Medication info
Caramafil Tablets 10 mg (Tadalafil)

Caramafil Tablets 10 mg (Tadalafil)

Prescription medicationTabletOral
Ingredient · strength
Tadalafil›10mg / 1 tablet
Manufacturer / importer
Genupharm Co., Ltd.
Appearance
Yellow film-coated tablet with a rounded triangular shape and a score line.
Packaging
8 tablets ((8 tablets/PTP)×1)
Approval status
Active

MFDS item code 201901612 · Approved 2019.03.18

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 with or without food 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. Long-term safety following extended daily dosing has not been established, and because the effect of this medicine usually lasts for more than one day, continuous daily administration is strongly discouraged. [See 1. Warnings and 12.1) Pharmacodynamic Properties] Use in elderly men No dosage adjustments are 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 12.2) Pharmacokinetic Properties]. Use in men with hepatic impairment The recommended dose of this product is 10mg, taken with or without food 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 prescriber should carefully assess the individual benefit/risk when prescribing it. There are no data on administration of doses higher than 10mg to patients with hepatic impairment. [See 3. Patients Requiring Caution and 12.2) Pharmacokinetic Properties]. Use in men with diabetes No dosage adjustment is required in patients with diabetes.
Child dose
Persons under 18 years of age: This product should not be used.

Ingredients

Manufacturer
Genupharm Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction

  • Erectile dysfunction
View approved original text

This medication is used for the treatment of erectile dysfunction, and it is important to note that sexual stimulation is needed for it to be effective. Additionally, this medication is intended for use by men only and is not indicated for women. It is used as a treatment that may help those who are struggling with erectile dysfunction.

How to take

Adult dose

Use in adult men The recommended dose of this medicine is 10mg, taken with or without food 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. Long-term safety following extended daily dosing has not been established, and because the effect of this medicine usually lasts for more than one day, continuous daily administration is strongly discouraged. [See 1. Warnings and 12.1) Pharmacodynamic Properties] Use in elderly men No dosage adjustments are 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 12.2) Pharmacokinetic Properties]. Use in men with hepatic impairment The recommended dose of this product is 10mg, taken with or without food 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 prescriber should carefully assess the individual benefit/risk when prescribing it. There are no data on administration of doses higher than 10mg to patients with hepatic impairment. [See 3. Patients Requiring Caution and 12.2) Pharmacokinetic Properties]. Use in men with diabetes No dosage adjustment is required in patients with diabetes.

Child dose

Persons under 18 years of age: This product should not be used.

Precautions

This medication is used for the treatment of erectile dysfunction, and before taking it, the underlying cause should be confirmed through a doctor's diagnosis and physical examination. Sexual activity can put strain on the heart, so patients with cardiovascular disease must assess their heart condition before taking this medication. If an erection lasts longer than 4 hours or is accompanied by pain, immediate medical attention should be sought, as untreated complications may result in damage to the tissue of the penis. This medication should not be taken with nitrate medications, as it may dangerously lower blood pressure, thus patients taking nitrate medications must not use it. Patients who have had recent cardiovascular diseases such as myocardial infarction, angina pectoris, heart failure, or stroke should not take this medication, and it is also contraindicated for patients with very low or uncontrolled high blood pressure. Patients with hereditary retinal disease or those who have hypersensitivity to this medication should also not take it. Using this medication in conjunction with other erectile dysfunction treatments is not recommended because safety and efficacy have not been confirmed. Patients with severely reduced kidney or liver function should use this medication with caution, and those taking certain antihypertensive medications may experience hypotension, thus attention is required. This medication is commonly reported to have side effects such as headaches, dyspepsia, back pain, myalgia, flushing, and other symptoms. If side effects are severe or persistent, consult a physician. Serious side effects, although rare, may include myocardial infarction, stroke, sudden hearing loss, and vision loss; if such symptoms occur, discontinue use immediately and visit a medical institution. Taking this medication with alcohol may lower blood pressure further, so excessive drinking should be avoided. It is not to be used by pregnant women, nursing mothers, or children, and there is no specific influence when driving or operating machinery, although dizziness may occur in some individuals, so caution is advised. In case of overdose, seek medical attention immediately for appropriate treatment, as it is not removed by dialysis, which requires caution. Store this medication out of the reach of children and keep it in its original packaging.

Side effects

Priapism, headache, dyspepsia, lower back pain, muscle pain, congestion, flushing, limb pain, nasopharyngitis, upper respiratory infection, cough, diarrhea, gastroesophageal reflux disease, abdominal pain, dizziness, hypertension, adverse reactions related to benign prostatic hyperplasia, generalized muscle weakness, facial swelling, 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, loose stools, nausea, upper abdominal pain, vomiting, hemorrhoidal bleeding, rectal bleeding, arthralgia, neck pain, sensory loss, insomnia, paresthesia, drowsiness, vertigo, renal impairment, dyspnea, nasal bleeding, pharyngitis, itching, rash, sweating, blurred vision, color vision abnormalities, conjunctivitis, eye pain, increased tear secretion, eyelid edema, sudden hearing loss or decrease, tinnitus, increased erection, spontaneous penile erection, urticaria, Stevens-Johnson syndrome, exfoliative dermatitis, migraine, seizure, transient global amnesia, visual field defect, retinal vein occlusion, retinal artery occlusion, permanent vision loss, angioedema, abnormal ECG, primary bradycardia, increased blood urea nitrogen, eye redness, increased SGPT, chest pressure, vomiting, nausea, increased alkaline phosphatase, fatigue, neck stiffness, urethral pain, renal colic, heartburn, gastrointestinal disease, drowsiness, increased white blood cell count, thrombocytopenia, anxiety, sleep disorder, decreased hemoglobin, eye pain, chest pain, arthralgia, hyperventilation, ocular hemorrhage, eyelid swelling, conjunctival hemorrhage, dry eye syndrome, abdominal cramps, increased bilirubin, ejaculatory dysfunction, external genital pain, erythema, penile dysfunction, myocardial infarction, tinnitus, nasal bleeding, dry nose, increased serum creatinine, hiccups, weakness, abdominal discomfort, abdominal pain, allergic reaction, facial swelling, fever, increased SGOT, increased hemoglobin, no effect, chills, skeletal pain

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture. It is best to keep it at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Yellow film-coated tablet with a rounded triangular shape and a score 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.