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|Lagesic Controlled-Release Tablets

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Lagesic Controlled-Release Tablets

Generic Name: Acetaminophen/Phenyltoloxamine Controlled-Release Tablets (ah-seet-ah-MIN-oh-fen/fen-ill-tole-OX-a-meen)
Brand Name: Examples include Lagesic and Myophen

Lagesic Controlled-Release Tablets is used for:

Treating mild to moderate aches and pains associated with headache, muscle and joint soreness, backache, menstrual cramps, colds and flu, sinusitis, toothache, and minor pain from arthritis, and to reduce fever. It may also be used for other conditions as determined by your doctor.

Lagesic Controlled-Release Tablets is an analgesic, antihistamine, and antipyretic combination. It works by blocking substances in the body that cause fever, pain, and inflammation. It also blocks histamine, which causes sneezing and itchy, watery eyes.

Do NOT use Lagesic Controlled-Release Tablets if:

you are allergic to any ingredient in Lagesic Controlled-Release Tablets
you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Lagesic Controlled-Release Tablets:

Some medical conditions may interact with Lagesic Controlled-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have bleeding problems, blood vessel problems in the brain, a blockage of the stomach or bowel, a blockage of the bladder, or difficulty urinating
if you have lung problems (eg, asthma, emphysema, chronic obstructive pulmonary disease [COPD]), an enlarged prostate, glaucoma, kidney problems, or liver problems

Some MEDICINES MAY INTERACT with Lagesic Controlled-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Isoniazid, monoamine oxidase (MAO) inhibitors (eg, phenelzine), or sodium oxybate (GHB) because the risk of side effects may be increased
Anticoagulants (eg, warfarin) because the risk of side effects, including the risk of bruising or bleeding, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lagesic Controlled-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Lagesic Controlled-Release Tablets:

Use Lagesic Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Lagesic Controlled-Release Tablets may be taken with or without food.
Swallow Lagesic Controlled-Release Tablets whole. Do not break, crush, or chew before swallowing.
If you miss a dose of Lagesic Controlled-Release Tablets and you are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Lagesic Controlled-Release Tablets.

Important safety information:

Lagesic Controlled-Release Tablets may cause drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Lagesic Controlled-Release Tablets. Using Lagesic Controlled-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
Lagesic Controlled-Release Tablets contains acetaminophen. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen. If it does or if you are uncertain, contact your doctor or pharmacist.
Avoid taking medicines that cause drowsiness (eg, sedatives, tranquilizers) while taking Lagesic Controlled-Release Tablets. Lagesic Controlled-Release Tablets will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
Do not exceed the recommended dosage or take Lagesic Controlled-Release Tablets for longer than prescribed without checking with your doctor.
If you consume 3 or more alcohol-containing drinks every day, ask your doctor whether you should take Lagesic Controlled-Release Tablets or other pain relievers/fever reducers. Acetaminophen may cause liver damage. Alcohol use combined with Lagesic Controlled-Release Tablets may increase your risk for liver damage.
If you are taking Lagesic Controlled-Release Tablets for pain or fever and your symptoms do not improve within 10 days or if they become worse, check with your doctor.
Before you have any medical or dental treatments or surgery, tell the doctor or dentist that you are taking Lagesic Controlled-Release Tablets.
Caution is advised when using Lagesic Controlled-Release Tablets in CHILDREN because they may be more sensitive to its effects.
PREGNANCY and BREAST-FEEDING: It is unknown if Lagesic Controlled-Release Tablets can cause harm to the fetus. If you become pregnant, discuss with your doctor the benefits and risks of using Lagesic Controlled-Release Tablets during pregnancy. Lagesic Controlled-Release Tablets is excreted in breast milk. Do not breast-feed while taking Lagesic Controlled-Release Tablets.

Possible side effects of Lagesic Controlled-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Drowsiness; dry mouth, nose, or throat; heartburn; nausea; thickening of mucus in the nose and throat; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; dark urine or pale stools; decreased urination; severe stomach pain; unusual bruising or bleeding; unusual tiredness; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include abnormal behavior; dark urine; excessive sweating; extreme tiredness; fast or deep breathing; loss of consciousness; ringing in the ears; stomach pain; vomiting.

Proper storage of Lagesic Controlled-Release Tablets:

Store Lagesic Controlled-Release Tablets at room temperature, 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lagesic Controlled-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Lagesic Controlled-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
Lagesic Controlled-Release Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Lagesic Controlled-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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