Tolectin DS

Tolectin DS is a nonsteroidal anti-inflammatory drug (NSAID).

Tolectin DS is used to relieve pain or swelling from osteoarthritis or rheumatoid arthritis. This medicine is also used to treat juvenile rheumatoid arthritis in children who are at least 2 years old.

Tolectin DS may also be used for reasons not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time. Use the lowest effective dose for your condition.

It may take up to 1 week before you notice improvement in your symptoms. Continue using the medication as directed and inform your doctor if your symptoms do not improve.

If you take Tolectin DS for a long time, you may need to have medical tests done frequently.

This medicine can affect the results of some medical tests. Inform any doctor who treats you that you are using Tolectin DS.

Store at room temperature, away from moisture, heat, and light.

Tolectin DS can raise your chances of having a deadly heart attack or stroke. Do not use Tolectin DS right before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Tolectin DS may also lead to serious issues with your stomach or intestines, such as bleeding, ulcers, or tears (perforation), which can be life-threatening. These issues can occur at any time while using this medicine and may happen without any warning. Older adults are at a higher risk. Stop taking this medicine and contact your healthcare provider immediately if you vomit blood or have bloody, black, or tarry stools.

Tolectin DS can raise your chance of having a fatal heart attack or stroke. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG). This medicine may also cause stomach or intestinal bleeding, which can be deadly. This can happen without warning, especially in older adults.

You should not use Tolectin DS if you are allergic to it, or if you have ever had an asthma attack, hives, or a severe allergic reaction after taking aspirin or an NSAID.

Tell your doctor if you have or have ever had:

• heart disease, high blood pressure, high cholesterol, smoking, diabetes;
• a heart attack, stroke, or blood clot;
• stomach ulcers or bleeding;
• asthma;
• fluid retention; or
• liver or kidney disease.

Tell your doctor if you are pregnant or plan to become pregnant. Tolectin DS may harm an unborn baby if used at 20 weeks or later in pregnancy. If you are between 20 to 30 weeks of pregnancy, only use this medicine if your doctor has told you to. Avoid using this medicine at about 30 weeks of pregnancy or later.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop taking Tolectin DS and call your doctor at once if you have:

• changes in your vision;
• any skin rash, no matter how mild;
• severe headache, pounding in your neck or ears;
• heart problems--swelling, rapid weight gain, feeling short of breath;
• stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• a hole (perforation) in your digestive tract--fever, severe stomach pain, change in bowel habits;
• liver problems--loss of appetite, nausea, vomiting, indigestion, flu-like symptoms, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney problems--urinating less, feeling tired or short of breath; or
• low red blood cells (anemia)--pale skin, tiredness, feeling light-headed, cold hands and feet.

Older adults may be more likely to have serious stomach problems while taking medicine that contains an NSAID.

Common side effects of Tolectin DS may include:

• stomach pain, nausea, vomiting;
• diarrhea, constipation, gas;
• heartburn;
• headache, dizziness;
• swelling in any part of your body;
• high blood pressure;
• weakness; or
• changes in weight.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take the medicine as soon as possible, but skip the missed dose if it is close to the time for your next dose. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Drinking alcohol may increase your risk of stomach or intestinal bleeding.

• Avoid taking aspirin unless your doctor tells you to.

• Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to Tolectin DS (such as aspirin, ibuprofen, ketoprofen, or naproxen).

Ask your doctor before taking Tolectin DS if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all your other medicines, especially:

• steroids; or
• a blood thinner--warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may affect Tolectin DS, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.