Tolmetin Oral Capsules

What is this medicine?

TOLMETIN (TOLE met in) is a non-steroidal anti-inflammatory drug, also known as an NSAID. It treats pain, inflammation, and swelling.

How should I use this medicine?

Take this drug by mouth. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew this drug. Swallow the capsules whole. Take it on an empty stomach, at least 30 minutes before and 2 hours after food. If it upsets your stomach, take it with a calcium, magnesium, or aluminum hydroxide antacid. Keep taking it unless your health care provider tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your health care provider about the use of this drug in children. While it may be prescribed for children as young as 2 for selected conditions, precautions do apply.

Patients over 65 years of age may have a stronger reaction and need a smaller dose.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)

• bleeding (bloody or black, tarry stools; red or dark brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eyes, gums, or nose)

• blood clot (chest pain; shortness of breath; pain, swelling, or warmth in the leg)

• changes in vision

• heart attack (trouble breathing; pain or tightness in the chest, neck, back or arms; unusually weak or tired)

• heart failure (trouble breathing; fast, irregular heartbeat; sudden weight gain; swelling of the ankles, feet, hands; unusually weak or tired)

• high potassium levels (chest pain; fast, irregular heartbeat; muscle weakness)

• increase in blood pressure

• kidney injury (trouble passing urine or change in the amount of urine)

• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; unusually weak or tired, yellowing of the eyes or skin)

• low red blood cell counts (trouble breathing; feeling faint; lightheaded, falls; unusually weak or tired)

• redness, blistering, peeling, or loosening of the skin, including inside the mouth

• stroke (changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination)

• unusual swelling

• wheezing (trouble breathing with loud or whistling sounds)

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• decreased hearing, ringing of the ears

• diarrhea

• dizziness

• headache

• heartburn (burning feeling in chest, often after eating or when lying down)

• nausea

• passing gas

• stomach pain

• vomiting

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• cidofovir

• methotrexate

This medicine may also interact with the following medications:

• alcohol

• aspirin and aspirin-like drugs

• diuretics

• lithium

• medicines for high blood pressure

• other NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen

• pemetrexed

• sodium bicarbonate-containing antacid

• steroid medicines like prednisone or cortisone

• warfarin

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Throw away any unused drug after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bleeding disorder

• coronary artery bypass graft (CABG)

• dehydration

• heart attack

• heart disease

• heart failure

• high blood pressure

• if you often drink alcohol

• kidney disease

• liver disease

• low red blood cell counts

• lung or breathing disease (asthma)

• receiving steroids like dexamethasone or prednisone

• smoke cigarettes

• stomach bleeding

• stomach ulcers, other stomach or intestine problems

• an unusual or allergic reaction to tolmetin, other NSAIDs, other drugs, foods, dyes or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

Do not take other drugs that contain aspirin, ibuprofen, or naproxen with this drug. Side effects such as stomach upset, nausea, or ulcers may be more likely to occur. Many non-prescription drugs contain aspirin, ibuprofen, or naproxen. Always read labels carefully.

This drug does not prevent a heart attack or stroke. This drug may increase the chance of a heart attack or stroke. The chance may increase the longer you use this drug or if you have heart disease. If you take aspirin to prevent a heart attack or stroke, talk to your health care provider about using this drug.

This drug may cause serious skin reactions. They can happen weeks to months after starting the drug. Contact your health care provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

This drug can cause serious ulcers and bleeding in the stomach. It can happen with no warning. Smoking, drinking alcohol, older age, and poor health can also increase risks. Call your health care provider right away if you have stomach pain or blood in your vomit or stool.

Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this drug.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug affects you. Do not stand up or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

Alcohol may interfere with the effect of this drug. Avoid alcoholic drinks.