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Esgic-Plus Important Safety Information

Monday, March 16th, 2009

* Esgic-Plus may cause drowsiness. This effect may be worse if you take it with alcohol or certain medicines. Use Esgic-Plus with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
* Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Esgic-Plus; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
* Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
* Pain medications work best if they are used as the first signs of pain (or migraine) occur. If you wait until the pain has significantly worsened, the pain medicine may not work as well.
* Esgic-Plus has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.
* Esgic-Plus may harm your liver. Your risk may be greater if you drink alcohol while you are using Esgic-Plus . Talk to your doctor before you take Esgic-Plus or other pain relievers/fever reducers if you drink more than 3 drinks with alcohol per day.
* Tell your doctor or dentist that you take Esgic-Plus before you receive any medical or dental care, emergency care, or surgery.
* Hormonal birth control (eg, birth control pills) may not work as well while you are using Esgic-Plus . To prevent pregnancy, use an extra form of birth control (eg, condoms).
* Lab tests, including liver and kidney function, may be performed while you use Esgic-Plus . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
* Use Esgic-Plus with caution in the ELDERLY; they may be more sensitive to its effects.
* Esgic-Plus should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
* PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Esgic-Plus while you are pregnant. Esgic-Plus is found in breast milk. Do not breast-feed while taking Esgic-Plus .

When used for long periods of time or at high doses, Esgic-Plus may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Esgic-Plus stops working well. Do not take more than prescribed.

Some people who use Esgic-Plus for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Esgic-Plus suddenly, you may have WITHDRAWAL symptoms. These may include anxiety, muscle twitching, trembling hands and fingers, weakness, dizziness, hallucinations, nausea, vomiting, sleeplessness, lightheadedness, or seizures.

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Before Using Esgic-Plus

Saturday, March 14th, 2009

Some medical conditions may interact with Esgic-Plus . 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 liver problems, severe kidney problems, severe heart disease, a lung or respiratory tract disease, or difficulty sleeping
* if you have a history of substance abuse or dependence, anxiety, depression, or suicidal thoughts or behaviors

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

* Anticoagulants (eg, warfarin) or isoniazid because the risk of side effects, including bleeding and liver problems, may be increased
* Benzodiazepines (eg, chlordiazepoxide), monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), narcotic analgesics (eg, morphine), sleeping medicines (eg, temazepam), or sodium oxybate (GHB) because they may increase the risk of Esgic-Plus ‘s side effects
* Beta-blockers (eg, atenolol), clozapine, corticosteroids (eg, prednisone), doxycycline, estrogens (eg, estradiol, oral contraceptives), metronidazole, quinidine, quinolone antibiotics (eg, ciprofloxacin), or theophylline, because their effectiveness may be decreased by Esgic-Plus

This may not be a complete list of all interactions that may occur. Ask your health care provider if Esgic-Plus 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.

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