Madophen Semi Tablet

Adult dose

Children aged 12 and older, and adults: The dosage is adjusted based on the patient's level of pain and therapeutic response. A loading dose of 4 tablets is recommended, with subsequent dosing intervals of at least 6 hours apart, and should not exceed 16 tablets in one day. The lowest effective dose should be administered for the shortest duration possible. Avoid use of this medication for longer than necessary, and in cases where prolonged use is required due to the nature and severity of the disease, regular monitoring should be conducted to determine the necessity for continued administration of this medication. Elderly patients Administer the usual adult dosage; however, in patients aged 75 or older, the elimination half-life of tramadol may increase by 17%, so it is advised to administer this medication with intervals of at least 6 hours. Patients with renal impairment For moderate renal impairment patients (creatinine clearance of 10-30 ml/min), the dosing interval should be extended to 12 hours. Use in patients with severe renal impairment (creatinine clearance less than 10 ml/min) is not recommended. Tramadol is removed very slowly during hemodialysis and filtration; thus, there is no need to redose this medication for maintaining analgesic effect post-dialysis. Patients with liver impairment Carefully consider extending the dosing interval for patients with moderate liver impairment. This medication should not be administered to patients with severe liver impairment.

Child dose

Children aged 12 and older are administered dosages adjusted to be the same as adults.

This medication may stress the liver; therefore, individuals who regularly consume more than three glasses of alcohol daily should consult a doctor or pharmacist before use. If symptoms such as rash or hypersensitivity appear during treatment, the medication must be discontinued immediately, and medical help should be sought. One of the ingredients in this medication may increase the risk of seizures; thus, caution is needed for patients with a history of seizures or high seizure risk. This medication may suppress respiration in patients with severe respiratory illnesses and should only be used in settings equipped with appropriate medical equipment. Taking this medication with alcohol or central nervous system depressants may cause severe drowsiness or respiratory suppression and, in severe cases, could lead to coma; therefore, co-administration should be avoided or conducted with great caution. Patients with high intracranial pressure or head injuries should exercise caution, as this medication's respiratory suppression effect may worsen their symptoms. This medication can cause dependency similar to narcotic analgesics; therefore, when used long-term, consultation with a physician regarding the potential for dependence or abuse is necessary along with monitoring. Patients with impaired liver function may experience liver damage due to one of the ingredients in this medication, so they must consult a physician before use. Especially for individuals who metabolize this medication quickly, there is an increased risk of serious side effects such as respiratory suppression, thus requiring careful dose adjustment and monitoring. This medication should not be administered to children under 12 or adolescents under 18 who have had specific surgeries; also, adolescents aged 12 to 18 should avoid use if there are risk factors. This medication may cause sleep apnea or hypoxemia; therefore, periodic checks for these symptoms or their worsening are needed, and the dose should be reduced or discontinued if necessary. While taking this medication, hyponatremia may occur; particularly elderly patients or those with risk factors should regularly check their serum sodium levels. Individuals with allergies to any components of this medication, central nervous system drug intoxication, severe respiratory suppression, head injuries, or those currently taking specific medications should never use this product. When taking this medication, care should be taken not to exceed the recommended dose and to avoid co-administration with other similar component drugs. Discontinuing this medication suddenly may lead to withdrawal symptoms; therefore, when ceasing, the dosage should be gradually reduced under the direction of a physician. This medication can induce drowsiness or dizziness, so caution is required when driving or operating machinery. In case of overdose, serious respiratory suppression, seizures, or liver damage may occur, necessitating immediate medical attention and, if required, detoxification treatment. This medication must be stored in a safe place out of the reach of children, and care should be taken to prevent misuse or accidental ingestion.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attack, coughing with fever and respiratory distress, yellowing of skin or eyes (jaundice), severe lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urinary issues

Mild side effects

• Decreased appetite
• insomnia
• depression
• dizziness
• headache
• drowsiness
• nausea
• vomiting
• constipation
• dry mouth

This medication should be stored in a well-closed container, away from air, and at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness and prevent deterioration.

Appearance

Pale yellow, oblong film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle