Pentacan Selha Tablet 400 micrograms (Fentanyl Citrate)

Adult dose

After removing this medicine from the blister, place it under the tongue. Do not chew, suck, or swallow it; allow the tablet to dissolve completely. Do not eat or drink until the tablet has completely dissolved. If any of this medicine remains after 30 minutes, it may be swallowed. Patients with dry mouth should moisten the mouth with water before taking this medicine. For each patient, determine a dose that provides adequate analgesia while minimizing adverse reactions. This medicine has a different pharmacokinetic profile and dosage regimen from other rapid-acting fentanyl products used for cancer breakthrough pain; therefore, it cannot be converted on a dose-for-dose (㎍) basis. Patients should not use two different fentanyl products simultaneously to treat breakthrough pain. When switching to this medicine, the other fentanyl product should be discontinued. To prevent confusion and the possibility of overdose, always minimize the number of tablets available at each strength. 1. Dose titration 1) Initiation of treatment The initial dose of this medicine for the treatment of cancer breakthrough pain is 133㎍. This medicine has a different absorption profile from other fentanyl products and should not be converted at a 1:1 ratio; follow the dose titration below. 2) Repeat dosing for a single episode of pain If adequate analgesia is not achieved within 15 ∼ 30 minutes, a second dose may be administered. Patients should not take more than 2 tablets of this medicine for a single episode of breakthrough pain. This medicine should not be administered for another episode of breakthrough pain until at least 2 hours later. 3) Dose escalation If more than one dose is required to treat breakthrough pain, consider increasing to the next dose according to the table below. Continue sequential dose escalation until adequate analgesia is achieved. At 533㎍, increase the additional (second) dose to 133㎍~267㎍. Once an adequate dose has been identified, maintain that dose. Titration process Start with 133㎍ Is adequate pain relief achieved within 15~30 minutes· Yes: Use this dose for subsequent episodes of breakthrough pain No: Administer a second dose* (see table below) Increase to the next higher dose for the next episode of breakthrough pain. * Administration of the second dose Initial sublingual tablet dose (㎍) used for the episode of breakthrough pain / Additional dose (㎍) to be taken 15∼30 minutes after the initial dose 133 / 133 267 / 133 400 / 133 533 / 267 800 / - 4) Maximum daily dose If breakthrough pain occurs more than 4 times per day, the dose of the long-acting opioid used for persistent cancer pain should be readjusted. Use of this medicine should be limited to no more than 4 times per day. 2. Dose readjustment If there is a significant change in the response to the adjusted dose of this medicine, dose adjustment may be necessary to identify the optimal dose. (For dose adjustment, see 3) Dose escalation.) If breakthrough pain occurs more than 4 times per day, the dose of the regularly taken opioid should be reassessed. The dose of this medicine should also be reassessed and retitrated if there is a change in the regularly taken opioid or its dose. If pain is not adequately controlled, consider the possibility of hyperalgesia, tolerance, and progression of the underlying disease. 3. Discontinuation If breakthrough pain no longer occurs, discontinue this medicine immediately. Treatment for persistent background pain should be maintained. If it is necessary to discontinue all opioid medicines, closely monitor the patient to avoid sudden withdrawal effects.

This medication is a powerful opioid analgesic used to relieve breakthrough pain in cancer patients. It should only be administered to patients who have developed a tolerance to opioids; administration to patients without tolerance poses a serious risk of respiratory depression and death. Opioid therapy should be continued during the use of this medication, and it must be used under professional guidance. It can be very dangerous for children, so it should be kept out of reach of children and non-patients, and any remaining medication should be disposed of safely. Caution is required when taken with other central nervous system depressants or alcohol, as it significantly increases the risk of sedation and respiratory depression. Especially in combination with narcotics or benzodiazepines, it should be used at the minimum dosage for the shortest possible duration, and the patient's condition should be closely monitored. This medication should not be administered to patients who have taken MAO inhibitors within the past 14 days. Opioids carry risks of tolerance, dependence, and abuse, so careful monitoring for side effects and signs of overdose is necessary. Side effects such as respiratory depression, hypotension, dizziness, drowsiness, may occur, thus caution is needed during administration. When driving or operating dangerous machinery, the risk of accidents may increase due to the sedative effects of this medication, so it should be avoided. During pregnancy, it may pose risks to the fetus, so it should only be used when necessary. In breastfeeding mothers, sedation and respiratory depression may occur in infants, so use should be avoided. Elderly patients, those with impaired kidney or liver function, or respiratory conditions should be treated with extra caution and dosage adjustments may be necessary. In the case of overdose, serious respiratory depression and decreased consciousness may occur, thus medical attention should be sought immediately for appropriate treatment. This medication should only be used under the prescription and management of a professional for the relief of breakthrough pain in cancer patients and should not be taken or discontinued arbitrarily.

• Respiratory depression
• apnea
• respiratory arrest
• blood circulation disorders
• hypotension
• shock
• anaphylactic reaction
• nausea
• vomiting
• constipation

This medication is sensitive to light and should be stored in a special container that blocks light. Additionally, it is best stored at room temperature between 1 to 30 degrees Celsius, avoiding excessively hot or cold environments.

Appearance

White, convex triangular film-coated tablet

Package unit

15 tablets (3 tablets * 5 PTP) / box