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|Melatonin Controlled-Release Tablets

Melatonin Controlled-Release Tablets

Melatonin Controlled-Release Tablets is used for:

Sleep disorders such as difficulty sleeping (insomnia) and jet lag. Check with your pharmacist for more details regarding the particular brand you use.

Melatonin Controlled-Release Tablets is a hormone product. It works by regulating the body"s sleep cycles.

Do NOT use Melatonin Controlled-Release Tablets if:

• you are allergic to any ingredient in Melatonin Controlled-Release Tablets
• you are taking immunosuppressants (eg, cyclosporine), corticosteroids (eg, prednisone), or nifedipine
• if you have a history of immune system disorders, liver disease, or stroke
• you are pregnant or breast-feeding

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

Before using Melatonin Controlled-Release Tablets:

Some medical conditions may interact with Melatonin 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 planning to become pregnant
• 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 kidney problems, depression, or a history of seizures

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

• Nifedipine because the effectiveness may be decreased by Melatonin Controlled-Release Tablets

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

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

• Dosing depends on the use and the source of the product.
• Use as directed on the package, unless instructed otherwise by your doctor.
• Swallow whole. Do not break, crush, or chew before swallowing.
• Melatonin is usually taken 2 hours before bedtime for insomnia. Results may be seen within 30 minutes, but it may take 1 to 3 days for the effects to be noticed.

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

Important safety information:

• Melatonin 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 this product. Using this product alone, with certain other medicines or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking this product. This product will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• This product has not been approved by the Food and Drug Administration (FDA) as safe and effective for any medical condition. The long-term safety of dietary supplements is not known. Before using any alternative medicine, talk with your doctor or pharmacist.
• PREGNANCY and BREAST-FEEDING: Do not use this product if you plan to become pregnant. It may have a contraceptive effect. Melatonin is not recommended for use during pregnancy. Consult your doctor before using this product. Because of the potential risk to the infant, breast-feeding while using this product is not recommended. Consult your doctor before breast-feeding.

Possible side effects of Melatonin 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:

Change in sleep pattern; headache.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; depression; fast heartbeat; hypothermia (fast breathing, shivering).

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.

Store at room temperature away from heat, moisture, and light unless otherwise directed on the package label. Do not store in the bathroom. Most dietary supplements are not in childproof containers. Keep Melatonin Controlled-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Melatonin Controlled-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Melatonin 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 Melatonin 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.