. Otherwise, there is a higher risk of serious injury to the esophagus. If problems occur with the esophagus or symptoms such as difficulty swallowing, pain behind the sternum, or heartburn appear, discontinue use immediately and consult with a physician. Especially, individuals with esophageal strictures, achalasia, hypocalcemia, severe renal impairment, pregnant women, or nursing mothers should not take this medication. This medication contains lactose, so those with lactose intolerance should also avoid it. When taking this medication, be cautious as the absorption may be hindered if taken simultaneously with drugs or foods containing divalent cations like calcium, magnesium, or iron. As this medication acts on the bones, it is important to ensure adequate intake of calcium and vitamin D, particularly for patients receiving long-term corticosteroid treatment. Some patients may experience side effects such as muscle pain, joint pain, bone pain, dyspepsia, diarrhea, headaches, dizziness, etc. Rarely, serious side effects such as esophagitis, esophageal ulcers, gastric ulcers, or osteonecrosis of the jaw may occur; therefore, if any abnormal symptoms arise, consult with a physician immediately. This medication may affect the fetus during pregnancy, so it should be avoided in pregnant women or those planning to become pregnant, and it is recommended to discontinue it while nursing or stop breastfeeding. Safety and efficacy for children under 18 years have not been established. In case of overdose, blood calcium and phosphorus levels may drop, so if symptoms appear, visit a medical institution immediately; calcium supplementation therapy may be necessary. This medication should be kept out of reach of children, and it is advisable to avoid transferring it to another container.

Side effects

  • esophagitis
  • esophageal ulcer
  • esophageal erosion
  • esophageal obstruction
  • esophageal perforation
  • bleeding
  • infection
  • low back pain
  • accidental injury
  • pain
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  • abdominal pain
  • flu symptoms
  • headache
  • weakness
  • 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
  • vomiting
  • uveitis
  • sclereitis
  • iritis
  • Sjögren's syndrome
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • Reiler syndrome
  • angioedema
  • blister
  • skin reaction
  • jawbone necrosis
  • liver dysfunction
  • jaundice
  • loss of appetite
  • asthenia
  • heartburn
  • epigastric pain
  • chest discomfort
  • palpitations
  • increased sweating
  • facial flushing
  • burning sensation
  • kidney stones
  • belching
  • hematuria
  • fever
  • ocular 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 or moisture. It is best to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Bright blue rectangular 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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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.