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|Tranxene-SD Sustained-Release Tablets

Tranxene-SD Sustained-Release Tablets

Tranxene-SD Sustained-Release Tablets is used for:

Treating nervousness or anxiety, seizures, and alcohol withdrawal. It may also be used for other conditions as determined by your doctor.

Tranxene-SD Sustained-Release Tablets is a benzodiazepine. It works by slowing down the movement of chemicals in the brain. This results in a reduction in nervous tension (anxiety) and causes little drowsiness.

Do NOT use Tranxene-SD Sustained-Release Tablets if:

• you are allergic to any ingredient in Tranxene-SD Sustained-Release Tablets
• you are taking sodium oxybate (GHB)
• you have narrow-angle glaucoma or severe liver disease

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

Before using Tranxene-SD Sustained-Release Tablets:

Some medical conditions may interact with Tranxene-SD Sustained-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 medicines, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have glaucoma, liver problems, seizures, muscle problems, a blood disorder, lung problems, depression, thoughts of suicide, or psychosis
• if you have a history of alcohol or substance abuse or dependence

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

• Hydantoins (eg, phenytoin) or rifampin because they may decrease Tranxene-SD Sustained-Release Tablets"s effectiveness
• Disulfiram, HIV protease inhibitors (eg, ritonavir), nefazodone, omeprazole, sodium oxybate (GHB), or valproic acid because side effects, such as confusion and increased drowsiness, may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tranxene-SD Sustained-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 Tranxene-SD Sustained-Release Tablets:

Use Tranxene-SD Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Tranxene-SD Sustained-Release Tablets by mouth with or without food.
• If you also take clozapine, do not take it within 2 hours before or after taking Tranxene-SD Sustained-Release Tablets. These doses must be separated. Check with your doctor if you have questions.
• Do not suddenly stop taking Tranxene-SD Sustained-Release Tablets. You may have an increased risk of serious side effects.
• If you miss a dose of Tranxene-SD Sustained-Release Tablets and are using it regularly, take it as soon as possible. If you do not remember until later, 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 Tranxene-SD Sustained-Release Tablets.

Important safety information:

• Tranxene-SD Sustained-Release Tablets may cause blurred vision, dizziness, drowsiness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Tranxene-SD Sustained-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol while you are using Tranxene-SD Sustained-Release Tablets.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Tranxene-SD Sustained-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• The risk of Tranxene-SD Sustained-Release Tablets becoming habit-forming may be greater if you take Tranxene-SD Sustained-Release Tablets in high doses or for a long time. Do NOT take more than the recommended dose or take for longer than prescribed without checking with your doctor.
• Lab tests, including liver and kidney tests, may be performed while you use Tranxene-SD Sustained-Release 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 Tranxene-SD Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.
• Tranxene-SD Sustained-Release Tablets should be used with extreme caution in CHILDREN younger than 9 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Tranxene-SD Sustained-Release Tablets has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using this medicine while you are pregnant. Tranxene-SD Sustained-Release Tablets is found in breast milk. Do not breast-feed while taking Tranxene-SD Sustained-Release Tablets.

When used for long periods of time or at high doses, Tranxene-SD Sustained-Release Tablets 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 Tranxene-SD Sustained-Release Tablets stops working well. Do not take more than prescribed. Some people who use Tranxene-SD Sustained-Release 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. Talk with your doctor if Tranxene-SD Sustained-Release Tablets stops working well. Do not take more than prescribed. If you suddenly stop taking Tranxene-SD Sustained-Release Tablets, you may experience WITHDRAWAL symptoms.

Possible side effects of Tranxene-SD Sustained-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:

Blurred vision; clumsiness; confusion; dizziness; drowsiness; dry mouth; headache; lightheadedness; nervousness; stomach upset; unsteadiness; unusual weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

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 clumsiness; confusion; deep sleep; drowsiness; impaired coordination; loss of consciousness; slow reflexes.

Store Tranxene-SD Sustained-Release Tablets between 59 and 77 degrees F (15 and 25 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tranxene-SD Sustained-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Tranxene-SD Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Tranxene-SD Sustained-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 summary only. It does not contain all information about Tranxene-SD Sustained-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.