Medication info
Osealram Tablet 10 Milligrams (Tadalafil)

Osealram Tablet 10 Milligrams (Tadalafil)

Prescription medicationTabletOral
Ingredient · strength
Tadalafil›10mg / 1 tablet
Manufacturer / importer
Boryung Pharmaceutical Co., Ltd.
Appearance
Film-coated tablet in a yellow, rounded triangle shape with a dividing line.
Packaging
8 tablets (8 tablets/PTP) × 1
Approval status
Active

MFDS item code 201904663 · Approved 2019.07.10

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults · Children
Adult dose
Use in adult men The recommended dose of this medicine is 10mg, taken regardless of meals before anticipated sexual activity. For patients in whom tadalafil 10mg does not provide an adequate effect, 20 mg may be tried. This medicine may be administered at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Continuous daily administration of this medicine is strongly discouraged because long-term safety after extended daily dosing has not been established and its effects usually last for more than one day. [See Sections 1. Warnings and 12.1) Pharmacodynamic Properties] Use in elderly men No dosage adjustment is required in elderly patients. Use in men with renal impairment No dosage adjustment is required in patients with mild to moderate renal impairment. The maximum recommended dose in patients with severe renal impairment is 10mg. [See Section 12.2) Pharmacokinetic Properties]. Use in men with hepatic impairment The recommended dose of this product is 10mg, taken regardless of meals before anticipated sexual activity. Since clinical data on the safety of this product in patients with severe hepatic impairment (Child-Pugh Class C) are limited, the physician should carefully assess the individual benefit/risk when prescribing it. There are no data on administering doses higher than 10mg to patients with hepatic impairment. [See Sections 3. Administration with Caution in the Following Patients and 12.2) Pharmacokinetic Properties]. Use in men with diabetes No dosage adjustment is required in patients with diabetes.
Child dose
Do not use in persons under 18 years of age.

Ingredients

Manufacturer
Boryung Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction

  • Erectile dysfunction
View approved original text

This medication is used for the treatment of erectile dysfunction. Sexual stimulation is required to achieve its effects, so please keep this in mind. Additionally, this medication is intended for the treatment of erectile dysfunction in males and should not be used in females. Therefore, you can safely use this drug to improve erectile dysfunction symptoms.

How to take

Adult dose

Use in adult men The recommended dose of this medicine is 10mg, taken regardless of meals before anticipated sexual activity. For patients in whom tadalafil 10mg does not provide an adequate effect, 20 mg may be tried. This medicine may be administered at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Continuous daily administration of this medicine is strongly discouraged because long-term safety after extended daily dosing has not been established and its effects usually last for more than one day. [See Sections 1. Warnings and 12.1) Pharmacodynamic Properties] Use in elderly men No dosage adjustment is required in elderly patients. Use in men with renal impairment No dosage adjustment is required in patients with mild to moderate renal impairment. The maximum recommended dose in patients with severe renal impairment is 10mg. [See Section 12.2) Pharmacokinetic Properties]. Use in men with hepatic impairment The recommended dose of this product is 10mg, taken regardless of meals before anticipated sexual activity. Since clinical data on the safety of this product in patients with severe hepatic impairment (Child-Pugh Class C) are limited, the physician should carefully assess the individual benefit/risk when prescribing it. There are no data on administering doses higher than 10mg to patients with hepatic impairment. [See Sections 3. Administration with Caution in the Following Patients and 12.2) Pharmacokinetic Properties]. Use in men with diabetes No dosage adjustment is required in patients with diabetes.

Child dose

Do not use in persons under 18 years of age.

Precautions

This medication is used to treat erectile dysfunction, and it is essential to confirm the underlying cause through a medical history and physical examination before use. Sexual activity may place stress on the heart, so a doctor should carefully evaluate whether cardiovascular condition is stable. If an erection lasts longer than 4 hours or is painful, seek medical attention immediately, as neglect could result in penile tissue damage or loss of erectile function. This drug should not be used in patients taking nitrate medications, as this can dangerously lower blood pressure. Patients who have recently had myocardial infarction, unstable angina, heart failure, or stroke should not take this medication. Patients with genetic retinal disorders or an allergy to any component of this drug should also avoid use. Combining with other erectile dysfunction treatments is not recommended due to unproven safety. Caution is needed for patients with severe kidney or liver impairment, and blood pressure lowering medications should be carefully monitored due to the risk of hypotension. This medication may cause side effects such as headaches, dyspepsia, back pain, muscle pain, flushing, and other mild to moderate effects. Rarely, serious adverse reactions such as myocardial infarction, stroke, vision loss, or hearing reduction have been reported, so contact medical professionals immediately if any unusual symptoms arise. Alcohol consumption may increase the risk of blood pressure reduction and dizziness, so caution is advised. This drug is not for use in pregnant or nursing women or children. In cases of overdose, standard treatment should be administered, as dialysis is not effective. It should be stored out of reach of children and preferably kept in its original packaging. It does not significantly impact driving or machine operation, but personal responses should be assessed for safety.

Side effects

  • Headache
  • dyspepsia
  • back pain
  • muscle pain
  • nasal congestion
  • flushing
  • limb pain
  • pharyngitis
  • upper respiratory infection
  • cough
Show 117 more
  • diarrhea
  • gastroesophageal reflux disease
  • abdominal pain
  • gastroenteritis
  • hypertension
  • dizziness
  • generalized weakness
  • facial edema
  • fatigue
  • pain
  • peripheral edema
  • angina
  • chest pain
  • hypotension
  • myocardial infarction
  • orthostatic hypotension
  • palpitations
  • syncope
  • tachycardia
  • abnormal liver function test results
  • dry mouth
  • dysphagia
  • esophagitis
  • gastritis
  • increased GGTP
  • watery stool
  • nausea
  • upper abdominal pain
  • vomiting
  • hemorrhoidal bleeding
  • rectal bleeding
  • arthralgia
  • neck pain
  • sensory impairment
  • insomnia
  • paresthesia
  • drowsiness
  • vertigo
  • kidney impairment
  • dyspnea
  • epistaxis
  • pharyngitis
  • itching
  • rash
  • sweating
  • blurred vision
  • color vision deficiency
  • conjunctivitis
  • eye pain
  • increased tear production
  • eyelid edema
  • sudden decrease or loss of hearing
  • tinnitus
  • increased erection
  • spontaneous penile erection
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizures and recurrence of seizures
  • transient global amnesia
  • visual field deficit
  • retinal vein occlusion
  • retinal artery occlusion
  • permanent vision loss
  • angioedema
  • ECG abnormalities
  • primary bradycardia
  • increased blood urea nitrogen
  • conjunctival injection
  • increased SGPT
  • chest tightness
  • vomiting
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • kidney pain
  • heartburn
  • gastrointestinal disease
  • drowsiness
  • increased white blood cell count
  • thrombocytopenia
  • anxiety
  • sleep disorders
  • decreased hemoglobin
  • eye pain
  • chest pain
  • arthralgia
  • hyperventilation
  • retinal hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eye syndrome
  • abdominal cramps
  • increased bilirubin
  • ejaculation disorders
  • pain in external genitalia
  • erythema
  • penile disorders
  • myocardial infarction
  • tinnitus
  • epistaxis
  • dry nose
  • increased serum creatinine
  • hiccups
  • weakness
  • abdominal discomfort
  • abdominal pain
  • allergic reactions
  • facial swelling
  • fever
  • increased SGOT
  • increased hemoglobin
  • chills
  • skeletal 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 avoid exposure to air or moisture and kept at a temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness.

Appearance and packaging

Appearance

Film-coated tablet in a yellow, rounded triangle shape with a dividing line.

Package unit

8 tablets (8 tablets/PTP) × 1

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.