MAXIPAIN Tablet

This product is used to treat moderate to moderately severe pain.

Dosage

- Adults and children over 12 years old

Dose can be controlled patient’s pain and treatment response.

2 tablets are recommended as first dose after than dosing interval is minimum 6 hours, but, do not exceed 8 tablets a day.

Do not administer for a long-term and if patient need for a long-term administer because of disease characteristic and severity, please conduct regular monitoring to determine continuous medication.

- Pediatric Use

Children under the age of 12 are not recommended, because the safety and effectiveness of Tramadol hydrochloride and Acetaminophen tablets has not been studied in the pediatric population.

- Geriatric Use

Senior should be dosed unusual adult’s dose, but when administer Tramadol by oral medication to elderly people over 75 years old, half-life has increased 17%, so administer this medicine at least with 6 hours of intervals.

See the package insert about the details below:

- Use in Renal Disease

- Use in Hepatic Disease

Any situation in which opioids are contraindicated, including acute intoxication with any of the following:

alcohol, centrally acting analgesics, hypnotics, narcotics, opioids, or psychotropic drugs;

Hypersensitivity to any component of the product or opioids.

Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, or sweating may occur. Some of these side effects may decrease after you have been using this medication for a while.

If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise.

Ask your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur:

mental/mood changes (such as agitation, confusion, hallucinations), severe stomach/abdominal pain, difficulty urinating.

Get medical help right away if any of these rare but serious side effects occur:

fainting, seizure, slow/shallow breathing, unusual drowsiness/difficulty waking up.

This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is used with certain other drugs.

Get medical help right away if you develop some of the following symptoms:

hallucinations, unusual restlessness, loss of coordination, fast heartbeat, severe dizziness, unexplained fever, severe nausea/vomiting/diarrhea, twitching muscles.

Taking more than the recommended dose of acetaminophen may cause serious (possibly fatal) liver disease.

Get medical help right away if you have any symptoms of liver damage, including:

dark urine, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms:

rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Certain pain medications (mixed narcotic agonist-antagonists such as pentazocine, nalbuphine, butorphanol)

Narcotic antagonists (such as naltrexone)

MAO inhibitors (isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine)

Drugs that increase serotonin (such as dextromethorphan, lithium, St John’s Wort, sibutramine, street drugs such as MDMA/”ecstasy”, tryptophan, certain antidepressants including SSRIs (such as citalopram, paroxetine) and SNRIs (such as duloxetine, venlafaxine), “triptans” used to treat migraine headaches (such as eletriptan, sumatriptan), among others.)

Quinidine, azole antifungals (such as itraconazole), HIV drugs (such as ritonavir), macrolide antibiotics (such as erythromycin), rifamycins (such as rifampin), drugs used to treat seizures (such as carbamazepine), among others.

Other products that may also affect breathing or cause drowsiness (such as alcohol, allergy or cough-and-cold produces, medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, other narcotic pain relievers (such as morphine), and psychiatric medicines (such as risperidone, amitriptyline, trazodone).

See the package insert about the details below:

Pregnancy

This medication should be used only when clearly needed.

Nursing Mothers

Consult your doctor before breast-feeding.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease - COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression, suicidal thoughts), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (such as due to enlarged prostate).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

This product contains acetaminophen, which may cause liver damage. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Avoid alcohol.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially dizziness, drowsiness, or urinary problems.

Tramadol is similar to narcotic analgesics. It works in the brain to change how your body feels and responds to pain.

Acetaminophen is used to relieve pain, and it can also reduce a fever.