Distalgesic 37.5+325Mg Tablet

Uses:

This product is used to treat moderate to moderately severe pain. It contains 2 medications: tramadol and acetaminophen. Tramadol is similar to opioid (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.

Side Effects:

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 dietary fiber drink enough water and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.

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. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects including: mental/mood changes (such as agitation hallucinations) severe stomach/abdominal pain difficulty urinating signs of your adrenal glands not working well (such as loss of appetite unusual tiredness weight loss).

Get medical help right away if you have any very serious side effects including: fast/irregular heartbeat severe dizziness fainting seizure.

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat hallucinations loss of coordination severe dizziness severe nausea/vomiting/diarrhea twitching muscles unexplained fever unusual agitation/restlessness.

Tramadol is changed into a strong opioid drug in your body. In some people this change happens faster and more completely than usual which increases the risk of very serious side effects. Get medical help right away if you notice any of the following: slow/shallow breathing severe drowsiness/difficulty waking up confusion.

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.

This is not a complete list of possible side effects. If you notice other effects not listed above contact your doctor or pharmacist.

Pre-Cautions:

Before taking this product tell your doctor or pharmacist if you are allergic to tramadol or acetaminophen; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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 a substance use disorder (such as overuse of or addiction to drugs/alcohol) stomach/intestinal problems (such as blockage constipation diarrhea due to infection paralytic ileus) difficulty urinating (such as due to enlarged prostate) gallbladder disease disease of the pancreas (pancreatitis) obesity.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive use machinery or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Tramadol/acetaminophen may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using tramadol/acetaminophen tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure slow heartbeat QT prolongation in the EKG) family history of certain heart problems (QT prolongation in the EKG sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating diarrhea or vomiting. Talk to your doctor about using tramadol/acetaminophen safely.

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

Some children may be more sensitive to very serious side effects of tramadol such as extreme sleepiness confusion or slow/shallow/noisy breathing. (See also Warning section.)

Older adults may be more sensitive to the side effects of this drug especially confusion dizziness drowsiness slow/shallow breathing and QT prolongation (see above).

During pregnancy this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. (See also Warning section.)

This medication passes into breast milk and may have undesirable effects on a nursing infant such as unusual sleepiness difficulty feeding or trouble breathing. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.