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|Talacen

Talacen

Talacen is used for:

Relieving mild to moderate pain.

Talacen is a narcotic and analgesic combination. It works in the brain to reduce pain.

Do NOT use Talacen if:

• you are allergic to any ingredient in Talacen
• you have a dependence on opiates (eg, morphine) or you are taking sodium oxybate (GHB)
• you have severe bowel problems (eg, pseudomembranous colitis)

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

Before using Talacen :

Some medical conditions may interact with Talacen . 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
• you have a history of stomach or bowel problems, asthma or breathing problems, growths in the brain, a recent head injury, liver or kidney problems, heart problems or a recent heart attack, high blood pressure, the blood disease porphyria, thyroid problems, an enlarged prostate, seizures, mental or mood problems, or suicidal thoughts or behaviors
• you have a history of drug or alcohol abuse or dependence

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

• Sodium oxybate (GHB) because the side effects of Talacen may be increased
• Anticoagulants (eg, warfarin), cimetidine, or isoniazid because the risk of bleeding or liver problems may be increased
• Naltrexone because the effectiveness of Talacen may be decreased
• Sibutramine because side effects may be increased by Talacen
• Methadone because effectiveness may be decreased by Talacen

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

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

• Talacen may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• If you miss a dose of Talacen , 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 Talacen .

Important safety information:

• Talacen may cause drowsiness, dizziness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Talacen . Using Talacen alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Talacen . Talacen will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Talacen 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.
• Talacen may contain sulfites, which can cause allergic reactions in certain individuals (eg, asthma patients). If you have previously had allergic reactions to sulfites, contact your doctor or pharmacist to determine if the medicine you are taking contains sulfites.
• Talacen may cause over-stimulation of your nervous system and increase your risk of seizures. Certain conditions (eg, recent head trauma, serious liver disease), the use of certain medicines (eg, stimulants, medicines for depression or mental health, theophylline, steroids taken by mouth or injected, insulin, diabetes medicines, sedatives), or excessive alcohol use can increase your risk of seizures while taking Talacen . Contact your doctor right away if you have any of the following symptoms while taking Talacen : trembling, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, nightmares, difficulty sleeping, depression, or suicidal thoughts or behaviors.
• Use Talacen with caution in the ELDERLY because they may be more sensitive to its effects.
• Use Talacen with extreme caution in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Talacen , discuss with your doctor the benefits and risks of using Talacen during pregnancy. It is unknown if Talacen is excreted in breast milk. If you are or will be breast-feeding while you are using Talacen , check with your doctor or pharmacist to discuss the risks to your baby.

When used for long periods of time or at high doses, some people develop a need to continue taking Talacen . This is known as DEPENDENCE or addiction.

If you suddenly stop taking Talacen , you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Talacen :

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; exaggerated sense of well-being; headache; lightheadedness; nausea; sweating; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistered, red, or swollen skin; confusion; disorientation; fast heartbeat; fainting; hallucinations; mental or mood changes; seizures; severe dizziness; severe stomach pain; tremor; trouble sleeping; trouble urinating; vision problems or blurred vision; weakness.

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 anxiety; confusion; dark urine; dizziness; excessive sweating; extreme fatigue; fast heartbeat; hallucinations; loss of consciousness; nausea; seizures; slow and shallow breathing; stomach pain; unusual bruising or bleeding; unusual drowsiness or dizziness; vomiting; yellowing of the eyes or skin.

Store Talacen at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Talacen out of the reach of children and away from pets.

General information:

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