Tolmetin

People who take nonsteroidal anti-inflammatory medications (NSAIDs) (other than aspirin) such as tolmetin may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time. Do not take an NSAID such as tolmetin if you have recently had a heart attack, unless directed to do so by your doctor. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, or a stroke, if you smoke,and if you have or have ever had high cholesterol, high blood pressure, or diabetes. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of the body, or slurred speech.

If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not take tolmetin right before or right after the surgery.

NSAIDs such as tolmetin may cause ulcers, bleeding, or holes in the stomach or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time, are older in age, have poor health, or drink large amounts of alcohol while taking tolmetin. Tell your doctor if you take any of the following medications: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); aspirin; other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); or serotonin norepinephrine reuptake inhibitors (SNRIs) such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), and venlafaxine (Effexor XR). Also tell your doctor if you have or have ever had ulcers, bleeding in your stomach or intestines, or other bleeding disorders. If you experience any of the following symptoms, stop taking tolmetin and call your doctor: stomach pain, heartburn, vomiting a substance that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools.

Keep all appointments with your doctor and the laboratory. Your doctor will monitor your symptoms carefully and will probably order certain tests to check your body's response to tolmetin. Be sure to tell your doctor how you are feeling so that your doctor can prescribe the right amount of medication to treat your condition with the lowest risk of serious side effects.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with tolmetin and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

Tolmetin is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). Tolmetin is also used to relieve pain, tenderness, swelling, and stiffness caused by juvenile rheumatoid arthritis in children 2 years of age and older. Tolmetin is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

Tolmetin comes as a tablet and a capsule to take by mouth. Adults usually take tolmetin three times a day on an empty stomach, and children older than 2 years of age usually take tolmetin three or four times a day on an empty stomach. Take tolmetin at around the same times every day. It is best to take the first dose of the day just after waking in the morning and to take the last dose of the day at bedtime. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tolmetin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Tell your doctor if tolmetin upsets your stomach. Your doctor may tell you to take tolmetin with an antacid to prevent stomach upset. Your doctor will tell you which antacids are safe to take with tolmetin.

Tolmetin may help to control your symptoms but will not cure your condition. Your symptoms may improve within one week after you start to take tolmetin, but it may take several weeks or longer for you to feel the full benefit of the medication. Talk to your doctor about how tolmetin is working for you.

Tolmetin is also used to treat ankylosing spondylitis (arthritis that mainly affects the spine). It is also sometimes used to treat certain conditions that cause muscle strain or swelling in the shoulder or elbow and injuries such as recent sprains.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking tolmetin,

• tell your doctor and pharmacist if you are allergic to tolmetin, aspirin, or other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn), any other medications, or any of the inactive ingredients in tolmetin tablets or capsules. Ask your pharmacist for a list of the inactive ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking tolmetin. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• the following nonprescription products may interact with tolmetin: aspirin and other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve). Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking tolmetin. Do not start any of these medications while taking tolmetin without discussing with your healthcare provider.
• tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose); heart failure; swelling of the hands, feet, ankles, or lower legs; or liver or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant; or are breast-feeding. Tolmetin may harm the fetus and cause problems with delivery if it is taken around 20 weeks or later during pregnancy. Do not take tolmetin around or after 20 weeks of pregnancy, unless you are told to do so by your doctor. If you become pregnant while taking tolmetin, call your doctor.
• talk to your doctor about the risks and benefits of taking tolmetin if you are 75 years of age or older. Do not take this medication for a longer period of time or at a higher dose than recommended by your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking tolmetin.
• you should know that this drug may make you dizzy. Do not drive a car or operate machinery until you know how this drug affects you.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Tolmetin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• constipation
• gas
• weight gain or loss
• headache
• depression
• skin irritation
• ringing in the ears

Some side effects can be serious. If you experience any of the following symptoms, or those mentioned in the IMPORTANT WARNING section, call your doctor immediately. Do not take any more tolmetin until you speak to your doctor:

• changes in vision
• unexplained weight gain
• shortness of breath or difficulty breathing
• swelling of the stomach, feet, ankles, or lower legs
• fever
• blisters
• rash
• itching
• hives
• swelling of the eyes, face, lips, tongue, throat, arms, or hands
• difficulty swallowing
• hoarseness
• yellowing of the skin or eyes
• excessive tiredness
• unusual bleeding or bruising
• lack of energy
• upset stomach
• loss of appetite
• pain in the upper right part of the stomach
• flu-like symptoms
• pale skin
• fast heartbeat
• cloudy, discolored, or bloody urine
• back pain
• difficult or painful urination

Tolmetin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking tolmetin.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Tolectin^®¶
• Tolectin^® DS^¶