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Methadose Dispersible Tablets is used for:

Temporarily treating a narcotic addiction as part of a treatment program. It may also be used for other conditions as determined by your doctor.

Methadose Dispersible Tablets is a synthetic narcotic analgesic with multiple actions similar to those of morphine, including pain relief. It also provides sedation and temporary maintenance treatment of narcotic addiction.

Do NOT use Methadose Dispersible Tablets if:

• you are allergic to any ingredient in Methadose Dispersible Tablets
• you have diarrhea due to poisoning, pseudomembranous colitis, or hypercapnia (abnormally increased carbon dioxide tension in your arteries), or are taking sodium oxybate (GHB)
• you drink alcohol

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

Before using Methadose Dispersible Tablets:

Some medical conditions may interact with Methadose Dispersible 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 asthma, prostate problems, a brain tumor, heart problems, liver disease, breathing problems, seizures, bowel problems, urination problems, a lesion or increased pressure on the brain, low blood levels of potassium or magnesium, underactive thyroid, anxiety, low blood volume, kidney problems, Addison disease, or suicidal thoughts
• if you have ever abused drugs, have head trauma, or have had GI tract surgery

Some MEDICINES MAY INTERACT with Methadose Dispersible Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following.

• Efavirenz, HIV protease inhibitors (eg, ritonavir), naltrexone, narcotic antagonists (eg, naloxone), nevirapine, pentazocine, risperidone, or St. John's wort because they may decrease Methadose Dispersible Tablets's effectiveness
• Barbiturate anesthetics (eg, thiopental), cimetidine, ethanol, fluconazole, fluvoxamine, ketorolac, quinolones (eg, ciprofloxacin), or sodium oxybate (GHB) because side effects such as sedation, confusion and slowed breathing may occur
• Barbiturate anesthetics (eg, thiopental), desipramine, sodium oxybate (GHB), or zidovudine because their actions and the risk of their side effects may be increased by Methadose Dispersible Tablets
• Mexiletine or nucleoside reverse transcriptase inhibitors (eg, lamivudine) because their effectiveness may be decreased by Methadose Dispersible Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Methadose Dispersible 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 Methadose Dispersible Tablets:

Use Methadose Dispersible Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Methadose Dispersible Tablets by mouth with or without food.
• Methadose Dispersible Tablets must be administered under close medical supervision.
• Take Methadose Dispersible Tablets on a regular schedule to get the most benefit from it. It is more effective in preventing pain than in treating pain after it occurs.
• Methadose Dispersible Tablets is for oral use only and must not be injected.
• If you miss a dose of Methadose Dispersible 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 Methadose Dispersible Tablets.

Important safety information:

• Methadose Dispersible Tablets may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Methadose Dispersible Tablets 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 Methadose Dispersible Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Methadose Dispersible Tablets may cause constipation. Constipation may be avoided by using a stool softener or fiber laxative.
• Tell your doctor or dentist that you take Methadose Dispersible Tablets before you receive any medical or dental care, emergency care, or surgery.
• Lab tests, including liver function, kidney function, and complete blood count, may be performed while you use Methadose Dispersible Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Methadose Dispersible Tablets with caution in the ELDERLY; they may be more sensitive to its effects.
• This medicine should not be used 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 Methadose Dispersible Tablets while you are pregnant. Methadose Dispersible Tablets is found in breast milk. If you are or will be breast-feeding while you use Methadose Dispersible Tablets, check with your doctor. Discuss any possible risks to your baby.

Some people who use Methadose Dispersible Tablets 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 Methadose Dispersible Tablets suddenly, you may have WITHDRAWAL symptoms. These may include convulsions, tremor, stomach and muscle cramps, vomiting, and sweating. Do not stop therapy suddenly or change the dosage without asking your doctor. Discuss overuse with your doctor or pharmacist.

Possible side effects of Methadose Dispersible 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:

Constipation; dizziness; drowsiness; headache; lightheadedness; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); excessive drowsiness; fainting; itching; pounding in the chest; seizures; shortness of breath; slow heartbeat; sweating.

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 cold and clammy skin; deep sleep; difficult or slow breathing, especially when lying down; dizziness; drowsiness; lightheadedness; loss of consciousness; low body temperature; pinpoint pupils; shock; shortness of breath; slow heartbeat.

Store Methadose Dispersible Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Methadose Dispersible Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Methadose Dispersible Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Methadose Dispersible 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 Methadose Dispersible 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.